- Micro cap Immunomedics (IMMU +32.4%) jumps out of the blocks this morning on a 6x surge in volume in apparent response to the news that the FDA has designated Fast Track-tagged IMMU-132 a Breakthrough Therapy for the treatment of triple negative breast cancer (TNBC), a type that is particularly resistant to therapy.
- In clinical studies, interim results from a Phase 2 study showed a 72% disease control rate in TNBC patients who had at least two prior lines of therapy. The disease control rate is the proportion of the patient population comprised of complete responders, partial responders and those with no cancer progression.
- IMMU-132 (sacituzumab govitecan) is an antibody-drug conjugate (ADC) consisting of an monoclonal antibody that binds to a protein found on the surface of many types of cancer cells called TROP-2. Specifically binding to the cancer cell enables the precise delivery of the cytotoxic payload, SN-38, the active metabolite of the chemo agent irinotecan. Its value proposition is the ability to deliver the drug over repeated cycles of therapy since SN-38 is less toxic than other chemotherapies.
- Breakthrough Therapy status provides for more intensive guidance from the FDA review team, the involvement of more senior agency personnel and a rolling review of the New Drug Application (NDA).
- It also announced a clinical trial collaboration with Merck in ovarian cancer yesterday which, no doubt, is adding fuel to the up move. Merck is basically just supplying product so the "collaboration" won't develop unless the early-stage study is successful.
- Previously: ImmunoGen to evaluate combo of lead product candidate and Merck's Keytruda in ovarian cancer (Feb. 4)