ScaleReady announces the inaugural G-Rex® Grant has been awarded to Stanford Medicine Laboratory for Cell and Gene Medicine

Rhea-AI Summary

ScaleReady, in collaboration with Wilson Wolf Manufacturing, Bio-Techne (NASDAQ: TECH), and CellReady, has awarded the inaugural G-Rex® Grant of $300,000 to Dr. Steve Feldman of Stanford Medicine's Laboratory for Cell and Gene Medicine (LCGM). The grant will support the development of Stanford's G-Rex platform for CAR-T cell therapy manufacturing.

Stanford Medicine LCGM plans to use the grant to:

• Deploy a G-Rex-centric manufacturing process in an upcoming Phase 1 trial for GPC2+ pediatric neuroblastoma and medulloblastoma
• Implement Bio-Techne's Ella™ platform as a potency assay for final drug product release
• Collaborate with CellReady to create efficient G-Rex master batch records
• Develop a novel closed-system T cell purification technology

The G-Rex Grant Program is a $20M initiative by ScaleReady to advance cell and gene-modified cell therapy development and manufacturing.

Positive

• Bio-Techne's (NASDAQ: TECH) Ella™ platform will be implemented for potency assays in clinical trials
• Collaboration with CellReady to create efficient G-Rex master batch records
• Development of a novel closed-system T cell purification technology
• Potential for increased clinical trial support and manufacturing capabilities at Stanford Medicine LCGM

Negative

• None.

Insights

Medical Research Analyst

This grant award signifies a significant boost for CAR-T cell therapy research at Stanford Medicine's LCGM. The $300,000 funding will accelerate the development of their G-Rex platform for CAR-T manufacturing, potentially expediting the path from lab to clinic for novel cancer treatments. The focus on pediatric neuroblastoma and medulloblastoma in the upcoming Phase 1 trial addresses an urgent need in childhood cancer therapy.

The implementation of Bio-Techne's Ella™ platform for potency assays aligns with FDA recommendations, potentially streamlining the regulatory approval process. Moreover, the collaboration with CellReady and the development of closed-system T cell purification could lead to more efficient and cost-effective manufacturing processes, important for scaling up CAR-T therapies.

Financial Analyst

While the $300,000 grant itself isn't substantial for Bio-Techne (NASDAQ: TECH), a $20 billion market cap company, the strategic implications are noteworthy. The adoption of Bio-Techne's Ella™ platform by a prestigious institution like Stanford could lead to increased market penetration in the growing cell therapy sector. This aligns with Bio-Techne's focus on high-growth areas in life sciences and diagnostics.

The broader $20 million G-Rex Grant Program positions ScaleReady and its partners as key players in the CGT space, potentially driving long-term revenue growth. Investors should monitor how this initiative translates into increased adoption of G-Rex technology and associated products, which could positively impact Bio-Techne's future earnings.

ST. PAUL, Minn., Aug. 27, 2024 /PRNewswire/ -- ScaleReady™, in collaboration with Wilson Wolf Manufacturing, Bio-Techne Corporation (NASDAQ: TECH) and CellReady™, today announced that Dr. Steve Feldman, Scientific Director and Site Head of Stanford Medicine's Laboratory for Cell and Gene Medicine (LCGM), has been awarded the inaugural G-Rex® Grant.  Dr. Feldman's $300,000 G-Rex Grant will enable expeditious development of Stanford Medicine's LCGM's G-Rex platform for CAR-T cell therapy manufacturing, which will be offered to internal investigators and external developers who are seeking its development and manufacturing services.

"Stanford's LCGM anticipates a need to support a greater number of clinical trials and the G-Rex Grant will be used to help meet that need," said Dr. Feldman.

"We are honored to award the inaugural G-Rex Grant to Dr. Feldman and his team at Stanford Medicine LCGM. Stanford University is a world-class institution with faculty who have a reputation for innovative and ground-breaking achievements. Their work aligns with Wilson Wolf's mission of bringing hope to cancer patients, one G-Rex at a time" said John Wilson, CEO of Wilson Wolf and co-inventor of G-Rex.

As part of the G-Rex Grant, Stanford Medicine LCGM will deploy their G-Rex-centric manufacturing process in an upcoming Phase 1 trial for GPC2⁺ pediatric neuroblastoma and medulloblastoma.  Previously, the FDA had recommended sponsors develop and implement potency assays earlier in the clinical trial process.  With that objective, Stanford Medicine LCGM plans to implement Bio-Techne's leading automated multiplexing immunoassay platform, Ella™, as a potency assay for final drug product release. 

Furthermore, Stanford Medicine LCGM will collaborate with CellReady, the world's first and only G-Rex based contract development and manufacturing organization (CDMO), to leverage their proven capacity to quickly create G-Rex master batch records that establish manufacturing simplicity, efficiency, and repeatability. 

Additionally, Stanford Medicine LCGM plans to further develop a novel technology (developed by Wilson Wolf) that enables closed-system T cell purification to be done directly in a G-Rex device, without the need for expensive ancillary equipment.

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-modfied 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 4 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

FAQ

What is the value of the G-Rex Grant awarded to Stanford Medicine LCGM?

The G-Rex Grant awarded to Stanford Medicine LCGM is valued at $300,000.

How will Stanford Medicine LCGM use the G-Rex Grant in their upcoming Phase 1 trial?

Stanford Medicine LCGM will deploy their G-Rex-centric manufacturing process in an upcoming Phase 1 trial for GPC2+ pediatric neuroblastoma and medulloblastoma.

What is the total value of ScaleReady's G-Rex Grant Program?

ScaleReady's G-Rex Grant Program is a $20 million initiative to advance cell and gene-modified cell therapy development and manufacturing.

Which Bio-Techne (NASDAQ: TECH) product will Stanford Medicine LCGM implement for potency assays?

Stanford Medicine LCGM plans to implement Bio-Techne's Ella™ platform, a leading automated multiplexing immunoassay platform, as a potency assay for final drug product release.