| |   | Good morning, everyone. Damian here with another biotech succession, a prolonged waiting game, and vindication for a vaccine laggard. | | | Agios CEO Jackie Fouse is stepping down About three years after taking the reins at Agios Pharmaceuticals, CEO Jackie Fouse is stepping down from the top job, the company said yesterday, replaced by a former Alexion Pharmaceuticals executive.
As STAT’s Adam Feuerstein reports, Fouse presided over the transformation of Agios, engineering a $1.8 billion deal to sell the company’s approved cancer medicines and focus on rare genetic diseases. Early returns from that pivot have been mixed, with one niche approval, some equivocal data, and quite a few unanswered questions.
Fouse, who will stay on as chair, will be replaced by Brian Goff, a 30-year industry veteran who most recently served as chief commercial at Alexion before AstraZeneca acquired the rare-disease company.
Read more. | The wait for Amgen’s KRAS combo data continues It was supposed to end last night with the release of abstracts for the World Conference on Lung Cancer. However, at the last minute, meeting organizers reclassified the closely tracked Amgen study — investigating a treatment that combines its KRAS-blocking lung cancer treatment Lumakras with a PD-1 checkpoint inhibitor — as a late-breaker abstract. The new designation means results won’t be disclosed until a full presentation at the conference on Aug. 7.
The successful development and approval of Lumakras was widely hailed as a signal achievement for cancer care; previously, KRAS was believed to be an “undruggable” target on tumors. Many companies are in the race to develop KRAS-targeted drugs. Amgen got there first, but commercially, Lumakras has been a bit of disappointment. The drug on its own has modest efficacy. Sales have also been hampered by bottlenecks in genetic testing.
And that’s why Amgen’s pursuit of combination regimens is so important. Combining Lumakras with immunotherapies like a PD-1 inhibitor could significantly boost the tumor-killing effect, allowing many more patients to benefit — and sales to accelerate.
But that all depends on the data. The wait continues | STAT E-Book: How technology is changing the face of medicine The 2022 STAT Health Tech Summit brought together the most prominent leaders working at the intersection of health and technology. Our latest e-book lays out the most pressing issues in health care that tech could help solve, the exciting new ideas to make that happen, and the barriers to pulling them off. | No news can be bad news Atara Biotherapeutics fell nearly 30% in after-hours trading yesterday on the news that its closely watched multiple sclerosis trial would continue as planned.
The discordance between the news and the reaction appears to reflect investors’ optimism that Atara would report early success from the small Phase 2 study. The company conducted a six-month interim analysis in June with four possible outcomes: The trial could be halted for futility, modified to increase its powering, allowed to continue as normal, or up-sized to support a potential approval.
It ended up being option three. Atara reached its enrollment target and decided that, after six months of the study, "there was not a sufficient dataset to draw conclusions" about whether the drug would work after one year. It expects to have data in the fall of 2023.
Management had described this as the “base-case scenario” back in May, but investors were apparently banking on door No. 4, in which the path to the FDA would be significantly shortened. That makes no news into bad news. | Novavax’s day is finally at hand After nearly two years of delays and missed deadlines, Novavax could win U.S. authorization for its Covid-19 vaccine as early as today, according to Politico, a long-awaited milestone for a company that has spent decades without developing a single commercial product.
The question facing Novavax’s business is whether demand has passed the company by. The FDA’s expected decision would clear Novavax’s product for first-time vaccination, meaning it would only be available to the roughly one-third of eligible Americans who have not received a single dose of another Covid-19 vaccine. Just what percentage of those people were simply holding out for a more traditional vaccine technology, like the one Novavax uses, remains to be seen.
The U.S. government, which spent about $1.6 billion helping Novavax develop and manufacture its vaccine, put in an order for 3.2 million doses earlier this week — enough for 1.6 million administrations. That suggests regulators aren’t expect a surge in demand once the vaccine wins authorization. | More reads - ‘Eye-opening’: The Covid-19 pandemic accelerated antimicrobial resistance across the U.S. STAT+
- They blazed a trail with ‘brain-computer interfaces.’ Now they want to help shape the field’s future STAT
| Thanks for reading! Until tomorrow,  | | | |
No comments