| |   | Good morning, all. Damian here with regulatory controversy, the end of a synbio saga, and a regretable inclusion of the term "Web3." | | | The paradox of ultra-rare drug development Walker Burger is certain his medicine is working. Burger is among the small number of patients with Barth syndrome, an ultra-rare disease that weakens muscles and shortens life expectancy. For the past two years, he’s been enrolled in a clinical trial of an experimental drug that has dramatically improved his symptoms. But the data from that tiny study weren’t sufficient to convince the FDA, and now Burger is afraid he’ll lose access to the drug that changed his life.
As STAT’s Ed Silverman reports, the situation illustrates a common issue in ultra-rare drug development: Regulators expect well-designed studies with clear outcomes, but when a disease affects only a handful of patients, meeting those demands can be exceedingly difficult.
The FDA has been flexible with drugs that would benefit just a few hundred patients, sometimes approving treatments based on open-label trials and natural-history studies. But the agency’s inconsistency has flustered patient groups and drug companies, who argue the FDA is needlessly slowing the progress of desperately needed drugs.
Read more. | The American Cancer Society wants in on the cap table The American Cancer Society is looking for friends in the VC world.
As STAT’s Allison DeAngelis reports, the storied charity has an investment arm, called BrightEdge, which puts money into companies working in under-addressed brain, esophageal, and pancreatic cancers, as well as racial and economic issues in cancer research and care.
Earlier this month, BrightEdge signed an agreement with Third Rock Ventures that gives it a chance to buy into the Series A rounds for all of the oncology companies that Third Rock backs. And the firm wants to forge similar agreements with VCs in health tech and fintech, aiming to invest in startups that could help address cancer prevention, diagnosis, and the cost of care.
Read more. | July 26 | A conversation with Admiral Rachel Levine Admiral Levine has used her position to prioritize the challenges that members of the LGBTQ+ community face when trying to access health care. Join her as she takes the virtual stage to share her story, and more about what she hopes to achieve, as part of our STATUS List Spotlight series. Register now. | What exactly is the ‘drug industry’? That question could be legally pertinent to Martin Shkreli, who is banned from ever again working in pharmaceuticals, as he moves forward with a startup designed to “democratize the costs, access, and rewards of computational drug discovery.”
The company, called Druglike, promises what is basically a free version of the software sold by companies including Schrödinger, which would allow users to design new drugs and virtually screen them against biological targets. This being 2022, Druglike’s number crunching work will be spread across a decentralized network of computers, according to a company white paper, and anyone who contributes their computational power will be rewarded with a cryptocurrency.
What’s unclear for Shkreli, released from federal prison earlier this year, is whether running this company is a violation of the court order banning him from the drug industry. “Druglike is a blockchain/Web3 software company and not a pharmaceutical company,” reads the company’s introductory press release. Reasonable parties may disagree. | The Zymergen saga ends with a whimper If you bought into Zymergen’s IPO in April 2021, you traded $31 for each share of the company. Fourteen months later, the company signed an all-stock deal that would give those shares a value of about $2.50.
The news is that Ginkgo Bioworks, an erstwhile competitor to Zymergen in the world of synthetic biology, has agreed to buy the company outright, acquiring all of its outstanding shares in a roughly $300 million deal. Each share of Zymergen would entitle its holder to about .92 shares of Ginkgo, which is trading for around $2.75, more than 70% below its 2021 SPAC debut.
If shareholders approve the deal, it’ll be an ignominious end for Zymergen, which raised more than $500 million at a $3 billion valuation on the promise of Hyaline, a bio-electronic film the company claimed would power “the electronics of tomorrow” with further applications in agriculture and pharmaceuticals. Four months later, the company walked back virtually all of its previous claims — including that anyone wanted to buy Hyaline — and replaced its founder and CEO on the way to a complete re-think of the company.
Whether Zymergen’s technology has any future within Ginkgo remains to be seen. And it might not really matter: Considering Zymergen’s reported $337 million in cash as of the last quarter, the acquisition “is essentially a financing” for Ginkgo, according to Cowen analyst Steven Mah. | More reads - ‘What can we do?’: Pharma lobbyists face their biggest test in a decade, as Democrats barrel toward a vote on drug pricing. STAT
- Despite their anger over high drug prices, Americans are giving pharma credit for helping contain Covid-19. STAT
- Frazier to bring Dutch biotech company public in SPAC deal. GeekWire
| Thanks for reading! Until tomorrow,  | | | |
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