Charles River and Rznomics Announce RNA-based Anticancer Gene Therapy Manufacturing Alliance

Rhea-AI Summary

Charles River Laboratories (NYSE: CRL) has partnered with Rznomics Inc. to utilize its expertise in adenoviral vector production, facilitating the clinical trials of RZ-001, an RNA-based gene therapy targeting hepatocellular carcinoma (HCC). RZ-001, the first ribozyme-based therapy approved by the FDA, aims to treat liver cancer, which accounts for 80% of primary liver cancer cases worldwide. Following its FDA IND approval in October, Rznomics is set to initiate a Phase I/IIa clinical study internationally and in Korea. This collaboration enhances Charles River's established capabilities in gene therapy and manufacturing services, promoting effective clinical development.

Positive

• Charles River's partnership with Rznomics enhances its service offerings in viral vector production for gene therapies.
• The FDA's IND approval for RZ-001 positions Rznomics for clinical advancement in treating HCC, a critical need area.

Negative

• None.

CDMO partnership to provide adenoviral vector production enabling initiation of clinical trials

WILMINGTON, Mass.--(BUSINESS WIRE)-- Charles River Laboratories International, Inc. (NYSE: CRL) and Rznomics Inc., a South Korea-based biopharmaceutical company specialized in the development of RNA-based gene therapeutics, today announced a viral vector contract development and manufacturing organization (CDMO) partnership. Rznomics will leverage Charles River’s viral vector CDMO experience to initiate clinical development of its RNA-based anticancer gene therapy in liver cancer patients.

RZ-001 is the first ribozyme-based RNA reprogramming approach approved by the US Food and Drug Administration (FDA) for evaluation in patients. The treatment was developed utilizing Rznomics’ proprietary RNA reprogramming and editing technology and takes the form of an adenoviral vector that expresses an hTERT targeting ribozyme to treat hepatocellular carcinoma (HCC) patients. HCC is the most common type of primary liver cancer, accounting for 80 percent of cases worldwide.

Rznomics received Phase I/IIa IND approval for RZ-001 from the FDA in October, allowing the initiation of an international clinical study in HCC patients. Early-phase trials have also commenced in Korea following IND approval for RZ-001 from the South Korean Ministry of Food and Drug Safety (MFDS), formerly the Korea Food & Drug Administration (KFDA) in June.

Adenoviral Vector Manufacturing Services

Charles River has standardized protocols for cell culture, transfection, and downstream purification, as well as a validated platform process with a proven track record. These high-yield, optimized methods increase speed to clinical manufacturing by reducing process development time and costs while ensuring the highest quality production.

Expanding its comprehensive cell and gene therapy portfolio to span viral vector, plasmid DNA, and cell therapy production, through the acquisitions of Vigene Biosciences, Cobra Biologics, and Cognate BioServices in 2021, Charles River offers end-to-end support and supply chain simplification for advanced therapy medical product (ATMP) developers.

Approved Quotes

• “This collaboration with Rznomics will tap into our industry-leading CDMO capabilities and we are thrilled that our expertise will help to bring RZ-001, a potentially curative therapy, to HCC patients.” – Birgit Girshick, Corporate Executive Vice President and Chief Operating Officer, Charles River
• “We are proud to have achieved FDA approval to begin Phase I/IIa trials and excited to take this next step with Charles River. A reliable and experienced manufacturing partner is of utmost importance, and we are keen to continue building this relationship to enable us to bring our leading pipeline, RZ-001, into clinical development.” – Seong-wook Lee, President and Chief Executive Officer, Rznomics

About Charles River

Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts. Our dedicated employees are focused on providing clients with exactly what they need to improve and expedite the discovery, early-stage development and safe manufacture of new therapies for the patients who need them. To learn more about our unique portfolio and breadth of services, visit www.criver.com.

About Rznomics

As a biopharmaceutical company founded in the laboratory of Professor Seong-wook Lee, Dankook University Department of Bio-convergence Engineering, Rznomics is researching with the goal of developing new biologic drugs for cancer and incurable diseases through gene therapy development. Rznomics’ core platform technology is based on an RNA replacement enzyme, known as a trans–splicing ribozyme, which can edit target RNA through simultaneous destruction and repair (and/or reprograming) to yield the desired therapeutic RNA, thus selectively inducing therapeutic gene activity in cells expressing the target RNA. Rznomics’ lead candidate is a treatment for hepatocellular carcinoma (HCC), with other treatments for glioblastoma, Alzheimer’s disease, and hereditary retinal dystrophy (RD) also under development. For more information, please visit www.rznomics.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221207005076/en/

Charles River Investor Contact:

Todd Spencer

Corporate Vice President,

Investor Relations

781.222.6455

todd.spencer@crl.com

Charles River Media Contact:

Amy Cianciaruso

Corporate Vice President,

Chief Communications Officer

781.222.6168

amy.cianciaruso@crl.com

Source: Charles River Laboratories International, Inc.

FAQ

What is the recent partnership between Charles River Laboratories and Rznomics?

Charles River Laboratories has entered into a CDMO partnership with Rznomics to support the clinical development of RZ-001, an RNA-based gene therapy for liver cancer.

What is RZ-001 and why is it significant for liver cancer treatment?

RZ-001 is the first ribozyme-based RNA therapy approved by the FDA for evaluating in liver cancer patients, targeting hepatocellular carcinoma, which constitutes 80% of primary liver cancer cases.

What FDA approval did Rznomics receive for RZ-001?

In October, Rznomics received FDA approval to initiate Phase I/IIa clinical trials for RZ-001, allowing for international studies on liver cancer patients.

How does Charles River's expertise benefit the RZ-001 clinical trials?

Charles River provides standardized protocols and high-yield processes in viral vector manufacturing, helping accelerate the clinical manufacturing of RZ-001.

What impact does this partnership have on CRL's stock?

The partnership may enhance investor confidence in CRL by expanding its portfolio in gene therapy services, though direct stock impact will depend on trial outcomes.