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]).

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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.

On July 8, 2025 Abdera Therapeutics Inc., a clinical-stage biopharmaceutical company leveraging its advanced antibody engineering ROVEr platform to design and develop tunable precision radiopharmaceuticals for cancer, reported the appointment of Rachael Brake, Ph.D., as chief scientific officer (Press release, Abdera Therapeutics, JUL 8, 2025, View Source [SID1234654295]). Dr. Brake brings more than 20 years of experience in the biopharmaceutical industry building and leading cross functional teams across basic and applied research, clinical and business development.

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"We are thrilled to welcome Dr. Rachael Brake as our new chief scientific officer," said Lori Lyons-Williams, president and chief executive officer. "Rachael brings a distinguished career in oncology research and clinical development, with a proven ability to drive innovative scientific discoveries into impactful therapies for patients. Her deep expertise and leadership will be instrumental in maximizing the potential of our proprietary precision radiopharmaceutical platform."

"Abdera’s ROVEr platform stands at the forefront of radiopharmaceutical innovation in cancer treatment, empowering us to engineer targeted medicines with tunable PK properties, optimizing tumor uptake, circulation half-life and clearance rates. Collectively, the features of ROVEr will maximize the therapeutic index for this class of drugs and has the potential to transform how we consider delivering precision medicine," said Dr. Brake. "This is a truly transformative time for Abdera with clinical validation of ABD-147 emerging and ABD-320 expected to begin human clinical trials soon. I am energized to join this exceptional team and eager to shape the future of precision medicine with this new class of cancer therapy."

Dr. Brake joins Abdera from Zephyr AI where she served as chief scientific officer. Previously, Dr. Brake was the chief scientific officer at Corbus Pharmaceuticals where she built and led a research and development team and advanced multiple oncology programs into clinical development. Prior to her work at Corbus, Dr. Brake spent 11 years at Takeda Oncology, most recently as head of U.S. medical affairs, oncology business unit and as vice president, global program leader, oncology therapeutic area. In these roles, Dr. Brake managed a portfolio of programs and cross-functional teams responsible for the preclinical and clinical exploration of various solid tumor drug candidates spanning diverse mechanisms of action. Prior to joining Takeda, Dr. Brake was a research scientist at Amgen where she held increasing levels of responsibility culminating in the site lead in Cambridge, MA for the therapeutic innovation unit.

Dr. Brake began her career as a research scientist at the Western Australian Institute for Medical Research and Woden Valley Hospital. She holds a Ph.D. in molecular biology and biochemistry from the University of Western Australia.

About ABD-147

ABD-147 is a targeted radiopharmaceutical biologic therapy designed to deliver Actinium-225 (225Ac), a highly potent alpha-emitting radioisotope, to solid tumors expressing delta-like ligand 3 (DLL3) with high affinity. DLL3 is a protein in the Notch pathway that is critical for the development and regulation of neuroendocrine versus epithelial cell differentiation in the lungs. In certain high grade neuroendocrine carcinomas including small cell lung cancer (SCLC), DLL3 is upregulated and specifically expressed on the cell surface in more than 80% of cases. In contrast, DLL3 is absent or very rarely expressed on the surface of nonmalignant cells. Given the high specificity of DLL3 expression on cancer cells and the distinct mechanism of action, DLL3 represents a compelling target for treating SCLC and other DLL3+ solid tumors with targeted radiotherapy.

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ABD-147 for the treatment of patients with extensive stage small cell lung cancer (ES-SCLC) who have progressed on or after platinum-based chemotherapy and Orphan Drug Designation to ABD-147 for the treatment of neuroendocrine carcinoma. ABD-147 is currently being evaluated in a first-in-human Phase 1 clinical trial in patients with SCLC or large cell neuroendocrine carcinoma of the lung who have previously received platinum-based therapy.

About ABD-320

ABD-320 is a targeted radiopharmaceutical biologic therapy engineered to deliver Actinium-225 (225Ac) to solid tumors expressing 5T4. This oncofetal protein is rarely expressed in normal adult tissues but has been shown to be up-regulated in multiple cancer types, including colorectal, head and neck, non-small cell lung, pancreatic, gastric, mesothelioma, bladder, renal, cervical, ovarian, and breast cancers. By driving tumor cell migration and survival, 5T4 plays a key role in cancer progression and is associated with advanced disease, increased invasiveness, and poor clinical outcomes in solid tumors. ABD-320 was developed leveraging Abdera’s ROVEr platform and is custom-engineered to achieve an ideal balance of tumor uptake and retention while avoiding systemic radiotoxicities. Preclinical data with ABD-320 demonstrates potent anticancer activity. ABD-320 represents the first radiopharmaceutical therapy in development to address 5T4.

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]).

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"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."

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."