NIAID and Moderna spell out a ‘robust’ immune response in PhI coronavirus vaccine test — but big questions remain to be answered

Tal Zaks, Moderna CMO (Moderna via YouTube)

July 14, 2020 05:00 PM EDTUpdated July 15, 06:26 AM

NIAID and Moderna spell out a 'robust' immune response in PhI coronavirus vaccine test — but big questions remain to be answered

John Carroll

Editor & Founder

The NIAID and Moderna have spelled out positive Phase I safety and efficacy data for their Covid-19 vaccine mRNA-1273 — highlighting the first full, clear sketch of evidence that back-to-back jabs at the dose selected for Phase III routinely produced a swarm of antibodies to the virus that exceeded levels seen in convalescent patients — typically in multiples indicating a protective response.

Moderna execs say plainly that this first stage of research produced exactly the kind of efficacy they hoped to see in humans, with a manageable safety profile.

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At the Inflection Point for the Next Generation of Cancer Immunotherapy

Willem Overwijk, Ph.D.

Vice President, Oncology Research, Nektar Therapeutics

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

December 4, 2021 06:00 AM EST

Weekly

All about Omicron; We need more Covid antivirals; GSK snags Pfizer’s vaccine exec; Janet Woodcock’s future at FDA; and more

Amber Tong

Senior Editor

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

The slate of products we’re offering here at Endpoints is continuing to grow, and it’s not just limited to editorial. If you haven’t, do visit your reader profile to see if there are any other weekly newsletters you’re interested in — as each comes with its own exclusive content. And don’t miss the publisher’s note from Arsalan Arif on Endpoints Studio, our latest avenue for advertising on Endpoints.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

December 2, 2021 09:02 AM ESTUpdated December 3, 12:57 PM

Pharma

Coronavirus

As Omicron spread looms, oral antivirals appear to be one of the best defenses — now we just need more

Paul Schloesser

Associate Editor

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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ENDPOINTS CAREERS

Lead Manager / Associate Director of Statistical Genetics

Deep Genomics

Boston, MA, USA

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December 3, 2021 10:54 AM EST

R&D

FDA+

Pfizer, Amgen and Janssen seek further clarity on FDA's new benefit-risk guidance

Zachary Brennan

Senior Editor

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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December 3, 2021 10:04 AM EST

Discovery

Coronavirus

Researchers move closer to deciphering blood clots from AstraZeneca, J&J's Covid-19 vaccines

Jason Mast

Editor

Researchers may be nearing an answer for the mysterious and life-threatening blood clots that appeared on very rare occasions in people who received the J&J or AstraZeneca Covid-19 vaccine.

The new work builds on an early hypothesis researchers in Norway put forward last spring, when the cases first cropped up. They proposed the events were similar to blood clots that can occur in a small subset of patients who receive heparin, one of the most commonly used blood thinners.

Usama Malik

December 2, 2021 04:37 PM EST

Pharma

Ex-Immunomedics CFO charged with insider trading, faces up to 20 years in prison after allegedly tipping off girlfriend and relatives of a PhIII success

Max Gelman

Editor

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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December 3, 2021 04:55 PM EST

Marketing

AbbVie tacks on a new warning to Rinvoq label as safety frets crimp JAK class

John Carroll

Editor & Founder

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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ENDPOINTS CAREERS

Executive Director - Data Analysis - Science & Technology

Alexandria Real Estate Equities

Pasadena, CA

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December 3, 2021 10:55 AM EST

News Briefing

Cell/Gene Tx

Biospecimen M&A: Discovery acquires Albert Li's hepatocyte project; PhIII trial on Bayer's Nubeqa reached primary endpoint

Josh Sullivan

Associate Editor

Paul Schloesser

Associate Editor

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.

Ed Kaye, Stoke Therapeutics CEO

December 3, 2021 10:00 AM ESTUpdated 11:39 AM

R&D

Stoke touts early signs of efficacy for Dravet syndrome drug

Nicole DeFeudis

Editor

Two and a half years after driving his antisense oligonucleotide platform to Wall Street, Stoke Therapeutics CEO Ed Kaye is painting a fuller picture of the company’s first clinical data. And though the trial wasn’t powered to detect statistical significance, Kaye says the readout shows early signs of efficacy in kids with a rare, drug-resistant form of epilepsy

STK-001 was well-tolerated in single and multiple doses in 22 Dravet syndrome patients between the ages of 2 and 18 years old, Stoke announced on Friday. What’s more, 12 of the 17 evaluable patients at the time (70.6%) saw reductions from baseline in convulsive seizure frequency, according to the company.