Company: SHPH
Filing Date: 2025-02-26
Form Type: 10-K
Source: 0001493152-25-008300
Chunk: 3

Company: Shuttle Pharmaceuticals Holdings, Inc.
Filing Date: 2025-02-26
Form: 10-K
Item: Item 1
Chunk 3
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Pipeline

We
are currently developing a pipeline of small molecule radiation sensitizers and immune response regulating drugs. Our most advanced product
candidate is Ropidoxuridine, an orally available halogenated pyrimidine with strong cancer radiation sensitizing properties in preclinical
studies. In addition, we have a pipeline of complimentary product candidates that we are developing to address a host of solid tumor
cancer indications. Our pipeline is represented in the diagram below:

Timeline
for our clinical phase (Ropidoxuridine) and pre-clinical phase (HDAC inhibitors) pipeline.

Our
lead product candidates include:

    ●
    Ropidoxuridine
    (IPdR) is our lead candidate radiation sensitizer for use in combination with RT to
    treat brain tumors (glioblastoma) and sarcomas. Phase I clinical trial results supported by an NIH contract to Shuttle Pharma and
    the NCI (CTEP) were reported in the medical journal, Clinical Cancer Research, in July 2019, by our SBIR subcontractor. Eighteen
    patients completed dose escalations to 1,800 mg/day for 30 days, establishing the maximum tolerated dose (MTD) of 1,200 mg/day in
    combination with RT. Four partial responses, nine stable disease and one progressive disease in target lesions were reported. Four
    patients did not have measurable disease and, as a result, were not evaluable. These Phase I trial results demonstrate oral bioavailability
    and an MTD of 1,200 mg per day for 28 days for use in combination with radiation for Phase II clinical trials that we proposed to
    perform in brain tumors and in sarcomas. The brain tumor, glioblastoma multiforme (GB) is eligible for orphan disease designations.
    Shuttle Pharma has advanced drug manufacture and formulation and prepared a clinical protocol of a “Phase 2 Single-Arm Study
    of IPdR as a Radiation Sensitizing Agent During Radiotherapy in Patients with Newly Diagnosed IDH-Wildtype MGMT Unmethylated Glioblastoma
    Multiforme.” In December 2023, we submitted an IND application with the FDA to support the next phase of development of Ropidoxuridine.
    In January 2024, we received the ‘Safe to Proceed’ letter from the FDA for our IND application for the Phase II study
    of Ropid