ScaleReady Announces a G-Rex® Grant has been awarded to Luminary Therapeutics

Rhea-AI Summary

ScaleReady announced that Luminary Therapeutics has been awarded a $300,000 G-Rex® Grant in collaboration with Wilson Wolf Manufacturing and Bio-Techne (NASDAQ: TECH). The grant will support development of novel CAR γδ T cell therapies for autoimmune conditions. Luminary's approach combines Vδ1 and Vδ2 subsets with immune cloaking mechanism and utilizes Bio-Techne's TcBuster™ technology. The company claims their manufacturing process can produce 180-200 patient doses per run at less than $10,000 per drug product. The grant is part of ScaleReady's $20M initiative to advance cell and gene therapy development.

Positive

• Grant award of $300,000 for therapy development
• Cost-efficient manufacturing at less than $10,000 per drug product
• High production capacity of 180-200 patient doses per manufacturing run

Negative

• None.

Insights

Medical Research Analyst

The $300,000 G-Rex Grant to Luminary Therapeutics represents a strategic advancement in CAR γδ T cell therapy development. Their innovative approach combining Vδ1 and Vδ2 subsets, coupled with "immune cloaking" technology and Bio-Techne's TcBuster™ platform, shows promising potential for cost-effective autoimmune disease treatments. The reported manufacturing cost of $10,000 per drug product, yielding 180-200 patient doses per run, is remarkably competitive in the cell therapy space.

The grant's impact extends beyond immediate research funding, as it enables optimization of multiple CAR γδ T cell therapies with enhanced safety features and functionality. The planned incorporation of safety switches and novel co-stimulatory domains strengthens the therapeutic profile. This development pipeline, leading to multiple IND applications, positions Bio-Techne favorably in the expanding cell therapy market.

Financial Analyst

This grant represents a strategic validation of Bio-Techne's TcBuster™ technology and strengthens its position in the cell therapy manufacturing space. The cost-effectiveness of Luminary's manufacturing process at $10,000 per drug product is particularly noteworthy, as it addresses one of the major challenges in cell therapy commercialization. The broader $20M G-Rex Grant Program initiative demonstrates Bio-Techne's commitment to expanding its presence in the CGT market through strategic partnerships and technology adoption.

ST. PAUL, Minn., Oct. 29, 2024 /PRNewswire/ -- ScaleReady, in collaboration with Wilson Wolf Manufacturing and Bio-Techne Corporation (NASDAQ: TECH), today announced that Luminary Therapeutics has been awarded a $300,000 G-Rex® Grant. Luminary's G-Rex® Grant will enable expeditious process development and IND-enabling studies of several novel CAR γδ T cell therapies that will be evaluated in Phase 1 clinical trials for the treatment of various autoimmune conditions.

Luminary Therapeutics' CAR γδ T cell drug products contain a combination of the Vδ1 and Vδ2 subsets, a distinct approach from other developers of γδ T cell therapies, which Luminary anticipates providing improved cytotoxicity, greater adaptive capacity, and increased persistence. Luminary's technology also employs an "immune cloaking" mechanism to assist the γδ T cells in evading the host's immune system by reducing the expression of MHC class I/II on the surface of the γδ T cells. Finally, Luminary Therapeutics deploys Bio-Techne's novel transposition-based gene engineering technology called TcBuster™ which has fundamental advantages in the reduction of time and cost associated with clinical translation of a cell therapy drug product. Luminary has previously presented cost analysis indicating that their CAR γδ T cell therapies can yield 180-200 patient doses per manufacturing run at a manufacturing cost of less than $10,000 per drug product.

"Luminary is very grateful to be a beneficiary of the G-Rex Grant Program. The G-Rex Grant Program is a very creative, non-dilutive funding mechanism that aligns the interest of all stakeholders. It will directly impact our ability to generate the clinically significant data we need to attract the investment required to advance the state of our γδ T cell pipeline," says Mr. Jeff Liter, CEO of Luminary Therapeutics.

"We're happy to support Luminary Therapeutics with a G-Rex Grant. The program will accelerate the clinical use of Luminary's γδ T cell therapy program and this is yet another example of how the G-Rex Grant Program is saving time and money for recipients," said John Wilson, CEO of Wilson Wolf Manufacturing and co-inventor of G-Rex.

As part of the G-Rex Grant, Luminary will optimize several CAR γδ T cell therapies to enhance the resiliency, safety, and function of their CAR by incorporating safety switches, novel co-stimulatory domains, endogenous growth factor production, and MHC-I/II inhibitory elements. Large-scale, cGMP-compliant manufacturing will occur to support multiple Investigational New Drug (IND) applications that are estimated to be filed with the Food and Drug Administration (FDA) for the initiation of several Phase 1 clinical trials to evaluate the safety and efficacy of the several CAR γδ T cell therapies in a suite of autoimmune diseases.

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.

For more information about the G-Rex® Grant Program, please contact info@scaleready.com.

About Luminary Therapeutics
Luminary Therapeutics is revolutionizing allogeneic CAR-T therapy by pioneering a triple receptor CAR design aimed at surpassing the efficacy of conventional single receptor CD19 treatments for autoimmune diseases. Additionally, our innovative split co-stimulatory CAR design is poised to propel the industry forward in addressing solid tumors. Currently, Luminary is conducting three Phase I First-in-Human trials utilizing an autologous format to establish safety and detect early indications of efficacy. Encouragingly, our second treated patient has already achieved a complete response (CR) without experiencing cytokine release syndrome (CRS). As we embark on the early stages of a Series A fundraising round, Luminary is committed to advancing our assets through the clinical trial pipeline, bringing hope and transformative therapies to patients in need.

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

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SOURCE Bio-Techne Corporation

FAQ

What is the value of the G-Rex Grant awarded to Luminary Therapeutics through Bio-Techne (TECH)?

Luminary Therapeutics was awarded a $300,000 G-Rex Grant through Bio-Techne (TECH) and ScaleReady's initiative.

How many patient doses can Luminary Therapeutics produce per manufacturing run?

Luminary Therapeutics can produce 180-200 patient doses per manufacturing run at a cost of less than $10,000 per drug product.

What is the total value of ScaleReady's G-Rex Grant Program associated with Bio-Techne (TECH)?

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