Shuttle Pharmaceuticals Provides Q1 2023 Corporate Update
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Recent Highlights
Shuttle Pharma continues to execute on the necessary steps to advance Ropidoxuridine, the Company's lead clinical sensitizer drug candidate, towards the commencement of its upcoming Phase II clinical trial in brain cancer patients undergoing radiation therapy with an expectation of pre-IND application submission to the FDA by the end of the second quarter of 2023.
Entered into agreements with TCG GreenChem, Inc. and UI Pharmaceuticals for drug manufacture and formulation development of Ropidoxuridine, the Company's lead clinical sensitizer drug candidate, for use in the Company's upcoming Phase II clinical trial evaluating Ropidoxuridine in combination with radiation therapy for the treatment of glioblastoma.
Engaged Theradex Oncology, a leading clinical research organization, to help prepare for its upcoming clinical study of Ropidoxuridine.
Entered into an agreement to lease new laboratory and office space, commencing in June 2023, to assist in furthering the development of the Company's lead drug candidates and accelerate broader diagnostic capabilities on predictive biomarkers.
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.
Shuttle Pharma was awarded U.S. Patent No. 11,654,157, "Methods And Compositions For Cancer Therapies That Include Delivery Of Halogenated Thymidines And Thymidine Phosphorylase Inhibitors In Combination With Radiation," which was issued by the U.S. Patent and Trademark Office on May 23, 2023.
Published manuscripts discussing prostate cancer cell lines derived from African American men for precision medicine and immune responses taking place in patients after radiation therapy for cancer.
Awarded patents in the U.S. and Hong Kong for its radiation sensitizing HDAC inhibitor technology platform.
Appointed Dr. Bette Jacobs to its Board of Directors as an independent director.
Rang the Nasdaq opening bell in January 2023.
Closed on private placement of $4.3 Million of Senior Secured Convertible Note and Warrants to purchase 1.018 million shares of common stock in exchange for $4.0 million investment.
At March 31, 2023, the Company had a working capital balance of $9 million. The Company anticipates that it has sufficient capital to fund operations into the first quarter of 2025.
"Shuttle Pharma is advancing our mission to improve the lives of cancer patients by developing therapies that are designed to maximize the effectiveness of Radiation Therapy while limiting the late effects of radiation in cancer treatment," commented Shuttle Pharma's Chairman and CEO, Anatoly Dritschilo, M.D. "During the first quarter, we made tangible progress advancing our pipeline, including Ropidoxuridine, our lead clinical drug candidate, which sensitizes rapidly growing cancer cells and, our various selective HDAC (histone deacetylase) inhibitors – which sensitize cancer cells and stimulate the immune system. With Ropidoxuridine, we are finalizing details to submit the final protocol details to the FDA at the end of the second quarter of 2023 with commencement of the Phase II clinical trial in brain cancer patients commencing shortly thereafter. Additionally, we are advancing pre-clinical work to support our 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. We look forward to an exciting 2023 as we advance our immuno-oncology and radio-oncology solutions."
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