Parexel Announces AI Partnership with Weave Bio to Accelerate Regulatory Submission Processes




Parexel Announces AI Partnership with Weave Bio to Accelerate Regulatory Submission Processes

Collaboration leverages Parexel’s proven regulatory expertise and Weave Bio’s AI-native platform, aims to speed up market introduction of new therapies

RALEIGH, N.C., Sept. 30, 2025 (GLOBE NEWSWIRE) — Parexel, a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry today announced a partnership with Weave Bio, a pioneer in AI-native regulatory automation management solutions, aimed to accelerate regulatory submission processes and the time to market for new therapies. Under the agreement, Parexel will serve as Weave’s CRO design partner and will leverage Parexel’s extensive regulatory consulting expertise across clinical, non-clinical, clinical pharmacology and chemistry, manufacturing, and controls (CMC) to enhance Weave’s AI platform and product pipeline. In addition, Parexel will maintain a period of exclusivity as the only CRO licensed to use Weave’s innovative solutions after new products launch.

“This partnership represents a significant advancement in Parexel’s vision to leverage AI to speed clinical research processes, enhance first-time quality and accelerate the delivery of life-changing therapies to patients,” said Paul Bridges, President, Consulting, Parexel. “We’re beginning this partnership by addressing an area where sponsors feel extreme urgency – early regulatory authoring and submission preparation. By combining Weave’s cutting-edge AI technology with the human-in-the-lead expertise of Parexel Consulting, we’re helping teams move faster and with greater confidence while maintaining the highest levels of quality and compliance.”

Parexel has already leveraged Weave’s flagship offering, AutoIND, to support Investigational New Drug (IND) applications, and has been able to complete them 50% faster than traditional IND authoring timelines. These scalable efficiency gains enable high quality INDs to be developed at a transformative pace, supporting sponsors with the time-sensitive step of initiating new clinical trials sooner than current industry timelines. Weave’s AutoIND functionality is now part of Weave’s comprehensive regulatory workflow solution, The Weave Platform, that spans the entire regulatory lifecycle.

“AI tools are only as strong as the people behind them. Human experts provide the context that guides our platform and help translate its findings into action,” said Lindsay Mateo, Chief Commercial Officer at Weave. “Through this partnership, Weave will tap into Parexel’s deep regulatory expertise to refine and expand our solutions across the drug development industry.”

Parexel and Weave are presenting at the Regulatory Affairs Professionals Society (RAPS) Convergence on October 7-9 in Pittsburgh, Pennsylvania and will discuss the partnership during presentations and at their booths.

Parexel Booth: #606

Weave Bio Booth: #421

Thought leadership session: Speed Without Shortcuts: Navigating Regulatory Boundaries for AI Applications in Clinical Trials featuring

• Tala Fakhouri, Vice President Consulting, AI & Digital Policy, Real-World Research, Parexel
• Ryan Zettle, Head of Regulatory Submissions, Americas, Regulatory Consulting, Parexel

Sponsored Presentation: Lessons from a comparative analysis of old and new AI-infused regulatory processes

• Brandon Rice, CEO & Co-Founder

About Parexel 
Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our 24,000+ professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™  We continue to earn recognition industrywide, including the 2024 Fierce Biotech CRO Award for “Innovative Approaches to Patient-Centric Research” and the 2024 and 2023 Society for Clinical Research Sites (SCRS) Eagle Award for advancing the clinical research profession through strong site partnerships. For more information, visit parexel.com and follow us on LinkedIn, X, Facebook and Instagram.   

Media  
Danaka Williams 
+1 984 298 4207 
Danaka.Williams@parexel.com  

Addison Stallings 
+1 984 833 6362 
Addison.Stallings@parexel.com  

About Weave Bio
Weave Bio is an AI-native, cloud-based, software company that is redesigning regulatory workflows — transforming how novel therapies navigate the complex path from lab to clinic. The Weave Platform is an end-to-end solution that streamlines regulatory content preparation and lifecycle management for pharmaceutical companies, biotech firms, CROs, and regulatory consultants. Weave infuses AI into every step of the workflow, from data extraction to authoring to review and data verification, yielding compliant, submission-ready regulatory dossiers with speed.

The Weave Platform has been widely adopted for preclinical IND preparation and earned industry recognition as the “Biotech AI Innovation of the Year” award winner. Weave has since expanded capabilities across the platform to encompass clinical and approval-stage submissions, delivering a comprehensive AI workbench that accelerates regulatory timelines by over 50% while improving review quality and ensuring compliance with FDA, EMA, and global regulatory standards.

Founded in 2022 and headquartered in San Francisco, Weave bridges life sciences, regulatory expertise, AI innovation, and enterprise software to solve critical bottlenecks in drug development. For more information, visit weave.bio and follow us on LinkedIn.

Media  
Tammy Lyons
+1 314 548 3811
Tammy@weave.bio

HCW Biologics Inc. (NASDAQ: HCWB) Participates in Virtual Investor “What This Means” Segment About its Proprietary T-Cell Engager Program




HCW Biologics Inc. (NASDAQ: HCWB) Participates in Virtual Investor “What This Means” Segment About its Proprietary T-Cell Engager Program

Watch the “What This Means” video here

Featuring Company’s second-generation T-Cell Engager program
 and advantages over first-generation

Company’s T-Cell Engager program has made improvements in manufacturability, preclinical safety profile, and ability to treat a wide spectrum of solid tumors

MIRAMAR, Fla., Sept. 30, 2025 (GLOBE NEWSWIRE) — HCW Biologics Inc. (the “Company” or “HCW Biologics”), (NASDAQ: HCWB), a U.S.-based clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen healthspan by disrupting the link between inflammation and age-related diseases, today announced that Peter Rhode, PhD, Chief Scientific Officer and Vice President of Clinical Operations of HCW Biologics, participated in a Virtual Investor “What This Means” segment.

As part of the segment, Dr. Rhode discussed the Company’s recent news announcing its TRBC-based second-generation T-Cell Engager (“TCE”) program and the positive safety profile from a non-human primate investigative study recently conducted by the Company for its TCE program. HCW Biologics believes its second-generation TCEs could alleviate the challenges of the first generation TCEs, such as complex manufacturing processes, tolerability, safety, antigen selection, and efficacy for solid tumors. The Company has joined a small group of innovative biotechnology companies who have discovered new TCEs that overcome resistance mechanisms and improve the ability to treat solid tumors.

The Virtual Investor “What This Means” segment featuring HCW Biologics is now available here.

About HCW Biologics:

HCW Biologics Inc. (NASDAQ: HCWB) is a clinical-stage biopharmaceutical company developing proprietary immunotherapies to treat diseases promoted by chronic inflammation, especially age-related and senescence-associated diseases. The Company’s immunotherapeutics represent a new class of drugs that it believes have the potential to fundamentally change the treatment of cancer and many other diseases and conditions that are promoted by chronic inflammation — and in doing so, improve patients’ quality of life and potentially extend longevity. Chronic inflammation, including inflammaging, is believed to be a significant contributing factor to senescence-associated diseases and conditions that diminish healthspan, including many types of cancer, autoimmune diseases, and neurodegenerative diseases, as well as many indications that impact quality-of-life that are not life-threatening. The Company’s lead product candidate, HCW9302, was developed using the Company’s legacy TOBI™ (Tissue factOr-Based fusIon) platform. The Company has created another drug discovery technology, the TRBC platform, which is not based on Tissue Factor. The TRBC platform has the capability to construct immunotherapeutics that not only activate and target immune responses but are also equipped with receptors that specifically target cancerous or infected cells. This platform is a versatile scaffold that enables the creation of multiple classes of immunotherapeutic compounds: Class I: Multi-Functional Immune Cell Stimulators; Class II: Second-Generation Immune Checkpoint Inhibitors; Class III: Multi-Specific Targeting Fusions and Enhanced Immune Cell Engagers. These novel immunotherapeutics are being developed for treatment of a wide range of disease indications, including oncology, autoimmune diseases, and improving quality of life conditions. The Company has constructed over 50 molecules using the TRBC platform. Further preclinical evaluation studies are currently being conducted for these molecules the Company has selected based on promising preclinical data. The Company has two licensing programs in which it has licensed exclusive rights for some of its proprietary molecules. See the Company Pipeline at https://hcwbiologics.com/pipeline/

Forward Looking Statements:

Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “expect,” “believe,” “will,” “may,” “should,” “estimate,” “project,” “outlook,” “forecast” or other similar words and include, the actual success and potency of the Company’s TCE-based TRBC fusion molecules; the ability of the Company’s TCE’s to target cancer antigens, CD3 activation of effector T cells, and reduce immunosuppression in the tumor microenvironment; the ability of the Company’s TCEs to exhibit potent and antigen-specific anti-pancreatic cancer activities both in vitro and in humanized mouse models; or whether the Company’s TCEs are effective in treatment of solid tumors and pancreatic cancers. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties that are described in the section titled “Risk Factors” in the annual report on Form 10-K filed with the United States Securities and Exchange Commission (the “SEC”) on March 28, 2025, the latest Form 10-Q filed with the SEC on August 18, 2025 and in other filings filed from time to time with the SEC.

Company Contact:
Dr. Peter Rhode
Chief Scientific Officer and Vice President of Clinical Operations
HCW Biologics Inc.
PeterRhode@HCWBiologics.com 

24/7 Market News: Sportswear and Smart Textiles are likely Key Spider Silk Target Markets for Kraig Labs




24/7 Market News: Sportswear and Smart Textiles are likely Key Spider Silk Target Markets for Kraig Labs

DENVER, Sept. 30, 2025 (GLOBE NEWSWIRE) — 247marketnews.com, a pioneer in digital media dedicated to the swift distribution of financial market news and information, highlights the opportunity for recombinant spider silk produced by Kraig Biocraft Laboratories (OTCQB: KBLB), the global leader in the development and commercialization of spider silk. 24/7 Market News believes that some of the most obvious projected use-cases include compression gear, perspiration-wicking layers, temperature-regulating base layers, apparel for skiing, snowboarding, skateboarding, and contact sports.

Spider silk’s natural properties, lightweight toughness, high elasticity, breathability, and thermal regulation, make it particularly suitable for athletic settings. As more consumers seek gear that performs and aligns with sustainability, spider silk can offer performance advantages over synthetic textiles without the environmental downsides.

Kraig Labs is preparing to deliver the first spider silk samples to three apparel/gear companies, two of which are in the sports arena. These samples will probably be tested for durability, washability, moisture handling, and comfort, factors essential in demanding sports applications.

Smart textile enhancements, such as integrating sensors or responsive fibers (e.g., humidity-responsive contraction or cooling fabrics), may find spider silk an ideal base substrate due to its biocompatible, responsive properties. Academic research has shown spider silk-inspired fibers can exhibit supercontraction and responsive behavior under varying humidity conditions.

With a global technical textiles market valued at $200 billion in 2024 and projected to grow at a 5.2% CAGR through 2030, Kraig Labs is poised to disrupt traditional synthetics like polyester and nylon by offering sustainable, high-performance alternatives for athletic and smart fabric applications.

Emerging use cases include compression gear, moisture-wicking base layers, temperature-regulating apparel, and gear for high-impact sports such as skiing, snowboarding, skateboarding, cycling, and contact athletics. The demand for materials that combine technical performance, comfort, and sustainability continues to rise in the $400+ billion global sportswear market, driven by sustainability trends and performance innovation, creating a prime opportunity for KBLB’s scalable silk production.

Please click here to read the full Kraig Labs analyst report on 247marketnews.com.

About Kraig Biocraft Laboratories, Inc.

Kraig Biocraft Laboratories, Inc. (OTCQB: KBLB) is a biotechnology company focused on the development and commercialization of spider silk-based fiber technologies. Through its proprietary silkworm-based genetic engineering platform, Kraig Labs produces high-performance, cost-effective, and scalable spider silk materials for use in defense, performance apparel, technical textiles, and medical applications.

For more information, please visit: www.kraiglabs.com

Contact sales@247marketnews.com for Analyst Report coverage and other investor/public relations services.

About 24/7 Market News

24/7 Market News (24/7 MN) is a leading market news platform for public companies. As a pioneer in digital media, 24/7 MN is dedicated to the swift distribution of financial market news and information. 24/7 MN takes great pride in creating innovative public relations campaigns that help clients reach the target audience.

24/7 MARKET NEWS, INC (247) Disclaimer and Disclosure
PAID EDITORIAL DISCLOSURE: This is a paid editorial communication intended for informational purposes only. 247 is a third-party media provider and has been compensated by one or more featured companies for providing ongoing KBLB market outreach and other services. This press release may include technical analysis and should not be construed as financial or investment advice. Trading stocks involves risks, and readers should consult with their financial advisor before making investment decisions. Please review 247’s Full Disclaimer https://www.247marketnews.com/disclaimer/. Please go to https://247marketnews.com/kblb-disclosure/ for further KBLB and 247marketnews.com disclosure information.

CONTACT:
24/7 Market News
Editor@247marketnews.com

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements that are subject to various risks and uncertainties. Such statements include statements regarding the Company’s ability to grow its business and other statements that are not historical facts, including statements which may be accompanied by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Actual results could differ materially from those described in these forward-looking statements due to a number of factors, including without limitation, the Company’s ability to continue as a going concern, general economic conditions, and other risk factors detailed in the Company’s filings with the SEC. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company does not undertake any responsibility to update such forward-looking statements except in accordance with applicable law.

PolyPid to Present Its Positive Phase 3 SHIELD II Topline Results at the 2025 American College of Surgeons Clinical Congress




PolyPid to Present Its Positive Phase 3 SHIELD II Topline Results at the 2025 American College of Surgeons Clinical Congress

The Company will present the reported topline results from its phase 3 SHIELD II trial at one of the world’s leading surgical conferences

PETACH TIKVA, Israel, Sept. 30, 2025 (GLOBE NEWSWIRE) — PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced that Dr. Shmuel Sharoni will present the topline results from the Company’s successful Phase 3 SHIELD II trial of D-PLEX₁₀₀ at the upcoming 2025 American College of Surgeons (ACS) Clinical Congress in Chicago, IL.

Dr. Shmuel Sharoni will deliver a presentation titled “Efficacy Of A Novel Local Prolonged-release Incisional Doxycycline On Surgical Site Infection Prophylaxis In Abdominal Colorectal Surgery: The Shield II Phase 3 Randomized Clinical Trial,” during the high-impact clinical trials session on Sunday, October 5, 2025, at 11:30 AM CT.

Conference Details:

• 2025 ACS Clinical Congress; October 4–7, McCormick Place, Chicago, IL
• Presentation Date: Sunday, October 5, 2025, at 11:30 AM CT
• Session: SF109 “High Impact Clinical Trials and Studies”

The PolyPid management team will be available for meetings during the conference. For more information or to schedule a meeting, please contact IR@Polypid.com.

About SHIELD II

The SHIELD II Phase 3 trial was a prospective, multinational, randomized, double-blind study that successfully met its primary and all key secondary efficacy endpoints. The trial demonstrated that D-PLEX₁₀₀, when administered alongside standard of care, achieved a 38% reduction (p<0.005) in the combined endpoint of surgical site infections, reinterventions, or mortality compared to standard of care alone. Additionally, the trial showed a 58% reduction (p<0.005) in the rate of surgical site infections in the D-PLEX₁₀₀ treatment arm.

About PolyPid
PolyPid Ltd. (Nasdaq: PYPD) is a late-stage biopharma company aiming to improve surgical outcomes. Through locally administered, controlled, prolonged-release therapeutics, PolyPid’s proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients (APIs), enabling precise delivery of drugs at optimal release rates over durations ranging from several days to months. Following positive phase 3 results, New Drug Application (NDA) submission of D-PLEX₁₀₀, PolyPid’s lead product candidate, for the prevention of abdominal colorectal surgical site infections, is expected in early 2026. In addition, the Company has an innovative pipeline in oncology, obesity and diabetes.

For additional Company information, please visit http://www.polypid.com and follow us on Twitter (X) and LinkedIn.

Forward-looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses the presentation of SHIELD II trial results at the upcoming conference, the planned NDA submission for D-PLEX₁₀₀ and timing thereof. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission, including, but not limited to, the risks detailed in the Company’s Annual Report on Form 20-F filed on February 26, 2025. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. PolyPid is not responsible for the contents of third-party websites.

Company Contact:
PolyPid Ltd. 
Ori Warshavsky
908-858-5995
IR@Polypid.com

Investor Relations Contact:
Arx Investor Relations
North American Equities Desk
polypid@arxhq.com

Dogecoin Cash Inc. (OTCQB:DOGP) Announces Special Distribution of DogeCoin Cash (MEMECOIN:DOG) to Shareholders




Dogecoin Cash Inc. (OTCQB:DOGP) Announces Special Distribution of DogeCoin Cash (MEMECOIN:DOG) to Shareholders

MESQUITE, NV, Sept. 30, 2025 (GLOBE NEWSWIRE) —

Mesquite, NV  — Dogecoin Cash Inc. (OTCQB:DOGP) today announced that its Board of Directors has approved a special distribution of DogeCoin Cash (MEMECOIN:DOG) to shareholders of record as of December 15, 2025. The pro rata distribution will be payable on December 22, 2025.

Each shareholder of record will receive one DogeCoin Cash (MEMECOIN:DOG) for every share of Dogecoin Cash Inc. (OTCQB:DOGP) common stock held. In total, approximately 150 million DogeCoin Cash (MEMECOIN:DOG) will be distributed.

The distribution will be affected through certificates with assigned CUSIPs or equivalent book-entry positions, which shareholders may redeem through the Company’s wholly owned subsidiary, DogeSPAC LLC. Shareholders who wish to redeem will be able to do so by following instructions provided separately by the Company.

“This special distribution underscores our commitment to delivering value directly to our shareholders,” said David Tobias, CEO of Dogecoin Cash Inc. “By structuring this as a direct allocation, every shareholder has the opportunity to benefit equally.”

Additional details, including redemption instructions and FAQs, will be provided to shareholders prior to the payment date and will be available on the Company’s investor relations website. No immediate action is required by shareholders in connection with this corporate action. Shareholders will only be required to take further steps if and when they choose to redeem their certificates into digital assets, and only after payment or consideration, if applicable, has been received. Any such redemption is voluntary, subject to applicable terms and conditions, and may involve additional risks and requirements. Additional details, including redemption instructions and FAQs, will be provided to shareholders prior to the payment date and will be available on the Company’s investor relations website.

In recent years, meme coins have evolved from novelty tokens into a recognized segment of the digital asset market. Industry reports suggest that the total meme coin market capitalization recently surpassed approximately USD 77 billion, representing a measurable portion of the broader crypto sector.

Some market research indicates that the meme coin market could grow from about USD 68.5 billion in 2024 to as much as USD 925.2 billion by 2035, which would imply a compounded annual growth rate (CAGR) of roughly 26.7%. Other analyses suggest that the global meme-coin development market (the sector focused on building, launching, and supporting meme coins) could expand from about USD 40 million in 2024 to nearly USD 296 million by 2031 (CAGR ~27.8%).

These projections are inherently uncertain and depend on multiple factors such as digital-asset adoption, regulatory frameworks, and investor sentiment. Meme coins and other digital assets remain highly speculative, involve substantial risks, and may lose significant value. Nonetheless, increased trading activity, social-media engagement, and the rise of meme coin launch platforms reflect growing interest from segments of the digital-finance community.

About Dogecoin Cash, Inc. (OTCQB: DOGP)

Dogecoin Cash Inc. (OTCQB: DOGP) is a publicly traded company that owns and operates PrestoDoctor, (www.prestodoctor.com), a trusted leader in medical cannabis telemedicine. DOGP also focuses on blockchain innovation and developing blockchain-based infrastructure and digital asset initiatives. Its subsidiary, MEME Coins Inc., currently holds DOG tokens as its sole digital asset and is  an emerging platform focused on meme based cryptocurrency innovation, token utility, and social crypto applications. DOGP holds the first patented cannabis strain, Ecuadorian Sativa aka “CTA”, and a patented cannabis lozenge for treatment of hypertension 
Investor & Media Contact
Dogecoin Cash, Inc.
Info@dogecoincashinc.com

Forward-Looking Statements Disclaimer

This communication may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other applicable securities laws. Forward-looking statements are based on current expectations, estimates, forecasts, and assumptions, and involve risks and uncertainties that could cause actual outcomes to differ materially from those anticipated. Words such as “may,” “could,” “expect,” “anticipate,” “project,” “estimate,” “believe,” “intend,” “forecast,” or similar expressions are intended to identify forward-looking statements.

These statements are not guarantees of future performance and are subject to risks and uncertainties, including but not limited to regulatory developments, market volatility, adoption trends, technological changes, and other factors beyond the Company’s control. Investors should not place undue reliance on forward-looking statements, which speak only as of the date made. The Company undertakes no obligation to update or revise forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.

Upstream Bio Presents Data Showing Structural and Mechanistic Drivers of Verekitug’s Potent Pharmacodynamic Activity and Differentiated Clinical Profile at European Respiratory Society Congress




Upstream Bio Presents Data Showing Structural and Mechanistic Drivers of Verekitug’s Potent Pharmacodynamic Activity and Differentiated Clinical Profile at European Respiratory Society Congress

– Data show verekitug prevents TSLP binding to the TSLP receptor by occupying ligand binding sites –

– Additionally, findings show that verekitug outcompetes TSLP in the presence of preformed heterodimeric receptor complexes –

– Data support the potential of verekitug’s unique mechanism of action to achieve a differentiated therapeutic effect across a broad range of TSLP-driven severe respiratory diseases –

WALTHAM, Mass., Sept. 30, 2025 (GLOBE NEWSWIRE) — Upstream Bio, Inc. (Nasdaq: UPB), a clinical-stage company developing treatments for inflammatory diseases, with an initial focus on severe respiratory disorders, today presented structural and mechanistic data showing verekitug’s potent pharmacodynamic activity through its unique approach of targeting the thymic stromal lymphopoietin (TSLP) receptor. Data were presented at the European Respiratory Society (ERS) Congress being held September 27 – October 1, 2025, in Amsterdam, Netherlands.

“We continue to deepen our understanding of verekitug’s unique TSLP receptor-targeting mechanism and its role in driving the rapid and durable effects that have been demonstrated to date,” said Aaron Deykin, MD, Chief Medical Officer and Head of R&D of Upstream Bio. “In the clinic, we are also now beginning to see that the potency driven by this mechanism of action can translate into a differentiated clinical profile with our recently reported Phase 2 top-line clinical data in patients with chronic rhinosinusitis with nasal polyps where verekitug delivered statistically significant and clinically meaningful effects on multiple endpoints when administered only once every 12 weeks. We look forward to continuing to build the clinical dataset for verekitug with Phase 2 top-line data in severe asthma anticipated in the first quarter of 2026.”

Preclinical and clinical data to date demonstrate verekitug’s highly potent inhibition of the TSLP receptor. In clinical trials, verekitug has demonstrated rapid, substantial, and sustained TSLP receptor inhibition for up to 24 weeks after the last dose. This unique mechanism of action may translate to a differentiated clinical profile with less frequent dosing as compared to currently approved biologic therapies.

Mechanistic studies were performed to elucidate drivers of this high magnitude of effect seen with verekitug’s TSLP receptor inhibition. Data presented are summarized as follows:

• With high affinity binding (K_D < 1 pM) to the TSLP receptor, verekitug outcompetes TSLP binding to the TSLP receptor even in the presence of preformed heterodimeric receptor complexes, inhibiting TSLP:TSLP receptor interaction.
• The high-resolution crystal structure reveals that verekitug binds and occupies most of the TSLP binding sites on the TSLP receptor.
• Semi-mechanistic pharmacokinetic/pharmacodynamic (PK/PD) models indicate that lower abundance and slower turnover of the TSLP receptor compared to the TSLP ligand may drive the greater potency of verekitug, observed in vitro and across clinical datasets, compared to published data for tezepelumab.
• These findings provide a mechanistic explanation for the empirically observed greater potency of targeting the TSLP receptor with verekitug as compared with targeting the TSLP ligand.

A digital version of the presentation can be found on the Publications section of the Upstream Bio website.

About TSLP and TSLP Receptor Blockade
Thymic stromal lymphopoietin (TSLP) is a cytokine that is a key driver of the inflammatory response in major allergic and inflammatory diseases, such as asthma, where disruption of TSLP signaling has been clinically validated as an effective therapeutic strategy.

TSLP activation is one of the first events in the inflammatory cascade stimulated by allergens, viruses and other triggers, initiating the activation of downstream targets such as IL-4, IL-5, IL-13, IL-17 and IgE. Because TSLP is a target upstream in the inflammatory cascade, blocking the TSLP receptor presents an opportunity for a single treatment to impact the drivers of multiple pathological inflammatory processes across a broad set of diseases.

About Verekitug
Verekitug is a novel recombinant fully human immunoglobulin G1 (IgG1) monoclonal antibody that binds to the TSLP receptor and inhibits proinflammatory signaling initiated by TSLP. It is the only known monoclonal antibody currently in clinical development that targets and inhibits the TSLP receptor. Verekitug has advanced into three separate global, placebo-controlled, randomized Phase 2 clinical trials including the recently completed VIBRANT trial (NCT06164704) in patients with chronic rhinosinusitis with nasal polyps (CRSwNP), which demonstrated that verekitug, dosed at 100 mg once every 12 weeks, met both the primary and secondary endpoints at Week 24 and was generally well tolerated. Two additional ongoing clinical trials include the VALIANT trial (NCT06196879) in patients with severe asthma and the VENTURE trial (NCT06981078) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). Additionally, in May 2025, Upstream Bio initiated the VALOUR trial (NCT06966479), a long-term extension study in eligible participants with severe asthma who completed the VALIANT Phase 2 clinical trial.

In preclinical studies, verekitug demonstrated high occupancy of the TSLP receptor and potent inhibition of TSLP signaling. Additionally, verekitug inhibited cytokine production from both CD4+ T cells and ILC2 cells and completely suppressed skin allergic reactions in a non-human primate model, suggesting that it may be effective against multiple types of inflammation.

Three Phase 1 clinical trials have been completed for verekitug, including a Phase 1 single-ascending dose (SAD) clinical trial and a Phase 1b multiple-ascending dose (MAD) clinical trial. In these trials, verekitug was well tolerated, had no clinically meaningful immunogenicity, and showed a predictable and consistent pharmacokinetic profile and high subcutaneous bioavailability. In patients with asthma, verekitug led to >50% reductions in fractional exhaled nitric oxide (FeNO) and blood eosinophils that were rapid and sustained for up to 24 weeks after the last dose in the Phase 1b MAD trial.

About Upstream Bio
Upstream Bio is a clinical-stage biotechnology company developing treatments for inflammatory diseases, with an initial focus on severe respiratory disorders. Upstream Bio is developing verekitug, the only known antagonist currently in clinical development that targets the receptor for thymic stromal lymphopoietin (TSLP), a cytokine which is a clinically validated driver of inflammatory response positioned upstream of multiple signaling cascades that affect a variety of immune mediated diseases. Upstream Bio has advanced this highly potent monoclonal antibody into separate Phase 2 trials for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP), severe asthma and chronic obstructive pulmonary disease (COPD). Upstream Bio’s team is committed to maximizing verekitug’s unique attributes to address the substantial unmet needs for patients underserved by today’s standard of care. To learn more, please visit www.upstreambio.com.

Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “continue,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “predict,” “project,” “seeks,” “should,” “target,” “will” and variations of these words or similar expressions. Any statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements include, without limitation, express or implied statements regarding: the clinical development of verekitug for the treatment of severe asthma, CRSwNP and COPD, including the initiation, timing, progress and results of ongoing and planned clinical trials; expectations for future discussions with regulatory authorities and the potential of the endpoints of the Company’s clinical trials to produce data that could support submissions for product approval; expectations regarding the differentiation, safety, efficacy or tolerability of verekitug; expectations regarding the translation of PK/PD modeling data of verekitug to clinical effects; and assessments comparing non-head-to-head clinical data of verekitug to published data for tezepelumab. Any forward-looking statements in this press release are based on the Company’s current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Readers are cautioned that actual results, levels of activity, safety, efficacy, performance or events and circumstances could differ materially from those expressed or implied in the Company’s forward-looking statements due to a variety of risks and uncertainties, which include, without limitation, risks and uncertainties related to: Upstream Bio’s ability to advance verekitug through clinical development, and to obtain regulatory approval of and ultimately commercialize verekitug on the expected timeline, if at all; the initiation, timing, progress and results of clinical trials; Upstream Bio’s ability to fund its development activities and achieve development goals; Upstream Bio’s dependence on third parties to conduct clinical trials and manufacture verekitug, and commercialize verekitug, if approved; Upstream Bio’s ability to attract, hire and retain key personnel, and protect its intellectual property; Upstream Bio’s financial condition and need for substantial additional funds in order to complete development activities and commercialize verekitug, if approved; regulatory developments and approval processes of the U.S. Food and Drug Administration and comparable foreign regulatory authorities; Upstream Bio’s competitors and industry; and other risks and uncertainties described in greater detail under the caption “Risk Factors” in Upstream Bio’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, as well as any subsequent filings with the SEC. Any forward-looking statements represent Upstream Bio’s views only as of today and should not be relied upon as representing its views as of any subsequent date. Upstream Bio explicitly disclaims any obligation or undertaking to update any forward-looking statements contained herein to reflect any change in its expectations or any changes in events, conditions or circumstances on which any such statement is based except to the extent required by law, and claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

Investor and Media Contact:
Meggan Buckwell
Director, Corporate Communications and Investor Relations
ir@upstreambio.com

MSInsight Joins PREDI-LYNCH Project to Advance Non-Invasive Cancer Detection in Lynch Syndrome — Aligning With Hereditary Cancer Awareness Week




MSInsight Joins PREDI-LYNCH Project to Advance Non-Invasive Cancer Detection in Lynch Syndrome — Aligning With Hereditary Cancer Awareness Week

Press Release

Paris, September 2025 – MSInsight, a French precision oncology start-up, is proud to announce its participation in PREDI-LYNCH^*, a six-year Horizon Europe consortium led by Oslo University Hospital. This ambitious project seeks to develop validated, non-invasive liquid biopsy tests to improve early cancer detection in people with Lynch syndrome (LS), one of the most common hereditary cancer syndromes.

The project launched in May 2025, and MSInsight is now pleased to share its role as a partner during Hereditary Cancer Awareness Week, underscoring the importance of raising awareness and building solutions for families at genetic risk of cancer.

Lynch Syndrome: A Major Unmet Need

Lynch syndrome is caused by inherited mutations in DNA mismatch repair (MMR) genes and greatly increases the lifetime risk of cancer (Dominguez-Valentin et al., 2019). People with this condition face a 50–80% chance of developing colorectal cancer, along with higher risks of endometrial, ovarian, gastric, and urinary tract cancers. The exact risk depends on which gene is affected: MLH1 and MSH2 mutations carry the highest risk, while MSH6 and PMS2 mutations are associated with lower—though still significant—risk (Dominguez-Valentin et al., 2019).

LS is responsible for an estimated 2-4% of all colorectal cancers in general, increasing to about 5% in studies that perform universal germline testing (Abu-Ghazaleh et al., 2022; Dinh et al., 2011). Improving early detection for LS carriers is thus both a preventive strategy and a path to improving survival across major cancer types.

Epidemiological modelling suggests that about 1 in 440 individuals of European ancestry carry LS-associated mutations. When applied to population estimates, this translates to approximately 2 million carriers in Europe. Yet only ~5% of these individuals are under active surveillance (PREDI-LYNCH estimates). This diagnostic gap underscores a profound public health challenge: despite the high lifetime risks, most carriers remain undiagnosed, untreated, or without appropriate monitoring.

About the PREDI-LYNCH Project

Approved by the European Commission in May 2025 with a total budget of €13.6 million, PREDI-LYNCH is a six-year (2025–2031) Horizon Europe initiative coordinated by Oslo University Hospital (OUS) and Pr. Mev Dominguez. The project brings together 28 leading institutions across 16 European countries to:

• Develop non-invasive liquid biopsy tests for the detection of colorectal, endometrial, and urothelial cancers in LS carriers.
• Validate biomarkers through multi-center trials, ensuring clinical robustness across diverse European healthcare systems.
• Integrate AI-based analytics to improve biomarker discovery, prediction, and longitudinal monitoring.
• Assess socio-economic and ethical aspects, ensuring new technologies are accessible, cost-effective, and patient-centered.

According to OUS, the project is motivated by the fact that current surveillance methods for LS patients (such as regular colonoscopies) are invasive, burdensome, and inconsistently followed. By shifting toward non-invasive tools like liquid biopsies, PREDI-LYNCH seeks to improve compliance, reduce delays in diagnosis, and ultimately save lives (OUS Research, 2025).

MSInsight’s Role: Leveraging MSIcare in PREDI-LYNCH

MSInsight contributes its expertise in microsatellite instability (MSI) diagnostics—a hallmark of Lynch syndrome–associated cancers—working closely with French partners at Inserm, Sorbonne University and La Pitié-Salpétrière Hospital. The company’s flagship solution, MSIcare, applies next-generation sequencing (NGS) and artificial intelligence algorithms to improve MSI detection accuracy (Ratovomanana et al., 2021).

While MSI testing is already a cornerstone of treatment selection in oncology—particularly for determining eligibility for immunotherapy—current diagnostic tools remain limited. Published studies have shown that traditional approaches can misclassify MSI status, with potentially serious consequences for patients (André et al., 2024).

By integrating MSIcare into the PREDI-LYNCH project, MSInsight will support the development of liquid-biopsy-based MSI detection, allowing non-invasive cancer prediction and surveillance in LS carriers. This work will build on the platform’s proven accuracy in tumor tissue samples and extend it into liquid-based diagnostics.

A Timely Commitment: Hereditary Cancer Awareness Week

The timing of MSInsight’s announcement reflects a broader commitment to public awareness. Hereditary Cancer Awareness Week draws attention to the millions of families worldwide living with inherited cancer risks. For LS carriers, awareness is often the first step to life-saving interventions, including surveillance, early detection, and preventive therapies.

In addition to our work on Lynch syndrome, we are committed to advancing the diagnosis of children affected by CMMRD (Constitutional Mismatch Repair Deficiency), an ultra-rare hereditary cancer syndrome with an estimated incidence of 1 in 1,000,000 births. CMMRD dramatically increases the risk of multiple, aggressive tumors at a very young age. This initiative is conducted in collaboration with Inserm, Sorbonne University, and Paris Hospitals. Improving early and accurate detection of CMMRD is essential to enable appropriate surveillance, timely care, and ultimately better outcomes for these children.

About MSInsight

Founded in Paris in 2022, MSInsight is a precision oncology start-up focused on improving cancer care through advanced diagnostics. The company builds on two decades of academic research from the “Microsatellite Instability and Cancer” team at Sorbonne University and Inserm, led by Prof. Alex Duval, a global expert in MSI. MSInsight’s flagship platform, MSIcare, integrates bioinformatics, artificial intelligence, and NGS to deliver accurate MSI/dMMR detection. Already clinically validated in tumor tissue, MSIcare is being expanded to blood-based applications, enabling non-invasive diagnostics that can transform cancer care. The company has been recognized as a winner of the 25th i-Lab Innovation Competition in France and collaborates with leading laboratories across Europe and the United States to validate and scale its technology.By combining cutting-edge science with a patient-focused mission, MSInsight is helping to redefine diagnostics in both sporadic and hereditary cancer contexts.

* PREDI-LYNCH project has received funding from the European Union’Horizon Europe research and innovation programme under grant agreement N°101213916.

Press Contacts:

MSInsight, Arnaud Cutivet ac@msinsight.tech & Sydney Normand sn@msinsight.tech

References

Abu-Ghazaleh et al. (2022), Genes, 13(2), 315.

Dinh, T. A et al. (2011), Cancer Prevention Research, 4(1), 9–22.

Dominguez-Valentin, M., et al. (2019), Journal of Clinical Oncology, 38(2), 136–147.

OUS Research. (2025, May 15). PREDI-LYNCH: Validated non-invasive liquid biopsy tests for cancer PREDIction in LYNCH Syndrome. Oslo University Hospital. https://www.ous-research.no/home/ous/news/26143

Ratovomanana, T., et al. (2021), Gastroenterology, 160(4), 1404–1417.

André, T. et al. (2024), New England Journal of Medicine, 391 (21), 2014-2026

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Pulselight appoints Sir Jonathan Van-Tam as an Advisor




Pulselight appoints Sir Jonathan Van-Tam as an Advisor

Sir Jonathan Van-Tam joins Pulselight to support its mission to transform the UK health system by reducing waiting lists, driving efficiencies and improving patient outcomes

LONDON, Sept. 30, 2025 (GLOBE NEWSWIRE) — Pulselight, a data analytics company that has developed software AI products capable of transforming the UK health system, today announces the appointment of Sir Jonathan Van-Tam MBE, FMedSci, as an Advisor, effective immediately.

Sir Jonathan will use his extensive experience in HM Government, academia and across the health industry to strengthen Pulselight’s offering to support the NHS with maximising resources, preventing ill-health caused by obesity, tackling health inequalities and the shift of care into the community.

As the Government sharpens its focus on technology and data as drivers of NHS transformation, Sir Jonathan will leverage his deep expertise in advising how companies can deliver and communicate value across the health system. His insights will guide the company’s efforts to showcase its breadth of applications across various care settings. Sir Jonathan’s experience working at the forefront of UK health policy will help shape the company’s efforts to support the Government and NHS on addressing the country’s most urgent public health challenges.

Sir Jonathan served as Deputy Chief Medical Officer to HM Government from 2017 to 2022, playing a central role in shaping the UK’s response to the COVID-19 pandemic. Over the course of his career, he has led major global health initiatives in partnership with the World Health Organization and Public Health England, focusing on pandemic preparedness and response. His extensive experience in the pharmaceutical industry includes senior leadership roles at SmithKline Beecham (now part of GSK), Roche, and Aventis Pasteur MSD (now part of Sanofi). A distinguished academic, Sir Jonathan is a former Pro-Vice Chancellor of the University of Nottingham and currently works as an independent consultant in the biopharmaceutical sector.

Irene Manautou, Founder and CEO at Pulselight, said: “We are thrilled to welcome Sir Jonathan as an Advisor. His appointment is an important milestone in Pulselight’s UK growth as we look to bring the proven success of our AI-driven solutions from the US to support the NHS. With his unique expertise at the intersection of government, healthcare and innovation, Sir Jonathan will help us demonstrate how Pulselight’s technology can play a central role in reducing waiting lists, improving patient outcomes and enabling a more efficient health system.”

Sir Jonathan Van-Tam, Advisor at Pulselight, said: “Pulselight brings a powerful and truly bespoke solution to UK healthcare at a pivotal moment as the Government accelerates its technology-enabled strategy to reduce waiting lists and improve patient outcomes. I look forward to working with the team and showcasing the power of Pulselight’s analytics ecosystem to make sure it delivers real and lasting benefits for patients and the health service throughout the UK.”

For further information, please contact:

Pulselight (Team@Pulselight.com)

Irene Manautou

For Media Enquiries:

5654 & Company (Pulselight@5654.co.uk)

Matthew Neal, Partner

Charlotte Dawson, Associate Director

NOTES TO EDITORS

Sir Jonathan Van-Tam has joined Pulselight as an Advisor on a part-time basis.

Pulselight – a data analytics company – has developed analytical products capable of transforming the health system.

Already delivering results in the US, Pulselight’s technologies maximise resources, deliver preventive health care, tackle health inequalities, and empower community health workers.

For more information, please visit: https://www.pulselight.com/