Treatments for cancer have advanced a lot in recent years, but many still rely on the use of chemotherapy to either shrink tumors before surgery or help remove cancerous cells the surgery missed. The chemo can be very effective, but it’s also very toxic. Angiocrine Bioscience Inc. is developing a way to reduce those toxic side effects, and they just got a nice vote of confidence for that approach.

RMAT

The US Food and Drug Administration (FDA) has granted Angiocrine Regenerative Medicine Advanced Therapy (RMAT) designation for their product AB-205.

RMAT is a big deal. It means the therapy, in this case AB-205, has already shown it is safe and potentially beneficial to patients, so the designation means that if it continues to be safe and effective, it may be eligible for a faster, more streamlined approval process. And that means it can get to the patients who need it, outside of a clinical trial, faster.

What is AB-205? It’s made from genetically engineered cells derived from cord blood, designed to help alleviate or accelerate recovery from the toxic side effects of chemotherapy for people undergoing treatment for lymphoma and other aggressive cancers of the blood or lymph system.

Clinical trial

CIRM awarded Angiocrine Bioscience $6.2 million in 2018 to help carry out the Phase 2 clinical trial testing the therapy.

In a news release, CIRM President and CEO Dr. Maria Millan said this therapy meets a real need.

“CIRM supported this project from an early stage, showing our commitment to moving promising research into people. Lymphoma is the most common blood cancer and the sixth most diagnosed cancer in California. Many patients still face serious complications from chemotherapy, so treatments that reduce those complications can improve quality of life and, we hope, long‑term outcomes.”

In a news release, Dr. Paul Finnegan, Angiocrine’s CEO, welcomed the RMAT designation. “It reflects the promising efficacy and safety data from our Phase 1b/2 study. This is an important step toward the first approval of AB‑205. We appreciate the FDA’s assessment and the support from CIRM.”

This investment marked CIRM’s 50th funded clinical trial—a milestone worth celebrating. The company hopes to begin a Phase 3 trial in the U.S. and Europe next year.