Luminary Therapeutics Receives G-Rex® Grant from ScaleReady

ST. PAUL, Minn., Oct. 29, 2024 — ScaleReady, in partnership with Wilson Wolf Manufacturing and Bio-Techne Corporation, has unveiled that Luminary Therapeutics has been granted a $300,000 G-Rex® Grant. This funding will accelerate the development and studies required for several innovative CAR γδ T cell therapies, which are set to be tested in Phase 1 clinical trials for treating various autoimmune diseases.

The CAR γδ T cell therapies developed by Luminary Therapeutics combine the Vδ1 and Vδ2 subsets, a unique approach that is expected to enhance cytotoxicity, adaptive capacity, and persistence compared to other γδ T cell therapies. Additionally, Luminary's technology incorporates an "immune cloaking" mechanism, which helps the γδ T cells evade the host's immune system by downregulating MHC class I/II expression on their surface. This is further complemented by the use of Bio-Techne's novel gene engineering technology, TcBuster™, which offers significant advantages in reducing both the time and cost of translating a cell therapy drug product to clinical applications. According to Luminary, their CAR γδ T cell therapies can produce 180-200 patient doses per manufacturing run at a cost of less than $10,000 per product.

Jeff Liter, CEO of Luminary Therapeutics, expressed gratitude for the G-Rex Grant, noting its role as a non-dilutive funding mechanism that aligns with stakeholder interests and will help Luminary generate crucial clinical data necessary to attract further investment and advance their γδ T cell pipeline.

John Wilson, CEO of Wilson Wolf Manufacturing and co-inventor of G-Rex, expressed support for Luminary Therapeutics, highlighting the grant program's role in expediting the clinical application of Luminary's therapies, thus saving considerable time and money.

Through the G-Rex Grant, Luminary will refine several CAR γδ T cell therapies to boost their resiliency, safety, and functionality by integrating safety switches, novel co-stimulatory domains, endogenous growth factor production, and MHC-I/II inhibitory elements. Large-scale, cGMP-compliant manufacturing will support multiple Investigational New Drug (IND) applications expected to be submitted to the FDA. These applications aim to initiate several Phase 1 clinical trials to assess the safety and effectiveness of various CAR γδ T cell therapies in treating autoimmune diseases.

The ScaleReady G-Rex Grant Program is a $20M initiative designed to advance cell and gene-modified cell therapy (CGT) development and manufacturing, offering individual grants of up to $300,000. Recipients also gain access to support from ScaleReady’s consortium of G-Rex Grant Partners, who provide leading tools and technologies, as well as expertise in cGMP manufacturing, regulatory affairs, CGT business operations, and more.

About Luminary Therapeutics:
Luminary Therapeutics is at the forefront of revolutionizing allogeneic CAR-T therapy, pioneering a triple receptor CAR design aimed at surpassing the efficacy of current single receptor CD19 treatments for autoimmune diseases. Their split co-stimulatory CAR design is set to address solid tumors. Luminary is currently conducting three Phase I First-in-Human trials in an autologous format to establish safety and identify early efficacy indicators. Their second treated patient has already achieved a complete response without experiencing cytokine release syndrome. As Luminary embarks on a Series A fundraising round, they remain committed to advancing their therapies through clinical trials, aiming to bring transformative treatments to patients in need.

About ScaleReady:
ScaleReady offers a G-Rex-centric manufacturing platform for cell and gene-modified cell therapy (CGT), enabling practical, flexible, scalable, and affordable CGT drug product development and manufacturing. The G-Rex platform is utilized by over 800 organizations and is instrumental in producing drug products for around 50% of CGT clinical trials and five commercially approved CGT drugs. ScaleReady's expertise helps CGT entities save significant time and money on the path to commercialization.

About Wilson Wolf Manufacturing:
Wilson Wolf simplifies cell and gene-modified cell therapy research, process development, and manufacturing through its scalable G-Rex technology, used worldwide in CGT applications ranging from basic research to commercial drug production. Wilson Wolf's mission is to bring hope to cancer patients through its innovative G-Rex devices.

About Bio-Techne Corporation:
Bio-Techne Corporation provides innovative tools and bioactive reagents for the research and clinical diagnostic communities. In partnership with Wilson Wolf, Bio-Techne creates products like media and cytokines tailored to G-Rex Bioreactors, supporting high throughput closed-system manufacturing.