Opexa Therapeutics, Inc. today announced the execution of an agreement with Merck Serono, a division of Merck, Darmstadt, Germany, for the development and commercialization of Tcelna™ (imilecleucel-T), a potential first-in-class personalized T-cell therapy for patients suffering from multiple sclerosis (MS). Tcelna (imilecleucel-T) is being developed by Opexa and currently is in a Phase IIb clinical trial in patients with Secondary Progressive MS (SPMS). Potential payments to Opexa from the option and license agreement could total $225 million based upon the successful development and commercialization of Tcelna for MS.
Tcelna (imilecleucel-T) is being developed as a personalized therapy specifically tailored to each patient’s individual disease profile and has been evaluated in Phase I and II clinical studies in MS that included SPMS patients. Tcelna (imilecleucel-T) has received Fast Track Designation from the United States Food and Drug Administration as a potential treatment for SPMS.
Under the terms of the agreement, Opexa will receive an upfront payment of $5 million for granting an option to Merck Serono for the exclusive license of the Tcelna (imilecleucel-T) program for the treatment of MS. The option may be exercised prior to or upon completion of Opexa’s ongoing Phase IIb clinical trial in patients with SPMS. Upon exercising this licensing option, Merck Serono would pay an upfront license fee of either $25 million or $15 million (depending upon whether certain conditions are met), and in return receive worldwide development and commercial rights to Tcelna (imilecleucel-T) in MS, excluding Japan. After exercising the option Merck Serono would be wholly responsible for funding clinical development, subject to Opexa’s co-funding option, as well as regulatory and commercialization activities for the MS program. Additional financial considerations of the agreement include development and commercial milestone payments to Opexa of up to $195 million and a tiered royalty rate from the high single digits to the mid-teens based on net sales payable to Opexa. The potential payments to Opexa could, therefore, total $225 million excluding royalty payments.
Under the agreement, Opexa will have an option right to co-fund development, under which the Company would participate in economic support for future clinical development of the program in exchange for additional royalty consideration. In addition to retaining all rights outside of MS as well as retaining the ability to commercialize Tcelna (imilecleucel-T) in Japan, Opexa also retains certain manufacturing rights related to the program. Further details of the transaction are included in a Form 8-K that was filed this morning by Opexa with the United States Securities and Exchange Commission.
“Merck Serono is strongly committed to developing innovative drug candidates like Tcelna (imilecleucel-T), a potential first-in-class personalized cell therapy for patients with multiple sclerosis,” said Susan Herbert, Head of Global Business Development and Strategy at Merck Serono. “This agreement illustrates Merck Serono’s commitment to employ creative ways of accessing external innovation to develop potential next generation multiple sclerosis treatments, especially in secondary progressive multiple sclerosis, an area of high unmet need.”
Neil K. Warma, President and Chief Executive Officer of Opexa, commented, “Opexa is pleased to partner with Merck Serono and given Merck Serono’s long-term strategic commitment to, and existing franchise position in the field of multiple sclerosis, we could not ask for a more experienced partner to carry Tcelna (imilecleucel-T) through development and hopefully to the market and to patients. We also are pleased to retain important rights through this transaction, such as certain manufacturing rights, commercialization rights to the Japanese market and a co-funding of development option, as well as rights for all indications outside of MS, all of which are intended to enhance Opexa shareholder value.”
About Tcelna (imilecleucel-T)
Tcelna (imilecleucel-T) is a potential personalized therapy that is under development to be specifically tailored to each patient's disease profile. Tcelna (imilecleucel-T) 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.
Opexa is currently conducting a Phase IIb study of Tcelna (imilecleucel-T). Named Abili-T, the trial is a randomized, double-blind, placebo-controlled clinical study in 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 (imilecleucel-T) 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. 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 and changes in disability as measured by EDSS and the MS Functional Composite.
Source: .Opexa Therapeutics, Inc. (05/02/13)
Opexa Therapeutics, Inc. a company developing Tcelna™, a novel T-cell therapy for multiple sclerosis (MS), today 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. Tcelna is the first ever personalized T-cell therapy for MS patients and has received Fast Track Designation from the United States Food and Drug Administration (FDA) for the treatment of SPMS. The therapy is specifically tailored to each patient’s individual disease profile and has demonstrated superior safety and encouraging indications of efficacy in previous clinical studies in MS that included the treatment of SPMS patients. There is currently only one FDA-approved treatment for SPMS but safety warnings have severely restricted its use.
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 multiple previously conducted clinical trials for the treatment of patients with MS, Tcelna has demonstrated one of the safest side effect profiles of any marketed or development-stage MS therapy, as well as encouraging efficacy signals indicating Opexa’s therapy may have the potential to be both safe and effective for the treatment of both SPMS and RRMS patients. 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.
“To witness the initiation of this clinical study following the extensive preparations that were required is a tremendous testament to the dedication and talent of the entire Opexa team. We believe this is a critical milestone for not just our Company, but for all of those SPMS patients who desperately need and deserve a better, safer and more effective treatment option,” said Neil K. Warma, President and Chief Executive Officer of Opexa. “We return to the clinic with an enhanced manufacturing process, an optimized clinical development strategy, Fast Track designation from the FDA and the belief that Tcelna is the most promising MS treatment in development today.”
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.
“It is very gratifying to see Opexa’s novel T-cell therapy return to the clinic and I am excited to be part of the ongoing investigation of a potential MS treatment that possesses such an impressive early safety profile. This is an exceedingly important study for the entire MS community as it will go a long way toward demonstrating how effective the therapy may be for the most in need and underserved progressive MS patient population,” stated Mark Freedman, M.D., director of the Multiple Sclerosis Research Unit at the Ottawa Hospital, member of Opexa's Scientific Advisory Board, and an investigator for the Abili-T trial. “While a positive trial outcome will certainly be good news for SPMS patients, it is also not difficult to envision that it could position Tcelna as a promising treatment for the larger RRMS patient population as well.”
“The initiation of this clinical trial is a very important milestone in the area of MS research, particularly in light of the significant need for new and effective treatments for these patients,” commented Hans-Peter Hartung, M.D., chairman of the department of neurology at Heinrich-Heine University, Dusseldorf and member of Opexa's Scientific Advisory Board. “As a personalized immunotherapy, Tcelna’s unique mechanism strongly differentiates it from other development stage MS treatments. This combined with a safety profile that is unmatched by other MS therapies currently available or in development positions Tcelna as a potentially very interesting therapy for a large, underserved patient population. Currently, there is no satisfactory treatment available for SPMS patients.”
While its current clinical trial targets SPMS patients, Opexa also intends to continue the development of Tcelna as a treatment for RRMS patients. Opexa has successfully completed End of Phase II meetings with the FDA and believes it is positioned to initiate Phase III pivotal trials in RRMS patients. Importantly, the results of the ongoing Abili-T trial should further enhance the Company’s future efforts in the RRMS indication. The primary focus at present, however, is the ongoing Phase IIb SPMS Abili-T trial and on securing the necessary capital required for the completion of that trial.
Source; Herald Online Copywrite Rock Hill Herald Online 2012 (13/09/12)
Opexa Therapeutics, a biotechnology company developing a novel T-cell therapy for multiple sclerosis (MS), announced today that the Company is rebranding its leading MS therapy with the new name Tcelna(TM). The product, previously known as Tovaxin(R), will now be known as Tcelna as the company positions itself towards the treatment of patients with Secondary Progressive MS (SPMS).
"Opexa has worked diligently in the optimization of its overall manufacturing process and clinical development program while concentrating its efforts in the SPMS indication. The rebranding of our lead product as Tcelna encompasses these advancements and our continued dedication to make a difference in the treatment of MS," commented Neil K. Warma, President and Chief Executive Officer of Opexa.
The name Tcelna (pronounced Te-SELL-nuh) reflects the T-cell derivation of the product. Opexa has requested a registered trademark for the new brand name.
Source: Market Watch Copyright © 2012 MarketWatch, Inc (21/05/12)