Eledon Pharmaceuticals Announces Use of Tegoprubart anti-CD40L Antibody in Second-ever Transplant of Genetically Modified Heart from a Pig to a Human
25 September 2023 - 1:00PM
Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today
announced that tegoprubart, the company’s investigational anti-CD40
antibody, was used as a cornerstone component of the chronic
immunosuppressive regimen administered following the second-ever
transplant of a genetically modified heart from a pig to a human.
The procedure was completed on September 20th at University of
Maryland Medical Center on a 58-year-old male suffering from heart
failure.
“This is a momentous milestone for the transplant community and
serves as a testament to the continued progress being made towards
advancing novel treatment options for patients requiring an organ
transplant,” said David-Alexandre C. Gros, M.D., Eledon Chief
Executive Officer. “As the field of organ transplantation continues
to make important scientific advances, Eledon is dedicated to
delivering a novel immunosuppressive regimen with the potential to
protect and prevent rejection of transplanted organs, and we are
honored to play a role in this historic development.”
Following the successful transplantation, tegoprubart was
administered to the patient as a novel, key component of a chronic
immunosuppressive regimen designed to suppress the immune system
and prevent the body from rejecting the implanted organ. In prior
clinical research, tegoprubart has demonstrated a favorable safety
and tolerability profile across multiple indications, including
kidney transplantation, as well as clinical benefit in the
prevention of rejection and the protection of organs after
transplantation.
“The historic procedure we conducted on our courageous patient
brings us to a pivotal moment in the history of organ
transplantation. It is also a critical step in our ongoing mission
to address the growing shortage of available organs,” said Muhammad
M. Mohiuddin, MD, professor of surgery at University of Maryland
School of Medicine (UMSOM) and scientific/program director of its
Cardiac Xenotransplantation Program. “The ability to expand options
in all areas including access to available organs and strategies to
reduce the risk of rejection means that we are getting closer to
realizing the full potential of transplantation for patients. I
look forward to continued advancements so that we can hopefully
make xenotransplantation an available organ source for patients in
the years ahead.”
Eledon is advancing multiple research efforts related to the use
of tegoprubart to reduce the risk of rejection in organ transplant.
In collaboration with eGenesis, the company is currently advancing
preclinical studies in which tegoprubart will be administered as
part of an immunosuppression regimen to reduce the risk of
rejection in nonhuman primate recipients in xenotransplant
procedures. The company recently announced initiation of patient
dosing in the phase 2 BESTOW clinical trial to further assess the
use of tegoprubart in kidney transplantation and expects to present
an updated readout from its ongoing phase 1b kidney transplantation
study in November 2023. BESTOW is a head-to-head superiority study
evaluating tegoprubart vs. standard of care in kidney
transplantation, with a primary endpoint assessment of kidney graft
function (eGFR) at 52 weeks.
The Risk of Organ Failure in
Transplantation
In transplantation procedures, organ rejection is a major cause
of graft failure which can be a life-threatening condition. To
reduce the risk of organ damage and rejection, patients are
typically treated with immunosuppressive therapies including
calcineurin inhibitors (CNIs) such as tacrolimus. Strategies to
better and more safely protect transplanted organs and thus
increase how long they function represent a significant area of
unmet need in organ transplantation.
About Eledon Pharmaceuticals and Tegoprubart
(formerly AT-1501)
Eledon Pharmaceuticals is a clinical stage biotechnology company
with immunology expertise that is developing therapies to protect
and prevent rejection of transplanted organs, as well as to treat
amyotrophic lateral sclerosis (ALS). The Company’s lead compound in
development is tegoprubart, an anti-CD40L antibody with high
affinity for CD40 Ligand (also called “CD154”), a well-validated
biological target with broad therapeutic potential. Eledon is
headquartered in Irvine, California. For more information, please
visit the company’s website at www.eledon.com.
Follow Eledon Pharmaceuticals on social
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Forward-Looking Statements
This press release contains forward-looking statements that
involve substantial risks and uncertainties. Any statements about
planned clinical trials and the Company’s other future
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Securities Litigation Reform Act of 1995. Forward-looking
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risks and uncertainties, including: risks relating to the safety
and efficacy of our drug candidates; risks relating to clinical
development timelines, including interactions with regulators and
clinical sides, as well as patient enrollment; risks relating to
costs of clinical trials and the sufficiency of the company’s
capital resources to fund planned clinical trials; and risks
associated with the impact of the ongoing coronavirus pandemic.
Actual results may differ materially from those indicated by such
forward-looking statements as a result of various factors. These
risks and uncertainties, as well as other risks and uncertainties
that could cause the company’s actual results to differ
significantly from the forward-looking statements contained herein,
are discussed in our quarterly 10-Q, annual 10-K, and other filings
with the U.S. Securities and Exchange Commission, which can be
found at www.sec.gov. Any forward-looking statements contained
in this press release speak only as of the date hereof and not of
any future date, and the company expressly disclaims any intent to
update any forward-looking statements, whether as a result of new
information, future events or otherwise.
Investor Contact:
Stephen JasperGilmartin Group(858) 525
2047stephen@gilmartinir.com
Media Contact:
Jenna UrbanBerry & Company Public Relations(212) 253
8881jurban@berrypr.com
Source: Eledon Pharmaceuticals
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