On January 5, 2022 Samus Therapeutics, Inc. ("Samus Therapeutics" or the "Company"), a privately held, Boston-based biopharmaceutical company with a novel approach to protein degradation and restoration of normal cellular functions to treat cancer and central nervous system (CNS) diseases, reported the first patient was dosed in the multicenter Phase 1b study of icapamespib in patients with recurrent malignant glioma (Press release, Samus Therapeutics, JAN 5, 2022, View Source [SID1234598295]).

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Over 24,000 patients are diagnosed with primary brain tumors (non-metastatic) in the U.S. per year and of these approximately half are classified as glioblastomas, a type of fast-growing high grade glioma1. The five-year survival rate for patients >55 years old is particularly poor (6-15%)1.

"Patients with recurrent malignant glioma face a poor prognosis. Currently, standard treatments are sub-optimal and there is an urgent need for the development of new promising therapeutics," said Howard Colman, MD, PhD, Co-Leader of the Center for Neurologic Cancers and Co-Leader of the Experimental Therapeutics Program at the Huntsman Cancer Institute at the University of Utah, and principal investigator of the Phase 1b study. "I look forward to investigating a therapy which may help address this significant unmet patient need."

The Phase 1b trial consists of two stages. The first stage is currently recruiting patients and will evaluate the safety, tolerability and pharmacokinetics of icapamespib. This dose escalation stage is designed to define a recommended Phase 2 dose (RP2D). The second stage, dose expansion, will confirm the safety and tolerability of the RP2D.

Icapamespib (PU-AD, PU-HZ151) is an oral small molecule that crosses the blood brain barrier and is designed to inhibit epichaperomes, protein complexes which support cancer growth. In a recently published article, Bolaender et al2 demonstrated in preclinical studies that glioblastomas express high levels of epichaperomes and that treatment response to icapamespib directly correlates with epichaperome expression levels. In ex-vivo studies using patients’ surgical explants from tumors resistant to temozolomide and bevacizumab, drugs routinely utilized to treat malignant glioma, inhibition of epichaperomes with icapamespib initiated aberrant protein degradation and induced cancer cell death.

"We are excited to test the novel approach of epichaperome inhibition with icapamespib and to evaluate how it can benefit patients with recurrent malignant glioma," said Dick Bagley, Chief Executive Officer of Samus Therapeutics.

References
1 American Cancer Society, View Source
2 Bolaender A. et al. NATURE COMMUNICATIONS 2021;12:4669