regenerative medicine industry veteran BG Rhee, Korean firm SCM Lifescience has engaged in several global M&A deals in the past year with the end goal of finding a combination of assets that will bring value to both investors and patients. With a US manufacturing facility now in place, as well as R&D operations in Italy, SCM raised USD 25 million by listing on the Korean Stock Exchange (KOSDAQ) on June 17th, 2020 with the aim of propelling the company to the next level
From US manufacturing…
In February 2019, SCM – in partnership with fellow Korean firm Genexine – acquired the US immuno-oncology company Argos Therapeutics for around USD 11.1 million. Argos, listed on the Nasdaq until early 2018, was a Durham, North Carolina-based biotech that developed personalised anti-cancer treatments with mRNA loaded dendritic cells. Argos had conducted Phase III clinical trials on 462 renal cancer patients in the US, Europe and Israel through more than 120 clinical sites but was not able to prove the statistical effectiveness of its treatments.
The acquired company – renamed CoImmune – now operates as an independent entity in the US and gives SCM the ability to manufacture high-purity stem cell treatments in the US using its original isolation of stem cell technology as well adding Argos’s original technology immuno-oncology using dendritic cells to its pipeline. Speaking at the time, SCM Lifescience CEO BG Rhee said that this would allow the company to make greater inroads into global markets.
SCM is not alone in being drawn to advanced manufacturing in the US. With the global regenerative medicine market expected to grow at a 23.7 percent CAGR and reach USD 50 billion in value by 2021, global firms are increasingly looking towards the infrastructure, talent and capabilities of the US market to meet their advanced biomanufacturing needs.
…to Italian R&D…
In the wake of the Argos acquisition and the rebranding to CoImmune in the US, an SCM project that had been on the back burner for some time reappeared: the acquisition of Formula Pharmaceuticals, a firm focused on the development of a best-in-class CAR-therapy platform to overcome key shortcomings of existing CAR-T approaches. Formula Pharmaceuticals’ CAR-CIK (Cytokine Induced Killer) technology leverages allogeneic cells from cord blood and proprietary non-viral transfection through the SB100X gene transfer system.
The merger between CoImmune and Formula went through in January 2020 and the merged company has continued to focus on running a Phase IIb trial for lead asset, CMN-001, in advanced metastatic renal cell carcinoma (mRCC). The US FDA approved CoImmune’s investigational new drug application (IND) CMN-001 in February 2020 and cleared it to move forward with the Phase IIb trial.
The close of the Formula deal was accompanied by a USD six million investment in the combined entity to fund the CAR-CIK program, which is currently in Phase I of the clinical trial process. Through sponsored research contracts with the M. Tettamanti Research Center, University of Milano-Bicocca and MBBM Foundation, San Gerardo Hospital, CoImmune will conduct non-clinical research and other necessary work for the development of CAR-CIK in Monza, Italy.
…to the Korean market…
SCM will be looking to market its treatments firstly in Korea. Against the backdrop of a government push for Korea to be recognised as a global leader in the field of regenerative medicine, in August 2019 a framework was set out for conditional approvals of next-generation treatments for rare diseases and cancer that had only passed through Phase II of the clinical trial process.
Currently, there are 6-7 stem cell products on the global market. Four of them are Korean products. This is thanks to the special committee which helped small companies such as Pharmicell and Medipost to receive conditional approval
BG Rhee, SCM Lifescience
Speaking to PharmaBoardroom in late 2018, Rhee commented on SCM’s role in putting this framework in place. “We are currently in discussions with the Korean government with the aim of amending the laws relating to advanced biopharmaceuticals and regenerative medicines,” he noted. “In Japan, which is now very aggressive in the field of stem cells and regenerative medicine, their laws were amended in November 2014, so that after phase I trials there is conditional approval, and the next seven years are spent collecting the data from the patients for phase II and III trials. In the worst case, there is no efficacy, but the product is safe then the product will be left on the Japanese market.”
Rhee continued, “In Korea, conditional approval may be granted only after phase II trials. Currently, there are 6-7 stem cell products on the global market. Four of them are Korean products. This is thanks to the special committee which helped small companies such as Pharmicell and Medipost to receive conditional approval.”
Although SCM does not have plans to merge the USA manufacturing and Italian R&D operations, the company raised around USD 25 million through a listing on the Korean Stock Exchange (KOSDAQ) on June 17th, 2020.
Funding for regenerative therapies, though still difficult to source, is more readily available than ever before. As Rhee admitted to PharmaBoardroom, “[regenerative medicine] is a new area for investment, which has a high return, and some risk involved. However, nowadays, it is more secure – even without 100 percent efficacy in an indication, it is still possible to find good and promising data.” The question remains how much funding SCM can secure and whether its next-generation therapies can eventually reach patients worldwide.