Adagene has signed a third clinical trial partnership and supply agreement with Merck (MSD) to develop its anti-CD137 agonist, ADG106, in combination with the latter’s Keytruda (pembrolizumab).
ADG106 is a fully human, ligand-blocking, agonistic anti-CD137 immunoglobulin G4 (IgG4) monoclonal antibody engineered with NEObody platform technology of Adagene.
CD137 induces the immune system to fight cancer cells and causes long-lasting T cell proliferation and survival.
Keytruda is an anti-programmed cell death protein 1 therapy.
According to the collaboration, the companies will conduct an open-label, dose-escalation and expansion ADG106-P2001/KEYNOTE-D12 trial of ADG106 plus Keytruda, in advanced or metastatic solid and/or haematological malignancies.
This trial builds on the favourable monotherapy and combination treatment data from a Phase I trial of ADG106.
Phase I trials enrolled approximately 100 subjects with advanced solid tumours and non-Hodgkin’s lymphoma in the US and China.
Adagene co-founder, CEO and chairman Peter Luo said: “While PD-1 drugs have advanced the cancer treatment paradigm, there are still a substantial number of patients with advanced metastatic solid and haematological malignancies who either relapse or are unresponsive, highlighting the need for new approaches.
“ADG106 targets a unique and highly conserved epitope with a novel mechanism of action and broad species cross-reactivity, which enables testing in immunocompetent hosts.
“In multiple syngeneic models, we have shown a strong additive effect between ADG106 and anti-PD-1/PD-L1 agents.”
ADG106 demonstrated strong antitumor activity in preclinical studies and was well-tolerated as monotherapy and together with current standard-of-care and other immuno-oncology treatments.
Last month, Adagene signed a clinical trial collaboration and supply agreement with Merck to assess its drug candidates, ADG116 and ADG126, in combination with the latter’s Keytruda (pembrolizumab) for the treatment of solid tumours.