September 27, 2020

The Niche

Knoepfler lab stem cell blog

The stem cell gestalt of Geron Goodbye and the future of ACT

GeronLast year one of the biggest events in the stem cell field was biotech Geron punting its embryonic stem cell (ESC) program.

Much consternation followed.

Some folks opposed to ESCs happily pronounced ESC research dead.

Some folks in favor of ESC thought the world was ending a year early.

Others tried to look on the bright side and hoped for a buyer for Geron’s ESC-related assets, but through the grapevine everything I was hearing was that that was not going to happen.

Now that many months have gone by we can look back at Geron’s goodbye and one would hope that we can learn something.

Such seems the impetus for a Nature Biotechnology opinion piece by Christopher Scott and Brady Huggett: Geron’s quixotic fate .

There is much to like about this article and it contains some amazing facts (e.g. Geron’s application to the FDA was 22,000 pages long and was the longest in FDA history), but at the same time the piece seems off key in some ways.

Starting with the title….

I don’t see anything quixotic about the fate of Geron.

ACTCIn fact, given that more than 9/10 biotech companies fail completely, one might predict that most individual research programs of biotech companies fail with a near, if not quite 100% rate. Thus, Geron’s ESC program had the odds stacked against it from Day 1. Then if you factor in the reality that this was the FDA’s first experience with ESCs, Geron’s odds became even longer as Geron not only had to navigate the challenging regulatory waters of the FDA, but from what I heard they also had to literally teach the FDA all about ESC.

The Scott and Huggett article also has a warning for Advanced Cell Technology (ACT; stock symbol ACTC), which is now currently the only company with active FDA trials on ESC. They write, addressing ACT directly:

your technology may be revolutionary, your team may be dedicated and you may believe. But it does not matter if no one else will stand at your side.

Sounds ominous, doesn’t it? But I think it is awfully gloomy and negative.

I believe that one big advantage that ACT has over Geron is that Geron had to pave the way all by itself. ACT now is enjoying the benefit of Geron having in essence prepped the FDA for how to handle ESC-related biologic products.

Another advantage is that I believe that ACT’s therapy and target disease are more fiscally practical.

I don’t have some magic biotech crystal ball to tell me the future of ACT, but I have not heard anything specific that makes me especially pessimistic.

The odds are long for any biotech, but ACT has shown something that most biotechs fail at:

longevity

To me that means something in biotech.

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