San Francisco, California. and Suzhou, China, May 29, 2020 — Adagene, Inc. a platform-driven, clinical-stage company, today announced that positive results of its novel anti-CD137 agonist, ADG106, from the Phase I trial in China will be presented in a poster at the 2020 American Society of Clinical Oncology (ASCO) Annual meeting.
- Phase 1, dose-escalation study of ADG106, a fully human anti-CD137 agonistic antibody, in subjects with advanced solid tumors or relapsed/refractory non-Hodgkin lymphoma
- 8:00 – 11:00 AM (EST), May 29th, 2020
- Developmental Therapeutics—Immunotherapy
- Lead Author:
- Li Zhang, M.D., Sun Yat-sen University Cancer Center, Guangzhou, China.
Highlights from ADG106 China Phase 1 Study:
- ADG106 has shown a well-tolerated safety profile in dose escalation, and also reported drug related DLT at the highest dose of 10mg/kg, demonstrating the possibility of generating a safe and potent monoclonal antibody agonist against this challenging target.
- Pharmacokinetic analysis of ADG106 showed dose proportional increases in exposure, with a half-life of around 7 days.
- Preliminary clinical activity was seen in patients with non-Hodgkin’s lymphoma and certain solid tumors, disease control rate was 60% and tumor shrinkage was observed in 25% of patients. In a heavily pretreated NHL patient, CT scans indicated >50% tumor reduction in two of the six targeted lesions while receiving ADG106. Potential biological activity and pharmacodynamic biomarker responses (proliferative Ki67+ CD8+ and effector memory T-cell) were also observed in connection with changes in soluble and membrane bound CD137 in multiple patients.
- Favorable safety profile and preliminary antitumor activity demonstrated by ADG106 warrant further evaluation. The dose expansion cohorts at selected doses along these lines were initiated in patients with advanced non-Hodgkin’s lymphoma and certain solid tumors.
About CD-137 (4-1BB)
CD137 or 4-1BB, a member of the tumor necrosis factor (TNF) receptor superfamily is a promising immune-oncology target. Ligation of CD137 induces a co-stimulatory signal on activated CD8+ T cells and natural killer (NK) cells, resulting in proliferation, increased pro-inflammatory cytokine secretion, and cytolytic function. CD137 or 4‐1BB co-stimulation is the clinically validated pathway for the optimal T cell activation and its anti-tumor response is highlighted by the successful approval of the 4‐1BB-containing CAR-T therapy by the U.S. FDA.
Adagene, Inc. is a private, clinical-stage, leading-edge oncology immunotherapy company driven by its powerful Dynamic Precision Library platform built to deliver treatments with increased efficacy and safety. Adagene combines computational biology and artificial intelligence to design novel antibodies that address unmet patient needs. Its wholly owned pipeline is comprised of novel immunotherapy programs with potential to be first or best in class. Adagene has forged strategic collaborations with reputable global partners that leverage its technology in multiple approaches at the vanguard of science. Founded and led by experienced leaders with a global track record in antibody discovery and engineering, Adagene has raised more than $150 million from high-profile investors including F-Prime, Eight Roads, WuXi AppTec, GP Healthcare Capital, New World TMT, Sequoia China and General Atlantic, among others.