| | | |   | Hello, everyone. Damian here with some hopeful news on banker bonuses, a novel idea in oncology, and a look at the FDA's unenviable task. | | | The bank might be back open for biotech Before this week, just four biotech companies managed to raise money through secondary stock offerings in all of 2022. That number could double in a matter of days thanks to a sudden spate of faith in what has been a brutal market.
It started with Argenx, which mounted a $500 million offering on Tuesday, just hours after disclosing positive Phase 3 data. After market close yesterday, Ascendis Pharma moved to raise $500 million of its own. And then Apellis Pharmaceuticals, which just last week suggested it wouldn’t be selling stock any time soon, filed to raise $300 million in a public offering.
If those efforts succeed, more and more biotech companies might start calling their bankers. According to Nasdaq, there are 20 drug developers with offerings on file. | What if bacteria can halt pancreatic cancer? A startup called Loki Therapeutics intends to find out, and some early animal data published this week suggests using a modified form of Listeria might dismantle tumors’ defense and galvanize the immune system.
As STAT’s Angus Chen reports, the idea comes from Albert Einstein College of Medicine immunologist and microbiologist Claudia Gravekamp, who came up with an engineered bacteria that doesn’t cause illness but does carry the biological hallmarks of tetanus. That means it has the infectious properties necessary to dig into tumor tissue and a signature that should be familiar to the immune system, working like a homing beacon for attacking T cells.
To test it out, scientists took mice with pancreatic cancer, injected them with a tetanus vaccine, and then administered the modified Listeria treatment. Mice with the most advanced cancer saw their pancreatic tumors shrink by 80% and their metastases by 87%, surviving about 40% longer than the control group. Whether it can translate to humans remains to be seen, but that’s where Loki, a New York-based biotech company, comes in.
Read more. | Rare disease patients deserve protection from Washington politics Right now, politicians need a win, but rare disease patients could lose. In Congress’ rush to pass something, therapies for rare diseases and cancers could face an increase of between 400% and 800% in Medicare Part D costs. There is a better way that protects patients. Learn more. | FDA approves Novartis’ novel prostate cancer drug Novartis won FDA approval for a drug that delivers a lethal dose of radiation directly to prostate cancer cells, a medicine that could become the standard of care for patients with advanced forms of the disease.
The treatment, approved under the brand name Pluvicto, combines a radioactive isotope to a drug that binds to a receptor on the surface of prostate cancer cells, radiating tumors while sparing healthy tissue. In a Phase 3 study presented last year, Pluvicto reduced the risk of death by 38% compared with standard treatment and cut the risk of tumor progression by 60%.
That trial enrolled patients with metastatic, castrate-resistant prostate cancer, a group with few other options for treatment. Novartis is running studies on patients with less advanced disease, before tumors grow resistant to hormone therapy or other drugs, in hopes Pluvicto might show a greater survival benefit. | Omicron has made judging vaccines a murky business Yesterday, Moderna said it will ask the FDA to authorize its Covid-19 vaccine for kids under 6 based on a pair of successful clinical trials. But the demonstrated efficacy came in below the agency’s initial bar for clearing vaccines, raising questions about how experts should judge study results in the face of a mutating virus.
As STAT’s Helen Branswell and Matthew Herper report, in Moderna’s study enrolling children 6 months to 23 months, cases of Covid-19 were decreased 43.7%. For kids in the 2 years to under 6 years age group, they were decreased by 37.5%. Both numbers fall short of the 50% efficacy threshold the FDA set at the dawn of the pandemic, but Moderna said that the efficacy was on par with what would be expected of a two-dose vaccine in adults against the Omicron variant, which predominated during both pediatric studies.
And many experts agree. But there’s still some ambiguity in Moderna’s data, said Phil Krause, a former deputy director of the FDA’s office of vaccines. “It may be that it’s impossible to get these vaccines to work as well in children as they do in adults,” Krause said. “There may still be some benefit in using these vaccines, but it will then be tricky and important to make sure that people understand the limitations of what can be said about the vaccines and the limitations in what to expect the vaccines to do.”
Read more. | More reads - 13 drug companies in a dangerous financial position and struggling to survive through 2022. Insider
- Covid vaccine maker Moderna flags Japan ambition with sumo sponsorship. Reuters
- Google’s ongoing stem cell problem points to a larger issue with its search results on unproven therapies. STAT
| Thanks for reading! Until tomorrow,  | | | |
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