Iovance Continues Path in Developing TIL Treatments for Solid Tumors

Maria Fardis, chief executive officer of Iovance Biotherapeutics, sees tumor infiltrating lymphocyte (TIL) therapies as the best immunotherapy option to treat solid cancers.

In an interview last year with BioSpace, Fardis explained that TIL technology is a “boosting” of the body’s natural immunity. The TIL is removed from a cancerous tumor, “amplified” through genome sequencing to attack the disease, then reinserted into the tumor to do the work. Because the amplified TILs can attack the whole tumor, including any potential mutations, Fardis described it as “the most exquisite kind of personalized medicine for a patient.”

Earlier this year, Iovance released preliminary data from two Phase II trials evaluating its lead candidate lifileucel (LN-145). One was the C-145-03 trial in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. The preliminary data showed three of the eight patients in the trial showed a 30 percent decrease in tumor size. That was noted as a partial response. The other trial, C-145-04, evaluated the effect of LN-145 in patients with recurrent, metastatic or persistent cervical carcinoma. BioSpace noted at the time that only two patients were evaluable, one confirmed Partial Response and one had stable disease. In May, the company was granted orphan-drug designation from the U.S. Food and Drug Administration (FDA) for autologous tumor infiltrating lymphocytes for the treatment of cervical cancer with a tumor size of greater than 2 cm in diameter.

LN-145 is also being developed as a potential treatment for metastatic melanoma. The FDA granted Fast Track designation for LN-144 in this indication. An update on the melanoma project is expected later this year and Iovance could be eying early talks with the FDA about a potential pathway to approval. Last year, the company presented some preliminary data that showed three of nine patients had partial responses and the company was waiting to confirm if a fourth patient showed a partial response. More data from this trial is expected to be disclosed later this year.

Despite Iovance’s work, though, the company is not getting any love in an article on Forbes. Titled “Does Tiny Iovance Deserve to Ride the T-Cell Wave?”, the article questions whether or not Iovance’s TIL technology is an effective path in treating solid tumors, or if it’s “riding a wave of hype?” The article points to a “lack of data” that Iovance has provided regarding its TIL therapies, particularly whether or not the treatments would be marketable and profitable. The article suggests that most data now is anecdotal and needs to be backed by hard data that demonstrates the efficacy of the TIL technology. The article also looked at some of the company’s past failures in cancer research before it became Iovance. Despite the question of hype, the Forbes piece outlines the scope of what Iovance is doing with TIL research.

Citing the National Cancer Institute’s Steven Rosenberg, a TIL pioneer that Iovance licensed its TIL technology from, Forbes said Iovance is not on his radar when it comes to TIL therapies. Rosenberg’s research, according to Forbes, shows that “24 percent of 101 patients with melanoma had a complete response to TIL therapy, with half of the patients still alive three years after treatment.” Rosenberg is bullish on TIL technology as a potential treatment for solid tumors.

“If you find something that works, the genius of modern industry will find out ways to make it available,” he told Forbes.

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