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PDS Biotech Announces Data from IMMUNOCERV Phase 2 Trial
PDS Biotech’s Versamune(r)-based investigational immunotherapy induces a precisely targeted immune response against cancers that express a specific protein. Interim data suggest that a combination of PDS0101 with standard therapies can demonstrate significant disease control by shrinking and/or shrinking tumors, delaying progression and prolonging survival.
PDS Biotech reported extended interim clinical results from IMMUNOCERV’s Phase 2 trial of PDS0101 in combination with chemoradiotherapy and Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in locally advanced cervical cancer.
Median Progression Free Survival (PFS)
PDS Biotechnology’s cancer vaccine candidate PDS0101 elicited an investigator-assessed objective response in 100% of patients with IB3-IVA high-risk cervical cancer when combined with standard-of-care chemoradiation. Chemoradiation uses a combination of chemotherapy drugs, which kill tumor cells or stop them from growing, and radiation therapy, which uses high-energy x-rays to destroy or shrink tumors.
In this study, presented at ASTRO 2023, PDS0101 was given in combination with cisplatin and radiation therapy. Cisplatin is a type of chemotherapy drug that works in different ways to kill tumor cells or prevent them from dividing. Radiation therapy uses a combination of high-energy x-rays and radioactive substances to damage or destroy tumor cells.
PDS Biotech is evaluating the safety and efficacy of PDS0101 in combination with anti-PD-1 therapy Merck Keytruda (pembrolizumab) in the VERSATILE-002 Phase 2 trial in ICI-naive HPV16-head and neck squamous cell carcinoma (HNSCC). Data from this first-in-person study, including interim efficacy and survival data, will be presented at ASCO 2023.
Confirmed and Unconfirmed Objective Response Rates
NetScientific shares rose after portfolio company PDS Biotechnology provided a promising update from its ongoing IMMUNOCERV Phase 2 trial of PDS0101 in combination with standard-of-care chemotherapy for locally advanced cervical cancer. PDS0101 demonstrated an objective response based on RECIST criteria of 1.1 in 14 of 54 patients, with clinical benefit observed in eight of those patients.
Moreover, one patient who received only 3 of 5 scheduled doses of PDS0101 showed signs of residual disease in PET CT at day 170. The 1-year overall survival rate was 87.5% (7/8).
PDS Biotechnology Corp develops early- and late-stage immunotherapy for the treatment of various cancers. Its lead product is PDS0101, a vaccine-like molecule designed to generate HPV16-specific multifunctional CD8+ T cells. The Company’s pipeline includes several other preclinical and clinical stage products. Its headquarters are in Princeton, New Jersey. Frank Bedu-Addo is the Founder & CEO of PDS Biotechnology. He founded KBI Biopharma and PDS Operating Corp.
Stable Disease Rates
The first abstract accepted for presentation shows results from the Phase 2 IMMUNOCERV trial led by The University of Texas Cancer Center evaluating PDS0101 in combination with standard of care chemoradiation (CRT) for the treatment of locally advanced cervical cancer. At Day 170, 8 of 17 patients enrolled in the IMMUNOCERV trial reached status evaluation by PET CT and 7 of those (87.5%) showed complete responses.
The second abstract presented data on a recently completed phase 1/2 study that examined the safety, tolerability, and immunogenicity of the CHIKV VLP Virus Particle-like Adjuvant Vaccine in 60 vaccine-naive or vaccinated healthy volunteers Venezuelan equine encephalitis (VEEV). . Results from this study showed that the CHIKV VLP vaccine was well tolerated and immunogenic in all subjects.
PDS Biotechnology Corporation develops clinical immunotherapies for early and late stage cancer. The Company’s lead product is PDS0101, an HPV-specific T cell immunotherapy in Phase 2 development.
Safety
PDS Biotech’s Versamune(r) T cell activation platform effectively stimulates a precise immune system response to a cancer-specific protein. When added to standard of care treatments, clinical data suggest that PDS0101 and other Versamune-based investigational immunotherapies demonstrate meaningful disease control by shrinking and shrinking tumors, delaying or prolonging survival. The Versamune platform has so far shown minimal toxicity and may allow it to be safely combined with other treatments.
IMMUNOCERV is a Phase 2 trial investigating PDS0101 in combination with standard of care chemoradiation therapy (CRT) for the treatment of locally advanced cervical cancer. The company will make an oral presentation of the data from this study at the annual meeting of the American Society for Radiation Oncology (ASTRO 2023) in October 2023.
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