CIRM awards $31 million to fund clinical-stage research for cancers and eye disease
FOR IMMEDIATE RELEASE
Contact:
Koren Temple-Perry
Sr. Director, Marketing & Communications
press@cirm.ca.gov
South San Francisco, CA, April 26, 2024 – The California Institute for Regenerative Medicine (CIRM), one of the world’s largest institutions dedicated to regenerative medicine, has approved awarding nearly $31 million to fund various clinical research across the spectrum of cancers and eye disease.
The awards will support three projects in the Agency’s clinical program which provides funding for eligible stem cell and gene therapy-based projects through all stages of clinical trial development. These awards bring the number of CIRM-funded clinical trials to 106.
The following awards approved at the CIRM Application Review Subcommittee (ARS) meeting include:
| Application
|
Program Title
|
Principal Investigator/Institution | Amount
|
| CLIN2-15282 | RPESC-RPE Therapy for dry Age-related Macular Degeneration | Stern, Jeffrey H – Luxa Biotechnology | $4,009,675 |
| CLIN2-15311 | A Phase I/IIa Study to Evaluate the Efficacy of a Gene Therapy with Standard of Care Therapy in Newly Diagnosed High Grade Glioma | Kasahara, Noriyuki – UCSF | $11,807,220 |
| CLIN2 -15343 | A Phase 1B Study Evaluating the Safety and Efficacy of an Allogenic Cell Therapy in Subjects with Clear Cell Renal Cell Carcinoma (ccRCC) | Le Gall, John – Allogene Therapeutics | $15,000,000 |
Advancing Research for Progressive Eye Disease
A $4 million award to Jeffrey Stern, MD, PhD of Luxa Biotechnology will advance clinical research focused on a pioneering therapy for dry age-related macular degeneration (AMD), a condition impacting almost 19.8 million people in the United States.
Dry AMD leads to the deterioration of retinal pigment epithelial (RPE) cells, which are essential for supporting the retina and maintaining clear vision. Currently, individuals suffering from dry AMD have no effective treatment options to improve their vision, leaving them facing significant challenges in their daily lives.
This research focuses on cell replacement of RPE cells lost during dry AMD disease progression with the aim of restoring vision.
“Encouraging preliminary results motivate Luxa Biotechnology to expand our cell manufacturing and clinical activities in California,” said Dr. Stern, the principal investigator of the project. “We are grateful to CIRM for support that will accelerate progress of RPE stem cell therapy for dry AMD patient benefit”.
“This therapy has the potential of restoring lost vision in patients with dry AMD and improving quality of life for people with this condition that affects millions,” said Dr. Abla Creasey, PhD, Vice President of Therapeutics Development at CIRM. “CIRM has funded various projects for dry AMD, underscoring our commitment to advancing research and treatments for patients with vision loss.”
Gene Therapy Trial Tests Cancer-killing Virus in Brain Tumors
An $11.8 million award to Noriyuki Kasahara, MD, PhD of UCSF will support a clinical trial targeting newly diagnosed high-grade gliomas. High-grade gliomas are fast-growing cancers that form in the brain or spinal cord that are difficult to treat.
This CIRM award will support research to explore the potential of DB107 (formerly Toca 511), which uses a gene therapy platform to selectively target and penetrate tumor cells, delivering a unique enzyme that transforms a harmless compound into a cancer-fighting drug right at the core of the cancer cells.
This first-in-human clinical trial will evaluate the safety and efficacy of a novel gene therapy technology in newly diagnosed high-grade glioma patients. This trial will be conducted at three institutions in California (UCSF, USC, UCSD).
This first in human clinical trial in newly diagnosed high-grade gliomas represents a novel treatment approach that aims to advance management of this devastating disease,” said Dr. Creasey.
Supporting a CAR-T Cell Trial for Kidney Cancer
Additionally, CIRM approved a $15 million award to John Le Gall, MD of Allogene Therapeutics to support the development of an anti-CD70 CAR-T cell product designed to treat metastatic clear cell renal cell carcinoma (ccRCC).
Metastatic RCC is the most common kidney cancer globally and there are limited options for treatment. Allogeneic CAR-T cells that target CD70 positive cancer cells show promising response rates.
By targeting CD70 expressions on ccRCC tumors, this therapy offers a different approach to cancer treatment, prioritizing both efficacy and patient safety.
This clinical study has the potential to demonstrate the value of Chimeric Antigen Receptor (CAR) T cell therapy in solid cancers such as kidney cancer with a high unmet medical need,” said Dr. Creasey.
About the California Institute for Regenerative Medicine (CIRM)
At CIRM, we never forget that we were created by the people of California to accelerate stem cell treatments to patients with unmet medical needs, and act with a sense of urgency to succeed in that mission.
To meet this challenge, our team of highly trained and experienced professionals actively partners with both academia and industry in a hands-on, entrepreneurial environment to fast track the development of today’s most promising stem cell technologies.
With $5.5 billion in funding and more than 150 active stem cell programs in our portfolio, CIRM is one of the world’s largest institutions dedicated to helping people by bringing the future of cellular medicine closer to reality.
For more information go to www.cirm.ca.gov