On March 23, 2026 Siren Biotechnology reported that the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application submitted by the University of California, San Francisco to initiate a Phase 1 clinical study evaluating the safety and biologic activity of SRN-101 in adult patients with recurrent high-grade glioma. The IND clearance enables the launch of a single-center, investigator-initiated Phase 1 study led by Nicholas Butowski, MD, Professor of Neurological Surgery and Neuro-Oncology at UCSF.

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"This IND clearance allows us to begin evaluating this novel investigational approach in patients with recurrent high-grade glioma," said Dr. Butowski. "This early-phase study will provide important safety and translational data to help inform future clinical development."

SRN-101 is an investigational gene therapy developed by Siren Biotechnology. Siren is providing study drug and collaborating with UCSF in support of the trial.

"We are honored to support Dr. Butowski and the UCSF team in advancing this investigator-initiated study," said Nicole K. Paulk, PhD, Founder, CEO, and President of Siren Biotechnology. "UCSF has long been a leader in neuro-oncology research, and we are excited to contribute to this important effort on behalf of patients with recurrent high-grade glioma."

This research was additionally made possible by funding from the California Institute for Regenerative Medicine (CIRM), a state of California Agency that funds regenerative medicine, stem cell, gene therapy research and clinical trials (Grant number: TRAN1-15325).

"People with recurrent high-grade glioma urgently need more effective treatment options," said Ross Okamura, PhD, Research Fellow in Preclinical Development at CIRM. "The launch of this trial at UCSF is a major step toward identifying new options and providing hope for people with this deadly condition."

About Recurrent High-Grade Gliomas
Recurrent high-grade gliomas are among the most aggressive and lethal brain tumors. Current treatments can include surgery, radiation, and chemotherapy, all of which offer limited benefit. Novel therapeutic approaches are urgently needed.

(Press release, Siren Biotechnology, MAR 23, 2026, View Source [SID1234663848])

On March 23, 2026 Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, SSE: 688796; HKEX: 02315), a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies, reported a strategic collaboration with Moonlight Bio, Inc., a Seattle-based biotech company pioneering advanced cell therapies. This partnership aims to develop cutting-edge cell therapies to address some of the most challenging and difficult-to-treat cancers.

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Dr. Yuelei Shen, President and CEO of Biocytogen, said, "We are thrilled to partner with Moonlight Bio, a pioneering leader in advanced cell therapies. This strategic collaboration leverages our proprietary off-the-shelf fully human antibody library to accelerate the development of cutting-edge cell therapies for difficult-to-treat cancers. It also demonstrates the versatility and broad applicability of Biocytogen’s antibody discovery platforms beyond traditional drug modalities. By combining our expertise, we are poised to accelerate the development of transformative cell therapies that could overcome resistance and offer new hope to patients battling the toughest cancers.

Under the terms of the agreement, Biocytogen will provide its off-the-shelf antibody binders against therapeutic targets, and Moonlight Bio will oversee the preclinical development of cell therapies.

(Press release, Biocytogen, MAR 23, 2026, View Source [SID1234663847])

On March 23, 2026 BostonGene, developer of the leading AI foundation model for tumor and immune biology, reported an oral presentation at the United States and Canadian Academy of Pathology (USCAP) 115th Annual Meeting. The session highlights new clinical data generated in collaboration with leading academic investigators, including Weill Cornell Medicine.

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The event, held from March 21-26 at the Henry B. González Convention Center in San Antonio, TX, is the world’s premier gathering for pathology professionals serving as a critical global platform for clinicians and researchers to exchange cutting-edge research and educational insights across pathology subspecialties, with a particular focus on the integration of AI and molecular advancements into clinical practice.

The study, which demonstrates a multimodal AI framework trained on approximately 20,000 tumors, will be presented by Juan Miguel Mosquera, MD, MSc. Dr Mosquera is a Professor of Pathology and Laboratory Medicine at Weill Cornell Medicine and Director of Research Pathology at the Englander Institute for Precision Medicine, and is widely recognized for his contributions to cancer genomics and biomarker development with more than 130 peer-reviewed publications.

The research integrated whole exome and transcriptomic data to address cancers of unknown primary (CUP). In real-world cases, the framework accurately identified tumor origin while uncovering actionable therapeutic targets in more than 65% of patients, including FDA-approved options.

The results reflect a broader shift from traditional tumor classification toward AI-driven disease modeling, enabling deeper biological understanding, more precise patient stratification, and improved treatment selection.

Details of the oral presentation are below:

Abstract: 942
Title: Cancer of Unknown Primary (CUP): Beyond the Identification of the Tumor of Origin by an Integrative Whole Exome (WES) and Transcriptome Sequencing (RNAseq) Approach
Date & Time: Tuesday, March 24 | 8:30 AM – 8:45 AM
Location: Room 303B
Presenter: Juan Miguel Mosquera, MD, MSc, Weill Cornell Medicine

Research done in collaboration with Weill Cornell Medicine

(Press release, BostonGene, MAR 23, 2026, View Source [SID1234663846])

On March 23, 2026 OverT Bio, a biotechnology company developing next-generation therapies for solid tumors, reported the formation of its Clinical Advisory Board, comprised of internationally recognized leaders in oncology and cellular immunotherapy. The members of OverT’s Clinical Advisory Board are Dr. Kristen Hege, Dr. David Miklos, Dr. Dmitriy Zamarin, and Dr. Robert Wenham.

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The Clinical Advisory Board will provide strategic guidance on OverT’s clinical development plans, including trial design, indication prioritization, and translational strategy, as the company advances its lead asset, OVT-101 towards the clinic. OVT-101 is an off-the-shelf gamma delta CAR-T therapy targeting Claudin-6 and programmed for potency and durability using novel reprogramming strategies discovered with OverT’s massively-parallel overexpression platform. Using DNA barcoding, OverT’s unique platform has analyzed thousands of genes in primary human immune cells and identified which ones make better therapies when challenged by multiple forms of tumor immunosuppression.

"We are honored to welcome this exceptional group of clinicians and scientists to our Clinical Advisory Board," said Dr. Mat Legut, co-founder and CEO of OverT Bio. "Each member brings deep expertise in immune therapies and solid tumor oncology, which will be critical for our success in the clinic."

Kristen Hege, MD is a clinician-scientist and seasoned executive who led the first-in-class BCMA CAR-T program (Abecma) in multiple myeloma from inception through FDA approval at Bristol-Myers Squibb. She was most recently Senior Vice President of Early Clinical Development in Oncology/Hematology and Cell Therapy at BMS. In addition to her corporate leadership, Dr. Hege was the Clinical Professor of Medicine at UCSF, where she cared for patients with blood cancers for nearly three decades. She continues to shape the future of innovative cancer therapies by serving on the board of directors for multiple biotechnology companies.

David Miklos, MD, PhD is the Chief of Stanford’s Bone Marrow Transplant and Cell Therapy Program that provides over 700 cancer cell therapies annually. As a leading clinical expert, he has served as a principal investigator on pivotal trials for several CAR-T cell therapies in lymphoma and multiple myeloma. His translational research focuses on human correlative assays to optimize CAR-T therapy including ctDNA MRD, tumor antigen quantification, CAR-T immune phenotyping (CAR-FACS), and their single cell RNA and DNA characterization.

Dmitriy Zamarin, MD, PhD is the Section Head of Gynecologic Medical Oncology, and co-director of Center of Excellence for Gynecologic Cancers at Icahn School of Medicine at Mount Sinai. He has served as a principal investigator and a translational chair on multiple institutional and cooperative group clinical trials and serves as the translational research co-chair on the NRG Oncology Cervical Cancer committee. His clinical and laboratory research is focused on cancer cell-intrinsic mechanisms of immune recognition and resistance and development of novel therapeutics. Prior to his leadership role at Mount Sinai, he was a physician-scientist at Memorial Sloan Kettering Cancer Center, where he led numerous early-phase clinical trials testing immune-based treatment combinations.

Robert Wenham, MD is the Chair of the Department of Gynecologic Oncology and Senior Member in the Molecular Medicine Program at H. Lee Moffitt Cancer Center and Research Institute. He has directed numerous clinical trials evaluating targeted therapies, immunotherapies, and novel chemotherapeutics for ovarian, cervical, and uterine cancers. Recognized for his commitment to surgical excellence and innovative patient care, he has played a critical role in bringing life-extending therapies from the laboratory directly to the clinic. He has received the Molly Cade Ovarian Cancer Research Award from the Gynecologic Cancer Foundation. Dr. Wenham also serves in vital leadership capacities within national oncology cooperatives, including the Gynecologic Oncology Group (GOG), where he helps shape the national research agenda for women’s cancers.

"Building a Clinical Advisory Board of this caliber is an important step as we translate our platform into the clinic," said Dr. Francesco Galimi, Chief Medical Officer of OverT Bio. "Their collective experience across cellular therapies and solid tumors will be invaluable in shaping a thoughtful and efficient clinical development strategy for our programs."

The formation of the Clinical Advisory Board marks an important milestone as OverT Bio continues to build its clinical strategy and advance its lead program toward first-in-human studies.

(Press release, OverT Bio, MAR 23, 2026, View Source [SID1234663845])

On March 23, 2026 Prestige Biopharma reported positive topline results from its Phase 3 SAMSON-II study evaluating HD204, a proposed biosimilar to Avastin (bevacizumab) in adult patients with advanced non-squamous non-small cell lung cancer (NSCLC).

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SAMSON-II is a randomized, double blind, parallel group, multicenter Phase 3 study conducted in 625 patients across 91 centers in 15 countries. Patients were randomized in a 1:1 ratio to receive HD204 or Avastin in combination with standard chemotherapy.

The study met its primary endpoint of overall response rate (ORR) at Week 18, demonstrating clinical equivalence between HD204 and Avastin within the prespecified equivalence margin. ORR at Week 18 was 48.7% in the HD204 arm compared with 46.5% in the Avastin arm. The risk ratio was 1.047 (95% confidence interval [CI]: 0.86–1.27), and the risk difference was 0.022 (95% CI: −0.07–0.11), with both estimates falling within the predefined equivalence range.

Secondary efficacy endpoints were supportive of the primary analysis. Comparable overall response rates were observed at Week 12, and time-to-event outcomes demonstrated similar progression-free survival (PFS) and overall survival (OS) between treatment groups, with no statistically significant differences identified.

HD204 demonstrated a safety and tolerability profile consistent with the established safety experience of bevacizumab. Treatment-related adverse events were reported in 33.9% of patients receiving HD204 and 34.4% of patients receiving Avastin, while treatment-related serious adverse events occurred in 5.2% and 8.3% of patients, respectively. No new or unexpected safety signals were identified.

The clinical outcomes observed in SAMSON-II were consistent with the high degree of analytical and clinical pharmacokinetic (PK) similarity demonstrated between HD204 and Avastin. SAMSON-II results strengthen the collective global experience showing that sensitive analytical characterization and comparative clinical PK studies can reliably predict equivalent clinical performance in biosimilar development. Prestige Biopharma is advancing regulatory pathways for HD204 based on the strong analytical and clinical PK programs, while sharing the SAMSON-II findings to further contribute to the global scientific experience in biosimilar evaluation.

"These results illustrate the increasing precision with which biosimilarity can be established through advanced analytical and clinical PK studies," said Dr. Lisa Park, Chief Executive Officer of Prestige Biopharma. "Our experience with HD204 supports the view that well-designed development programs can reliably anticipate clinical performance, enabling more focused and efficient biosimilar development. By reducing unnecessary clinical burden, such advances can accelerate patient access to high-quality biologic medicines and support more sustainable healthcare systems worldwide."

(Press release, Prestige BioPharma, MAR 23, 2026, View Source [SID1234663844])