Aduro Biotech launched a collaboration with Novartis to research, develop, and commercialize new immuno-oncology products, under a partnership that could generate up to $750 million for Aduro.

The companies committed themselves to developing new cancer immunotherapies based on Aduro’s cyclic dinucleotides (CDNs), synthetic small molecule immune modulators that are designed to target and activate the Stimulator of Interferon Genes (STING) receptor.

The STING receptor is generally expressed at high levels in immune cells, including dendritic cells. Once activated, the STING receptor initiates an innate immune response through multiple pathways, inducing the expression of a broad profile of cytokines that include interferons and chemokines. According to Aduro, this activity leads to the development of an effective tumor antigen-specific T-cell adaptive immune response.

Novartis agreed to pay Aduro $200 million upfront, and up to $500 million in payments tied to development milestones. The pharma giant also made an initial 2.7% equity investment in Aduro for $25 million, and committed itself to making another $25 million investment at a future date.

Aduro’s agreement with Novartis covers joint research, development, and commercialization of CDN-based therapies in the field of oncology. Aduro maintains rights to its CDN technology in all other therapeutic areas, including infectious disease and autoimmunity.

Aduro will lead commercialization activities and will book sales in the U.S. for any products developed and commercialized pursuant to this collaboration, with Novartis leading commercialization activities elsewhere in the world. The companies said they will share in profits, if any, in the U.S, Japan and “major” European countries, with Novartis agreeing to pay Aduro a mid-teens royalty for sales in the rest of the world.

“We look forward to collaborating with Novartis to begin a Phase I clinical trial with our first novel immuno-oncology candidate,” Aduro CSO Thomas W. Dubensky, Jr., Ph.D., said in a statement.

Last year, Dr. Dubensky presented preclinical data at the American Association for Cancer Research Tumor Immunology and Immunotherapy Conference demonstrating antitumor activity in mouse tumor models treated with an Aduro compound based on its CDN technology, ADU-S100.

Aduro’s data showed that direct intratumoral injection of ADU-S100 into melanoma, colon, and breast tumors profoundly inhibited tumor growth both locally and systemically, protected against tumor regrowth, and significantly inhibited growth of distal tumors.

“We believe these small molecules may have value as a monotherapy, delivered in proximity to tumor sites to re-stimulate immune system recognition of and response to cancer cells,” Aduro states on its website.

Yet the company also reasons that immune-mediated destruction of distal tumors could be significantly enhanced by a combination of ADU-S100 and radiotherapy—a combination that Aduro says may eventually be tested in clinical trials.

Novartis also envisions incorporating CDN as part of combination treatments: “We anticipate many clinical opportunities will be explored with the CDN approach, both directly and in combination with other agents,” stated Mark C. Fishman, M.D., president of the Novartis Institutes for BioMedical Research.








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