Date: 2014-12-02
Type of information: Licensing agreement
Compound: bispecific antibody candidate designed to target two undisclosed immune checkpoints
Company: Tesaro (USA - MA) AnaptysBio (USA - CA)
Therapeutic area: Cancer - Oncology
Type agreement: development - licensing
Action mechanism:
Disease:
Details:
- • On March 13, 2014, Tesaro and AnaptysBio announced an exclusive, worldwide license agreement and immuno-oncology antibody collaboration. Under the terms of the agreement, TESARO receives rights to monospecific antibody drug candidates targeting TIM-3, LAG-3 and PD-1 and dual reactive antibody drug candidates targeting PD-1/TIM-3 and PD-1/LAG-3. Therapeutic antibodies selected from these programs will form the basis of a strategic platform that will enable Tesaro to develop novel monotherapy and combination-based approaches with immuno-oncology and other anti-cancer agents in a variety of indications. Antibody candidates from these programs are expected to enter clinical trials over the next 18 to 24 months.
- PD-1, or programmed death-1, is a key immune checkpoint molecule that can limit T-cell-mediated immune responses. The presence of the PD-1 ligand, PD-L1 has been identified on many tumor types, and expression of PD-L1 has been linked to poor clinical outcomes in a variety of cancers. Anti-PD-1 antibodies have demonstrated in vivo efficacy in tumor models and have shown promising results in several clinical studies. TSR-042 is anticipated to begin clinical trials in mid-2015, and combination preclinical pharmacology studies with TSR-011, niraparib and other anti-tumor agents are planned to initiate during 2014.
- TIM-3, or T-cell immunoglobulin and mucin domain-3, functions as a pattern recognition receptor that dampens the anti-tumor immune response. In collaboration with AnaptysBio, Tesaro expects to select a TIM-3 antibody for clinical development during the second quarter of 2014.
- LAG-3, or lymphocyte activation gene-3, is a negative regulator of T-cell activity. Preclinical studies have demonstrated anti-tumor activity by blocking LAG-3 and PD-1 in tumor models, and LAG-3 IgG fusion protein has demonstrated promising results in clinical trials for various solid tumors. In collaboration with AnaptysBio, Tesaro expects to select a LAG-3 antibody for clinical development in the third quarter of 2014.
Financial terms:
- Under the terms of the initial agreement with AnaptysBio, Tesaro will pay an upfront license fee of $17 million, as well as provide funding of costs incurred by AnaptysBio related to the development programs. For each development program, AnaptysBio is eligible to receive milestone payments of $18 million if certain research and development events are achieved and an additional $90 million associated with certain U.S. and ex-U.S. regulatory submissions and approvals in multiple indications. AnaptysBio will also be eligible to receive tiered single-digit royalties related to worldwide net sales of products developed under the collaboration and certain commercial milestone payments if specified levels of annual worldwide net sales are attained. AnaptysBio and Tesaro will together complete preclinical development of the antibody candidates, with Tesaro being solely responsible for all clinical development, manufacturing, regulatory and commercial activities.
- Under the terms of the expansion, Tesaro will pay AnaptysBio an undisclosed upfront fee and will provide funding for all costs incurred by AnaptysBio related to the development of a clinical antibody candidate. For each program within the collaboration, AnaptysBio is eligible to receive milestone payments if certain research and development events are achieved and additional payments for achievement of certain U.S. and ex-U.S. regulatory submissions and approvals in multiple indications. AnaptysBio will also be eligible to receive royalties related to worldwide net sales of products developed under the collaboration, and may earn certain commercial milestone payments if specified levels of annual worldwide net sales are attained.
Latest news:
- • On December 2, 2014, Tesaro and AnaptysBio announced an expansion of their immuno-oncology collaboration and exclusive license agreement to include development of a novel bispecific antibody candidate designed to target two undisclosed immune checkpoints. AnaptysBio and Tesaro first initiated their collaboration in March of 2014, and have together focused on the development of monospecific antibody drug candidates targeting TIM-3, LAG-3 and PD-1 and dual reactive antibody drug candidates targeting PD-1/TIM-3 and PD-1/LAG-3. Since the beginning of this partnership, Investigational New Drug (IND) enabling preclinical studies of TSR-042 (anti-PD-1 antibody candidate) have been initiated, and additional clinical candidates have been identified, including lead candidates targeting TIM-3 and LAG-3. AnaptysBio and Tesaro will together complete preclinical development of the antibody candidates, with Tesaro being solely responsible for all clinical development, manufacturing, regulatory and commercial activities.
Is general: Yes
