Rigenerand Gene Therapy Key Technology Published in Scientific Journals

PRESS RELEASE 1 - 2019 Medolla – 19 February 2019 Scientific Reports just publishes the anti-pancreatic cancer gene therapy approach based on modified adipose-derived cells capable to release a novel TRAIL variant with a potent anti-tumor approach. The study, performed in collaboration with the Division of Oncology, Plastic Surgery and Pathology of the University Hospital of Modena and Reggio Emilia and with the laboratory of the Mirandola Technopole, shows for the first time that a novel engineered TRAIL released by human adipose cells can target a variety of human pancreatic cancer cells demonstrating pre-clinical safety and efficacy. The Scientific Report publication parallels an additional piece of scientific information just published on Theranostics regarding the possibility to combine chemotherapy agents and gene delivery for synergies to counteract possible mechanisms of resistance also impacting on tumor stromal cells as key players pancreatic cancer development. This work paves the way towards the clinical translation of the technology in humans within a Phase I/II trial expected for the coming year. “We are extremely excited about these scientific achievements that also arrive after encouraging regulatory feedbacks collected in the last part of 2018”- says Massimo Dominici MD, Rigenerand co-founder and scientific coordinator - “It surely represents a very good start for 2019 indicating the quality of the RR001 platform within our upcoming therapeutic strategy”. Further Readings Spano C, Grisendi G, Golinelli G, Rossignoli F, Prapa M, Bestagno M, Candini O, Petrachi T, Recchia A, Miselli F, Rovesti G, Orsi G, Maiorana A, Manni P, Veronesi E, Piccinno MS, Murgia A, Pinelli M, Horwitz EM, Cascinu S, Conte P, Dominici M. Soluble TRAIL Armed Human MSC As Gene Therapy For Pancreatic Cancer. Sci Rep. 2019;9:1788. Available if you like to read it Rossignoli F, Spano C, Grisendi G, Foppiani EM, Golinelli G, Mastrolia I, Bestagno M, Candini O, Petrachi T, Recchia A, Miselli F, Rovesti G, Orsi G, Veronesi E, Medici G, Petocchi B, Pinelli M, Horwitz EM, Conte P, Dominici M. MSC-Delivered Soluble TRAIL and Paclitaxel as Novel Combinatory Treatment for Pancreatic Adenocarcinoma. Theranostics 2019; 9:436. Available if you like to read it Safe Harbor. This release may contain forward-looking statements regarding RR001 and its future events and results that involve inherent risks and uncertainties. The words “expect,” “intend,” “plan” and similar expressions, as they relate to RR001 or its management, are intended to identify forward-looking statements. Important factors, many of which are beyond the control of Rigenerand srl, could cause actual results to differ materially from those set forth in the forward-looking statements. Rigenerand srl does not assume any obligation to update any of these forward-looking statements.

Rigenerand Announces Orphan Drug Designations from both EMA and FDA Obtained by RR001 for the Treatment of Pancreatic Cancer

Rigenerand srl announces the positive opinion on orphan drug designation (ODD) issued by the European Medicines Agency (EMA) for RR001 as treatment of pancreatic cancer. This relevant milestone immediately follows the ODD granted by the FDA (USA) on May 2018 for the same indication. RR001 is a gene therapy product based on adipose derived cells stably modified to produce pro-apoptotic ligands. RR001 is expected to reach the clinical phase within a planned Phase I/II trial as a first-line treatment in combination with chemotherapy in subsets of patients with pancreatic cancer. In addition to provide an access to incentives (e.g. in the EU: fee reductions, no limitation of protocol assistance, possibility to request a conditional approval and specific research grants), the ODD is the recognition by the Agencies of the plausibility of Rigenerand therapeutic approach as well as of its potential to bring in significant benefit to the existing treatments. Rigenerand srl, originally a spin-off by a joint venture between the University of Modena and Reggio Emilia and Rand srl (Italy), fights against cancer by gene modified effector cells and by developing novel 3D culture diagnostic tools. ODD released by key regulatory Agencies represents a boost for the development of RR001 against a still lethal tumor. Rigenerand is very pleased to release the news during the 2018 World Pancreatic Cancer day (http://www.worldpancreaticcancerday.org) that raises the awareness on the unacceptable prognosis of pancreatic cancer calling for global action in better diagnostics and therapeutics. Safe Harbor. This release may contain forward-looking statements regarding RR001 and its future events and results that involve inherent risks and uncertainties. The words “expect,” “intend,” “plan” and similar expressions, as they relate to RR001 or its management, are intended to identify forward-looking statements. Important factors, many of which are beyond the control of Rigenerand srl, could cause actual results to differ materially from those set forth in the forward-looking statements. Rigenerand srl does not assume any obligation to update any of these forward-looking statements. For more info: info@rigenerand.it