Foster City, California-based Notable Labs – known for its automated research system for personalized drug testing – has launched its first drug development program targeting pediatric leukemia and is relying on a nonprofit partner to help bring it to market.
Notable’s platform uses blood cancer cell samples to predict the efficacy of potential drugs, identify new drug combinations and split patients into
subgroups that may be responsive to specific drugs. The idea is that Notable Labs can more efficiently and successfully run drug trials using its technology.
“We’re focusing more around taking a drug that either already been in trials, that’s a generic or is a natural product and then really making sure that that gets given to the right patient by testing their samples beforehand,” Notable Labs CEO Matthew De Silva said in an interview.
The company’s initial program, known as ND-1000, is a combination of an existing generic cancer medication with a natural product that is meant to boost the effectiveness of CAR T-Cell therapy by causing cancer cells to upregulate proteins targeted by existing immuno-oncology drugs.
ND-1000 drug trials are scheduled to start at the University of Kansas Cancer Center later this year.
Notable Labs is monetizing its initial drug program through a novel partnership with Cures Within Reach, a nonprofit dedicated towards using existing drugs and devices to develop new treatments for disease.
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The company is donating commercial rights to price, manufacture, and distribute ND-1000 for pediatric leukemia to Cures Within Reach, opening up access to the medication to more patients.
ND-1000 meets the criteria of the FDA’s Rare Pediatric Disease Priority Review Voucher Program which means that if the drug manages to make it through the clinical trial process and earns regulatory approval, Notable Labs will also receive a voucher for expedited review for a different product.
Vouchers can used for Notable’s future programs or be sold to another pharma company and De Silva said the market for vouchers has ranged from $60 million to more than $300 million.
“We think it’s a great program and that’s a part of the reason why we’re doing this was to announce upfront that we’re only able to do this innovative partnership with the non-profit because of this incentive program,” De Silva said.
Notable Labs was inspired by De Silva’s father’s battle with cancer and has raised roughly $22 million from investors including Founders Fund, Lightspeed Venture Partners and Y Combinator since launching in 2014.
While ND-1000 represents the company’s first drug development program, the company plans to announce another program by the end of the year and has a total of 15 drugs in development pipeline across six types of adult and pediatric blood cancers.
“Our view here is that there are lots of great drugs that potentially get given to the wrong patients, so if we can find a drug in combination with a therapy that makes it more efficacious or identify a biomarker that lets us match that drug to the right sub-population that can benefit, we think that the success rate for drug development can go up considerably,” De Silva said. “That’s going to be where we focus.”
Photo: Natali_Mis, Getty Images