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Orca Bio announced today that the FDA has awarded the company's cell therapy Orca-T Advanced Therapy for Regenerative Medicine (RMAT).
Orca-T is an allogeneic, high-precision cell therapy for blood cancer patients with hematopoietic stem cell transplantation.
addition, Orca-T has been awarded an FDA-granted orphan drug to enhance cell implantation for hematopoietic stem cell transplants.
Orca Bio just a week ago on the industry's leading media Endpoints launched the 2020 "Biopharmaceuticals Most Potential New" list.
RMAT aims to accelerate the development of new regenerative therapies, and RMAT-recognized cell therapies also benefit from fast-track qualification and breakthrough therapies.
include early FDA guidelines for guiding production and clinical development, such as determining intermediate endpoints that support accelerated approval.
for many patients with blood cancer, transplanting hematopoietic stem cells from donors is the only hope for a cure.
, however, traditional transplants are often associated with complications such as cancer recurrence and graft anti-host disease (GvHD).
GvHD is caused by immune cells from the donor attacking the patient's healthy cells, leading to organ failure and even death.
Orca-T is a precisely controlled formula for hematopoietic stem cells and T-cells designed to improve the prognosis of these patients.
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