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The Readout Damian Garde & Meghana Keshavan

Merck is ditching one of its Covid-19 drugs

Merck is discontinuing development of a treatment meant to tamp down the immune symptoms of Covid-19, shifting its focus to an antiviral that might help clear the virus in the early days of infection.

Merck is abandoning the drug, acquired in a $425 million buyout of OncoImmune last year, because running trials and scaling up manufacturing would delay its availability until 2022. Considering the uncertainties of development and the number of medicines available for patients hospitalized with Covid-19, Merck decided its time would be better spent working on the antiviral molnupiravir and helping Johnson & Johnson manufacture doses of its vaccine.

Speaking of molnupiravir, Merck has decided to study the drug only for patients in the early stages of Covid-19, nixing plans for a Phase 3 study enrolling those already hospitalized. The move should come as little surprise given the mounting evidence that treatments for Covid-19 are effective only when given before the disease progresses. Merck expects to have Phase 3 data from those patients in September or October.

Read more.

Another promising idea in immunotherapy takes a blow

Among the acronymical stew of biological targets in immuno-oncology, ICOS emerged as a promising pathway for turning T cells’ attention to tumors. The latest news from GlaxoSmithKline, however, suggests it might not be as viable a target as once believed.

GSK has stopped a pair of studies testing its ICOS-targeting antibody alongside Merck’s blockbuster Keytruda, following the recommendation of its independent data monitors. The studies had enrolled patients with head and neck cancer. GSK didn’t disclose whether the decision was related to safety, efficacy, or both, but the company did say it would evaluate “the totality of the data” before determining what this means for the overall development of its treatment, called feladilimab.

That could be a bad omen for other ICOS drugs in development, including treatments from Jounce Therapeutics and Kymab. The idea behind targeting ICOS is that doing so can rev up immune cells that are already activated, making it seem like an ideal partner to a treatment like Keytruda or Bristol Myers Squibb’s Yervoy. But the field of immuno-oncology has seen plenty of seemingly promising combinatory ideas turn out to be no better than Keytruda by itself, and ICOS could be headed for a similar fate.

A biotech company is suing an academic journal over a ‘deeply flawed’ manuscript

Back in February, the journal run by the American Society of Anesthesiologists printed a meta-analysis of Pacira Biosciences’ injectable painkiller, one that reviewed nine clinical trials and concluded that the drug had a “statistically significant but clinically unimportant” improvement over generic anesthetic. And now the company is suing.

Pacira claims the analysis of its drug, Exparel, was “deeply flawed” and alleges that its authors failed to disclose relevant conflicts of interest in the manuscript. The company wants monetary damages and a retraction of the paper “in order to prevent the continued spread of misinformation.” Furthermore, Pacira will file for expedited discovery “to obtain crucial documents exposing the ASA’s unconscionable conflicts of interest and anti-Exparel bias,” the company said.

While drug companies are frequently sued for exaggeratedly positive claims about drugs, this is the first case in memory in which a manufacturer is suing over a negative review. What’s unclear in Pacira’s case is where exactly the journal broke a law. Undisclosed conflicts, if proved, would violate the rules of academic publishing, but there’s no law against having a “bias” in publishing.

A SPAC found its home

While there’s been a flurry of biotech blank-check companies going public in recent months, the pace of actual SPAC mergers has been comparatively slow, with only nine completed deals in the past 12 months, according to SPAC Track. Thanks to Tango Therapeutics, however, that number will soon be 10.

As the Boston Globe reports, Tango is going public through a $353 million merger with BCTG Acquisition Corp., a SPAC launched by Boxer Capital in September. Under the agreement, Tango gets the $167 million BCTG raised in its IPO plus another $186 million from private investors including Bain, Fidelity, and Blackrock. 

Meanwhile, scores of SPACs are still out there, ticking toward their expiration dates in search of a merger target. The primary concern about the SPAC boom — that there simply won’t be enough quality private companies to justify all these blank checks — probably isn’t going away, but the Tango deal means the market is now that much less flooded.

More reads

  • Startups are eyeing a market for glucose monitors that stretches far beyond diabetes. (STAT)
  • Biotech R&D startup Benchling hits $4 billion valuation as the company starts laying groundwork for an IPO. (Forbes)
  • Thermo Fisher nears deal to buy PPD for more than $15 billion. (Wall Street Journal)

Thanks for reading! Until tomorrow,

Thursday, April 15, 2021

STAT

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