FDA Clears Investigational NDA for BPX-603

June 16, 2020

The FDA has cleared an investigational new drug application for BPX-603, a GoCAR-T product candidate targeting solid tumors that express human epidermal growth factor receptor 2.

The FDA has cleared an investigational new drug application for BPX-603, a GoCAR-T product candidate targeting solid tumors that express human epidermal growth factor receptor 2 (HER2), according to Bellicum Pharmaceuticals, the developer of the agent.1

BPX-603 incorporates both the company’s inducible coactivation domain MyD88/CD40 or “iMC” and CaspaCIDe safety switching technologies, making it Bellicum’s first dual-switch GoCAR-T product candidate. The company indicated that this dual-switch technology is intended to enhance real-time control of both efficacy and safety.

The agent was designed to improve upon the modest antitumor activity of CAR T-cells in HER2 solid tumors, primarily through the incorporation of the iMC. MC signaling is currently thought to boost effector cell proliferation and survival; enhance functional persistence by resisting exhaustion and the suppressive tumor microenvironment; and stimulate the immune system of a patient with cancer.

Bellicum indicated that a phase 1/2 clinical trial of BPX-603 is already planned in HER2-positive solid tumors.2

Other GoCAR-T products created by the company include the BPX-601, which is an autologous GoCAR-T product candidate containing the iMC co-activation technology. BPX-601 is designed to treat solid tumors expression prostate stem cell antigen (PSCA). This cancer antigen is expressed in several solid tumor indications, including pancreatic cancer.

Findings from several ongoing studies have provided clinical evidence suggesting that BPX-601 drives expansion and persistence of therapeutic T-cells in patients with advanced solid tumors. The most recent study results, presented at the 2020 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancer Symposium, found that BPX-601 GoCAR-T cells exhibited enhanced survival and persistence up to 9 months in patients with previously treated PSCA-positive metastatic pancreatic cancer.3

“The FDA’s clearance of our IND for BPX-603 marks a significant milestone for Bellicum, adding a second clinical program to further evaluate our novel GoCAR-T technology’s ability to enhance CAR-T and host immune cell activity against solid tumors,” Rick Fair, president and chief executive officer of Bellicum, said in a press release. “We look forward to initiating our phase 1/2 trial with BPX-603 targeting solid tumors that express HER2 later this year.”

References:

1. Bellicum Receives FDA IND Clearance to Initiate a Phase 1/2 Clinical Trial for BPX-603, a Dual-Switch GoCAR-T® for HER2+ Solid Tumors [news release]. Houston. Published June 15, 2020. globenewswire.com/news-release/2020/06/15/2047971/0/en/Bellicum-Receives-FDA-IND-Clearance-to-Initiate-a-Phase-1-2-Clinical-Trial-for-BPX-603-a-Dual-Switch-GoCAR-T-for-HER2-Solid-Tumors.html. Accessed June 15, 2020.

2. Bellicum. Going Further for More Patients. Bellicum website. Published 2020. bellicum.com/gocart-product-candidates/. Accessed June 15, 2020.

3. Shaw J, Ballard B, Yi X, et al. Tumor Infiltration and Cytokine Biomarkers of Prostate Stem Cell Antigen (PSCA)-Directed Go-CAR-T Cells in Patients with Advanced Pancreatic Tumors. Presented at: 2020 ASCO Gastrointestinal Cancers Symposium; held January 23-25, 2020 in San Francisco, CA. bellicum.com/wp-content/uploads/2020/01/ShawJ_ASCO-GI_24Jan2020_Poster_FINAL_WEB2.pdf