Roche will partner with Warp Drive Bio to develop new classes of antibiotics against multidrug-resistant bacterial infections, through a collaboration that will generate up-to-$387 million-plus for Warp Drive, the Cambridge, MA-based biotech said today.
The partnership is designed to advance “multiple” novel classes of natural antibiotics that show activity against clinically important, drug-resistant, Gram-negative pathogens by applying Warp Drive’s Genome Mining™ platform, the company said.
Genome Mining is a “genomes to molecules” synthetic biology platform designed to search the genomes of microbes in order to uncover genes that encode hidden natural products, then engineer them to produce novel drugs. Warp Drive says it has assembled a genomic database of over 135,000 strains with the potential to encode more than four million biosynthetic gene clusters.
Using Genome Mining, Warp Drive plans to identify and evaluate over 100 novel classes of potential antibiotics previously undiscovered, thus never analyzed for their impact on human health. Microbial genome sequencing has revealed the enormous biosynthetic capacity of Actinomycetes, with about 90% to 95% of all biosynthetic pathways being “silent” or “cryptic” under standard laboratory fermentation conditions, according to the company.
“Our ultimate vision for this program is that we will identify the complete natural product armamentarium of the Actinomycete family, thus creating a unique new set of pharmaceutical chemical diversity with broad application in the discovery of new human therapeutics,” Warp Drive states on its website.
According to Warp Drive, 10 classes of natural antibiotics have been approved for patient use, compared with five classes of synthetic antibiotics.
The last antibiotic from a novel natural class approved by the FDA was Cubicin® (daptomycin), discovered more than 30 years ago but for which authorization was granted in 2003 to Cubist Pharmaceuticals, acquired by Merck & Co. in 2014 for $9.5 billion.
“An Extraordinary Threat”
“Antimicrobial resistance is an extraordinary threat to global human health, and Warp Drive’s unique platform allows us to access a vast reservoir of uncharacterized natural products from which to identify novel antibiotics,” Warp Drive CEO Laurence Reid, Ph.D., said in a statement.
These previously untapped antibiotic classes “may play a key role in the future strategy to combat antimicrobial resistance,” added Karen Bush, Ph.D., professor of practice in biotechnology at Indiana University.
Warp Drive has granted Roche an option for an exclusive worldwide license to develop and commercialize certain antibiotic classes that emerge from their collaboration, to be triggered upon the selection of a drug development candidate from the particular class. Warp Drive will retain worldwide rights to all other novel antibiotic classes from the collaboration.
In return for the option, Roche agreed to pay Warp Drive up to $87 million consisting of an unspecified up-front payment, option fees, and payments tied to achieving preclinical milestones; up to $300 million in payments tied to achieving clinical, regulatory, and sales milestones on products licensed to Roche; and tiered royalties for development candidates up to double digits on future net sales, also for products licensed to Roche.
Warp Drive Bio was launched in 2012 with $125 million in initial funding, through a strategic partnership with Sanofi and with capital from Third Rock Ventures and Greylock Partners. Last year, Sanofi and Warp Drive overhauled their partnership, launching a five-year, up-to-$750 million collaboration designed to discover novel oncology therapeutics and antibiotics by using Genome Mining and Warp Drive’s Small Molecule Assisted Receptor Targeting (SMART™) platform.
In November, Sanofi assumed all preclinical and clinical R&D efforts for Warp Drive’s novel aminoglycoside antibiotic candidates, after the companies achieved a milestone in their antibiotic discovery program.
