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Cell Therapy for Melanoma Impresses in
Phase 2

Research Report

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Positive clinical data for this U.S. company's immunotherapy for metastatic melanoma are both encouraging and impressive, says one analyst.

Joe Pantginis of Rodman & Renshaw commented on Iovance Biotherapeutics Inc.'s (IOVA:NASDAQ) progress in an Aug. 2 research report, noting data presented at the American Society of Clinical Oncology (ASCO) conference in June highlighted the company's "technical capabilities and ability to reproduce positive clinical results."

With the ASCO presentation, the company "took a positive step towards answering two primary questions: 1) can Iovance deliver the first internally driven efficacy of TILs (tumor infiltrating lymphocytes; T cells) in melanoma; and 2) can Iovance internally recapitulate the NCI (National Cancer Institute) [six-week] manufacturing process," Pantginis wrote. "Data from 16 patients were presented and showed an overall response rate of 29%, including one [complete response] (achieved at six months post a single TIL treatment and continuing beyond 15 months). Reductions in target tumor lesions were observed in 77% of patients."

Pantginis wrote that he found the data "encouraging and impressive."

The analyst also described ongoing research at the company, formerly known as Lion Biotherapeutics.

The second cohort in Iovance's LN-144 study "is up and running; data from both cohorts expected by YE17," Pantginis wrote.

The two cohorts are receiving cells produced via different manufacturing processes, the second of which "offers a reduced timeframe from tumor excision to TIL infusion of approximately three weeks. In addition, the TILs for cohort two are being cryopreserved and then thawed before infusion, which allows for additional flexibility in scheduling," the analyst explained.

"With regards to comparison of the two manufacturing processes, Iovance plans to look for similar response rates between the two cohorts, which it believes its in vitro assays are predictive of equivalency," Pantginis stated. Once data is analysed at the end of 2017, the company "plans to choose the manufacturing process to be utilized for clinical studies going forward."

Pantginis also noted that "at the end of 1Q17, the manufacturing capacity was sufficient to provide TILs for all clinical programs including the three Iovance sponsored studies, a study at MD Anderson, and a future study in collaboration with MedImmune which is expected to initiate in early 2018."

Additionally, studies in "melanoma and cervical cancer are to be expanded into the E.U. (separate from Karolinska collaborations), which includes the existing ongoing LN-144 trial for metastatic melanoma, and LN-145 for cervical cancer. In 3Q17, Iovance plans to submit a clinical trial authorization (CTA) for these trials in the E.U.," Pantginis stated.

Rodman & Renshaw has a Buy rating and target price of $16 per share on Iovance. The stock is currently trading at approximately $5.60.

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