Harpoon Therapeutics Receives FDA Fast Track Designation 

Harpoon Therapeutics, Inc. recently announced the US FDA has granted Fast Track designation to HPN217, a BCMA-targeting TriTAC, for the treatment of patients with relapsed, refractory multiple myeloma (RRMM) who have received at least four lines of therapy. A Phase 1/2 clinical trial is currently ongoing for HPN217 in the RRMM patient population.

“We are pleased that HPN217 has received FDA Fast Track designation because it highlights the serious unmet medical need for patients with relapsed, refractory multiple myeloma who received multiple lines of therapy,” said Julie Eastland, President and CEO, Harpoon Therapeutics. “We are focused on selecting an initial dose to study in the expansion phase of the ongoing Phase 1/2 clinical trial in the first half of this year as we progress HPN217 forward as an innovative new treatment option for these patients.”

In November 2019, Harpoon Therapeutics and AbbVie announced a licensing agreement and option to advance HPN217 and expand an existing discovery collaboration. Under the terms of the agreement, AbbVie may exercise its option to license HPN217 after completion of the Phase 1/2 clinical trial.

Fast Track is a process designed to facilitate the development, and expedite the review, of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions and the request can be initiated by the drug company at any time during the development process. FDA will review the request and decide based on whether or not the drug fills an unmet medical need in a serious condition. Once a drug receives Fast Track designation, early and frequent communication between the FDA and the sponsor is encouraged throughout the entire drug development and review process.

Harpoon Therapeutics is a clinical-stage immunotherapy company developing a novel class of T cell engagers that harness the power of the body’s immune system to treat patients suffering from cancer and other diseases. T cell engagers are engineered proteins that direct a patient’s own T cells to kill target cells that express specific proteins, or antigens, carried by the target cells. Using its proprietary Tri-specific T cell Activating Construct (TriTAC) platform, Harpoon is developing a pipeline of novel TriTACs initially focused on the treatment of solid tumors and hematologic malignancies. HPN217 targets BCMA and is in a Phase 1/2 trial for relapsed, refractory multiple myeloma. HPN328 targets DLL3 and is in a Phase 1/2 trial for small cell lung cancer and other DLL3-associated tumors. HPN536 targets mesothelin and is in a Phase 1/2a trial for cancers expressing mesothelin, initially focused on ovarian and pancreatic cancers. HPN424 targets PSMA and is in a Phase 1/2a trial for metastatic castration-resistant prostate cancer. Harpoon has also developed a proprietary ProTriTAC platform, which applies a prodrug concept to its TriTAC platform to create a therapeutic T cell engager that remains inactive until it reaches the tumor. The company’s third proprietary technology platform, extended release TriTAC-XR, is designed to mitigate cytokine release syndrome. For more information, visit www.harpoontx.com.