#ASH18: Can Amgen break through the BCMA CAR-T line and take a BiTE of the multiple myeloma market? It won’t be quick or easy

December 3, 2018 09:16 PM EST

John Carroll

#ASH18: Can Amgen break through the BCMA CAR-T line and take a BiTE of the multiple myeloma market? It won't be quick or easy

Amgen’s R&D group has been focusing considerable attention on its development of AMG 420 — a bispecific T-cell engager, or BiTE, in brand name parlance — that it believes can point them to a competitive position with the BCMA CAR-Ts now angling for first-mover advantage, and likely better than an antibody-drug conjugate. They came to San Diego with a first look at the Phase I data that include a high rate of response for one dose that could capture some support.

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February 26, 2020 05:50 AM ESTUpdated 08:23 AM

Amber Tong

Deals

Takeda swoops in to buy little biotech partner and its celiac drug poised to 'change standard of care'

Having spent three years carefully grooming PvP Biologics and its drug for celiac disease, Takeda is happy enough with the proof-of-concept data to buy it all.

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Growing acceptance of accelerated pathways for novel treatments: but does regulatory approval lead to commercial success?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

February 26, 2020 06:53 AM ESTUpdated 07:56 AM

Natalie Grover

Discovery

Microbiome Q&A: New study maps the vagina's 'optimal microbiota' — and its implications for biopharma

The widely-held notion that the “optimal” vaginal microbiota is dominated by one strain of lactic-acid producing bacteria has now been challenged in a new paper, published in Nature Communications on Wednesday, which used advanced gene sequencing methods to map out the most comprehensive gene catalog of the human vaginal microbiome.

Things have changed in the more than 50 years since the concept of vaginal microbiota transplants was proposed and subsequently tainted by a Texas-based gynecologist who transplanted the vaginal fluid of women who had bacterial vaginosis into healthy females, suspecting he had isolated the bacteria responsible for the condition.

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ENDPOINTS CAREERS

Clinical Trial Manager

Cold Genesys, Inc.

Irvine, CA

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February 26, 2020 06:18 PM EST

Amber Tong

Coronavirus

R&D

Following US, China hospital efforts, Gilead plots its own PhIII trials for closely watched Covid-19 drug

Gilead is launching its own Phase III trials of remdesivir, the repurposed antiviral that a WHO official called the “one drug right now we think may have real efficacy” against Covid-19 as the novel coronavirus originating from Wuhan, China ravages the world.

Announced just a day after the NIH and the University of Nebraska Medical Center registered their US-based trial online, Gilead’s program will comprise two studies enrolling around 1,000 patients beginning in March. They will recruit primarily in Asian countries but will also include patients from other locations with “high numbers of diagnosed cases,” the company said.

February 25, 2020 10:24 AM EST

Jason Mast

Cell/Gene Tx

R&D

Biogen touts new evidence from the gene therapy company it wagered $800M on

A year ago, Biogen made a big bet on a small gene therapy company. Now they have new evidence one of their therapies could work.

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Anthony Fauci (AP Images)

February 25, 2020 06:55 AM ESTUpdated 07:59 AM

Amber Tong

R&D

UPDATED: NIH-partnered Moderna ships off its PhI-ready coronavirus vaccine candidate to a sea of uncertainty

Off it goes.

Moderna has shipped the first batch of its mRNA vaccine against SARS-CoV-2 from its manufacturing facility in Norwood, Massachusetts, to the National Institute of Allergy and Infectious Diseases in Bethesda, Maryland, for a pioneering Phase I study.

It’s a hectic race against time. In the 42 days since Moderna selected the sequence they would use to develop their vaccine — a record time, no less — the number of confirmed cases around the world has surged astronomically from a few dozen to over 80,000, per WHO and Johns Hopkins estimates.

The candidate that they came up with, mRNA-1273, encodes for a prefusion stabilized form of the spike protein, which gives the virus its crown shape and plays a key role in transmission. The Coalition for Epidemic Preparedness Innovations, the Oslo-based group better known as CEPI, funded the manufacture of this batch.

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February 26, 2020 10:57 AM ESTUpdated 11:36 AM

Jason Mast

R&D

In at least one life-sci hub, gender and diversity initiatives haven’t made a dent

Gender and racial diversity at the top of UK life science companies has hardly budged over the last seven years despite repeated advocacy efforts, according to a new report.

The report, from the recruiting firm Liftstream, found that 14.8% of directors on life sciences boards were women and 21.1% of top executives were women. That’s a modest bump from the 9.8% of directors and 18.1% of executives Liftstream identified in their last report from 2014. The percentage of women CEOs moved from 8% to 9.8%.

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Associate- Science & Technology

Alexandria Real Estate Equities

San Francisco, CA

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February 26, 2020 10:23 AM EST

Amber Tong

Cell/Gene Tx

Deals

Will a 'risk-off' mindset hasten cell therapy M&A? Iovance surges on buyout chatter

Is it time for some cell therapy M&A?

Investors of Iovance Biotherapeutics certainly thought so, sending its stock $IOVA up as much as 40% after Bloomberg reported that the cancer-focused biotech is talking to potential buyers.

While 2019 saw a number of high-profile gene therapy company takeovers — led by Roche’s $4.3 billion bid of Spark as Astellas went for Audentes, Biogen snapped up Nightstar and Vertex absorbed Exonics — large players appeared to prefer partnering on the cell therapy front, particularly when it comes to cancer. Hal Barron put his weight behind Rick Klausner’s startup as he rebuilt GlaxoSmithKline’s cancer pipeline. Takeda turned to MD Anderson to license their natural killer cell therapy.

February 26, 2020 09:25 AM ESTUpdated 02:40 PM

Natalie Grover

R&D

One less rival for Immunovant, as Alexion abandons FcRn inhibitor

Less than one year after Alexion parted with $25 million upfront to secure access to a second anti-FcRn asset, it is abandoning the experimental drug. The discontinuation, disclosed at the SVB Leerink Global Healthcare Conference in New York during a fireside chat, bodes well for rival Immunovant.

The drug (ABY-039), partnered for development with Sweden’s Affibody, was forsaken on the basis of early-stage data that was not viewed favorably, Baird and SVB Leerink analysts noted.