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

Rhea-AI Summary

Immune-Onc Therapeutics has initiated the first patient dosing in the Phase 1 study of IO-108, a myeloid checkpoint inhibitor, targeting solid tumors. The company has established a clinical supply agreement with Regeneron (NASDAQ: REGN) to evaluate IO-108 alongside Regeneron's Libtayo® (cemiplimab). IO-108 has shown promising activity in various tumor types and will be assessed in multiple expansion cohorts as both a monotherapy and in combination therapies. Immune-Onc retains global commercialization rights and is focused on combining its treatments with existing T-cell checkpoint therapies.

Positive

• First patient dosed in Phase 1 study of IO-108, indicating progress in clinical development.
• Collaboration with Regeneron to accelerate clinical trials enhances potential for IO-108's market entry.
• IO-108 has demonstrated promising clinical activity, making it a competitive option in cancer therapies.

Negative

• None.

IO-108 is being studied as a monotherapy and in combination with select anti-PD-1 antibodies in multiple expansion cohorts of solid tumors

Clinical supply agreement with Regeneron accelerates Immune-Onc’s solid tumor clinical development program

PALO ALTO, Calif.--(BUSINESS WIRE)-- Immune-Onc Therapeutics, Inc. (“Immune-Onc”), 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. (NASDAQ: REGN) (“Regeneron”) 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.”

ABOUT IO-108

IO-108 is a fully human IgG4 monoclonal antibody with high affinity and specificity towards LILRB2 (also known as ILT4). It blocks the interaction of LILRB2 with multiple ligands that are involved in cancer-associated immune suppression, including HLA-G, ANGPTLs, SEMA4A and CD1d. Preclinical data presented at the 2020 Society for Immunotherapy of Cancer’s annual meeting and the 2022 American Association for Cancer Research annual meeting demonstrate that IO-108 functions as a myeloid checkpoint inhibitor and promotes innate and adaptive anti-cancer immunity.

The ongoing Phase 1 study of IO-108 in adult cancer patients in the U.S. (NCT05054348) has completed dose escalation and is actively enrolling several expansion cohorts, as a monotherapy and in combination with anti-PD-1 antibodies (pembrolizumab or cemiplimab). To date, IO-108 has been well tolerated with demonstrated clinical activity in multiple tumor types, both as a monotherapy and in combination with pembrolizumab. The company is also actively enrolling a Phase 1 clinical trial in China to evaluate IO-108 in solid tumors.

ABOUT IMMUNE-ONC THERAPEUTICS, INC.

Immune-Onc Therapeutics Inc. (“Immune-Onc”) is a private, clinical-stage cancer immunotherapy company dedicated to the discovery and development of novel myeloid checkpoint inhibitors for cancer patients. The company aims to translate unique scientific insights in myeloid cell biology and immune inhibitory receptors to discover and develop first-in-class biotherapeutics that inhibit immune suppression in the tumor microenvironment.

Immune-Onc has a differentiated pipeline with a current focus on targeting the Leukocyte Immunoglobulin-Like Receptor subfamily B (LILRB) of myeloid checkpoints. Immune-Onc’s focused platform approach has led to the development of several promising therapeutics across various stages of development. Those include IO-108, an antagonist antibody targeting LILRB2 (also known as ILT4), in Phase 1 clinical development for solid tumors and IO-202, a first-in-class antagonist antibody targeting LILRB4 (also known as ILT3), in Phase 1 clinical development for the treatment of acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), and solid tumors. Additional assets in Immune-Onc’s pipeline include IO-106 (first-in-class antagonist antibody targeting LAIR1), IO-312 (bi-specific antibody targeting LILRB4), and multiple undisclosed programs for solid tumors and hematologic malignancies.

Immune-Onc has established agreements with leading biopharmaceutical companies, including BeiGene and Regeneron, to support its global product development plans for IO-108 and IO-202. It has received research grants from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) and the California Institute for Regenerative Medicine (CIRM) and investment from The Leukemia & Lymphoma Society Therapy Acceleration Program® (LLS TAP®). Headquartered in Palo Alto, California, Immune-Onc has assembled a diverse team with deep expertise in drug development and proven track records of success at leading biopharmaceutical companies. For more information, please visit www.immune-onc.com and follow us on Twitter and LinkedIn.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221017005273/en/

Tara Cooper

The Grace Communication Group

tara@gracegroup.us

media@immuneonc.com

650-303-7306

Source: Immune-Onc Therapeutics, Inc.

FAQ

What is the significance of the first patient dosing in the Phase 1 study of IO-108?

The first patient dosing marks a critical milestone in Immune-Onc's clinical development of IO-108, indicating progress in its evaluation as a treatment for solid tumors.

How does the agreement with Regeneron impact IO-108's development?

The agreement allows Immune-Onc to utilize Regeneron's Libtayo® (cemiplimab) in clinical trials, potentially speeding up the development and evaluation of IO-108 in combination therapies.

What types of tumors is IO-108 being studied for?

IO-108 is being evaluated for advanced or refractory solid tumors in multiple expansion cohorts during the Phase 1 study.

What are the clinical applications of IO-108?

IO-108 is intended as a novel treatment for solid tumors, functioning as a myeloid checkpoint inhibitor to enhance anti-cancer immune responses.

What are the potential benefits of combining IO-108 with anti-PD-1 therapies?

Combining IO-108 with anti-PD-1 therapies may improve response rates in patients who do not achieve durable responses with T-cell checkpoint therapies alone.