In anticipation of potential approval of its MultiStem stem cell therapy, Cleveland biotechnology company Athersys Inc. is taking steps to be ready for possible commercialization.
Twenty-five years after it was founded in Cleveland, the company is actively preparing for what it expects to be successful results of multiple studies in the United States, as well as abroad in collaboration with its Japanese partner Healios K.K.
"Making that transition from being a development company or a late-stage development company into becoming a full-blown commercialization company is critically important," said Gil Van Bokkelen, chairman and CEO of Athersys. "It's a transition that few companies have been able to make, but the ones that have have become household names."
As part of that effort, Athersys hired two new executives earlier this year to bolster its management team. Veteran pharmaceutical executive Ivor Macleod joined as the company's chief financial officer, and Maia Hansen, formerly a senior partner at global management consulting firm McKinsey & Co., is now the senior vice president of operations and supply chain at Athersys. Macleod's commercialization experience and Maia's supply chain experience will be integral to the company's work moving forward.
Athersys' MultiStem cell therapy is a patented, proprietary stem cell product currently under evaluation in several clinical trials. It has shown promise for treating indications in the areas of neurological, inflammatory and immune, and cardiovascular diseases, as well as other critical care conditions.
The opportunity to join Athersys was exciting to Hansen because of MultiStem's potential to serve a broad population with its off-the-shelf product, rather than precision medicine, which is the application of individualized, tailored treatments. Plus, she noted, Athersys is working in therapies that have long been critical clinical needs — stroke, trauma and acute respiratory distress syndrome (ARDS).
Healios is studying MultiStem in the TREASURE study for treatment of ischemic stroke and in the ONE-BRIDGE study for treatment of ARDS. They expect to complete enrollment in both studies by the end of this year, with results available in the first few months of next year. Van Bokkelen said Athersys and Healios have already started work preparing the regulatory package that would ultimately be submitted to authorities in Japan for potential approval.
In the United States, Athersys plans to complete enrollment next year in its MASTERS-2 study, a Phase 3 program for ischemic stroke, as well as in its MACOVIA study, which was initiated in April to evaluate using MultiStem to treat COVID-19-induced ARDS.
Athersys also is getting ready to launch a Phase 2 study in trauma treatment. Next on the horizon is a trial to study treating hemorrhagic stroke.
"The reality of it is if we're successful in any of those, then it's going to create a huge opportunity," Van Bokkelen said.
Macleod gets many questions about why he would join a small biotech company after his experience in large pharma, including holding leadership positions at Merck & Co., F. Hoffmann-La Roche and Boehringer Mannheim Therapeutics, among others. Before Athersys, he was CFO of Eisai, the U.S. subsidiary of Japanese company Eisai Ltd.
He said the science and regenerative medicine initially attracted him to Athersys, as well as the opportunity to impact the critical care space, which has a lot of unmet medical need. He was impressed with the "very driven, very intelligent" leadership team.
In the six months Hansen has been with Athersys, she has spent a lot of her time building fundamentals for the future — thinking about what a new, larger scale production site would look like to build out the company's supply chain capabilities. Because the company is in Phase 2 and Phase 3 trials, it needs to produce more clinical doses both for existing work and to prepare to produce at a much larger scale, she said.
"And that, given my background, is very exciting," Hansen said. "Going from a clinical stage company to a commercial stage company is also about transitioning your internal processes, building your manufacturing and supply chain capacity, and that's something that I've done for 25 years in other contexts. And it's kind of exciting to roll up my sleeves in a company that has a lot of opportunity for developing those processes kind of from the ground up."
While Hansen and Macleod will help the company work toward commercialization in North America, Athersys is looking for a partner to help advance toward that in Europe. Finding a partner that can help Athersys drive forward development and commercialization in Europe is a big priority for the company that Van Bokkelen said could be transformational in addition to the clinical progress. With so many different countries — each with their own rules around promotion, reimbursement structures, etc. — finding a partner to navigate them makes the most sense.
He said the companies Athersys is considering are multinational with capabilities in other parts of the world as well, hopefully giving Athersys the latitude to work with them to grow the partnership over time.
Because Athersys works in the critical care space, it will serve a more focused market rather than, for instance, a typical primary care launch that requires "endless promotion" with all major doctors across the country, Macleod said. The targeted approach and concentrated marketplace puts Athersys in a unique position for commercialization, he said. The company can decide which capabilities to have internally and which to subcontract.
"Whereas (in) traditional pharma, you tend to go through the big wholesalers, and so it's just a question of which ones you contract with, how much you pay them, all the different middlemen," he said. "We actually have a possibility of not necessarily having any middlemen. You know, these are some of the things we're looking at, so it really is quite a unique opportunity."
Athersys intentionally avoided markets that are pretty well served with existing standards of care and opted to focus on areas with limited treatment options, Van Bokkelen said.
"And that's because we believe our technology can effectively address those indications based on the evidence, clinical and other evidence that we've generated over many years," he said. "But also because we think it's a smart thing to do from a development standpoint. If you go after the opportunities that many other companies have been forced to shy away from because they haven't figured out an effective way to deal with those challenges, or solve those problems, then that means you've got a huge potential advantage if you are the company that actually succeeds in fundamentally improving clinical care for those patients that really need help."
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Recent hires help Athersys prepare for potential commercialization - Crain's Cleveland Business
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