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Invivoscribe Expands Flow Cytometry Services to Accelerate CAR-T Immunotherapy Development and Regulatory Readiness with the Initiation of CERo Therapeutics Phase 1 Clinical Trial

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.

Cogent Biosciences Announces Proposed $150 Million Public Offering of Common Stock

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.

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].

Certara Announces Expansion of Clinical Technology Collaboration with Merck

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.

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."

Avenzo Therapeutics Announces First Patient Dosed in Phase 1/2 Clinical Study of AVZO-1418, a Potential Best-in-Class EGFR/HER3 Bispecific Antibody-Drug Conjugate

On July 8, 2025 Avenzo Therapeutics, Inc. ("Avenzo"), a clinical-stage biotechnology company developing next-generation oncology therapies, reported that the first patient has been dosed in the Phase 1 portion of a Phase 1/2 clinical study evaluating its potential best-in-class EGFR/HER3 bispecific antibody-drug conjugate, AVZO-1418, in patients with advanced solid tumors (Press release, Avenzo Therapeutics, JUL 8, 2025, View Source [SID1234654280]).

"AVZO-1418 represents a unique approach to deliver a single targeted therapy to patients with diverse tumor types driven by EGFR and HER3 co-expression," said Anthony Tolcher, M.D., FRCPC, CEO and Founder, NEXT Oncology. "We believe this bispecific approach has the potential to improve tumor cell selectivity and maximize therapeutic impact across multiple solid tumor types that share this biology."

The Phase 1/2 first-in-human, open-label clinical study is designed to assess the safety, tolerability, and preliminary clinical activity of AVZO-1418 as a single agent and in combination therapy in patients with advanced solid tumors.

"We are proud to have dosed the first patient just over a month after receiving IND clearance," said Mohammad Hirmand, M.D., Co-founder and Chief Medical Officer of Avenzo Therapeutics. "This milestone highlights the strong momentum behind our program. We plan to evaluate this bispecific ADC in a range of indications – including lung, breast, and head and neck cancers – where treatment options remain limited, including for patients who have progressed on standard therapies."

U.S. FDA Grants Orphan Drug Designation to Adcentrx Therapeutics’ ADRX‑0405 STEAP1 ADC for Gastric Cancer

On July 8, 2025 Adcentrx Therapeutics ("Adcentrx"), a clinical-stage biotechnology company redefining Antibody-Drug Conjugate (ADC) therapies for cancer treatment and other life-threatening diseases, reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to ADRX-0405, for the treatment of patients with gastric cancer (Press release, Adcentrx Therapeutics, JUL 8, 2025, View Source [SID1234654279]).

ADRX-0405 is a STEAP1 ADC being evaluated in the Phase 1a portion of an ongoing Phase 1a/b clinical trial (NCT06710379) for the treatment of select advanced solid tumors, including metastatic castration resistant prostate cancer, gastric cancer, and non-small cell lung cancer. While STEAP1 is primarily associated with prostate cancer, there is a meaningful amount of target expression in gastric cancer, making this a potential indication of interest for future clinical development.

"Receiving orphan drug designation from FDA is a notable milestone for Adcentrx and reinforces the potential for ADRX-0405 to improve the lives of patients with gastric cancer," said Hui Li, Ph.D., Founder and Chief Executive Officer of Adcentrx. "We are encouraged by the progress of our Phase 1a trial and look forward to further evaluating the safety, tolerability and anti-tumor activity of ADRX-0405 in gastric and other cancers."

Gastric cancer, or stomach cancer, is a serious malignancy that develops in the stomach lining and is often diagnosed at advanced stages. The American Cancer Society estimates there will be 30,300 new cases of gastric cancer in the U.S. in 2025, meeting FDA’s criteria for a rare disease. The orphan drug designation is a program designed to stimulate the development of treatments for rare diseases, defined as conditions affecting fewer than 200,000 people in the U.S. Benefits of this designation include access to grant funding and scientific assistance, tax credits for qualified clinical trials, waiver of Prescription Drug User Fee Act (PDUFA) application fees, and the potential for seven years of market exclusivity following regulatory approval.

About ADRX-0405

ADRX-0405 is a clinical-stage next-generation ADC targeting six-transmembrane epithelial antigen of the prostate 1 (STEAP1), a cell surface protein that is upregulated in prostate cancer and certain other cancers with limited expression in normal healthy tissue. The ADC is composed of a humanized IgG1 antibody coupled with a novel topoisomerase inhibitor linker-payload through Adcentrx’s innovative i-Conjugation technology platform – a core component in the design of the company’s ADCs. The platform utilizes a cleavable linker and stable conjugation chemistry to enhance payload delivery. This novel technology enables a highly stable ADC with a drug-antibody ratio of eight (DAR 8) to maximize payload delivery to solid tumors. ADRX-0405 preclinical studies have demonstrated its favorable pharmacokinetics, safety profile, and significant efficacy across multiple animal tumor models. ADRX-0405 is currently being evaluated in a Phase 1a/b clinical trial.

For more information about the ADRX-0405 Phase 1a/b clinical trial, please refer to the Study ID NCT06710379 on ClinicalTrials.gov.