Healios and Minaris Advanced Therapies partner in commercial manufacturing to launch late phase cell therapies for ARDS and other indications with unmet patient need
Today, we are pleased to announce that we have entered into a commercial Manufacturing agreement with Healios K.K. for the manufacturing of invimestrocel (HLCM051), Healios’ proprietary investigational cell (MAPC) therapeutic product for use in the treatment of Acute Respiratory Distress Syndrome (ARDS) and potentially other critical care indications currently under development by Healios. The manufacturing process is based on a cutting-edge 3D bioreactor process, which will reduce costs. This agreement marks a significant milestone in advancing the manufacturing, scalability and access of cell therapies.
HLCM051 is currently being evaluated for the treatment of ARDS and ischemic stroke, two serious conditions with high unmet medical needs. Clinical trials in Japan have shown promising results, including improved survival and functional recovery outcomes.
Healios selected Minaris as its manufacturing partner based on Minaris’s extensive experience and proven track record in cell therapy manufacturing, including bioreactor expertise. The decision reflects Healios’ confidence in Minaris’s technical capabilities and quality systems, which are essential for the successful development and commercialization of HLCM051.
The two companies will also work together to further improve and scale the existing bioreactor-based manufacturing process to improve efficiency and further reduce costs.
About Healios K.K.
HEALIOS K.K. is a leading clinical stage biotechnology company harnessing the potential of stem cells for regenerative medicine. It aims to offer new therapies for patients suffering from diseases without effective treatment options. Healios is a pioneer in the development of regenerative medicines in Japan and owns proprietary, global platforms utilizing both somatic stem cells and iPS cells.
In the somatic stem cell field, Healios is developing invimestrocel (HLCM051), a proprietary cell product comprised of multipotent adult progenitor cells (“MAPCs”) derived from the bone marrow of healthy adult donors. Invimestrocel has been shown to exhibit powerful anti-inflammatory and immunomodulatory properties with applicability in a range of disease states, has been tested in hundreds of patients in late-stage clinical trials, is manufactured consistently at scale in 3D bioreactors, and has demonstrated both safety and suggested efficacy in hundreds of patients across multiple indications. Healios is seeking to advance invimestrocel on a global basis for ischemic stroke, ARDS, and trauma.
In the iPSC regenerative medicine field, Healios is developing HLCN061, a next generation NK cell treatment for solid tumors that has been functionally enhanced through gene-editing. These cells have demonstrated robust anti-tumor efficacy in animal models, benefit from a scalable 3D bioreactor manufacturing process, and are currently being prepared for initial human testing in collaboration with Akatsuki Therapeutics. The company has also established a proprietary, gene-edited “universal donor” induced pluripotent stem cell line to develop next generation regenerative treatments in immuno-oncology, ophthalmology, liver diseases, and other areas of severe unmet medical need.
Healios was established in 2011 and has been listed on the Tokyo Stock Exchange since 2015 (TSE Growth: 4593). https://www.healios.co.jp/en
About Minaris Advanced Therapies
Minaris Advanced Therapies is a global contract development and manufacturing organization with a focus on cell and gene therapies and a contract testing provider. Minaris Advanced Therapies is headquartered in Philadelphia, Pennsylvania, and has more than 600,000 square feet of infrastructure across the United States, Europe and Asia. The organization has manufactured over 7,500 GMP batches and has a global network that supports therapy developers through early-stage development, clinical trials and commercial manufacturing.