Company: SHPH
Filing Date: 2025-03-31
Form Type: DEF 14A
Source: 0001641172-25-001889
Chunk: 2

Company: Shuttle Pharmaceuticals Holdings, Inc.
Filing Date: 2025-03-31
Form: DEF 14A
Chunk 2
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225 is ready for IND-enabling studies followed by Phase I clinical testing.

Development of other preclinical assets, including our next generation radiation sensitizer formulation of Ropidoxuridine / Tipiracil
and our Class I selective HDAC inhibitor for ER+ breast cancer, will be prioritized as funds become available. In addition, we plan to submit applications for NIH funding and seek
collaborations or joint ventures to support further development of selected preclinical assets.

DIAGNOSTICS

Our Shuttle Diagnostics
subsidiary aims to develop pretreatment diagnostic blood tests and imaging agents for prostate cancer patients. The PC-Rad test was developed for predicting outcomes following radiation
therapy for localized prostate cancer and the PSMA-B ligand is a theranostic molecules offering diagnosis and therapeutics capability
for metastatic prostate cancer.

The intellectual property
underlying the PC-Rad Test predictive biomarker
technology was developed by a collaboration of Shuttle Pharma and Georgetown University scientists through analytical validation and
is ready for clinical validation to seek FDA approval as a medical device. Current plans focus on initiation of the clinical trial for
clinical validation of the PC-Rad Test by an investigator-initiated clinical trial, working with colleagues at MedStar-Georgetown University
Hospital, and expanding to a multi- institutional clinical trial as resources become available.

For our PSMA-B development program, we have entered into a sponsored research agreement with the University of California, San Francisco
(UCSF) to advance pre-clinical development as a potential diagnostic and therapeutic, or theranostic, molecule. In a discovery project
to develop a novel, boron- containing PSMA ligand to enhance proton radiation therapy of prostate cancer, we observed that the PSMA-B molecule containing boron and demonstrating nanomolar binding activity to PSMA also offered the potential for imaging metastatic prostate
cancer. 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.

Our intellectual property
within both diagnostic programs (PC-Rad and PSMA-B ligand) offers an opportunity for further development through a potential Shuttle
Diagnostics spin-out.

ENHANCED BUSINESS FOCUS

With scientific and clinical trial activities accelerating, Christopher Cooper