Infinity Pharmaceuticals, Inc. Announces its Second Potent, Oral PI3K-Delta,Gamma Inhibitor, IPI-443; Provides Earnings Guidance for 2013
January 07, 2013 at 08:00 am EST
Share
Infinity Pharmaceuticals, Inc. announced its second potent, oral PI3K-delta,gamma inhibitor, IPI-443. Nonclinical studies of IPI-443 are now under way, which are designed to enable the initiation of Phase 1 clinical development. Infinity is developing a portfolio of PI3K inhibitors which includes IPI-145 and IPI-443, potent, oral inhibitors of PI3K-delta and PI3K-gamma, as well as retaspimycin hydrochloride, a potent and selective Hsp90 inhibitor. Infinity anticipates achieving the following development milestones in 2013: IPI-145 in Hematologic Malignancies:- First half of 2013: Initiate up to five cohort expansions in the ongoing Phase 1 trial in patients with advanced hematologic malignancies; Define the recommended Phase 2 dose; In 2013: Initiate at least two additional trials. IPI-145 in Inflammation:- First half of 2013: Initiate a Phase 2 trial in patients with rheumatoid arthritis; Second half of 2013: Provide update on Phase 2a trial in patients with mild, allergic asthma. PI3K Pipeline Expansion:- Second half of 2013: Complete nonclinical studies of IPI-443 to enable Phase 1 development. Retaspimycin HCl in NSCLC:- First half of 2013: Report topline overall survival data from Phase 2 trial in combination with docetaxel; Provide update on Phase 1b/2 trial in combination with everolimus.
The company provided earnings guidance for 2013. The company expects net loss for 2013 to range from $115 million to $125 million.
Infinity Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company that is focused on developing medicines for people with cancer. The Company is focused on advancing eganelisib, also known as IPI-549, an orally administered, clinical-stage, immuno-oncology product candidate that reprograms macrophages through selective inhibition of the enzyme phosphoinositide-3-kinase-gamma (PI3K-gamma). Its eganelisib clinical development program includes MAcrophage Reprogramming in Immuno-Oncology-3 (MARIO-3), MARIO-275 and MARIO-1. MARIO-3 is a multi-arm Phase II study designed to evaluate eganelisib in the front-line treatment for both metastatic triple-negative breast cancer (TNBC), and renal cell carcinoma (RCC). MARIO-275 is its global, randomized, placebo-controlled Phase II study evaluating the effect of adding eganelisib to nivolumab, also known as Opdivo, in checkpoint-naive advanced urothelial cancer (UC). MARIO-1 is in the Phase I/Ib clinical study.
INFINITY PHARMACEUTICALS, INC. 
