Stride and UNITY Fitness Announce Market-First Partnership, Redefining Personal Health Optimisation in Canada

Stride and UNITY Fitness Announce Market-First Partnership, Redefining Personal Health Optimisation in Canada




Stride and UNITY Fitness Announce Market-First Partnership, Redefining Personal Health Optimisation in Canada

Industry-leading debut of Canada’s most advanced health and wellness model that combines advanced health diagnostics with a premium fitness and recovery membership experience.

TORONTO–(BUSINESS WIRE)–In a bold move set to reshape Canada’s health and wellness landscape, Stride — the digital-first leader in health optimisation — has partnered with UNITY Fitness Harbourfront, Toronto’s destination for holistic fitness and recovery, to launch the first integrated health enhancement membership of its kind in the Canadian market.


Launching May 29th, the new UNITY360 memberships will offer an unprecedented combination of advanced health diagnostics, personalised wellness services, and exclusive lifestyle perks — marking a significant step toward democratising elite wellness experiences.

A Preventative, Data-Driven Health Revolution

At the heart of this partnership is a shared mission: to shift the narrative from reactive care to proactive, preventative health. Powered by Stride’s comprehensive health optimisation ecosystem, UNITY360 members will now have access to a suite of best-in-class tests — including DNA, blood, gut biome, and methylation panels — alongside VO2 max and musculoskeletal assessments.

“This collaboration is about making optimal health accessible and actionable,” says Josh Allan, Director of Fitness and Athletics at UNITY. “The UNITY 360 membership is designed to prioritise health span over life span, providing our community with an all-encompassing and actionable approach to wellness. By housing fitness, recovery, and diagnostic health services under one roof, we will be able to truly personalise our support to members at all points of their wellbeing journey.”

Partnership Sets a New Standard for Health Optimisation in the Canadian Wellness Industry

This partnership marks the first time a Canadian wellness brand has integrated data-led health optimisation testing into a fitness membership offering — a model already gaining traction in global wellness hubs like Los Angeles and New York.

Andrew Steele, Stride’s CEO, adds, “At Stride, we believe in setting health standards, not just health goals. Through this partnership with UNITY, we’re bringing scientifically-backed, data-informed health insights directly to where people move, train, and recover. It’s about bringing optimal health to people where they are and giving them the tools to thrive.”

Providing An Elevated All-In-One Health Optimisation Membership

The enhanced UNITY 360 membership experience includes:

  • StrideDNA: The ultimate health optimisation bundle testing of 9,000 genetic locations across 110 key genes, including MTHFR & COMT for enhanced resilience and longevity. Key reports include:

    • Methylation pathway profiles (e.g. folate cycle, methionine cycle)
    • Nutrient needs & sensitivities (e.g. carbohydrate response, vitamin needs, lactose intolerance predisposition)
    • Fitness markers (e.g. power/endurance balance, recovery efficiency, injury risk)
    • Cognitive insights (e.g. sleep quality, stress tolerance, chronotype)
    • Skin health (e.g. ageing predisposition, inflammation tendency, glycation sensitivity).
  • StrideBiome: Testing microbiome diversity, bacterial balance, digestive efficiency, and neurotransmitter pathways. Advanced 16S rRNA sequencing of 70+ bacterial species across 31 genera. Key reports include:

    • Gut ecosystem diversity and balance assessment
    • Neurotransmitter production influences (e.g. serotonin, dopamine, GABA)
    • Digestive efficiency markers (e.g. nutrient absorption, barrier function)
    • Metabolic health indicators linked to weight management and energy regulation.
  • VO2 max and Knee KG assessments.
  • Quarterly Myodetox sessions at preferred rates.
  • Priority booking privileges and personalised recovery plans.
  • Exclusive access to workshops, events, and retail collaborations.
  • Early access to StrideBloods (launching in Q2 of 2025): Testing 70+ Biomarkers across cardiovascular, hormonal, vital functions and longevity health markers.

With both brands approaching their first anniversary and experiencing rapid growth, the timing underscores a significant moment in Toronto’s wellness evolution.

“Our community of biohackers, athletes, and everyday wellness enthusiasts is craving deeper, more meaningful ways to optimise their health,” says Adam Reynolds, Director of Strategy and Operations at UNITY Fitness. “UNITY 360 is designed to support anyone passionate about upgrading their wellness, no matter where they are on their fitness journey.”

Launch Details

The program officially launches June 1st, with UNITY+ memberships available from June. Early member interest signals strong demand, with UNITY already boasting over 4,200 active members, including 1,280 corporate memberships.

Pricing Details

Prices start at $280+tax p/m (CAD) with a 12-month minimum commitment.

About Stride

Stride is a digital-first health optimisation company from the UK, revolutionising how people understand and optimise their health, fitness and longevity. On a mission to make tracking internal biomarkers as common as tracking wearable data, Stride has created the world’s most comprehensive health testing membership. Stride bridges the gap between proactive wellness and reactive healthcare by analysing over 250 biomarkers across DNA, microbiome, and bloods. Stride empowers individuals to unlock their health potential through combining these advanced tests with personalised protocols, expert support, tailored supplementation, and continuous optimisation. This integrated, data-driven approach reveals the complete picture of an individual’s internal biology, enabling truly personalised recommendations rather than generic health advice for measurable, long-term health optimisation.

For more information about Stride, please visit getstride.com

About UNITY Fitness

Located in the heart of Toronto’s Sugar Wharf district, UNITY Fitness Harbourfront is a 45,000 sq ft state-of-the-art wellness club designed to inspire and empower individuals on their fitness journeys. With premium equipment, boutique-style classes, and curated services, UNITY offers an inclusive environment where members can achieve their goals while fostering a sense of belonging. Amenities include a full-sized basketball court that doubles as two pickleball courts, a two-lane saltwater pool, an infrared hot yoga studio, and a cycling studio, catering to diverse needs and lifestyles. As a versatile neighbourhood hub, UNITY combines fitness spaces, lounge areas, and boutique studios, bringing people together to build community through movement.

For more information about UNITY, please visit joinunity.ca

Contacts

Stride / UNITY:

Natalie Elmitt

nataliee@jacktaylorpr.com

Rosie Davis

rosie@jacktaylorpr.com

Fluor-Built Pharmaceutical Facility in California is First Industrial Manufacturing Facility in Western United States to Achieve LEED v4 Platinum Certification

Fluor-Built Pharmaceutical Facility in California is First Industrial Manufacturing Facility in Western United States to Achieve LEED v4 Platinum Certification




Fluor-Built Pharmaceutical Facility in California is First Industrial Manufacturing Facility in Western United States to Achieve LEED v4 Platinum Certification

Facility also named 2025 ISPE Facility of the Year Winner for Social Impact – Unmet Medical Needs

IRVING, Texas–(BUSINESS WIRE)–#FluorBuildsABetterWorldFluor Corporation (NYSE: FLR) announced today that Bayer’s Cell Therapy Launch Facility in Berkeley, California, has been designated the first industrial manufacturing facility in the Western United States to achieve Leadership in Energy and Environmental Design (LEED) v4 Platinum Certification. The project was also named the 2025 Facility of the Year for Social Impact – Unmet Medical Needs by the International Society for Pharmaceutical Engineering (ISPE).




LEED v4 Platinum certification is the highest level of recognition for sustainable building practices and indicates that a building meets the highest standards for sustainability.

Fluor’s scope of work included the engineering, procurement, construction management, commissioning, qualification and validation for the 144,000-square-foot, state-of-the-art facility. It features 30,000 square feet of cleanroom space dedicated to advancing cell therapy production for neurological degenerative disorders, cardiovascular disease and other unmet medical needs.

Fluor and Bayer collaborated to deliver Bayer’s first fully electric pharmaceutical manufacturing plant, and we met an aggressive schedule to support client and patient needs,” said Richard Meserole, President of Fluor’s Advanced Technologies & Life Sciences business. “Fluor secured LEED v4 Platinum Certification and ISPE Facility of the Year designation through effective collaboration with our trade partners, lean construction methods, and dedication to quality.”

Sustainability benefits for the facility include 52.6% energy cost savings via LED, high-efficiency lighting, heat pump and rooftop solar installation. The facility boasts 100% process water reduction, 98% onsite management of rainfall high efficiency plumbing fixtures, 65% recycled content installation, high use of sustainable materials, land use maximization and various innovation credits.

This is the second new facility built by Fluor on Bayer’s Biotech campus in Berkeley. Previously, Fluor completed construction of Bayer’s state-of-the-art Single Use Technology biopharmaceutical manufacturing Cell Culture Technology Center in 2021.

About Fluor Corporation:

Fluor Corporation (NYSE: FLR) is building a better world by applying world-class expertise to solve its clients’ greatest challenges. Fluor’s nearly 27,000 employees provide professional and technical solutions that deliver safe, well-executed, capital-efficient projects to clients around the world. Fluor had revenue of $16.3 billion in 2024 and is ranked 265 among the Fortune 500 companies. With headquarters in Irving, Texas, Fluor has provided engineering, procurement and construction services for more than a century. For more information, please visit www.fluor.com or follow Fluor on Facebook, Instagram, LinkedIn, X and YouTube.

#atls

Contacts

Brett Turner

Media Relations

864.281.6976

Jason Landkamer

Investor Relations

469.398.7222

Zai Lab Receives U.S. FDA Fast Track Designation for ZL-1310, a DLL3-Targeted Antibody-Drug Conjugate, for Treatment of Extensive-Stage Small Cell Lung Cancer

Zai Lab Receives U.S. FDA Fast Track Designation for ZL-1310, a DLL3-Targeted Antibody-Drug Conjugate, for Treatment of Extensive-Stage Small Cell Lung Cancer




Zai Lab Receives U.S. FDA Fast Track Designation for ZL-1310, a DLL3-Targeted Antibody-Drug Conjugate, for Treatment of Extensive-Stage Small Cell Lung Cancer

– The Company is on track to initiate a pivotal study for ZL-1310 in small cell lung cancer (SCLC) in 2025


SHANGHAI & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ZL-1310, the Company’s potential first-in-class Delta-like ligand (DLL3) antibody-drug conjugate (ADC), for the treatment of extensive-stage small cell lung cancer (ES-SCLC). ZL-1310, which is being evaluated in an ongoing global Phase 1a/1b clinical trial (NCT06179069), previously received an Orphan Drug designation for SCLC from the FDA. The company will present updated data at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.

“The FDA’s decision to grant Fast Track designation to ZL-1310 highlights the significant need for expanded treatment options for patients with SCLC and represents an important step in our efforts to advance a novel therapeutic option as quickly as possible,” said Rafael G. Amado, M.D., President, Head of Global Research and Development, Zai Lab. “This designation reinforces the clinical progress we have achieved for ZL-1310 to-date, and we remain on track to initiate a pivotal study in small cell lung cancer later this year, positioning us for a potential accelerated approval in 2027.”

Fast Track designation facilitates the expedited development and review of new drugs to address an unmet medical need or treat serious or life-threatening diseases. Benefits of this designation include more frequent engagements with the FDA to discuss the drug’s clinical development plan and eligibility for Accelerated Approval and Priority Review if relevant criteria are met. More information on the Fast Track process is available here.

Zai Lab will hold an investor conference call and webcast to highlight updated ZL-1310 data at ASCO and outline the next steps in clinical development.

Details regarding upcoming ZL-1310 webcast and conference call are as follows:

Date/Time: Monday, June 2, 2025, at 7:00 a.m. CT / 8:00 a.m. ET / 8:00 p.m. HKT., please register at:

Webcast presentation (preferred): https://edge.media-server.com/mmc/p/jnqqzjod;
Dial-in: https://register-conf.media-server.com/register/BIc7326906f3764306accd7708d21d2ecb.

Presenter: Rafael G. Amado, M.D., President, Head of Global Research and Development, Zai Lab

About Small Cell Lung Cancer and ZL-1310

SCLC is one of the most aggressive and lethal solid tumors, accounting for approximately 5% of the approximately 2.5 million patients diagnosed with lung cancer worldwide each year. 1,2 Additionally, two-thirds of all SCLC patients are diagnosed at extensive stage. 3

DLL3 is an antigen overexpressed in many neuroendocrine tumors, such as SCLC, and is often associated with poor clinical outcomes. ZL-1310 comprises a humanized anti-DLL3 monoclonal antibody connected via a cleavable linker to a novel camptothecin derivative (a topoisomerase 1 inhibitor) as its payload. The compound was designed with a novel ADC technology platform called TMALIN®, which leverages the tumor microenvironment to overcome challenges associated with first-generation ADC therapies.

About Zai Lab

Zai Lab is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health worldwide.

For additional information about Zai Lab, please visit www.zailaboratory.com or follow us at www.X.com/ZaiLab_Global, www.twitter.com/ZaiLab_Global.

Zai Lab Forward-Looking Statements

This press release contains forward-looking statements relating to our future expectations, plans, and prospects, for Zai Lab, including, without limitation, statements relating to our prospects and plans for developing and commercializing next generation ADCs, including ZL-1310, the potential benefits of ZL-1310, and the potential treatment of SCLC and neuroendocrine tumors. These forward-looking statements may contain words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would,” and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact or guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products, (2) our ability to obtain funding for our operations and business initiatives, (3) the results of our clinical and pre-clinical development of our product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates, (5) risks related to doing business in China, and (6) other factors identified in our most recent annual and quarterly reports and in other reports we have filed with the U.S. Securities and Exchange Commission (SEC). We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Our SEC filings can be found on our website at www.zailaboratory.com and on the SEC’s website at www.sec.gov.

References:

1 J Thorac Oncol. 2023 Jan;18(1):31-46; Lung Cancer Foundation of America.

2 WHO Globocan 2022.

3 Sabari JK, et al. Nat Rev Clin Oncol. 2017;14:549-561.

Contacts

Investor Relations:
Christine Chiou / Lina Zhang

+1 (917) 886-6929 / +86 136 8257 6943

christine.chiou1@zailaboratory.com / lina.zhang@zailaboratory.com

Media:
Shaun Maccoun / Xiaoyu Chen

+1 (857) 270-8854 / +86 185 0015 5011

shaun.maccoun@zailaboratory.com / xiaoyu.chen@zailaboratory.com

Ionis announces positive topline results from Essence study of olezarsen in people with moderately elevated triglycerides

Ionis announces positive topline results from Essence study of olezarsen in people with moderately elevated triglycerides




Ionis announces positive topline results from Essence study of olezarsen in people with moderately elevated triglycerides

Olezarsen met the primary endpoint with a statistically significant mean reduction in triglycerides versus placebo at 80 mg and 50 mg doses –

– Olezarsen met all key secondary endpoints –

– Olezarsen demonstrated a favorable safety and tolerability profile –

– Nearly 1,500-person Phase 3 study supports the exposure database for olezarsen –

– Data from pivotal Phase 3 CORE and CORE2 studies of olezarsen in severe hypertriglyceridemia (sHTG) expected in Q3 2025 –

CARLSBAD, Calif.–(BUSINESS WIRE)–Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced positive topline results from the Essence study of olezarsen in people with moderate hypertriglyceridemia (fasting triglycerides ≥150 mg/dL to <500 mg/dL) with or at risk for atherosclerotic cardiovascular disease (ASCVD). Nearly all the participants were on current standard of care lipid-lowering medicines. The trial met its primary endpoint with a statistically significant placebo-adjusted 61% and 58% reduction in triglyceride (TG) levels at 6 months with the 80 mg and 50 mg monthly doses, respectively (p <0.0001). Olezarsen also met all key secondary endpoints in the study. The vast majority of participants reached <150mg/dL, reflecting a reduction to normal TG levels. Olezarsen demonstrated a favorable safety and tolerability profile in the study. Ionis plans to submit an abstract for presentation at an upcoming scientific conference. Data from the pivotal Phase 3 CORE and CORE2 studies evaluating olezarsen for the treatment of severe hypertriglyceridemia (sHTG) are expected in Q3 2025.


“The positive results of this study are an important step in bringing forward a potential new treatment for people with severely elevated triglycerides. Following the FDA approval and encouraging launch of TRYNGOLZA (olezarsen) for people living with familial chylomicronemia syndrome (FCS), a rare, genetic form of severely elevated TGs, these data support olezarsen’s potential to benefit the much broader population of people living with sHTG,” said Sam Tsimikas, M.D., senior vice president, global cardiovascular development at Ionis. “We look forward to seeing the results of our pivotal Phase 3 studies, CORE and CORE2, in Q3 2025, which will be the basis for our potential sNDA filing in sHTG by year-end.”

Olezarsen demonstrated a favorable safety and tolerability profile in the study. The most common treatment-emergent adverse event that occurred more frequently than placebo in the olezarsen groups was injection site reactions, with the majority being mild in severity.

About the Essence Study

The Phase 3 global, multicenter, randomized, double-blind, placebo-controlled study (Essence-TIMI 73b), conducted with Ionis’ research partner, The TIMI Study Group, supports the exposure database for olezarsen (NCT05610280). Essence enrolled 1,478 participants aged 18 and older with moderate hypertriglyceridemia (HTG), defined as fasting triglyceride levels ≥150 mg/dL to <500 mg/dL, who were diagnosed with or at risk for atherosclerotic cardiovascular disease (ASCVD). A small percentage of participants (9%) had fasting triglycerides ≥500 mg/dL at baseline. Participants in the study received stable and optimized standard of care lipid-lowering therapies for at least four weeks prior to screening. Participants were randomized to receive 50 mg (n=276) or 80 mg (n=832) of olezarsen or placebo (n=369) every 4 weeks via subcutaneous injection for 12 months.

The primary endpoint was the percent change from baseline in fasting TG levels at six months compared to placebo. Key secondary endpoints included percent changes in triglyceride levels at 12 months, proportion of patients who achieve fasting TG<150 mg/dL and percent changes in other lipid parameters, including apoC-III, remnant cholesterol, non-HDL-C and apoB, compared to placebo over the treatment period.

About Hypertriglyceridemia

Triglycerides (TG) are a type of fat the body uses as a source of energy. While optimal levels for adults are typically below 150 mg/dL, levels higher than 150 mg/dL are a sign of hypertriglyceridemia. Levels higher than 500 mg/dL are a sign of a common condition called severe hypertriglyceridemia (sHTG), which puts millions of people at risk of potentially life-threatening acute pancreatitis (AP) and atherosclerotic cardiovascular disease (ASCVD) despite current standard of care. People with sHTG whose triglyceride levels are more than 880 mg/dL, including those with familial chylomicronemia syndrome (FCS), face a greater risk of AP.

About Olezarsen

Olezarsen is an investigational RNA-targeted medicine being evaluated for the treatment of sHTG. Olezarsen is designed to lower the body’s production of apoC-III, a protein produced in the liver that regulates triglyceride metabolism in the blood. The investigational medicine is currently being evaluated in two Phase 3 clinical trials – CORE and CORE2 – for the treatment of sHTG. Olezarsen has not been approved for the treatment of sHTG by regulatory authorities.

Olezarsen was recently approved in the U.S. as an adjunct to diet to reduce triglycerides in adults with FCS under the tradename TRYNGOLZA™ (olezarsen). For more information about TRYNGOLZA, visit TRYNGOLZA.com.

U.S. INDICATION for TRYNGOLZA™ (olezarsen)

TRYNGOLZA is an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS).

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

TRYNGOLZA is contraindicated in patients with a history of serious hypersensitivity to TRYNGOLZA or any of the excipients in TRYNGOLZA. Hypersensitivity reactions requiring medical treatment have occurred.

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions

Hypersensitivity reactions (including symptoms of bronchospasm, diffuse erythema, facial swelling, urticaria, chills and myalgias) have been reported in patients treated with TRYNGOLZA. Advise patients on the signs and symptoms of hypersensitivity reactions and instruct patients to promptly seek medical attention and discontinue use of TRYNGOLZA if hypersensitivity reactions occur.

ADVERSE REACTIONS

The most common adverse reactions (incidence >5% of TRYNGOLZA-treated patients and >3% higher frequency than placebo) were injection site reactions, decreased platelet count and arthralgia.

Please see full Prescribing Information for TRYNGOLZA.

About Ionis Pharmaceuticals, Inc.

For three decades, Ionis has invented medicines that bring better futures to people with serious diseases. Ionis currently has six marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient need. As the pioneer in RNA-targeted medicines, Ionis continues to drive innovation in RNA therapies in addition to advancing new approaches in gene editing. A deep understanding of disease biology and industry-leading technology propels our work, coupled with a passion and urgency to deliver life-changing advances for patients. To learn more about Ionis, visit Ionis.com and follow us on X (Twitter), LinkedIn and Instagram.

Ionis Forward-looking Statements

This press release includes forward-looking statements regarding Ionis’ business and the therapeutic and commercial potential of our commercial medicines, olezarsen, additional medicines in development and technologies. Any statement describing Ionis’ goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties including those inherent in the process of discovering, developing and commercializing medicines that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such medicines. Ionis’ forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Ionis’ forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Ionis. Except as required by law, we undertake no obligation to update any forward-looking statements for any reason. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Ionis’ programs are described in additional detail in Ionis’ annual report on Form 10-K for the year ended December 31, 2024, and most recent Form 10-Q, which are on file with the Securities and Exchange Commission. Copies of these and other documents are available from the Company.

In this press release, unless the context requires otherwise, “Ionis,” “Company,” “we,” “our” and “us” all refer to Ionis Pharmaceuticals and its subsidiaries.

Ionis Pharmaceuticals® and TRYNGOLZA™ are trademarks of Ionis Pharmaceuticals, Inc.

Contacts

Ionis Investor Contact:
D. Wade Walke, Ph.D.

IR@ionis.com 760-603-2331

Ionis Media Contact:
Hayley Soffer

media@ionis.com 760-603-4679

IDeate-Esophageal01 Phase 3 Trial of Ifinatamab Deruxtecan Initiated in Certain Patients with Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma

IDeate-Esophageal01 Phase 3 Trial of Ifinatamab Deruxtecan Initiated in Certain Patients with Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma




IDeate-Esophageal01 Phase 3 Trial of Ifinatamab Deruxtecan Initiated in Certain Patients with Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma

BASKING RIDGE, N.J. & RAHWAY, N.J.–(BUSINESS WIRE)–The first patient has been dosed in the IDeate-Esophageal01 phase 3 trial evaluating the efficacy and safety of investigational ifinatamab deruxtecan (I-DXd) versus investigator’s choice of chemotherapy in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) with disease progression following treatment with a platinum-containing systemic therapy and an immune checkpoint inhibitor.


Ifinatamab deruxtecan is a specifically engineered, potential first-in-class B7-H3 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed with Merck (NYSE: MRK), known as MSD outside of the United States and Canada.

ESCC accounts for nearly 90% of esophageal cancers globally with a five-year overall survival rate around 15% to 20% and has a worse prognosis for those diagnosed at an advanced stage of the disease.1,2 While the evolved landscape in the first-line metastatic setting of ESCC has helped to improve outcomes for patients, treatment options are limited for patients progressing after first-line therapy, reinforcing the need for new approaches.

“Patients with metastatic esophageal squamous cell carcinoma continue to experience poor outcomes despite currently available treatments,” said Mark Rutstein, MD, Head, Therapeutic Area Oncology Development, Daiichi Sankyo. “The encouraging clinical activity seen in our early-phase signal finding trial supports further evaluation of ifinatamab deruxtecan as a potential treatment strategy for these patients.”

“Advanced esophageal squamous cell carcinoma is a difficult-to-treat disease, and unfortunately overall survival remains low,” said Marjorie Green, MD, Senior Vice President and Head of Oncology, Global Clinical Development, Merck Research Laboratories. “The initiation of the pivotal phase 3 IDeate-Esophageal01 clinical trial demonstrates our shared commitment with Daiichi Sankyo to further expand our clinical development program evaluating this potentially first-in-class ADC across multiple solid tumors where there are unmet needs for new treatment options.”

The initiation of IDeate-Esophageal01 is based on results from the IDeate-PanTumor01 phase 1/2 trial presented at both the 2022 and 2023 European Society of Medical Oncology (ESMO) where ifinatamab deruxtecan showed promising responses in heavily pretreated patients with ESCC.

About the IDeate-Esophageal01 Trial

IDeate-Esophageal01 is a global, multicenter, open-label, randomized phase 3 trial evaluating the safety and efficacy of ifinatamab deruxtecan (12 mg/kg) versus treatment of physician’s choice of chemotherapy (paclitaxel, docetaxel or irinotecan hydrochloride) in patients with advanced or metastatic ESCC with disease progression following treatment with platinum-based chemotherapy therapy and an immune checkpoint inhibitor. Eligible patients must have received no more than one prior line of systemic therapy in the advanced or metastatic setting.

The primary endpoint of the trial is overall survival. Secondary endpoints include progression-free survival and objective response rate as assessed by blinded independent central review, and safety.

IDeate-Esophageal01 will enroll approximately 510 patients across Asia, Europe and North America. For more information, please visit ClinicalTrials.gov.

About Esophageal Squamous Cell Carcinoma

More than half a million esophageal cancer cases were diagnosed in 2022, with nearly half a million deaths globally.3 ESCC accounts for nearly 90% of esophageal cancers globally with a five-year overall survival rate around 15% to 20% and has a worse prognosis for those diagnosed at an advanced stage of the disease.1,2 ESCC is most prevalent in Eastern Asia where mortality rates are also the highest.1,2

While the evolved landscape in the first-line metastatic setting of ESCC has helped to improve outcomes for patients, treatment options are limited for patients progressing after first-line therapy, reinforcing the need for new approaches.

About B7-H3

B7-H3 is a transmembrane protein that belongs to the B7 family of proteins which bind to the CD28 family of receptors that includes PD-1.4,5 B7-H3 is overexpressed in a wide range of cancer types, including ESCC, and its overexpression has been shown to correlate with poor prognosis, making B7-H3 a promising therapeutic target.6-9 There are currently no B7-H3 directed medicines approved for the treatment of any cancer.

About Ifinatamab Deruxtecan

Ifinatamab deruxtecan is an investigational potential first-in-class B7-H3 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, ifinatamab deruxtecan is comprised of a humanized anti-B7-H3 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

In addition to IDeate-Esophageal01, ifinatamab deruxtecan is being evaluated in a global development program that includes IDeate-Lung01, a phase 2 monotherapy trial in patients with previously treated extensive-stage small cell lung cancer (ES-SCLC); IDeate-Lung02, a phase 3 trial in patients with relapsed SCLC versus investigator’s choice of chemotherapy; IDeate-Lung03, a phase 1b/2 trial in patients with ES-SCLC in combination with atezolizumab with or without carboplatin as first-line induction or maintenance therapy; IDeate-PanTumor02, a phase 2 monotherapy trial in patients with recurrent or metastatic solid tumors; and, IDeate-PanTumor01, a phase 1/2 first-in-human monotherapy trial in patients with advanced solid malignant tumors in collaboration with Sarah Cannon Research Institute (SCRI) with study operational oversight and delivery provided through SCRI’s early phase oncology clinical research organization, SCRI Development Innovations in Nashville, TN.

Ifinatamab deruxtecan has been granted orphan drug designation in the EU, Japan, Taiwan and US for the treatment of SCLC.

About the Daiichi Sankyo and Merck Collaboration

Daiichi Sankyo and Merck entered into a global collaboration in October 2023 to jointly develop and commercialize patritumab deruxtecan (HER3-DXd), ifinatamab deruxtecan (I-DXd) and raludotatug deruxtecan (R-DXd), except in Japan where Daiichi Sankyo will maintain exclusive rights. Daiichi Sankyo will be solely responsible for manufacturing and supply. In August 2024, the global co-development and co-commercialization agreement was expanded to include gocatamig (MK-6070/DS3280), which the companies will jointly develop and commercialize worldwide, except in Japan where Merck will maintain exclusive rights. Merck will be solely responsible for manufacturing and supply for gocatamig.

About the ADC Portfolio of Daiichi Sankyo

The Daiichi Sankyo ADC portfolio consists of seven ADCs in clinical development crafted from two distinct ADC technology platforms discovered in-house by Daiichi Sankyo.

The ADC platform furthest in clinical development is Daiichi Sankyo’s DXd ADC Technology where each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADC portfolio currently consists of ENHERTU®, a HER2 directed ADC, and DATROWAY®, a TROP2 directed ADC, which are being jointly developed and commercialized globally with AstraZeneca. Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being jointly developed and commercialized globally with Merck. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo.

The second Daiichi Sankyo ADC platform consists of a monoclonal antibody attached to a modified pyrrolobenzodiazepine (PBD) payload. DS-9606, a CLDN6 directed PBD ADC, is the first of several planned ADCs in clinical development utilizing this platform.

Ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan, DS-3939 and DS-9606 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established.

About Daiichi Sankyo

Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical needs. For more information, please visit www.daiichisankyo.com.

Merck’s Focus on Cancer

Every day, we follow the science as we work to discover innovations that can help patients, no matter what stage of cancer they have. As a leading oncology company, we are pursuing research where scientific opportunity and medical need converge, underpinned by our diverse pipeline of more than 25 novel mechanisms. With one of the largest clinical development programs across more than 30 tumor types, we strive to advance breakthrough science that will shape the future of oncology. By addressing barriers to clinical trial participation, screening and treatment, we work with urgency to reduce disparities and help ensure patients have access to high-quality cancer care. Our unwavering commitment is what will bring us closer to our goal of bringing life to more patients with cancer. For more information, visit https://www.merck.com/research/oncology.

About Merck

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2024 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

 

References:

1. Matz M, et al. Cancer Commun (Lond). 2023;43(9):963-980.

2. Zhao, YX, et al. World J Gastroenterol. 2024;30:2638–2656.

3. Bray F, et al. CA Cancer J Clin. 2024;74(3):229-263.

4. Zhao B, et al. J Hematol Oncol. 2022;15(1):153.

5. Janakiram M, et al. Immunol Rev. 2017;276(1):26-39.

6. Qiu M-j, et al. Front. Oncol. 2021;11:600238.

7. Picarda E, et al. Clin Cancer Res. 2016;22(14):3425-3431.

8. Bendell JC, et al. J Clin Oncol. 2020;39(15 suppl 1). Abstract TPS3646.

9. Kontos F, et al. Clin Cancer Res. 2021;27(5):1227-1235.

 

Contacts

Media Contacts:

Global/US Media:
Jennifer Brennan

Daiichi Sankyo, Inc.

jennifer.brennan@daiichisankyo.com
+1 908 900 3183 (mobile)

Japan:
Daiichi Sankyo Co., Ltd.

DS-PR_jp@daiichisankyo.com

Investor Relations Contact:
DaiichiSankyoIR_jp@daiichisankyo.com

Merck
Media:
Julie Cunningham

(617) 519-6264

julie.cunningham@merck.com

Michael McArdle

(908) 447-9453

michael.mcardle@merck.com

Investors:
Peter Dannenbaum

(732) 594-1579

peter.dannenbaum@merck.com

Steven Graziano

(732) 594-1583

steven.graziano@merck.com

Genethon Presents Two Year Consolidated Results of Its Gene Therapy Trial for Duchenne Muscular Dystrophy: Maintenance of Motor Functions and Significant, Sustained Reduction in CPK Levels in Patients Treated at the Effective Dose at ASGCT 2025

Genethon Presents Two Year Consolidated Results of Its Gene Therapy Trial for Duchenne Muscular Dystrophy: Maintenance of Motor Functions and Significant, Sustained Reduction in CPK Levels in Patients Treated at the Effective Dose at ASGCT 2025




Genethon Presents Two Year Consolidated Results of Its Gene Therapy Trial for Duchenne Muscular Dystrophy: Maintenance of Motor Functions and Significant, Sustained Reduction in CPK Levels in Patients Treated at the Effective Dose at ASGCT 2025

  • GNT0004 product confirms its clinical efficacy with stabilization of motor functions in patients treated at the effective dose for up to 2 years.
  • Sustained significant reduction in levels of creatine phosphokinase (CPK), a biomarker of muscle damage, with an average decrease of over 75% at 18 months in the 3 patients treated at the effective dose.
  • Pivotal phase planned for mid-2025 in Europe and the United States.

PARIS–(BUSINESS WIRE)–Genethon unveiled the 2-year follow-up data from its GNT0004 gene therapy clinical trial for Duchenne Muscular Dystrophy (GNT-016-MDYF) at the annual meeting of the American Society of Gene & Cell Therapy (ASGCT) in New Orleans, May 13 – 17, 2025. Five patients, aged 6 to 10 years, were treated, 2 at the first dose level and 3 at the second dose level (3×10¹³ vg/kg). The initial part of the clinical trial aimed at selecting the optimal dose (dose escalation phase), evaluating the tolerance and preliminary efficacy of the treatment and determined the effective dose for the pivotal phase of the GNT-016-MDYF trial, which is expected to start in mid-2025 (3×10¹³ vg/kg).


Genethon CEO Frederic Revah observed, “The results of our gene therapy GNT0004 are very positive in patients treated at the dose of 3×10¹³ vg/kg, both in terms of microdystrophin expression and clinical efficacy criteria. Besides these results, the advantage of our product lies in the selected dose for the pivotal phase, which is lower than those used in other gene therapy trials for Duchenne Muscular Dystrophy. We are currently preparing the pivotal phase that we will conduct in Europe and the US.”

Safety, efficacy, and pharmacodynamic results show good tolerance of GNT0004 associated with transient immunological prophylactic treatment, as well as efficacy data in terms of microdystrophin expression, CPK reduction, and clinical criteria (NSAA, timed tests). Patients treated at the effective dose show prolonged improvement or stabilization of motor functions and significant persistent reduction in creatine kinase (CPK) levels, a key marker of muscle damage.

One-year post-treatment, the comparison of the three patients treated at the effective dose with a group of 34 untreated patients, matched by age and followed in the same centers and by the same practitioners, shows a difference of +4.7 points in the score obtained using the internationally recognized clinical evaluation scale NSAA between treated and untreated patients.

At 24 months post-treatment, key observations include:

  • For the 2 patients who reached 2 years post-treatment out of the 3 treated at the effective dose, the trial shows stabilization of motor functions measured by the NSAA scale , while untreated patients from the parallel natural history study showed a continuous and significant average decline in NSAA. For one treated patient, the observed improvement allowed reaching the maximum score of 34 at 12 months, confirmed at 24 months post-treatment.
  • Stabilization of CPK reduction between 50% and 87% on average: >75% at 18 months post-treatment (data from the 3 patients treated at the effective dose), and persistent (up to 24 months follow-up for the first two patients treated at this dose).
  • The reassuring safety profile of the gene therapy drug is confirmed two years after injection, without the occurrence of serious adverse effects at the selected dose, which is notably lower than that used for other gene therapy products under development for Duchenne Muscular Dystrophy.

About GNT0004 and the trial

The GNT0004 gene therapy is composed of an AAV8 (adeno-associated virus) vector and the optimized hMD1 transgene, a shortened but functional version of the gene encoding dystrophin, the protein deficient in people with DMD. This vector is designed to be expressed in muscle tissue and also in the heart, thanks to a tissue-specific Spc5-12 promoter sequence. GNT0004 is administered by a single intravenous injection. It was developed by Genethon, in partnership with the teams of Prof. Dickson (University of London, Royal Holloway) and the Institut de Myologie (Paris). The trial, sponsored by Genethon, combines Phases 1/2/3, a dose-escalation phase followed by a pivotal phase at the dose finally chosen. The trial is being carried out in France and the UK and includes boys aged 6 to 10 with DMD who have retained their ability to walk.

About Duchenne muscular dystrophy

DMD is a rare, progressive genetic disease affecting all the body’s muscles, and mainly boys (1 in 5000). It is due to abnormalities in the gene responsible for producing dystrophin, a structural protein essential for the stability of muscle fiber membranes and their metabolism. The absence of dystrophin leads to progressive degeneration of skeletal and cardiac muscles, loss of walking and respiratory capacity, cardiomyopathy and death between the ages of 20 and 40.

About Genethon

A pioneer in the discovery and development of gene therapies for rare diseases, Genethon is a nonprofit organization created by the AFM-Téléthon. The first gene therapy to treat spinal muscular atrophy, incorporating technologies developed at Genethon, is marketed worldwide. With over 240 scientists and professionals, Genethon pursues its goal of developing innovative therapies that change the lives of patients suffering from rare genetic diseases. Thirteen products from Genethon’s R&D or collaborations are in clinical trials for diseases of the liver, blood, immune system, muscles and eyes. A further seven products could enter clinical trials in the next five years. To find out more visit: http://www.genethon.com/.

Genethon made five oral presentations and seven poster presentations by 12 researchers, scientists, engineers and medical experts at ASGCT 2025. Learn more https://urlr.me/kTPBtW

Contacts

Press contact:
Stephanie Bardon

communication@genethon.fr
06.45.15.95.87

Jason Hancock Joins BioRewards as Head of IT and Digital Operations, Advancing Tech-Driven Plasma Supply Experience

Jason Hancock Joins BioRewards as Head of IT and Digital Operations, Advancing Tech-Driven Plasma Supply Experience




Jason Hancock Joins BioRewards as Head of IT and Digital Operations, Advancing Tech-Driven Plasma Supply Experience

SCOTTSDALE, Ariz.–(BUSINESS WIRE)–#BiotechStartupBioRewards Plasma Services (“BioRewards”), a next-generation U.S.-based plasma collection network, is pleased to announce that Jason Hancock has joined the company as Head of IT and Digital Operations. Hancock brings over two decades of healthcare technology leadership, most recently serving as Senior Director of IT at one of the world’s top four global plasma fractionators.


Hancock’s appointment reflects BioRewards’ rapid evolution from a strong startup into a technology-forward partner of choice for global fractionators seeking dependable plasma supply. In his role, Hancock will lead the design and implementation of BioRewards’ digital infrastructure— overseeing platform architecture, systems integration, and the application of data analytics to optimize the donor experience.

“BioRewards exists to help ensure the global plasma-derived medicines supply chain remains strong and resilient,” says Charles Auger, CEO of BioRewards. “Jason’s leadership will help us scale efficiently while deepening our commitment to innovation and donor-centric operations.”

As BioRewards advances its plan to open more than 20 plasma centers across the U.S., Hancock’s expertise will support the company’s goals of operational excellence, regulatory compliance, and technology-enabled donor engagement.

“Jason’s background with a top-tier global plasma fractionator gives BioRewards a major advantage,” added Chris Barber, Chief Operating Officer of BioRewards. “He will lead the implementation of technologies that enhance both quality and cost-efficiency across our national footprint.”

This leadership addition follows BioRewards’ recent formal launch and more than $100 million in strategic funding from Alpha-1 Plasma Holdings. The company is uniquely positioned to help fractionators meet rising global demand for immunoglobulins and other PDMPs by delivering high-quality source and hyperimmune plasma through a digitally optimized collection network.

About BioRewards Plasma Services

BioRewards Plasma Services is an emerging leader in the independent plasma collection industry, dedicated to delivering high-quality source and hyperimmune plasma material to pharmaceutical companies worldwide. With a leadership team boasting over 100 years of combined experience, BioRewards leverages cutting-edge technology to enhance the donor experience, improve operational efficiency, and ensure a stable high-quality plasma supply chain.

Contacts

Media Contact
Company Name: BioRewards Plasma Services

Contact Person: Media Relations

Email: Info@BioRewards.com
City: New York City

State: New York

Country: United States of America

www.BioRewards.com

Innate Pharma Highlights Abstracts Selected for ASCO 2025 Annual Meeting

Innate Pharma Highlights Abstracts Selected for ASCO 2025 Annual Meeting




Innate Pharma Highlights Abstracts Selected for ASCO 2025 Annual Meeting

  • Long term follow-up results of TELLOMAK Phase 2 trial in Sézary syndrome and mycosis fungoides
  • Trial in Progress poster on IPH4502, Innate’s differentiated ADC in development in advanced solid tumors expressing Nectin-4
  • AstraZeneca to present a poster on updated results from the Phase 2 trial NeoCOAST-2 in resectable NSCLC

MARSEILLE, France–(BUSINESS WIRE)–#ANKET–Regulatory News:


Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) announced today that four abstracts with Innate’s drugs in clinical development have been accepted for the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting, taking place May 30-June 3, 2025 in Chicago, Illinois.

We are looking forward to participating in the ASCO Annual Meeting 2025, where four abstracts with Innate’s drugs in clinical development have been selected. In particular, we are pleased to share the long-term follow-up data from the TELLOMAK Phase 2 study, which underscores our continued commitment to advancing innovative therapies for patients,” commented Dr Sonia Quaratino, Chief Medical Officer of Innate Pharma.

ASCO abstract details:

Lacutamab

Abstract: 2522
Abstract Title: Lacutamab in patients with relapsed and refractory Sézary syndrome: Long term follow-up from the TELLOMAK phase 2 trial

Session Type: Poster Session

Session Title: Developmental Therapeutics—Immunotherapy

Session Date and Time: Monday, June 2, 2025 – 1:30 – 4:30 PM CDT

Abstract: 2523
Abstract Title: Lacutamab in patients with relapsed and/or refractory mycosis fungoides: Long-term follow-up and translational data from the TELLOMAK phase 2 trial

Session Type: Poster Session

Session Title: Developmental Therapeutics—Immunotherapy

Session Date and Time: Monday, June 2, 2025 – 1:30 – 4:30 PM CDT

IPH4502

Abstract: TPS3159
Abstract Title: A phase 1, open-label, multi-center study of the safety, tolerability, and efficacy of IPH4502 as a single agent in advanced solid tumors

Session Type: Poster Session

Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

Session Date and Time: Monday, June 2, 2025 – 1:30 – 4:30 PM CDT

Monalizumab (partnered with AstraZeneca)

Abstract: 8046
Abstract Title: Neoadjuvant durvalumab (D) + chemotherapy (CT) + novel anticancer agents and adjuvant D ± novel agents in resectable non-small-cell lung cancer (NSCLC): Updated outcomes from NeoCOAST-2.

Session Type: Poster Session

Session Title: Lung Cancer—Non–Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

Session Date and Time: Saturday, May 31, 2025 – 1:30 – 4:30 PM CDT

About Innate Pharma

Innate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. Its innovative approach aims to harness the innate immune system through three therapeutic approaches: multi-specific NK Cell Engagers via its ANKET® (Antibody-based NK cell Engager Therapeutics) proprietary platform and Antibody Drug Conjugates (ADC) and monoclonal antibodies (mAbs).

Innate’s portfolio includes several ANKET® drug candidates to address multiple tumor types as well as IPH4502, a differentiated ADC in development in solid tumors. In addition, anti-KIR3DL2 mAb lacutamab is developed in advanced form of cutaneous T cell lymphomas and peripheral T cell lymphomas, and anti-NKG2A mAb monalizumab is developed with AstraZeneca in non-small cell lung cancer.

Innate Pharma is a trusted partner to biopharmaceutical companies such as Sanofi and AstraZeneca, as well as leading research institutions, to accelerate innovation, research and development for the benefit of patients.

Headquartered in Marseille, France with a US office in Rockville, MD, Innate Pharma is listed on Euronext Paris and Nasdaq in the US.

Learn more about Innate Pharma at www.innate-pharma.com. Follow us on LinkedIn and X.

Information about Innate Pharma shares

ISIN code
Ticker code
LEI

FR0010331421

Euronext: IPH Nasdaq: IPHA

9695002Y8420ZB8HJE29

Disclaimer on forward-looking information and risk factors

This press release contains certain forward-looking statements, including those within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. The use of certain words, including “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “may,” “might,” “potential,” “should,” “will,” or the negative of these and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including related to safety, progression of and results from its ongoing and planned clinical trials and preclinical studies, review and approvals by regulatory authorities of its product candidates, the Company’s reliance on third parties to manufacture its product candidates, the Company’s commercialization efforts and the Company’s continued ability to raise capital to fund its development. For an additional discussion of risks and uncertainties, which could cause the Company’s actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risque”) section of the Universal Registration Document filed with the French Financial Markets Authority (“AMF”), which is available on the AMF website http://www.amf-france.org or on Innate Pharma’s website, and public filings and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form 20-F for the year ended December 31, 2024, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public by the Company. References to the Company’s website and the AMF website are included for information only and the content contained therein, or that can be accessed through them, are not incorporated by reference into, and do not constitute a part of, this press release.

In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by the Company or any other person that the Company will achieve its objectives and plans in any specified time frame or at all. The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Innate Pharma in any country.

Contacts

For additional information, please contact:
Investors

Innate Pharma
Henry Wheeler

Tel.: +33 (0)4 84 90 32 88

Henry.wheeler@innate-pharma.fr

Media Relations

NewCap
Arthur Rouillé

Tel.: +33 (0)1 44 71 00 15

innate@newcap.eu

Savara Presented New Data From Pivotal Phase 3 IMPALA-2 Trial of Molgramostim Inhalation Solution (Molgramostim) in Patients With Autoimmune Pulmonary Alveolar Proteinosis (aPAP) at American Thoracic Society Conference (ATS) 2025

Savara Presented New Data From Pivotal Phase 3 IMPALA-2 Trial of Molgramostim Inhalation Solution (Molgramostim) in Patients With Autoimmune Pulmonary Alveolar Proteinosis (aPAP) at American Thoracic Society Conference (ATS) 2025




Savara Presented New Data From Pivotal Phase 3 IMPALA-2 Trial of Molgramostim Inhalation Solution (Molgramostim) in Patients With Autoimmune Pulmonary Alveolar Proteinosis (aPAP) at American Thoracic Society Conference (ATS) 2025

LANGHORNE, Pa.–(BUSINESS WIRE)–Savara Inc. (Nasdaq: SVRA) (the Company), a clinical-stage biopharmaceutical company focused on rare respiratory diseases, today announced new data in two poster presentations at the ATS International Conference 2025. Data presented were from the Phase 3 IMPALA-2 clinical trial of molgramostim in aPAP and demonstrated that molgramostim reduces surfactant burden and improves health-related quality of life outcomes in patients with aPAP.


ATS 2025 Posters

Poster Title: Molgramostim Reduces Surfactant Burden and Number of Whole Lung Lavage Procedures in Patients with Autoimmune Pulmonary Alveolar Proteinosis (aPAP): Results From the IMPALA-2 Phase 3 Clinical Trial

Presenter: Tisha S. Wang, M.D., Professor of Clinical Medicine, Senior Executive Clinical Vice Chair, University of California Los Angeles Department of Medicine

Poster Number: 918

Poster Location: PD05, Room 3009/3011 West Building, Level 3

Summary:

  • Molgramostim reduced surfactant burden as measured by ground-glass opacification (GGO) scores, a radiological measure of surfactant burden. The mean reduction in GGO score from baseline to Week 24 was greater in the molgramostim group (n=78) than in the placebo group (n=79) (-2.1 vs. -1.1; P=0.0004)
  • Fewer patients in the molgramostim group required rescue whole lung lavages (WLL) compared with placebo. During the 48-week double-blind treatment period, 6 patients (7.4%) in the molgramostim group underwent a total of 15 WLLs and 11 patients (13.3%) in the placebo group underwent a total of 24 WLLs
  • Molgramostim reduces pulmonary surfactant burden, which drives the clinical manifestations of aPAP, and provides support for the potential beneficial treatment effect of molgramostim

Poster Title: The Effects of Molgramostim on Respiratory Health-related Quality of Life and Patient-reported Outcomes in Patients with Autoimmune Pulmonary Alveolar Proteinosis (aPAP)

Presenter: Ali Ataya, M.D., Associate Professor of Medicine, University of Florida, Division of Pulmonary and Critical Care Medicine

Poster number: P31

Poster Location: TP22, Area A, Hall F (North Building, Exhibition Level)

Summary:

  • Molgramostim showed benefit on measures of health-related quality of life (HRQoL) and patients’ assessment of breathing problems and physical activity, including changes from baseline in St. George’s Respiratory Questionnaire (SGRQ) Impact and Symptom scores, the EuroQol 5 Dimensions, 5 Levels (EQ-5D-5L), Patient Global Impression of Severity (PGIS), and Patient Global Impression of Change (PGIC) at Weeks 24 and 48, which were included as exploratory endpoints in the trial
  • Molgramostim improved respiratory HRQoL as measured by changes from baseline to Week 24 in SGRQ Impact (P=0.0084) and Symptom scores compared with placebo, and the EQ-5D-5L, a generic HRQoL instrument comprised of a short descriptive system questionnaire that allows patients to rate their health across 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Odds ratios of responses on the EQ-5D-5L numerically favored the molgramostim group on 3 of the 5 dimensions (mobility, self-care, and usual activities) at Weeks 24 and 48
  • Molgramostim reduced the severity of breathing problems, as assessed by PGIS, at both Weeks 24 (P=0.0305) and 48 (P=0.0049). Additionally, more molgramostim patients reported improvements in overall change in daily physical activity level, as measured by more patients assessing themselves as “Much better” or “A little better” compared with placebo at Week 24 (P=0.0368) and Week 48 (P=0.0193)

The abstracts were published in a supplement of the American Journal of Respiratory and Critical Care Medicine. For more details about the ATS International Conference please visit their website.

The posters are available on the Congresses & Publications page of the Company’s corporate website.

About the IMPALA-2 Trial

IMPALA-2 is a global, pivotal, Phase 3, 48-week, randomized, double-blind, placebo-controlled clinical trial designed to compare the efficacy and safety of molgramostim 300 mcg self-administered once daily by inhalation with matching placebo in patients with aPAP. The trial is being conducted at 43 clinical trial sites across 16 countries, including the U.S., Canada, Japan, South Korea, Australia, and countries in Europe, including Turkey. The primary efficacy assessment was diffusing capacity of the lungs for carbon monoxide (DLCO), a gas exchange measure, and the primary endpoint was change from baseline to Week 24 in percent predicted DLCO, with a secondary endpoint of change from baseline to Week 48 in percent predicted DLCO. Three additional secondary efficacy variables evaluated clinical measures of direct patient benefit: St. George’s Respiratory Questionnaire (SGRQ) Total score, SGRQ Activity score, and exercise capacity using a treadmill test, with each endpoint measured at Weeks 24 and 48. The primary time point for efficacy assessments was at Week 24; however, efficacy was assessed through Week 48 to evaluate durability of effect. Safety was assessed through Week 48. All patients who completed the 48-week double-blind treatment period continued into a 96-week open-label period during which they are receiving molgramostim 300 mcg administered once daily.

About Autoimmune Pulmonary Alveolar Proteinosis (aPAP)

Autoimmune PAP is a rare lung disease characterized by the abnormal build-up of surfactant in the alveoli of the lungs. Surfactant consists of proteins and lipids and is an important physiological substance that lines the alveoli to prevent them from collapsing. In a healthy lung, excess surfactant is cleared and digested by immune cells called alveolar macrophages. Alveolar macrophages need to be stimulated by granulocyte-macrophage colony-stimulating factor (GM-CSF) to function properly in clearing surfactant, but in aPAP, GM-CSF is neutralized by antibodies against GM-CSF, rendering macrophages unable to adequately clear surfactant. As a result, an excess of surfactant accumulates in the alveoli, causing impaired gas exchange, resulting in clinical symptoms of shortness of breath, often with cough and frequent fatigue. Patients may also experience episodes of fever, chest pain, or coughing up blood, especially if secondary lung infection develops. In the long term, the disease can lead to serious complications, including lung fibrosis and the need for a lung transplant.

About Savara

Savara is a clinical-stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, molgramostim inhalation solution (molgramostim), is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP). Molgramostim is delivered via an investigational eFlow® Nebulizer System (PARI Pharma GmbH) specifically developed for inhalation of a large molecule. Our management team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization. More information can be found at www.savarapharma.com and LinkedIn.

Contacts

Media and Investor Relations Contact
Savara Inc.

Temre Johnson, Executive Director, Corporate Affairs

ir@savarapharma.com

IMVARIA Reports Multi-Site Clinical Experience With FDA-Authorized AI Diagnostic Service for Idiopathic Pulmonary Fibrosis at ATS 2025

IMVARIA Reports Multi-Site Clinical Experience With FDA-Authorized AI Diagnostic Service for Idiopathic Pulmonary Fibrosis at ATS 2025




IMVARIA Reports Multi-Site Clinical Experience With FDA-Authorized AI Diagnostic Service for Idiopathic Pulmonary Fibrosis at ATS 2025

Presenting real-world use of Fibresolve, the first-of-its-kind AI-powered adjunctive diagnostic service supporting assessment of suspected Interstitial Lung Disease (ILD) and Idiopathic Pulmonary Fibrosis (IPF)

BERKELEY, Calif.–(BUSINESS WIRE)–#ATSIMVARIA Inc., a health tech company pioneering AI-driven digital biomarker solutions, today reported results from multi-site clinical experiences with IMVARIA’s diagnostic referral service, where pulmonologists send cases for AI-supported diagnostic evaluation of suspected Interstitial Lung Disease (ILD) and Idiopathic Pulmonary Fibrosis (IPF). Built by medical doctors with software engineering expertise, Fibresolve is the first ever FDA-authorized AI adjunctive diagnostic service of any type in lung fibrosis. Clinical data from use around the U.S. will be presented by pulmonary experts from Harvard’s Mass General Hospital at ATS 2025 International Conference, focusing on respiratory diseases, held on May 16-21, 2025 in San Francisco.

“We’re excited that our clinical users are sharing real-world experience with Fibresolve at the ATS Conference,” said Joshua Reicher, MD, Co-founder and CEO of IMVARIA. “At IMVARIA, we’ve taken a different approach to AI – one that makes it far easier for pulmonologists to benefit from this new technology without changing workflows or installing complex systems. As practicing medical doctors, my co-founder Dr. Michael Muelly and I designed Fibresolve to meet the highest medical standards, deliver new insights, and make it easy for clinicians to use AI with confidence and minimal burden. We’re proud to see that approach working in real clinical settings.”

IMVARIA’s Fibresolve received FDA authorization in early 2024 and has gone through a rigorous process to make it useful and reliable for pulmonologists. Fibresolve is available through IMVARIA’s centralized service that uses AI to help guide safe, non-invasive diagnoses. Fibresolve also has the distinction as the first FDA Breakthrough-Designated AI diagnostic tool with simultaneously adopted CPT billing codes by the American Medical Association (AMA) in any disease.

IMVARIA is additionally presenting data on ScreenDx and Bronchosolve, two more AI solutions in its pulmonary portfolio. ScreenDx, FDA-cleared in 2025, is the first AI technology authorized to assess interstitial lung findings compatible with ILD. Bronchosolve is an investigational tool designed to support more accurate assessment of indeterminate lung nodules and is currently under research investigation.

Poster Presentations at ATS 2025 Conference

Fibresolve

Title: Clinical Experience with the First FDA-Authorized Artificial Intelligence Tool in Interstitial Lung Disease and Idiopathic Pulmonary Fibrosis

Session: A46 – New Research in Biomarkers and Imaging for ILD

Poster: P1547

Date and Time: Sunday, May 18, 2025: 9:15 AM – 4:15 PM

ScreenDx

Title: Automated Al Detection of Interstitial Lung Disease by Computed Tomography (CT) in the COPDGene Trial; Subanalysis and Characteristics of Accurately Detected Cases

Session: A57 – Late Breaking Abstracts in Clinical Problems

Poster: P1006

Date and Time: Sunday, May 18, 2025: 9:15 AM – 4:15 PM

Bronchosolve

Title: Closed Loop, Full Automation of Suspicious Lung Nodule Risk Assessment with AI in Screening Cases

Session: B110 – The Road to Early Detection: Advancing Lung Cancer Screening Through AI, Risk Models, And Real-World Data

Poster: 619

Date and Time: Monday, May 19, 2025: 2:15 PM – 4:15 PM

Title: Age-Stratified Subanalysis of a Closed Loop, Fully Automated Lung Nodule Risk Assessment Al Software

Session: B80-1 – From Bench to Bedside: Innovative Biomarkers, Screening Approaches, And Personalized Treatments In Lung Cancer

Poster: P804

Date and Time: Monday, May 19, 2025: 9:15 AM – 4:15 PM

Together, these presentations reflect IMVARIA’s mission to empower clinicians to make the best decisions through clinically meaningful AI.

For more information about IMVARIA, click here.

About IMVARIA Inc.

IMVARIA is a health tech company pioneering AI-driven solutions that empower clinicians to make accurate diagnoses and prognoses at earlier stages of disease. Founded in 2019 by physician-engineers from Google and Stanford University, the company operates its AI Lab with automated, machine-learning algorithm technology to transform clinical decision-making into data science. IMVARIA is based in Berkeley, CA. For more information, go to www.imvaria.com.

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