On January 5, 2022 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) a clinical-stage biotechnology company developing eganelisib, a first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic, reported an update on eganelisib clinical development plans and 2022 guidance (Press release, Infinity Pharmaceuticals, JAN 5, 2022, View Source [SID1234598172]).
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"Eganelisib is a unique drug for which we have presented positive results in multiple indications where checkpoint inhibitors have provided little to no patient benefit. Based on these strong data, we will be initiating a registration study in frontline TNBC in 2022 – due to the magnitude of the unmet need in this very large patient population and the magnitude of the eganelisib benefit. Eganelisb combination therapy has demonstrated tumor volume reductions of 92.8% and 85.2%, and disease control rates of 92.8% and 81.4%, in PD-L1(+) and PD-L1 (-) frontline TNBC patients, respectively, as well as improvements in progression free survival over standard of care benchmarks regardless of PD-L1 status," said Adelene Perkins, Chief Executive Officer and Chair, Infinity Pharmaceuticals.
"We are aggressively advancing a registration focused study in TNBC with the goal of bringing eganelisib to patients in need as quickly as possible. We also continue to be encouraged by the overall survival benefit seen in patients with urothelial cancer, and to support the initiation of future registration trials in 2023 and beyond, we are also expanding the development of eganelisib in a platform study in additional indications where checkpoint inhibitors and other current therapies have offered little benefit," said Robert Ilaria, Jr. M.D., Chief Medical Officer, Infinity Pharmaceuticals.
Program Updates and Guidance:
The Company plans to initiate a frontline mTNBC randomized, double-blind, pivotal trial by the end of 2022 with progression free survival (PFS) and overall survival (OS) as endpoints. In the PD-L1 negative patients eganelisib will be evaluated in combination with chemotherapy and a checkpoint inhibitor (the eganelisib triplet) vs chemotherapy. In the PD-L1 positive patients the eganelisib triplet will be evaluated vs chemotherapy and a checkpoint inhibitor. Pending feedback from a MARIO-3 end-of-Phase 2 meeting with global regulatory authorities, Infinity will finalize the MARIO-4 trial design.
Infinity also plans to initiate MARIO-P, a platform study to evaluate the clinical benefit of eganelisib to support the initiation of future registration focused studies across various solid tumor indications, on a rolling basis in 3Q 2022.
The Company expects multiple data releases in 2H 2022:
MARIO-3 study in mTNBC patients
MARIO-3 study in renal cell carcinoma patients
MARIO-275 study in urothelial cancer patients
Window of Opportunity IST study in head and neck squamous cell carcinoma patients sponsored by Dr. Ezra Cohen
2022 Financial Guidance:
Infinity ended 2021 with approximately $81 million in cash and investments (unaudited) and plans to report its fourth quarter and full-year 2021 financial results in March 2022. The Company expects to end 2022 with between $25 million to $35 million in cash and investments based on its current operating plans, which excludes additional financing or business activities. The company expects net loss for 2022 to range between $45 million to $55 million.