Category Archives: Biotech Companies

Cardurion Pharmaceuticals Presents Positive Clinical Results from CARDINAL‑HF Phase 2a Clinical Trial of PDE9 Inhibitor in Patients With Heart Failure

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– PDE9 inhibitor, CRD-740, demonstrated favorable safety profile and achieved statistical significance for the trial’s primary endpoint, median increase in plasma cyclic guanosine monophosphate (cGMP) –

– This clinical trial confirms that high levels of PDE9 inhibition lead to increases in cGMP, reflecting increased activation of the myocardial natriuretic peptide (NP) signaling pathway –

– Targeting PDE9 represents a novel approach to activating the NP signaling pathway, a highly validated pathway with established clinical benefits in heart failure –

– Clinical results presented today at the Annual Congress of the Heart Failure Association of the European Society of Cardiology –

BURLINGTON, Mass.–(BUSINESS WIRE)–Cardurion Pharmaceuticals, Inc. (“Cardurion”), a clinical-stage biotechnology company developing next-generation therapeutics for the treatment of cardiovascular diseases, today announced the presentation of positive clinical data from CARDINAL‑HF, the first Phase 2 proof-of-concept clinical trial of a phosphodiesterase-9 (PDE9) inhibitor in patients with heart failure. These data were presented today at the Annual Congress of the Heart Failure Association of the European Society of Cardiology taking place on May 11-14 in Lisbon, Portugal.

In the CARDINAL-HF Phase 2a trial, CRD-740 met the primary endpoint in patients with heart failure with reduced ejection fraction (HFrEF), demonstrating a statistically significant median increase in plasma cyclic guanosine monophosphate (cGMP) after four weeks of treatment. Plasma cGMP is a biomarker for intracellular cGMP whose levels reflect the activity of the protective myocardial natriuretic peptide (NP) signaling pathway, which has proven clinical benefits in heart failure. CRD-740 was generally well tolerated in the trial.

“These very promising data from the first Phase 2 proof-of-concept clinical trial of a PDE9 inhibitor in patients with heart failure represent an important next step in the development of this novel mechanism,” said James Udelson, MD, Chief of Cardiology at Tufts Medical Center and Principal Investigator for the CARDINAL-HF trial. “The results of this trial are impressive, showing robust PDE9 inhibition with significant increases in plasma and urinary cGMP, along with a favorable safety profile, both of which support moving into further clinical testing in heart failure.”

“Therapeutic targeting of the NP signaling pathway is precedented by today’s standard of care treatment for patients with heart failure, and PDE9 inhibition represents a new mechanism for activating this pathway to seek improved patient outcomes. Significant unmet needs remain, as heart failure is a prevalent and growing chronic condition that causes significant morbidity and mortality for millions of people,” said Scott D. Solomon, MD, Professor of Medicine at Harvard Medical School.

The oral presentation of these results, entitled, “A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Tolerability and Pharmacodynamic Effects of CRD-740, a PDE9 Inhibitor, in Participants with Chronic Heart Failure,” were presented today by James Udelson, M.D., Principal Investigator of CARDINAL-HF and Chief of Cardiology at Tufts Medical Center, in the “Late-Breaking Clinical Trials: Medical Therapy” session at the Annual Congress of the Heart Failure Association of the European Society of Cardiology. Key findings presented include:

  • CRD-740 was generally well-tolerated in patients with HFrEF, a disease representing approximately one-half of patients with chronic heart failure.
  • PDE9 inhibition with CRD-740 achieved statistically significant median increases in plasma cGMP at four weeks, compared to placebo, which was the primary endpoint in the trial. Statistically significant median increases in urinary cGMP were also observed in the patients who received CRD-740, compared to placebo.
  • Increases in cGMP of the magnitude seen in the trial demonstrate that CRD-740 achieves high levels of PDE9 inhibition, which prevents cGMP metabolism by the PDE9 enzyme and leads to increased activation of the NP signaling pathway. Activation of the clinically validated NP signaling pathway has been shown to benefit patients with chronic heart failure in outcome studies with sacubitril/valsartan.
  • These increases in plasma and urinary cGMP were observed in patients who received CRD‑740 with and without background treatment with sacubitril/valsartan, supporting the potential for CRD-740 as a monotherapy, and as a new approach to augment efficacy in the setting of sacubitril/valsartan therapy and to further activate the NP signaling pathway.

Based on the results of the CARDINAL-HF Phase 2a trial, Cardurion has launched two Phase 2 clinical trials in 640 patients, including a dose-ranging trial in patients with HFrEF and a proof-of-concept trial in patients with heart failure with preserved ejection fraction (HFpEF).

“These findings from Cardurion’s pioneering program in PDE9 support our conviction that PDE9 inhibition presents an important new mechanism for independently targeting and further activating the well-validated NP signaling pathway. The data from this trial suggest that PDE9 inhibition has the potential to provide benefit to patients when administered alone or in combination with guideline directed medical therapy, and ultimately become standard of care for patients with both types of heart failure,” said Peter Lawrence, Chief Executive Officer of Cardurion Pharmaceuticals.

“We are delighted to share these clinical results for CRD-740 as our team advances PDE9 inhibition as a novel approach to addressing the unmet needs of patients with chronic heart failure,” said Howard Surks, MD, Chief Medical and Scientific Officer of Cardurion Pharmaceuticals. “We thank our patients and investigators for their partnership and look forward to continuing the development of our PDE9 inhibitors to improve outcomes for patients.”

About the CARDINAL-HF clinical trial

CARDINAL-HF is the first Phase 2 proof-of-concept trial of a PDE9 inhibitor for the treatment of patients with heart failure. The Phase 2a clinical trial is a randomized, placebo-controlled trial of 60 chronic, stable patients with heart failure with reduced ejection fraction (HFrEF) who were receiving guideline-directed medical therapy (GDMT). The primary endpoints of the trial are safety and tolerability of CRD-740 and changes in plasma cGMP at four weeks, a precedented biomarker for activation of the NP signaling pathway. Other endpoints include changes in urinary cGMP and N-terminal pro b-type natriuretic peptide (NTpro-BNP) and effect of CRD-740 administration on the Kansas City Cardiomyopathy questionnaire (KCCQ), which measures symptoms, physical and social limitations, and quality of life in patients with heart failure.

The Executive Committee for the CARDINAL-HF trial includes Dr. James Udelson, Principal Investigator and Chief of Cardiology at Tufts Medical Center; Dr. Scott Solomon, Professor of Medicine at Harvard Medical School; and Dr. John McMurray, Professor of Medical Cardiology and Deputy Director of the Institute of Cardiovascular and Medical Sciences at the University of Glasgow. Drs. Udelson, Solomon and McMurray, along with Dr. Eugene Braunwald, the Distinguished Hersey Professor of Medicine at Harvard Medical School, also lead Cardurion’s Clinical Advisory Board. The CARDINAL-HF Steering Committee is further comprised of leading international heart failure clinical investigators.

About PDE9 inhibition

PDE9 inhibitors target phosphodiesterase (PDE) 9, an enzyme whose elevated activity in patients with heart failure reduces the beneficial effects of the natriuretic peptide (NP) pathway, fundamental to cardiovascular homeostasis. The beneficial effects of the NP signaling pathway in the heart muscle cell are mediated by cyclic guanosine monophosphate (cGMP) and activation of its downstream signaling molecule protein kinase G1. PDE9 is an enzyme that selectively degrades cGMP; therefore, by inhibiting PDE9, our goal is to preserve cGMP generation and enhance the beneficial natriuretic peptide signaling within heart muscle cells.

About Chronic Heart Failure

Heart failure is a prevalent and growing condition that is responsible for substantial morbidity and mortality. Approximately 6.5 million people in the United States suffer from heart failure, and 50 percent of these patients die from the condition within five years of diagnosis. One in five patients with heart failure are hospitalized annually, and 25% of these patients will be admitted again within a month of discharge. Approximately half of all patients with heart failure have reduced ejection fraction (HFrEF) and half have preserved ejection fraction (HFpEF). Despite the availability of drugs indicated to reduce morbidity and mortality in patients with both types of heart failure, substantial unmet medical need remains.

About Cardurion Pharmaceuticals

Cardurion Pharmaceuticals is a clinical-stage biotechnology company focused on the discovery and development of novel, next-generation therapeutics for the treatment of cardiovascular diseases. Cardurion was founded by physician-scientists with world-class expertise in cardiovascular signaling pathways, and a shared passion to find and develop a pipeline of novel treatment options to improve the lives of patients. Cardurion has two groundbreaking clinical programs in development, a PDE9 inhibitor targeting heart failure and the first ever CaMKII inhibitor in clinical development targeting multiple cardiovascular indications.

Cardurion Pharmaceuticals has facilities in Burlington, Massachusetts and Shonan, Japan. For more information, please visit the company’s website at https://cardurion.com.

Contacts

Kathryn Morris

The Yates Network

kathryn@theyatesnetwork.com

Be Biopharma Announces New Preclinical Data for Novel B Cell Medicine for the Potential Treatment of Hypophosphatasia

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  • Preclinical research demonstrates that CRISPR/Cas9-based precision B cell gene engineering coupled with artificial intelligence-guided protein design produces active tissue-nonspecific alkaline phosphatase (“ALP”)
  • Data presented at American Society of Gene & Cell Therapy 27th Annual Meeting

Be Biopharma, Inc. (“Be Bio”), a company pioneering the discovery and development of Engineered B Cell Medicines (BCMs), today presented results from new preclinical research demonstrating production of active ALP by a BCM, which highlights BCMs as a potential treatment for Hypophosphatasia (HPP). Researchers used CRISPR/Cas9 precision gene engineering and artificial intelligence-guided protein design to modify primary human B cells to produce ALP, an enzyme deficient in people living with HPP. The findings were presented during a poster presentation at the American Society of Gene & Cell Therapy (ASGCT) 27th Annual Meeting on Friday, May 10, at 12:00pm ET.

HPP is a rare genetic disease caused by loss of function mutations in the ALPL gene which leads to deficient ALP activity. People living with HPP can experience wide ranging systemic complications, with impaired bone mineralization, such as rickets/osteomalacia, being a major clinical hallmark of severe disease. The only approved therapy for HPP is an enzyme replacement therapy, asfotase alfa, which requires multiple injections every week and is approved only for use in patients with pediatric-onset forms of HPP.

“This study demonstrates how BCMs coupled with artificial intelligence-guided protein design broaden the potential of our medicines to express highly effective conjugated therapeutic proteins such as ALP-Fc fusion proteins,” said Rick Morgan, Chief Scientific Officer. “BCMs are designed to provide constant and durable protein levels without preconditioning, are redosable, and can be applied to a wide range of diseases, including a potential first-in-class medicine for people living with HPP.”

In this study, primary human B cells were expanded and precision engineered by CRISPR/Cas9 genome editing with AAV-mediated homology directed repair (HDR) to insert an ALP gene expression cassette into various loci, including CCR5 (a safe harbor locus). Guided by an artificial intelligence-based ALP protein structure design engine, protein constructs were optimized for activity and stability of ALP-Fc fusion proteins. Engineered BCMs secreted active ALP proteins up to 200 ng/1e6 cells/24hr. Robust in vitro phenotypic correction using ALP secreting BCMs (ALP-BCMs) was demonstrated in the MC3T3 osteoblast precursor mineralization model.

About Engineered B Cell Medicines – A New Class of Cellular Medicines

The B cell is a powerful cell that produces thousands of proteins per cell per second at constant levels, and over decades. Precision genome editing can now be used to engineer B Cells that produce therapeutic proteins of interest, driving a new class of cellular medicines – Engineered B Cell Medicines (BCMs) – with the potential to be durable, allogeneic, redosable, and administered without pre-conditioning. The promise of BCMs could transform therapeutic biologics with broad application — across protein classes, patient populations and therapeutic areas.

About Be Biopharma

Be Biopharma (“Be Bio”) is pioneering Engineered B Cell Medicines (BCMs) to dramatically improve the lives of patients who are living with Hemophilia B and other genetic diseases, cancer, and other serious conditions. With eyes locked on the patient, our team of purpose-driven scientists, technologists, manufacturing experts and business builders collaborate to create a bold new class of cell therapies. Be Bio was founded in October 2020 by B cell engineering pioneers David Rawlings, M.D., and Richard James, Ph.D., from Seattle Children’s Research Institute. Be Bio is backed by ARCH Venture Partners, Atlas Venture, RA Capital Management, Alta Partners, Longwood Fund, Bristol Myers Squibb, Takeda Ventures, Seattle Children’s Research Institute and others. Since our founding, Be Bio’s investors have committed over $180 million to enable the Company to re-imagine medicine based on the power of B cell therapy. For more information, please visit us at Be.Bio and our LinkedIn page.

Contacts

Investors:
ir@be.bio

Media:
media@be.bio

EGLE Therapeutics Strengthens its Leadership Team with the Appointment of Pejvack Motlagh, MD, MSc, as Chief Medical Officer and its Board of Directors with Appointment of John Celebi, MBA, as Independent Board Member

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EGLE Therapeutics, a clinical-stage biotechnology company uniquely positioned to advance the next generation of regulatory T cell-focused therapies for oncology and auto-immunity, announced today the appointment of Pejvack Motlagh MD, MSc, as Chief Medical Officer and John Celebi, as Independent Board Member.

“We are excited to welcome Pejvack and John at Egle and to benefit from their strong experience.

The appointment of Dr Motlagh is critical for Egle, as the company is moving to clinical development of assets in oncology and auto-immunity. Pejvack will impact the future development of the rich pipeline at Egle, based on the modulation of regulatory T cells.

As we advance toward the clinical development of EGL-001, John’s expertise in business development in the field of oncology is instrumental for us to successfully execute on our strategic priorities.” said Vincent Brichard, M.D., EGLE’s Interim CEO and Board member.

“I am excited to join Egle Therapeutics to translate into the clinic the company’s groundbreaking and unique science, whose innovative and versatile regulatory T-cell focused platform, a key component of the immune system, has a tremendous potential to change the treatment paradigm for the many patients with high unmet medical needs in oncology and auto-immunity” said Pejvack Motlagh, MD, MSc, CMO at Egle Therapeutics. As CMO, Pejvack will drive the clinical and medical strategy and development of our Company in the years to come.

“This is a transformational period for Egle Therapeutics as the company further strengthens its team and advances toward the clinic a series of highly novel candidates aimed at arming or disarming Treg function to achieve the desired therapeutic outcome. I look forward to collaborating with this talented Board and management team as we advance Egle’s compelling pipeline for patients with unmet need,” said John Celebi, Independent Board Member at Egle Therapeutics.

Pejvack Motlagh, MD, MSc, a seasoned clinical development executive who has previously held overall responsibility for candidate development from first in human through registrational studies, brings to Egle Therapeutics the appropriate expertise and successful drug development experience. As Chief Medical Officer, he will be responsible for advancing Egle’s pipeline towards the clinic and notably EGL-001 (a Treg-selective anti-CTLA4-IL-2m) in oncology and EGL-003 (a non-targeted IL-2 Treg engager) in auto-immune diseases. Prior to Egle Therapeutics, Dr. Motlagh was Chief Medical Officer at Mablink, an ADC biotech company, where through the establishment of a differentiating clinical development plan he contributed to the value creation leading to an acquisition by Eli Lilly. Previously, he held global positions at leading oncology companies such as GSK, Bristol-Myers Squibb and AstraZeneca, where he was instrumental in the transition of several compounds towards the late clinical development phases of now approved drugs. At Boehringer Ingelheim, he oversaw, managed and prioritized their whole IO portfolio.

John Celebi, MBA, brings over 25 years of experience building innovative entrepreneurial biotechnology companies. He currently serves as President and CEO of Sensei Biotherapeutics (NASDAQ: SNSE), a biotechnology company focused on the discovery and development of novel immunotherapies for cancer patients with unmet needs. Previously, Mr. Celebi served as the Chief Operating Officer of X4 Pharmaceuticals where he established and oversaw the company’s oncology business strategy. He also served as Chief Business Officer of Igenica Biotherapeutics, Inc., an immunotherapy company formed by The Column Group, 5AM Ventures, Orbimed, and Third Rock Ventures, where he established key academic and industry relationships, including with MedImmune. Mr. Celebi has extensive transactional and alliance management experience, having served as Vice President of Business Development, New Product Planning and Alliance Management at ArQule, Inc., where he played a central role in the formation of alliances with Roche, Daiichi-Sankyo, and Kyowa Hakko Kirin. Mr. Celebi was an early employee at Tularik, Inc., where he conducted drug discovery and basic research. Mr. Celebi received an MBA from Carnegie Mellon University and a B.S. in biophysics from the University of California, San Diego.

About Egle Therapeutics SAS (Egle)

Egle Therapeutics is a biotechnology company focused on developing immunotherapies targeting suppressive regulatory T cells. Egle is leveraging a proprietary discovery platform to unveil novel Treg specific targets and to develop innovative Treg-focused drug candidates for oncology and autoimmune diseases. Egle aspires to advance toward the clinic its most advanced drug candidates, EGL-001 (a Treg-selective anti-CTLA4-IL-2m) and EGL-003 (non-targeted IL-2 Treg engager), which are currently developed in IND-enabling studies.

Find out more at www.egle-tx.com.

Contacts

contact@egle-tx.com / 0033 (0)1 86 64 08 57

investor.relations@egle-tx.com / 0033 (0)1 86 64 08 57

Sanofi and Novavax announce co-exclusive licensing agreement to co-commercialize COVID-19 vaccine and develop novel flu-COVID-19 combination vaccines

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Sanofi and Novavax announce co-exclusive licensing agreement to co-commercialize COVID-19 vaccine and develop novel flu-COVID-19 combination vaccines

  • Agreement provides patients with broader access to a protein-based non-mRNA adjuvanted COVID-19 vaccine through combined commercial strength, from 2025 onwards
  • Accelerates potential for development of a novel flu-COVID-19 combination product based on authorized vaccines with demonstrated efficacy and tolerability, potentially offering patients enhanced convenience and protection

Paris and Gaithersburg, Md., United States. May 10, 2024. As part of Sanofi’s commitment to developing a diverse portfolio of best-in-class vaccines, the company has entered into a co-exclusive licensing agreement with Novavax, a biotechnology company headquartered in Maryland, US.

The terms of the agreement include: a co-exclusive license to co-commercialize Novavax’s current stand-alone adjuvanted COVID-19 vaccine worldwide (except in countries with existing Advance Purchase Agreements and in India, Japan, and South Korea where Novavax has existing partnership agreements); a sole license to Novavax’s adjuvanted COVID-19 vaccine for use in combination with Sanofi’s flu vaccines; and a non-exclusive license to use the Matrix-M adjuvant in vaccine products. In addition, Sanofi will take a minority (<5%) equity investment in Novavax.

Jean-Francois Toussaint
Global Head of Vaccines R&D
“With flu and COVID-19 hospital admission rates now closely mirroring each other, we have an opportunity to develop non-mRNA flu-COVID-19 combination vaccines offering patients both enhanced convenience and protection against two serious respiratory viruses. We’re excited by the prospect of combining Novavax’s adjuvanted COVID-19 vaccine that has shown high efficacy and favorable tolerability, with our rich portfolio of differentiated flu vaccines that have demonstrated superior protection against flu and its serious complications. Improved tolerability and thermostability, without compromise on efficacy, are what regulators, recommending bodies, and patients will demand.”

John Jacobs
CEO, Novavax

“This collaboration is important for Novavax and for global public health. Our new partnership combines Novavax’s proprietary recombinant protein and nanoparticle technologies, Matrix™ adjuvant, and R&D expertise with Sanofi’s world-class leadership in launching and commercializing innovative vaccines. Together, we can broaden access to both our COVID-19 vaccine and our adjuvant to ensure more individuals can benefit from the protection vaccines can provide. Novavax is now in a stronger position to refocus our efforts on leveraging our technology platform and novel adjuvant in research and development and pipeline expansion to help advance our mission of developing life-saving vaccines to fight infectious diseases.” 

Under the terms of the licensing agreement:

  • Novavax will receive an upfront payment of $500 million and up to $700 million in development, regulatory and launch milestones, up to $1.2 billion in total.
  • Starting in 2025, Sanofi will book sales of Novavax’s adjuvanted COVID-19 vaccine and will support certain R&D, regulatory, and commercial expenses.
  • Novavax will receive tiered double-digit percentage royalty payments on sales by Sanofi of COVID-19 vaccines and flu-COVID-19 combination vaccines.
  • Sanofi will be solely responsible for development and commercialization of any novel flu-COVID-19 combination vaccine containing a Sanofi flu vaccine.
  • Outside of the collaboration, each party may develop and commercialize their own flu-COVID-19 vaccines and adjuvanted products at their own cost.
  • Novavax is entitled to additional launch and sales milestones opportunities of up to $200 million plus mid-single digit royalties for each additional Sanofi vaccine product developed under a non-exclusive license with Novavax’s Matrix-M adjuvant technology.
  • In addition, Sanofi will take a minority (<5%) equity investment in Novavax.

About Novavax
Novavax, Inc. (Nasdaq: NVAX) promotes improved health by discovering, developing and commercializing innovative vaccines to help protect against serious infectious diseases. Novavax, a global company based in Gaithersburg, Md., U.S., offers a differentiated vaccine platform that combines a recombinant protein approach, innovative nanoparticle technology and Novavax’s patented Matrix-M adjuvant to enhance the immune response. The Company’s portfolio includes its COVID-19 vaccine, and its pipeline includes CIC and stand-alone influenza vaccine candidates. In addition, Novavax’s adjuvant is included in the University of Oxford and Serum Institute of India’s R21/Matrix-M malaria vaccine. Please visit novavax.com and LinkedIn for more.

About Sanofi
We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across the world, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

Media Relations
Sandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.com
Sally Bain | + 1 617 834 6026 | sally.bain@sanofi.com
Evan Berland | + 1 215 432 0234 | evan.berland@sanofi.com

Nicolas Obrist | + 33 6 77 21 27 55 | nicolas.obrist@sanofi.com

Investor Relations
Thomas Kudsk Larsen |+ 44 7545 513 693 | thomas.larsen@sanofi.com
Alizé Kaisserian | + 33 6 47 04 12 11 | alize.kaisserian@sanofi.com
Arnaud Delépine | + 33 6 73 69 36 93 | arnaud.delepine@sanofi.com
Corentine Driancourt | + 33 6 40 56 92 21 | corentine.driancourt@sanofi.com
Felix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com
Tarik Elgoutni| + 1 617 710 3587 | tarik.elgoutni@sanofi.com
Nathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com

Sanofi Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi’s ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2023. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

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Seragon Biosciences completes Pre-Clinical Studies of its novel anti-aging candidate SRN-901

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Seragon Biosciences, Inc. today announced the completion of a pre-clinical study on its novel anti-aging candidate, SRN-901. This pivotal study, conducted in mice, was undertaken to evaluate the impact of SRN-901 on aging as well as various health markers.

Seragon Biosciences is a research-based biopharmaceutical company dedicated to improving human and animal health through innovative science.

Results from the study show that SRN-901 achieved one of the largest extensions of lifespan and healthspan to date in the treated population. Whole-genome transcriptome sequencing was performed on over 300 mice to assess the effects of SRN-901 at a molecular level. The results highlighted a significant increase in the expression of many genes associated with longevity and a notable reduction in the expression of genes linked to aging. Additionally, a metabolic panel revealed beneficial changes in several biomarkers associated with younger biological age.

Other tests were conducted to evaluate the effect of SRN-901 on healthspan, a measure of how long health is maintained over the course of one’s life. The study also evaluated physical and cognitive function. Treadmill tests showed significantly enhanced endurance in elderly mice. Frailty scores showed marked improvement in the elderly mice receiving SRN-901, and there was a significant reduction in tumor occurrence in the treated group.

The research team at Seragon Biosciences is encouraged by the study’s results and will conduct further analysis to uncover additional findings. These results will be published once the supplementary analysis is complete.

About Seragon Biosciences

Seragon Biosciences, Inc., headquartered in Irvine, California, is a research-based biopharmaceutical company dedicated to improving human and animal health through innovative science. Seragon Biosciences is committed to applying cutting-edge scientific and technological advancements to the fields of aging, metabolism, gene therapy, and bioinformatics. From the research end to consumer products and clinical applications, Seragon strives to bring people access to the most significant breakthroughs in medicine. For more information, please visit www.seragon.com.

Neurenati Therapeutics Strengthens Its Board of Directors With the Appointment of Dr. Marielle Cohard-Radice

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MONTREAL–(BUSINESS WIRE)–Neurenati Therapeutics, a pediatric rare diseases-focused company, is delighted to announce the appointment of a highly-experienced executive in the pharma industry as an independent board member.

Dr Marielle Cohard-Radice is a gastroenterologist who held various executive positions in several therapeutic areas over three decades. She is currently Executive Vice-president, Global Head of Development Operations at Daiichi Sankyo.

“Marielle’s role will be key in refining our clinical development strategy and maximize our development success rate. Welcome on the board of directors,” added Maxime Ranger, CEO of Neurenati.

“Newborns with Hirschsprung’s disease deserve a treatment option to avoid surgery. Preclinical efficacy data showed that NEU-001 hold promise in regenerating the enteric nervous system of these children. Looking forward to supporting Neurenati in its efforts,” said Dr. Cohard-Radice

Both independent board members, Dr Alexandre Lebeaut and Dr Marielle Cohard-Radice will assist Neurenati to create its scientific and clinical advisory board in upcoming months.

NEW MANAGEMENT TEAM MEMBER

Neurenati also announces the appointment of Dr Marie-Eve Bordeleau as Senior Director, Preclinical development. Prior to joining Neurenati’s team, Dr Bordeleau was Deputy Director of the Molecular genetics of stem cells research unit, IRIC, Université de Montréal, under the direction of Dr. Guy Sauvageau. She will be responsible for the entire preclinical program in addition to overseeing the manufacturing of NEU-001.

ABOUT NEURENATI

Neurenati Therapeutics is a Québec-based biotech company dedicated to developing therapies for rare diseases. The first technology targets Hirschsprung disease (HSCR), a life-threatening gastrointestinal (GI) birth defect characterized by the lack of nerves in parts of the lower GI tract. Neurenati proposes an innovative therapy involving growth factor to treat newborns with HSCR, thereby averting the need for surgery and associated complications.

Contacts

MEDIA CONTACT
Maxime Ranger, PhD MBA

President and CEO

Neurenati Therapeutics Inc

E: maxime@neurenati.com
T: +1.514.825.9035

ENA Respiratory Receives USPTO Notice of Allowance for Key Patent Covering INNA-051, a First-in-Class Antiviral Innate Immunomodulator

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MELBOURNE, Australia, May 08, 2024 (GLOBE NEWSWIRE) — ENA Respiratory, a clinical-stage pharmaceutical company developing innate immune modulators for the prevention of complications associated with respiratory viral infections in at-risk populations, announces today that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for patent application US 18/112091 entitled “Novel molecules” covering claims for its lead program, INNA-051 and its composition.

A virus-agnostic intranasal antiviral host defence immunomodulator, INNA-051 is a potent first-in-class agonist of toll-like receptor 2/6 (TLR2/6) which plays a key role in recognizing pathogens and triggering the innate immune response.

This USPTO allowance further strengthens ENA Respiratory’s strong IP portfolio related to INNA-051, with 30 granted patents and allowed applications in the major markets, including the US, Europe, the United Kingdom, Japan and China. The portfolio covers seven distinct patent families, with claims directed to the composition of matter for INNA-051 and various backup molecules, formulations and method of use protection, as part of a comprehensive lifecycle management strategy. ENA Respiratory has an additional 39 pending applications in various jurisdictions.

ENA Respiratory’s CEO, Christophe Demaison, PhD said: “Our IP portfolio provides robust and long-lasting protection with potential exclusivity for INNA-051 out to at least 2042 and likely for five years post that date. This gives us great confidence in the future global commercial value of our innate immune modulators as we continue to drive forwards in clinical development.”

Having demonstrated accelerated viral clearance and local stimulation of antiviral host defences for INNA-051 in a Phase IIa proof-of-principle study using a liquid formulation in an influenza-challenge model, ENA Respiratory has developed an improved dry powder formulation to take into further clinical development. This formulation recently received FDA IND clearance and the Company has submitted ethics approval for a Phase 1b study in Australia. This study is expected to be initiated in mid-2024 with the aim to assess the safety, tolerability, pharmacodynamics, and pharmacokinetics of the dry powder formulation of INNA-051 in older adults.

About ENA Respiratory

ENA Respiratory is a clinical-stage pharmaceutical company tackling serious respiratory viral infections through the development of host defence immune modulators which locally prime and boost the body’s innate immune response – the natural first line of defence. Being virus-agnostic, immune modulators are complementary to often virus-specific vaccines and existing direct-acting antivirals.

The company’s lead product, INNA-051, is a potent agonist of toll-like receptor 2/6 (TLR2/6) which plays a key role in recognising pathogens and triggering the innate immune response. With a safe profile supporting prophylaxis use, it has demonstrated accelerated viral clearance and stimulation of antiviral host defences, including IFN Type I & III responses, in a Phase IIa proof-of-principle study using an influenza-challenge model. INNA-051 is being developed as a convenient, once-a-week nasal dry powder product to prevent complications associated with respiratory viral infections in at-risk populations, including the elderly, those with an underlying medical condition (including chronic lung conditions, diabetes, kidney disease, and cardiovascular disease) and individuals with occupational risk (e.g. first responders, military or essential services personnel).

Headquartered in Melbourne, Australia, the company has raised US$26M (AU$44million) in equity financing from Brandon Capital, The Minderoo Foundation and Uniseed. It is partnered with the COPD Foundation to support the clinical development of INNA-051 in COPD and has been awarded a US$8.18million contract from the U.S. Department of Defence. It is a member BLUE KNIGHT™, a joint initiative between Johnson & Johnson Innovation and BARDA designed to accelerate next-gen potential solutions for future pandemics.

For more information, please visit https://enarespiratory.com

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Cagent Vascular appoints Chairman Brian Walsh to expanded role as Chief Executive Officer

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WAYNE, Pa.–(BUSINESS WIRE)–#CLI–Cagent Vascular announced today that Brian Walsh has been named Chief Executive Officer by the Cagent Vascular Board of Directors. He has served as Chairman of the Board since March 2018 and will continue in this capacity. Mr. Walsh will succeed Carol Burns as CEO.

Cagent Vascular

Mr. Walsh previously served as Head of Carl Zeiss Meditech Cataract Technology from 2018 until 2024. Prior to that, he was President and CEO of IanTECH Medical, Inc. (acquired by Carl Zeiss Meditech AG) and Transcend Medical, Inc which was acquired by Alcon, a division of Novartis Co (NYSE: NVS) at the time. Brian Walsh brings over 25 years of medical device and health care industry experience in Marketing, Sales, and Executive Leadership which positions him as the ideal candidate to drive the market adoption of Cagent Vascular’ s flagship product, Serranator.

“Cagent Vascular is an exceptional company with a disruptive technology platform and a highly talented team,” Mr. Walsh said. “It is a privilege to lead this company through the next phase of growth. Our focus in the weeks, months, and years ahead will be on driving superior execution as we scale up and realize further market adoption.

Marc-Andre Marcotte, a Cagent Vascular board member and Partner at Sectoral Asset Management, said, “Brian Walsh’s tenure as Chairman of the Board and previous executive leadership positions give him the perfect vantage point from which to take the company forward. The board is dedicated to working with Brian and team to accelerate market adoption of Serranator and help elevate the patient care journey. On behalf of the board, I thank Carol for her significant contributions both as co-founder and as CEO over the past 10 years.”

About Cagent Vascular

Cagent Vascular, founded and led by serial medical technology entrepreneurs, is the leader in Serration Technology to treat peripheral artery disease. The company has developed a transformative improvement to conventional angioplasty, which is the most commonly performed procedure to restore blood flow. Although angioplasty has been used clinically for over 50 years, there remain significant opportunities to optimize the therapy and to improve the treatment outcomes of cardiovascular disease. To learn more about Cagent Vascular’s mission to fight PAD, visit www.cagentvascular.com.

The information contained herein obtained from Cagent Vascular management is believed to be reliable. This does not constitute the solicitation of the purchase or sale of securities. Except for historical information contained herein, matters discussed in this document are forward-looking statements, the accuracy of which is subject to risks and uncertainties.

This project is supported by the Ben Franklin Technology Partners of Southeastern PA, an initiative of the Pennsylvania Department of Community and Economic Development funded by the Ben Franklin Technology Development Authority.

Contacts

Cagent Communications and Media Contact:

Lauren Pfeiffer

+1 610 668-2006

LPfeiffer@cagentvascular.com

EyeDNA Therapeutics Announces Positive 24-month Data from Ongoing Phase I/II Trial of HORA-PDE6b Gene Therapy in Patients with Retinitis Pigmentosa Caused by Bi-allelic Mutations in PDE6b

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Clinically meaningful benefit in visual functions and good safety profile of HORA-PDE6b is confirmed at 24-month follow-up

Phase I/II results will be discussed with US and European health authorities to define optimal path to making HORA-PDE6b available to patients with PDE6b Retinitis Pigmentosa

Paris, France, May 7, 2024 – eyeDNA Therapeutics (‘eyeDNA’), a newly created subsidiary of Coave Therapeutics (‘Coave’), a genetic medicine company focused on developing life-changing therapies, today announces positive 24-month follow-up results from its Phase I/II study (NCT03328130) evaluating the safety and efficacy of HORA-PDE6b, its investigational gene therapy for retinitis pigmentosa (RP) caused by bi-allelic mutations in the PDE6b gene (PDE6b RP). These data were reported during an oral presentation* on May 6, at the Association for Research in Vision and Ophthalmology (ARVO) 2024 meeting in Seattle, WA, US.

The positive 24-month follow-up data presented confirm results from the previous interim analysis of the trial conducted at the 12-month follow-up point and support preparation for a registrational trial for HORA-PDE6b in PDE6b RP patients. Further discussions with health authorities in the US and Europe are planned to define the optimal path to making HORA-PDE6b available to PDE6b RP patients.

To date, HORA-PDE6b has been administered in 17 evaluable patients aged 18 years and older presenting an advanced form of PDE6b RP using two ascending doses in four consecutive cohorts. The treatment was administered in the more affected eye while the other eye served as an untreated control.

In a subgroup of clinical interest of six patients receiving the high dose, with less advanced disease (Best Corrected Visual Acuity (BCVA) score ≤75 ETDRS letters [ ≤ 20/32 Snellen equivalent], Goldmann Visual Field (GVF) ≥ 10 degrees), positive efficacy results were reported at 24 months on the BCVA and the GVF outcomes. The BCVA mean change from baseline increased by +0.09 LogMar in the untreated eye, while acuity in the treated eye was stabilized (+0.02 LogMar). From baseline, the mean reduction of the GVF was over 300 deg² superior in the untreated eyes compared to the treated eye.

Interestingly, long-term data available from patients from the low dose group (n=7) followed up over a five-year period found that the BCVA of the untreated eyes consistently declined (increase of 0.05 to 0.08 LogMAR/year from the second year), which is in line with the natural history of the disease. Meanwhile, the mean change from baseline of BCVA of the treated eyes in the same group is stabilized (between +0.03 and +0.06 LogMAR over the same follow-up period). The difference of BCVA mean change from baseline between the treated eyes and the untreated eyes at five years is 0.25 LogMAR (12 Letters).

Furthermore, the full-field stimulation test (FFST) in blue light assessing rod function continues to show an improvement of the light perception threshold in favor of the treated eyes, which is considered clinically meaningful (improvement of almost six decibels). The interesting positive trend on the retinal anatomical evaluation by Optical Coherence Tomography (OCT; Ellipsoid Zone horizontal length) observed at 12-month follow-up on the subgroup of clinical interest is maintained after 24 months.

Following the 24-month study period, both doses were well tolerated (n=17). Five ocular Serious Adverse Events (SAEs) occurred including two resolved SAEs possibly related to HORA-PDE6b (one chorioretinitis and one reduced visual acuity). Patients did not receive preventive oral corticosteroids.

An additional cohort of four to six younger patients aged 13-17 years old with a GVF at baseline ≥ 20 degrees in each meridian and at an earlier disease stage is ongoing with three patients enrolled.

“The highly encouraging safety and efficacy data observed in patients two years after treatment with HORA-PDE6b continue to support our view that this novel gene therapy could provide an important clinical benefit for PDE6b RP patients. These data will support our discussions with regulators to determine the optimal route for getting HORA-PDE6b to patients,” said Rodolphe Clerval, Chief Executive Officer. “At the same time, we continue to evaluate HORA-PDE6 in an expansion cohort of younger patients with less advanced disease, for whom treatment with HORA-PDE6b could have an even greater therapeutic impact.”

“PDE6b retinitis pigmentosa is a progressive and irreversible inherited degenerative disease that leads to significant visual impairment and blindness. These two-year safety and promising efficacy results are of great medical interest and could represent a significant step towards providing an effective treatment for patients with this devastating disease,” commented Dr. Jean-Baptiste Ducloyer, MD, Nantes University Department of Ophthalmology.

*Abstract 2134:

JB Ducloyer, et al. 12-month Safety and Efficacy Evaluation of HORA-PDE6b, a Gene Therapy Targeting Patients with Retinitis Pigmentosa Due to Biallelic PDE6B Gene Mutation

***

About eyeDNA Therapeutics and HORA-PDE6b

eyeDNA Therapeutics, a wholly owned subsidiary of Coave Therapeutics, is a clinical-stage gene therapy company, focused on developing life-changing therapeutics for inherited retinal disorders. Our lead program HORA-PDE6b, an AAV5-based gene replacement therapy, is being evaluated in a Phase I/II trial for the treatment of retinitis pigmentosa (RP) caused by bi-allelic mutations of the PDE6b gene (PDE6b RP) (NCT03328130).

eyeDNA and Théa Open Innovation (‘TOI’) are partners for the development and commercialization of HORA-PDE6b. eyeDNA is responsible for the global development of HORA-PDE6b and retains commercial rights to the product in the US, Japan, South Korea, China and other territories outside Europe. In Europe and certain other countries, HORA-PDE6b is being co-developed by Coave and TOI under a license and development agreement with exclusive rights granted to TOI to commercialize HORA-PDE6b in these territories.

About Coave Therapeutics

At Coave Therapeutics, we are leading the transition of genetic medicine from rare to prevalent conditions, starting with neurodegenerative and eye diseases. Our proprietary ALIGATER™ (Advanced Vectors-Ligand Conjugates) platform introduces chemical modifications onto AAV capsids or Lipid Nanoparticles (LNPs) to overcome the limitations of current vectors on efficacy, safety, and manufacturability.

With low doses and optimized routes of administration, our conjugated vectors have demonstrated markedly improved transduction and biodistribution in the central nervous system and the eye across different species. Our diverse pipeline of novel genetic medicines can potentially transform the lives of people afflicted by rare and prevalent neurodegenerative and ocular diseases – including genetically and non-genetically defined indications.

Coave recently created its subsidiary eyeDNA Therapeutics to focus on the development – up to the marketing authorization application – of its unique gene therapy HORA-PDE6b for the treatment of inherited retinal diseases caused by mutations in the human PDE6b gene.

Headquartered in Paris, France, Coave Therapeutics is backed by leading international life sciences investors. For more information about the science, pipeline, and people, please visit https://coavetx.com/ and follow us on LinkedIn.

CONTACTS
eyeDNA Therapeutics and Coave Therapeutics
Rodolphe Clerval, CEO
contact@coavetx.com

MEDiSTRAVA
Sylvie Berrebi, Leila Adlam, Mark Swallow
coavetx@medistrava.com

FDA Approves ColoSense™ – Geneoscopy’s Noninvasive Multi-target Stool RNA (mt-sRNA) Colorectal Cancer Screening Test

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  • In average-risk individuals, ColoSense demonstrated 93% sensitivity for detecting colorectal cancer (CRC) and 45% sensitivity for detecting advanced adenomas (AA).
  • The CRC-PREVENT study evaluated more than 1,800 average-risk individuals aged 45-49, representing over 20% of participants. Results in this subgroup showed 100% sensitivity in detecting CRC and 44% sensitivity for AA, offering a promising new tool to combat early-age onset CRC.

ST. LOUIS–(BUSINESS WIRE)–Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, today announced that the U.S. Food and Drug Administration (FDA) approved its noninvasive colorectal cancer screening test, ColoSense. ColoSense is indicated as a screening test for adults, 45 years of age or older, who are at typical average risk for developing CRC.

Designated as a Breakthrough Device by the FDA, ColoSense is the first noninvasive colorectal cancer screening test to provide a dynamic view of disease activity by using RNA biomarkers. RNA biomarkers are not subject to age-related methylation patterns that can lead to variability in test performance across different age groups.1-2

“Securing FDA approval for ColoSense marks a significant milestone for Geneoscopy and demonstrates that our patented RNA technology can provide millions of eligible adults with a safe and effective option for detecting CRC and advanced adenomas,” said Andrew Barnell, CEO and co-founder of Geneoscopy. “This achievement is a testament to our deep dedication and commitment to bringing innovative technology to market that will improve outcomes for this deadly, yet preventable, disease.”

Geneoscopy’s CRC-PREVENT trial evaluated participants aged 45 and older from various racial, ethnic, and socioeconomic backgrounds. Using a novel decentralized enrollment approach, 64% of participants had never been screened for colorectal cancer, and 68% of participants had not scheduled a colonoscopy at the time of enrollment. This is unlike traditional centralized trials, in which patients are typically already engaged in healthcare screening programs. In average-risk individuals, ColoSense successfully demonstrated 93% sensitivity for CRC and importantly identified 100% of CRC in Stage I, when the disease is most curable. Additionally, ColoSense detected 45% of advanced adenomas, when the disease is most preventable. Notably, the study reported 100% CRC sensitivity and 44% AA sensitivity in patients aged 45-49, a critically important screening demographic.

Colorectal cancer is the second deadliest cancer in the United States. However, millions of eligible Americans do not get screened due to a lack of access to or avoidance of invasive options like colonoscopies. CRC incidence rates are also rising among younger populations under 50 years old, prompting a recent shift in the United States Preventive Services Task Force’s guidelines to recommend initiation of CRC screening at age 45.3 Underscoring the critical nature of this issue, the American Cancer Society recently reported that colorectal cancer is now the leading cause of cancer death for males and the second leading cause of death for females under 50.4 Further compounding this challenge, approximately 40% of unscreened and eligible Americans are ages 45-49.5,6

“The growing number of adults diagnosed with colorectal cancer underscores the urgent need for innovative approaches in screening. It’s essential to eliminate obstacles and broaden the availability of screening methods for healthcare providers and patients,” said Anjee Davis, president of Fight CRC. “We hope that introducing new FDA-approved diagnostic tools, including stool-based tests like ColoSense, will help to advance access and increase screening rates, ultimately reducing the impact of late-stage colorectal cancer diagnoses.”

FDA approval of ColoSense is a significant step in making this important screening tool available to patients. Geneoscopy is working with payors, professional societies, and advocacy partners to support a commercial launch later this year or early in 2025 to ensure patients have timely access to ColoSense to support CRC screening. Geneoscopy will launch ColoSense in collaboration with Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services.

About ColoSense

ColoSense is intended for the qualitative detection of colorectal neoplasia-associated RNA markers and for the presence of occult hemoglobin in human stool. ColoSense is for use with the ColoSense Collection Kit, the ColoSense Test Kit, the ColoSense Software, and the following instruments: Polymedco iFOBT Analyzer; bioMérieux EMAG Nucleic Acid Extraction System; and Bio-Rad QXDx ddPCR System. ColoSense is a single-site test performed at Geneoscopy, Inc.

A positive ColoSense result may indicate the presence of colorectal cancer (CRC), advanced adenomas (AA), or serrated precancerous lesions (SPL) and should be followed by a colonoscopy. ColoSense is indicated as a screening test for adults, 45 years of age or older, who are at typical average risk for developing CRC. ColoSense is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals.

Results from Geneoscopy’s pivotal CRC-PREVENT trial were published in The Journal of the American Medical Association (JAMA) in October 2023. For more information, visit www.colosense.com.

About Geneoscopy, Inc.

Geneoscopy, Inc. is a life sciences company focused on developing diagnostic tests for gastrointestinal health. Leveraging its proprietary, patented stool-derived eukaryotic RNA (seRNA) biomarker platform, Geneoscopy’s mission is to empower patients and providers to transform gastrointestinal health through innovative diagnostics. Beyond colorectal cancer screening, Geneoscopy is developing diagnostic tests for treatment selection and therapy monitoring in other disease areas in partnership with leading universities and biopharmaceutical companies. For more information, visit www.geneoscopy.com and follow the company on LinkedIn.

References:

  1. Ahlquist DA, Taylor WR, Yab TC, et al. Abstract 3572: Methylated gene marker levels in stool: Effects of demographic, drug, and body mass and other patient characteristics. Cancer Research. 2012;72(8_Supplement):3572-3572. https://doi.org/10.1158/1538-7445.am2012-3572
  2. Ahlquist DA, Taylor WR, Yab TC, Devens ME, Mahoney DW, et al. Aberrantly methylated gene marker levels in stool: effects of demographic, exposure, body mass, and other patient characteristics. J Mol Biomark Diagn. 2012;3:133. doi:10.4172/2155-9929.1000133
  3. Mehta SJ, Morris AM, Kupfer SS. Colorectal Cancer Screening Starting at Age 45 Years—Ensuring Benefits Are Realized by All. JAMA Netw Open. 2021;4(5):e2112593. doi:10.1001/jamanetworkopen.2021.12593
  4. American Cancer Society https://pressroom.cancer.org/acs-cff-2024
  5. Hyams T, Mueller N, Curbow B, King-Marshall E, Sultan S. Screening for colorectal cancer in people ages 45-49: research gaps, challenges and future directions for research and practice. Translational Behavioral Medicine. 2022;12(2):198–202. https://doi.org/10.1093/tbm/ibab079
  6. US Census data, Geneoscopy estimates (includes US markets only)

 

Contacts

Media

Andrea Sampson

Sampson Public Relations Group

asampson@sampsonprgroup.com

Investor Relations

Carrie Mendivil / Ji-Yon Yi

Gilmartin Group

investors@geneoscopy.com