- Micro cap Infinity Pharmaceuticals (NASDAQ:INFI) is down 67% premarket on increased volume in response to its announcement that will close down its discovery research organization and lay off 46 employees (21% of its workforce) prompted by less-than-expected results in a mid-stage study assessing lead product candidate duvelisib for the treatment of refractory indolent non-Hodgkin lymphoma (iNHL), a slow-growing blood cancer. In addition, the company and development partner AbbVie (ABBV) have agreed to pause AbbVie's Phase 1b/2 trial evaluating the combination of duvelisib and venetoclax while Infinity evaluates its options with duvelisib.
- The Phase 2 clinical trial, DYNAMO, assessed duvelisib as monotherapy in 129 patients with follicular lymphoma (n=83), small lymphocytic lymphoma (n=28) or marginal zone lymphoma (n=18) whose disease progressed or did not respond to treatment with Biogen's (BIIB) Rituxan (rituximab) and either chemotherapy or radiotherapy. The primary endpoint was overall response rate (ORR).
- Results showed an ORR of 46%, all partial responders and below expectations. The ORR in the three lymphoma types listed above were 41%, 68% and 33%, respectively. The data will be submitted to presentation at a future medical conference.
- The most common serious adverse events (Grade 3 or higher) were neutropenia (low neutrophils) (28%), diarrhea (15%), thrombocytopenia (low blood platelets) (13%) and anemia (12%). 20% of participants experienced an infection of least Grade 3 (serious).
- CEO Adelene Perkins says, "While DYNAMO met its primary endpoint, we hoped that treatment with duvelisib as monotherapy would have provided a larger clinical benefit....We plan to seek feedback from the FDA to determine our next steps with respect to duvelisib in iNHL."
- Duvelisib is an investigational inhibitor of Class 1 phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma being jointly developed by Infinity and AbbVie. The PI3K pathway plays a key role in regulating the growth and survival of certain blood cancers. Inhibiting PI3K-delta and PI3K-gamma signaling blocks the growth and survival of tumor cells.
- Infinity will release updated guidance after all these activities have been completed. Management will host a conference call at 8:30 am to discuss the situation.