Just a few days after reporting third quarter 2019 earnings, late-stage biotechnology company Iovance Biotherapeutics Inc. (IOVA:NASDAQ), which develops novel T cell-based cancer immunotherapies, today announced that new data from Cohort 2 of the ongoing Phase 2 lifileucel metastatic melanoma study (C-144-01) were presented Friday, Nov. 8, 2019, at the Society for Immunotherapy of Cancer (SITC) 34th Annual Meeting in National Harbor, Maryland.
The company advised that new data from the second Cohort in the ongoing C-144-01 study includes consecutively dosed post-PD-1 patients with Stage IIIC/IV unresectable melanoma who also have received BRAF/MEK therapy if clinically indicated. In the presentation to the SITC, the firm highlighted that the study's "Cohort 2 objective response rate (ORR) as determined by independent review committee (IRC) was 35 percent, which aligns well with the investigator assessed ORR of 36 percent".
Maria Fardis, Ph.D., MBA, President and CEO of Iovance Biotherapeutics commented, "We are pleased to see continued evidence of durability with lifileucel therapy as patients are evaluated with longer term follow-up... Concordance between IRC assessment and investigator reported results is highly favorable in this metastatic disease setting as compared with the published literature. These results continue to show that lifileucel offers a potential therapeutic option for the metastatic melanoma patients enrolled in this study. We continue to enroll patients in the pivotal cohort of the study, Cohort 4, which is expected to serve as the basis for an expected Biologics License Application (BLA) submission for lifileucel in late 2020."
Earlier this week the company reported earnings for the third quarter ended September 30, 2019. Being a clinical stage company the company did not recognize any revenue for the quarter or year-to-date. For Q3/19, the company reported a Net loss of $49.5 million, or $0.40 per share, compared to a net loss of $33.8 million, or $0.36 per share in Q3/18. Research and development expenses increased $13.7 million in the same period to $41.6 million, up from $27.9 in Q3/18, which according to the company was primarily due to higher manufacturing costs resulting from increased capacity added to support enrollment in the pivotal and other clinical trials. General and administrative expenses increased by $2.9 million to $10.0 million in Q3/19, compared to $7.1 million in Q3/18 mostly due to adding employees and increased legal fees in order to support the growing patent portfolio.
In the earnings release CEO Maria Fardis stated, "We continue making great progress in developing tumor infiltrating lymphocyte (TIL) therapy, which could become the first approved cell therapy product for solid tumor indications...Our pivotal studies in metastatic melanoma and advanced cervical cancer are on track to complete enrollment in early 2020. We expect to submit for regulatory approval for TIL therapies lifileucel and LN-145 in late 2020...We are very pleased to have a new IND active in order to investigate the polyclonal blood-based T cell, or PBL therapy (IOV-2001), in chronic lymphocytic leukemia (CLL). This candidate was developed based on Iovance research efforts focused on the generation of novel cell therapy products. We anticipate the initiation of IOV-CLL-01, an Iovance-sponsored trial with IOV-2001 PBL product, before the end of 2019."
Iovance Biotherapeutics is a clinical-stage biopharmaceutical company based in San Carlos, Calif. The company states that it "intends to improve patient care by making T cell-based immunotherapies broadly accessible for the treatment of patients with solid tumors and blood cancers. Tumor infiltrating lymphocyte (TIL) therapy uses a patient's own immune cells to attack cancer." The company's TIL therapies are being investigated for the treatment of patients with locally advanced, recurrent or metastatic cancers including head and neck and non-small cell lung cancer. In addition, clinical studies of T cell therapy for peripheral blood lymphocyte (PBL) blood cancers therapy are being planned.
Iovance began the day with a market capitalization of approximately $2.6 billion with about 12.62 million shares outstanding, along with a 11.3% short interest. IOVA shares opened today at $22.27 (+$1.60, +7.74%) over yesterday's $20.67 closing price. The stock has traded today between $21.78 to $23.75 per share and currently is trading at $23.04 (+$2.38 +11.52%).[NLINSERT]
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