Simnova to lead clinical development, regulatory submissions, and commercialization across all oncology indications in Greater China
SHANGHAI, CHINA & CAMBRIDGE, Mass., January 5, 2023 — Shanghai Xianbo Biotech Co., Ltd., also known as Simnova outside of China, an affiliate of Simcere Investment Group and a clinical-stage biotechnology company developing proprietary off-the-shelf CAR-NK and BiTE-armed CAR-T cell therapies, and Orna Therapeutics, a biotechnology company pioneering a new investigational class of engineered circular RNA (oRNA) therapies, today announced a collaboration agreement to discover, develop, and commercialize multiple potential therapeutics in the area of oncology.
Under the terms of the agreement, Simnova will gain access in greater China to certain programs built on Orna’s breakthrough isCAR technology, including Orna’s lead anti-CD19 in situ CAR (isCAR) program, ORN-101. In addition, Orna will gain access to investigator-initiated clinical trials in China to accelerate the validation of select programs in patients. Orna will receive an upfront payment from Simnova and be eligible for development, regulatory, and sales milestones as well as royalties on any approved products derived from the collaboration.
Orna’s proprietary isCAR technology comprises two components: elegantly engineered circular RNAs (oRNAs) expressing chimeric antigen receptors, and custom-built lipid nanoparticles (LNPs) designed to deliver the oRNAs to cells of the immune system. oRNAs have greater stability in immune cells and are engineered to produce more proteins inside the body, than linear mRNAs. More broadly, Orna’s oRNA-LNP platform has potential across a range of indications including oncology, genetic and infectious disease, and more.
“This strategic collaboration broadens Orna’s capability to develop circular RNA therapeutics in China through Simnova’s development capabilities,” said Dr. Zhouxiao Cao, Simnova’s Chief Executive Officer. “We look forward to closely working with the innovative scientific and technical teams at Orna.”
“This collaboration again recognizes the value of our oRNA-LNP platform and will allow us together to diversify the number of programs using isCAR technology while bringing the value of isCAR to patients more efficiently,” said Tom Barnes Ph.D., Orna’s Chief Executive Officer. “This marks another important step in our overall business strategy where we look to thoughtfully engage partners to deliver on the promise of circular RNA therapies.”
ORN-101, Orna’s lead program, is an in situ CAR therapy designed to modify a patient’s immune cells inside their body. Comprising an oRNA molecule packaged inside a proprietary LNP, this easily redosable format could avoid patient lymphodepletion and allow for reliable dose control, overcoming barriers of existing ex vivo CAR-T therapies without sacrificing efficacy. Preclinical data presented at a scientific conference demonstrated tumor suppression and eradication in an animal model, suggesting the possibility that oRNA-LNP based cancer therapies could eventually overtake cell therapies.
About Orna Therapeutics:
Orna Therapeutics was founded on groundbreaking research by Alex Wesselhoeft, Ph.D., and Daniel G. Anderson, Ph.D. from MIT and built by MPM Capital and its affiliate BioImpact Capital. Orna’s proprietary circular RNA (oRNA) is engineered as linear RNA that self-circularizes. oRNA exhibits numerous advantages over traditional linear mRNA therapies such as simplified production, increased protein expression, and a superior immunogenicity profile. With proprietary lipid nanoparticles (LNPs), our technologies expand the possibilities of what RNA therapeutics can achieve. To learn more visit: www.ornatx.com and follow Orna Therapeutics on Twitter and LinkedIn.
Shanghai Xianbo Biotech Co., Ltd., also known as Simnova Biotherapeutics outside of China, is dedicated to creating life changing cell therapies for cancer patients with either hematologic malignancies or solid tumors. Simnova has a rich R&D pipeline including both clinical and pre-clinical programs and is developing proprietary off-the-shelf CAR-NK and BiTE armed CAR-T cell therapies. Simnova operates in Boston and Shanghai and is a sister company of Simcere Pharmaceutical Group Limited (2096.HK). To learn more, please visit www.simnovabio.com and follow Simnova on LinkedIn.
Peg Rusconi, Verge Scientific Communications