Gamida Cell is initiating a rolling FDA submission for the blood cancer treatment omidubicel, but it is looking for a little help from a strategic partner and slashing staff to get it across the finish line.
The submission is expected to get underway in the first quarter and be completed by the end of the half, the company said in a Monday morning release. Omidubicel is being developed as an off-the-shelf bone marrow stem cell transplant for patients with blood cancers. Gamida Cell said that the rolling submission was cleared after positive feedback arrived from a Type B meeting with the FDA. These meetings can be held for therapies that have received a breakthrough therapy designation, like omidubicel.
In November 2021, the FDA asked for more data on Gamida Cell’s manufacturing facility before the submission could move forward. The agency specifically asked for a comparison of omidubicel from the manufacturing plant with records from other facilities, which were used to produce the drug for the company’s phase 3 study.
The biotech reported last year that omidubicel showed benefits over umbilical cord blood and met the main goals of its registrational trial.
The submission may be underway, but to get the drug onto the market, Gamida Cell is seeking strategic partners for commercialization in the U.S. or globally.
At the same time, Gamida Cell is reducing operating expenses by slashing 10% of its staff and delaying planned hirings and spending in 2022. These actions are expected to extend the biotech’s cash runway into mid-2023, a timeline that matches with a potential omidubicel launch.
And in other news, Gamida Cell said that it is also working on addressing concerns the FDA raised that led to a clinical hold for GDA-201 as the biotech was seeking authorization to run human trials. The biotech first mentioned the clinical hold in October 2021. While a phase 1/2 was previously planned for the end of 2021, Gamida Cell now hopes to start the follicular and diffuse large B-cell lymphoma study sometime this year.
Gamida Cell ended 2021 with $96.1 million in cash and cash equivalents, according to the release. The companies shares were up a few percentage points at $2.99 apiece as the markets opened on Monday morning, compared to a prior close of $2.93.