NEW YORK, April 01, 2019 (GLOBE NEWSWIRE) -- Incysus Therapeutics, Inc. (“Incysus”), a biopharmaceutical company focused on delivering an innovative gamma-delta (γδ) T cell immunotherapy for the treatment of cancers, today announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for the clinical study of a genetically modified γδ T cell in combination with chemotherapy for the treatment of patients with newly-diagnosed glioblastoma (GBM). This approval will allow Incysus to initiate a first-in-human Phase 1 clinical trial of gene-modified γδ T cells for cancer immunotherapy.
“This IND enables the initiation of a clinical development program utilizing our novel Drug Resistant Immunotherapy (DRI) platform to target solid tumor cancers,” said William Ho, President and Chief Executive Officer of Incysus. “This represents a significant milestone for Incysus as we continue to work toward improving patient outcomes. We are pleased to have received FDA approval to conduct this clinical trial and look forward to the initiation of this Phase 1 study.”
Incysus’ DRI technology is the first genetically modified γδ T cell product candidate that the FDA has cleared for a clinical trial. The Company and its collaborator, The University of Alabama at Birmingham (UAB), plan to initiate a Phase 1 clinical trial during 2019. This study will evaluate the safety and activity of the DRI platform, combining standard-of-care chemotherapy with genetically engineered γδ T cells that are resistant to the effects of chemotherapy.
“The initiation of this study at UAB’s O’Neal Comprehensive Cancer Center is a critical step to advance our unique approach and DRI platform,” said Lawrence S. Lamb, Ph.D., co-founder and Chief Scientific Officer of Incysus. “Incysus seeks to change the landscape of cancer therapy and is well positioned to bring patients an innovative approach to cancer treatment.”
Incysus’ DRI technology allows the simultaneous combination of standard-of-care chemotherapy with activated γδ T cells that are genetically-engineered to resist chemotherapy-induced cell death, allowing these T cells to attack the tumor at the time that it is most vulnerable. This combination allows the chemotherapy to maximally shrink chemo-sensitive tumor cells while disrupting the immune-suppressive tumor microenvironment (TME). Additionally, by preserving immune cell function during a chemotherapy challenge, DRI can drive synergies by upregulating immune activating markers on the tumor surface to significantly increase tumor immunogenicity.
“The UAB Neuro-oncology Program is excited to see the novel laboratory research led by Dr. Lamb move forward into an innovative first-in-human clinical trial,” said L. Burt Nabors, M.D., Director of the Division of Neuro-oncology and the Medical Director for the Clinical Research Unit at UAB’s Center for Clinical and Translational Science, and principal investigator of the trial. “Deploying the immune system as an anti-glioma therapeutic strategy is exciting and offers new hope for patients with glioblastoma and their families.”
Glioblastoma multiforme, (GBM or glioblastoma) is a devastating and fast-growing tumor that develops from star-shaped glial cells (astrocytes and oligodendrocytes) in the brain, typically resulting in death within the first 15 months after diagnosis. GBM is inherently resistant to conventional therapy and account for 52 percent of all primary brain tumors.
About Incysus Therapeutics, Inc.
Incysus is focused on delivering a novel off-the-shelf cell therapy for the treatment of cancer. By using genetically modified gamma-delta (γδ) T cells, the Company’s technology addresses the challenges that immunotherapies face targeting cold, low mutation cancers. Incysus’ immuno-oncology programs include activated and gene-modified adoptive cellular therapies that protect cells from chemotherapy and allow novel combinations to disrupt the tumor microenvironment and more selectively target cancer cells. Since the Company’s inception in early 2016, Incysus has received approval of two Investigational New Drug applications (IND) and has initiated several cancer programs in early pre-clinical stages, including a checkpoint combination program. The Company’s first program is targeted to leukemia and lymphoma patients and its second program is targeted to the treatment of patients with newly-diagnosed glioblastoma (GBM). In collaboration with our academic partners, including the University of Alabama at Birmingham (UAB), Incysus has advanced its technology and expects to begin both Phase 1 trials during 2019. For more information, visit www.incysus.com.
Forward Looking Statements.
Certain statements herein concerning the Company’s future expectations, plans and prospects, including without limitation, the Company’s current expectations regarding its business strategy, product candidates, and clinical development process and timing, constitute forward-looking statements. The use of words such as “may,” “might,” “will,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” the negative of these and other similar expressions are intended to identify such forward looking statements. Such statements, based as they are on the current expectations of management, inherently involve numerous risks and uncertainties, known and unknown, many of which are beyond the Company’s control. Consequently, actual future results may differ materially from the anticipated results expressed in such statements. In the case of forward-looking statements regarding investigational product candidates and continuing further development efforts, specific risks which could cause actual results to differ materially from the Company’s current expectations include: scientific, regulatory and technical developments; failure to demonstrate safety, tolerability and efficacy; final and quality controlled verification of data and the related analyses; expense and uncertainty of obtaining regulatory approval, including from the U.S. Food and Drug Administration; and the Company’s reliance on third parties, including licensors and clinical research organizations. Do not place undue reliance on any forward-looking statements included herein, which speak only as of the date hereof and which the Company is under no obligation to update or revise as a result of any event, circumstances or otherwise, unless required by applicable law.
Contact:
Incysus Therapeutics, Inc.
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