Pharma Focus America

Shuttle Pharmaceuticals Enters into Manufacturing Agreement for Ropidoxuridine

Wednesday, September 21, 2022

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) while reducing its side effects, entered into an agreement with TCG GreenChem, Inc. to manufacture Ropidoxuridine, the Company's lead clinical sensitizer drug candidate, for use in formulating the drug product for testing in clinical trials of Ropidoxuridine and RT of cancers.

"Shuttle Pharma's platform of sensitizers offers a pipeline of product candidates designed to address the urgent clinical need and the current limitations of using 'off-label' drugs with potential new sensitizer agents," said Dr. Anatoly Dritschilo, Chief Executive Officer of Shuttle Pharmaceuticals. "Ropidoxuridine, our lead clinical sensitizer drug candidate, sensitizes rapidly growing cancer cells and selective histone deacetylase (HDAC) inhibitors, to sensitize cancer cells and stimulate the immune system. Our novel technologies will be tested in combination with radiation therapies, such as conventional X-ray and proton radiation therapies, and in combination with immune therapies."

"Today's agreement with TCG GreenChem allows us to advance our clinical research, including our proposed Phase II clinical trials, to establish the data necessary for the FDA to determine efficacy in treating brain tumors, sarcomas and pancreatic cancers, diseases that offer potential for orphan designations. For instance, the FDA has already granted approval of our application for orphan-drug designation for Ropidoxuridine for the treatment of glioblastoma. We look forward to working with TCG GreenChem to advance our clinical work to improve outcomes for these cancer patients," Dr. Dritschilo concluded.

In conjunction with manufacturing Ropidoxuridine, TCG GreenChem will perform process research, development and optimization work for Shuttle Pharma related to Ropidoxuridine and create working standards of starting materials and intermediates to support the qualitative/quantitative analysis of the drug reaction progress, determination of impurities, total mass balance and assay yields of the reactions. Shuttle Pharma will own all intellectual property and improvements developed through the Manufacturing Agreement.

TCG GreenChem, Inc. was founded by former large pharma pharmaceutical executives with a track record in the development of hundreds of New Chemical Entities into the clinic and commercialization of several well-known pharmaceutical products for Boehringer Ingelheim Pharmaceuticals, Inc., Sepracor, Inc., and Merck & Co, Inc. Dr. Chris Senanayake, the CEO and CSO of TCG GreenChem, CSO of TCG Lifesciences Pvt Ltd., and who serves on the board of directors of Shuttle Pharma, is a pioneering scientist and business executive who recently received two 2022 Business Worldwide Magazine CEO Awards, including "Best CEO in the Pharmaceutical Industry - North America" and the "Growth Strategy CEO of the Year - USA." In addition, he has been recognized as one among the "Top 20 Dynamic CEOs of 2022" in The CEO Publication Magazine. Also, Dr. Joseph D. Armstrong, III, co-founder and COO of TCG GreenChem, and one of the recipients of the Presidential Green Challenge Award, as determined by the EPA, is on Shuttle Pharma's Scientific Advisory Board. In this capacity, Dr. Armstrong provides insight on green technologies to manufacture and formulate clinical supplies of Ropidoxuridine, to accelerate this molecule rapidly through the drug development pathway to commercialization.

Various sources have estimated that more than 800,000 patients in the US are treated with radiation therapy for their cancers. According to the American Cancer Society about 50% are treated for curative purposes and the balance for therapeutic care. The market opportunity for radiation sensitizers lies with the 400,000 patients treated for curative purposes. The number of patients being treated with RT is expected to grow by more than 22% over the next five years. Based on a rough estimate of a course of radiation sensitizing brand drug therapy (off label at this time) of $12,000 per patient—the market size would be in excess of $4.0 billion.

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