Cellenkos, Inc. Announces FDA Clearance of Investigational New Drug Application for CK0801 for Treatment-Resistant Guillain-Barré Syndrome

Phase I trial of single agent CK0801 for patients with Guillain-Barré Syndrome who have relapsed after intravenous immunoglobulin (IVIG) and/or plasmapheresis (PE) therapy to commerce

News provided by

Cellenkos, Inc.

Oct 16, 2018, 06:17 ET

HOUSTON, Oct. 16, 2018 /PRNewswire/ -- Cellenkos, Inc., a clinical-stage biotechnology company, announced that the United States Food and Drug Administration has cleared its Investigational New Drug (IND) application to proceed with a phase I clinical trial of CK0801, allogeneic cord blood-derived regulatory T cells, in patients with treatment-resistant Guillain-Barré Syndrome (GBS). Cellenkos submitted its IND application on September 11, 2018 and received approval on October 11, 2018.

The Phase I clinical trial of CK0801 will be led by Kazim Sheikh, MD, Professor and Director of the Neuromuscular Program at the University of Texas Health Sciences Center at Houston (UTHealth), Houston, Texas.

"The timely clearance of this IND and commencement of the Phase I trial will unlock the tremendous potential of cellular therapy application for neuro-inflammatory disorders. This is yet another significant milestone for Cellenkos, and marks an important step forward in finding effective treatments for autoimmune diseases", said Founder and Chief Medical Officer, Simrit Parmar, MD. "For a rare and debilitating disease with no known cure, this is an exciting opportunity to bring a novel cellular therapy, CK0801, that works to replace and replenish the defective regulatory T cells and protects the neurological system from the constant attack as a result of uncontrolled inflammatory signals. Such an interruption of the neural insult loop can allow for reinstating the immune balance and support neuron regeneration leading to clinical improvement".

Tara Sadeghi, Senior Clinical Director at Cellenkos, added, "The US FDA's clearance of this IND continues to validate our commitment and progress towards creating an 'off-the-shelf' cord blood-derived regulatory T cell therapeutic platform and reinforces our strive to bring forth 'on-demand', affordable, point-of-care delivery cellular therapies that can have a tremendous impact on patient care by providing novel, non-pharmacologic options". Cellenkos also holds an approved FDA IND to proceed with a phase I study of CK0801 in bone marrow failure syndromes (www.cellenkosinc.com).

About Guillain-Barré Syndrome
Guillain-Barré Syndrome is a rare disorder that destroys the protective covering of the peripheral nerves (myelin sheath), preventing the nerves from transmitting signals to the brain. The exact cause of Guillain-Barré Syndrome is unknown. But it is often preceded by an infectious illness such as a respiratory infection or the stomach flu. The first symptoms of this disorder include varying degrees of weakness or tingling sensations in the legs. In many instances the symmetrical weakness and abnormal sensations spread to the arms and upper body. These symptoms can increase in intensity until certain muscles cannot be used at all and, when severe, the person is almost totally paralyzed. Guillain-Barré Syndrome can affect anybody. It can strike at any age and both sexes are equally prone to the disorder. There are no known cures for Guillain-Barré Syndrome.

About CK0801
CK0801, is a first-in-class, allogeneic, cord blood-derived T-regulatory cellular product, developed using Cellenkos' proprietary manufacturing platform, that can be infused at the point of care. Adoptive therapy with CK0801 will allow for the infused healthy regulatory T cells to preferentially traffic to the area of inflammation; engage with the key regulators of immune dysfunction and secrete suppressor cytokines to inhibit proliferating auto-reactive effector T cells and restore immune homeostasis. CK0801 will be manufactured in the Cellenkos FDA registered GMP facility located in Houston, Texas.

About Cellenkos, Inc.
Cellenkos is an early stage biotechnology company that focuses on cord blood-derived T regulatory cellular therapies for the treatment of autoimmune diseases and inflammatory disorders. Cellenkos is founded on the technologies arising from the laboratory investigations of Simrit Parmar, MD, Associate Professor, who holds joint appointments in the Departments of Lymphoma and Myeloma and Experimental Therapeutics at The University of Texas MD Anderson Cancer Center, Houston, TX.

For more information, please visit www.cellenkosinc.com.

CONTACT:
Erin Horne
832-962-7628
[email protected]

SOURCE Cellenkos, Inc.