On July 8, 2025 BostonGene, a leader in AI-powered solutions for drug discovery and development, reported a collaboration with the SWOG Cancer Research Network, a global cancer research community that designs and conducts publicly funded clinical trials, on a new multicohort study titled "S2409, PRISM: PRecIsion in SCLC via a Multicohort Study: Randomized Phase II Studies Evaluating Maintenance Durvalumab with or without Biomarker-Directed Therapy for Extensive Stage Small Cell Lung Cancer (ES-SCLC) (Press release, BostonGene, JUL 8, 2025, View Source [SID1234654296])." This study, which is supported by the National Cancer Institute (NCI), part of the National Institutes of Health, aims to redefine the standard of care for patients with ES-SCLC by employing biomarker-driven personalized treatment strategies.

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Currently, the standard treatment for ES-SCLC involves combination chemotherapy and anti-PD-L1 immunotherapy, followed by maintenance immunotherapy. While this broad approach extends overall survival by 2-3 months, it still results in disease progression in most patients.

The PRISM study is designed to utilize novel biomarkers to identify and treat patients who may benefit from the addition of targeted agents, such as PARP inhibitors, to standard therapy. The study will be led by SWOG, conducted within the NCI’s National Clinical Trials Network, and chaired by Drs. Anne Chiang, of the Yale Cancer Center, and Alberto Chiappori, of the Moffitt Cancer Center, in conjunction with Translational Medicine chairs Drs. Lauren Byers and Carl Gay, of The University of Texas MD Anderson Cancer Center.

The trial will enroll up to 900 patients and use BostonGene’s AI-powered multiomic platform to identify molecular subtypes, assigning patients to therapy based on their subtype. The platform enables deep characterization of each patient’s tumor and immune profile, supporting the selection of more effective therapies and helping to accelerate translational insights that inform future drug development.

The trial builds on the ongoing collaborative work between MD Anderson’s lung cancer group, including Drs. Byers and Gay, and BostonGene to identify and validate four molecular subtypes of SCLC that exhibit distinct biological and therapeutic profiles. Initial findings from the SWOG S1929 trial demonstrated promising improvements in progression-free survival using this targeted approach. The goal of the upcoming study is to optimize outcomes for each subtype, offering patients more effective and individualized treatments.

"S2409 PRISM will test the hypothesis that we can be more effective in treating extensive-stage small-cell lung cancer by targeting the vulnerabilities of specific molecular subtypes," said study chair Dr. Chiang, who also serves as SWOG’s executive officer overseeing lung cancer and breast cancer research.

"We hope to demonstrate that it’s feasible to identify the SCLC subtype in the clinical setting and to use that information to select the best therapy for each patient."

"Collaborating with SWOG on this landmark study aligns with our mission to deliver innovative, data-driven insights that are transforming cancer care," said Nathan Fowler, MD, Chief Medical Officer at BostonGene. "By combining advanced molecular profiling with AI, we’re not only able to classify patients more precisely but also to advance therapy selection and accelerate the development of next-generation treatments. This study is poised to reshape the treatment landscape in lung cancer and provide a roadmap of how to build and validate biomarker-driven treatment approaches across cancers."

On July 8, 2025 Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, reported a new collaboration with Merck, known as MSD outside of the United States and Canada, that expands Merck’s use of the Certara Pinnacle 21 software platform to include a metadata repository and data standards workflow management (Press release, Certara, JUL 8, 2025, View Source [SID1234654281]). This agreement builds upon Merck’s existing technology collaboration with Certara to aid in regulatory submissions.

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Reducing the time from data collection to validated, analysis-ready datasets has become more complex across drug development. Phase III clinical trials now average 3.6 million datapoints, a threefold increase over the last decade.1 The Certara Pinnacle 21 platform is designed to solve the data standardization challenges of modern digital trials at scale.

"We are pleased to strengthen our ongoing collaboration with Merck to assist with data standards management and to expand the value of the Pinnacle 21 platform," said William F. Feehery, Chief Executive Officer. "Merck is a premier research-intensive company, and our teams are well-aligned in the goal of delivering high-quality research data faster to help save and improve lives around the world."

On July 8, 2025 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported that it has commenced an underwritten public offering of $150 million of its shares of common stock (Press release, Cogent Biosciences, JUL 8, 2025, View Source [SID1234654282]). In addition, Cogent intends to grant the underwriters a 30-day option to purchase up to an additional $22.5 million of its shares of common stock on the same terms and conditions. All of the securities in the offering are being offered by Cogent. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering.

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Cogent intends to use the net proceeds from the offering for continued development, regulatory and commercial preparation activities relating to bezuclastinib and other product candidates, activities to support the planned commercial launch of bezuclastinib, as well as for working capital and general corporate purposes.

J.P. Morgan, Leerink Partners and Guggenheim Securities are acting as joint book-running managers for the offering. LifeSci Capital is also acting as lead manager for the offering.

The securities described above will be offered pursuant to an automatic shelf registration statement on Form S-3ASR (File No. 333-269707), which was filed with the Securities and Exchange Commission (SEC) on February 10, 2023 and automatically became effective upon filing.

A preliminary prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering will be filed with the SEC. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC. The securities described above have not been qualified under any state blue sky laws. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. The offering can be made only by means of a prospectus, copies of which may be obtained at the SEC’s website at www.sec.gov, or by request to J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected] and [email protected]; Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Ave., New York, NY 10017, or by telephone at (212) 518-9544, or by email at [email protected].

On July 8, 2025 Syntara Limited (ASX: SNT), a clinical-stage drug development company, reported that the World Health Organization (WHO) has formally granted the International Non-Proprietary Name (INN) of amsulostat to its advanced clinical development asset SNT-5505 (Press release, Syntara, JUL 8, 2025, View Source [SID1234654266]).

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Commonly known as a generic name, an INN is a globally recognised, unique name for a pharmaceutical substance or active ingredient.

Amsulostat is an innovative oral therapy currently in clinical development for myelofibrosis (MF), a debilitating bone marrow disorder characterised by fibrosis that severely impacts blood cell production.

Recent interim Phase 2 clinical trial results, which demonstrated promising efficacy and an excellent safety profile in combination with ruxolitinib, underscore the potential of amsulostat as a differentiated treatment option for patients with MF who exhibit suboptimal responses to existing therapies.

The designation of an INN represents an important milestone in the drug development process, providing global recognition of amsulostat’s unique chemical identity and facilitating clearer communication among healthcare professionals and regulatory bodies worldwide.

Syntara CEO Gary Phillips said: "After very recently being awarded Fast Track Designation by the FDA, the granting of amsulostat as the INN for SNT-5505 is another important step forward, reflecting the drug’s unique mechanism of action and clinical promise. We remain focused on advancing amsulostat through clinical development to address significant unmet medical needs in myelofibrosis and other fibrotic diseases."

On July 8, 2025 Invivoscribe Inc., a global leader in precision diagnostics and measurable residual disease (MRD) testing, reported its support to CERo Therapeutics Holdings, Inc., an innovative immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that employ phagocytic mechanisms (Press release, Invivoscribe Technologies, JUL 8, 2025, View Source [SID1234654283]).

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Through this collaboration, LabPMM (Invivoscribe’s global reference laboratories), have customized their multiparametric flow cytometry (MFC) services and implemented their sensitive MFC AML MRD assay to support CERo’s clinical trial of its lead compound, CER-1236. The trial targets Acute Myeloid Leukemia (AML) in patients who are relapsed/refractory, in remission with MRD, or newly diagnosed with TP53-mutated MDS/AML.

AML is an aggressive blood cancer characterized by the rapid accumulation of abnormal myeloid cells in the bone marrow and blood, disrupting normal hematopoiesis.1 Treating AML is especially complex due to its genetic heterogeneity and the high risk of relapse. CAR-T (chimeric antigen receptor T-cells) and Chimeric Engulfment Receptor T-cells ("CER-T") therapies, which involve engineering a patient’s own T-cells to recognize and attack cancer cells, have shown promise in other hematologic malignancies and are now being explored for AML. However, because these therapies are manufactured from patient-derived cells, it’s critical to confirm that leukemic blasts are not inadvertently included in the final therapeutic product – underscoring the need for sensitive, validated assays like those offered by Invivoscribe and its global accredited regional laboratories, LabPMM.

LabPMM’s CAP/CLIA-Validated AML MRD MFC assay which was designed to quantify residual leukemic cells in patients undergoing treatment, was customized to meet two critical needs in CERo’s drug development program: (1) assessing the purity of the manufactured T-cell product by detecting residual AML blasts prior to infusion, and (2) evaluating therapeutic response to CER-1236 during the trial.

Kristen Pierce, Ph.D., CERo Chief Development Officer, commented, "Invivoscribe has played an integral role in the execution of this clinical trial. Its technology and expertise have facilitated our advancement into the clinic by helping to ensure the purity of our investigational product, and now we are reaping the benefits of our collaboration as the trial is underway and we seek to assess therapeutic response."

This collaborative effort was instrumental in advancing CER-1236, which recently received FDA Orphan Drug Designation for the treatment of AML2. The designation highlights the growing urgency of integrated diagnostic support in the advancement of personalized immunotherapies and reflects Invivoscribe’s commitment to driving innovation and standardization across the oncology treatment landscape – now helping bring immunotherapies to patients faster.

For more information about LabPMM’s flow cytometry and molecular testing services, please visit View Source or contact us at [email protected] and follow us on LinkedIn.