Last checked at 30 Mar 2023 15:51
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NetScientific plc
("NetScientific" or the "Company")
PDS Biotech Announces Plan to Initiate Phase 3 Study Evaluating PDS0101 in Combination with KEYTRUDA® in Head and Neck Cancer in 2023
Company has completed Phase 3 manufacturing of PDS0101 for randomized, controlled, registrational trial in recurrent/metastatic HPV16-positive head and neck cancer
NetScientific Plc (AIM: NSCI), the investment and commercialisation group with an international portfolio of innovative life science, sustainability and technology companies, reports that its portfolio company, PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today announced that it has completed key tech transfer, scale up and manufacturing activities required to initiate a global, multicenter Phase 3 registrational trial investigating the combination of PDS0101 and KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in the fourth quarter of 2023.
The Phase 3 trial, named VERSATILE-003, will investigate the combination compared to KEYTRUDA® monotherapy for the treatment of unresectable, recurrent/metastatic human papillomavirus (HPV) 16-positive head and neck squamous cell carcinoma (HNSCC).
In preparation for the VERSATILE-003 trial, PDS Biotech plans to submit an amended Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) in the third quarter of 2023. VERSATILE-003 is expected to involve approximately 90-100 clinical sites globally.
PDS Biotech's plan to initiate the VERSATILE-003 trial follows the successful completion of an End-of-Phase 2 meeting in the third quarter of last year with the FDA, during which PDS Biotech received guidance from the FDA on key elements of the Phase 3 program that will support the submission of a Biologics License Application (BLA). Data reported at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting indicated the combination of PDS0101 and KEYTRUDA® achieved an objective response rate of 41% and an overall survival rate of 87% at nine months in 17 evaluable patients with HPV16 and PD-L1 positive recurrent or metastatic HNSCC. Safety data reported on the first 43 patients enrolled in the trial suggested that the combination was well tolerated with no treatment-related Grade 3 or 4 Adverse Events. Based on these data, the FDA granted Fast Track designation to the combination of PDS0101 and KEYTRUDA for the treatment of HPV16-positive HNSCC.
Dr. Frank Bedu-Addo, PDS Biotech CEO commented:
"With the maturing data from VERSATILE-002, we are pleased to now have visibility into the progression free survival and potential overall survival, and we are excited to move into the final stage of development for our lead asset, PDS0101. The initiation of a randomized, controlled Phase 3 registrational trial of PDS0101 in combination with KEYTRUDA® as a potential treatment for recurrent or metastatic HPV16-positive head and neck squamous cell carcinoma is a significant milestone for the Company."
He added: "Head and neck cancer remains a devastating diagnosis with a significant unmet medical need. Our goal is to advance this Phase 3 trial as expeditiously as possible to provide additional treatment options for these patients. We are proud to have achieved this milestone on the eve of Oral, Head and Neck Cancer Awareness Month."
Dr Ilian Iliev, CEO of NetScientific, said:
"NetScientific initiated its support for PDS when they were a pre-clinical company, and it has been a privilege to watch how Frank and his team have navigated the company to this important and major milestone. We look forward to the launch of the Phase 3 trial, and the results of the rest of PDS' pipeline."
A full version of PDS Biotech's announcement can be accessed here:
https://www.pdsbiotech.com/index.php/investors/news-center/press-releases/press-releases1/125-2023-news/805-iotechnnounceslantonitiatehase3tudyvalua20230330
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For more information, please contact:
NetScientific
Ilian Iliev, CEO Via Belvedere Communications
WH Ireland (NOMAD, Financial Adviser and Broker)
Chris Fielding / Darshan Patel / Enzo Aliaj +44 (0)20 7220 1666
Belvedere Communications
John West / Llew Angus +44 (0) 203 008 6867
Email: nsci@belvederepr.com
About NetScientific
NetScientific plc (AIM: NSCI) is an investment and commercialisation group with an international portfolio of innovative life science, sustainability and technology companies.
NetScientific identifies, invests in, and builds high growth companies in the UK and internationally. The company adds value through the proactive management of its portfolio, progressing to key value inflection points, and delivering investment returns through partial or full liquidity events.
NetScientific differentiates itself by employing a capital-light investment approach, making judicial use of its balance sheet and syndicating investments through its wholly owned VC subsidiary, EMV Capital. The group secures a mixture of direct equity stakes and carried interest stakes in its portfolio of companies, creating a lean structure that can support a large portfolio.
NetScientific is headquartered in London, United Kingdom, and is admitted to trading on AIM, a market operated by the London Stock Exchange.
www.netscientific.net
About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune®, Versamune® plus PDS0301, and Infectimune™ T cell-activating platforms. We believe our targeted immunotherapies have the potential to overcome the limitations of current immunotherapy approaches through the activation of the right type, quantity and potency of T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the ability to reduce tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV16-associated cancers in multiple Phase 2 clinical trials. and will be advancing into a Phase 3 clinical trial in combination with KEYTRUDA® for the treatment of recurrent/metastatic HPV16-positive head and neck cancer in 2023. Our Infectimune™ based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.
About PDS0101
PDS0101, PDS Biotech's lead candidate, is a novel investigational human papilloma virus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers. PDS0101 is given by a simple subcutaneous injection in combination with other immunotherapies and cancer treatments. Interim data suggests PDS0101 generates clinically effective immune responses, and the combination of PDS0101 with other treatments can demonstrate significant disease control by shrinking tumors, delaying disease progression and/or prolonging survival. The combination of PDS0101 with other treatments does not appear to compound the toxicity of other agents.
About VERSATILE-003
VERSATILE-003 is a randomized, controlled Phase 3 trial evaluating the safety and efficacy of PDS0101, an HPV16-targeted investigational T cell-activating immunotherapy that leverages PDS Biotech's proprietary Versamune® technology, in combination with Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) compared to KEYTRUDA® monotherapy. The combination is being evaluated in immune checkpoint inhibitor (ICI)-naïve patients with recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC) and was granted Fast Track designation by the Food and Drug Administration in June 2022.