Shuttle Pharma Enters into Sponsored Research Agreement with the University of California, San Francisco to Advance PSMA Development Program

Rhea-AI Summary

Shuttle Pharmaceuticals Holdings (SHPH) has entered into a sponsored research agreement with the University of California, San Francisco (UCSF) to advance pre-clinical development of its PSMA-B ligand for prostate cancer diagnosis and treatment. The research will focus on developing the molecule as a potential diagnostic and therapeutic (theranostic) tool.

UCSF researchers, led by Dr. Robert Flavell, will develop radiosynthetic methods for producing [18F]FPA-ACUPA probe, investigate cellular binding properties, and explore diagnostic potential across various prostate cancer phenotypes. The global PSMA PET Imaging Market reached $1.5 billion in 2022 and is projected to reach $2.0 billion by 2030.

Positive

• Company has exclusive license to PSMA-B intellectual property with pending patent application
• PSMA-B demonstrates nanomolar binding activity to PSMA
• Targeting a significant market opportunity with PSMA PET Imaging projected at $2.0 billion by 2030

Negative

• Product is still in early pre-clinical development phase
• No proven efficacy in human trials yet

Insights

Biotech Research Analyst

This sponsored research agreement with UCSF represents a strategic advancement in Shuttle Pharma's PSMA development program, targeting a $3.5 billion combined market opportunity ($1.5 billion for PSMA PET imaging and $2 billion for therapeutic applications). The company's novel PSMA-B ligand, featuring nanomolar binding activity, could potentially serve dual purposes as both a diagnostic tool and therapeutic agent.

The collaboration with UCSF's team will focus on critical preclinical validation steps, including radiosynthetic methods development and cellular binding studies. The most compelling aspect is PSMA-B's unique boron-containing structure, which could enhance proton radiation therapy effectiveness - a distinctive feature in the crowded PSMA market dominated by players like Novartis's Pluvicto.

Breaking this down for retail investors: Imagine PSMA-B as a "smart missile" that can both detect (diagnostic) and destroy (therapeutic) prostate cancer cells. The boron component acts like a radiation amplifier, potentially making treatments more effective. However, it's important to note that this is still in early preclinical stages, with significant development milestones ahead before any potential commercialization.

Medical Research Specialist

The technical aspects of this research agreement deserve careful scrutiny. PSMA-B's reported nanomolar binding activity suggests strong target affinity, but the real differentiator lies in its boron-containing structure. This unique characteristic could theoretically enhance proton beam therapy through localized dose amplification - a mechanism distinct from current PSMA-targeted therapeutics.

The planned investigation of [18F]FPA-ACUPA probe across various prostate cancer phenotypes is particularly noteworthy, as it could help identify specific patient populations most likely to benefit from this approach. However, the success of the program will heavily depend on achieving optimal biodistribution and demonstrating clear advantages over existing PSMA-targeting agents in the preclinical mouse model studies.

Intellectual Property Analyst

The intellectual property strategy appears robust with an exclusive license and pending USPTO patent application. However, the PSMA targeting space is highly competitive with multiple established players and extensive patent coverage. Shuttle Pharma's IP position will likely depend on the novelty of their boron-containing PSMA ligand structure and its specific applications in radiation enhancement.

For context, the PSMA diagnostic and therapeutic field has seen significant patent activity, particularly around radiopharmaceutical applications. The success of Pluvicto has sparked increased interest in this space. The company's ability to carve out strong patent protection for their novel boron-containing approach will be important for future commercialization prospects and potential partnering opportunities.

GAITHERSBURG, Md., Dec. 19, 2024 (GLOBE NEWSWIRE) -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) (“Shuttle Pharma”), a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy (RT), today announced a sponsored research agreement with the University of California, San Francisco (UCSF) to advance pre-clinical development of Shuttle Diagnostics, Inc.’s (a wholly-owned subsidiary of Shuttle Pharma) ligand to the prostate-specific membrane antigen (PSMA) as a potential diagnostic and therapeutic, or theranostic, molecule. Theranostic molecules are suitable for diagnosis and therapy of cancers.

“From a clinical perspective, PSMA is a valuable target for diagnosis and therapy of prostate cancer,” commented Shuttle Pharma's Chairman and CEO, Anatoly Dritschilo, M.D. “In a discovery project to develop a novel, boron-containing PSMA ligand to enhance proton radiation therapy of prostate cancer, we discovered PSMA-B, a molecule containing boron and demonstrating nanomolar binding activity to PSMA. Preclinical evaluations have been initiated to explore the PSMA-B ligand as a potential prostate cancer sensitizer in combination with proton therapy, as well as a PET diagnostic reagent and as a targeted prostate cancer therapeutic. The agreement with UCSF will support further preclinical testing in a mouse model of prostate cancer for its potential to bind to prostate cancer deposits in mice.”

Specifically, UCSF researchers, led by principal investigator, Robert Flavell, M.D., PhD., will aim to develop radiosynthetic methods for producing [¹⁸F]FPA-ACUPA probe; investigate cellular binding properties of [¹⁸F]FPA-ACUPA in PCa cell lines; and investigate the diagnostic potential of the probe across various PCa phenotypes. Shuttle Pharma has an exclusive license to the PSMA-B intellectual property and has filed a patent application with the US Patent and Trademark Office.

A significant opportunity exists for PSMA ligands for prostate cancer diagnosis and treatment, particularly in the development of highly specific and effective theranostic agents for metastatic castration-resistant prostate cancer, leveraging its high expression on prostate cancer cells for accurate imaging and targeted therapy delivery using radio labelled PSMA ligands. The Global PSMA PET Imaging Market reached $1.5 billion in 2022 and is expected to reach $2.0 billion by 2030. Pluvicto®, a targeted radiopharmaceutical treatment for PSMA-positive metastatic prostate cancer, has a predicted market size of $2 billion.

“We are excited to be working with Dr. Flavell and his team at UCSF to advance development of our PSMA-B ligand, a theranostic that has the potential to play a significant role in the future diagnosis and treatment of prostate cancer,” Dr. Dritschilo concluded.

About Shuttle Pharmaceuticals

Founded in 2012 by faculty members of the Georgetown University Medical Center, Shuttle Pharma is a discovery and development stage specialty pharmaceutical company focused on improving the outcomes for cancer patients treated with radiation therapy (RT). Our mission is to improve the lives of cancer patients by developing therapies that are designed to maximize the effectiveness of RT while limiting the side effects of radiation in cancer treatment. Although RT is a proven modality for treating cancers, by developing radiation sensitizers, we aim to increase cancer cure rates, prolong patient survival and improve quality of life when used as a primary treatment or in combination with surgery, chemotherapy and immunotherapy. For more information, please visit our website at www.shuttlepharma.com.

Safe Harbor Statement

Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include, but are not limited to, statements concerning the development of our company. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The reader is cautioned not to rely on such forward-looking statements. Such forward-looking statements relate to future events or our future performance. In evaluating these forward-looking statements, you should consider various factors, including our expectations regarding the success and/or completion of our pre-clinical research; our success in completing any newly initiated clinical trials, commence new trials and obtain regulatory approval following such trials; challenges and uncertainties inherent in product research and development; and the uncertainty regarding future commercial success. These and other factors may cause our actual results to differ materially from any forward-looking statements. Forward-looking statements are only predictions and actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including factors discussed in the “Risk Factors” section of Shuttle Pharma’s Annual Report on Form 10-K for the year ended December 31, 2023, as amended, filed with the SEC on September 4, 2024, as well other SEC filings. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, Shuttle Pharmaceuticals specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Shuttle Pharmaceuticals
Anatoly Dritschilo, M.D., CEO
240-403-4212
info@shuttlepharma.com

Investor Contacts
Lytham Partners, LLC
Robert Blum
602-889-9700
shph@lythampartners.com 

FAQ

What is the market potential for SHPH's PSMA-B technology?

The Global PSMA PET Imaging Market reached $1.5 billion in 2022 and is expected to reach $2.0 billion by 2030, indicating significant market potential for SHPH's PSMA-B technology.

What is the current development stage of SHPH's PSMA-B ligand?

PSMA-B is currently in pre-clinical development stage, with testing being conducted in mouse models of prostate cancer to evaluate its binding potential to prostate cancer deposits.

What is the purpose of SHPH's research agreement with UCSF?

The agreement aims to advance pre-clinical development of PSMA-B ligand, including developing radiosynthetic methods, investigating cellular binding properties, and exploring diagnostic potential across various prostate cancer phenotypes.

What intellectual property protection does SHPH have for PSMA-B?

SHPH has an exclusive license to the PSMA-B intellectual property and has filed a patent application with the US Patent and Trademark Office.