Iovance plant on track for 2022 and lifileucel BLA set for next year

Iovance Biotherapeutics says its new cell therapy plant in Philadelphia is on track to begin commercial production in 2022.

The firm updated on development of the facility at the Navy Yard complex in Philadelphia during its Q3 earnings call, telling analysts clean rooms are due to be operational for clinical trial supply production in 2021.

Iovance announced plans for the $125 million Philadelphia facility in May last year, explaining it would be used to make autologous TIL products including lifileucel (LN-144) – a candidate therapy for metastatic melanoma.

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Commercialization

CEO Maria Fardis cited Iovance’s development of the tumor-infiltrating lymphocyte (TIL) as an important step on the path to commercial production.

“Iovance has transformed TIL manufacturing from a lengthy academic process to a shorter, scalable centralized GMP process, yielding a cryopreserved product which can address the need of thousands of cancer patients.”

She added, “To date, more than 400 patients have received TIL manufactured at Iovance with a continuing success rate above 90%.

“We have also built and continue to augment our intellectual property surrounding the Gen 2 process, which is covered by 20 granted or allowed US patents.”

CDMO options

At present Iovance’s product candidates are made by WuXi AppTec’s Advanced Therapies Business Unit. However, according to Fardis, once the Philadelphia facility is operational production will switch to the site.

“We certainly have been working very closely with WuXi, our CMO provider for our manufacturing to date, and there’s ample capacity secured at WuXi for us to initialize our commercial manufacturing and then switch over to ICTC.

“So we do have a number of different options, and we work on all fronts to make sure that we are completely ready,” she said.

BLA delay

Quite when commercial lifileucel production will begin is an open question.

In October, Iovance revealed it has not been able to agree the required potency assays to fully define the product during discussions with the US Food and Drug Administration (FDA).

At the time Iovance said, “As a result of these developments, the BLA submission is not expected by the end of 2020. The Company will continue to work closely with the FDA and now anticipates a BLA submission to occur in 2021.”

Fardis expanded on this during the Q3 call.

“We held a Type B meeting with the U.S. FDA, where we reached agreement on the duration of clinical data follow-up for our pivotal cohort 4 to support the BLA. We have further work to do to refine existing potency assays and develop new assays.

“We are actively working on a matrix of assays to offer to FDA to better define TIL. Reaching agreement with FDA on the potency assay is a top priority for Iovance. While the length of time until BLA submission depends on future dialogue with the agency, we plan on the BLA submission in 2021.”