Opexa Therapeutics, Inc. a biopharmaceutical company headquartered in Woodlands, Texas, has announced the successful conclusion of negotiations amending its option and license agreement with Darmstadt, Germany based pharma multinational Merck’s “Merck Serono” division. Under terms of the revised agreement, Opexa will receive a $3 million payment to support an ongoing Phase 2b clinical study of Opexa’s personalized immunotherapy drug candidate Tcelna (imilecleucel-T), which the company has under development for treating patients with Secondary Progressive MS (SPMS), as well as preparation and planning for potential Phase 3 clinical studies.
Opexa’s focus on personalized immunotherapy is hoped to yield treatments for major illnesses, including multiple sclerosis (MS)and other autoimmune diseases such as neuromyelitis optica (NMO). These developmental therapies are based on Opexa’s proprietary T-cell technology. The company’s leading therapy candidate, Tcelna, is a personalized T-cell immunotherapy currently in a Phase IIb clinical development (the Abili-T trial) for the treatment of secondary progressive MS. Tcelna is derived from T-cells isolated from the patient’s own peripheral blood, expanded ex vivo, and reintroduced into the patients via subcutaneous injections — a process that triggers potent immune response against specific subsets of autoreactive T-cells known to attack the myelin sheathing that insulates and protects nerves.
“Tremendous progress has been achieved in the treatment of multiple sclerosis over the past two decades but there remains a high unmet medical need for certain areas of the disease,” says Merck Executive Board Member CEO Healthcare Belén Garijo in an Opexa release. “Building on our strong heritage in multiple sclerosis, we will continue to focus our innovation efforts on areas where we can make a difference, such as secondary progressive multiple sclerosis where there are currently very limited therapeutic options. The additional support to Opexa to further develop Tcelna is another sign of our long-standing and continuing commitment to improving the lives of people living with multiple sclerosis.”
Tcelna (formerly known as Tovaxin) is a personalized T-cell immunotherapy for treatment of Secondary Progressive Multiple Sclerosis — specifically tailored to each patient’s immune response profile to myelin and designed to reduce the number and/or functional activity of specific subsets of myelin-reactive T-cells (MRTC) known to attack myelin.
Tcelna is manufactured using “ImmPath,” Opexa’s proprietary method for producing patient-specific T-cell immunotherapy, is described as encompassing 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 return of these expanded, irradiated T-cells back to the patient. These attenuated T-cells are then reintroduced into the patient via subcutaneous injection to trigger a therapeutic immune system response.
Tcelna is specifically tailored to each patient’s immune response profile to myelin and is designed to reduce the number and/or functional activity of specific subsets of myelin-reactive T-cells (MRTC) known to attack myelin. 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.
Tcelna has been granted Fast Track status by the U.S. Food and Drug Administration (FDA) for treating Secondary Progressive MS (SP-MS) based on the unmet need of the progressive indication and potential of Tcelna to benefit this patient population. Opexa notes that while patients with Secondary Progressive MS (SP-MS) represent approximately 50 percent of the total MS population, treatment options for SP-MS remain very limited. Currently, only one product is specifically approved for patients with SP-MS, and it carries a black box warning due to severe cardiotoxicity.
Opexa has also completed formal End of Phase II meetings with the FDA and has received support to move forward with the design of pivotal Phase III clinical trials in Relapsing Remitting MS (RR-MS). Opexa is currently conducting a Phase IIb clinical trial in SP-MS patients and continues to evaluate its plans in the RR-MS indication.
Tcelna’s unique mechanism of action combats demyelination of the central nervous system nerve fibers — the underlying cause of MS. Five clinical trials have been completed with Tcelna in 356 patients, many with multiple years of treatment, and Opexa believes Tcelna may possess a number of advantages compared to other MS therapies currently available or in development, including:
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