A veteran oncology startup crew is making a very serious bet that they’ve found the key to unlocking the promise of oncolytic viruses

Clodagh O’Shea (Salk)

January 5, 2021 06:00 AM ESTUpdated 07:03 AM

A veteran oncology startup crew is making a very serious bet that they’ve found the key to unlocking the promise of oncolytic viruses

John Carroll

Editor & Founder

Five years ago, when Amgen ushered the oncolytic virus T-Vec over the finish line at the FDA, 2 things seemed completely clear in short order.

One was that an important new avenue in cancer therapy had been opened up, finding a clean shot at solid tumors while recruiting an immune system attack to “mop up” cancer cell survivors. The other was that any of a number of upstart rivals following that path could do a lot better.

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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.

Janet Woodcock (AP Images)

January 21, 2021 07:49 AM ESTUpdated 08:04 AM

People

Regulatory

Endpoints poll: Janet Woodcock takes the (interim) helm at the FDA. And a large majority of our readers want her to stay there

Amber Tong

Senior Editor

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

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An Endpoints Zoom meeting; and the email header employees will see if your company is a Premium subscriber

January 21, 2021 07:01 AM ESTUpdated 08:32 AM

Publisher's note

What’s next for Endpoints — and how to support our independent biopharma news mission

Arsalan Arif

Publisher & Founder

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Mike Grey, Plexium chairman (Horizon Therapeutics)

January 21, 2021 08:00 AM EST

Financing

Plexium adds industry vet Mike Grey to the brain trust with new investor cash funding its protein degradation play

Max Gelman

Associate Editor

About 15 months since closing a $28 million Series A, a San Diego protein-degradation upstart returned to the venture well Thursday with an extension of that round and some new hires, including one of the city’s best-connected biotech execs.

Plexium has bagged an additional $35 million in financing, the biotech said, money that will push undisclosed oncology and immuno-oncology programs into the clinic. In addition, longtime industry vet Mike Grey is jumping on as chairman of the board, and two others from Thursday’s leads — Adam Goulburn from Lux Capital and Rob Hopfner from Pivotal BioVentures — joined the board too.

January 21, 2021 08:00 AM EST

R&D

Coronavirus

Eli Lilly's antibody cuts risk of Covid-19 by up to 80% among the most vulnerable — but will it have a place next to vaccines?

Amber Tong

Senior Editor

Eli Lilly says bamlanivimab lowered the risk of contracting symptomatic Covid-19 in a first-of-its-kind trial involving nursing home residents and staff, paving the way for a new option to protect against the virus.

But how big of an impact it might have, and what role it will play, at a time vaccines are being rolled out to the exact population it is targeting still remains unclear.

Among 965 participants in the study — all of whom tested negative for the coronavirus at baseline — the number of symptomatic cases reported in the bamlanivimab arm was 57% lower than that in the placebo arm (odds ratio 0.43, p=0.00021). In addition to that primary endpoint, all secondary endpoints reached statistical significance.

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Michelle McMurry-Heath, BIO CEO (BIO via YouTube)

January 21, 2021 07:29 AM ESTUpdated 08:03 AM

Pharma

BIO looks to restructure, laying off staff amid challenge to the trade org's normal face-to-face style

Kyle Blankenship

Senior Editor

The biopharma industry, on the whole, had a red-letter year in 2020 amid Covid-19, with fundraising at an all-time high and major players speeding vaccines ahead to approval. But for BIO, the industry’s leading trade organization, the pandemic has prompted a reconsideration of the game plan.

BIO will pivot to digital as the Covid-19 pandemic continues to rage, making “some staff reductions” as it looks to bring its roughly 37,000 in-person meetings each year to the web, the organization said Thursday.

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Hal Barron, GSK R&D chief (GSK via YouTube)

January 20, 2021 08:48 AM ESTUpdated 10:39 AM

R&D

GlaxoSmithKline's $4B bispecific cancer drug alliance with Merck KGaA hit by big setback with a PhIII failure on NSCLC

John Carroll

Editor & Founder

Close to 2 years ago, GSK’s R&D team eagerly agreed to pay up to $4 billion-plus to ally itself with Merck KGaA on a mid-stage bispecific called bintrafusp alfa, which intrigued them with the combination of a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein.

But today the German pharma company says that their lead study on lung cancer was a bust, as independent monitors said there was no reason to believe that the experimental drug — targeting PD-L1/TGF-Beta — could beat Keytruda.

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Biohaven CEO Vlad Coric (Photo Credit: Andrew Venditti)

January 18, 2021 11:48 AM ESTUpdated January 19, 07:20 AM

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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January 21, 2021 08:30 AM ESTUpdated 09:46 AM

Coronavirus

Covid-19 roundup: Italy wonders aloud if it can sue Pfizer for vaccine shortfalls; Flood, deadly fire threaten AstraZeneca vaccine plants

Nicole DeFeudis

Associate Editor

Jason Mast

Editor

As reports crop up that deliveries of Pfizer and BioNTech’s Covid-19 vaccine are being unexpectedly cut, Italy wonders if it can take the vaccine developers to court, according to the Wall Street Journal.

After its shipment for this week was cut by 29%, the Italian government consulted its attorney general about taking legal action, the WSJ reported. Pfizer and BioNTech had warned the EU and Canada last week that their allocations would be reduced as Pfizer upgrades its Belgium factory. What Italy says it doesn’t appreciate, though, is the short notice.