Notable will donate the commercial rights to price, manufacture, and distribute ND-1000 for pediatric leukemia to Cures Within Reach.
One argument for the high price of some prescription drugs put forth by biopharma companies is due to the significant investments made in taking an asset from a concept, through multiple clinical trials and the regulatory process, all before making it available for sale.
One company though may have found an alternative to offset drug development costs as it moves forward with plans to develop a treatment for a rare form of leukemia and then distribute the drug at a low cost. As Foster City, Calif.-based Notable Labs prepares to initiate clinical testing on its compound ND1000, the company has partnered with the non-profit organization Cures Within Reach to provide a path to distribute the drug to patients. Notable will donate the commercial rights to price, manufacture, and distribute ND-1000 for pediatric leukemia to Cures Within Reach. The nonprofit will then provide the drug to pediatric leukemia patients at a very low cost. Cures Within Reach has a mission to, in part, support the repurposing of a drug for patients.
“The idea of the partnership with Cures Within Reach was born from a conversation on how to do something different to bring a therapy to market that’s affordable for all patients,” Notable Labs Founder Matt De Silva told BioSpace in an exclusive interview.
Through the partnership, Cures Within Reach will be able to use its status as a nonprofit organization to raise funds to help financially support Notable’s clinical development of ND1000. Once the drug makes its way through the clinic, and then potentially through regulatory approval, Notable will then be able to see potential payment because the drug will be eligible for the U.S. Food and Drug Administration’s Pediatric Priority Review Voucher Program. The voucher has a significant financial value and can be sold to other companies, De Silva said.
“The vouchers are really valuable and can be sold to other companies,” De Silva said. He noted that the vouchers can fetch between $60 million and $300 million, which would be suitable compensation for Notable and its other development projects. In total, the company has 15 drugs in development, with ND100 the first into the clinic. De Silva said another blood cancer drug, one for myeloid leukemia, is expected to go into the clinic later this year.
Notable’s ND1000 is a combination drug. It’s a blend of a generic drug already used in cancer patients, one not disclosed, and a natural product that has been used as a treatment for cancer. The natural product was also not disclosed. But, combined, ND-1000 is expected to enhance immunotherapy treatments already in use for these patients, such as CAR-T therapies. It does so by upregulating three proteins CD-19,-20 and -22. Most of the patients who will benefit from ND1000 have already failed multiple treatment options, so the patient pool is fairly small, only a few hundred in the U.S., De Silva said.
Under the partnership with Cures Within Reach, Notable will keep the proceeds from the FDA voucher and the nonprofit will have the drug for as close to cost as possible, De Silva said. This type of partnership that the two companies have developed is a first-time approach, De Silva said.
Notable Labs, now has 35 employees, was founded by De Silva, a former analyst at noted biotech investor Peter Thiel’s Clarium Capital, nearly five years ago. De Silva said the concept for the company came out of his experiences caring for his father, who was diagnosed with glioblastoma multiforme. None of the approved medications benefitted the elder De Silva and he was not eligible to participate in any clinical trial due to the advanced form of the disease. De Silva said that all of the treatment solutions for his father were sort of a “one-size-fits-all” approach. De Silva wanted to find a way to focus on personalized treatment for individual cancer patients, and Notable Labs was born. The company is currently focused on blood cancers, but De Silva said he still thinks about going after the cancer that killed his father.
“This is just the beginning of our story,” he said.
