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.