Hospital San Gerardo

Publication January 11, 2023 Takis and Rottapharm Biotech announce the advance publication of the article “A first-in-human trial on the safety and immunogenicity of COVID-eVax, a cellular response-skewed DNA vaccine against COVID-19” by L. Aurisicchio et al in Molecular Therapy, the leading journal for research in the areas of gene transfer, vector development, stem cell manipulation, gene- and cell-based therapeutics, and vaccine development. COVID-eVax is a DNA vaccine encoding the receptor binding domain (RBD) of the SARS-CoV-2 spike protein. It is the first COVID-19 vaccine based on the DNA platform to reach clinical development in Europe and it was developed in synergy with an innovative technology called “electroporation”, which thanks to short electrical stimuli mediates the passage of DNA inside the cells and activates the immune system. Among the important advantages, DNA is cheap, does not need complex formulations and does not need the cold chain. The study is the result of a fruitful collaboration within a 100% Italian network: the two companies developing COVID-eVax (Takis and Rottapharm Biotech); the leader in the electroporation technology (IGEA); important academic institutions and clinical centers (San Gerardo Hospital in Monza with the University of Milan-Bicocca, the National Cancer Institute IRCCS Pascale in Naples and the Clinical Research Center in Verona); the VisMederi laboratories in Siena, worldwide expert in viral and immune assays. COVID-eVax was well tolerated and induced an immune response (binding antibodies and/or T cells) in up to 90% of the volunteers at the highest dose. However, the vaccine did not induce neutralizing antibodies, while particularly relevant was the T cell-mediated immunity, with a robust Th1 response. This T cell-skewed immunological response adds significant information to the DNA vaccine platform and should be assessed in further studies for its protective capacity and potential usefulness also in other therapeutic areas, such as Oncology. Takis Takis is a biotechnology company created by a group of scientists formerly from Merck Research Laboratories (MRL) and it is located in Rome (Italy). The group has more than 15 years of experience and proven expertise in drug discovery in Oncology and is recognized for the design and implementation of a number of innovative technologies, including that of DNA gene therapy. One of Takis’s core assets is its experience with electroporation, a technology that can be used for a variety of clinically useful applications, from vaccine development to somatic gene therapy. Takis’ pipeline includes four cancer vaccine candidates based on this technology. Takis is also actively involved in the generation of humanized monoclonal antibodies for use in oncology and infectious diseases, including COVID-19. For more information on the company, visit www.takisbiotech.it Takis contact Dr. Luigi Aurisicchio (CEO/CSO) aurisicchio@takisbiotech.it Rottapharm Biotech Rottapharm Biotech is a research company dedicated to the discovery and development of innovative drugs. It is located in Monza (Italy) The company expertise in research and development includes medicinal / computational chemistry for small molecules, a proprietary platform for the generation and selection of new monoclonal antibodies and the development of other biological drugs and advanced therapies, the validation of new molecular targets, the pharmacological, pharmacokinetic, toxicological and pharmaceutical characterization of new drug candidates; the design and conduct of innovative clinical trials. The company strategy is to develop its own pipeline independently and then seek partnerships with pharmaceutical companies, as well as investing in alliances on innovative projects of other biotech companies or university spin-offs. Rottapharm Biotech contact Dr. Federica Girolami (Business Development, Scientific Liaison and Drug Safety Director) federica.girolami@rottapharmbiotech.com

DURHAM, N.C. , April 30, 2020 (GLOBE NEWSWIRE) -- CoImmune, Inc. today announced that it has successfully completed the merger with Formula Pharmaceuticals, Inc., bringing together two therapeutic immuno-oncology platforms. Formula Pharmaceuticals merged into CoImmune with CoImmune as the surviving company. CoImmune will continue to focus on running a Phase 2b trial for lead asset, CMN-001, in advanced renal cell carcinoma. With the merger’s completion, CoImmune will use the newly acquired technology, CAR-CIK (cytokine-induced killer cells), for clinical development in acute lymphoblastic leukemia. The proprietary CAR-CIK technology platform derives from work mainly performed by the Tettamanti Foundation of Monza, Italy, in connection with one of the pioneering centers for cell therapy in Europe, located at the San Gerardo Hospital in Monza, Italy. This technology has the potential to overcome commercial limitations related to existing CAR-T approaches by allowing production from allogeneic donors for an off-the-shelf product, non-viral gene transfer, multifunctional ‘killing’ mechanisms and enhanced safety based on prior clinical data. The merger positions CoImmune as an innovative immuno-oncology therapeutics company by broadening its platform portfolio and pipeline of therapies addressing unmet needs in oncology. The merger was accompanied by a $6 million lead investment in CoImmune’s Series A Financing to fund the CAR-CIK program. The lead investment was made by Italian entrepreneurs Dr. Lucio Rovati, Mr. Aldo Fumagalli and Mr. Beppe Fumagalli. Dr. Lucio Rovati is currently the Chief Executive Officer and Chief Scientific Officer of the FIDIM Group, an Italian company with much experience in the pharmaceutical and biotech business, and he is a member of the Board of Directors of CoImmune. Mr. Aldo Fumagalli and Mr. Beppe Fumagalli have a long-lasting engagement in the household appliances industry and have interests in several business sectors. Italian companies FIDIM S.r.l., Alisei Forinvestment S.r.l., and Buenafortuna Capital S.r.l. are making the lead investment. “We are excited about bringing together two therapeutic immuno-oncology platforms to maximize our clinical and commercial value,” said Charles Nicolette, Chief Executive Officer of CoImmune. He continued that, “Both of our lead clinical programs are based on encouraging prior or on-going clinical trials and we have a strong team to advance our pipeline. We believe that the CAR-CIK approach represents a best-in-class allogeneic CAR-based technology that can deliver significant value. We believe that both companies complement each other, and together, this relationship will enable us to continue to advance our therapies toward US FDA approval in the near future.” Maurits Geerlings, Chief Executive Officer of Formula Pharmaceuticals, Inc. said, “We are very excited to transition the development of our CAR-CIK platform to CoImmune’s team, given their deep experience in cell and gene therapy drug development and GMP manufacturing facilities.” “Special thanks go out to our research collaborators led by Prof. Andrea Biondi of Tettamanti Foundation and San Gerardo Hospital of Monza, Italy, for the excellent work they have done in validating the clinical potential for CAR-CIK therapy,” Dr. Geerlings added. Italian investment bank Mediobanca assisted Formula Pharmaceuticals, Inc. and its main shareholders (a group of Italian entrepreneurs) in the fund-raising and in the negotiation of the merger. Cole Schotz P.C. provided legal counsel to CoImmune, Inc., in connection with the merger and the $6 million lead investment in CoImmune’s Series A Financing to fund the CAR-CIK program. Morgan Lewis Bockius LLC, General Counsel Steven J. Feder and the Italian Law Firm NASaW Avvocati provided legal counsel to Formula Pharmaceuticals, Inc., and to the investment companies FIDIM S.r.l., Alisei Forinvestment S.r.l., and Buenafortuna Capital S.r.l. in connection with the merger and the $6 million lead investment in CoImmune’s Series A Financing to fund the CAR-CIK program. About CoImmune, Inc. CoImmune specializes in the development of personalized immuno-oncology therapies including its lead candidate, CMN-001, for treatment of metastatic renal cell carcinoma. CMN-001 is a dendritic cell-based, individualized immunotherapy that captures both mutated and variant antigens that are unique to each patient’s tumor, specifically designed to induce an immune response targeting each patient’s particular tumor antigens. CoImmune Inc., was incorporated in Delaware and funded in February 2019 by two companies, SCM Lifescience Co., Ltd. and Genexine, Inc. SCM Lifescience is a privately-held South Korean biotech company focused on development of next-generation clonal mesenchymal stem cell therapies and Genexine is a KOSDAQ-listed biotech focused on development of innovative immunotherapies based on hybrid Fc technology. For more information visit www.coimmune.com Media Contact: Lori Harrelson CoImmune, Inc. 919-287-6349 lharrelson@coimmune.com