TOKYO, Jan. 9, 2020 /PRNewswire/ -- Healios K.K. ("the Company"); (TSE: 4593), Japan's leading clinical stage biotechnology company harnessing the potential of stem cells for regenerative therapies announces that its Chairman and Chief Executive Officer, Hardy TS Kagimoto, MD, will provide a strategic overview and company update at the 38th Annual J.P. Morgan Healthcare Conference. In addition, the Company's CFO Richard Kincaid will make a presentation at the Biotech Showcase also being held in San Francisco, CA, between 13-16 January 2020. The Company will hold meetings with investors around both events.
Healios will present its unique strategy in regenerative medicine, which combines near-term and potentially accelerated commercialization of Somatic Stem Cell (SSC) -based treatments in Japan, with the development of next generation therapies derived from its world-leading induced Pluripotent Stem Cell (iPSC) technology platform.
Healios's SSC candidate (HLCM051) is in a pivotal Phase 2/3 trial in Japan in ischemic stroke in which it offers the potential to provide an effective treatment over a much longer treatment window as compared with standard-of-care acute therapies, such as clot-dissolving agents.
HLCM051 is also in a Phase 2 trial in acute respiratory distress syndrome (ARDS) in Japan aiming to become the first approved therapeutic drug for this serious medical condition.
Pending the successful completion of these studies, Healios intends to pursue an accelerated path to approval and commercialization owing to Japan's progressive and positive regulatory framework for regenerative medicine (known as the Conditional and time-limited authorization system, or "SAKIGAKE" in Japanese*).
In parallel, Healios is developing a proprietary gene-modified iPSC platform of non-immunogenic, off-the-shelf (allogenic) 'Universal Donor Cells' for applications in next-generation therapies in ophthalmology (wet and dry age-related macular degeneration), organ regeneration (e.g. following metabolic liver disease), and immuno-oncology (targeting solid tumors) including the development of iPSC derived gene-modified natural killer cells. These next generation iPSCs offer the potential for avoiding the requirement for immunosuppressive drug treatment while offering long duration of effect.
Details of the presentations are as follows:
At the J.P. Morgan Healthcare Conference:
Presenter: Hardy TS Kagimoto, CEO
Date: Wednesday, January 15, 2020
Time: 09.30 - 09.55 Pacific Standard Time (PST)
Location: Mission Bay Room, Westin St. Francis Hotel
The presentation will be accessible via live webcast here: https://jpmorgan.metameetings.net/events/hc20/sessions/30294-healios-k-k/webcast, as well as the investor section of the Company's website, www.healios.co.jp. The webcast and presentation slides will also be archived on the site following the event.
At the Biotech Showcase:
Presenter: Richard Kincaid, CFO
Date: Monday, January 13, 2020
Time: 14.00 – 14:30 PST
Location: Yosemite A, Hilton San Francisco Union Square
*About the Conditional and time limited authorization system (SAKIGAKE Designation)
In 2014, Japan's Ministry of Health, Labour and Welfare (MHLW) formed the "Strategy of SAKIGAKE".
The Conditional and time limited authorization system (SAKIGAKE) aims to promote R&D in Japan aimed at the early application of innovative pharmaceutical products, medical devices and regenerative medicines. It provides a process for the accelerated authorization of unapproved drugs for serious and life-threatening diseases and aims to improve the environment for companies to undertake development of such drugs.
Healios is Japan's leading clinical stage biotechnology company harnessing the potential of stem cells for regenerative medicine. Its aim is to offer new therapies for patients suffering from diseases without effective treatment options.
Healios's near-term pipeline includes its Somatic Stem Cell (SSC) platform products, with candidate HLCM051 currently being evaluated in Phase 2/3 and Phase 2 trials in ischemic stroke and acute respiratory distress syndrome (ARDS), respectively. HLCM051 is in-licensed from Athersys, Inc.
Healios is a pioneer in the development of regenerative medicines in Japan, using gene-modified induced pluripotent stem cells (iPSCs) to develop regenerative treatments in ophthalmology, liver diseases, and immuno-oncology cell therapies targeting solid tumors.
Healios was established in 2011 and to date has raised over US$300 million in funds to support its growth and development. The Company is listed on the Tokyo stock exchange in 2015 (TSE Mothers: 4593). www.healios.co.jp
FOR MORE INFORMATION
Email: [email protected]
Citigate Dewe Rogerson
Frazer Hall, Nathaniel Dahan PhD, Mark Swallow PhD
Tel: +44 (0)20 7638 9571
Email: [email protected]
SOURCE Healios K.K.