Allogene Therapeutics have been given green light to start a Phase 1 trial for their investigational cell therapy ALLO-501 targeting non-Hodgkin’s lymphoma patients who failed prior therapies. The treatment is part of a new wave of CAR T-cell immunotherapies designed to empower the patient’s own immune system to fight cancer.
Following the FDA decision, David Chang, M.D., Ph.D., President of Allogene stated that “I am very pleased with the Allogene team’s ability to accelerate the ALLO-501 program by securing the FDA’s clearance of our IND. This significant milestone for the company, as well as the planned initiation of the ALPHA trial, brings us one step closer to making CAR T therapy ‘on demand’ and more broadly accessible to patients when they are at a critical stage in their disease”.
One of the drawbacks with CAR T treatment is the time required to harvest a patient’s cells and then genetically modify them, before infusing back in the host. For advanced cases, where the health of the patient declines much rapidly, this approach often becomes unfeasible.
To counteract this issue, Allogen began producing CAR T-cells from healthy donors and is developing several off-the-shelf products for cancer patients. These are also engineered to prevent adverse immune reactions that normally occur with donor-derived transplants, most notably graft-versus-host disease.
“We are delighted that this program will soon be moving into the clinic. The upcoming clinical study will enable the teams to investigate the potential benefits of allogeneic CAR T therapy in patients with non-Hodgkin lymphoma, one of the largest hematological indications”, noted Patrick Therasse, M.D., Ph.D., head of Oncology at Servier, a development partner company.
An upcoming clinical trial has already gathered 24 participants with the most common non-Hodgkin’s lymphoma subtypes, including diffuse large B-cell lymphoma and follicular lymphoma. It is scheduled to start in the first half of 2019.
According to estimates from the American Cancer Society, more than 74,000 people are diagnosed with non-Hodgkin’s lymphoma. ALLO-501 could represent an important step forward in improving prognosis and patient care.
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