Manufacturing UpdateIovance announced today that it has selected its Gen 2 manufacturing process for all three Phase 2 trials and for all future TIL clinical development. The protocols for the company's three existing studies have all been amended to allow for enrollment of new patients with TIL manufactured with the Gen 2 process. Cohort 1 of the C-144-01 melanoma study will be closed and new patients will be enrolled in cohort 2. The Gen 2 manufacturing process takes 22 days and the final cell product is cryopreserved for ease of scheduling and handling. The decision to use the Gen 2 manufacturing process was based on data recently presented at the SITC 2017 Annual Meeting in November, the approximately 35 percent reduction in cost of manufacturing as well as the benefits to patients which include minimizing the time a patient has to wait to receive their TIL and flexibility of scheduling the dosing. Iovance has filed multiple provisional patent applications specific to this process, which if granted, could provide exclusive rights through 2038. Highlights from Three Lead Clinical Programs Phase 2 trials are ongoing with adoptive cell transfer (ACT) therapies that utilize an autologous TIL manufacturing process in metastatic melanoma, recurrent, metastatic, or persistent cervical cancer and recurrent and/or metastatic squamous cell carcinoma of the head and neck. C-144-01 is a Phase 2 multicenter study evaluating the safety and efficacy of LN-144, Iovance's lead product candidate for treatment of patients with metastatic melanoma. The study is currently enrolling. To date, Iovance has 11 active clinical sites in the United States and intends to start enrolling patients at clinical sites in Europe in early 2018. In November 2017, the company reported results from cohort 2 of the C-144-01 study at the SITC Annual Meeting. The data being presented today show an objective response rate of 40 percent, with four of ten patients showing a partial response. The most common side effects were pyrexia, anemia and decreased neutrophil count. These patients had a high tumor burden despite a median of 3.6 prior therapies including anti-CTLA and PD-1 treatment.
C-145-03 is a Phase 2, multicenter study that will enroll up to 47 patients and will assess the safety and efficacy of LN-145 for the treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. The trial has met the efficacy threshold for the first stage of the Simon's two stage design and will therefore continue to enroll patients to the full sample size of 47 per protocol. Iovance has amended the protocol so that newly enrolled patients can be treated using TIL produced from the Gen 2 manufacturing process. Iovance anticipates reporting early data from this study in 2018.C-145-04 is a Phase 2, multicenter, study that will enroll up to 47 patients and will assess the safety and efficacy of LN-145 for the treatment of patients with recurrent, metastatic, or persistent cervical carcinoma. The study is enrolling patients in the Unites States and is expected to start enrollment of patients in Europe in the first half of 2018. Iovance has amended the protocol so that newly enrolled patients can be treated using TIL produced from the Gen 2 manufacturing process. TIL Pipeline Expansion into Lung Cancer The company announced today that patient enrollment has begun in a study in collaboration with researchers at H. Lee Moffitt Cancer Center and Research Institute (Moffitt), Stand Up to Cancer, and other collaborators. Patients with advanced non-small cell lung cancer (NSCLC) will be enrolled in a study combining TIL and nivolumab in patients who have progressed on nivolumab. The company also announced that a Phase 2 study in PD-1 and PD-L1 naïve NSCLC patients, sponsored by Iovance, in collaboration with MedImmune, the global biologics research and development arm of AstraZeneca, will initiate in the first half of 2018. The study with MedImmune will allow for enrollment with LN-145 alone or in combination with durvalumab.
MD Anderson Collaboration UpdateIovance provided an update on its collaboration with the MD Anderson Cancer Center (MDA). Under the collaboration, MDA will initiate two basket studies in sarcoma and platinum resistant ovarian cancer. One study will utilize TIL manufactured by Iovance and for the second study, TIL will be manufactured by MDA. Under the agreement with MDA, Iovance also retains the rights to MDA preclinical research in expanding the understanding of TIL and certain intellectual property related to the MDA TIL manufacturing process. Today's Guest Speakers Key Opinion Leaders will discuss current treatment options and the role of TIL in melanoma, head and neck, lung and cervical cancers. Invited guest speakers include:
- Sylvia Lee, MD, University of Washington, Fred Hutch Cancer Research Center
- Jason Chesney, MD, PhD, University of Louisville, Brown Cancer Center
- Emese Zsiros, MD, PhD, Roswell Park Cancer Institute