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Osmol Therapeutics, Inc.

October 17, 2023
Franciscan C
Oncology
Osmol is an IND-stage biopharma company based in New Haven, CT, developing technology licensed from Yale School of Medicine to address chemotherapy induced peripheral neuropathy (CIPN). CIPN is a significant unmet need associated with microtubule-based chemotherapies including taxanes, the most widely used chemotherapy treatment for breast cancer. There are no approved treatments for CIPN, leaving patients' only option to reduce the dose or length of chemo treatment. Osmol’s initial focus is in breast cancer where up to 80% of patients develop CIPN. CIPN is driven by the dysregulation of neuronal calcium sensor-1 (NCS1), a calcium sensor protein that maintains resting calcium concentration and dynamically enhances responses to cellular stimuli. Osmol is developing a novel, patented drug (OSM-0205) to modulate NCS1 function and prevent neuronal damage caused by the off-target effects of chemotherapy. In vivo and in vitro data support the development and effectiveness of OSM-0205 including: characterization of mechanism of efficacy, validation in mouse models of CIPN, and in vivo demonstration of no effect on chemotherapy efficacy. In addition, a limited clinical experience supports the therapeutic hypothesis. Finally, in vivo data support the potential for efficacy in a follow-on indication, chemotherapy-induced cognitive impairment (CICI). Market research with breast cancer specialists at leading US cancer centers confirmed the significant need for effective CIPN treatments that would allow clinicians to provide the optimal planned chemotherapy treatment.
Speakers
Bob LINKE, President & CEO - Osmol Therapeutics, Inc.

Company Type

Privately Funded

Website

http://www.osmoltherapeutics.com

CEO/Top Company Official

Bob Linke

Lead Product in Development

OSM-0205 is a potent NCS1 stabilizer discovered by Dr. Barbara Ehrlich, Professor of Pharmacology at Yale School of Medicine. Calcium homeostasis is critical to the homeostasis of cellular function. NCS1 is a highly sensitive calcium sensor protein that maintains resting calcium concentrations and dynamically enhances responses to cell stimuli. Certain chemotherapy agents destroy tumor cells by disrupting microtubules. These agents also bind to NCS1 leading to a calcium surge that causes neuronal atrophy subsequently resulting in CIPN and CICI. OSM-0205 is hypothesized to protect NCS1 function by preventing the chemotherapy induced calcium surge and thereby averting CIPN and CICI, while not impacting the chemotherapy’s microtubule effect on tumor cells. OSM-0205 is a patented intravenous formulation of an FDA-approved oral CNS medication following the 505 (b)(2) regulatory pathway. The product would be administered to patients immediately prior to the chemotherapy infusion to protect neurons from off target effects of the chemotherapy.

Number Of Unlicensed Products

1

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