invIOs selects INV501 lead candidate to progress into IND-enabling studies in glioblastoma and melanoma

• invIOs has filed patents for its novel small molecule program, INV501, which shows strong activation of tumor-specific T cells
• Preclinical testing in melanoma and breast cancer successfully completed; IND-enabling toxicology studies in preparation
• Pre-clinical testing in glioblastoma is being conducted under a collaboration with the Dana-Farber Cancer Institute

Vienna, Austria, 17 July 2024: invIOs GmbH (“invIOs”), a privately held biotechnology company developing novel therapies for cancer, today announced that the company has selected a lead candidate from the INV501 compound family to bring forward in development. Initially, the compound will be evaluated as a potential treatment for glioblastoma, an aggressive form of brain cancer, as well as for melanoma, a potentially deadly skin cancer. The identified target is clinically validated and is involved in immune activation. For competitive reasons, the target is not being disclosed at this time.

The INV501 family of compounds was identified as part of a phenotypic screen for substances that can activate T cells. Members of the compound hit series can induce elevated levels of T cell activation markers and killing capacity in the presence of the T cell’s target antigen. The INV501 clinical candidate compound was selected based on extensive medicinal chemistry and pharmacological testing. It belongs to a compound class which is orally available showing favorable bioavailability for a potent immune therapy. invIOs has filed patents covering INV501 and its applications.

at the 2023 Annual Congress of the European Association for Cancer Research (EACR) show that INV501 can selectively enhance tumor-reactive cytotoxicity in preclinical in vivo model systems, resulting in prolonged survival even beyond the end of treatment. Pharmacokinetic investigation in higher species further supports translatability into a clinical setting and the compound demonstrates highly accurate anti-tumor dose-responses in vitro and in vivo. Furthermore, INV501 candidate compound is capable of crossing the blood-brain barrier, making it a promising candidate for the treatment of brain tumors, including glioblastoma.

invIOs is planning to conduct IND-enabling toxicology studies, and manufacturing under GMP conditions is in preparation.

“We have reached a significant milestone in selecting our clinical candidate to bring forward in development, and we are eager to explore the potential of INV501. The preclinical results seen to date are compelling in terms of both efficacy and safety, and the ability of INV501 to cross the blood-brain barrier and initiate anti-tumoral immune reactions is particularly promising,” commented Romana Gugenberger, PhD, Chief Medical and Scientific Officer of invIOs. “Our collaboration with the Dana-Farber Cancer Institute is a testament to the strength of our science and enhances our research efforts as we work together to bring new hope to seriously ill cancer patients.”

The preclinical work in glioblastoma with INV501 is being conducted as part of a with the Dana-Farber Cancer Institute (DFCI), led by David Reardon, MD, Clinical Director, Center for Neuro-Oncology at the DFCI and Professor of Medicine at Harvard Medical School. Dr. Reardon is a world-renowned expert in brain cancer, particularly glioblastoma research and treatment. The research group will evaluate INV501 alone and in combination with the current standard of care (temozolomide or radiation) or anti-myeloid therapies in preclinical glioblastoma models. Depending on the outcome, further studies to understand the mechanisms of action of INV501 will be conducted.

“We have made excellent progress with INV501, and I am excited about the significant strides we are making towards bringing this promising immuno-oncology approach to patients. We are encouraged by Ligand Pharmaceutical’s recent commitment to invest up to USD 4 million in invIOs, which further validates our innovative approach to cancer treatment. Based on this commitment, we have just commenced a fundraising process to further advance our pioneering treatment approaches in the field of immuno-oncology and bring us closer to providing new hope to patients in need;” added Peter-Llewellyn-Davies, CEO and CFO of invIOs.

About invIOs

invIOs is a privately held biotech company based in Vienna, Austria, focusing on the discovery and development of novel therapies for cancer. The invIOs team leverages deep expertise in immune system activation to develop individualized and targeted approaches against solid tumors. invIOs is advancing a pipeline of three programs encompassing small molecule and cell therapy approaches.

EPiC, invIOs’ proprietary cell therapy platform, enables rapid treatment of patients in an out-patient setting. EPiC is a technology platform that allows the creation of personalized cell therapies based on localized processing of a patient’s fresh immune cells. The first asset from the EPiC platform, APN401, is in Phase 1 clinical trials against various solid tumors. The second asset, INV441, is being developed against glioblastoma and is in preclinical . The third EPiC program, INV451, is a novel CAR-T cell approach against lung cancer being developed with the Medical University of Innsbruck.

INV501 is a novel small molecule candidate that can selectively enhance T cell mediated anti-tumor immune responses. INV501 is currently in preclinical testing and has demonstrated preclinical proof of concept with strong data in multiple solid tumor indications after oral administration. A lead candidate compound for clinical development has been declared and is undergoing IND-enabling studies.

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Peter Llewellyn-Davies
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