| | | |   | Good morning, one and all. Damian here. You will be delighted to learn the terms "XBI," "sell-off," and "panic" do not appear in this morning's newsletter. | | | Stoffels’ next act: Saving Belgium’s biggest biotech Paul Stoffels looked poised to ride off into the pharmaceutical sunset at the end of last year, ending a long career as Johnson & Johnson’s top scientist after leading development of the company’s vaccine for Covid-19. Instead, he’s taking the reins at one of biotech's biggest recent disappointments, signing up to become the next CEO of Galapagos.
The news, disclosed yesterday, puts Stoffels in charge of the biggest biotech in his native Belgium starting April 1. He inherits a firm known mostly for expensive clinical failures in recent years, whose stock price has fallen by 50% in the past 12 months. The company now trades at a valuation below its cash balance, a reflection of just how little faith investors put in its ability to develop drugs.
Things probably can’t get much worse. And Stoffels, who will replace Galapagos co-founder Onno van de Stolpe as CEO, has a track record of turning promising scientific ideas into actual products. | The ‘don’t eat me’ theory of cancer treatment takes a hit The history of cancer immunotherapy is a scientific search for ways to stop tumors from evading the body’s natural defenses. But one of the field’s latest bright ideas has run into a safety problem.
This week, Gilead Sciences said the FDA had asked it to stop recruitment in five studies involving magrolimab, an antibody targeting the protein CD47, which tumors hijack to send a “don’t eat me” signal to certain types of immune cells. The problem is an “apparent imbalance in investigator-reported suspected unexpected serious adverse reactions” between study arms in one or more of the trials, Gilead said in a statement.
Gilead’s setback adds to yearslong concerns that CD47 might be an imperfect target. While tumors can exploit it to escape immune detection, healthy red blood cells use CD47 to go about their business without meddling from the immune system. Blocking it risks exposing those cells to destruction, which could lead to dangerous bouts of anemia and make for an unsafe medicine.
Read more. | How retailers are disrupting the clinical trial delivery model Local pharmacies and big-box stores are no longer just purveyors of prescriptions and laundry detergent; many have crossed the line into healthcare providers — offering everything from flu vaccines to primary care checkups. This shift for retailers, and the disruption to conducting clinical trials at academic medical centers and hospitals by Covid-19, has given the biopharma industry an opportunity to significantly accelerate alternative clinical trial delivery approaches. Learn how retailers are transforming clinical trial delivery. | Immunotherapy might deliver a final blow to HIV While modern treatments for HIV can render the virus undetectable in patients’ blood, they can’t touch the viral reservoirs that hide in immune cells. Now, early evidence from a small study suggests a commonly used immuno-oncology treatment might offer a way to flush out the last vestiges of the virus and light the way to a cure.
As STAT’s Angus Chen reports, researchers looked at 32 patients who had both cancer and HIV and found that the combination of antiviral therapy and Merck’s blockbuster treatment Keytruda appeared to eradicate what’s known as latent virus.
Outside experts described it as a proof-of-concept study, full of scientific promise but lacking practicality. Treatments like Keytruda bring toxicities that are worth the risk for patients with cancer but would be intolerable to those with well-controlled HIV. The path forward, scientists said, would be to try lower doses or find another way to replicate the benefits of Keytruda without the side effects.
Read more. | The therapeutic video game company is SPAC’ing Akili Interactive, which has spent years developing an FDA-cleared video game to treat ADHD, is going public through a SPAC merger giving it a roughly $1 billion valuation.
As STAT’s Mario Aguilar reports, Akili is merging with a blank-check firm run by venture capitalist and former Facebook executive Chamath Palihapitiya, who is expected to become chair of the company’s board. The deal values Akili’s existing equity at $600 million and gives the company $250 million in SPAC cash plus another $162 million private investment.
The money will help Akili commercialize EndeavorRx, its prescription video game, which the company believes has the potential to bring in annual revenue of $500 million within the next seven years.
Read more. | More reads - Moderna starts testing Omicron vaccine in people. Wall Street Journal
- Michigan attorney general pursues investigation into Lilly’s ‘grossly’ excessive insulin prices. STAT+
- A senior Biogen commercial exec exits Alzheimer's unit amid exodus as Aduhelm woes mount. Endpoints
- Chinese hackers target German pharma and tech firms. Reuters
| Thanks for reading! Until tomorrow,  | | | |
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