| | | |   | Good morning, all. Damian here with a curveball in immunotherapy research, details on a biotech CEO's arrest, and a guy who made $700,000 for two days of work. | | | What if immunotherapy’s next big thing is a bust? The drug industry’s quest to find the next blockbuster cancer immunotherapy got a little more complicated yesterday, after Roche disclosed that its investigational medicine failed in yet another late-stage trial.
As STAT’s Adam Feuerstein reports, Roche’s drug, aimed at a seemingly promising molecular target called TIGIT, did not significantly slow tumor growth in a study enrolling newly diagnosed non-small cell lung cancer. The outcome is a setback for Roche, as the treatment is the most important cancer medicine in its pipeline and a linchpin in the company’s quest to expand the number of patients who might benefit from immunotherapy.
But Roche’s latest failure, which follows news last month that the same treatment showed no benefit in a less common form of lung cancer, could prove ominous for the entire TIGIT field, which includes Merck, Gilead Sciences, GlaxoSmithKline, and Bristol Myers Squibb.
Read more. | Details of Seagen CEO’s arrest raise questions for the company Seagen CEO Clay Siegall was arrested and charged with domestic assault after a drunken night at his suburban Seattle mansion turned violent, according to newly released police records, raising questions about when the biotech company learned of the incident and how quickly it took action afterward.
On April 23, Siegall repeatedly shoved his wife to the ground during a late-night dispute, according to an arrest report, resulting in bruises and abrasions. Siegall, who told police he did not harm his wife, was arrested and charged with fourth-degree assault.
Sixteen days later, Seagen, the $22 billion company Siegall co-founded in 1997, disclosed that he had taken a leave of absence following “an alleged incident of domestic violence” at his home. Seagen did not disclose his arrest, saying only that Siegall “has denied these allegations and has informed the company that he is engaged in a divorce.”
It’s unclear when Siegall told his employer about his arrest — and what the company did about it. Seagen, formerly known as Seattle Genetics, declined to answer multiple questions from STAT.
Read more. | How to navigate the requirements and pressure of disclosing clinical trial data When releasing clinical trial data, finding the right balance between the “duty to disclose” vs. “pressure to disclose” conundrum is not easy. Handled correctly, for both private and public companies, these milestones are a great way to raise visibility within the investment, clinical, and scientific communities. If done incorrectly, the consequences can be severe. Best practices are discussed in this article. | The remarkably short tenure of Moderna’s new CFO “Jorge Gomez joins Moderna as chief financial officer,” reads an April 11 press release from the company, noting that Gomez will begin his new job on Monday, May 9. Moderna’s “recently appointed chief financial officer, Jorge Gomez, has departed the company, effective immediately,” reads a press release issued yesterday, May 11, thus ending his two-day stint at the financial reins of a world-famous biotech company worth about $50 billion.
The issue relates to Gomez’s former employer, the dental products firm Dentsply Sirona, which on May 10 disclosed an internal investigation into matters including its financial reporting. Last month, Dentsply abruptly fired its CEO and removed him from its board of directors.
For his two days on the job, Gomez will receive his $700,000 annual salary in full, Moderna said in a regulatory filing. However, he will forfeit a $500,000 signing bonus. | Lawmakers wade into a contentious fight over orphan drug monopolies The decade-long fight between a family-run firm and a publicly traded biotech has attracted the attention of two influential lawmakers, a development that could change the process by which drugmakers monopolize orphan medicines.
As STAT’s Ed Silverman reports, Sens. Bill Cassidy (R-La.) and Tammy Baldwin (D-Wisc.) have introduced a bill aimed at clarifying federal incentives for companies that win approval for orphan drugs, defined as medicines for patient populations of fewer than 200,000 people. Current law allows companies to win FDA approvals for narrow indications and then block would-be rivals from marketing products for different uses or patient populations.
The legislation is a response to a closely watched legal battle, which the U.S. Supreme Court was recently asked to review, that has pitted the small, family-run Jacobus Pharmaceuticals against Catalyst Pharmaceuticals over the market for treating a rare neuromuscular disorder called Lambert-Eaton myasthenic syndrome, or LEMS.
Read more. | More reads - Seven health insurance CEOs raked in a record $283 million last year. STAT
- Pfizer's $11.6 billion Biohaven buy could spark more biotech deals. Reuters
- In radical claim, study suggests inflammation wards off chronic pain instead of causing it. STAT
- Moderna asks FDA to authorize Covid vaccine for kids under 6 years old. CNBC
| Thanks for reading! Until tomorrow,  | | | |
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