eldn Archives - Page 2 of 3

Release – Eledon Pharmaceuticals to Present Updated Data from Ongoing Phase 1b Trial of Tegoprubart in Patients Undergoing Kidney Transplantation at the American Transplant Congress

Posted on May 9, 2024May 9, 2024 by aweinsoff@channelchek.com

May 9, 2024

IRVINE, Calif., May 09, 2024 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today announced that the Company will participate in the American Transplant Congress (ATC) taking place in Philadelphia, PA from June 1-5, 2024. The Company will present a poster that features updated data from Eledon’s ongoing open-label Phase 1b trial and open-label extension study evaluating tegoprubart for the prevention of rejection in patients undergoing kidney transplantation.

Details on the poster presentation are below:

Title: Biomarkers of Inflammation and eGFR in an Ongoing Phase 1B Study of an Anti-CD40L Antibody Tegoprubart, for the Prevention of Rejection in Kidney Transplant
Presenter: Steve Perrin, Ph.D., President and Chief Scientific Officer, Eledon Pharmaceuticals
Poster Number: 6647

Session Date and Time: Monday, June 3, 9:15-10:00 A.M. ET & 2:30-3:15 P.M. ET

Following the poster presentation, a copy of the poster can be found on the Investor section of the Company’s website at https://ir.eledon.com/news-and-events/publications-and-presentations.

The Company will also sponsor a satellite symposium at ATC titled: Blazing a path towards “Total Success” in Solid Organ Transplantation, to be held on Sunday, June 2, at 12:15pm ET. Faculty include, Flavio Vincenti, M.D., University of California San Francisco, Diane Cibrik, M.D., University of Kansas Health System, Allan Kirk, M.D., Duke University School of Medicine, Jay Fishman, M.D., Massachusetts General Hospital, Klemens Budde, M.D., Charité Universitätsmedizin Berlin and Roslyn Mannon, M.D., University of Nebraska Medical Center.

About Eledon Pharmaceuticals and tegoprubart

Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for CD40 Ligand, a well-validated biological target within the costimulatory CD40/CD40L cellular pathway. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.

Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter

Investor Contact:

Stephen Jasper
Gilmartin Group
(858) 525 2047
stephen@gilmartinir.com

Media Contact:

Jenna Urban
Berry & Company Public Relations
(212) 253 8881
jurban@berrypr.com

Source: Eledon Pharmaceuticals

Source: Eledon Pharmaceuticals, Inc.

Eledon Pharmaceuticals (ELDN) – Islet Cell Transplant Patient Treated As Kidney Data Presentation Is Announced

Posted on May 8, 2024May 8, 2024 by cpereira@noblefcm.com

Wednesday, May 08, 2024

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

New IIT Study Has Started, With Phase 1b Data Kidney Trial Update In June. An Investigator-Initiated Trial (IIT) testing tegoprubart in islet cell transplantation has treated its first patient. Interim data from the Phase 1b trial testing tegoprubart in kidney transplantation was announced, with presentation at a medical meeting scheduled for June 1 to June 5, 2024.

Tegoprubart Is Currently In Two Kidney Transplant Trials. Eledon continues to report follow-up data from its Phase 1b open-label trial for tacrolimus as it enrolls patients in the double-blind Phase 2 BESTOW trial. Tegoprubart acts through a different mechanism than tacrolimus (the current standard treatment), with potential to have greater protection against rejection with improved function.

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Eledon Pharmaceutical’s Novel Transplant Drug Delivering Promising Early Results

Posted on May 7, 2024May 7, 2024 by slightbourne@noblecapitalmarkets.com

Eledon Pharmaceuticals (NASDAQ:ELDN) is making exciting progress with its lead drug candidate tegoprubart, potentially ushering in a new era of safer and more effective immunosuppression for transplant recipients. The clinical-stage biotech recently achieved two major milestones that increase confidence in tegoprubart’s best-in-class prospects as a next-generation solution for preventing organ rejection.

First, the first participant has successfully received an islet cell transplant and treatment with tegoprubart in a pioneering trial at the University of Chicago. The study is evaluating tegoprubart as part of a novel immunosuppressive regimen aimed at reversing type 1 diabetes by allowing insulin independence after an islet cell transplant. Currently, toxic side effects from standard anti-rejection drugs limit broader utilization of this potential cure.

Tegoprubart’s selective mechanism of action blocking the CD40L pathway could open up islet transplantation to many more patients by avoiding the nephrotoxicity, neurotoxicity, hypertension and other issues seen with calcineurin inhibitors like tacrolimus. Reversing type 1 diabetes through a safe, functional islet cell transplant would provide transformative benefits for patient quality of life.

In addition to this groundbreaking study, Eledon also reported very promising interim Phase 1b results demonstrating tegoprubart’s ability to preserve kidney function with a well-tolerated safety profile following kidney transplantation. Through 1 year of treatment, participants averaged estimated glomerular filtration rates (eGFRs) greater than 60 mL/min/1.73m2 at all timepoints after day 30. This is substantially higher than the typical eGFRs in the low 50s seen in kidney transplant recipients on standard immunosuppressants during the first year.

These eGFR results highlight tegoprubart’s potential to protect transplanted kidneys from the nephrotoxic effects of current anti-rejection medications over the long-term. With similarly impressive 1-year eGFR data north of 90 mL/min/1.73m2 in two subjects, the drug could potentially enable kidney transplants to last significantly longer before failure versus what is currently possible.

From a safety perspective, tegoprubart was very well-tolerated in the Phase 1b trial. Only 3 out of 13 participants discontinued treatment due to manageable side effects like hair loss and fatigue, with no reports of graft loss or death. This clean profile contrasts starkly with the harsh toxicities of current calcineurin inhibitor regimens that often lead to treatment discontinuations.

With its unique mechanism avoiding general immunosuppression, tegoprubart represents a paradigm shift in preventing transplant rejection that could finally break the tradeoff between organ rejection and drug toxicity. Eledon plans to showcase the full Phase 1b kidney transplant dataset at an upcoming medical conference, setting the stage for additional catalysts from the ongoing Phase 2 BESTOW trial expected to read out in the coming months.

Analysts forecast peak sales for tegoprubart well into potential blockbuster territory above $1 billion across multiple transplant indications and autoimmune diseases like lupus that also involve the CD40/CD40L pathway. With its excellent early efficacy and safety results, tegoprubart is steadily derisking its path to becoming the next standard of care in immunosuppression for transplantation.

At a modest $50 million market cap, Eledon is currently an undervalued opportunity for investors considering tegoprubart’s multi-billion dollar commercial prospects. As the drug continues to make strides in the clinic, the company’s shares have tremendous upside potential. Eledon is definitively a clinical-stage biotech to keep high on the watchlist.

Take a moment to take a look at Eledon’s company presentation at NobleCon19.

Release – Eledon Announces Clinical Progress with Tegoprubart in the Prevention of Transplant Rejection

Posted on May 7, 2024May 7, 2024 by aweinsoff@channelchek.com

Research News and Market Data on ELDN

May 7, 2024

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First participant dosed in clinical trial at University of Chicago Medicine assessing the use of tegoprubart to prevent islet cell transplant rejection in patients with type 1 diabetes

Company reports updated data from ongoing Phase 1b trial evaluating tegoprubart for prevention of rejection in kidney transplantation

IRVINE, Calif., May 07, 2024 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced that the first participant in an investigator-led clinical trial has received an islet cell transplant and is being treated with a novel immunosuppression regimen including tegoprubart, the company’s novel anti-CD40L antibody, which is in development for the prevention of pancreatic islet cell transplant rejection in patients with type 1 diabetes. The study is being conducted by the research team at University of Chicago Medicine’s Pancreatic and Islet Transplant Program. Separately, the company reported updated data from its ongoing Phase 1b trial demonstrating tegoprubart successfully prevented kidney transplant rejection and was generally safe and well-tolerated.

In January 2024, Eledon announced a collaboration with the University of Chicago Transplant Institute for an investigator sponsored trial in pancreatic islet cell transplantation in patients with type 1 diabetes (NCT06305286). Eledon is supplying tegoprubart as a cornerstone component of the immunosuppressive regimen for trial participants and tegoprubart is being evaluated for the prevention of transplant rejection in the trial. Funding for the study includes grants from the Juvenile Diabetes Research Foundation (JDRF) and the Cure Alliance.

“There is clinical evidence from our studies and others conducted by the National Institute of Health’s Clinical Islet Transplantation Consortium that demonstrate islet cell transplantation may reverse diabetes by eliminating the need for exogenous insulin and reinstating metabolic control in selected patients with difficult to control type 1 diabetes. However, the required use of current standard of care anti-rejection medications, specifically calcineurin inhibitors, has limited the benefit of these procedures due to well-known associated toxicity to the islets, nephrotoxicity, neurotoxicity and risk of hypertension. We hope that tegoprubart will effectively protect islets from rejection without side effects related to current standard therapy,” said Piotr Witkowski, M.D., Ph.D., Director, Pancreatic and Islet Transplant Program, University of Chicago Medicine, and principal investigator of the trial with John Fung, M.D., Ph.D.

“This first islet cell transplant as part of the University of Chicago trial is a significant milestone in our efforts to advance tegoprubart as a novel and much-needed treatment option for transplant patients,” said Steven Perrin, Ph.D., President and Chief Scientific Officer of Eledon. “We look forward to continuing our work with the University of Chicago team and further studying tegoprubart and its potential ability to prevent islet cell transplant rejection that may lead to improved outcomes and quality of life for people living with type 1 diabetes.”

The company also announced updated data as of April 2024 from 13 participants in the ongoing Phase 1b trial evaluating tegoprubart for the prevention of rejection in kidney transplantation. Results demonstrated that tegoprubart is generally safe and well-tolerated and support tegoprubart’s potential to protect organ function in patients undergoing kidney transplantation. Aggregate mean estimated glomerular filtration rate (eGFR) – a measure of kidney function – measured above 60 mL/min/1.73m² at all reported time points after day 30. Two subjects completed 12 months on therapy post-transplant and both demonstrated mean eGFRs above 90 mL/min/1.73m² at one year. Historical studies using standard of care immunosuppression therapy have reported average eGFRs generally in the low 50 mL/min/1.73m² range during the first year after kidney transplant. To date, three subjects discontinued the study because of hair loss and fatigue, viral infection, and rejection, respectively. There have been no cases of graft loss or death. The company plans to present this data at the upcoming American Transplant Congress in Philadelphia, PA, in early June 2024.

Eledon is currently conducting a Phase 1b trial (NCT05027906), the Phase 2 BESTOW trial (NCT05983770), and a Long-Term Safety and Efficacy extension study (NCT06126380) to evaluate tegoprubart for the prevention of organ rejection in patients receiving a kidney transplant.

About Eledon Pharmaceuticals and tegoprubart

Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.

Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, expected or future results of tegoprubart trials and its ability to prevent rejection in connection with islet cell transplantation or kidney transplantation, the company’s capital resources and ability to finance planned clinical trials, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous 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; and risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials. 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 Jasper
Gilmartin Group
(858) 525 2047
stephen@gilmartinir.com

Media Contact:

Jenna Urban
Berry & Company Public Relations
(212) 253 8881
jurban@berrypr.com

Source: Eledon Pharmaceuticals

Source: Eledon Pharmaceuticals, Inc.

Release – Eledon Pharmaceuticals Announces Oversubscribed $50 Million Private Placement

Posted on May 7, 2024May 7, 2024 by aweinsoff@channelchek.com

Research News and Market Data on ELDN

May 7, 2024

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IRVINE, Calif., May 07, 2024 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced that it has entered into a securities purchase agreement with certain institutional and accredited healthcare investors for a private investment in public equity financing that is expected to result in gross proceeds of approximately $50 million, before deducting offering expenses. Pursuant to the terms of the securities purchase agreement, Eledon is selling an aggregate of 13,110,484 shares of its common stock (“Common Stock”) at a price of $2.37 per share and pre-funded warrants at a price of $2.369 per underlying share, which are exercisable to purchase 7,989,516 shares of Common Stock at a price of $0.001 per share. The financing is expected to close the week of May 6, 2024, subject to satisfaction of customary closing conditions. The oversubscribed financing was led by BVF Partners LP and includes participation from new and existing investors.

The Company intends to use the net proceeds from the private placement to fund pre-commercial activities for its products and general corporate purposes, which will include the clinical development of its lead asset tegoprubart.

The securities sold in the private placement, including the common shares underlying the pre-funded warrants, are being made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended, or applicable state securities laws and may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and applicable state securities laws. Concurrently with the execution of the securities purchase agreement, Eledon and the investors entered into a registration rights agreement pursuant to which the Company has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the securities issued in the private placement.

Leerink Partners is acting as lead placement agent. LifeSci Capital and Noble Capital Markets are acting as co-placement agents in connection with the financing.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About Eledon Pharmaceuticals and tegoprubart

Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.

Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter

Investor Contact:

Stephen Jasper
Gilmartin Group
(858) 525 2047
stephen@gilmartinir.com

Media Contact:

Jenna Urban
Berry & Company Public Relations
(212) 253 8881
jurban@berrypr.com

Source: Eledon Pharmaceuticals

Release – Eledon Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Operating and Financial Results

Posted on March 28, 2024March 28, 2024 by aweinsoff@channelchek.com

Research News and Market Data on ELDN

March 28, 2024

Enrolled 12 participants in Phase 2 BESTOW trial evaluating tegoprubart for the prevention of kidney rejection

Tegoprubart used as a component of the immunosuppressive treatment regimen following the first-ever transplant of a kidney from a genetically modified pig to a human

Additional data from 11 participants in Phase 1b trial in kidney transplantation demonstrated that tegoprubart was generally safe and well tolerated, successfully prevented rejection and permitted above historical average post-transplant kidney function

IRVINE, Calif., March 28, 2024 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today reported its fourth quarter and full year 2023 operating and financial results and reviewed recent business highlights.

“Eledon continues to execute on time and as promised towards our goal of extending the functional life of transplanted organs,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “Our latest Phase 1b data further support the potential of tegoprubart to significantly reduce the risk of rejection as well as harmful side effects associated with current standard of care in immunosuppression. In addition to our clinical development progress, tegoprubart was used for immunosuppression in historical kidney and heart pig-to-human xenotransplant procedures. As we advance our clinical program to assess the use of tegoprubart in kidney transplant procedures, we remain committed to supporting groundbreaking advancements that can lead to broader organ availability for patients around the world.”

“Looking ahead, we anticipate completing enrollment of our Phase 2 BESTOW study by the end of the year as we also continue to enroll participants in the second cohort of our Phase 1b study and open-label extension study designed to provide additional insights into tegoprubart’s long-term effectiveness,” continued Dr. Gros. “We look forward to providing updated interim clinical data from both the Phase 1b and open-label studies in the second quarter of this year.”

Fourth Quarter 2023 and Recent Corporate Developments

Announced the use of tegoprubart as a component of the immunosuppressive treatment regimen following the first-ever transplant of a kidney from a genetically modified pig to a human. The procedure was completed on March 16, 2024, at Massachusetts General Hospital on a 62-year-old man with end-stage kidney disease.
Announced 12^th participant enrolled in the Phase 2 BESTOW trial assessing tegoprubart head-to-head with tacrolimus for the prevention of rejection in kidney transplantation.
Reported updated safety and efficacy data from the ongoing Phase 1b open-label trial evaluating tegoprubart for the prevention of rejection in patients undergoing kidney transplant. Data from 11 participants demonstrated that tegoprubart was generally safe and well-tolerated in patients undergoing kidney transplantation, with aggregate mean estimated glomerular filtration rate (eGFR) above 70 mL/min/1.73m² at all reported time points after 90 days post-transplant. Results were presented at the American Society of Nephrology Kidney Week 2023 Annual Meeting held in Philadelphia, PA in November 2023.
Amended Phase 1b trial protocol to add a second cohort, now allowing enrollment of up to 24 trial participants who are undergoing kidney transplantation.
Enrolled first patient in a Phase 2 open-label extension (OLE) study, which will evaluate the long-term safety, pharmacokinetics, and efficacy of tegoprubart in participants who have completed one year of treatment in either the ongoing Phase 1b or Phase 2 BESTOW study. The participant completed the Phase 1b study with an eGFR of 91 at one year (day 374).
Partnered with the University of Chicago Transplantation Institute to secure financing from the Juvenile Diabetes Research Foundation (JDRF) and The Cure Alliance to fund an investigator sponsored study in pancreatic islet cell transplantation in participants with type 1 diabetes. Tegoprubart treatment will be evaluated for the prevention of transplant rejection.
Strengthened leadership team with appointment of Eliezer Katz, M.D., FACS as Chief Medical Officer and strengthened board of directors with appointment of Allan Kirk, M.D., Ph.D. and James Robinson.

Anticipated 2024 Milestones

Second quarter 2024: Report updated interim clinical data from the ongoing Phase 1b trial of tegoprubart in kidney transplantation.
End of 2024: Complete enrollment in the Phase 2 BESTOW trial of tegoprubart in kidney transplantation.
2024: Dose the first islet cell transplant participant for the treatment of type 1 diabetes at the University of Chicago Transplantation Institute.

Fourth Quarter 2023 Financial Results

The Company reported a net loss of $9.6 million, or $0.32 per share, for the three months ended December 31, 2023, compared to a net loss of $58.4 million, or $4.09 per share, for the same period in 2022. The net loss for the three months ended December 31, 2022 includes a non-cash goodwill impairment charge totaling $48.6 million. Excluding the non-cash impairment charge, net loss would be $9.7 million, or $0.68 per share.

Research and development expenses were $7.1 million for the three months ended December 31, 2023, compared to $7.3 million for the comparable period in 2022, a decrease of $0.2 million.

General and administrative expenses were $3.3 million for the three months ended December 31, 2023, compared to $2.8 million for the comparable period in 2022, an increase of $0.5 million.

Full Year 2023 Financial Results

The Company reported a net loss of $40.3 million, or $1.64 per share, for the year ended December 31, 2023, compared to a net loss of $88.0 million, or $6.16 per share, in 2022. The net loss for the year ended December 31, 2022 includes a non-cash goodwill impairment charge totaling $48.6 million. Excluding the non-cash impairment charge, net loss would be $39.3 million, or $2.75 per share.

Research and development expenses were $30.3 million for the year ended December 31, 2023, compared to $27.1 million for the year ended December 31, 2022, an increase of $3.2 million.

General and administrative expenses were $12.7 million for the year ended December 31, 2023, compared to $12.7 million for the year ended December 31, 2022.

The Company ended the year with approximately $51.1 million in cash and cash equivalents and short-term investments, compared to $56.4 million in cash and cash equivalents as of December 31, 2022.

About Eledon Pharmaceuticals and tegoprubart

Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, the company’s capital resources and ability to finance planned clinical trials, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous 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-Qs, 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 Jasper
Gilmartin Group
(858) 525 2047
stephen@gilmartinir.com

Media Contact:

Jenna Urban
Berry & Company Public Relations
(212) 253 8881
jurban@berrypr.com

Source: Eledon Pharmaceuticals

Release – Eledon Pharmaceuticals Announces 12th Participant Enrolled in Phase 2 BESTOW Trial Evaluating Tegoprubart for the Prevention of Organ Rejection

Posted on March 25, 2024March 26, 2024 by aweinsoff@channelchek.com

Research News and Market Data on ELDN

March 25, 2024

PDF Version

IRVINE, Calif., March 25, 2024 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced the enrollment of the 12^th participant on March 23, 2024, in the Company’s ongoing Phase 2 BESTOW trial assessing tegoprubart head-to-head with tacrolimus for the prevention of rejection in kidney transplantation.

“We are pleased with the strong pace of enrollment in our Phase 2 BESTOW trial and believe it speaks to the underlying demand for a new immunosuppressive regimen for the tens of thousands of patients each year who undergo kidney transplantation,” said David-Alexandre C. Gros, M.D., Chief Executive Officer.

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. Rejection occurs due to allorecognition, wherein the recipient’s immune system identifies the transplanted organ as foreign tissue, triggering an immune response against the transplanted organ. To reduce the risk of rejection, patients are treated with immunosuppressive therapies for life. Calcineurin inhibitors (“CNIs”) are a critical component of most immunosuppressive regimens to prevent acute and long-term organ transplant rejection. However, chronic exposure to CNIs (tacrolimus is the drug most commonly used) is associated with nephrotoxicity, hypertension, new onset diabetes due to pancreatic beta cell toxicity, as well as central nervous system side effects like tremor. Regarding kidney transplantation, the toxicity associated with CNIs causes 30-50% of kidney transplants to fail with 10-15 years of transplantation. 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

Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.

Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the demand for a new and better immunosuppressive regimen for patients who undergo kidney transplantation, or statements about the Company’s other future expectations, plans and prospects, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous 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-Qs, 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 Jasper
Gilmartin Group
(858) 525 2047
stephen@gilmartinir.com

Media Contact:

Jenna Urban
Berry & Company Public Relations
(212) 253 8881
jurban@berrypr.com

Source: Eledon Pharmaceuticals

Eledon Pharmaceuticals (ELDN) – First Transplant Of A Pig Kidney Uses Tegoprubart To Prevent Immune Rejection

Posted on March 22, 2024March 22, 2024 by cpereira@noblefcm.com

Friday, March 22, 2024

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

First Transplant Of A Genetically Modified Kidney To A Human. Eledon announced that tegoprubart, its drug in development to prevent organ transplant rejection, was used in the first transplant of an engineered pig kidney into a human patient. The kidney was genetically engineered by eGenesis, Inc, a company that has been collaborating with Eledon. Tegoprubart is currently in a Phase 2 clinical trial testing it against tacrolimus in prevention of kidney transplant rejection.

Eledon Has A Research Collaborated With eGenesis. The pig kidney was engineered by eGenesis, Inc, a company that formed a research collaboration with Eledon in January 2023. eGenesis has proprietary technology for engineering genetic changes to animal organs to make them compatible for transplantation into humans. As described in our Research Note on October 16, these genetic changes reduce the cross-species immunological barriers. The agreement allows eGenesis to use tegoprubart in its xenotransplantation research.

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Breakthrough: First Genetically Modified Pig Kidney Transplanted into Human

Posted on March 21, 2024March 21, 2024 by slightbourne@noblecapitalmarkets.com

In a groundbreaking medical procedure, surgeons at Massachusetts General Hospital have successfully transplanted a genetically modified pig’s kidney into a human patient – the first xenotransplantation of its kind. This historic operation, performed on March 16th, 2024, provides hope that xenotransplantation could one day help alleviate the chronic shortage of human organs available for those desperately awaiting a life-saving transplant.

The recipient was a 62-year-old man suffering from end-stage kidney disease. After his body initially accepted the pig kidney, a drug regimen was immediately administered to prevent rejection, including the experimental anti-rejection therapy tegoprubart developed by Eledon Pharmaceuticals.

“This first-ever kidney xenotransplant marks a pivotal moment for the transplant community,” stated David-Alexandre C. Gros, M.D., CEO of Eledon Pharmaceuticals. “We are thankful for the opportunity to participate in this landmark procedure as we work to develop tegoprubart as a new and potentially superior immunosuppressive option for transplant patients.”

Preventing Rejection Key to Xenotransplant Success
The greatest challenge in xenotransplantation is preventing the recipient’s body from violently rejecting the foreign organ. Tegoprubart targets a protein called CD40 ligand (CD40L) that plays a central role in activating the immune system’s responses against the transplanted organ.

“Therapies targeting CD40L, like tegoprubart, are critical to controlling the immune response to the xenograft, potentially leading to superior long-term outcomes compared to other immunosuppressive therapies,” explained Andrew Adams, M.D., Ph.D., Chief of Transplant Surgery at the University of Minnesota.

Tegoprubart has already shown promise in preventing rejection in previous pig-to-human heart xenotransplants as well as in ongoing clinical trials for human-to-human kidney transplants.

“We have seen tegoprubart be safe and well-tolerated while successfully preventing rejection and enabling above-average kidney function post-transplant when used as part of an immunosuppressive regimen in our Phase 1b kidney transplant study,” said Dr. Gros.

A Pivotal Moment of Hope
For the medical team at Massachusetts General Hospital, this pioneering procedure represents a significant milestone with profound implications for the future of transplant medicine.

“Xenotransplantation represents a unique approach with the potential to provide patients with additional options to access life-saving treatments in a timely manner,” said Dr. Leonardo V. Riella, Medical Director for Kidney Transplantation at MGH. “We commend the courage of our patient and look forward to continued advancements to make this option available to more patients.”

More than 90,000 Americans are currently on the national waiting list for a kidney transplant, with thousands more awaiting other life-saving organ donations. The ability to use genetically engineered animal organs could dramatically increase the supply available for transplant.

“This procedure provides hope that xenotransplantation may one day help solve the current shortage of available organs,” noted Dr. Gros. “While still at an experimental stage, it’s an exciting development for the entire transplant field.”

Critical Next Steps
Eledon is conducting further preclinical studies evaluating tegoprubart’s ability to prevent rejection in non-human primate recipients of xenotransplanted organs. The company is also running a Phase 2 clinical trial called BESTOW directly comparing tegoprubart head-to-head against the standard anti-rejection drug tacrolimus for preventing kidney rejection in human-to-human transplants.

While this first xenotransplant procedure is an incredible medical achievement, significant additional research is still needed to prove the technique can lead to consistently successful long-term outcomes. However, this unprecedented operation has opened up a new frontier of possibilities for making organ transplants more widely available to the hundreds of thousands in need.

Take a moment to watch an intriguing panel discussion on xenotransplantation with CEO of Eledon Pharmaceuticals, Dr. DA Gros and other prominent figures in the field at NobleCon19.

Release – Eledon Pharmaceuticals Announces Use of Tegoprubart in First-ever Transplant of Genetically Modified Kidney from a Pig to a Human

Posted on March 21, 2024March 21, 2024 by aweinsoff@channelchek.com

Research News and Market Data on ELDN

March 21, 2024

Historic kidney xenotransplantation procedure conducted at Massachusetts General Hospital

Tegoprubart administration has now been used investigationally to prevent rejection in both kidney and heart pig-to-human xenotransplantations, as well as in human-to-human kidney transplantation

Eledon recently presented results from its ongoing Phase 1b kidney transplantation study which demonstrated that tegoprubart was generally safe and well tolerated and successfully prevented rejection with post-transplant kidney function above historical averages

IRVINE, Calif., March 21, 2024 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced that tegoprubart, the company’s investigational anti-CD40L antibody, was used as a component of the immunosuppressive treatment regimen following the first-ever transplant of a kidney from a genetically modified pig to a human. The procedure was completed on March 16, 2024, at Massachusetts General Hospital on a 62-year-old man living with end-stage kidney disease.

“This first-ever kidney xenotransplant marks a pivotal moment for the transplant community and provides hope that this option may one day help solve the current shortage of available organs,” said David-Alexandre C. Gros, M.D., Eledon Chief Executive Officer. “Eledon has now participated in both heart and kidney xenotransplant procedures, further demonstrating tegoprubart’s broad potential in transplant. We are thankful to the patient, the entire medical team at Massachusetts General Hospital, and our partner eGenesis for the privilege to participate in this landmark procedure as we work to achieve our goal of developing tegoprubart as a new and better immunosuppressive option for transplant patients.”

Tegoprubart is being administered to the patient investigationally as part of a regimen designed to suppress the immune system and prevent the body from rejecting the transplanted pig organ. Tegoprubart has been observed to be safe and well-tolerated in multiple studies and in multiple indications, including for the prevention of rejection following kidney transplantation.

“It is exciting to see the clinical application of xenotransplantation to a patient with end stage renal disease,” said Andrew Adams, MD, PhD, Chief, Division of Transplant Surgery, University of Minnesota. “Based on all of the studies performed in preclinical models to date, it is clear that therapies targeting CD40L, like tegoprubart, are critical to controlling the immune response to the xenograft, potentially leading to superior long-term outcomes compared to other immunosuppressive therapies. CD40L sits at the interface of the adaptive and innate immune responses which may explain why therapies designed to block it have such potent effects in xenotransplantation.”

“This procedure represents a significant milestone in the transplantation field and a promising step to address a medical crisis: the worldwide shortage of available organs,” said Leonardo V. Riella, MD, PhD, Medical Director for Kidney Transplantation at Massachusetts General Hospital. “Xenotransplantation represents a unique approach with the potential to provide patients with additional options to access life-saving treatments in a timely manner. We commend the courage of our patient and the skill of the entire team involved in the operation, and I look forward to continued advancements in research with the hope that we can make this novel treatment option available to more patients in the future.”

Multiple clinical and preclinical research efforts are currently underway to evaluate the ability of tegoprubart to reduce the risk of rejection in organ transplant. Eledon is advancing preclinical studies in which tegoprubart is being used as a part of the immunosuppression regimen designed to reduce the risk of rejection in nonhuman primate recipients in xenotransplant procedures. In parallel, Eledon is running two global clinical studies evaluating tegoprubart for the prevention of organ rejection in persons receiving a de novo kidney transplant. The company recently presented results from 11 participants enrolled in its ongoing Phase 1b kidney transplantation study, which demonstrated that tegoprubart, as part of a calcineurin inhibitor free immunosuppressive regimen, was generally safe and well tolerated and both successfully prevented rejection as well as permitted above historical average post-transplant kidney function. The company’s Phase 2 BESTOW study, assessing tegoprubart head-to-head with tacrolimus for the prevention of rejection in kidney transplantation, is currently recruiting participants, and plans to complete enrollment at the end of 2024.

About Eledon Pharmaceuticals and tegoprubart

Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.

Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous 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 Jasper
Gilmartin Group
(858) 525 2047
stephen@gilmartinir.com

Media Contact:

Jenna Urban
Berry & Company Public Relations
(212) 253 8881
jurban@berrypr.com

Source: Eledon Pharmaceuticals

Source: Eledon Pharmaceuticals, Inc.

Release – Eledon Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Posted on February 14, 2024February 14, 2024 by aweinsoff@channelchek.com

Research News and Market Data on ELDN

February 13, 2024

IRVINE, Calif., Feb. 13, 2024 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced that the Company’s Compensation Committee granted 42,500 restricted stock units (RSUs) and stock options to purchase an aggregate of 90,000 common shares, at a per share exercise price of $1.77, the closing price of Eledon’s common stock on the grant date, to one employee. The RSUs and stock options were granted as inducements material to the new employee entering employment with Eledon in accordance with Nasdaq Listing Rule 5635(c)(4).

The RSUs vest fully on the one-year anniversary of the grant date. The stock options have a ten-year term and vest over four years, with 25% of the original number of shares vesting on the one-year anniversary of the grant date and 6.25% of the stock options vesting quarterly thereafter until fully vested on the fourth anniversary of the grant date. In each case, vesting is subject to the relevant employee’s continued service with Eledon on the applicable vesting date.

About Eledon Pharmaceuticals and tegoprubart

Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter

Investor Contact:

Stephen Jasper
Gilmartin Group
(858) 525 2047
stephen@gilmartinir.com

Media Contact:

Jenna Urban
Berry & Company Public Relations
(212) 253 8881
jurban@berrypr.com

Source: Eledon Pharmaceuticals

Release – Eledon Pharmaceuticals Highlights Recent Business Milestones and Provides 2024 Outlook

Posted on January 5, 2024January 5, 2024 by aweinsoff@channelchek.com

Research News and Market Data on ELDN

January 4, 2024

PDF Version

Reported updated data from ongoing Phase 1b trial in kidney transplantation demonstrating tegoprubart treatment successfully prevented kidney transplant rejection and was generally safe and well-tolerated

Dosed first participants in Phase 2 BESTOW trial in kidney transplantation

Tegoprubart dosed in second-ever pig to human xenotransplant procedure

IRVINE, Calif., Jan. 04, 2024 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced a summary of 2023 accomplishments and provided guidance for anticipated upcoming 2024 milestones.

2023 Key Highlights

Reported updated data from ongoing Phase 1b trial evaluating tegoprubart for prevention of rejection in kidney transplantation. Data from 11 trial participants demonstrated that tegoprubart was generally safe and well-tolerated in patients undergoing kidney transplantation, with aggregate mean estimated glomerular filtration rate (eGFR) above 70 mL/min/1.73m² at all reported time points after 90 days post-transplant. Amended the Phase 1b trial protocol to add a second cohort, now allowing enrollment of up to 24 trial participants who are undergoing kidney transplantation.
Dosed first participants in Phase 2 BESTOW trial assessing tegoprubart head-to-head with tacrolimus for the prevention of rejection in kidney transplantation.
Dosed tegoprubart in second-ever transplant of genetically modified heart from a pig to a human.
Completed financing of up to $185 million, with $35 million in upfront funding and additional aggregate financing of up to $105 million, subject to achieving clinical development milestones, volume weighted share price levels, and trading volume conditions, as well as up to an additional $45 million upon exercise of warrants. If all commitments are met, the financing is expected to be sufficient to fund the Company through the completion of the Phase 2 BESTOW trial, subject to the achievement of specified milestones, including clinical development enrollment targets.
Partnered with the University of Chicago Transplantation Institute to secure financing from the Juvenile Diabetes Research Foundation (JDRF) and The Cure Alliance to fund an investigator sponsored study in pancreatic islet cell transplantation in participants with type 1 diabetes. Tegoprubart treatment will be evaluated for the prevention of transplant rejection.
Strengthened leadership team with appointment of Eliezer Katz, M.D., FACS as Chief Medical Officer and strengthened board of directors with appointment of Allan Kirk, M.D., Ph.D. and James Robinson.

“Eledon made significant progress in 2023 on multiple fronts, highlighted by the presentation of the first clinical evidence of tegoprubart’s potential to prevent organ rejection while producing robust improvements in eGFR and maintaining a favorable safety profile. We were also honored to play an important role in the second-ever transplant of a genetically modified heart from a pig to a human with the use of tegoprubart as part of the patient’s cornerstone immunosuppressive regimen,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “In the coming year, we look forward to building upon the promising results from our tegoprubart kidney transplant Phase 1b trial, generating additional long-term data from the Phase 1b extension study, and completing enrollment in our Phase 2 BESTOW trial.”

Anticipated 2024 Milestones

First half of 2024: Report updated interim clinical data from the ongoing Phase 1b trial of tegoprubart in kidney transplantation.
First half of 2024: Dose the 12^th participant in the Phase 2 BESTOW trial. Upon the dosing of the 12^th participant, the Company will have completed both clinical development milestones related to the second financing tranche from the private placement announced on May 1, 2023.
End of 2024: Complete enrollment in the Phase 2 BESTOW trial of tegoprubart in kidney transplantation.
2024: Dose the first islet cell transplant participant for the treatment of type 1 diabetes at the University of Chicago Transplantation Institute.

About Eledon Pharmaceuticals and tegoprubart

Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, the company’s capital resources and ability to finance planned clinical trials, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous 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 Jasper
Gilmartin Group
(858) 525 2047
stephen@gilmartinir.com

Media Contact:

Jenna Urban
Berry & Company Public Relations
(212) 253 8881
jurban@berrypr.com

Source: Eledon Pharmaceuticals

Pushing the Frontiers: Innovation and Investment in Organ Transplantation

Posted on December 8, 2023December 8, 2023 by slightbourne@noblecapitalmarkets.com

The NobleCon19 panel discussion moderated by Nathan Cali, investment banker at Noble Capital Markets, on organ transplantation featured prominent figures in the field, including Dr. Karin Hehenberger, an organ transplant patient and founder of Lyfebulb, Dr. David Alexandre Gros, CEO of Eledon Pharmaceuticals, Dr. Muhammed Mohiuddin, director of the cardiac xenotransplantation program at the University of Maryland, and Dr. Pietr Witoski, surgery director of pancreatic and islet tranplant program at the University of Chicago. The discussion delved into their experiences, challenges in the organ transplant landscape, and revolutionary advancements, especially focusing on the concept of xenotransplantation.

Organ transplantation has come a remarkably long way since the first successful procedures in the 1950s and 60s. Yet there remain significant unmet needs and opportunities to further improve patient outcomes, quality of life, and access to these lifesaving procedures. At a presentation during NobleCon19, a panel of experts explored some of the latest breakthroughs and remaining challenges in areas ranging from immunosuppression to cross-species transplantation.

A Complex Treatment Paradigm

As patient-turned-advocate Dr. Karin Hehenberger related from personal experience, undergoing an organ transplant and living with a graft is filled with difficulties. The trauma of the surgery itself and needing immune-suppressing drugs just to avoid rejection deliver blows to physical health and mental wellbeing. This begins with a harrowing wait for a matching donor organ, continues through post-operative complications like infections, and extends for the rest of one’s life.

The panelists agreed the pressure on patients could be significantly reduced through innovation. More targeted immunosuppressants without harmful side effects would greatly improve quality of life after transplant surgery. Some emerging drug candidates like Eledon Pharmaceuticals Tegoprubart show early signs of progress on this front. There is also a global shortage of donor organs trailing far behind demand; new sources through xenotransplantation or regenerative medicine techniques could help resolve this shortage.

“We need a community where transplanted patients can come together, generate data, and advocate for change,” urged Dr. Hehenberger.

The valuable role of patient communities mirrors the interdisciplinary cooperation needed among the surgeons, specialists, social workers, and other caregivers that make organ transplantation successful. As Dr. Hehhenberger explained, the assessment process for transplant eligibility spans physical health, mental fitness, medication compliance, accessible transportation, and financial support. It is complex care with little margin for error.

An Evolving Market Landscape

Currently, the organ transplant market racks up over $5 billion in value each year and continues expanding at a steady pace. Much of this activity centers specifically around kidney transplants, where surgical innovations and public policy initiatives keep pushing the boundaries. As Dr. DA Gros noted, there are now a quarter million Americans living with a functioning kidney graft – proof of concept for an underappreciated treatment paradigm.

And yet, the surface has barely been scratched in terms of serving potential patients. Over half a million more remain tethered to dialysis as a stand-in for natural kidney function, with 125,000 added to this group annually in the U.S. alone. Dialysis generates its own burdens: decreased workplace productivity, infection risks, lower quality of life. From both humanitarian and financial viewpoints, empowering wider transition from dialysis to transplantation promises tremendous upside.

Experts on the panel targeted improved education around organ transplant options as a key opportunity. Many patients lack full information about the benefits transplant procedures can offer, or they confront social stigmas against this route. Policy revisions to widen access and increase support for lower-income patient communities could have an outsized impact as well.

Meanwhile, the business of organ transplantation continuously evolves. Major pharma companies like Bristol Meyers Squib remain heavily invested, yet a series of smaller players also drive momentum through novel immuno-therapy products. Audience members were encouraged to track firms like Aelix and Tacus for the next wave of clinical updates that will shape standard of care.

Pioneering the Future

Homing in on the future, speakers keyed in on barriers still to be conquered in transplantation medicine. While kidney procedures serve as a beachhead, there is a pressing need to expand reliable methods across more organ types while lengthening graft duration at the same time. This is no small task.

It will require rethinking conventional assumptions for a field that has relied predominantly on broad immune suppression since its inception. Some emerging biotech pipelines target specific T and B cell pathways implicated in chronic organ rejection, attempting to avoid toxicity associated with generalized immunosuppression. Early data hints at improved longevity for liver and heart grafts, but longer studies are still needed.

An even more radical solution highlighted by multiple panelists is the concept of xenotransplantation: introducing organs from other species like pigs into human patients. Recent demonstrations of human-pig heart and skin grafts saw patients survive months post-procedure compared to an anticipated span of days or weeks. The results electrified the transplant community given implications for essentially eliminating organ supply constraints.

That said, experts admit there are hurdles left to address before clinical adoption. Ethical quandaries exist around genetically modifying donor animals and infectious disease transmission risks from one species to another. Questions also persist about which immune pathways necessitate targeting for prolonged graft survival and how to refine the anti-rejection pharmaceutical regimens employed.

Signs point to countries with more flexible regulatory regimes as the likely springboards for refining xenotransplant methods and technology in the shorter-term. Yet the longer-term promise seems resoundingly clear. “If allowed, we will solve the organ shortage problem,” declared surgeon Dr. Peter Witoski when asked about outlook for the field.

A Call to Action

In closing the panel presentation, speakers underscored a sense of guarded optimism balanced with persistent unmet needs in transplantation medicine today. Limitations around donor organ supply and chronic graft failure continue exacting a real human toll, even if raw statistics showcase a steady rise in life-saving procedures overall.

It will take coordinated effort from policy makers, researchers, clinicians, investors and patient advocates to push new discoveries over the finish line – where they can impact the maximum number of lives. Key questions around optimal business models for novel therapeutics, data transparency, and equitable access are unlikely to solve themselves.

Yet the convergence of breakthrough technologies and innovative platforms for generating evidence, educating stakeholders and disseminating insights points toward a sea change for what the future may hold in this vital area of healthcare. The experts and audience members left the discussion around organ transplantation feeling energized to play their respective parts in driving that change.

Watch the webcast from The Organ Transplant presentation at NobleCon19 here