| | | |   | Good morning, all. Damian here with a look at the next Covid-19 vaccine debate, an arguably promising biotech deal, and another disappointment in depression treatment. | | | Does Novavax’s Covid vaccine have a commercial future? After a year of delays and disappointments, Novavax’s date with the FDA has finally arrived. But as agency advisers convene to discuss the company’s supporting data, one question remains unclear: Does the U.S. really need a fourth Covid-19 vaccine?
Later today, the now-familiar faces of the FDA’s vaccine advisory group will gather to debate the evidence supporting Nuvaxovid, which uses an older vaccine technology to confer protection comparable to mRNA vaccines. Analysts expect Novavax’s vaccine to eventually win an emergency use authorization and become available later this summer. But that hardly guarantees demand.
Under its $1.6 billion funding agreement with the U.S. government, Novavax has already committed to supplying 100 million doses of its vaccine, meaning there will be no immediate revenue bump after authorization. And, as the Washington Post reported yesterday, rare cases of heart inflammation tied to Novavax’s vaccine could dissuade the small number of people who were holding out for a non-mRNA option. | Biotech has one less bottom-dwelling company to kick around Yumanity, a once-promising neuroscience company decimated by clinical failure, will soon shuffle off of biotech’s beleaguered stock indices, replaced by a privately held upstart in what could be a sign of things to come in 2022.
The news is that Yumanity, which has traded at around $1 per share all year, signed a reverse-merger agreement with a cancer-focused company called Kineta. Once the transaction is complete, Yumanity will have sold off its remaining drugs and functionally ceased to be, ceding its place on the Nasdaq to Kineta, which will then raise money through a private placement.
As a standalone deal, the Yumanity merger won’t do much for biotech sentiment. But a wave of similar transactions could address one of the sector's biggest problems: There are too many public companies worth too little money. With more than 200 biotech firms with valuations below the cash they have in the bank, analysts have pointed to reverse mergers as a viable way to stop foundering companies from throwing good money after bad. | How can we collaboratively leverage digital innovation to bring better care to patients faster? For traditional healthcare organizations, their name and brand are familiar to consumers, they hold patients’ trust being already established in their market. Now, leaders for legacy organizations across the industry must consider: “How can we collaboratively leverage digital innovation to bring better care to patients faster?”. Learn how integrating digital solutions across the healthcare ecosystem—from providers to health plans to life sciences—is vital to improving health outcomes. | Praxis shelves its novel antidepressant after clinical failure Praxis Precision Medicines had a plan to succeed where so many novel antidepressants had failed, crafting a drug to hit specific receptors in the brain and designing a trial to limit the placebo effect that has derailed countless prior efforts.
And the company failed anyway. Yesterday, Praxis said its drug, PRAX-114, failed to outperform placebo on a common measure of depression symptoms. The treatment missed its primary endpoint, measured after two weeks of treatment, and all secondary endpoints, including one comparing PRAX-114 to placebo after a month. The company did not disclose detailed data.
Praxis is now discontinuing development of PRAX-114, its most advanced drug, and shifting its attention to pipeline treatments for movement disorders and epilepsy. The company’s share price fell about 75% on the news.
Read more. | A meeting of the minds at ASCO For the past year or so the biotech company Cel-Sci has been insisting that a Phase 3 trial of its cancer treatment, which failed on its primary endpoint, was actually a success. And STAT’s Adam Feuerstein has been explaining that that is not how clinical trials work.
Fate, in the form of the American Society of Clinical Oncology meeting, brought the two together yesterday, and you can read all about the experience. The news is that Cel-Sci finally presented detailed data from that study, and the results are just as negative as they seemed. At 18 months, Cel-Sci’s drug showed no survival benefit compared to standard therapy, and after 18 months, patients treated with the drug actually fared worse.
But that did not deter Cel-Sci CEO Geert Kersten, who points to a subset of patients in the trial for whom the drug reduced the risk of death by 32% compared to standard therapy. That, according to Kersten, will be enough to convince the FDA to grant an approval. As to just when Cel-Sci will submit its data to regulators, Kersten wouldn’t say.
Read more. | More reads - Many Black cancer patients say they aren’t offered the chance at clinical trials, survey finds. STAT
- Amarin to slash jobs as generic rivals dull U.S. prospects of heart drug. Reuters
- It’s time to move past Aduhelm and focus on a broader Alzheimer’s drug pipeline. STAT
- Greater Boston’s biotech industry has spilled out all over the region, leading some to ask: How much is too much? Boston Globe
| Thanks for reading! Until tomorrow,  | | | |
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