Dr. Tim Bertram CEO
Chronic kidney disease (CKD) affects 40 million people in the US (one in seven adults), causes more deaths than prostate or breast cancer; yet there are no therapies that can reverse the insidious progression once started. The current standards-of-care (SOC) simply slow the decline of renal function that ultimately ends in renal failure. End stage renal disease (ESRD) is resolved only by renal replacement consisting of dialysis or for a very few, organ transplant. Thirty percent of patients die every 3-5 years on dialysis.
Today, there are over 100,000 people in the U.S. on the waiting list for a kidney transplant, and 13 of them die every day. Those who do receive transplants face a lifetime of immune suppressants predisposing them to deadly infections and cancer. Even for those who receive an organ, 50 percent of transplanted kidneys are no longer functional after 10 years. Collectively, these “disease management” strategies cost the U.S. health care system over $30 billion dollars per year. Once a patient progresses to ESRD the health care costs alone consume 40 percent of the Medicare/Medicaid budget in the USA.
inRegen has the potential to transform the treatment of this huge underserved patient population, 850 million people worldwide, with a personalized injectable cell therapy. Today, inRegenis developing the only treatment with the potential to increase renal function and thus to delay or prevent the need for dialysis or organ transplantation. inRegen’s REACT (Renal Advanced Cell Therapy) harnesses and multiplies the kidney’s intrinsic ability to repair kidney function and bring a halt to the steady decline of CKD.
REACT is in Phase 2/3 clinical trials currently active in the USA and enjoys a robust safety profile. This technology is based on over 15 years of patented proprietary breakthroughs in progenitor cell biology research, manufacturing, and advanced therapy developments.
The Insights That Drive A Potential Cure
REACT was founded by the observation that special cell populations were responsible for replacing damaged cells during the healing process in chronic kidney disease.
This realization led to break through research efforts that defined the selection and multiplication of individual kidney progenitor cells that can be obtained from both healthy, as well as people suffering from CKD. Renal progenitor cells are the precursors to each part of the kidney’s functional units–the nephron. These progenitor cells have the potential to restore kidney function and are specific to everyone. The challenge inRegen faced was to identify, multiply, and formulate these cells from diseased kidneys so that a patient suffering from CKD could obtain the needed cells that restore their intrinsic ability to repair the damaged nephrons. If the challenge could be addressed, each patient’s own kidney progenitor cells would be captured, multiplied, formulated and reintroduced safely via minimally invasive injections that would occur via an outpatient procedure. These goals drove years of clinical and manufacturing research that led to this advanced, personalized, scalable cell therapy with the potential to be cost-efficient and treat chronically diseased kidneys.
Transforming Patients’ Lives…and the Medical Landscape
We select the few progenitor cells remaining in a chronically diseased kidney, then multiply, package and return them to the patient to restore damaged kidneys
The existing standards-of-care for CKD, do not reverse certain CKD disease processes. As CKD worsens, it can complicate treatment for both high blood pressure and diabetes, both of which cause CKD in the first place, increasing the risk of heart disease and death. By stabilizing kidney function, REACT can enable better treatment of CKD’s underlying causes and comorbidities and transform patients’ lives.
REACT has the potential to mitigate the need for dialysis or a transplant. Because REACT is autologous and uses each patient’s own progenitor cells, the injected kidney can repair, and restore functioning kidney tissues as would occur naturally because it is accepted by the body and does not require immuno-suppressants. Thus, REACT enjoys a robust safety profile.
Fast-Tracking A Potential Cure
REACT is the only therapy with the potential to increase renal function in CKD and to delay or eliminate the need for dialysis or organ transplantation. In a manufacturing partnership with Twin City Bio, inRegen is expanding clinical trials into multiple countries, incorporating new markers to guide the proper time to treat affected patients. In close collaboration with regulators from the United States Food and Drug Administration (FDA) and the European Union, inRegen hopes to bring this advanced medical therapy to patients as quickly as possible.
inRegen’s executive leadership team is guided by Dr. Tim Bertram who has pioneered this research effort since its inception in 2004. This team enjoys over 75 years of combined experience in cell-therapy development and has previously commercialized nearly 20 medicines. Their commitment, combined with REACT’s robust intellectual property position, supports REACT’s longevity once it is approved and marketed. Tim’s commitment is patient-centric and focuses on people suffering with CKD - “To have an impact on this disease, we must have an unwavering commitment to restore kidney function for each patient. There are 850 million people worldwide that are afflicted by declining kidney function and we aim to make a difference for each of them,” concludes Dr. Tim Bertram