On March 22, 2023 Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH), a discovery and development stage specialty pharmaceutical company focused on improving the outcomes of cancer patients treated with radiation therapy (RT), reported it has entered a research agreement with Georgetown University focused on the evaluation of the Company’s lead HDAC6 inhibitor candidate, SP-2-225, evaluating the anti-tumor effect of the combination of SP-2-225 and RT in a syngeneic breast cancer model (Press release, Shuttle Pharmaceuticals, MAR 22, 2023, View Source [SID1234629178]). The pre-clinical work outlined in the research agreement with Georgetown will support the Company’s IND-enabling studies in 2023 with a goal to submit an investigational new drug application (IND) for the selective HDAC6 inhibitor and initiation of a Phase I clinical trial in 2024.
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Shuttle Pharmaceuticals has a longstanding strategic relationship with Georgetown University having been founded by Georgetown University Medical School faculty members. Alejandro Villagra, Ph.D., an associate professor at Georgetown University and member of the Shuttle scientific advisory board, will lead research efforts under the agreement. Dr. Villagra has expertise in cellular signaling pathways, epigenetics and immunology.
SP-2-225 is Shuttle Pharma’s pre-clinical class IIb selective HDAC inhibitor under development for regulating the immune system after RT. With the introduction of check-point inhibitors, CAR-T therapies and personalized medicine in cancer, regulation of the immune response following RT is of significant clinical and commercial interest.
Shuttle Pharma’s platform of sensitizers offers a pipeline of product candidates designed to address the urgent clinical need for new radiation sensitizer agents. In addition to the HDAC inhibitor candidates, the Company’s pipeline includes Ropidoxuridine, its lead clinical sensitizer drug candidate, to sensitize rapidly growing cancer cells which is advancing towards Phase II clinical testing in brain cancer patients undergoing radiation therapy.
"We are excited to extend and strengthen our collaboration with Dr. Villagra and Georgetown University to further evaluate our lead HDAC6 inhibitor candidate, SP-2-225," commented Shuttle Pharma’s Chairman and CEO, Anatoly Dritschilo, M.D. "Our goal is to build upon our leadership position in radiation sensitization, a market which is experiencing dynamic growth through the development of new radiation technology, the introduction of new agents, and growth in the number of diagnosed patients who may benefit from these treatments."