Pharma Focus Asia

Immune-Onc Therapeutics Initiates Expansion Cohorts for IO-108 and Enters into Clinical Supply Agreement with Regeneron

Tuesday, October 18, 2022

Immune-Onc Therapeutics, Inc., a private, clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting myeloid checkpoints, today announced the dosing of the first patient in the expansion cohorts of its ongoing Phase 1 study for IO-108. The Company also entered into a clinical supply agreement with Regeneron Pharmaceuticals, Inc. to evaluate IO-108 in combination with Regeneron’s anti-PD-1 therapy, Libtayo® (cemiplimab), as part of its ongoing clinical development program.

IO-108 is a novel myeloid checkpoint inhibitor targeting Leukocyte Immunoglobulin-Like Receptor B2 (LILRB2, also known as ILT4) in adult patients with advanced or refractory solid tumors.

“We are incredibly excited to have enrolled the first patient in an expansion cohort of the IO-108 study. To date, IO-108 has been well tolerated and has demonstrated promising clinical activity in various tumor types, both as a monotherapy and in combination with an anti-PD-1 antibody,” said Paul Woodard, M.D., chief medical officer of Immune-Onc. “Additionally, on the heels of initiating this important phase of our study, we are excited to enter into a supply agreement with Regeneron, which enables us to accelerate the global development of IO-108 in multiple expansion cohorts of select solid tumors. We hope to establish our pipeline products as the preferred combination agents with T cell checkpoint inhibitors and other standard of care therapies.”

The Phase 1 expansion phase includes IO-108 monotherapy cohorts and IO-108 combination cohorts with anti-PD-1 antibodies (pembrolizumab or cemiplimab, depending on tumor types). Under the terms of the agreement, Immune-Onc will sponsor and fund the planned clinical trials and Regeneron will provide cemiplimab (Libtayo®). Immune-Onc retains global development and commercial rights to IO-108.

“I have been very encouraged by both the pre-clinical and early clinical data observed for IO-108 in the ongoing Phase 1 study, and look forward to better understanding how combination therapy with various anti-PD1 therapies can further activate the body’s immune system to attack some of the hardest-to-treat cancers,” said IO-108 Phase 1 investigator, Matthew H. Taylor, M.D., assistant member, Developmental Cancer Therapeutics Laboratory and co-medical director, Providence Melanoma Program, Earle A. Chiles Research Institute, Providence Cancer Institute, Portland, Oregon. “Currently, 70-80 percent of cancer patients with solid tumors do not achieve durable responses to T-cell checkpoint therapies alone, and people with many types of cancer have yet to benefit from the promise of this class of immunotherapy. This underscores the need for investigating novel combination regimens.”

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