Immunotherapy

CatalYm Doses First Patient in Phase 2b Trial Evaluating Visugromab in Combination with Chemoimmunotherapy as Second-Line Treatment in Unresectable/Metastatic Hepatocellular Carcinoma

04/24/2026

Excerpt from the Press Release: MUNICH & SAN FRANCISCO–(BUSINESS WIRE)–CatalYm today announced that the first patient has been dosed in the GDFATHER-HCC-01 trial (NCT07219459). The trial evaluates the company’s lead anti-GDF-15 antibody visugromab in combination with chemoimmunotherapy as a second-line (2L) treatment for patients with unresectable or metastatic hepatocellular carcinoma (HCC). The Phase 2b trial…

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…