Amgen posts upbeat assessment of PhII KRAS data on AMG510 — but there’s no clear picture of what researchers saw

October 6, 2020 04:09 AM EDTUpdated 06:15 AM

Amgen posts upbeat assessment of PhII KRAS data on AMG510 — but there's no clear picture of what researchers saw

It’s not unusual to be left wanting after reading a top-line press release on closely-watched trial data. But Amgen is taking it to a whole new level with its Phase II snapshot on the KRAS G12c drug sotorasib — aka AMG 510.

The drug’s one solid shot at breakthrough status is in lung cancer, where researchers found evidence of efficacy in early-stage work. Now, they’re up to Phase II data, which execs earlier maintained could pave the way to a quick OK, and the team is giving little away.

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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.

Hal Barron, GSK via YouTube

January 22, 2021 08:25 AM EST

R&D

What does $29B buy you in Big Pharma? In GlaxoSmithKline’s case, a whole lot of uncomfortable questions about the pipeline

John Carroll

Editor & Founder

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

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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 22, 2021 09:16 PM ESTUpdated 01:24 PM

R&D

Fast on GlaxoSmithKline's heels, Aurinia wins OK to steer a second lupus nephritis drug straight to the market

Amber Tong

Senior Editor

GlaxoSmithKline’s Benlysta isn’t alone in the small circle of approved lupus nephritis drugs anymore.

Little Aurinia Pharmaceuticals has gotten the green light from the FDA to start marketing its first and only program, voclosporin, under the brand name Lupkynis — something CEO Peter Greenleaf says it’s been ready to do since December.

Regulators went right down to the wire on the decision, keeping the company and the entire salesforce it’s already assembled on its toes.

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.

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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Charlie Fuchs, Roche and Genentech global head of product development for oncology and hematology (Yale Cancer Center)

January 22, 2021 10:47 AM EST

People

Yale cancer specialist Charlie Fuchs tapped as new global development chief for Roche/Genentech

John Carroll

Editor & Founder

Roche and their big sub Genentech have just recruited a top cancer specialist at Yale to head up global product development in oncology and hematology.

I just got word that the pharma giant, which leads one of the most active cancer research operations in the world, recruited Charlie Fuchs, director of the Yale Cancer Center and physician-in-chief of Smilow Cancer Hospital. He’ll join the global operation March 1 and will be based in South San Francisco, where Genentech is based.

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