Sutro Biopharma has achieved a milestone under its collaboration and license agreement with the healthcare division of Merck KGaA, Darmstadt, Germany, in the United Stated and Canada known as EMD Serono.
The milestone was achieved upon the designation by Merck KGaA of an undisclosed bispecific antibody-drug conjugate as a clinical development candidate with approval to advance to IND-enabling studies.
The announcement was made at the start of World ADC, the ‘must attend’ industry meeting for anyone involved in the development and manufacturing of ADCs, held October 8 – 11, 2019 in San Diego, CA.
This new candidate was discovered using Sutro’s XpressCF+™ drug discovery and manufacturing technology and includes a proprietary linker-payload which also discovered by Sutro.
The ADC is based on Merck KGaA´s strand-exchange engineered domain (SEED) platform to generate bispecific antibody-like molecules.
Based on the agreement, signed in 2014, Sutro and Merck KGaA, have collaborated to discover and develop ADCs utilizing Sutro’s cell-free protein synthesis platform, Xpress CF+™. As part of the agreement, Merck KGaA will be responsible for drug product, clinical development and commercialization of any resulting products.
Sutro is eligible to receive certain pre-commercial milestone payments and tiered royalties ranging from low-to-mid single digit percentages, along with certain additional one-time royalties, on worldwide sales of any commercial products.
Under the terms of the agreement, Sutro will manufacture the ADC immediately for the early clinical supply of the candidate.
The companies did not disclose financial details related to the milestone.
4th Clinical Product Candidate
“The achievement of this milestone marks our fourth ADC clinical product candidate in three years, further validating our XpressCF+™ drug discovery and manufacturing technology which enables iterative optimization through cell-free protein synthesis and site specific conjugation as well as our linker-payload, all of which are designed to achieve an improved therapeutic window,” said Bill Newell, Sutro’s Chief Executive Officer.
“We look forward to continuing our collaboration with Merck KGaA, as we seek to discover the next-generation of oncology therapeutics and transform the lives of cancer patients in urgent need of new therapies,” Newell added.
“We are extremely excited to reach this milestone; the development of a therapeutic candidate that incorporates site-specific homogeneous drug conjugation onto a bispecific antibody for the treatment of solid tumors is another demonstration of the versatility of our technology platform,” commented Trevor Hallam, PhD, Sutro’s Chief Scientific Officer.
To date, Sutro has designed cytokine-based immuno-oncology therapies, ADCs, vaccines and bispecific antibodies primarily directed at clinically-validated targets for which the current standard of care is suboptimal.
The company’s platform allows it to accelerate discovery and development of potential first-in-class and best-in-class molecules through rapid and systematic evaluation of protein structure-activity relationships to create optimized homogeneous product candidates.
In addition to developing its own oncology pipeline, Sutro is collaborating with select pharmaceutical and biotech companies to discover and develop novel, next-generation therapeutics. As the pace of clinical development accelerates, Sutro and its partners are developing therapeutics designed to more efficiently kill tumors without harming healthy cells.