London, UK, 2 July 2020 - Rexgenero, a regenerative medicine company developing advanced cell therapies to treat chronic limb-threatening ischaemia (CLI), today announces that Dr Gilbert Wagener has joined the Company as Senior Vice President and Chief Medical Officer. In this new role, Gilbert will be responsible for cell therapy development, clinical and medical activities, and regulatory strategy.
Gilbert has more than 20 years of experience in global drug development for cardiovascular and immune-mediated indications. Prior to his role at Rexgenero, Gilbert was a Senior Partner at TranScrip Partners LLP where he was the strategic lead on several drug programmes. This involved work on assets at various stages in the drug development life cycle and leading on due diligence, development strategy, proof-of-concept (PoC) and Phase I–III clinical studies across several auto-immune disease indications, including PoC and development strategy for a cell therapy candidate for CLI.
After practising as a physician, Gilbert started his drug development career at Bayer Health AG in 1993, where he held positions of increasing responsibility in late-stage development, life-cycle management and Phase I and PoC studies for drug candidates for cardiovascular indications. Following this, he held a number of senior roles at Genzyme B.V., including Vice President, Vice President of Clinical Research (Genzyme Europe) and Head of Department for Cardiovascular (Genzyme Europe), and was responsible for PoC trials for stem cell and gene therapies in cardiovascular indications and coordination of medical due diligence.
Joe Dupere, Rexgenero’s CEO, commented: “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.”
Gilbert 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.”
Gilbert is a fellow of the European Society of Hypertension and member of the European Society of Cardiology, the Working Group on Cardiovascular Pharmacology and Drug Therapy. He is also a member of the German Society of Pharmacology and Toxicology and the German Society of Physiology.
Gilbert studied medicine in Marburg, Germany, completed an MD in Pharmacology and gained experience in Neurophysiology and Clinical Neurology at Marburg University Hospital. Gilbert holds a PhD in Epidemiology and Public Health from Erasmus University, the Netherlands, and an MBA in Pharmaceutical Medicine from University of Basel, Switzerland.
Rexgenero is a privately held, UK-based cell and gene therapy company pioneering the development of therapies to treat serious diseases such as chronic limb-threatening ischemia (CLI), cancer and immunological disorders.
Rexgenero’s lead product, REX-001, consists of a suspension of immune and progenitor cells involved in immune modulation, blood vessel regeneration and remodelling and improvement in blood flow. It is manufactured using a patient’s own cells, avoiding undesired immune responses. REX-001 is currently being tested in pivotal, placebo-controlled, double-blind, adaptive Phase III SALAMANDER trials in patients with CLI and diabetes mellitus at multiple sites across Europe. Previous randomised REX-001 clinical trials have already demonstrated statistically significant proof of concept. In a Phase I/II and Phase II clinical trial, REX-001 showed very strong positive results in improvement of blood flow, healing of ulcers and alleviating chronic ischemic rest pain. All ulcers healed within 12 months in 82% of patients after treatment with REX-001 at the dose being currently tested in Phase III trials.
The company also has a pioneering synthetic gene delivery platform, including an off-the-shelf CAR-T therapy allowing the in vivo targeting and transduction of T-cells.
Rexgenero’s lentivector, encoding for the Chimeric Antigen Receptor, is coated with a polymeric envelope grafted with an anti-CD3 targeting moiety to target T-cells. In contrast to approved ex vivo CAR T-cell therapies, the company’s in vivo technology requires low-cost manufacturing. The genetic modification to express the CAR is generated directly in the patient. Rexgenero’s inducible, switchable, in vivo CAR-T platform, represents a significant advantage over current recently approved ex vivo CAR-T therapies, with the potential for more effective, more universal, and safer treatments.
Rexgenero has offices in London, UK with R&D and manufacturing operations in Seville, Spain and Paris, France and additional manufacturing capability in Frankfurt, Germany.
For more information, please visit www.rexgenero.com
Connect with us: Twitter: @_Rexgenero; LinkedIn: https://www.linkedin.com/company/rexgenero-limited/
About REX-001 and the Phase III SALAMANDER clinical trials
REX-001 consists of bone-marrow-derived white blood cells extracted from the patient (autologous) and has shown efficacy in 80% of patients in Phase II and I/II studies.
Rexgenero is in the process of treating a total of 138 patients with CLI and diabetes in two pivotal, placebo-controlled, double-blind and adaptive Phase III clinical trials (dubbed the ‘SALAMANDER’ clinical trials) at approximately 30 sites across Europe.
The clinical trials use a highly innovative and adaptive trial design with novel primary endpoints that increase the sensitivity of the study and increase the likelihood of REX-001 succeeding as a breakthrough treatment for CLI.
For more information, please visit: https://www.cli-treatment.com/en/home
Issued for and on behalf of Rexgenero by Instinctif Partners.
For more information please contact: Rexgenero@instinctif.com