With KRAS breakthrough on the horizon, Amgen’s David Reese reflects on sotorasib’s looming review date and murky future

January 13, 2021 04:56 AM ESTUpdated 02:23 PM

With KRAS breakthrough on the horizon, Amgen's David Reese reflects on sotorasib's looming review date and murky future

Kyle Blankenship

Senior Editor

After decades of failures laid waste to R&D outfits looking to solve the KRAS G12C puzzle, Amgen is as close as anyone ever has been to an approval with sotorasib. For Amgen R&D head David Reese, the drug’s looming review date is a point of reflection for his own career and a big milestone for Amgen’s blooming — if controversial — next-gen oncology pipeline.

Amgen filed its FDA application for sotorasib in December to treat metastatic non-small cell lung cancer with the KRAS mutation — once thought to be “undruggable” — months after the agency offered its breakthrough designation based on pivotal Phase I data showing previously unheard of response rates.

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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 10:11 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.

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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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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Northway Biotech's new manufacturing facility in Greater Boston

January 21, 2021 10:24 AM EST

Manufacturing

Northway Biotech sets up shop in Boston hub, looking to court more customers with biologics-focused plant

Conner Mitchell

Associate Editor

Getting a foot in the door in Boston’s bustling biopharma hub is a rite of passage for many companies, but it comes with a steep price tag. Lithuanian CDMO Northway — now with a new moniker — will set up a new plant in close proximity, and it’s hoping its biologics focus will find a willing customer base.

Northway Biotech (formerly Northway Biotechpharma) on Wednesday held a virtual grand opening ceremony for its $40 million Waltham, MA facility — a 30,000 square-foot cGMP manufacturing and process development plant that will widely expand on the company’s previous capabilities.

January 21, 2021 10:23 AM EST

News Briefing

News briefing: Five public biotechs, over 2 days, raise $883M from fresh offerings; Belgian biotech expands Series B funding

John Carroll

Editor & Founder

Conner Mitchell

Associate Editor

The wave of biotech IPOs we’ve been seeing in the last few days underscores that the public markets remain one of the key channels for fresh investments in drug R&D. And that trend was in full view this week as a slate of biotechs nailed down hundreds of millions of dollars in fresh funds.

One of the big winners of the week is Editas $EDIT, which nailed $231 million to back its pioneering work on a gene editing platform. The biotech sold 3.5 million shares at $66 each.

January 21, 2021 07:33 AM EST

R&D

With patent concerns looming, Roche gets a new priority review on blockbuster IPF drug

Jason Mast

Editor

Seven years after the FDA first approved Esbriet, the blockbuster Roche IPF drug is getting an expedited review for a second indication.

On Thursday, the agency gave Esbriet priority review for unclassified interstitial lung diseases, or forms of pulmonary inflammation and scarring that don’t fit easily into the over 200 known types of ILD. The move comes 10 months after Esbriet received breakthrough designation and sets Roche up for a decision by May.

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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