Revolutionary CAR-T Program Launched by UC Irvine and GlyTR with ProBio's AAV Manufacturing
In a groundbreaking collaboration, the University of California, Irvine (UC Irvine) School of Medicine and GlyTR Therapeutics have unveiled an innovative AAV (Adeno-Associated Virus) mediated CAR-T platform named GlyTR, which is set to revolutionize the treatment landscape for cancer therapies. This newly developed system has been specifically engineered to identify and target tumor-associated carbohydrate antigens prevalent across a diverse range of cancers. The GlyTR approach offers a distinctive mechanism that resembles a 'velcro' binding technique, differing notably from traditional high-affinity antibody-based CAR designs. The advantage of this mechanism lies in its ability to selectively destroy cancer cells while significantly reducing off-target toxicity, thus expanding the applicability of CAR-T therapies into solid tumors—a domain that has historically faced significant safety hurdles.
In the context of this ambitious initiative, ProBio has played a pivotal role as a strategic manufacturing partner. Their success in providing AAV scale-up materials has been crucial for facilitating in vivo IND-enabling studies. ProBio's comprehensive Contract Development and Manufacturing Organization (CDMO) capabilities have been leveraged, including plasmid DNA development, GMP (Good Manufacturing Practice) production, and their seasoned expertise in scalable Chemistry Manufacturing and Controls (CMC). This integration not only minimizes risks in early development stages but also accelerates the journey towards clinical evaluation.
Highlighting the crucial contributions of ProBio, Dr. Ani Grigorian, Associate Project Scientist at UC Irvine, underscored the importance of their GMP AAV6 product. "ProBio's GMP AAV6 product demonstrated robust on-target CAR gene insertion of approximately 80%, which greatly exceeds the typical 40% insertion efficiency achieved with older research-grade materials. This product has resulted in the production of highly potent CAR T cells capable of effectively eradicating tumors in mouse models, marking a significant milestone on the road to human clinical applications," stated Dr. Grigorian.
The proprietary technology developed at UC Irvine, now licensed to GlyTR Therapeutics for commercialization, is recognized as a pioneering pan-cancer immunotherapy platform. This advancement has garnered significant support, highlighted by a funding boost of about $30 million, including a substantial grant of $4.6 million from the California Institute for Regenerative Medicine (CIRM).
Dr. Michael Demetriou, Principal Investigator and Professor at UC Irvine, acknowledged ProBio's thoroughness throughout the manufacturing phase: "From the onset, we have been impressed with ProBio's communication, accountability, and sheer dedication throughout the entire process. They consistently delivered on their promises and concluded the project powerfully."
ProBio’s mission focuses on empowering innovators to transition from concept to clinical application with efficiency, quality, and assurance. The successful execution of the GlyTR AAV program exemplifies how ProBio's scalable platforms and technical proficiency can help mitigate risks related to early-stage development and catalyze timely advancements in next-generation cell and gene therapies.
The promising findings from the preclinical phase of the GlyTR program will inform critical toxicology studies and the overarching clinical strategy moving forward. As the team gears up for clinical trial preparations and the IND submission—a significant value-adding step—collaborative efforts will be undertaken via UC Irvine's Chao Family Comprehensive Cancer Center and its Alpha Clinic, the clinical trial division of the stem cell research center.
About ProBio
ProBio stands out as a global CDMO that supports biotech and pharmaceutical firms in advancing the development and commercialization of cutting-edge therapies. Renowned for its deep expertise in cell and gene technologies, ProBio offers seamless, comprehensive solutions across mRNA, plasmid DNA, viral vectors, and in vivo CAR-T treatment modalities. Their GMP-compliant platforms are designed to bolster partners from the early developmental phase to full-blown commercial manufacturing, effectively expediting timelines and mitigating complexities. Through a collaboration-driven, risk-sharing model, ProBio facilitates flexible licensing and co-development solutions, assisting partners in navigating the intricate scientific and regulatory landscapes presented by advanced therapeutics.
About UC Irvine School of Medicine
Every year, UC Irvine's School of Medicine graduates over 500 medical students alongside more than 180 PhD and MS candidates. It trains nearly 900 residents and fellows across its medical center and linked institutions. The School provides numerous degree options while encouraging students to explore an expansive array of interests. Regarded as one of the nation’s top 50 medical schools for research, UC Irvine’s School of Medicine is accredited by the Liaison Committee on Medical Education.
About GlyTR Therapeutics
GlyTR Therapeutics emerges as a pioneering early-stage biotech entity focused on crafting novel immunotherapeutics and CAR-T cell treatments for combating cancer. Their GlyTR platform is adept at generating both bispecific proteins and CAR T cells, ensuring a single therapeutic solution can effectively target and eradicate various cancers, ranging from breast cancer to leukemia. By harnessing advanced genetic engineering and pivotal academic collaborations, GlyTR Therapeutics aims to establish a robust pipeline of CAR-T and cell-based therapies that address significant unmet medical requirements.
About CIRM
The California Institute for Regenerative Medicine (CIRM) is an essential state-funded body that seeks to expedite the research of stem cells and regenerative medicine. By supporting initiatives that successfully translate transformative discoveries from the laboratory to the clinical environment, CIRM aims to provide groundbreaking treatments to patients with critical health challenges.
In the context of this ambitious initiative, ProBio has played a pivotal role as a strategic manufacturing partner. Their success in providing AAV scale-up materials has been crucial for facilitating in vivo IND-enabling studies. ProBio's comprehensive Contract Development and Manufacturing Organization (CDMO) capabilities have been leveraged, including plasmid DNA development, GMP (Good Manufacturing Practice) production, and their seasoned expertise in scalable Chemistry Manufacturing and Controls (CMC). This integration not only minimizes risks in early development stages but also accelerates the journey towards clinical evaluation.
Highlighting the crucial contributions of ProBio, Dr. Ani Grigorian, Associate Project Scientist at UC Irvine, underscored the importance of their GMP AAV6 product. "ProBio's GMP AAV6 product demonstrated robust on-target CAR gene insertion of approximately 80%, which greatly exceeds the typical 40% insertion efficiency achieved with older research-grade materials. This product has resulted in the production of highly potent CAR T cells capable of effectively eradicating tumors in mouse models, marking a significant milestone on the road to human clinical applications," stated Dr. Grigorian.
The proprietary technology developed at UC Irvine, now licensed to GlyTR Therapeutics for commercialization, is recognized as a pioneering pan-cancer immunotherapy platform. This advancement has garnered significant support, highlighted by a funding boost of about $30 million, including a substantial grant of $4.6 million from the California Institute for Regenerative Medicine (CIRM).
Dr. Michael Demetriou, Principal Investigator and Professor at UC Irvine, acknowledged ProBio's thoroughness throughout the manufacturing phase: "From the onset, we have been impressed with ProBio's communication, accountability, and sheer dedication throughout the entire process. They consistently delivered on their promises and concluded the project powerfully."
ProBio’s mission focuses on empowering innovators to transition from concept to clinical application with efficiency, quality, and assurance. The successful execution of the GlyTR AAV program exemplifies how ProBio's scalable platforms and technical proficiency can help mitigate risks related to early-stage development and catalyze timely advancements in next-generation cell and gene therapies.
The promising findings from the preclinical phase of the GlyTR program will inform critical toxicology studies and the overarching clinical strategy moving forward. As the team gears up for clinical trial preparations and the IND submission—a significant value-adding step—collaborative efforts will be undertaken via UC Irvine's Chao Family Comprehensive Cancer Center and its Alpha Clinic, the clinical trial division of the stem cell research center.
About ProBio
ProBio stands out as a global CDMO that supports biotech and pharmaceutical firms in advancing the development and commercialization of cutting-edge therapies. Renowned for its deep expertise in cell and gene technologies, ProBio offers seamless, comprehensive solutions across mRNA, plasmid DNA, viral vectors, and in vivo CAR-T treatment modalities. Their GMP-compliant platforms are designed to bolster partners from the early developmental phase to full-blown commercial manufacturing, effectively expediting timelines and mitigating complexities. Through a collaboration-driven, risk-sharing model, ProBio facilitates flexible licensing and co-development solutions, assisting partners in navigating the intricate scientific and regulatory landscapes presented by advanced therapeutics.
About UC Irvine School of Medicine
Every year, UC Irvine's School of Medicine graduates over 500 medical students alongside more than 180 PhD and MS candidates. It trains nearly 900 residents and fellows across its medical center and linked institutions. The School provides numerous degree options while encouraging students to explore an expansive array of interests. Regarded as one of the nation’s top 50 medical schools for research, UC Irvine’s School of Medicine is accredited by the Liaison Committee on Medical Education.
About GlyTR Therapeutics
GlyTR Therapeutics emerges as a pioneering early-stage biotech entity focused on crafting novel immunotherapeutics and CAR-T cell treatments for combating cancer. Their GlyTR platform is adept at generating both bispecific proteins and CAR T cells, ensuring a single therapeutic solution can effectively target and eradicate various cancers, ranging from breast cancer to leukemia. By harnessing advanced genetic engineering and pivotal academic collaborations, GlyTR Therapeutics aims to establish a robust pipeline of CAR-T and cell-based therapies that address significant unmet medical requirements.
About CIRM
The California Institute for Regenerative Medicine (CIRM) is an essential state-funded body that seeks to expedite the research of stem cells and regenerative medicine. By supporting initiatives that successfully translate transformative discoveries from the laboratory to the clinical environment, CIRM aims to provide groundbreaking treatments to patients with critical health challenges.
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