September 7, 2017
By Alex Keown, BioSpace.com Breaking News Staff
SAN CARLOS, Calif. – The end of August belongs to CAR-T therapies with the regulatory approval of Novartis ’ Kymriah (tisagenlecleucel) and Gilead Sciences ’s $12 billion acquisition of CAR-T drugmaker Kite Pharma . But Maria Fardis, chief executive officer of Iovance, believes her company’s TIL technology will be a strong contender in the immuno-oncology field.
Since taking over the reins at Iovance last year, Fardis has implemented a number of changes with the end goal of becoming a leader in immuno-oncology. One of the most visible changes has been the name change and rebranding of the company. Until June, the company was known as Lion Biotech. Fardis said the name change is a better representation of the company’s focus on the field of immuno-oncology.
“Lion Biotechnologies was a wonderful name, but they needed a unique name to represent what they wanted as far as the immuno-oncology therapy,” Fardis, the former chief operating officer for Acerta Pharma, told BioSpace in an exclusive interview.
While much of the focus in immuno-oncology has been on CAR-T technology, Iovance is working on tumor-infiltrating lymphocyte (TIL) technology. For Fardis, TIL technology is the best available therapy for solid tumors. However, she believes TIL technology has been overlooked and overshadowed by the CAR-T field.
The U.S. Food and Drug Administration is taking some notice though. On Sept. 1, the company’s technology reached a major milestone when the FDA granted Fast Track designation for LN-144, a TIL treatment for advanced melanoma. LN-144 is currently being evaluated in a Phase II study. The study is being conducted with two cohorts. The first cohort allows for non-cryopreserved TIL product to be administered to patients. The second involves administration of a cryopreserved product.
Unlike CAR-T, TIL technology is not a genetic modification. Fardis said it’s a removal of the TIL from the tumor. The TIL is then amplified and reinserted into the tumor.
“To me, this is the most exquisite kind of personalized medicine for a patient. It’s not genetically modified, it’s a boosting of their natural immunity. We’re just getting their own cells back to them,” Fardis said.
At the American Society of Clinical Oncology meeting in June, Iovance presented data from 16 patients involved in the first cohort that showed clinically meaningful outcomes. Patients showed a 29 percent objective response rate including one complete response continuing beyond 15 months post-administration of a single TIL treatment. Company data also showed that 77 percent of dosed patients had a reduction in target tumor size.
The company is also conducting tests in cervical cancer with LN-145, an adoptive cell transfer (ACT) therapy that utilizes an autologous TIL manufacturing process. In August, the company dosed its first patient in a Phase II trial for the treatment of patients with recurrent, metastatic or persistent cervical carcinoma.
Fardis also believes TIL technology is safer than CAR-T treatments. Hundreds of patients have been dosed with TIL technology by Iovance as well as the university which discovered the technology. So far there have been no serious adverse events associated with it, which Fardis believes gives it an advantage over CAR-T that has been associated with cytokine release syndrome (CRS).
“We’re monitoring things closely, but we’re not seeing anything adverse so far,” she added.
As a member of the immuno-oncology family, Fardis praised the Kite and Novartis news. She said the FDA approval and acquisition brings “a degree of validity for cell therapy as a main stream for oncology.”
“It’s something that people have been really excited about,” she said.
Fardis said small molecules and antibodies have been commonly used in oncology and now cell therapy is part of the mix. “This is just the beginning. This is the reason I came to Iovance. I’m trained in small molecules, but for something as complicated as cancer… cell therapy brings a very powerful tool,” Fardis said.
The company’s advancing TIL technology program has spurred strong growth at Iovance over the past year. Since June 2016, the company has grown from a team of about 20 people to approximately 70, Fardis said. The majority are based at the company’s California site, but some also operate out of New York and Florida.
As the company’s product moves through mid-stage research Fardis said there is still some room for the company to grow in its current stage. She anticipated hiring about 10 more employees through the end of 2017. After those positions are filled, Fardis believes Iovance will remain at that size for the foreseeable future.
