Human Trials

Harbour BioMed gets FDA nod to begin clinical trial for HBM4003 in cancer

Harbour BioMed has secured approval from the US Food and Drug Administration (FDA) to move ahead with clinical studies in the US for its anti-CTLA-4 antibody HBM4003 for the treatment of cancer.

Pandion announces first subject dosed in phase 1 trial of PT101, an IL-2 mutein Fc fusion therapy for autoimmune disease

Pandion Therapeutics, Inc., a biotechnology company developing modular protein therapeutics for autoimmune disease, announced the dosing of the first subject in a Phase 1 clinical trial of PT101, a novel and proprietary interleukin 2 (IL-2) mutein Fc fusion protein therapy. PT101 has shown potential to treat autoimmune diseases by expanding populations of regulatory T cells.

Harbour BioMed announces completion of phase 1 study in China of HBM9161, an anti-FcRn antibody

Harbour BioMed (HBM) announced completion of a Phase 1 study of HBM9161, a fully human anti-FcRn monoclonal antibody, to evaluate its safety, tolerability, pharmacokinetics and pharmacodynamics in healthy Chinese subjects.

First patient dosed with Transgene’s TG6002 in colorectal cancer with liver metastases

Transgene, a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, announces that the first patient has successfully received TG6002, via an intrahepatic artery (IHA) infusion, as a locoregional treatment for unresectable liver metastases from colorectal cancer (CRLM).

Opdivo delivers superior five-year survival results in renal cell carcinoma

Bristol-Myers Squibb said that a five-year follow-up of the phase 3 CheckMate -025 study showed that Opdivo (nivolumab) delivered superior five-year survival results in patients with renal cell carcinoma (RCC).

Celltrion showcases positive one-year results for subcutaneous formulation of infliximab in patients with active Crohn’s disease and ulcerative colitis

Celltrion Healthcare announced new 1-year data from a randomised controlled trial to evaluate the pharmacokinetics (PK), efficacy and safety of CT-P13 subcutaneous (SC) formulation compared to the CT-P13 intravenous (IV) formulation in patients with active Crohn’s disease (CD) and ulcerative colitis (UC).

New phase 3b interim data from STARDUST study show majority patients with moderately to severely active Crohn’s Disease achieved clinical remission after two doses of STELARA

The Janssen Pharmaceutical Companies of Johnson & Johnson announced interim data from the Phase 3b STARDUST study. At week 16, 79 percent of patients with moderately to severely active Crohn’s disease (CD) achieved clinical responsea and 67 percent were in clinical remissionb after receiving one ~6 mg/kg intravenous (IV) dose followed by one 90 mg subcutaneous (SC) dose of STELARA® (ustekinumab), open label.

Merck’s Keytruda plus chemotherapy meets primary endpoint in mTNBC trial

Merck’s Keytruda in combination with chemotherapy has achieved the primary endpoint of progression-free survival (PFS) as first-line treatment for metastatic triple-negative breast cancer (mTNBC) in the phase 3 KEYNOTE-355 trial.

Pfizer, Astellas’ Xtandi significantly improves OS in phase 3 prostate cancer study

Pfizer and Astellas Pharma announced that Xtandi (enzalutamide) has shown significant improvement in overall survival (OS) in phase 3 PROSPER trial.