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Infinity Pharmaceuticals Inc. (NASDAQ:INFI) just announced its third quarter 2018 financial results and provided an update on the company and its progress with IPI-549, a first-in-class oral immuno-oncology product candidate that selectively inhibits phosphoinositide-3-kinase-gamma (PI3K-gamma) and targets immuno-suppressive tumor macrophages/myeloid-derived suppressor cells (MDSCs).

“We approach the end of 2018 with tremendous momentum in developing IPI-549 as an effective therapy for patients whose cancers are not adequately treated by existing immuno-therapies,” said Adelene Perkins, Chief Executive Officer and Chair of Infinity Pharmaceuticals. “Our clinical and translational data have laid the foundation for the broader, later-stage development of IPI-549, including Infinity’s clinical development of IPI-549 in a Phase 2 trial in urothelial cancer in collaboration with Bristol-Myers Squibb. We look forward to providing an update at the SITC annual meeting on November 10.”

Infinity Pharmaceuticals Inc. (NASDAQ:INFI) trumpets itself as a biopharmaceutical company that develops medicines for people with cancer in the United States.

Its product candidate is IPI-549, an orally administered clinical-stage immuno-oncology product candidate that inhibits the enzyme phosphoinositide-3-kinase-gamma (PI3K-gamma), which is in Phase 1/1b clinical study.

The company has strategic alliances with Intellikine, Inc. to discover, develop, and commercialize pharmaceutical products targeting the delta and/or gamma isoforms of PI3K; Verastem, Inc. to research, develop, commercialize, and manufacture duvelisib and products containing duvelisib, as well as duvelisib program, including DUO study that is in randomized and monotherapy Phase III clinical study for patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma; PellePharm, Inc. to develop and commercialize rights to its hedgehog inhibitor program, IPI-926, a clinical-stage product candidate; and AbbVie Inc. to develop and commercialize products containing duvelisib in oncology indications., as well as collaboration agreement with Arcus Biosciences, Inc.

Infinity Pharmaceuticals, Inc. is headquartered in Cambridge, Massachusetts.

According to company materials, “Infinity is an innovative biopharmaceutical company dedicated to advancing novel cancer treatments. Infinity is advancing IPI-549, a potentially transformative immuno-oncology approach that aims to reprogram tumor-associated macrophages by selectively inhibiting PI3K-gamma. A Phase 1/1b study in approximately 200 patients with advanced solid tumors is ongoing. Infinity will also initiate a Phase 2 study to evaluate the effect of adding IPI-549 to Opdivo in checkpoint-naïve advanced urothelial cancer patients who have progressed or recurred following treatment with platinum-based chemotherapy. Approximately 150 patients will be randomized between combination therapy and Opdivo monotherapy.”

 

Fresh Mo

As we discussed earlier, INFI just announced its third quarter 2018 financial results and provided an update on the company and its progress with IPI-549, a first-in-class oral immuno-oncology product candidate that selectively inhibits phosphoinositide-3-kinase-gamma (PI3K-gamma) and targets immuno-suppressive tumor macrophages/myeloid-derived suppressor cells (MDSCs).

This announcement has popped the stock higher, which certainly isn’t surprising. INFI shareholders are now sitting on about 25% in gains over the past week. Shares of the stock have powered higher over the past month, rallying roughly 11% in that time on strong overall action.

According to the release, “Infinity is evaluating IPI-549 as a monotherapy and in combination with Opdivo® (nivolumab), a PD-1 immune checkpoint inhibitor, in collaboration with Bristol-Myers Squibb, in the MARIO-1 Phase 1b study in approximately 200 patients with advanced solid tumors. Infinity is also planning to initiate the MARIO-275 global, randomized Phase 2 study to evaluate the effect of adding IPI-549 to Opdivo in checkpoint inhibitor-naïve advanced urothelial cancer patients who have progressed or recurred following treatment with platinum-based chemotherapy. Approximately 150 patients will be randomized between combination therapy and Opdivo monotherapy. In addition, Arcus Biosciences will initiate two triple combinations investigating IPI-549 with their dual adenosine receptor antagonist, AB928, anti-PD-1 antibody, AB122, and chemotherapy in triple negative breast cancer and ovarian cancer. One triple combination therapy will evaluate IPI-549 in combination with AB928 and AB122 and the second will evaluate IPI-549 in combination with AB928 and chemotherapy, with topline data expected in 2019.”

Infinity Pharmaceuticals Inc. (NASDAQ:INFI) had no reported sales in its last quarterly financial data. In addition, the company has a strong balance sheet, with cash levels far exceeding current liabilities ($49.2M against $5.7M).