BioCentury This Week

Upcoming catalysts could drive value creation at NASDAQ’s newest biotech, Boundless Bio, after it stumbled in its trading debut last week. On the latest BioCentury This Week podcast, BioCentury’s editors discuss Boundless’ IPO in the context of the current market for fresh paper and profile the “sweat equity” model of Avalon, the VC firm led by Jay Lichter. Turning to Washington, BioCentury’s editors assess possible outcomes for the Supreme Court case on abortion drug mifepristone, and why the court’s pending decision could safeguard FDA from judicial second-guessing. The team also analyzes the agency’s first ever complete response letter for lack of confirmatory trial enrollment.  This week’s podcast is sponsored by Jeito Capital.

View full story: https://www.biocentury.com/article/651937

0:01 - Sponsor Message: Jeito Capital
4:15 - Biotech IPOs
7:50 - Avalon BioVentures
11:14 - FDA at SCOTUS
16:29 - Confirmatory Trials

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Bills seeking to rein in Chinese CDMOs and genomics companies will deal a massive blow to biotech companies, if passed in their current form, according to results from an industry survey conducted by BioCentury. On The latest BioCentury This Week podcast, BioCentury’s editors discuss results from the survey, including responses that underscore executives’ concerns that the legislation would cause delays in drug development and a majority’s displeasure with BIO’s about-face to support the measures.
They also discuss takeaways from Editor in Chief Simone Fishburn’s conversation on The BioCentury Show with Atlas Venture’s Bruce Booth, and lessons from Orchard Therapeutics on what it takes to get FDA’s approval for an ultrarare disease drug.
For BioCentury’s complete coverage of the Biosecure Act and similar legislation in Senate, visit the Hot Topics page for the topic

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Putting patients at center stage is at the core of John Crowley’s vision for BIO as he begins his tenure leading the biotech trade group. On the latest BioCentury This Week podcast. Washington Editor Steve Usdin details Crowley’s plans to revitalize BIO at a time when effective representation in Washington is more important than ever.
BioCentury’s editors also discuss FDA’s landmark approval of Madrigal's liver disease drug and a decision by FDA’s Oncologic Drugs Advisory Committee to support a pair of BCMA-directed CAR T cell therapies in earlier lines to treat multiple myeloma, and what’s needed to help avoid deaths during the period while patient wait for the CAR T cells to be produced.

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A congressional committee meeting last week on biotech and national security provided a glimmer of hope that lawmakers could be persuaded to consider taking steps to bolster the U.S. bioeconomy, BioCentury Washington Editor Steve Usdin explains why the at times cartoonish spectacle of lawmakers pushing anti-China biotech bills highlights the need for scientists and entrepreneurs to build relationships in Washington.
Plus: Editor in Chief Simone Fishburn argues that the future of diversity should not be bound up in the fate of DEI. And BioCentury's editors discuss the pivotal trial setback for Amylyx in ALS and what may be on FDA’s agenda as is schedules an advisory meeting for Lilly's Alzheimer's therapy donanemab.

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The $3 billion raised by biotechs in a series of follow-ons and PIPEs last week marked another strong showing for a sector seeking to outrun the bear market. On the latest BioCentury This Week podcast, BioCentury’s editors assess the state of fundraising for biotechs and their performance in the after-market. They also preview a forthcoming analysis of preclinical papers published in the Distillery, BioCentury’s coverage of translational science, describe the latest on anti-China bills in Congress and Inflation Reduction Act litigation, and discuss Closed Loop Medicine’s program that seeks to bring precision medicine to obesity.

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Asia’s emerging “Arc of Innovation” spans from China, Japan and South Korea through the turf-neutral gateway of Singapore and west to India, with the ecosystems of these countries contributing to the arsenal of therapeutics and diagnostics that benefit patients globally.
On a special edition of the BioCentury This Week podcast, Aslan’s Carl Firth, McKinsey’s Franck Le Deu and Wendy Pan of BayHelix and Goodwin join BioCentury on the eve of next week’s BioCentury-BayHelix Biopharma Summit in Singapore to discuss innovation across Asia, rising East-West deal flow and the opportunities and challenges faced by the region’s various biotech ecosystems. They also detail highlights among the speakers, panels and fireside chats of the three-day event.

Join BioCentury, BayHelix and McKinsey March 4-6 in Singapore or virtually for the third East-West Biopharma Summit.

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 Arch Venture Partners’ Bob Nelsen is excited about AI’s potential in biotech and convinced the U.S. healthcare system could do a far better job delivering on the promise of the biopharma industry’s innovations. On the latest BioCentury This Week podcast, BioCentury’s editors discuss takeaways from Nelsen’s appearance on The BioCentury Show, including how the longtime investor in China’s life sciences sector has adopted a more cautious stance on the country given increasing geopolitical tensions. BioCentury’s editors also discuss whether TL1A inhibitors are poised to bring precision medicine to large inflammatory and autoimmune indications, and why participants in a Feb. 21 Reagan-Udall Foundation workshop hope the meeting could help establish precedents that will revitalize the development of effective treatments for extremely rare diseases. 

Music for The East-West Biopharma Summit: Singapore teaser:
Composed by: Moa Michaeli
Produced by: Samuel Aneheim Ulvenäs, Albin Lewin, Epidemic Sound via Getty Images

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Off switches and non-viral delivery technologies may be the solution to CAR T therapies’ most recent safety problem. On the latest BioCentury This Week podcast, BioCentury’s editors discuss alternative CAR T technologies already in development that avoid or reduce the risk of secondary malignancy.
The editors also discuss the world-first approval of Iovance's tumor-infiltrating lymphocyte (TIL) therapy, highlights from BioCentury’s most recent survey of the translational literature in the Distillery, and the path to approval for Sarepta's Elevidys delandistrogene moxeparvovec, a gene therapy for Duchenne muscular dystrophy.

Music for The East-West Biopharma Summit: Singapore teaser:
Composed by: Moa Michaeli
Produced by: Samuel Aneheim Ulvenäs, Albin Lewin, Epidemic Sound via Getty Images

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Anti-China biotech bills are raising alarms at U.S. biotechs, with CEOs worried they could lose access to CDMOs WuXi AppTec and WuXi Biologics, and that legislation could imperil collaboration with Chinese companies more broadly. BIO has warned Congress the bills “would immediately and negatively” affect the U.S. biotech ecosystem. On this special edition of the BioCentury This Week podcast BioCentury Washington Editor Steve Usdin and colleagues discuss the pending legislation.

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Innate immunity is getting another shot at cancer through antibody-drug conjugates, with immunostimulatory antibody-drug conjugates moving from concept to clinical product. On the latest BioCentury This Week podcast, BioCentury’s editors discuss how the therapies work and what sets them apart from conventional ADCs.
The editors also survey the companies developing psychedelic therapies that aim to overcome the difficulties of the business model, and assess Gilead's $4.3 billion takeout of liver disease company CymaBay, and the performance of IPOs by genomic editing tools company Metagenomi and immunology company Kyverna.

Music for The East-West Biopharma Summit: Singapore teaser:
Composed by: Moa Michaeli
Produced by: Samuel Aneheim Ulvenäs, Albin Lewin, Epidemic Sound via Getty Images

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