Regeneron ends four clinical trials of its rolled-back Covid-19 antibody – Endpoints News


Regeneron has terminated four studies of its monoclonal antibody combination, known as REGEN-COV, in recent days, months after the FDA halted use of the drug for which the federal government had doled out billions of dollars, according to the federal clinical trials database.
A BLA review for REGEN-COV has also gone beyond the previously extended PDUFA date of July 13, a company spokesperson confirmed to Endpoints News in an email.
Unlock this story instantly and join 146,700+ biopharma pros reading Endpoints daily — and it’s free.
The field of gene therapy has been diligently moving forward over the past several decades to bring potentially life-saving treatments to patients with genetic diseases. In addition to two approved adeno-associated viral (AAV) gene therapies, there are more than 250 AAV gene therapies in various clinical trial stages.1 AAV vectors remain the most frequently used vector for delivering therapeutic transgenes to target tissues due to their demonstrated and lasting clinical efficacy and extensive safety track record. As AAV therapies advance through clinical trials and into commercialization, many biotech companies are turning to contract development and manufacturing organizations (CDMOs) to prepare their programs for late-stage clinical and commercial scale manufacturing. Given the scope and scale of the manufacturing needs that will accompany regulatory approvals for these assets, CDMOs continue to expand their capacity to meet the needs of increasing prevalent patient populations. However, despite rapid growth, projected gene therapy manufacturing demands still outpace the collective capacity of the CDMO industry.
On Friday, the FDA slapped a hold on Beam Therapeutics’ preclinical off-the-shelf CAR-T therapy, the biotech announced this morning.
At the end of June, the base editing biotech submitted its application to begin clinical trials for its CAR-T therapy in patients with relapsed/refractory T-cell acute lymphoblastic leukemia and lymphoma — aggressive white blood cell cancers that do not respond well to treatment.
Unlock this story instantly and join 146,700+ biopharma pros reading Endpoints daily — and it’s free.
As a high schooler, Kevin Eisenfrats turned to an unusual source when applying to chemical and biomedical engineering programs: “16 and Pregnant.” The MTV show took center stage in his college application essay, providing a view into the 17-year-old’s desire to research male contraceptive pills. “Why has there never been a male pill?” he posed. “Doesn’t the male partner have the same responsibility as the female partner?”
Unlock this article along with other benefits by subscribing to one of our paid plans.
Having turned to layoffs earlier this year to tighten its financial belt, microcap biotech Avalo Therapeutics has now added some much-needed cash to the bank.
The Rockville, MD-based biotech is selling AVTX-007 (camoteskimab), an IL-18 antibody, to the UK’s Apollo Therapeutics, which is dishing out $15 million to grab the drug and promising up to $74 million in milestones. Apollo will be in charge of all future development.
Four months ago, the FDA placed a clinical hold on Celyad’s CAR-T trial for colorectal cancer after two patients died during the study. Regulators have now lifted the hold, allowing the Belgian company’s trial to set sail once again.
On Feb. 28, Celyad announced that it had “voluntarily paused” the trial of its off-the-shelf CAR-T in combination with Merck’s PD-1 inhibitor Keytruda as it investigated the deaths. Both patients had “presented with similar pulmonary findings,” the company added without further explanation. The FDA imposed the hold shortly after the company’s announcement.
The latest biotech to sound the alarm comes from a David Hung startup, and it comes a little over a month after receiving a series of FDA holds.
Nuvation Bio announced Monday it would discontinue development on one of its early-stage clinical programs after regulators halted a handful of studies in late June. On top of this, Nuvation plans to lay off 30 employees, representing about 35% of its workforce, according to an SEC filing.
Concert Pharmaceuticals has been waiting to tout Phase III data amidst a sell-off of the bulk of its pipeline to Terran Biosciences and several other events for the biotech. And on Monday, the company rolled out the red carpet.
Concert unveiled topline results from its second Phase III clinical trial, dubbed THRIVE-AA2, evaluating its oral candidate currently called CTP-543 in adult patients with moderate to severe alopecia areata. The candidate is an inhibitor of Janus kinases JAK1 and JAK2.
Last week, a hearing disorder biotech thought it was headed toward a Phase III trial in the first half of next year for its drug to reduce ringing and buzzing in the ear.
But the San Diego biotech is on a different path this week, with early morning “unexpected” results Monday showing Otonomy’s OTO-313 did not beat placebo in the condition known as tinnitus.
With that, the biotech will shutter development of the program and shift its priorities to the only other clinical-stage asset in its pipeline. The R&D fine-tuning will entail “other measures to extend its cash runway,” a phrase that sounds eerily familiar to layoffs. The company had 51 full-time employees at the end of 2021.
With Keytruda bulling its way past the $5 billion mark for Q2 sales, you could say that the top execs at Merck can be believed when they say how keenly interested they are in using its cash reserves for new M&A and licensing deals. Just don’t ask what they’re negotiating to buy right now.
The analysts largely tiptoed around the biggest buzz about Merck today: that it’s engaged in discussions to buy Seagen for $40 billion-plus. They’re a polite bunch that needs to be on a first-name basis with CEO Rob Davis. But Davis was willing to emphasize that the pharma giant has the means and the intent to do more deals.
Unlock this article along with other benefits by subscribing to one of our paid plans.
Bioscience & Technology Business Center
The University of Kansas
Lawrence, Kansas<!–
2029 Becker Drive,
(785) 813-1733 –>
© Endpoints Company 2022
If you’re already an Endpoints subscriber, enter your email below for a magic link that lets you log in quickly without using a password. Please note the magic link is one-time use only and expires after 24 hours.
We’ll e-mail you a link to set a new password. Please note this link is one-time use only and is valid for only 24 hours.
ENDPOINTS NEWS Daily at 11:30 AM ET
EARLY EDITION Daily at 7:15 AM ET
ENDPOINTS PHARMA Daily at 2 PM ET
ENDPOINTS MARKETING RX Tue at 2 PM ET
ENDPOINTS FDA+ Wed at 2 PM ET
ENDPOINTS MANUFACTURING Thu at 2 PM ET
ENDPOINTS WEEKLY Sat at 6 AM ET

source


Leave a Reply

Your email address will not be published.