Date: 2016-10-28
Type of information: Results
phase: 2
Announcement: results
Company: Opexa Therapeutics (USA - TX)
Product: Tcelna (imilecleucel-T)
Action
mechanism: cell therapy/immunotherapy product. Tcelna is the first ever personalized T-cell therapy for MS patients and has received Fast Track Designation from the FDA for the treatment of secondary progressive multiple sclerosis (SPMS). Tcelna is manufactured using ImmPath®, Opexa's proprietary method for the production of a patient-specific T-cell immunotherapy, which encompasses the collection of blood from the MS patient, isolation of peripheral blood mononuclear cells, generation of an autologous pool of myelin-reactive T-cells (MRTCs) raised against selected peptides from myelin basic protein (MBP), myelin oligodendrocyte glycoprotein (MOG) and proteolipid protein (PLP), and the return of these expanded, irradiated T-cells back to the patient. These attenuated T-cells are reintroduced into the patient via subcutaneous injection to trigger a therapeutic immune system response. In February 2013, Opexa entered into an option and license agreement for Tcelna with Merck Serono.
Disease: secondary progressive multiple sclerosis
Therapeutic area: Autoimmune diseases - Neurodegenerative diseases
Country: Canada, USA
Trial
details: The Abili-T trial is a Phase IIb study of Tcelna in patients with secondary progressive multiple sclerosis (SPMS) in 35 leading clinical sites in the U.S. and Canada. Each patient is receiving two annual courses of Tcelna treatment consisting of five subcutaneous injections per year. The trial’s primary efficacy outcome is the percentage of brain volume change (atrophy) at 24 months. Top line data is expected in mid-2016. Opexa has received Fast Track designation from the FDA for Tcelna in SPMS.(NCT01684761)
Latest
news: * On October 28, 2016, Opexa Therapeutics announced that the Phase 2b Abili-T clinical trial designed to evaluate the efficacy and safety of Tcelna® (imilecleucel-T) in patients with secondary progressive multiple sclerosis did not meet its primary endpoint of reduction in brain volume change (atrophy), nor did it meet the secondary endpoint of reduction of the rate of sustained disease progression. Tcelna® did show a favorable safety and tolerability profile. The trial involved 183 patients and was conducted at 35 clinical trial sites in the U.S. and Canada. Patients in the Tcelna arm of the study received two annual courses of Tcelna treatment consisting of five subcutaneous injections per year. * On March 2, 2016, Opexa Therapeutics announced that it was implementing a restructuring initiative to focus the use of its resources, which should extend the company's current cash runaway into the first quarter of 2017. The move comes as the company prepares to complete its Phase IIb clinical trial in secondary progressive multiple sclerosis and report top-line data, with the announcement of such data currently expected in early Q4 2016. As the Company's 190-patient Phase IIb Abili-T trial approaches completion, with the final dose for the last patient having been administered last week, the company is reducing its work force by approximately 30%. The reduction-in-force includes the Company's Chief Financial Officer, Karthik Radhakrishnan. The Company estimates that it will record in the first quarter of 2016 a one-time severance-related charge of approximately $325,000. * On May 13, 2014, Opexa Therapeutics reported it has reached the targeted enrollment in its Phase IIb clinical trial in secondary progressive multiple sclerosis (SPMS). As of today, 180 patients with SPMS have been randomized in the Phase IIb “Abili-T” clinical study of Tcelna. The company will also allow patients who are currently in the screening process at the time of full enrollment and who meet the trial’s entry criteria to also be enrolled in the trial. Even though the Company has reached the full 180-patient enrollment it sought for the Abili-T trial, the Company will continue to support those patients currently in the screening process. This likely means that the Abili-T trial will complete enrollment with a modest number of patients in excess of the 180 targeted as the Company believes it is important to support patients that had already started the enrollment process. * On December 16, 2013, Opexa Therapeutics announced the enrollment of the 126th patient in the Phase IIb “Abili-T” clinical study of Tcelna (imilecleucel-T) in patients with secondary progressive multiple sclerosis (SPMS). The company has reached the 70% enrollment target out of a total of 180 patients. Opexa intends to have the trial fully enrolled in early 2014. * On November 13, 2012, Opexa Therapeutics announced that Health Canada has approved its Clinical Trial Application (CTA). The application was filed with the Biologics and Genetic Therapies Directorate. With this approval by the Canadian Health Authority, Opexa expects to expand its ongoing clinical trial in secondary progressive multiple sclerosis patients to include several sites in Canada. The Abili-T trial is currently enrolling patients in the United States. To date, over a half of the clinical sites have been initiated and approximately ten percent of subjects have been enrolled. Enthusiasm and support remains strong among the patients and the treatment sites. The trial is expected to enroll 180 patients in approximately 30 sites in the U.S. and Canada and conclude in 2015. * On September 12, 2012, Opexa Therapeutics announced the initiation of a Phase IIb clinical trial of Tcelna in patients with secondary progressive multiple sclerosis (SPMS). Several patients have already been enrolled in the study and enrollment is expected to increase rapidly as additional sites begin screening and enrolling patients in the coming weeks. The newly initiated trial, named Abili-T, is a randomized, double-blind, placebo-controlled clinical study in SPMS patients who demonstrate evidence of disease progression without associated relapses. The trial is expected to enroll 180 patients at approximately 30 leading clinical sites in the U.S. and Canada with each patient receiving two annual courses of Tcelna treatment consisting of five subcutaneous injections per year. The study will assess a number of clinical endpoints to evaluate the efficacy and safety of Tcelna in patients with SPMS. The primary efficacy outcome of the trial is the percentage of brain volume change (atrophy) at 24 months. Study investigators will also measure several important secondary outcomes commonly associated with MS including disease progression as measured by the Expanded Disability Status Scale (EDSS), annualized relapse rate (ARR) and changes in disability as measured by EDSS and the Multiple Sclerosis Functional Composite (MSFC). In Phase I/II studies involving SPMS patients treated with Tcelna (n=36), 80 percent of the patients treated with Tcelna showed no evidence of disease progression at 24 months (a 50% improvement, with respect to patients showing evidence of disease progression, over historical controls). Following two years of treatment, a subset of these patients (n=10) reported no worsening of their physical or psychological condition. Additionally, in 21 years of cumulative follow up in the same SPMS patients treated with Tcelna, the annualized relapse rate for this same subset of patients was reduced significantly compared to baseline and only one patient experienced a relapse during this time. The initiation of this trial follows a number of key enhancements to the Tcelna clinical development program. First, Opexa has optimized its Chemistry, Manufacturing and Control (CMC) process for the therapy in order to improve efficiency, reduce overall costs and bring it further in line with commercial stage requirements. Following completion of these manufacturing and logistical enhancements, the Company submitted an updated CMC application which has been fully reviewed by the FDA. In addition, the Company has modified its clinical development strategy for Tcelna to focus current efforts on the SPMS patient population in order to address the severe lack of treatment options currently available or in development for these patients. Finally, to reflect its work in optimizing the overall manufacturing process and clinical development strategy for the program, Opexa's lead product candidate, formerly known as Tovaxin, has been rebranded as Tcelna.
