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Karius and eGenesis partner to help accelerate xenotransplantation for patients in need of organ transplants

Karius, a leader in infectious disease diagnostics, will collaborate with eGenesis, a pioneer in xenotransplantation, to expand the Karius microbial cell-free DNA sequencing platform to include detection of pig pathogens

REDWOOD CITY, Calif., and CAMBRIDGE, Mass., April 11, 2023

REDWOOD CITY, Calif., and CAMBRIDGE, Mass., April 11, 2023 – Karius®, the world leader in liquid biopsy for infectious diseases, and eGenesis, Inc. a biotechnology company developing human-compatible organs and cells for the treatment of organ failure, today announced a partnership through which the two companies will develop infectious disease diagnostics for xenotransplantation initially from porcine to primates and ultimately to humans. Through the partnership, Karius will leverage its platform to power the detection and quantification of pathogens with potential to occur in porcine organ donors.

Karius’ expanded platform for detection of microbial cell-free DNA will power the surveillance and diagnosis of potential infection in both the porcine organ donor and recipient, pre- and post-transplant. Karius and eGenesis will collaborate in the development of this expanded platform and plan to complete this work by early 2024.

More than 100,000 people in the U.S. wait on the organ transplant list each year, and many more never get approved to be on the waiting list. An estimated 6,000 of these patients will die each year before they receive an organ transplant1. The field of xenotransplantation has evolved to meet this growing demand, with companies working to genetically modify animal-derived organs for successful transplantation into humans. While great advancements have been made in recent years, infection is still a major threat.

Mitigating the risk of xenogeneic disease transfer is a core tenet of eGenesis’s approach to xenotransplantation. The company’s proprietary eGenesis Genome Engineering and Production (EGEN™) Platform leverages cutting-edge gene editing technologies to inactivate all detectable copies of endogenous retrovirus sequences within the porcine genome to prevent the virus from being passed from the organ donor to the recipient.

“While we are taking numerous measures to ensure our porcine donors are free from infectious agents, the ability to broadly monitor for infection transmission between species is important for ensuring the safety of xenotransplantation,” said Michael Curtis, Ph.D., Chief Executive Officer at eGenesis. “With our gene-editing technology, we have an unprecedented ability to engineer human compatible organs to address the organ shortage, and this partnership is a key step in our goal to make xenotransplantation safe.”

“We are excited to partner with eGenesis to accelerate the availability of safe xenotransplantation for the many people and families who may benefit from this important progress,” said Brad Perkins, M.D, Chief Medical Officer at Karius. “Patients who receive solid organ transplants regardless of source are at high risk for varied causes of infection, and can particularly benefit from Karius’ unbiased, rapid, and non-invasive detection of pathogens.”

Early in 2022, Karius’ technology was able to observe microbial cell-free DNA originating from a porcine pathogen in a patient who underwent the first xenotransplant, as published in New England Journal of Medicine. The porcine cytomegalovirus was consistently detected over 60 days post transplant, through serial testing, which was later confirmed by orthogonal technologies.2

Karius’ technology employs an unbiased approach to detecting pathogens and offers a versatile and adaptable platform that can be modified to include new pathogens of both human and animal origin.

“One of the fundamental advantages of our technology lies in its differentiated ability to provide a wide lens into the organisms that may threaten patients, regardless of their origin,” said Sivan Bercovici, Chief Technology Officer at Karius. “The expansion into infectious disease diagnostics in xenotransplantation provides another proof point for our platform’s plasticity through data and AI.”

About Karius
Karius, Inc., the world leader in liquid biopsy for infectious diseases, harnesses genomics and AI to transform infectious disease diagnostics. The Karius Test ® is a lab developed test which enables rapid and non-invasive detection of more than 1,000 pathogens from a single blood draw. Through the use of its test, Karius aims to improve patient outcomes, support antimicrobial stewardship efforts, and reduce invasive diagnostic use. The company today is focused on transforming the diagnosis of infections in immunocompromised patients to address the more than 800 infection related deaths that occur daily in cancer patients across the US. For more information, visit www.kariusdx.com.

About eGenesis
eGenesis is leveraging a genome engineering-based approach in the development of safe, effective, and transplantable organs. The company’s EGEN™ platform is the only technology of its kind to address both viral risk and cross-species molecular incompatibilities. eGenesis has demonstrated durable preclinical success to date and is advancing development programs for kidney transplant, pediatric as well as adult heart transplant, ex-vivo liver perfusion, and islet cell transplant. Learn more at www.egenesisbio.com.

Karius Media Contact:
karius@consortpartners.com

eGenesis PR Contact
Greg Kelley
gkelley@vergescientific.com

eGenesis IR Contact
Aidan Gold
aidan.gold@egenesisbio.com

References:
1. Health Resources and Service Administration. Organ donation statistics. Organ Donation U.S. Government. March 1, 2023. Accessed April 7, 2023. https://www.organdonor.gov/learn/organ-donation-statistics
2. Griffith BP, Goerlich CE, Singh AK, et al. Genetically modified porcine-to-human cardiac xenotransplantation. New England Journal of Medicine. 2022;387(1):35-44. doi:10.1056/nejmoa2201422