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ImmuneOnco Announced Preliminary Safety & Efficacy Data from the Clinical Trial Studying IMM2510/AXN-2510, a PD-L1xVEGF Bispecific Antibody, in Combination with Chemotherapy in Front-line NSCLC in China

On July 31, 2025 ImmuneOnco Biopharmaceuticals reported preliminary safety and efficacy data from the Phase 2 open-label, multicenter study of IMM2510 in combination with chemotherapy for front-line patients with advanced non-small cell lung cancer (NSCLC) conducted in China (Press release, ImmuneOnco Biopharma, JUL 31, 2025, View Source [SID1234655712]).

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As of July 1, 2025, 33 patients were dosed at 10 mg/kg, with 21 patients having at least one tumor assessment (efficacy evaluable). Partial responses were observed in 62% of efficacy evaluable patients, comprising partial responses in 80% (8/10) of patients with squamous NSCLC and 46% (5/11) of patients with non-squamous NSCLC. The majority of efficacy evaluable patients had only one tumor assessment at data cut-off. ImmuneOnco expects to present safety and efficacy data in the IMM2510 chemotherapy combination trial in front-line NSCLC at a future medical conference.

The IMM2510 safety profile supports further clinical development, with no dose-limiting toxicities observed in the 33 safety evaluable patients. In these patients, there were no treatment-related adverse events (TRAE) leading to dose reduction or death, and only one TRAE leading to drug discontinuation. The most common Grade 3+ TRAEs were hematologic, with uncommon clinical sequelae. Adverse events typically associated with VEGF inhibition (e.g., hypertension, proteinuria, hemoptysis) and immune-related adverse events were uncommon and generally low-grade, and infusion-related reactions were nearly all low-grade.

Professor Caicun Zhou, M.D., Ph.D., director of the Department of Oncology at Shanghai East Hospital, Tongji University, and lead investigator on the study of IMM2510 in 1L NSCLC said： "IMM2510 has demonstrated early but compelling activity in front-line NSCLC patients. The PD-(L)1xVEGF bispecific class has the potential to become the new standard of care for front-line NSCLC, and I look forward to the generation of additional data with IMM2510 in this setting."

Dr. Wenzhi Tian, CEO of ImmuneOnco said: "We are delighted to witness the progress of IMM2510 in front-line non-small cell lung cancer (NSCLC). This data paves the way for its advancement into Phase 3 clinical studies and provides valuable insights to support further research across multiple indications."

Bronson Crouch, CEO of Instil said: "We are pleased with the preliminary clinical results of the combination of IMM2510/AXN-2510 with chemotherapy in patients with front-line NSCLC, which suggest the potential for best-in-class efficacy in the promising PD-(L)1xVEGF bispecific antibody class. We look forward to further public updates from ImmuneOnco on these data, as well as the initiation of our previously announced US phase 1 clinical trial before the end of this year."

BriaCell Adds UCLA Health as Key Site in Pivotal Phase 3 Breast Cancer Study

On July 31, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, reported the addition of UCLA Health Jonsson Comprehensive Cancer Center, a leading cancer center in California, to its ongoing pivotal Phase 3 clinical study (Bria-ABC, NCT06072612) evaluating Bria-IMT in combination with a checkpoint inhibitor versus physician’s choice in patients with advanced metastatic breast cancer (MBC) (Press release, BriaCell Therapeutics, JUL 31, 2025, View Source [SID1234655022]).

"The randomized Phase 2 data reported with the Bria-IMT combination regimen are encouraging, and we believe BriaCell’s Phase 3 study represents an opportunity for meaningful progress towards improving survival outcomes in patients with metastatic breast cancer," stated Kelly E. McCann, MD, PhD, Breast Medical Oncologist, and Lead Investigator at UCLA Health Jonsson Comprehensive Cancer Center. "We are excited to support this important study and anticipate strong patient enrollment through our large multi-center clinical site."

"The inclusion of UCLA Health underscores our strategy to partner with top-tier institutions to accelerate trial enrollment and execution," said Dr. Giuseppe Del Priore, BriaCell’s Chief Medical Officer. "We remain confident in our timeline for sharing top-line data in 2026."

Interim analysis of the pivotal Phase 3 study will be conducted after 144 patient events (deaths) have occurred, with overall survival (OS) as the primary endpoint. The study compares the Bria-IMT combination regimen with immune checkpoint inhibitor against physician’s choice in patients with advanced metastatic breast cancer. This design builds upon maturing positive survival data from BriaCell’s Phase 2 study, most recently presented at ASCO (Free ASCO Whitepaper) 2025, which evaluated the same combination in a similar MBC patient population . Notably, the Bria-IMT combination regimen has been granted FDA Fast Track designation, underscoring its potential to address a serious unmet medical need.

For additional information on BriaCell’s pivotal Phase 3 study of Bria-IMT and an immune check point inhibitor in metastatic breast cancer, please visit ClinicalTrials.gov NCT06072612 .

H1 2025 results

On July 31, 2025 Ipsen reported first half 2025 financial results (Presentation, Ipsen, JUL 31, 2025, View Source [SID1234654821]).

Ipsen delivers strong results in the first half of 2025 and upgrades its full-year guidance

On July 31, 2025 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-care biopharmaceutical company, reported its financial results for the first half of 2025 (Press release, Ipsen, JUL 31, 2025, View Source [SID1234654820]).

Revisions to patient enrollment

On July 31, 2025 Pyxis Oncology, Inc.’s (the "Company") reported revisions to patient enrollment participants related to Phase 1 monotherapy clinical trial to evaluate micvotabart pelidotin ("MICVO", formerly PYX-201) were made available on ClinicalTrials.gov (Press release, Pyxis Oncology, JUL 31, 2025, View Source [SID1234654730]). This clinical trial is a first-in-human, open-label, multicenter, Phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of Micvo in participants with advanced solid tumors and includes a part 1 dose escalation and part 2 dose expansion (NCT05720117).

Consistent with the industry practices, the revision in patient enrollment participants reflects the maximum number of patients that will be allowed to be enrolled as per protocol. The Company confirms its prior guidance related to estimated number of head and neck squamous cell carcinoma ("HNSCC") patients to be enrolled in the dose expansion phase (Part 2) of the PYX-201-101 monotherapy study as disclosed in its quarterly report on Form 10-Q filed with the Securities and Exchange Commission on May 15, 2025.