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People often complain about how long it can take to turn a scientific discovery into an approved therapy for patients. And they’re right. It can take years, decades even. But for Immune-Onc Therapeutics the path to FDA approval may just have been shortened.
Back in April of 2021 the California Institute for Regenerative Medicine (CIRM) approved investing $6 million in Immune-Onc to conduct a clinical trial for patients with acute myeloid leukemia (AML) and chronic myelomonocytic leukemia (CMML). AML and CMML are both types of blood cancer. AML affects approximately 20,000 people in the United States each year and has a 5-year survival rate of about 25 percent. Anywhere from 15-30 percent of CMML cases eventually progress into AML.
Dr. Paul Woodard and his team are treating patients with an antibody therapy called IO-202 that targets leukemic stem cells. The antibody works by blocking a signal named LILRB4 which is associated with decreased rates of survival in AML patients. The goal is to attain complete cancer remissions and prolonged survival.
Well, they must be doing something right because they just received Fast Track designation from the US Food and Drug Administration (FDA) for IO-202. Getting this designation is a big deal because its goal is to speed up the development and review of drugs to treat serious conditions and fill an unmet medical need to get important new medicines to patients earlier.
Getting a Fast Track designation means the team at Immune-Onc may be:
- Eligible for more written communications and even face-to-face meetings with the FDA to discuss the development plan of IO-202
- Eligible for Accelerated Approval and Priority Review if relevant criteria are met, which may result in faster approval.
In a press release Dr. Woodard said this was great news. “We are pleased that 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 the clinical development of IO-202, which is currently being evaluated as a monotherapy and in combination with other agents in a Phase 1 dose escalation and expansion trial in patients with AML with monocytic differentiation and in chronic myelomonocytic leukemia (CMML).”
The FDA also granted IO-202 Orphan Drug Designation for treatment of AML in 2020. That’s defined as a therapy that’s intended for the treatment, prevention or diagnosis of a rare disease or condition, affecting less than 200,000 persons in the US.
Getting Orphan Drug Designation qualifies Immune-Onc for incentives including tax credits for clinical trials and the potential for seven years of market exclusivity if and when it is fully approved by the FDA.