XenoTherapeutics Granted U.S. Patent Covering Method of Producing Clinically Acceptable Porcine Cells, Tissues, and Organs for Human Xenotransplantation

Company Solidifies Patent Position Relating to FDA-Cleared Pathway for Live-Cell Transplantation Solutions

Boston, Massachusetts, UNITED STATES

BOSTON, MA, Oct. 15, 2020 (GLOBE NEWSWIRE) -- XenoTherapeutics, a clinical-stage cell and gene therapy company engineering immune-compatible cells, tissues, and organs, announced that the U.S. Patent and Trademark Office (USPTO) has granted U.S. Patent No. 10,799,614 to XenoTherapeutics, the patent covering methods for producing live-cell biological products from source animal donors for human xenotransplantation.

The claimed methods were referenced by the U.S. Food and Drug Administration (FDA) to justify its clearance to conduct a first-in-human Phase I clinical trial for investigational use involving swine-to-human organ transplantation to evaluate the safety and tolerability of XenoTherapeutics’ first genetically-engineered non-human organ, Xeno-Skin™.

“This patent claims the first of many technological advances that our team has developed, and we are thankful to the USPTO for its speedy consideration. We look forward to similar success with our ongoing patent applications that cover innovative approaches to unlock the promise of non-human cell therapies on behalf of patients in need,” said XenoTherapeutics Chief Executive Officer Paul Holzer.

For decades, the world has faced a critical shortage of organs for human transplantation resulting in morality for thousands of people annually while on the waiting list. The prospect of using porcine organs for human xenotransplantation has intrigued scientists for many decades, but no group before XenoTherapeutics had yet advanced the science from theory to clinical reality. The newly granted patent covers and discloses the innovations developed by XenoTherapeutics in achieving the milestone.

XenoTherapeutics is represented by the widely recognized technology and intellectual property law firm Rothwell, Figg, Ernst and Manbeck, P.C. (RFEM).

“It is exciting for our team to serve an aggressive, pioneering company like XenoTherapeutics as they work tirelessly to realize the dream of xenotransplantation for patients in critical need. We are pleased the USPTO recognized XenoTherapeutics’ innovative and groundbreaking work as set forth in this patent, and it is an honor for us to help secure this foundational IP for them,” said RFEM Partner Dan Shores.

Since 2016, XenoTherapeutics worked strategically to gain a first-mover advantage in the field of clinical xenotransplantation. Over a four-year period, the company developed methods for harvesting non-human cells, tissues, and organs from a clinically acceptable, genetically engineered source animal donor which offers the promise of endless applications for an array of disease burdens that can be treated through xenotransplantation.

XenoTherapeutics closed a bridge financing round in 2020 and is preparing to raise additional capital to support a Phase II trial of Xeno-Skin™ and further development of immune-compatible, patient-specific cells, tissues, and organs under its Xeno-Genomics™ program. A second patent application for this program is currently under review with the USPTO.

About XenoTherapeutics

XenoTherapeutics is a clinical-stage cell and gene therapy company engineering immune-compatible cells, tissues, and organs. XenoTherapeutics has pioneered the clinical advancement of xenotransplantation by initiating human trials for the first-in-human, live-cell xenotransplantation surgery with Xeno-SkinTM.  XenoTherapeutics and their collaborators support and vigorously adhere to all applicable laws, regulations, and policies governing the ethical treatment of animals, including the Animal Welfare Act and Public Health Service Policy of Humane Care and Use of Laboratory Animals. More information is available at www.xenotherapeutics.com



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