FDA Grants Fast-Track Status to ImmPACT Bio’s IMPT-314 for Treatment of Aggressive B-cell Lymphoma!

ImmPACT Bio, a clinical-stage company developing groundbreaking CAR T-cell therapies for cancer and autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted its lead therapy, IMPT-314, Fast Track Designation (FTD).

This first-of-its-kind CD19/CD20 CAR T therapy is designed to treat B-cell lymphomas, including relapsed or refractory (R/R) aggressive B-cell lymphoma, diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), high grade B cell lymphoma (HGBCL), primary mediastinal B-cell lymphoma (PMBCL), and DLBCL arising from follicular lymphoma (FL), following two or more lines of systemic therapy. This is a major milestone for ImmPACT Bio and a major step forward in the fight against cancer.

The FDA’s fast track designation of ImmPACT Bio’s IMPT-314 is a testament to the urgent need for treatments of aggressive B cell lymphomas. Despite the availability of treatments, these relapsed or refractory B cell lymphomas still experience high rates of relapse, low survival rates, and serious toxicity. With its design to target two prevalent B cell antigens, CD19 and CD20, IMPT-314 is expected to help overcome treatment resistance and prolong durability.

In addition, a UCLA-led investigator study found the bispecific CAR construct underlying IMPT-314 to be exceptionally safe, with only Grade 1 cytokine release syndrome and no neurotoxicity. It is hoped that IMPT-314 can help extend duration of response with a safe and well-tolerated profile, and the first patient is set to be dosed in the Phase 1/2 trial in aggressive B-cell malignancies in the second quarter of 2021.

In 2019, UCLA researchers Yvonne Chen, Ph.D., and Sarah Larson, M.D., initiated an exciting Phase 1 study of the ground-breaking IMPT-314 CAR T-cell therapy in patients with relapsed/refractory non-Hodgkin lymphoma. Developed by Dr. Chen and in-licensed by ImmPACT Bio, IMPT-314 is a unique logic-gate-based CAR T-cell platform that has the potential to revolutionize cancer treatment.

Fast track designation is an incredible opportunity for drugs to reach patients quicker than ever before. By offering support and guidance throughout the clinical development process, the FDA has the ability to expedite the review of drugs with the potential to treat serious or life-threatening conditions.

With the help of FTD, the FDA may even review portions of the marketing application before the sponsor submits the entire application, giving those in need the access to treatments they need faster than ever.

ImmPACT Bio is excited to launch a Phase 1/2 clinical trial to evaluate the efficacy and safety of IMPT-314 in aggressive B-cell lymphoma and DLBCL. The first patient is set to receive dosing in Q2 2023, with initial data expected in the second half of the same year. We look forward to seeing the potential of this innovative therapy!

About ImmPACT Bio

ImmPACT Bio USA, Inc. is a clinical-stage company that is revolutionizing cancer treatment through the development of transformative chimeric antigen receptor (CAR) T-cell therapies. Licensed from the University of California, Los Angeles (UCLA) Technology Development Group, these logic-gate-based CAR T-cell platforms are designed to prevent antigen escape while overcoming the immunosuppressive tumor microenvironment.

This innovative technology was pioneered by scientists Yvonne Chen, Ph.D., Antoni Ribas, M.D., Ph.D., and Gideon Gross, Ph.D., from UCLA and the MIGAL-Galilee Research Institute, respectively, and is a major breakthrough in preventing ‘on-target, off-tumor’ toxicities. With these cutting-edge therapies, ImmPACT Bio is providing hope to cancer patients who have exhausted their treatment options.

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