Incysus Therapeutics Initiates Enrollment In Phase 1 Study Of A Genetically Modified Gamma Delta (γδ) T Cell Immunotherapy In Patients With Newly-diagnosed Glioblastoma

First-in-Patients Trial of Incysus’ Drug Resistant Immunotherapy (DRI) Technology Is Being Conducted at The University of Alabama At Birmingham (UAB)

First-in-Patients Trial of Incysus’ Drug Resistant Immunotherapy (DRI) Technology Is Being Conducted at The University of Alabama At Birmingham (UAB)

NEW YORK, February 27, 2020 -- 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 Company has initiated a Phase 1 clinical study of a novel Drug Resistant Immunotherapy (DRI) technology for the treatment of patients with newly-diagnosed glioblastoma. This trial is being conducted at the University of Alabama at Birmingham (UAB) and is now active and open for enrollment.

Glioblastoma multiforme, (GBM or glioblastoma) is a devastating and fast-growing brain tumor that typically results in death within the first 15 months after diagnosis. GBM is inherently resistant to conventional therapy and accounts for ~52% of all primary brain tumors.

Incysus’ innovative DRI approach, seeks to combine conventional chemotherapies with a γδ T cell based immunotherapy to modify the tumor microenvironment and drive the immune system. By using alkylating agents such as temozolomide, chemotherapy can activate immunity through the upregulation of the DNA damage response (DDR) pathway. A significant challenge is that such chemotherapies also kill the white blood cells needed to drive an immune response. Incysus’ technology ‘chemo-protects’ immune cells to allow them to remain functional while DDR activation creates an immune signal that allows directed killing activity against cancer cells.

Lawrence Lamb, PhD, scientific co-founder, Chief Scientific Officer of Incysus and an inventor of the DRI technology commented, “By using genetically modified γδ T cells, our technology addresses challenges that immunotherapies face when targeting cold, low mutation cancers. I am excited to have taken our DRI platform from discovery and now into cancer patients as a novel approach for a devastating disease with few treatment options. We look forward to advancing our programs as we seek to address the un-met needs of oncology patients.”

γδ T cells are a type of lymphocyte or white blood cell that may help the immune system to recognize and kill cancer cells. Incysus’s DRI technology utilizes γδ T cells that have been modified to be resistant to, or not affected by chemotherapy. This Phase I trial will study Incysus’ DRI technology in patients with newly diagnosed GBM during the maintenance phase of standard temozolomide (TMZ) chemotherapy. Further information about this clinical trial (NCT04165941) is available from the National Institutes of Health and can be found here: http://bit.ly/2Xx5MN6

L. Burt Nabors, MD, the co-head of neuro-oncology at the University of Alabama at Birmingham (UAB) and the study’s principal investigator commented, “The initiation of this clinical trial represents a significant milestone towards developing effective immune based therapies for the treatment of GBM. We are pleased to work with Dr. Lamb and the team at Incysus to bring this innovative therapy to patients for the first time.”

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. The Company’s first clinical program is targeted for the treatment of newly diagnosed glioblastoma (GBM) and its second program is for leukemia and lymphoma patients. Information about the Company’s clinical trial in GBM (NCT04165941) can be found here: http://bit.ly/2Xx5MN6 and for leukemia and lymphoma (NCT03533816) can be found here: http://bit.ly/2pyYFHq. For more information about the Company and its programs, 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.
+1 646.600.6GDT
info@incysus.com
www.incysus.com

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