On August 16, 2018 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported updates from its clinical collaborations with The University of Texas MD Anderson Cancer Center (MD Anderson) and Moffitt Cancer Center (Moffitt) (Press release, Iovance Biotherapeutics, AUG 16, 2018, View Source;p=RssLanding&cat=news&id=2363888 [SID1234528960]). Under the MD Anderson collaboration, the company announced that the first patient was dosed with LN-145 in the Phase 2, multi-arm clinical trial (NCT03449108). The company also announced that preliminary data from an investigator-sponsored Non-Small Cell Lung Cancer (NSCLC) study with Moffitt will be presented at the upcoming IASLC 19th World Conference on Lung Cancer (WCLC) on September 24, 2018 in Toronto, Canada.
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"The start of patient dosing in the study at MD Anderson allows for exploration of TIL as a platform for treatment of multiple new solid tumors. Furthermore, this targeted patient population is left with very few treatment options and therefore is an unmet medical need. We are extremely pleased to be collaborating with MD Anderson as we investigate the potential of LN-145 to treat these patients with sarcomas and ovarian cancer," said Dr. Maria Fardis, PhD, MBA, president and chief executive officer of Iovance Biotherapeutics. "We are also pleased that the preliminary data from the investigator-sponsored study at Moffitt has been accepted for presentation at the upcoming World Lung Conference in September. We look forward to further exploring the possibility of TIL as a potential treatment option for patients with lung cancer."
The first MD Anderson study will enroll up to 54 patients. The endpoints for the trial are safety and efficacy of Iovance-manufactured LN-145 for the treatment of patients with soft tissue sarcoma, osteosarcoma and platinum-resistant ovarian cancer. The trial utilizes Iovance’s Gen 2 manufacturing process. A second clinical study is also in start-up under the collaboration using TIL manufactured by MD Anderson and using urelumab as a co-stimulatory agent during the manufacturing process. Additional information on this study is available at www.clinicaltrials.gov using the identifier number NCT03610490.
The ongoing investigator-sponsored study in NSCLC is currently underway in collaboration with Moffitt, Stand Up To Cancer, and other collaborators and is designed to allow dosing of the combination of TIL manufactured by Moffitt and nivolumab in NSCLC patients. An abstract titled, Safety and Clinical Activity of Adoptive Cell Transfer Using Tumor Infiltrating Lymphocytes (TIL) Combined with Nivolumab in NSCLC, has been accepted for presentation at the upcoming WCLC. The full details of the presentation are expected to be released in September. Additional information on this study is available at www.clinicaltrials.gov using the identifier number NCT03215810.