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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5AM Ventures: Fueling the Next Generation of Innovators

Brian Abrahams

Managing Director and Co-Head of Biotechnology Equity Research

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Biohaven CEO Vlad Coric (Photo Credit: Andrew Venditti)

January 18, 2021 11:48 AM ESTUpdated 15 hours ago

Bioregnum

Pssst: That big Biohaven Alzheimer's study? It was a bust. Even the subgroup analysis execs touted was a flop

You know it’s bad when a biopharma player plucks out a subgroup analysis for a positive take — even though it was way off the statistical mark for success, like everything else.

So it was for Biohaven $BHVN on MLK Monday, as the biotech reported on the holiday that their Phase II/III Alzheimer’s study for troriluzole flunked both co-primary endpoints as well as a key biomarker analysis.

The drug — a revised version of the ALS drug riluzole designed to regulate glutamate — did not “statistically differentiate” from placebo on the Alzheimer’s Disease Assessment Scale-Cognitive Subscale 11 (ADAS-cog) and the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB). The “hippocampal volume” assessment by MRI also failed to distinguish itself from placebo for all patients fitting the mild-to-moderate disease profile they had established for the study.

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Janet Woodcock and Joshua Sharfstein (AP, Images)

January 19, 2021 09:38 AM EST

Regulatory

Poll: Should Joshua Sharfstein or Janet Woodcock lead the FDA from here?

John Carroll

Editor & Founder

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

Dan Skovronsky, Eli Lilly CSO (Lilly via Facebook)

January 19, 2021 09:25 AM EST

Deals

Discovery

Eli Lilly tees up discovery pact worth more than $1.6B with Merus for T cell-focused bispecific antibodies

Kyle Blankenship

Senior Editor

Under science chief Dan Skovronsky, Eli Lilly has taken some big swings at next-gen therapies, including trying to find the next big thing in oncology. Now, after one early failure in the field, Lilly is going back to the bispecific antibody well with a new deal with a Dutch biotech.

Lilly will pay $40 million upfront with an additional $20 million equity stake in Merus NV to identify and develop three bispecific antibodies looking to engage the CD3 antigen on T cells and redirect immune cells, the Indianapolis pharma giant said Tuesday.

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Andrew Cuomo, AP

January 19, 2021 07:15 AM ESTUpdated 11:36 AM

Coronavirus

Covid-19 roundup: Convalescent plasma flops in UK trial; New York Gov. Andrew Cuomo seeks to purchase vaccines directly from Pfizer

Nicole DeFeudis

Associate Editor

The UK’s RECOVERY trial is no longer recruiting patients for the convalescent plasma arm after an independent data monitoring committee found no significant improvement in mortality — another nail in the coffin for President Donald Trump’s so-called “historic breakthrough” treatment.

The RECOVERY trial spans several potential Covid-19 treatments, including Regeneron’s antibody cocktail, and the anti-inflammatories colchicine and tocilizumab. But convalescent plasma missed its primary endpoint in a preliminary analysis, and the DMC “saw no convincing evidence that further recruitment would provide conclusive proof of worthwhile mortality benefit either overall or in any pre-specified subgroup,” according to a report by the trial’s co-chairs, Peter Horby and Martin Landray.

Andrew Allen (Gritstone)

January 19, 2021 06:00 AM ESTUpdated 04:49 PM

Discovery

As coronavirus variants trigger new alarms, the NIH is putting an under-the-radar ‘next-gen’ vaccine into PhI

John Carroll

Editor & Founder

Over the past year, the world has been transfixed by the development of new vaccines to fight SARS-CoV-2. In a frenzy of activity, the new mRNA approach has delivered pioneering emergency approvals in record time. And with some setbacks, the more traditional big players are coming along with added jabs as the most affluent nations in the world begin to vaccinate large portions of their populations.

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January 19, 2021 11:36 AM EST

Financing

The IPO queue adds 5 more biotechs hoping to ring in 2021 by blitzing Nasdaq

Nicole DeFeudis

Associate Editor

Max Gelman

Associate Editor

Following a record year for IPOs — in terms of both proceeds and count — there’s already a long lineup of biotechs ready to jump onto Nasdaq in the new year. The companies are likely looking for much higher raises than they initially projected on their S-1s. Now it’s time to see if investors are still hungry for another round of biotech stocks.

Sana helped set the pace early on, as its founders look to divvy up a fortune from their IPO. And late last week 5 more biotechs crowded in, looking to pick up the pace where 2020 left off. Here they are:

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January 19, 2021 11:09 AM ESTUpdated 11:31 AM

News Briefing

News briefing: Beam bags a $260M private placement; miRagen rebrands to Viridian Therapeutics

John Carroll

Editor & Founder

Max Gelman

Associate Editor

Amber Tong

Senior Editor

Agios vet John Evans has demonstrated how to raise big money for a little biotech.

The Beam Therapeutics CEO — and ARCH partner — has pieced together a $260 million private placement from a group of backers that includes Perceptive Advisors, Farallon Capital, Casdin Capital, Redmile Group and Cormorant Asset Management. And there are 3 main goals they’ll pursue with it: clinical development, strategic partnerships and general corporate purposes.

January 19, 2021 11:00 AM EST

Pharma

Regulatory

AstraZeneca keeps the ball rolling on Daiichi-partnered Enhertu, picking up 2nd indication in gastric cancer

Kyle Blankenship

Senior Editor

AstraZeneca’s big gamble on Daiichi Sankyo’s antibody-drug conjugate Enhertu has already paid off with a big approval in breast cancer more than a year ago. But the partners have big plans for their blockbuster in the making, and a new nod in gastric cancer will raise their spirits even higher.

The FDA on Friday approved Enhertu to treat locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma in patients who have previously undergone at least one round of treatment with a Herceptin-based regimen, AstraZeneca said in a release.