Immunotherapy

Affinia Therapeutics Announces FDA Acceptance of IND Application to Advance AFTX-201 to a Phase 1/2 Trial for the Treatment of BAG3-Associated Dilated Cardiomyopathy (DCM)

02/10/2026

AFTX-201 uses Affinia’s proprietary capsid engineered for efficient cardiac transduction at doses that are 5-10-fold lower than doses of gene therapies using conventional capsids Company on track to initiate the UPBEAT© clinical trial to investigate safety, pharmacodynamics, and preliminary efficacy of AFTX-201 in BAG3 DCM in the first half of 2026 Excerpt from the Press Release:…

GT Biopharma Announces IND Submission for GTB-5550 TriKE®, a B7-H3-targeted natural killer (NK) cell engager for B7-H3 expressing solid tumor cancers

01/19/2026

GT Biopharma targets a portion of the estimated $362 billion global solid tumor market Preliminary, unaudited cash balance of approximately $7 million as of December 31, 2025 anticipated to extend cash runway into Q3 2026 Excerpt from the Press Release: SAN FRANCISCO, CALIFORNIA, Jan. 15, 2026 (GLOBE NEWSWIRE) — GT Biopharma, Inc. (the “Company”) (NASDAQ:…

Astria Therapeutics Announces Final Positive Results from All Enrolled HAE Patients in the ALPHA-STAR Phase 1b/2 Trial of Navenibart

11/18/2025

— Final ALPHA-STAR Phase 1b/2 Results from the Full-Enrollment Population (n=29) Remain Highly Consistent with Prior Results from the Target-Enrollment Population (n=16), Demonstrating Strong Efficacy, Favorable Safety, and Potential for Infrequent Dosing — — Phase 3 ALPHA-ORBIT Trial for Navenibart is Progressing as Planned with Topline Results Anticipated in Early 2027; First Patient Now Enrolled…

GT Biopharma Provides Enrollment Update on GTB-3650 Phase 1 Trial in Patients with Relapsed or Refractory (r/r) CD33 Expressing Hematologic Malignancies

10/20/2025

The Company is well on track with Phase 1 enrollment now that both patients in Cohort 3 have successfully initiated treatment with no evidence of dose-limiting toxicities or tolerability concerns to date The first patient in Cohort 3 has shown promising evidence of immune activation consistent with levels of activity observed in patients from the…

IMUNON Presents IMNN-001 Phase 2 Translational Data in Advanced Ovarian Cancer Demonstrating 13-Month OS Extension via Tumor Micro-Environment Shift

10/02/2025

Results from OVATION 2 Study reinforce IMNN-001 efficacy benefits observed in the clinic and unique mechanism of action, producing key anti-cancer immune cytokines post-treatment Pivotal Phase 3 trial of IMNN-001 underway, with four trial sites activated to date and on plan for site expansion to accelerate patient recruitment Excerpt from the Press Release: LAWRENCEVILLE, N.J.,…

Children’s Hospital of Philadelphia Researchers Find that Missing Messenger RNA Fragments Could be Key to New Immunotherapy for Hard-to-Treat Tumors

08/25/2025

The researchers identified a potential therapeutic vulnerability in pediatric high-grade gliomas Excerpt from the Press Release: PHILADELPHIA, Aug. 15, 2025 /PRNewswire/ — A new study, led by researchers at Children’s Hospital of Philadelphia (CHOP), identified tiny pieces of messenger RNA that are missing in pediatric high-grade glioma tumors but not in normal brain tissues. Preclinical…

Adicet Bio Announces First Systemic Sclerosis (SSc)Patient Dosed in Ongoing Phase 1 Clinical Trial of ADI-001 in Autoimmune Diseases

07/29/2025

Phase 1 clinical trial of ADI-001 in autoimmune diseases actively enrolling patients with lupus nephritis (LN), systemic lupus erythematosus (SLE) and SSc Preliminary clinical data from Phase 1 trial of ADI-001 in autoimmune diseases expected in 2H/2025 Excerpt from the Press Release: REDWOOD CITY, Calif. & BOSTON–(BUSINESS WIRE)–Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage…

Oncolytics Biotech® Highlights Transformative Pelareorep Survival Data in Multiple Tumors and Commitment to Registration-Enabling Studies

07/24/2025

Comparison with multiple landmark first-line metastatic pancreatic ductal adenocarcinoma studies substantiates strong two-year survival benefit of 21.9% vs. 9.2% historical benchmark Consistent survival benefit compared to standard-of-care chemotherapy in randomized studies in the large HR+/HER2- metastatic breast cancer indication Data from over 1,100 patients across tumor types reveals a favorable, well-understood safety profile Excerpt from…

BriaCell Highlights Additional Phase 3 Clinical Sites Including Los Angeles Cancer Network and Smilow Cancer Hospital at Yale New Haven

07/10/2025

Excerpt from the Press Release: PHILADELPHIA and VANCOUVER, British Columbia, July 02, 2025 (GLOBE NEWSWIRE) — 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, is pleased to announce the addition of two key large cancer centers to its ongoing…

Marengo Presents Monotherapy Activity of Invikafusp Alfa, a First-in-Class Selective Dual T Cell Agonist in PD-1 Resistant GI Tumors, as a Late-Breaking Oral Presentation at ESMO Gastrointestinal Cancers Congress 2025

07/09/2025

Excerpt from the Press Release: CAMBRIDGE, Mass., July 2, 2025 /PRNewswire/ — Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering novel approaches for precision immunotherapy, today presented new clinical data from the ongoing STARt-001 Phase 1/2 trial of Invikafusp alfa during an oral session at the European Society of Medical Oncology (ESMO) Gastrointestinal Cancers Congress 2025.…