Gamida Cell will initiate a BLA submission for lead cell therapy omidubicel later this year and grow inhouse manufacturing capabilities to support production of cancer candidate GDA-201.

Israeli cell therapy company Gamida Cell raised $60 million (€55 million) last week through a public share offering. The money will be used to support the approval application and manufacturing capabilities of its cell therapy products, the firm said on an investor call last week.

Lead candidate omidubicel – formerly known as NiCord – is a hematopoietic stem cell transplantation (HSCT), or bone marrow transplant, which recently met its primary endpoint in a Phase III study.

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“We have focused on working towards initiating a BLA submission on a rolling basis in the fourth quarter of this year, which will position us for a potential launch in the second half of 2021,” Gamida CEO Julian Adams said on the call. “We are also advancing key activities to bring omidubicel to patients following potential FDA approval.”

The firm has been using Lonza to produce clinical material of omidubicel, with the contract development and manufacturing organization (CDMO) constructing dedicated suites at its site in Geleen, The Netherlands to support the candidate’s progression towards commercialization last year, but Adams said Gamida is also expanding its own production capabilities.

“Work is ongoing to build out our manufacturing infrastructure both as Lonza and at our own facility to help ensure sufficient and reliable commercial supply. We are also working to develop comprehensive hospital services and patient assistance programs designed to seamlessly bring omidubicel to patients.”

Gamida is also actively recruiting for medical affairs talent and reps to support a launch, now the financing has closed. “It was dependent on the successful financing, so that we would have the wherewithal to continue to build out all of the infrastructure both for medical affairs, commercial and manufacturing.”

GDA-201

Gamida’s second candidate is GDA-201, an investigational, natural killer (NK) cell-based cancer immunotherapy in Phase I development in patients with non-Hodgkin lymphoma (NHL) and multiple myeloma.

“It’s based on the platform that brought us the omidubicel program and a lot of experience knowledge and relationships that we’ve made are ones that we’re leveraging for development of GDA-201,” Gamida’s chief medical officer Ronit Simantov told stakeholders. “We continue to develop that program with development of cryopreserved products in our laboratories, and we will intend to bring that to a clinical study of company sponsored multi-center studies for patients next year.”

But while Gamida will rely somewhat on Lonza for omidubicel, for GDA-201 the firm wants to manufacture fully inhouse.

“We are undertaking to manufacture the NK GDA-201 product in our own facilities,” said Adams, “and the key advantage now that we’ve learned how to cryopreserve and recover NK activity is to turn that into a GMP process. So, there’s still some process development going on, but we’re quite confident that we will achieve [this].”