(Sergio Santos, nursingschoolsnearme.com, Flickr)
22 Jan. 2020. A company developing cancer therapies with stem cells from human placentas says FDA cleared its request to start a clinical trial of a treatment for brain cancer. Celularity Inc. in Warren, New Jersey says the Food and Drug Administration cleared its investigational new drug application, in effect giving permission to begin clinical trials of the company’s treatment for glioblastoma multiforme.
Glioblastoma multiforme, also known simply as glioblastoma, is an aggressive brain cancer that affects astrocyte or glial cells supporting neurons or nerve cells in the brain. The disease is often difficult to treat, where usually the best hope is to slow progression of the cancer with radiation or chemotherapy. Survival from initial tumors is typically 15 months and those with recurring glioblastoma usually survive for less than a year. Senator and U.S. presidential candidate John McCain died from glioblastoma in August 2018, after an initial diagnosis in July 2017.
Celularity develops treatments for cancer and other diseases with blood-forming stem cells derived from donated human placenta tissue. The company’s technology extracts natural killer cells, white blood cells in the immune system with cancer-killing capabilities, then frozen and preserved. Celularity says a single placenta can generate thousands of doses, with its placenta cell products produced quickly and used off-the-shelf with no adverse immune effects, rather than cells cultured from individual patients.
The biotechnology company’s lead product, code-named CYNK-001, is already being tested in early stage clinical trials for blood-related cancers, multiple myeloma and acute myeloid leukemia. At the annual meeting of Society for Neuro-Oncology in November 2019, the company reported preclinical results of tests that show a single treatment of CYNK-001 is active against glioblastoma and is well tolerated in lab animals.
An investigational new drug application or IND is technically a request to FDA to allow for transport of experimental drugs across state lines, and granting the application provides the requesting company an exemption from the law prohibiting those shipments. Thus, granting an IND is essentially an authorization to begin clinical trials of that experimental drug.
In this case, Celularity expects the trial to assess the safety, feasibility, and tolerability of multiple doses of CYNK-001 in people with relapsed glioblastoma. The tests, says the company, will include intravenous infusions of CYNK-001, as well as injections directly into glioblastoma tumors, the first in-human assessments of these injections with natural killer cells.
“This IND,” says Robert Hariri, chairman and CEO of Celularity in a company statement released through BusinessWire, “represents a significant step toward a potential immunotherapy option that is more accessible and tolerable to patients with glioblastoma multiforme.”
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