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Preliminary Phase 2 Clinical Data Provides 'First Spark to Game-Changing Thesis'
Research Report

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H.C. Wainwright & Co. reported on the significance of preliminary data for treatments for head and neck cancer, as well as for cervical cancer.

In a Jan. 25 research note, analyst Joseph Pantginis of H.C. Wainwright & Co. reported that Iovance Biotherapeutics Inc. (IOVA:NASDAQ) announced preliminary data from two Phase 2 studies assessing the safety and efficacy of its autologous tumor infiltrating lymphocyte (TIL) therapy, LN-145, in two different indications, head and neck cancer and cervical cancer. Clinical trial C-145-03 involves patients with recurrent and/or metastatic, head and neck, squamous cell carcinoma. C-145-04 comprises individuals with recurrent, metastatic or persistent cervical carcinoma.

"These data are an early but encouraging look at efficacy in solid tumors beyond melanoma," Pantginis said, "especially based on the very advanced nature of the disease (gauged by prior treatments) and limited treatment options." Additionally, the follow-up period for these patients exceeds three months.

The head and neck cancer trial results indicated "three of the eight evaluable patients had tumor size reductions of greater than 30%, which qualify as partial responses, and the objective response rate is 38%," Pantginis noted. "These patients had a median of four prior treatments, and all received prior anti-PD-1 therapy and two received prior anti-CTLA-4 therapy (heavily pretreated population)."

In the cervical cancer study, of the two evaluable patients, one had a confirmed partial response and the other showed stable disease.

About the early data, Pantginis concluded they "represent a game changing thesis" in that they "importantly, expand the clinical database of solid tumors that TIL therapy has observed activity against, an area where CAR-Ts continue to falter. We believe that LN-145 may represent a more efficacious therapy for these solid tumor indications."

Iovance may pursue earlier therapies in conjunction with checkpoint inhibitors for certain disease indications. About this approach, the analyst purported, "We believe such combinations may be beneficial for the patient by: 1) reducing the time a patient is on a checkpoint inhibitor with the potential benefit of reducing toxicities associated with them (sometimes irreversible) and 2) acting synergistically to clear tumor burden and develop a durable response."

Pantginis reiterated that prior conditioning chemotherapy treatments are primarily to blame for the adverse side effects associated with, but not from, TIL therapy. "This continues to be a major differentiator when comparing CAR-T approaches to Iovance's TILs, in our belief."

Also in the research note, Pantginis reported that Iovance, on Jan. 24, announced an equity raise of $125 million ($125M), plus an $18.75M 30-day option, "which we believe should be exercised." This cash balance of approximately $272M should allow Iovance to advance LN-144 to potential approval in melanoma, a disease population in which checkpoint inhibitors failed, along with release of Phase 2 data in several indications. "Ultimately, we believe this cash balance could result in two outcomes for Iovance: 1) significant partnership or 2) outright acquisition," Pantginis added.

Finally, the analyst listed the upcoming milestones and catalysts for Iovance. Anticipated in the first half of this year are initiation of both a melanoma trial and a cervical cancer study in Europe and a Phase 2 trial of LN-145 in combination with Medimmune's durvalumab in nonsmall cell lung cancer.

Sometime in 2018 the company should engage with the U.S. Food and Drug Administration to define the regulatory path for LN-144. Additionally, data are expected from the melanoma, cervical cancer, and head and neck cancer studies, potentially at one or more annual medical association meetings.

H.C. Wainwright increased its target price on Iovance to $22 from $16 per share and maintains its Buy rating on the company. The biotech is currently trading at around $15.25 per share.

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1) Doresa Banning compiled this article for Streetwise Reports LLC and provides services to Streetwise reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.
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Additional disclosures

Disclosures from H.C. Wainwright, Iovance Biotherapeutics Inc., Target Price Revision, Jan. 25, 2018

I, Joseph Pantginis, Ph.D. and Pete Stavropoulos, Ph.D., certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.

The research analyst and/or the research analyst’s household has a financial interest in and own the securities of Iovance Biotherapeutics, Inc. (including, without limitation, any option, right, warrant, future, long or short position).

As of Dec. 31, 2017 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Iovance Biotherapeutics, Inc.

The Firm or its affiliates did receive compensation from Iovance Biotherapeutics, Inc. for investment banking services within twelve months before, and will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report.

H.C. Wainwright & Co., LLC managed or co-managed a public offering of securities for Iovance Biotherapeutics, Inc. during the past 12 months. The Firm does not make a market in Iovance Biotherapeutics, Inc. as of the date of this research report.

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