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
CD8α/β-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