PDS Biotech - new data for ongoing clinical trials

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NetScientific PLC

27 May 2022

 

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NetScientific plc

("NetScientific", the "Group" or the "Company")

PDS Biotech presents new data for two ongoing clinical trials

NetScientific plc (AIM: NSCI), the international life sciences and sustainability technology investment and commercialisation Group, announces that its portfolio company, PDS Biotechnology Corporation (Nasdaq: PDSB), has provided updates for two their ongoing Phase 2 clinical trials, ahead of presentations at the ASCO 2022 oncology research conference on 6 June 2022.

Efficacy and Safety Data from VERSATILE-002 Phase 2 Clinical Trial in Recurrent or Metastatic Head and Neck Cancer at ASCO 2022:

Highlights:

· 76.5% of patients had either disease stabilization or tumour shrinkage

· 89% of patients alive at median 9 months suggesting survival benefit

· Combination treatment well tolerated to date. 94% of patients received 4/5 PDS0101 doses with no treatment-related grade 3 or higher adverse events

The VERSATILE-002 trial is a single-arm Phase 2 study evaluating the safety and efficacy of PDS0101, an HPV16-targeted immunotherapy, leveraging PDS Biotech's proprietary Versamune® technology, in combination with Merck's anti-PD-1 therapy KEYTRUDA®. The combination is being evaluated in checkpoint inhibitor (CPI) -naïve and CPI-refractory patients with recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC).

Preliminary data from first 19 patients treated with PDS0101 in combination with KEYTRUDA® (pembrolizumab) demonstrates 41% response rate thus far for first line recurrent or metastatic head and neck cancer, in comparison to the published results of approximately 19% for approved checkpoint inhibitors used as monotherapy. After 9 months the overall survival rate was 87.2%; whilst progression free survival was 55.2%.

https://bit.ly/3wTxu9O

Presentation of Data from NCI-Led Triple Combination Phase 2 Clinical Trial in Advanced, Refractory HPV-Positive Cancers at ASCO 2022:

Highlights:

· 77% of checkpoint inhibitor (CPI) refractory patients alive at median follow up of 12 months

· 75% of CPI naïve patients alive at median follow up of 17 months

· Anti-tumour objective responses seen in 88% of CPI naïve patients and 63% CPI refractory patients (high dose of M9241)

· Study shows early evidence of durable clinical responses

The Phase 2 triple combination trial (NCT04287868) is evaluating the safety and efficacy of PDS0101, an investigational HPV16-targeted immunotherapy, in combination with two investigational immune-modulating agents.

The triple combination is being studied in CPI-naïve and -refractory patients with advanced HPV-positive anal, cervical, head and neck, vaginal, and vulvar cancers who have failed prior therapy. Objective response is measured by radiographic tumour responses. Early data from the study suggests that the triple combination is preferentially active in HPV16-positive cancer.

Combinations of CPI and chemotherapy are being evaluated in refractory HPV-associated cancers. For most patients with CPI refractory HPV-associated disease, there is no clear effective standard of care therapy. Data strongly suggests, in agreement with the published preclinical studies, that all 3 drugs contribute to the clinical outcomes.

https://bit.ly/3wV5amv

Dr. Ilian Iliev, CEO of NetScientific, added:

"These are early results, which nevertheless provide real world - and positive - evidence from PDS's Phase 2 trials. The positive results from two parallel trials support the company's thesis that Versamune® is a platform applicable in multiple clinical applications. We look forward to the ASCO presentation and further results by the company."

For more information, please contact:

NetScientific	Via Walbrook PR
Ilian Iliev, CEO
WH Ireland (NOMAD, Financial Adviser and Broker)
Chris Fielding / Darshan Patel	[phone]
Walbrook PR	[phone] or [e-mail]
Nick Rome / Tom Cooper	07748 325 236 / 07971 221 972

About NetScientific

NetScientific plc (AIM: NSCI) is a holding company, that invests in, develops, commercialises and realises shareholder value in life sciences/healthcare, sustainability and technology companies, which offer significant growth potential predominately in the UK, EU and USA.

With the acquisition of EMV Capital in August 2020 and further investment activities, the Group more than doubled its portfolio from 8 to 22 companies. These are held as direct subsidiary and minority stakes, through balance sheet investment or capital under advisory, varying from start-up private companies to publicly listed equities. 

NetScientific delivers shareholder returns through a proactive and hands-on management approach to their portfolio companies; identifying, investing in, and helping to build game-changing companies. The Group targets value inflection points and the release of value through partial or full exits from trade sales, public listings, or equity sales. The Company has a strong transatlantic and growing international presence, providing attractive expansion prospects. 

NSCI can deploy a capital-light investment structure; utilising the power of the PLC Brand, and the NetScientific balance sheet to anchor future investments and achieve a multiplier effect by attracting 3rd party investment for the portfolio companies. 

NetScientific is headquartered in London, United Kingdom, and was admitted to trading on AIM, a market operated by the London Stock Exchange, in 2013 (website: netscientific.net ).

 

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