People often point out how long it takes to turn a scientific discovery into an approved therapy—and they’re right. It can take years, even decades. But for Immune‑Onc Therapeutics, that path may have just shortened.

In April 2021, CIRM approved a $6 million investment in Immune‑Onc to run a clinical trial for patients with acute myeloid leukemia (AML) and chronic myelomonocytic leukemia (CMML). AML affects about 20,000 people in the U.S. each year and has a five‑year survival rate of roughly 25%. Between 15–30% of CMML cases eventually progress to AML.

Dr. Paul Woodard and his team are testing an antibody therapy called IO‑202 that targets leukemic stem cells. The antibody blocks LILRB4, a signal linked to poor survival in AML patients. The goal is complete remission and longer survival.

They must be doing something right—IO‑202 just received Fast Track designation from the FDA. This designation helps speed drug development and review for serious conditions with unmet medical needs, getting promising therapies to patients sooner.

Fast Track designation means Immune‑Onc may be:

• Eligible for additional written communication and face‑to‑face meetings with the FDA about IO‑202’s development
• Eligible for Accelerated Approval and Priority Review if the therapy meets the criteria, potentially leading to faster approval

In a press release, Dr. Woodard welcomed the news:
“We are pleased the FDA has granted IO‑202 Fast Track designation in recognition of its potential to improve outcomes for people with relapsed or refractory AML. We look forward to working closely with the FDA to accelerate its clinical development.”

The FDA also granted IO‑202 Orphan Drug Designation in 2020. This status applies to therapies targeting rare diseases affecting fewer than 200,000 people in the U.S. It provides incentives such as tax credits for clinical trials and up to seven years of market exclusivity after approval.