In a worldwide license agreement and an immuno-oncology antibody collaboration, Tesaro is picking up the rights to monospecific antibody drug candidates from AnaptysBio targeting TIM-3, LAG-3 and PD-1 and dual-reactive antibody drug candidates targeting PD-1/TIM-3 and PD-1/LAG-3. Tesaro says it will be using the antibodies selected from these platforms to develop novel monotherapy and combination-based approaches with immuno-oncology and other anticancer agents for a range of indications.
Tesaro is paying AnaptysBio an upfront license fee of $17 million and also paying for costs incurred by AnaptysBio related to the development programs. AnaptysBio is eligible to receive milestone payments of $18 million for each of those programs linked to specific R&D events; it could also receive an additional $90 million linked to certain U.S. and ex-U.S. regulatory submissions and approvals for multiple indications. AnaptysBio could also get tiered single-digit royalties related to worldwide net sales of products developed under the collaboration and commercial milestone payments if specified levels of annual worldwide net sales are attained.
PD-1, TIM-3, and LAG-3, according to the firms, are all checkpoint regulators that modulate the function of the immune system via different mechanisms, and could limit the ability of the immune system to respond effectively to tumors. PD-1 (programmed death-1) is an immune checkpoint molecule that can limit T-cell-mediated immune responses. TIM-3 (T-cell immunoglobulin and mucin domain-3) functions as a pattern recognition receptor that dampens the antitumor immune response. LAG-3 (lymphocyte activation gene-3) is a negative regulator of T-cell activity.
AnaptysBio and Tesaro will be completing preclinical development of the antibody candidates together, but Tesaro alone will be responsible for all clinical development, manufacturing, regulatory, and commercial activities. The firms expect the candidates from these programs to enter clinical trials over the next 18 to 24 months.
“These antibody candidates are being developed to address some of the most validated and promising targets in immuno-oncology,” Tesaro's president Mary Lynne Hedley, Ph.D., said in a statement. “We are also interested in evaluating combinations of these antibodies with TSR-011, our ALK/TRK inhibitor, and niraparib, our PARP inhibitor, in addition to other antitumor agents with complementary mechanisms, such as immune-modulating agents.”