Targeting overactive white blood cells known as eosinophils has become a hot drug target with multiple approvals in recent years. One company with big platform hopes targeting those cells has now blown up in spectacular fashion after a lead drug showed little symptom relief for patients.
In two separate Phase II/III studies across multiple types of eosinophilic gastrointestinal disease, Allakos’ lirentelimab showed a significant reduction in eosinophil levels in the blood, but those results didn’t carry over into alleviating symptoms. On co-primary endpoints in both studies of self-reported symptom relief, patients didn’t see any significant improvement over placebo.
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CALQUENCE is a registered trademark of the AstraZeneca group of companies.
At the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition, blood cancer researchers from around the world gathered virtually to discuss the progress that has been made in the field of hematology. Over the past decade, that progress has been tremendous. We’ve seen not only breakthrough approaches to care, but also significant improvement upon existing novel treatments and exploring combinations within those medicines.1 These advances have transformed expectations of what a blood cancer diagnosis now means for patients. While we’ve come a long way, I believe the most exciting scientific discovery is yet to come, and that future advances will truly transform patient care.
Angie You and Volker Schellenberger, Amunix
Sanofi is crashing the year-end M&A party with a deal of its own.
Immuno-oncology is the name of the game as it swallows Mountain View, CA-based Amunix for $1 billion upfront and up to $225 million in biobucks, tagging a suite of T cell engagers and cytokine therapies as well as a tech platform for making ‘conditionally activated biologics.’
‘The Amunix technology platform utilizes a next generation smart biologics approach to precisely tailor-deliver medicines to become active only in tumor tissues while sparing normal tissues,’ said Sanofi R&D chief John Reed, ‘thus bringing the promise of more effective and safer treatment options for cancer patients.’
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The FDA on Wednesday signed off on Pfizer’s Covid-19 pills, which are meant to help keep people out of the hospital.
The news comes at a crucial moment, as the Omicron variant has taken over Delta as the prominent strain in the US, and as monoclonal antibody infusions will likely be in very short supply as two of the three currently marketed are ineffective against Omicron.
Pfizer will see early supply constraints of their pills, which are made up of nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use, meaning doctors will have to be very careful on how they’re doled out. And if Merck’s pill is authorized soon too, there may be more options, although there’s also a drastic difference in efficacy between the two.
Khurem Farooq, Gyroscope CEO
Christmas is coming early for Gyroscope.
In its latest gene therapy gambit, Novartis is paying $800 million upfront to acquire the Syncona-backed biotech, with another $700 million reserved for milestones.
Novartis has been diving deep into retinal disorders, and Gyroscope’s lead candidate adds a potential one-time treatment for geographic atrophy — a leading cause of blindness — to the pipeline.
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Michael Yang, ViaCyte CEO
Over the last 20 years, ViaCyte — under one name or another — has pursued one of the most audacious goals in biotech: a cure for type 1 diabetes.
The company’s plan was to take lab-grown stem cells and turn them into the insulin-producing cells that are destroyed in T1D patients. The first attempt to implant these cells into patients in 2014 failed entirely. But the San Diego biotech regrouped and launched trials for a new candidate in 2017, raising $80 million in the process.
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Christophe Weber (Miho Takahashi/The Yomiuri Shimbun via AP Images)
Takeda CEO Christophe Weber thought he had a win in the bag for TAK-721 — one of the experimental drugs spotlighted in the company’s $62 billion Shire acquisition — and went so far as to announce a brand name after snagging priority review last year. But months after missing its PDUFA date, the FDA’s now saying better luck next time.
Regulators handed TAK-721 a complete response letter for the treatment of eosinophilic esophagitis (EoE), a chronic inflammatory disease of the esophagus, Takeda revealed on Tuesday. While the pharma company didn’t share much information on the FDA’s reasoning behind the rejection, execs shared that the agency has recommended an additional clinical study ‘in order to help resolve FDA feedback.’
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Alzheimer’s disease researchers along with medical professors from Harvard and Johns Hopkins issued a formal statement Monday asking the FDA to quickly pull Biogen’s Aduhelm from the market.
‘An accelerated withdrawal would mitigate some of the harm of its unwarranted accelerated approval,’ they wrote to FDA, explaining how Aduhelm ‘did not meet the FDA’s own criteria for accelerated approval based on surrogate markers because amyloid plaque does not correlate well with symptoms, severity of disease or progression.’
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Graphic: Alexander Lefterov for Endpoints News
Drug pricing reform has been a political football for years, with both Donald Trump and Joe Biden championing changes during their presidencies. Little has moved the needle on Capitol Hill, however, thanks in part to the drug industry’s powerful lobbyists.
In the most recent example, Democrats tried to allow Medicare to negotiate drug prices — an immediate non-starter for biopharma proponents. After months of negotiation, the measure fell apart in favor of provisions on a small subset of drugs that passed the House but marked a far cry from Biden’s promises and what many activists had hoped for. The bill, included as part of Biden’s broad social policy agenda, now appears dead after Democrats failed to secure 50 votes in the Senate.
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As the FDA is poised to authorize the new Pfizer and Merck pills to treat those with Covid-19 who haven’t been hospitalized, Bloomberg reports that the US will only have limited supplies of each pill initially.
US officials said Americans should have nearly 400,000 courses of Merck’s pill available upon its authorization and 65,000 courses of Pfizer’s pill. By the end of January, the government expects 3 million Merck courses — its entire order — and 250,000 Pfizer courses. Merck’s pill has been shown to be less effective in early trials than Pfizer’s, although Merck did not test its pill head-to-head against Pfizer.
https://endpts.com/allakos-drops-a-pair-of-duds-on-patient-reported-symptom-relief-for-gi-disease-vaporizing-much-of-the-companys-value/
