Allakos trials under investor scrutiny

Allakos is in the midst of an intense clinical trial controversy, with billions of dollars on the line. The Bay Area biotech is again testing its digestive disease drug, antolimab, in a Phase 1 safety and tolerability trial — despite having already promised investors it’d soon be moving into Phase 3. 

Just last fall, Allakos had a $6 billion-plus market value, though that’s since dropped by half. Critics argue that the company is promoting positive study results while hiding data that might call into question antolimab’s safety and efficacy. 

“The new Phase 1 trial is worrisome,” one analyst told STAT’s Adam Feuerstein. “It makes me wonder if Allakos believes their own Phase 2 data, or if the FDA has signaled a problem. In any event, the company is being less than transparent.” 

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We have the $100 genome ... maybe

Six years ago, it was a huge deal to sequence a human genome for under a grand. Now, China’s BGI Group says that it’s cracked an even tougher benchmark: The genetics powerhouse has managed to decode genomes for under $100, according to MIT Technology Review. The news will likely stir up further competition between BGI and stateside sequencing giant Illumina. 

The company’s managed to do this with high throughput screening, of course, but also through sheer volume: It’s able to settle on this price tag through screening 100,000 people per year. But even if the company indeed manages to sequence so many genomes on this massive scale, it’s still early to know if the pricing claim is legit.

“I think there is some natural skepticism about whether it’s really for real,” Stacey Gabriel, a top Broad Institute researcher, said.

It's hard to track drugs in the supply chain

It isn’t possible to trace back 16% of drugs to their original manufacturers, according to a new government report. That’s a stunning figure, considering that Americans are considering importing drugs from Canada to help allay rising costs. But the pharmaceutical supply chain looks to be full of holes — particularly when it comes to certain diabetes and HIV drugs. Issues of theft, diversion, and counterfeiting are rampant. 

“Pharmaceuticals rest on three legs — safety, efficacy, and quality, and if we don’t have proper data to ensure quality, it points to need for improvement,” one former FDA wonk told STAT’s Ed Silverman. “This shines a bright light on ways for criminals to introduce substandard products into American medicine chests.” 

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Coronavirus: first come the drugs

Drugs to treat patients with coronavirus will come relatively quickly. Vaccines, however, will take longer, according to a top FDA official. After all, it’s much more time-consuming to craft — and clinically test — a vaccine for a healthy individual than it is to find a drug for a patient who has already fallen ill. 

Several companies are working on such inoculations, led by Moderna Therapeutics, but trials won’t even begin until later this spring. Meanwhile, several medications — including Gilead’s remdesivir — are already showing promise in helping curb the infection. 

“The development of a vaccine is not going to prevent a pandemic here,” Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, told STAT.

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• How Field Trip raised $8.5 million to take psychedelic medicine mainstream. (Business Insider)
• Senators threaten to subpoena Express Scripts for failing to produce insulin documents. (STAT)
• Twist Biosciences secures $140 million, plus a slew of new DNA partnerships. (FierceBiotech)