Bioncotech Therapeutics Announces Oncology Clinical Trial Collaboration with MSD

Phase II Trial with Combination of BO-112 and Pembrolizumab


MADRID, Spain, Dec. 10, 2019 (GLOBE NEWSWIRE) -- Bioncotech Therapeutics ("Bioncotech"), a clinical-stage biopharmaceutical company developing RNA-based therapies against cancer, announces it has entered into a Phase II clinical trial collaboration with a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey, U.S.A., known as MSD outside the U.S. and Canada.

The collaboration will focus on the Phase II clinical evaluation of the combination of BO-112, Bioncotech's lead program, and KEYTRUDA® (pembrolizumab), MSD's anti-PD-1 therapy, in patients with select advanced stage solid tumors with liver metastases. The trial will evaluate if the combination of stimulation of the innate immune system by direct intra-tumoral administration of BO-112, combined with systemic administration of pembrolizumab, shows safety and efficacy in patients with tumors that are poorly or only moderately responsive to monotherapy with an anti-PD1 agent.

"This collaboration is an important next step in the clinical development of BO-112 and the potential of the innate immune system and intra-tumoral route of administration to provide improved outcomes for cancer patients," said Marisol Quintero, CEO of Bioncotech. "We consider MSD, with its extensive expertise in immune-oncology, as the ideal partner for Bioncotech to complete this study."

"Early clinical data suggest BO-112 induces immunological changes in the tumor microenvironment and beyond, which may render previously anti-PD1 refractory tumors susceptible to checkpoint inhibition," added Dominique Tersago, CMO of Bioncotech. "Cancers that have metastasized to the liver present a significant therapeutic challenge. By targeting the metastatic liver lesions as the site for intra-tumoral injection we aim to reduce organ-related variability of the injection site, and also evaluate if BO-112 has potential to break through the generally immune tolerant hepatic environment and trigger or improve responsiveness to anti-PD1 therapy."

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, U.S.A.

For more information, please contact:

Bioncotech Therapeutics S.Linfo@bioncotech.com
Marisol Quintero, CEO 
  
Mo PR AdvisoryTel: +44 (0) 7876 444977 / 07860 361746
Mo Noonan / Jonathan Birt 

Notes to Editors

About Bioncotech
Bioncotech is a Spanish biopharmaceutical company focusing on the development of RNA-based therapies against validated and novel targets in cancer and immune cells.

About BO-112
Bioncotech's lead candidate, BO-112, is a formulated non-coding double stranded RNA (dsRNA) that acts as an agonist to toll-like receptor 3 (TLR-3), and the cytosolic helicases melanoma differentiation associated gene 5 (MDA5) and retinoic acid-inducible gene I (RIG-I). It is a stimulator of the innate immune system, activates dendritic cells and induces interferons (IFNs), and also has been shown to trigger apoptosis and cause immunogenic cell death in tumor cells. BO-112 is being evaluated in combination with anti-PD1 treatment in a Phase I clinical trial. For information on clinical trials, please visit www.clinicaltrials.gov.

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.