With one pandemic still raging, J&J bets $780M on a potential flu therapy for the next
Nicole DeFeudis
Associate Editor
As it rolls out the first jabs of its Covid-19 vaccine in the US, J&J already has its eyes on the next pandemic. Now, it’s willing to bet up to $780 million on a new class of drugs that Cidara Therapeutics says could take out all strains of the flu.
Janssen, J&J’s Belgian subsidiary, is plunking down $27 million upfront for access to Cidara’s lead antiviral conjugate CD388, which CEO Jeffrey Stein says has the potential to treat and protect against all flu strains with a single dose. The deal is one example of the next wave of pipeline work being established as the US begins to get its hands around the current pandemic.
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April 12, 2021 06:00 AM EDT
BYOD Best Practices: How Mobile Device Strategy Leads to More Patient-Centric Clinical Trials
Jonathan Andrus
Chief Business Officer, Clinical Ink
Some of the most time- and cost-consuming components of clinical research center on gathering, analyzing, and reporting data. To improve efficiency, many clinical trial sponsors have shifted to electronic clinical outcome assessments (eCOA), including electronic patient-reported outcome (ePRO) tools.
In most cases, patients enter data using apps installed on provisioned devices. At a time when 81% of Americans own a smartphone, why not use the device they rely on every day?
After being goaded to sell the company, Alexion's CEO set some ambitious new goals for investors. Then Pascal Soriot came calling
John Carroll
Editor & Founder
Back in the spring of 2020, Alexion $ALXN CEO Ludwig Hantson was under considerable pressure to perform and had been for months. Elliott Advisers had been applying some high public heat on the biotech’s numbers. And in reaching out to some major stockholders, one thread of advice came through loud and clear: Sell the company or do something dramatic to change the narrative.
In the words of the rather dry SEC filing that offers a detailed backgrounder on the buyout deal, Alexion stated: ‘During the summer and fall of 2020, Alexion also continued to engage with its stockholders, and in these interactions, several stockholders encouraged the company to explore strategic alternatives.’
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Nearly a year after Audentes' gene therapy deaths, the trial continues. What happened remains a mystery
Jason Mast
Editor
Natalie Holles was five months into her tenure as Audentes CEO and working to smooth out a $3 billion merger when the world crashed in.
Holles and her team received word on the morning of May 5 that, hours before, a patient died in a trial for their lead gene therapy. They went into triage mode, alerting the FDA, calling trial investigators to begin to understand what happened, and, the next day, writing a letter to alert the patient community so they would be the first to know. “We wanted to be as forthright and transparent as possible,” Holles told me late last month.
The brief letter noted two other patients also suffered severe reactions after receiving a high dose of the therapy and were undergoing treatment. One died a month and a half later, at which point news of the deaths became public, jolting an emergent gene therapy field and raising questions about the safety of the high doses Audentes and others were now using. The third patient died in August.
“It was deeply saddening,” Holles said. “But I was — we were — resolute and determined to understand what happened and learn from it and get back on track.”
Eleven months have now passed since the first death and the therapy, a potential cure for a rare and fatal muscle-wasting disease called X-linked myotubular myopathy, is back on track, the FDA having cleared the company to resume dosing at a lower level. Audentes itself is no more; last month, Japanese pharma giant Astellas announced it had completed working out the kinks of the $3 billion merger and had restructured and rebranded the subsidiary as Astellas Gene Therapies. Holles, having successfully steered both efforts, departed.
Still, questions about precisely what led to the deaths of the 3 boys still linger. Trial investigators released key details about the case last August and December, pointing to a biological landmine that Audentes could not have seen coming — a moment of profound medical misfortune. In an emerging field that’s promised cures for devastating diseases but also seen its share of safety setbacks, the cases provided a cautionary tale.
Audentes “contributed in a positive way by giving a painful but important example for others to look at and learn from,” Terry Flotte, dean of the UMass School of Medicine and editor of the journal Human Gene Therapy, told me. “I can’t see anything they did wrong.”
Yet some researchers say they’re still waiting on Astellas to release more data. The company has yet to publish a full paper detailing what happened, nor have they indicated that they will. In the meantime, it remains unclear what triggered the events and how to prevent them in the future.
“Since Audentes was the first one and we don’t have additional information, we’re kind of in a holding pattern, flying around, waiting to figure out how to land our vehicles,” said Jude Samulski, professor of pharmacology at UNC’s Gene Therapy Center and CSO of the gene therapy biotech AskBio, now a subsidiary of Bayer.
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Anti-aging biotech upstart plucks a drug from Amgen's discard pile, pivoting from heart failure to muscle conditions
Amber Tong
Senior Editor
Back in April 2019, Amgen quietly shut down a Phase I trial for a drug named AMG 986. There was no safety concern; the molecule just didn’t hit the mark on helping the small band of heart failure patients who received it.
A small biotech, though, believes it would stand a chance in the burgeoning anti-aging field.
BioAge Labs has licensed AMG 986 — now renamed BGE-105 — with plans to parlay the existing IND into a quick Phase I trial teasing out the pharmacodynamic effects and set the stage for mid-stage tests focused on acute muscle indications.
Former head of FDA’s medical and scientific affairs on Covid: ‘FDA has never been tested like this’
Zachary Brennan
Senior Editor
Anand Shah has served the American public in a unique way, crisscrossing over the last two administrations between serving as an attending radiation oncologist focused on prostate cancer at NIH, serving as CMO at the Center for Medicare and Medicaid Innovation, and most recently, leading the FDA’s operations on medical and scientific affairs from within the commissioner’s office.
Shah, who stepped down from the FDA in January, caught up with Endpoints News in a phone interview on Tuesday afternoon, offering his thoughts on the agency’s latest decision to pause the J&J vaccinations in the US, and reflecting on his time at an agency during this once-in-a-lifetime pandemic.
Launched by MIT grads, a small startup gets $20M to back a robotics revolution in cell therapy manufacturing
John Carroll
Editor & Founder
As co-director of an experimental cellular therapy process development and manufacturing group at UCSF specializing in T cell therapies for autoimmune conditions, Jonathan Esensten has learned a lot about the challenges involved when his group hand-fashions a cell therapy. Esensten — who was a postdoc in Wendell Lim’s lab and counts the legendary Jeffrey Bluestone as a mentor — gives them all high marks at being great at what they do, but time and again there are variations in the treatments they construct.
It takes two to Tango: The biotech using CRISPR to discover new cancer gene targets rides a $353M SPAC deal to Nasdaq
Max Gelman
Associate Editor
Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.
The latest biotech-SPAC deal has arrived, and it’s dancing its way to Nasdaq to the tune of several hundred million dollars.
Tango Therapeutics and its CRISPR-focused search for new cancer genes is reverse merging with Boxer Capital’s blank-check company, the biotech announced Wednesday morning. With a spotlight on three lead programs, Tango expects total proceeds to equal about $353 million in the deal, which includes the roughly $167 million held in the SPAC and an additional $186 million in PIPE financing.
Eli Lilly seeds a well-connected China neuro startup with drugs aiming at where Biogen, Voyager missed
Amber Tong
Senior Editor
When Min Li took the wraps off a $100 million round for his Bob Nelsen-backed startup last December — as with most biotech CEOs when they launch — he left a couple cards unturned.
Keen to build a first-of-its-kind neuro play in China, the GlaxoSmithKline R&D vet already had a good idea of which assets he wanted to in-license for SciNeuro, conducting Zoom negotiations from the East Coast office that he’s been somewhat stuck in since JP Morgan early in the year. Now, he’s finally ready to shine a spotlight on the first program: a slate of alpha-synuclein targeted antibody therapies from Eli Lilly.
UPDATED: J&J pauses vaccine rollout as feds probe rare cases of blood clots
Zachary Brennan
Senior Editor
The FDA and CDC have jointly decided to stop administering J&J’s Covid-19 vaccine after reviewing data involving six reported US cases of a rare and severe type of blood clot in individuals after receiving the vaccine.
CDC will convene a meeting of its Advisory Committee on Immunization Practices on Wednesday to further review these cases and assess their potential significance. “FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research and Anne Schuchat, Principal Deputy Director of the CDC, said in a joint statement Tuesday morning.
