NovaRock Biotherapeutics Limited, a clinical-stage biopharmaceutical company delivering innovative specialty pharmaceuticals to address patients' unmet medical needs, today announced that they have entered into an exclusive license agreement and strategic partnership with Flame Biosciences.

"We are very pleased to be partnering with Flame and their world-class clinical team," said Dr. Han Li, CEO of NovaRock. "The collaboration with Flame marks a solid step towards getting NovaRock's innovative portfolio into the global market. The proceeds from this collaboration will be primarily used to fund the clinical advancement of NBL-012 and NBL-015 as well as the advancement of our preclinical programs."

NBL-015 is a fully human anti-Claudin 18.2 monoclonal antibody optimized through protein engineering to achieve enhanced ADCC, CDC, and ADCP effects. Its Investigational New Drug Application has also been approved by the U.S. FDA in May 2021.

Under the terms of the Agreement, NovaRock has granted Flame Biosciences the exclusive rights to NBL-015 outside of Greater China (including mainland China, Hong Kong, S.A.R., China, Macau, S.A.R., China, and Taiwan, China). Flame shall be responsible for the development, regulatory approval, and commercialization of NBL-015. NovaRock will, at Flame Biosciences's expense, collaborate with Flame on the discovery and preclinical development of two new bispecific antibodies based on NovaRock's NovaTE bi-specific antibody technology platform and subsequently grant Flame Biosciences the exclusive rights to further develop, manufacture and commercialize the Licensed Products. The lead product candidates from this collaboration are expected to enter clinical development in late 2023.

NovaRock will receive an upfront payment of US$7.5 million and is eligible to receive development milestone payments of up to US$172.5 million subject to achievement of the development milestone events. NovaRock is also eligible to receive sales milestone payments of up to US$460 million subject to the achievement of the sales milestone events and royalties based on a certain percentage of the net sales of the Licensed Products in the Territory.

About NBL-015

NBL-015 is a fully human anti-Claudin 18.2 monoclonal antibody optimized through protein engineering to achieve enhanced ADCC, CDC, and ADCP effects. Preclinical studies have demonstrated that NBL-015 has significant advantages over similar drugs in terms of low immunogenicity, good safety, high affinity, and high anti-tumor activity, providing a promising prospect of becoming the best-in-class target therapy to treat pancreatic and gastric cancer. NBL-015 has been granted the orphan-drug designation for the treatment of pancreatic cancer and gastric cancer, including cancer of gastroesophageal junction by the U.S. Food and Drug Administration (FDA). Its Investigational New Drug Application (IND) has also been approved by the U.S. FDA in May 2021.

About NovaTE bi-specific antibody technology platform

NovaTE is a novel tumor antigen and CD-137 bispecific antibody technology platform that is designed to selectively activate the antigen-experienced T cells in the tumor microenvironment. Its proprietary scaffold can maximize the tumor cell engaging and T cell activation while minimizing the systematic adverse events. Antibodies developed using NovaTE have demonstrated superior efficacy and safety in preclinical studies. Moreover, the unique bi-specific antibody structure offers exceptional stability and manufacturability.

About NovaRock Biotherapeutics Limited

Founded in 2018, NovaRock Biotherapeutics is an innovative and dynamic biotech company based in the U.S and is dedicated to the development of novel antibody therapies for cancer and autoimmune diseases. NBL-015 is the second molecule developed by NovaRock Biotherapeutics that is entering into clinical trials. NovaRock has several additional monoclonal and multi-specific antibody molecules in its diverse pipeline in the pre-clinical and discovery stages of development.

This strategic cooperation between NovaRock and Flame Biosciences will be able to accelerate the clinical development of the licensed products and represents significant progress in getting NovaRock's innovative portfolio into the global market.