Pfizer shares surge on positive impact of their mRNA Covid-19 vaccine — partnered with BioNTech

July 1, 2020 09:37 AM EDTUpdated 09:53 AM

Pfizer shares surge on positive impact of their mRNA Covid-19 vaccine — partnered with BioNTech — in an early-stage study

John Carroll

Editor & Founder

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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Healthcare Disparities and Sickle Cell Disease

Frank Lee

CEO of Forma Therapeutics

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

September 20, 2021 07:55 AM EDT

People

Fresh off FerGene's meltdown, David Meek takes over at Mirati with lead KRAS drug racing to an approval

Kyle Blankenship

Managing Editor

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Volker Wagner (L) and Jeff Legos

September 20, 2021 10:12 AM EDTUpdated 10:27 AM

R&D

In Focus

As Bayer, Novartis stack up their radiopharmaceutical data at #ESMO21, a key debate takes shape

Amber Tong

Senior Editor

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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ENDPOINTS CAREERS

Senior Analyst, Oncology

Brass Tacks Health

Remote

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September 20, 2021 11:30 AM EDT

R&D

FDA+

Exelixis pulls a surprise win in thyroid cancer just days ahead of final Cabometyx readout

Nicole DeFeudis

Editor

Exelixis added a thyroid cancer indication to its super-seller Cabometyx’s label on Friday — months before the FDA was expected to make a decision, and days before the company was set to unveil the final data at #ESMO21.

At a median follow-up of 10.1 months, differentiated thyroid cancer patients treated with Cabometyx (cabozantinib) lived a median of 11 months without their disease worsening, compared to just 1.9 months for patients given a placebo, Exelixis said on Monday.

Dave Lennon, former president of Novartis Gene Therapies

September 20, 2021 11:09 AM EDT

Cell/Gene Tx

Zolgensma patent spat brews between Novartis and Regenxbio as top Novartis gene therapy exec departs

Zachary Brennan

Senior Editor

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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September 20, 2021 07:30 AM EDT

R&D

Mirati triumphs again in KRAS-mutated lung cancer with a closely watched FDA filing now in the cards

Kyle Blankenship

Managing Editor

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.

September 18, 2021 09:05 AM EDTUpdated 33 minutes ago

R&D

AstraZeneca, Daiichi Sankyo's ADC Enhertu blows away Roche's Kadcyla in second-line advanced breast cancer

Kyle Blankenship

Managing Editor

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

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ENDPOINTS CAREERS

Senior Scientific Research Analyst

American Association for Cancer Research

Philadelphia, PA, USA

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

September 17, 2021 04:59 PM EDTUpdated 4 hours ago

Coronavirus

Chaotic adcomm sees Pfizer/BioNTech boosters rejected for general population, but recommended for older and high-risk populations

Max Gelman

Editor

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

September 20, 2021 10:59 AM EDT

News Briefing

Denmark's Gubra to collaborate with Bayer on peptides; Samsung and Biogen receive FDA approval for Lucentis biosimilar

Paul Schloesser

Editorial Intern

Danish biotech Gubra announced a research collaboration and license agreement with Bayer to develop peptide therapeutics to treat cardiorenal diseases. The collaboration will utilize Gubra’s peptide drug discovery platform to identify potential candidates.

This is not the first time Gubra has partnered with a company on peptide therapeutics — they partnered with Boehringer Ingelheim back in 2017 to create peptide therapeutics to treat obesity.