Updated: Iovance Continues Path in Developing TIL Treatments for Solid Tumors
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 are 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 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. At the end of 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. Iovance confirmed with BioSpace that the fourth patient has indeed shown a partial response, making it four of 10 patients with a partial response.
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 the small amount of data that Iovance has provided regarding its TIL therapies. 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. An Iovance spokesperson told BioSpace that the company is currently in Phase II and plans to present more data on LN-144.
Initially, the Forbes article noted TIL pioneer Steven Rosenberg of the National Cancer Institute did not include Iovance on his radar when it comes to TIL therapies. Iovance said its relationship with Rosenberg is a strong one.
“Dr. Rosenberg is on Iovance’s scientific advisory board, the company supports his lab, he has presented on Iovance’s behalf to investors, and the company frequently consults with him,” the spokesperson said.