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Rexgenero Successfully Expands Manufacturing of REX-001 through Partnership with German Red Cross Blood Donor Service

May 28, 2019 Off By BusinessWire

Enables new sites to participate in the European Phase III SALAMANDER
trials

LONDON–(BUSINESS WIRE)–Rexgenero, a regenerative medicine company developing advanced
cell-based therapies to treat critical limb ischaemia (CLI), today
announces that it has successfully expanded manufacturing of its lead
development candidate REX-001 through a partnership with the German Red
Cross Blood Donor Service in Frankfurt, Germany, signed earlier this
year.

REX-001 is an autologous cell-based therapy and is manufactured using
the patient’s own bone marrow. It contains immune cells (lymphocytes,
monocytes and granulocytes) and progenitor cells involved in immune
modulation and tissue regeneration. Manufacturing is time critical as it
is important to ensure administration of the fresh product within 48
hours. Successfully transferring the manufacturing technology to this
second GMP facility in Europe is a key milestone to ensure sufficient
supply to patients enrolled in Rexgenero’s European Phase III SALAMANDER
trials of REX-001 for the treatment of CLI in patients with diabetes.

REX-001 is already manufactured at Rexgenero’s own GMP manufacturing
facility in Seville, Spain and used predominantly at clinical trial
sites in Spain and Portugal. Under a manufacturing partnership, the
German Red Cross Blood Donor Service will manufacture REX-001,
principally for use at additional trial sites in Germany, Poland, Czech
Republic, Hungary, The Netherlands, the U.K. and Austria. However, both
sites are able to manufacture and deliver product for most clinical
sites within the limited time frame, ensuring manufacturing flexibility
and backup possibilities.

The German Red Cross Blood Donor Service is one of the largest blood
donor services in Europe and has significant expertise in GMP
manufacturing of cell-based investigational medicinal products. The
manufacture of REX-001 is overseen by Professor Halvard Bönig, Institute
for Transfusion Medicine and Immunohematology, Goethe-University and
German Red Cross Blood Service Baden-Württemberg-Hessen, Frankfurt am
Main, Germany.

Edwin Wagena, COO of Rexgenero commented, “I would like to
congratulate Professor Halvard Bönig and his team at the German Red
Cross Blood Donor Service for successfully manufacturing REX-001 in
Germany. This new manufacturing site complements the activities of our
own facility in Spain and enables us to reduce delivery time to clinical
trial sites across Central and Eastern Europe.”

Liesbeth de Jong, Vice President, Manufacturing and Research &
Development at Rexgenero added, “Successfully transferring the
manufacturing technology for REX-001 to the German Red Cross Blood Donor
Service confirms we have full control over all aspects of the
manufacturing process. Manufacturing REX-001 involves a lot of technical
expertise and know-how so it is excellent news that Professor Bönig and
his team can now also manufacture REX-001. This will significantly
increase the capacity and flexibility of product supply in our Phase III
program.”

REX-001 Phase III SALAMANDER clinical
trials are open and recruiting patients at sites in Spain, Austria,
Portugal, Poland, the Czech Republic, Hungary and The Netherlands.

– ENDS –

About Rexgenero

Rexgenero is a clinical-stage regenerative medicine company developing
innovative cell-based therapies targeting serious diseases with unmet
medical needs.

The Company’s lead candidate REX-001, is a highly innovative autologous
cell therapy that is being studied in a Phase III clinical programme in
patients with critical limb ischemia (CLI) with diabetes, a poorly
treated disease with a high risk of amputation and death. REX-001 has
been shown to be effective in Phase I/II and Phase II trials,
alleviating CLI in the majority of patients, offering the potential to
increase the quality of life of CLI patients by reducing pain,
alleviating ulcers, increasing mobility, improving sleep and reducing
the need for amputation. Rexgenero is developing REX-001 in a range of
indications and, pending approval, intends to launch and market this
specialty product in major territories.

Rexgenero is a privately-owned company, which draws on an exceptional
understanding of the fundamental science of cell therapies developed by
the Andalusian Health Authority (Servicio Andaluz de Salud) and
Andalusian Initiative of Advanced Therapies.

The Company was founded in 2015 and is headquartered in London (UK) with
R&D and manufacturing operations in Seville (Spain) and Frankfurt
(Germany).

For more information, please visit www.rexgenero.com.

About the REX-001 Phase III SALAMANDER Trials

Rexgenero is planning to treat a total of 60 patients with CLI and rest
pain and 78 patients with CLI and non-healing ischemic ulcers in two
independent Phase III SALAMANDER trials in approximately 30 hospitals
across Europe. Clinical trials sites are open and recruiting patients in
Spain, Austria, Portugal, Poland, the Czech Republic, Hungary and The
Netherlands. The trials are given the name SALAMANDER in reference to
the amphibian’s ability to regenerate its tail and limbs.

For more information about the REX-001 Phase III SALAMANDER trials,
please visit the clinical
trial website.

About the German Red Cross Blood Donor Service

The German Red Cross Blood Donor Service Baden-Württemberg-Hessen (BSD)
is one of the world’s largest blood and transfusion medicine services.
As a research-oriented pharmaceutical manufacturer, BSD is heavily
invested in ATMP development and manufacturing, in collaboration with
both academic and commercial entities.

For more information, please visit www.blutspende.de/ueber-uns/institute-einrichtungen/frankfurt/institut-frankfurt.php