Aduro Biotech Establishes Major Collaboration with Novartis for Global Research, Development and Commercialization of Immuno-Oncology Products Derived from its Proprietary STING-Targeted CDN Platform Technology

- Aduro to Receive $200M Upfront, Equity Stake and Future Potential Milestones Collectively Totaling up to $750M, Plus Profit Sharing in the Collaboration

BERKELEY, Calif.--()--Aduro Biotech, Inc. today announced the establishment of a major collaboration with Novartis for the worldwide research, development and commercialization of novel immuno-oncology products derived from Aduro’s cyclic dinucleotide (CDN) approach to target the STING (Stimulator of Interferon Genes) receptor, that, when activated, is known to initiate broad innate and adaptive tumor-specific immune responses.

“We are extremely pleased to enter into this relationship with Novartis as their strong commitment and spirit of collaboration was evident early in our conversations,” said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. “We believe they are an ideal partner not only because of their stature as a premier healthcare company with a major focus in oncology, but also because they demonstrated a keen understanding and appreciation for our novel CDN approach, have synergistic innovation and scientific strengths and of course offer tremendous clinical and commercial expertise which we expect will broaden and accelerate the potential to bring products developed from this novel technology to patients in need.”

Under the terms of the agreement, Novartis will make an upfront payment of $200 million to Aduro and, if all development milestones are met, Aduro is eligible to receive up to an additional aggregate amount of $500 million. In addition, Novartis has made an initial 2.7 percent equity investment in Aduro for $25 million, with a commitment for another $25 million investment at a future date.

Aduro will lead commercialization activities and will book sales in the United States for any products developed and commercialized pursuant to this collaboration, with Novartis leading commercialization activities in all other regions. The companies will share in profits, if any, in the United States, Japan and major European countries. Novartis will pay Aduro a mid-teens royalty for sales in the rest of the world.

Novartis’ Mark C. Fishman, M.D., president of the Novartis Institutes for BioMedical Research, commented, “We are delighted to collaborate with Aduro. We believe this target is among the most exciting in oncology today, the drug candidate to be of the highest quality, and the talent of our new colleagues from Aduro to be fantastic. We anticipate many clinical opportunities will be explored with the CDN approach, both directly and in combination with other agents.”

The agreement covers the 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, among others.

Thomas W. Dubensky, Jr., Ph.D., chief scientific officer for Aduro added, “This is a tremendous validation of our CDN technology and the preclinical data that we’ve generated in the program thus far. We look forward to collaborating with Novartis to begin a Phase 1 clinical trial with our first novel immuno-oncology candidate.”

Last year, Dr. Dubensky presented preclinical data at the American Association for Cancer Research Tumor Immunology and Immunotherapy Conference demonstrating potent anti-tumor activity in preclinical models treated with ADU-S100, the company’s compound based on its CDN technology. The preclinical studies included evaluation of ADU-S100 to stimulate and activate the STING pathway as an approach to generate an immune response that can specifically attack tumor cells. ADU-S100 is a novel synthetic CDN-based molecule that was developed based on its ability to stimulate human immune cells from a large pool of human donors that comprised all of the known STING receptors. In preclinical mouse tumor models, the data showed that direct intratumoral injection of ADU-S100 into melanoma, colon and breast tumors profoundly inhibited tumor growth both locally and systemically, with a durable response that provided protection against tumor regrowth and significantly inhibited growth of distal tumors. In addition, Aduro believes the immune-mediated destruction of distal tumors could be significantly enhanced by a combination of ADU-S100 and radiotherapy, a combination that may eventually be tested in human clinical trials.

About Cyclic Dinucleotide (CDN)

Aduro’s proprietary CDN product candidates are synthetic small molecule immune modulators that are designed to target and activate a receptor known as the Stimulator of Interferon Genes, or STING, receptor. The STING receptor is generally expressed at high levels in immune cells, including dendritic cells. Once activated, the STING receptor initiates a profound innate immune response through multiple pathways, inducing the expression of a broad profile of cytokines, including interferons and chemokines. This subsequently leads to the development of an effective tumor antigen-specific T cell adaptive immune response.

About Aduro

Aduro Biotech, Inc. is a private, clinical-stage immuno-oncology company focused on the development of technology platforms to stimulate an immune response against cancer. Aduro’s lead platform is based on proprietary strains of live-attenuated, double-deleted (LADD) Listeria monocytogenes that induce a potent innate immune response and have been engineered to express tumor-associated antigens to induce tumor-specific T cell-mediated immunity. Aduro has received Breakthrough Therapy designation from the FDA for its lead LADD regimen, CRS-207 in combination with GVAX Pancreas in pancreatic cancer. The company is evaluating the proprietary immuno-oncology combination in the ongoing Phase 2b ECLIPSE clinical trial and has additional ongoing clinical trials with its LADD platform in mesothelioma and glioblastoma. The company is also developing clinical candidates using cyclic dinucleotide (CDN) synthetic small molecule immune modulators that are designed to activate the intracellular STING receptor, a central mediator of the innate immune response. For more information, please visit www.aduro.com.

Contacts

Aduro Biotech, Inc.
Sylvia Wheeler, 510-809-9264
SVP, Corporate Affairs
or
Media Contact:
Angela Bitting, 925-202-6211
press@aduro.com

Contacts

Aduro Biotech, Inc.
Sylvia Wheeler, 510-809-9264
SVP, Corporate Affairs
or
Media Contact:
Angela Bitting, 925-202-6211
press@aduro.com