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Please introduce yourself. What is your background and experience in cell and gene therapy?

My basic training was as a scientist, I earned a PhD in Pharmacology from the University of Washington and carried out 3 post-doctoral fellowships in the Seattle area.  Subsequently, I moved in industry with BD roles in several small, innovative biotech companies, one of which was a Japan-based job with iPierian (then known as iZumi Bio) in 2008-9. There, I was working to set up operations, licensing and collaboration activities with Prof. Shinya Yamanaka’s laboratories in the region and learned about commercialization of iPSCs at the nascent stages of the technology.  In my next job, I worked for a spin-out from Chuck Murry’s lab in Seattle developing his ESC-derived cardiac tissue patches, which technology has evolved by passing through Sana and now once again being advanced in its own new company.  Finally, beginning in 2021 I spent a little over a year as a Director of BD, Scouting and Strategy at Astellas focusing on cell therapy opportunities in the IO as well as Regenerative Medicine and Immune Homeostasis spaces.

Not directly related to cell and gene therapy, I Founded a clinical-stage cancer vaccine company called EpiThany with technology from the University of Washington as CEO in 2014, and in 2019 helped launch the Japan-based venture capital firm Catalys Pacific as a Venture Partner.  I currently serve as President of Astellas Venture Management.

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How do your experiences as co-founder of EpiThany Inc. influence you as a CGT Investor?

At EpiThany I learned the origins and foundations of cancer cell therapy in its various forms from my co-founder Nora Disis at UW and other pioneers in the Seattle area; it was a luxury to have regular, direct access to scientists who founded and ran companies like Xcyte Therapies, Dendreon, Juno and Nohla Therapeutics.  EpiThany is a cancer vaccine platform company focused on generating CD4+ T cell titers against tumor-overexpressed antigens, as opposed to CD8+ responses.  Crafting the best business and investment case for EpiThany meant staying abreast of the most current, basic scientific understanding of what is needed to enable the most effective anti-tumor cellular immune response and pushing that envelope in a small, nimble company.  This environment of pure scientific innovation instilled in me a great appreciation for scientist-entrepreneurs and the invaluable vision and commitment they bring to their ventures.  That tendency persists as my team encounters new investment opportunities, I enjoy hearing business strategies inspired by scientific Founders’ vision and ambition.

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What is your preferred investment profile (cell-type and stage of financing)?

AVM’s role is to gain access to assets and technologies that we anticipate may have direct impact on Astellas’ pipeline in the foreseeable future.  A crucial piece of any investment is visibility of the company’s progress from the Board of Directors’ perspective, i.e. Board rights need to be part of any investment.  This priority, along with our budget and target number of investments guides us to focus on early-stage (pre-CN) financings, usually Seed or Series A where the valuations and target raise are still fairly modest.  We are interested in cell therapy pipelines and technologies that cover immune-oncology, antigen-specific tolerance, and regenerative medicine.  In each of these areas, Astellas is developing allogeneic and hypo-immune cell therapies leveraging its own platform for the Universal Donor Cell.

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In your opinion, what is the most important type of due diligence to perform when evaluating a new company?

I’m a scientist by training and instinct, so I tend to gravitate initially to the purely technical aspects of an opportunity, its differentiation and what can be ascertained of its probability of success in a competitive landscape.  However, my experience as an investor and board observer/director has made me more keenly aware of the crucial importance of management.  The cutting-edge nature of emerging platforms and products in cell therapy makes the early stages of their development fraught with unforeseeable obstacles and difficult, urgent decisions.  Since AVM is a purely strategic investor, with no overt interest in financial ROI, I like to look carefully at the development plan being proposed, the incorporation of decision tree-like thinking and some cuts and bruises on the management team as evidence of having navigated adversity with success.  I like to sense that the team will follow the science and bring it to its greatest potential with respect to impact on Astellas’ pipeline, as opposed to planning for the quickest, richest exit.

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Any advice you would give to someone new to investing in the cell and/or gene therapy field?

If at all possible, it is highly valuable to have someone on the team with thorough, recent hands-on experience in these spaces as a drug development scientist.  The space moves very quickly with technical innovation and it is extremely difficult to understand the risks and upsides without practical familiarity with the actual work being proposed.

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What company/organization do you have your eye on currently, and why?

AVM’s practice of making strategic LP investments in well-positioned funds allows us to explore new ways to capture innovation for Astellas’ pipeline.  We’ve done well to expand our regional access to innovation by investing in funds with a geographical strategy, we’re becoming more interested in other investors who are hammering out a niche in this area of biotechnology with very focused strategies. I really like what I’ve seen from Dynamk Capital, who focus on life science “industrials” – tools and technologies to enable the advancement of therapeutics in the cell and gene therapy spaces, among others.  The exuberance with which our industry pursues and deploys new modalities in therapy like CAR-T cells, viral gene therapy, gene editing, and so forth seems from my perspective to put us almost “out over our skis” with respect to the unanticipated challenges they present when approaching and entering clinical use.  It seems very astute on the part of Dynamk Capital to recognize that step-change improvements in areas such as manufacturing, targeting, safety and so forth should have profound and far-reaching positive impact on both the future success of these therapies and their feasibility from the point of view of cost.  This last issue, cost, is clearly becoming a thorny issue for companies aspiring to push the innovation envelope in view of increasing restraints on the financial return for product development.

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What is a recent piece of CGT industry news that you found interesting, and why?

I was thrilled with Blue Rock Therapeutics’ news in August reporting their successful Phase 1 study of bemdaneprocel in Parkinson’s Disease patients.  It was heartening to see durable engraftment and even dose-related trends in clinical outcome signals in this study, I think it marks a true leap forward for the field which I hope will provide a springboard in this indication and others for allogeneic cell therapy platforms.  In particular, it will be intriguing to see if demonstrating the benefits of a hypoimmune-engineered allogeneic product, like that being developed at Astellas, is possible or necessary for product differentiation in certain indications.  Curtailing the need for long-term immune suppression should certainly constitute at least one benefit, I look forward to seeing allogeneic cell therapies emerge in other disease indications where there are no other viable options for patients.

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