10 July 2017
PDS Biotechnology Announces Clinical Collaboration with Merck & Co., Inc.
London, UK – July 10th 2017 – NetScientific plc (“NetScientific”, AIM:NSCI), the transatlantic IP commercialisation group focused on healthcare, announces a new clinical trial collaboration agreement between its portfolio company PDS Biotechnology Corporation (“PDS”) and a subsidiary of Merck & Co., Inc. (known as MSD outside the United States and Canada). The agreement will enable PDS to evaluate the combination of its Versamune®-based PDS0101 immunotherapy treatment with Merck & Co., Inc.’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in a Phase II clinical trial.
The trial will focus on the safety and efficacy of the combination treatment in patients with recurrent or metastatic head and neck cancer and high-risk human papillomavirus-16 (HPV16) infection after failure with platinum-based chemotherapy.
NetScientific holds an 17.4% stake (14.5% on a fully diluted basis) in PDS.
“We believe this exciting collaboration between PDS and Merck & Co., Inc. validates our confidence in the Versamune® platform’s potential to deliver superior outcomes to cancer patients. Following on from this successful agreement we look forward to commencing further clinical trials with additional commercial partners.”
Francois R. MarteletNetScientific’s Chief Executive Officer
The full text of the announcement from PDS Biotechnology can be found below.
# # #
For more information, please contact:
François R. Martelet, M.D., CEO
Ian Postlethwaite, CFO
Tel: +44 (0)20 3514 1800
Consilium Strategic Communications
Mary-Jane Elliott Jessica Hodgson /
Chris Welsh / Laura Thornton
Tel: +44 (0)20 3709 5700
Stifel Nicolaus Europe Limited (NOMAD and Broker)
Jonathan Senior / David Arch / Ben Maddison
Tel: +44 (0) 20 7710 7600
NetScientific is a transatlantic healthcare technology group with an investment strategy focused on sourcing, funding and commercialising technologies that significantly improve the health and well-being of people with chronic diseases. For more information, please visit the website at www.netscientific.net
PDS Biotechnology Corp. Announces Clinical Collaboration with Merck Inc. to Evaluate Combination of Versamune® PDS0101 and KEYTRUDA® (pembrolizumab) for Metastatic Head and Neck Cancer
North Brunswick, NJ, July 10, 2017 /PRNewswire/ -- PDS Biotechnology Corporation ("PDS”), a private clinical stage immuno-oncology company developing novel immunotherapies, has entered a clinical trial collaboration agreement with a subsidiary of Merck Inc. (known as MSD outside the United States and Canada) to evaluate the combination of PDS's lead Versamune®-based immunotherapy, PDS0101, with Merck Inc.'s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in a Phase II clinical trial. The planned clinical trial will evaluate the safety and efficacy of the combination in patients with recurrent or metastatic head and neck cancer and high-risk human papillomavirus-16 (HPV16) infection after failure with platinum-based chemotherapy.
"We are honored to collaborate with Merck Inc. – one of the world's leading cancer immuno-oncology companies – on this innovative, investigational combination cancer treatment for head and neck cancer patients," said Dr. Frank Bedu-Addo, CEO of PDS. "This collaboration is supported by our recent Phase IIa human clinical data demonstrating that PDS0101 uniquely combined induction of high levels of active tumor-targeting T-cells with an excellent safety profile. If PDS0101’s strong human immunological responses and superior safety profile are confirmed by demonstration of clinical benefit for HPV-cancer patients in multiple upcoming Phase IIb trials, including this important alliance with Merck Inc. in combination with a checkpoint inhibitor, PDS will be uniquely positioned to meaningfully impact clinical outcomes across a wide range of patients with HPV-related cancers.”
Details of the collaboration were not disclosed.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
Versamune® is a registered trademark of PDS Biotechnology Corporation, North Brunswick, NJ, USA.
About the Versamune® T-Cell Activating Platform:
Versamune® is a synthetic T-cell activating nanoparticle platform that overcomes a key obstacle facing cancer immunotherapy by facilitating efficient presentation of cancer proteins recognized by the immune system to powerful tumor-attacking immune cells called killer T-cells. This process trains the body’s T-cells to recognize and attack the cancer. The Versamune® platform has also demonstrated the ability to induce the immunological stimuli locally within the lymph nodes to recruit T-cells, and to enhance both the proliferation and potency of the trained T-cells. Thirdly, Versamune® has also been demonstrated to significantly reduce the population of immune suppressive cells within the tumors in preclinical models, thus facilitating effective killing of the cancer cells. Efficient activation of each of the above mechanisms by Versamune® in order to effectively treat cancer is being actively studied in human clinical trials.
PDS0101 is a combination of Versamune® with harmless multi-epitope peptides derived from cancer-causing proteins of the HPV virus which are recognized by the immune system. PDS plans to evaluate PDS0101 in multiple HPV-advanced cancer and HPV pre-cancer Phase IIb clinical trials.
About PDS Biotechnology Corporation:
PDS is a clinical stage immuno-oncology company committed to the development of simpler, safer and more effective immunotherapies. An example of the company’s approach is the versatile Versamune® T-cell activating platform, which has also demonstrated the potential for a uniquely safe profile based on early clinical results. PDS Biotechnology’s active Versamune®-based oncology pipeline includes products for prostate, ovarian, lung, breast and colorectal cancers, in addition to the its lead PDS0101 program for several HPV-related cancers including cervical, head and neck and anal cancers.