HTG Molecular Diagnostics said today it will partner with Oncologie to develop biomarkers for use with Oncologie's pipeline of immuno-oncology treatments, through a collaboration whose value was not disclosed.
Oncologie’s pipeline consists of two candidates. The company’s lead candidate is lefitolimod, an immunomodulator and toll-like receptor 9 (TLR-9) agonist being studied in the Phase III IMPALA trial (NCT02077868) in patients with metastatic colorectal cancer; and in a Phase I trial (NCT02668770) in patients with advanced solid tumors, where the drug is being used in combination with Bristol-Myers Squibb’s marketed checkpoint inhibitor Yervoy® (ipilimumab).
Through an agreement it signed with Mologen in February, Oncologie has the exclusive license to develop, manufacture and commercialize lefitolimod in China, Taiwan, Singapore, Hong Kong and Macao. The companies have agreed to co-develop lefitolimod globally.
Oncologie’s other candidate, bavituximad, an immune-modulatory monoclonal antibody designed to block activation by phosphatidylserine (PS) of TAM and TIM receptors on immune cells.
Bavituximad is in Phase II trials for newly-diagnosed glioblastoma in combination with the chemotherapy drug Temozolomide and radiation (NCT03139916), and advanced hepatocellular carcinoma in combination with Merck & Co.’s marketed immunotherapy Keytruda® (pembrolizumab) (NCT03519997); as well as a Phase I study in unresectable hepatocellular carcinoma in combination with the Bayer-marketed Nexavar® (sorafenib) and stereotactic body radiation therapy (NCT02989870).
Additional trials of bavituximad are planned in Asian-prevalent solid tumors, according to Oncologie.
“HTG is committed to the development of NGS-based precision diagnostics to support biomarker driven drug development, and we share a common focus with Oncologie in the field of Immuno-oncology,” HTG CEO Timothy (TJ) B. Johnson said in a statement.
Based in Tucson, AZ, HTG is a provider of instruments, reagents, and services for molecular profiling applications. The company markets several proprietary molecular profiling panels designed to address the needs of customers in biomarker discovery and translational research, as well as potentially companion diagnostics. HTG says its product strategy is to develop a suite of profiling panels with initial focus in immuno-oncology and next generation pathology.
“We believe HTG's technology and assay development capabilities will assist our clinical development efforts as we strive to bring innovative new medicines to cancer patients globally,” added Oncologie CEO Laura Benjamin, Ph.D.
The collaboration comes nearly two months since Oncologie was launched with $16.5 million in seed financing led by Pivotal bioVenture Partners China. The round was led by Pivotal bioVenture Partners China Fund, with participation by Nan Fung Life Sciences, China Merchant Bank Investments and Volcanics Ventures.
Oncologie has operations in Boston and Shanghai, where it conducts parallel clinical development in both countries following recent regulatory changes by China.