BJ-001 / BJ Biosci - LARVOL DELTA

Breeding records and the detection of nesting predators of wild-release red-crowned cranes into non-breeding areas of the Yancheng National Nature Reserve, China. (PubMed, Ecol Evol) - "BJZ001 and BJZ008) from the first group of released cranes were found breeding in 6 of 7 years in the YNNR from 2017 to 2023...Although these released cranes breed successfully in the YNNR, nestlings might face the threat of predators in non-traditional breeding areas. Further research is needed to determine whether offsprings of released individuals migrate with wild cranes and if breeding in their original wintering grounds is truly beneficial for population growth."

Journal

FIH: Safety Study of BJ-001, an IL-15 Fusion Protein, for Locally Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1b | N=92 | Active, not recruiting | Sponsor: BJ Bioscience, Inc. | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Metastases • Cholangiocarcinoma • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

BJ Bioscience Announces Clinical Collaboration with MSD to Evaluate BJ-001 in Combination with KEYTRUDA (pembrolizumab) (PRNewswire-Asia) - "BJ Bioscience...announced that it entered into a clinical trial collaboration and supply agreement with MSD....The collaboration will allow for the evaluation of safety and efficacy of BJ-001, a tumor-targeting IL-15 fusion protein, in combination with MSD's anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in an ongoing Phase 1 clinical trial. BJ Bioscience will evaluate BJ-001 plus KEYTRUDA as part of the company's ongoing trial in patients with locally advanced/metastatic solid tumors. In this trial, BJ-001 is studied as monotherapy or in combination with KEYTRUDA, for safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and antitumor activity."

Licensing / partnership • Oncology • Solid Tumor

FIH: Safety Study of BJ-001, and IL-15 Fusion Protein, for Locally Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1b | N=92 | Recruiting | Sponsor: BJ Bioscience, Inc. | Trial completion date: Oct 2022 ➔ Oct 2024 | Trial primary completion date: Apr 2022 ➔ Apr 2024

Combination therapy • Trial completion date • Trial primary completion date • Cholangiocarcinoma • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

[VIRTUAL] Phase I study of BJ-001, a tumor-targeting interleukin-15 fusion protein, in patients with solid tumor. (ASCO 2021) - P1b | "To date, BJ-001 is well tolerated up to 6 µg/kg . The safety evaluation for 10 µg/kg is ongoing . The observed NK and Treg cell profiles are consistent with known IL-15 biology."

Clinical • P1 data • Anorexia • Immunology • Inflammation • Oncology • Solid Tumor • IL15

FIH: Safety Study of BJ-001, and IL-15 Fusion Protein, for Locally Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1b; N=92; Recruiting; Sponsor: BJ Bioscience, Inc.

Clinical • Combination therapy • New P1 trial