ST. PAUL, Minn., Oct. 7, 2024 /PRNewswire/ -- ScaleReady™, in collaboration with Wilson Wolf Manufacturing, Bio-Techne Corporation (NASDAQ: TECH) and CellReady™, today announced that Christopher A. Klebanoff, MD, a physician-scientist at Memorial Sloan Kettering Cancer Center (MSK) has been awarded a G-Rex® Grant. Dr. Klebanoff's $300,000 G-Rex® Grant will provide enabling reagents to facilitate process development, IND-enabling studies, and support clinical manufacturing of a novel CD8a/ß-armored TCR-T cell therapy targeting an HLA-A*11:01-restricted RAS (G12D) public neoantigen in a Phase 1 clinical trial.
"Dr. Klebanoff is a leader in the field with over 20 years of experience, and we are fortunate to be able to support his novel approach to cancer treatment. We are confident that this G-Rex Grant will significantly accelerate the path to clinical results and simultaneously set the stage for highly efficient closed system scale out. We are also hopeful that patients will receive significant benefit from treatment with armored TCR-T drug products," said John Wilson, CEO of Wilson Wolf and co-inventor of G-Rex.
"Our armored TCR-T therapy is designed to recognize antigen targets that are specific to every cancer cell. We are diligently working to bring this public neoantigen cellular immunotherapy into the clinic to assess its safety and potential efficacy against common solid cancers with significant unmet medical need. The G-Rex Grant will expedite development and accelerate our entrance into human clinical trials," said Dr. Klebanoff, who serves as an Attending Physician, Laboratory Head, Human Oncology & Pathogenesis Program, and Member Investigator, Center for Cell Engineering at MSK. Dr. Klebanoff is also a Scientific Co-Founder of Affini-T Therapeutics, and a member of the Parker Institute for Cancer Immunotherapy (PICI).
As part of the G-Rex Grant, Dr. Klebanoff and Dr. Chandran at MSK plan to complete their pre-clinical process development which will include the incorporation of Wilson Wolf's fully closed-system G-Rex bioreactors and the GatheRex for semi-automated volume reduction, cell concentration, and harvest. Additionally, Dr. Klebanoff expects to perform a technology transfer to MSK's cGMP facility, which will perform engineering runs in support of an Investigational New Drug (IND) application to be filed with the FDA with the hope of initiating a Phase 1 clinical trial.
"Our goal is to thoughtfully develop and expeditiously transfer a robust manufacturing framework that will reliably and reproducibly enable the generation of infusion products for cancer patients by our cGMP facility. Our hope is that this public-neoantigen specific TCR-T therapy will benefit a patient population that currently does not have many treatment options available. We also recognize this as an invaluable opportunity to holistically learn from this bench-to-bedside experience as we continue to discover and innovate in the lab.", said Smita S. Chandran, PhD, a Scientific Research Lead in the Klebanoff Lab at MSK, who led the discovery and development of the HLA-A*11/RAS(G12D) TCR-T therapeutic.
The G-Rex Grant will also support clinical manufacturing runs of their autologous TCR-T cell therapy. Expedited patient enrollment is expected to occur because of MSK's unique IMPACT Program, that prescreens (via next generation sequencing) all incoming patients for commonly mutated genes.
MSK will also get early access to a new line of closed system GMP reagents from Bio-Techne that are tailor-made for use with fully-closed system G-Rex bioreactors. The G-Rex ProPak™ CAR-TCR Cytokine Kits, estimated to be commercially available later this year, are weldable bags of liquid cytokines and are designed to streamline reagent preparation and administration in a GMP manufacturing setting without the use of a biosafety cabinet (BSC).
ScaleReady's G-Rex Grant Program is a $20M initiative to advance the state of cell and gene-modified cell therapy (CGT) development and manufacturing by awarding individual Grant Awards worth up to $300,000. G-Rex Grant Recipients also gain access to exclusive support from ScaleReady's growing consortium of G-Rex Grant Partners who bring best-in-class tools and technologies as well as unparalleled knowledge and expertise in the areas of cGMP manufacturing, quality and regulatory affairs, CGT business operations, and more.
About ScaleReady
ScaleReady provides the field of cell and gene-modified cell therapy (CGT) with a G-Rex centric manufacturing platform that enables the world's most practical, flexible, scalable, and affordable CGT drug product development and manufacturing.
The G-Rex manufacturing platform is currently used by a rapidly growing list of over 800 organizations and is producing drug products for approximately 50% of CGT clinical trials as well as 5 commercially approved CGT drugs.
CGT entities relying on the breadth and scope of ScaleReady's expertise can expect to save years of time and millions of dollars on the path to CGT commercialization.
For more information about the ScaleReady G-Rex® Grant Program, please contact info@scaleready.com.
About Wilson Wolf Manufacturing
Wilson Wolf (www.wilsonwolf.com) is dedicated to simplifying cell and gene-modified cell (CGT) therapy research, process development, and manufacturing. This is being accomplished through its scalable G-Rex® technology, which is used throughout the world in CGT applications ranging from basic research to commercial drug production.
Wilson Wolf's mission is to create hope for cancer patients, one G-Rex device at a time.
About Bio-Techne Corporation
Bio-Techne Corporation (NASDAQ: TECH) is a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities. Bio-Techne, in partnership with Wilson Wolf, is creating products such as media and cytokines that are specifically tailored to G-Rex Bioreactors, including right-sized reagent quantities in containers that are tailored to high throughput closed-system manufacturing. For more information on Bio-Techne and its brands, please visit https://www.bio-techne.com or follow the Company on social media at: Facebook, LinkedIn, Twitter or YouTube.
Contact: David Clair, Vice President, Investor Relations & Corporate Development
david.clair@bio-techne.com
612-656-4416
About CellReady LLC
CellReady is the world's first and only G-Rex centric contract development and manufacturing organization (CDMO) specializing in G-Rex based cell and gene-modified cell therapy development and manufacturing. The company offers a wide range of services to support the development and commercialization of these therapies.
CellReady's mission is to create hope for cancer patients, one G-Rex process at a time.
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SOURCE Bio-Techne Corporation
