How crowdsourced cells could kill hard-to-treat cancers

Scientists have spent years tinkering with human immune cells in hopes of crafting cancer-killing medicines. One startup is betting that nature has already designed the perfect tumor-hunting cell — one just has to go out and find it.

As STAT's Jonathan Wosen reports, a company called ImmuneBridge is collecting umbilical cord blood from public repositories in search of samples that can produce natural killer cells with unusually potent cancer-killing activity.

"In the digital world, if there's a computer virus, and then we patch it, we can disseminate it and share the solution," said Peretz Partensky, ImmuneBridge's co-founder and CEO. "Our bodies contain solutions; we solve problems. And yet isn't it a shame that we can't share them?"

Policy

PhRMA's copy-paste mifepristone response

As more than 300 biopharma executives signed an open letter opposing a judge's decision to suspend FDA approval of an abortion pill, the industry's most powerful lobbying organization is sitting on the sidelines.

As STAT's Rachel Cohrs reports, PhRMA, the top-spending lobbying group in health care, has not weighed in on the ruling, despite the possibility that the decision could destabilize the FDA approval process on which its member companies rely. Instead, PhRMA is sending a restrained statement to reporters upon request — identical to one the organization provided in February, before the decision came down.

PhRMA's membership has been less circumspect. Among the signatories on the aforementioned open letter are PhRMA board treasurer and Pfizer CEO Albert Bourla, board member and Lundbeck CEO Deborah Dunsire, Merck executive Christopher Tan, Bayer executive Imran Nasrullah, and Biogen President Alisha Alaimo.

R&D

Amgen averts embarrassment

Amgen's roughly $28 billion acquisition of Horizon Therapeutics, disclosed in December, was predicated on the belief that Horizon's best-selling drug still had room to grow. Yesterday brought data that made Amgen look shrewd — but the ultimate wisdom of paying so much for Horizon remains to be determined.

The news is that Tepezza, Horizon's treatment for thyroid eye disease, succeeded in a trial enrolling a broader patient population. The results are expected to lead payers to loosen restrictions on the drug, which accounts for about $2 billion a year in revenue, and increase the number of people eligible to receive it.

But in order for Amgen to break even on its acquisition, Tepezza will have to become a $4 billion drug, according to Evercore ISI analyst Umer Raffat, who has been skeptical of the price tag on Horizon. And there's no guarantee the latest data will make enough of a difference to double its revenue. Instead, Tepezza's positive trial ensures that Amgen has averted what would have been an embarrassing failure, and there's plenty of work ahead to turn it into a success.

Regulatory

The FDA's latest Alzheimer's do-over

The last time the FDA convened a panel of experts to talk about a new Alzheimer's disease drug, a bunch of them resigned in protest and then a scathing congressional report chastised the agency for running a review "rife with irregularities." The next one, scheduled for this summer, will likely be different.

On June 9, the FDA's advisers will convene to discuss whether the agency should grant full approval to Leqembi, a medicine developed by partners Eisai and Biogen, which won conditional approval in January. Based on Leqembi's supporting data, the drug is widely accepted to win over the panel and secure approval the following month.

The meeting marks the latest opportunity to depart from the disastrous review, approval, and launch of Aduhelm, the companies' Biogen-developed Alzheimer's treatment that got a resounding rejection from the same panel in 2020. Leqembi, under Eisai's direction, has successively succeeded where its predecessor failed, and the panel review is the next step.

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