According to a statement, Koligo is a leader in developing personalized cell therapies utilizing the patient’s own (autologous) cells. Koligo has successfully launched its first commercial product, KYSLECEL, and plans to commence a Phase 2 trial of KT-PC-301 for COVID-19-related acute respiratory distress syndrome (ARDS).
Koligo’s development stage technology utilizes 3D bioprinting and vascularization with autologous cells (3D-V technology) to create biodegradable and shelf-stable three-dimensional cell and tissue implants. The 3D-V technology is being developed for diabetes and pancreatitis, with longer-term applications for neural, liver, and other cell/tissue transplants.
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Following the closing of the transaction, Orgenesis plans to accelerate the commercial scaleup of KYSLECEL throughout the US and in international markets as well.
Also after closing and eventual clearance by the US Food and Drug Administration, Orgenesis expects to start patient recruitment for a Phase 2 randomized clinical trial of KT-PC-301 in COVID-19 patients. Koligo already has completed a pre-Investigational New Drug consultation with the FDA to start clinical trials of KT-PC-301 in COVID-19-related ARDS. Orgenesis also plans to leverage Koligo’s 3D-V bioprinting technology across its POCare platform.
Under the deal, Orgenesis will acquire all of the outstanding stock of Koligo from its shareholders. The agreed consideration terms are an aggregate of $15 million in shares of Orgenesis’ common stock valued at $7 share, which will be issued to Koligo’s accredited investors (with certain non-accredited investors to be paid solely in cash) and an assumption of $1.3 million in Koligo’s liabilities, estimated to be substantially all of Koligo’s liabilities.
Koligo’s management team will be joining Orgenesis to continue commercial and development activities. Koligo CEO Matthew Lehman is an accomplished executive in the biotech and regenerative medicine fields.
“We are pleased to announce this transformative acquisition, which we expect will add broad capabilities to our therapeutic and technology platform, and will further our leadership in the cell and gene therapy field,” said Orgenesis CEO Vered Caplan.
“Based on several phase 1 studies, Koligo’s KT-PC-301, using a patient’s own cells, has demonstrated safety and tolerability, and has shown signs of efficacy to support continued development in COVID-19-related ARDS. If successful for the treatment of COVID-19-related ARDS, KT-PC-301 is likely to have applications in other acute and chronic respiratory indications, areas that represent significant unmet medical need.”
Koligo CEO Lehman added: “The merger with Orgenesis marks a major milestone for our company and builds on our recent progress, including the Pre-IND package submitted to the U.S. FDA for KT-PC-301 and our pilot commercial program for KYSLECEL. The Orgenesis team brings extensive clinical, regulatory, and manufacturing expertise well suited to supporting Koligo’s goals. Orgenesis’ intellectual property is highly complementary to Koligo’s technology and the combined companies will work to advance a robust commercial and development product portfolio.”
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