Month: December 2025

Anixa Biosciences Announces Positive Phase 1 Data for Investigational Breast Cancer Vaccine; Primary Endpoints Were Met and Immune Response Observed in 74% of Participants

12/15/2025

Vaccine Was Safe and Well Tolerated at the Maximum Tolerated Dose Results Support Advancement of the Program into Phase 2 Development Combination of Keytruda® and the vaccine generated T cell responses and showed no major additional side effects, supporting plans for a Phase 2 neoadjuvant combination study in newly diagnosed breast cancer patients Excerpt from…

Mission Bio’s Tapestri Single Cell Multi-Omics Platform for Exploratory Biomarker Analysis Supports Myeloproliferative Neoplasms (MPNs) Data Presentation at ASH 2025

12/12/2025

Mission Bio’s Tapestri® Platform and custom assay development platform supported exploratory biomarker analysis for Incyte’s INCA033989 clinical trial for myeloproliferative neoplasms (MPNs), enabling single-cell DNA and protein profiling to better understand clonal evolution, treatment response, and resistance mechanisms. Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Mission Bio, Inc., a leader in single-cell multi-omic…

Ajax Therapeutics Presents Preclinical Data on Differentiated Efficacy Profile of AJ1-11095, a First-in-Class Type II JAK2 Inhibitor, at the American Society of Hematology Annual Meeting

12/11/2025

– Data demonstrate superior efficacy compared to ruxolitinib, an approved type I JAK2 inhibitor, including reductions in mutant allele burden and bone marrow fibrosis, key markers of disease modification – – AJ1-11095 is currently in a Phase 1 clinical trial in patients with myelofibrosis, previously treated with a type I JAK2 inhibitor – Excerpt from the…

Alpha-9 Oncology Announces First Patient Dosed in Phase 1 Study of A9-3408 for the Treatment of Melanoma

12/10/2025

Phase 1 study advances A9-3408, an Actinium-225-based radiotherapeutic, building on the progress of the company’s imaging agent, A9-3202, which entered the clinic last year Robert Meehan, M.D., appointed as Chief Medical Officer, bringing extensive clinical development expertise to advance the Company’s radiotherapeutic pipeline Excerpt from the Press Release: BOSTON and VANCOUVER, BC, Dec. 4, 2025…

Estrella Advances STARLIGHT-1 Trial into Phase II Following Positive DSMB Recommendation

12/09/2025

Excerpt from the Press Release: EMERYVILLE, Calif.–(BUSINESS WIRE)–Estrella Immunopharma, Inc. (NASDAQ: ESLA) (“Estrella” or the “Company”), a clinical stage biopharmaceutical company developing CD19 and CD22-targeted ARTEMIS® T-cell therapies to treat cancer and autoimmune diseases, today announced that an independent Data Safety Monitoring Board (DSMB) has completed its review of safety data from the Phase I…

Kelonia Therapeutics Announces Late-Breaking Oral Presentation of First-in-Human Data from in vivo BCMA CAR-T Therapy at the American Society of Hematology (ASH) 2025 Annual Meeting

12/08/2025

Early results from the Phase 1 inMMyCAR™ study demonstrate ongoing MRD-negative responses in all patients with a tolerable safety profile Robust CAR-T cell expansion occurred in the absence of preparative chemotherapy Persistent, memory CAR-T cells in all patients Excerpt from the Press Release: BOSTON–(BUSINESS WIRE)–Kelonia Therapeutics, Inc., a clinical-stage biotechnology company pioneering in vivo gene…

Artera Unveils Data Demonstrating Prognostic and Predictive Utility in Breast Cancer at SABCS 2025

12/05/2025

First multi-country study validates AI model for risk stratification and chemotherapy prediction Excerpt from the Press Release: SAN FRANCISCO–(BUSINESS WIRE)–Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer tests, today announced that three abstracts will be presented at the San Antonio Breast Cancer Symposium (SABCS), held December 9-12. The studies collectively highlight…

Vertero Initiates Phase 1 Study of VT-5006, A Selective Small Molecule Therapy for Parkinson’s Disease

12/04/2025

VT-5006 is a first-in-class small molecule designed to precisely engage a validated peripheral target to delay onset and slow progression of Parkinson’s disease WOBURN, Mass., Nov. 24, 2025 (GLOBE NEWSWIRE) — Vertero Therapeutics, a clinical-stage biotechnology company breaking barriers in neurodegenerative disease treatment, today announced that it has initiated a Phase 1 study of its…

Ocular Therapeutix™ Announces First Patient Randomized in HELIOS-3 Phase 3 Registrational Program for AXPAXLI™ in NPDR

12/03/2025

First patient randomized into HELIOS-3, which along with HELIOS-2 form the basis of AXPAXLI’s registrational program in non-proliferative diabetic retinopathy (NPDR) HELIOS-2 and HELIOS-3 are global, complementary superiority trials using a novel ordinal diabetic retinopathy severity scale (DRSS) primary endpoint Targeting a broad diabetic retinopathy (DR) label by including patients with non-center-involved diabetic macular edema…

Parabilis Medicines Highlights Promising Preliminary Clinical Results in Patients with Adamantinomatous Craniopharyngioma from Ongoing FOG-001 Clinical Trial at SNO 2025

12/02/2025

Consistent, significant tumor reductions across all ACP patients mark the second low-complexity Wnt/β-catenin-driven tumor subgroup – alongside desmoid tumors – showing uniform monotherapy activity in multiple patients treated with FOG-001 Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–Parabilis Medicines, a clinical-stage biopharmaceutical company committed to creating extraordinary medicines for people living with cancer, today announced…