Innovations in oncology explode as new treatments gain approval – Business Day (registration)

Posted: September 4, 2017 at 3:46 pm

“CAR-T therapy is in open water, vastly uncharted,” said Jay Bradner, president of Novartis Institutes for BioMedical Research, which is leading cell-therapy development at the Swiss drug maker. “We have to make bold bets on where we can make the biggest impact.” Many competitors Part of the reason why the first CAR-T products will be so vulnerable to newcomers comes from the complex, boutique process behind the treatments. Unlike mass-produced pills, the one-time treatments are tailored for each patient through an intricate, weeks-long process that involves extracting infection-fighting cells from blood; sending them to a centralised manufacturing plant to get reprogrammed; and shipping them back to be re-infused into the patient at medical centres.

Competition will come from a wide array of innovations that could simplify the process: from ready-to-use vials of donated cells that could be stored in hospitals, to equipment the size of a large espresso machine that could create CAR-T therapies on-site. Companies developing technologies that could disrupt the CAR-T model range from biotech startups to giants like Johnson & Johnson and General Electrics healthcare unit.

Among the most promising products on the horizon are off-the-shelf versions of CAR-T. The off-the-shelf versions use infection-fighting T-cells from healthy donors, rather than the patients own, meaning they could be made in large batches and be readily available. The current leader, Cellectis, hopes to have a product in the next two to three years, and companies including J&J are looking into such therapies, known as allogeneic transplants.

The way to go Cellectiss product is licensed to Pfizer and privately held Servier Laboratories from France. The companies have presented data on their first seven patients, including two patients dubbed the “London babies” who responded to treatment under a compassionate use programme.

“You can give these immediately to the patients, without having to wait for manufacturing,” said Andre Choulika, chief executive officer and co-founder of Cellectis. “This is the way to go.” Novartis is also experimenting with allogeneic therapies, and Kite Pharma, the California company being acquired by Gilead for $11.9bn, is watching the space. Gilead CEO John Milligan said Kite had what he called a “pathway” to allogeneic, but pointed to the risks inherent to grafts, including infections carried by donors and rejection.

Crying out for efficiency

Also emerging are manufacturing advances that would allow hospitals and researchers to produce CAR-T therapies themselves, bypassing drugmakers. Existing technology requires specialised clinicians and scientists to re-engineer infection-fighting cells, a costly, complex process. That wont be sustainable as the drugs get approved for more types of cancer and theyre needed in far greater quantities, said Ger Brophy, GM of GE Healthcares cell therapy business.

Innovations in oncology explode as new treatments gain approval – Business Day (registration)

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