CRO

British cell therapy biotech Rexgenero nabs life science veteran as CMO

With stints at the likes of Genzyme, Bayer and, most recently, TranScrip Partners, Gilbert Wagener, M.D., Ph.D., is now signing up to U.K. biotech Rexgenero.

As senior vice president and chief medical officer, a new role for the company, Wagener will be tapped to lead cell therapy development, clinical and medical activities, and regulatory strategy.

Rexgenero is currently working on an late-stage cell therapy, known as REX-001, for critical limb ischemia (CLI) that causes burning pain in the feet as a result of blocked arteries in the lower limbs. Patients often get ulcers that can lead to amputation of the affected limb.

A year after initial diagnosis, around 12% of patients have had an amputation. Five years after diagnosis, the situation is even worse with mortality at 50%, rising to 70% after 10 years.

The biotech started two phase 3 tests late last year in the U.K. known as Salamander, specifically in diabetic patients with CLI.

Its leading asset works as an autologous cell therapy manufactured using the patient’s own bone marrow and consists of immune cells (lymphocytes, monocytes and granulocytes) and progenitor cells involved in immune modulation and tissue regeneration. It is given as a single dose within four days after collection of bone marrow cells.

The London-based biotech, with a manufacturing center in Spain, also just last month snapped up all the key assets of aratinga.bio SAS Group, a preclinical-stage immunotherapy biotech company based in Paris.

Joe Dupere, Ph.D., Rexgenero’s CEO, said: “We are delighted to welcome Gilbert who brings deep medical and scientific experience and expertise, particularly in the areas of cardiovascular diseases and cell and gene therapies. He has been a highly valued advisor during the development of REX-001 over the last five years and was instrumental in the establishment of our scientific advisory board. Gilbert will play a crucial role in steering our development programs through the next critical stage and beyond.”

Wagener added: “I have followed the development of Rexgenero’s cell therapy candidate for chronic limb-threatening ischaemia closely as it has progressed through clinical development, and I strongly believe in its potential for the treatment of this serious and life-threatening disease. I look forward to working with Joe and the wider clinical teams as we advance the Phase III clinical trial and overarching drug development strategy.”