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Sutro-Celgene partnership a strategic fit
SAN FRANCISCO, Calif.—Sutro Biopharma will collaborate with Celgene Corp. to design and develop novel antibody drug conjugates (ADCs) and bispecific antibodies for two undisclosed targets and to manufacture a proprietary Celgene antibody. The deal could be worth more than $500 million to Sutro, which will receive a substantial upfront payment, an equity investment in the company and payments for the completion of research, development and regulatory milestones, plus royalties on product sales.
"The collaboration between Sutro and Celgene arose due to the strong strategic fit for both companies, as Sutro has built a platform for creating the next-generation ADC and bispecific products Celgene seeks to develop and commercialize," says William Newell, CEO of Sutro. The companies met at the JPMorgan Healthcare conference in January 2012.
Newell explains that Sutro has developed a cell-free biochemical protein synthesis technology that allows the creation of "best-in-class ADCs and bispecific antibodies," which are made up of pieces of two separate antibodies and can bind to two different antibody-producing antigens. Additionally, Sutro has established a Good Manufacturing Practice (cGMP) facility for the production of clinical supplies of materials using its biochemical protein synthesis platform and is "an expert in the field of protein engineering," he says.
Celgene, a global biopharmaceutical company, "has a world-class reputation for the discovery of breakthrough medicines and has significant expertise in development and commercialization of therapeutic products in various disease areas," Newell adds. It focuses on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune or inflammatory conditions.
More than 300 clinical trials at major medical centers use compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid-tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocyte leukemia, non-Hodgkin's lymphoma, myelofibrosis, small-cell lung cancer and prostate cancer.
Dr. Thomas Daniel, Celgene's president of global research and early development, says, "We look forward to working with the team at Sutro and to exploring their platform's potential to accelerate the discovery and development of superior multifunctional biologics."
Celgene was interested in applying Sutro's platform to generate many types of proteins and using Sutro's cGMP manufacturing facility, thus reducing the time for the preclinical development, according to Daniel.
Sutro's antibody-based therapeutics for targeted cancer therapies will "significantly extend the clinical impact of current oncology therapeutic approaches and are beyond what can be envisioned with current, cell-based expression technologies," Newell says. Sutro's biochemical synthesis technology "allows the rapid and systematic exploration of many protein drug variants to identify drug candidates." Once these product candidates are identified, production can be rapidly and predictably scaled up to commercial levels.
"Sutro aims to successfully complete the research, development and regulatory milestones in the Celgene collaboration," Newell says. "Additionally, Sutro continues to develop its own pipeline and to establish additional collaborations with pharma and biotech companies interested in developing next-generation ADCs and bispecific antibodies."
Sutro will be responsible for product design and production of preclinical materials and will make clinical batches of a Celgene-developed "naked" antibody that works without carrying a drug.
As to the state of ADC technology, Newell explains that ADCs are a new class of targeted therapies that "hold much promise, especially in oncology." Technology platforms for the development of next-generation ADCs "should provide control over the number and placement of the drugs conjugated to the antibody," he says. "The current state of the art results in mixtures of multiple species of ADCs which potentially results in suboptimal pharmacokinetics, stability and efficacy."
Sutro's cell-free biochemical protein synthesis technology enables the introduction of site-specific chemical modifications, including non-natural amino acids, generating hundreds of variants of proteins, such as antibodies, and also enables the rapid and systematic screening for best-in-class therapeutics, according to Newell.
"The candidate selected can be manufactured utilizing the same platform in accordance with current GMP standards," he concludes.