BioCentury This Week

The world’s first approval of a CRISPR-based gene editing therapy, granted by the U.K.’s MHRA, was a milestone for the technology that was just discovered about 12 years ago. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the implications of the landmark and the challenges that still face partners Vertex Pharmaceuticals and CRISPR Therapeutics in launching and scaling the rollout of Casgevy exagamglogene autotemcel (exa-cel) in the U.K. and beyond. The editors also discuss the unintended consequences of the Inflation Reduction Act (IRA) on the development of orphan drugs and new legislation that aims to address the problem by providing an exemption to price negotiations for therapies that are approved only for orphan indications, regardless of how many. The team also reflects on the legacy of FDA’s Janet Woodcock ahead of her planned retirement next year; the sentiment coming out of last week’s Jefferies Healthcare Conference in London; and the aftermarket performance of two market debuts last week from antibody-drug conjugate CMO WuXi XDC Cayman and Mural Oncology.

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Verve achieved the first proof of concept for an in vivo base editing therapy, but investor concerns weighed on the company’s stock, clouding the readout’s reception. On the latest BioCentury This Week podcast, BioCentury’s editors dissect the data for VERVE-101 in heterozygous familial hypercholesterolemia and discuss how the choice of initial target and indication for a new modality or technology can have a major impact on how POC data are perceived by investors. The editors also assess the latest developments related to the Inflation Reduction Act and assess a selection of biopharma deals and IPOs.

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The controversy around Sarepta continues as the company’s executives were confident last week that the data from the Phase III EMBARK trial of Duchenne muscular dystrophy gene therapy Elevidys were enough to warrant full approval despite missing the study’s primary endpoint. On the latest BioCentury This Week podcast, BioCentury’s editors analyze the pitfalls facing FDA as the agency considers whether to apply regulatory flexibility in its decision-making and the impact its decision could have for patients and future therapies that are submitted to the agency with less than clear-cut positive data. The editors also discuss innovations around new endpoints and technologies for clinical trials and the tepid reception for the latest biotech IPO, the debut by Lexeo.

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The European Society for Medical Oncology (ESMO) had everything from practice changing Phase III data readouts to new solid tumor targets. On the latest BioCentury This Week podcast, BioCentury’s editors recap the biggest data presentations from last week’s annual ESMO meeting, including the impact of Phase III data for ADCs and bispecifics on the treatment landscape for tumors such as urothelial cancer and EGFR-mutant non-small cell lung cancer (NSCLC). The editors also discussed takeaways from the most recent progress in the confirmation of Monica Bertagnolli as director of the National Institutes of Health (NIH), and the latest step CMS has taken in implementing the Inflation Reduction Act (IRA). They also discussed Abingworth’s new $356 million co-investment fund, which, coupled with its 2021 vintage co-development fund, brings the VC firm’s firepower for investing in late-stage development programs to nearly $1 billion.

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Daiichi Sankyo has drawn more value from its antibody-drug conjugate pipeline via a $4 billion deal with Merck & Co. On the latest BioCentury This Week podcast, BioCentury’s editors analyze the deal in the context of the burgeoning ADC space and size up the assets that Merck is in-licensing as well as how the deal fits with Daiichi’s pipeline strategy.
The editors break down Monday’s $7.1 billion deal by Roche for the Telavant subsidiary of Roivant Sciences, the latest in the evolving TL1A space; and offer highlights from BioCentury’s deep dive into how academics and biotechs are expanding the therapeutic potential of base editors.

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BayHelix’s Guo-Liang Yu and McKinsey’s Josie Zhou join the BioCentury This Week podcast to discuss cross-border innovation and deal flow in the biopharma sector during a preview of the BioCentury-BayHelix China Healthcare Summit. The summit kicks off at a time of record cross-border deals and validating comments from the leaders of MNCs such as Pfizer, Novartis and Sanofi that innovation by China biopharmas is world class. The 10th annual BioCentury-BayHelix China Healthcare Summit is Nov. 2-3 in Shanghai. Digital passes are also available.

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Now that Vas Narasimhan has finished the major dismantling of Novartis, he’s turning his attention to fixing R&D. On the latest BioCentury This Week podcast, BioCentury’s editors discuss what’s next for the Swiss pharma now that Narasimhan has focused it down to what he calls a pure play innovative medicines company.
The editors also analyze the European Parliament’s proposed changes to the first major overhaul of European pharmaceutical law in 20 years, including suggested adjustments related to data exclusivity, orphan drugs and antimicrobials.
They also discuss what Novo Nordisk gains via a deal with Singapore’s KBP BioSciences and how the Inflation Reduction Act has prompted Relay Therapeutics to delay development of lirafugratinib (RLY-4008) to treat cholangiocarcinoma in favor of a larger indication

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BMS’s acquisition of Mirati for up to $5.8 billion not only gives the big pharma a potential best-in-class KRAS inhibitor in a field that appears to be opening up, but also a clinical program against one of the hottest targets in precision cancer, PRMT5. On the latest BioCentury This Week podcast, BioCentury’s editors discuss what Bristol Myers Squibb stands to gain from its acquisition of Mirati Therapeutics, which had rumors swirling about its potential takeout last week. 
BioCentury’s editors also discuss their 4Q23 Public Markets Preview, including how private biopharma companies looking to go public in the next 12 months should be managing their path to that transition. Following last week’s analysis of the companies leading the transition of CAR T therapies into the autoimmune space, BioCentury’s editors also touch on the targets and technologies coming up behind the leading programs that could expand use of CAR Ts to a wider set of autoimmune indications. 
They also discuss takeaways from ICER’s report on how CMS might approach drug price negotiation under the Inflation Reduction Act.

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Biopharma companies are moving quickly to figure out how to optimize CAR T cell therapies for autoimmune diseases now that it’s becoming clear the modality has clinical activity and possibly even curative potential in the disease area. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the trigger for this surge of interest, the indications, targets and companies in play and whether the technology can meet the higher safety bar in autoimmune indications.
BioCentury’s editors also discuss takeaways from BioCentury’s recent conversation with Sanofi CEO Paul Hudson; the latest developments for the Inflation Reduction Act; and notable biotech financings, including a $300 million private placement for Structure Therapeutics.

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BayHelix’s Guo-Liang Yu and McKinsey’s Olivier Leclerc join the BioCentury This Week podcast to discuss cross-border innovation and deal flow in the biopharma sector and preview the upcoming BioCentury-BayHelix East-West Summit. Yu discusses the importance of the event for BayHelix, and Leclerc previews McKinsey’s second East-West Summit report, which will focus on the impact of AI on the sector. BioCentury co-founder, President and CEO Dave Flores, Editor in Chief Simone Fishburn, and head of BD Josh Berlin also join the podcast to discuss the importance of globalization for biopharma and patients, the growth of cross-border dealmaking, and panel topics and speakers at the East-West Summit, which takes place Oct. 2-4 in Kendall Square.

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