Tiny Aduro Biotech Snags $750M Cancer Deal With Drug Giant Novartis AG

Astellas Pharma, Proteostasis Therapeutics Forge $1.2 Billion Genetic Disease Drug Development Pact

March 30, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor

Scrappy Bay Area clinical stage cancer therapy company Aduro Biotech is celebrating Monday, after announcing drug behemoth Novartis AG will pay $200 million upfront to gain a 2.7 percent equity stake in Aduro for $25 million, the companies said. Under the terms of the deal, Novartis will also pour in another $25 million investment, with Aduro eligible for an extra $500 million in milestone payments.

Novartis made the deal primarily to gain access to Aduro’s promising STING (Stimulator of Interferon Genes) receptor technology. The deal will now give it the rights to the worldwide research, development and commercialization of novel immuno-oncology products derived from Aduro’s cyclic dinucleotide (CDN) approach to target STING.

“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,” said NovartisMark C. Fishman, M.D., president of the Novartis Institutes for BioMedical Research. “We anticipate many clinical opportunities will be explored with the CDN approach, both directly and in combination with other agents.”

Aduro has been riding high since January, after raking in $51.4 million in a Series D funding round from 11 investors including OrbiMed, Franklin Advisers, Foresite Capital Management, Clough Capital Partners, Janus Capital Management and Jennison Associates. Leerink Partners acted as bookrunners on the deal.

Berkeley, Calif.-based Aduro said it will use the investment for to expand its research and clinical development capabilities, as it attempts to roll out its immuno-oncology platform in 2015. The company is best known for its experimental combo of proprietary drugs CRS-207 and GVAX Pancreas, a mix that is attracting investor interest as it goes through ECLIPSE, a 240 patient Phase 2b clinical trial to treat metastatic pancreatic cancer.

The cocktail received a breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) last year, a “golden ticket” which has investors circling around the company as it fast-tracks its drug program.

The startup last received a $55 million Series C round from Morningside Group and Johnson & Johnson Development Corporation, bringing its total investment so far to $143.4 million.

Aduro has been focusing on developing a platform of live-attenuated double-deleted Listeria monocytogenes strains (or LADD) that it has engineered to jumpstart an immune response in cancer patients. Its lead drug, CRS-207, works by expressing the tumor-associated antigen mesothelin, which makes it useful for treating mesothelioma and pancreatic, lung, ovarian and gastric cancers.

“2014 was a watershed year for Aduro and this financing demonstrates investor confidence in our future,” said Stephen Isaacs, chairman, president and chief executive officer of Aduro.

Aduro’s other primary candidate is GVAX Pancreas, a drug that is a type of GVAX vaccines produced from human cancer cell lines and created to target T cells as a way to boost cancer immunity. Most of the company’s research is based on cyclic dinucleotides (CDNs), which are naturally occurring molecules that target an immunity regulator, dubbed the STING receptor.

“Our accomplishments during the year, including demonstrating positive results in our pancreatic cancer and mesothelioma programs, receiving Breakthrough Therapy designation from the FDA for the combination of CRS-207 and GVAX Pancreas, and establishing two worldwide collaboration agreements with Johnson and Johnson Innovation (Janssen Biotech Inc. ) for the development and commercialization of novel immunotherapies for prostate and lung cancers, have positioned us well to achieve our goal of providing patients with more effective and more tolerable alternatives to treat cancer,” he said. “

We look forward to completing enrollment in our Phase 2b ECLIPSE trial in patients with metastatic pancreatic cancer and further exploring the broad versatility and applicability of our LADD and CDN technologies in other cancers.”

Last October Aduro inked a $30 million deal with the Johnson & Johnson Innovation Center in California to help it develop its nascent lung cancer therapies, the company announced Thursday.

Under the terms of the pact, Janssen Biotech Inc. (JNJ), part of the Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ), will receive an exclusive, worldwide license to several of the cancer drugs in Aduro’s LADD immunotherapy platform

Aduro received a $30 million up front and as much as $817 million as it hits development, regulatory and commercialization milestones payments.

The company’s primary focus is experimental therapies using Listeria bacteria, which they genetically modify with disease-specific antigens. It had an earlier, existing partnership with Johnson & Johnson, but the larger company appears to be doubling down on the company as research evolves.

Aduro lauded the agreement as a major step forward for the tiny biotech. The deal is still subject to clearance by American antitrust authorities under the Hart-Scott-Rodino Act.

“Since our initial agreement with Janssen in May [2014] year for new immunotherapies for prostate cancer, they have been terrific partners and we’ve established a strong collaboration focused on advancing our technologies forward in their licensed indications,” said Isaacs at the time.

Isaacs said Aduro continues to make progress with a broad array of immunotherapy platforms in a number of other oncology indications, including pancreatic cancer, mesothelioma and glioblastoma.

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