Shorla Pharma scores an expedited review for its mystery candidate to treat T-cell malignancies
Since launching Shorla Pharma three years ago to design better versions of existing cancer drugs, co-founders Sharon Cunningham and Orlaith Ryan have offered scarce details on what it is they’re working on. But the FDA clearly likes what it sees.
The agency has granted priority review to SH-111, Shorla’s mystery candidate for the third-line treatment of adults and children with T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL), the company said on Friday.
Ryan, Shorla’s CTO, told Endpoints News that the candidate is a new take on a standard-of-care treatment which she says is in short supply, but declined to comment any further. While most leukemias target older people, T-cell leukemia is an aggressive blood and bone marrow cancer that’s most common among children.
“In this instance it’s really a treatment that has frequently been in shortage,” Ryan said, adding that manufacturing has posed a challenge. “Given our expertise and our resource we were in a position to, basically, bring a scalable and secure source of the drug to market.”
She and Cunningham both hail from Ireland’s EirGen Pharma, which was bought out by Miami-based Opko Health in 2015. The move inspired them to launch Shorla in 2018 — a combination of their first names — to “reimagine” medicines for indications where existing treatments are limited, or inadequate, or not effective as they could be. Back in June, they nabbed an $8.3 million Series A round led by Seroba Life Sciences.
“We decided to really focus our attention on bringing the products to market in the US first, followed by Europe and rest of world,” Cunningham, Shorla’s CEO said.
The Clonmel, Ireland-based biotech has two other programs — one for breast and ovarian cancer, and another for glioma. Cunningham and Ryan plan on approaching regulators with the former, SH-105, in Q1 of 2022. That treatment is a more easily administered version of a drug that was approved as a freeze-dried powder in the 1950s. SH-110, a liquid version of a hard-to-swallow pill used to treat glioma, is likely headed for the clinic at the end of the year.
All three programs are based on established drugs, though they declined to say what those drugs are.
“We really believe in bringing affordable and accessible treatments to patients, and that’s very much what we intend to do,” Ryan said.