The US FDA has released Gamida Cell from a clinical hold imposed last year, clearing the way for trials of GDA-201, a candidate off-the-shelf treatment for large B cell lymphomas.
The Boston biotech firm announced the decision last week, also revealing that the US regulatory agency cleared its investigational new drug (IND) application for the product.
CEO Julian Adams said, “FDA clearance of our IND for the cryopreserved formulation of GDA-201 represents a significant milestone for the company and reflects our team’s expertise in the development of NAM-enabled cell therapies.
Image c/o Moritz Kindler on Unsplash
“We are pleased to advance our plans to begin the company sponsored Phase 1/2 study and progress our novel cryopreserved formulation of GDA-201 with objective to address the unmet need that exists for patients with follicular and diffuse large B cell lymphomas.”
The FDA imposed the clinical hold in October last year and asked Gamida to modify donor eligibility procedures and sterility assay qualification processes used during the production of GDA-201.
Cash infusion?
The lifting of the clinical hold comes after a series of less positive developments for Gamida.
Last November, the FDA asked Gamida for more information about the manufacturing process and facility used to make omidubicel, a candidate blood cancer treatment for patients in need of a stem cell transplant.
In response a few months later, Gamida said that following receipt of positive Type B meeting correspondence from the FDA it plans to initiate a rolling Biologics License Application (BLA) submission for omidubicel.
At the time Adams said, “We are very pleased that our productive interactions with the FDA have resulted in alignment on the omidubicel manufacturing comparability analysis and agreement to initiate a rolling submission of our BLA application.
“We plan to complete the full BLA submission in the first half of this year, which will be an important achievement for Gamida Cell and the bone marrow transplant community.”
And then in January Gamida sacked 10% of its workforce and put any planned spending on hold in a bid to reduce its operating expenses.
In a note issued in response to the lifting of the clinical, Evercore ISI analyst John Miller said although the cost cutting measures had given Gamida a “cash runway” that extends into the middle of next year “this is less wiggle room than we’d like to see.”
He added that “however management addresses it, a cash infusion this year would likely drive substantial upside.”