Infinity Pharmaceuticals, Inc. INFI provided an update on lead pipeline candidate–IPI-549 and also issued financial guidance for 2018.
Infinity is currently focused on the development of its lead immuno-oncology candidate IPI-549. It is an orally administered treatment that selectively inhibits phosphoinositide-3 kinase (PI3K)-gamma. Infinity has a clinical trial collaboration with Bristol-Myers BMY to evaluate IPI-549 in combination with the latter’s PD-1 immunecheckpoint inhibitor Opdivo (nivolumab), in patients with advanced solid tumors.
In January 2018, the company has announced the achievement of four development milestones for IPI-549. In 2018, the company also plans to report data from the monotherapy expansion and combination dose escalation components. The company expects to announce initial data from the combination expansion component of the Phase I/Ib study of IPI-549 with Opdivo in the second quarter of 2018. In the second half of 2018, Infinity expects to report more mature clinical data from the combination expansion component of the study including translational insights from paired tumor biopsies across multiple diseases.
The company also announced the expansion of its phase I/Ib study of IPI-549 to include a combination cohort of IPI-549 plus Opdivo that will enroll patients with high baseline levels of myeloid derived suppressor cells.
IPI-549 represents a potentially complementary approach to restoring anti-tumor immunity in combination with other immunotherapies such as checkpoint inhibitors. If successfully developed, approval of IPI-549 will provide a massive boost to Infinity’s portfolio.
The company also provided financial guidance for 2018 and expects to end 2018 with a year-end cash and investments balance ranging from $10-$20 million.
Based on its current operational plans, Infinity expects that its existing cash, cash equivalents and available-for-sale securities at December 31, 2017, will be adequate to satisfy the company's capital needs into the first quarter of 2019.
In October 2016, Infinity entered into a license agreement with Verastem, Inc. under which it granted exclusive worldwide rights to develop and commercialize its oncology candidate duvelisib to the latter. In October 2017, Infinity received $6-million cash payment from Verastem. Verastem plans to submit a new drug application for duvelisib in the first quarter of 2018.
Infinity’s progress with the candidate has been impressive. Moreover, clinical trial collaboration with Bristol-Myers has provided Infinity with a strong partner with expertise in the field of immuno-oncology. Further, it will allow Infinity to expedite the development of IPI-549.
However, Infinity faces stiff competition in the fields of immuno-oncology from companies like Bristol-Myers, AstraZeneca AZN, Celgene CELG, Merck, Novartis, Pfizer, Roche and Eli Lilly among others.
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