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.
Data From Phase 1b Trial Updated. Eledon presented data from the Phase 1b trial testing tegoprubart, its drug for prevention of kidney transplant rejection, at the American Transplant Congress. We found the data to continue to show improved kidney function during the first year after transplantation, a strong indicator of organ survival, with continued safety and tolerability.
Kidney Function Measures Continue To Show Improvements Over Tacrolimus. The Phase 1b data included 13 patients who had reached 30-day post-transplant evaluation. Their mean eGFR was above 60 mL/min/1.73m² at each reported time point. The overall mean eGFR after day 30 reached 70.5 mL/min/1.73m². This is an improvement over standard-of-care immunosuppressive regimens that have eGFR rates around the 50ml/min/1.73m² level during the first year after the transplant.
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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.
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.
“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.
