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 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 (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.
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).
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 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).
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 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 and Astellas Pharma announced that Xtandi (enzalutamide) has shown significant improvement in overall survival (OS) in phase 3 PROSPER trial.
Eli Lilly and Company (Lilly) said that its anti-amyloid monoclonal antibody solanezumab failed to meet the primary endpoint in the phase 2/3 Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) Study.
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