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Cellevolve Bio Submits Investigational New Drug (IND) Application for Global Phase 2, Placebo-controlled Study of CE-VST01-JC for the Treatment of Progressive Multifocal Leukoencephalopathy (PML)

  • CE-VST-01-JC is a novel, allogeneic, off-the-shelf, T cell therapy that targets the JC Virus, the virus that causes progressive multifocal leukoencephalopathy (PML)
  • ASCEND-JC is a randomized, double-blind, placebo-controlled, phase 2 study with sites planned across US, Europe, and Canada
  • Licensed and developed in collaboration with QIMR Berghofer Medical Research Institute’s Professor Rajiv Khanna; NIH’s Irene Cortese, M.D. will be the Lead Primary Investigator for the study

Excerpt from the Press Release:

SAN FRANCISCO, Sept. 20, 2022 /PRNewswire/ — Cellevolve Bio, Inc. (“the Company” or “Cellevolve”), a development and commercialization platform company focused on cell therapies, today announced the submission of an investigational new drug (IND) application to the US Food and Drug Administration (FDA) for CE-VST01-JC, it’s most advanced clinical stage program. This experimental therapeutic is a JC Virus Specific T Cell Therapy (JC-VST) that has been engineered to specifically target the JC polyoma virus (JCV) and it’s immunogenic antigens. The IND supports a proposed indication for the treatment of progressive multifocal leukoencephalopathy (PML) secondary to JCV.

ASCEND-JC is a global, randomized, double-blind, placebo-controlled, phase 2 study that will enroll up to 60 patients with PML. This study will evaluate the ability of CE-VST01-JC to slow or halt the progression of PML as measured by modified Rankin Score (mRS). The first patient to enroll is anticipated in the first half of 2023.

“This significant regulatory milestone is a very important step in our journey to bring an effective treatment to PML patients and their families, who are in dire need of new treatment options.

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