| | | |   | Good morning, everyone. Damian here with signs of life in the dealmaking world, Moderna's second act, and the possible end of a quixotic biotech quest. | | | That’s billion with a B Takeda’s decision to pay $4 billion in cash for a single drug, invented by the private firm Nimbus Therapeutics, provided a stirring reminder that — despite more than a year of declining valuations — biotech companies can make real money doing science.
As STAT’s Jason Mast reports, Takeda is buying an investigational treatment that blocks TYK2, a signaling protein that affects how cells respond to common inflammatory molecules in the blood. Early studies have focused on its potential to treat psoriasis, but Takeda intends to develop it as a medicine for autoimmune disorders including inflammatory bowel disease, psoriatic arthritis, and lupus.
The transaction represents the largest up-front fee ever paid for a single, unapproved drug, and it comes just days after Amgen agreed to pay about $28 billion for Horizon Pharmaceuticals. Takeda, like Amgen, is facing key patent expirations that threaten its business, suggesting cash-rich pharmaceutical companies are still willing to pay big when the pressure’s on.
Read more. | The rare FDA setback with a silver lining Cytokinetics is a biotech company with one promising heart drug and a stubborn insistence on trying to win FDA approval for a second, troubled heart drug. Last night, a panel of FDA advisers voted against recommending approval for the second medicine, a setback for Cytokinetics that might end up benefiting its long-term prospects.
The drug is omecamtiv mecarbil, meant to treat heart failure. Presented with Cytokinetics’ supporting data, a group of independent experts voted 8-3 that its benefits did not outweigh its risks. The FDA is not required to follow the recommendations of its advisers, but the vote, combined with some decidedly negative briefing documents released ahead of the vote, suggest omecamtiv mecarbil is likely to be rejected.
That might convince Cytokinetics to finally call it quits on the drug, which has endured disappointing clinical results, an aborted partnership with Amgen, and years of pressure from investors to simply move on and focus on aficamten — the aforementioned other heart drug that has impressed in early studies. | Watch these stunning videos of T cells killing cancer Today, advanced microscopy techniques are revealing how immune cells kill tumor cells and how cancer evades our normal defenses. Scientists at Genentech are unraveling these complex relationships to develop more effective cancer immunotherapy treatments. Watch these killer T cells in action and see what the scientists see as they carefully observe these dynamic interactions under the microscope. | Moderna’s second act is taking shape For the past two years, Wall Street has grown increasingly antsy as to whether Moderna, flush with cash thanks to its Covid-19 vaccine, can sustain its momentum by coming up with another mRNA product. Yesterday, the company disclosed some preliminary data suggesting its long-in-development cancer therapy might finally come good.
As STAT’s Matthew Herper reports, Moderna said its individualized cancer vaccine, tested in combination with Merck’s immunotherapy Keytruda, reduced the risk of patients’ melanoma recurring by 44% compared to Keytruda alone. The results, disclosed in a press release, follow Merck’s decision to pay $250 million for opt-in rights on Moderna’s cancer vaccine candidate, called mRNA-4157.
Moderna’s share price, down nearly 60% from its 2021 heights, rose about 20% on the news, which suggested the company might find a second act in oncology as demand for its Covid-19 vaccine continues to wane.
Read more. | Madrigal is running out of 2022 Madrigal Pharmaceuticals, racing to win the first approval for a drug to treat people with the prevalent fatty liver disease known as NASH, promised all-important data on its investigational medicine in the fourth quarter, which calendars suggest has nearly elapsed.
Madrigal’s drug, resmetirom, met its goals in an earlier Phase 3 trial, enrolling about 1,000 patients and demonstrating it could be administered chronically without causing potentially harmful side effects. The second study, slated to read out any day now, will determine whether resmetirom can effectively treat and resolve the fat deposits and fibrotic scarring in the liver that characterize NASH.
The disease, which affects roughly 20 million people in the U.S., became a pharmaceutical gold rush in the last decade, with companies big and small angling to develop medicines for what appears to be a massive untapped market. But regulatory resistance, clinical disappointment, and biological complexity have derailed NASH treatments from Gilead Sciences, Genfit, and AbbVie, among others. | More reads - Study points to new ‘king on the block’ for treatment of chronic lymphocytic leukemia, STAT
- Illumina defends $7.1 billion Grail buy to fend off antitrust regulators, Reuters
- New Biden changes to Obamacare coverage for generics splits the industry, STAT
- Wave Life Sciences to receive $170 million upfront in new partnership with GSK to develop a large number of candidates, Endpoints
| Thanks for reading! Until tomorrow,  | | | |
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