Bet­ting on al­losteric mu­ta­tions dri­ving can­cer, Black Di­a­mond rais­es $85M in fresh round

Near­ly a month af­ter emerg­ing from “stealth mode,” David Ep­stein-led can­cer up­start Black Di­a­mond Ther­a­peu­tics said it has raised $85 mil­lion in a Se­ries B round, bring­ing the funds raised by the first com­pa­ny out of Ver­sant’s Ridge­line dis­cov­ery en­gine in Basel to $105 mil­lion.

David Ep­stein

Onco­genes — which have the po­ten­tial to cause the growth of can­cer cells — are ac­ti­vat­ed by ki­nase do­main mu­ta­tions or by al­losteric mu­ta­tions. Al­lostery is a com­mon process by which pro­teins trans­mit the ef­fect of bind­ing at one site to an­oth­er, of­ten dis­tal, func­tion­al site, al­low­ing for reg­u­la­tion of ac­tiv­i­ty.

While in­hibitors used to sup­press ki­nase do­main mu­ta­tions are con­sid­ered stan­dard-of-care treat­ment for many types of can­cer, al­losteric mu­ta­tions are still un­chart­ed ter­ri­to­ry. Us­ing their tech plat­form, Black Di­a­mond is look­ing to map al­losteric mu­ta­tions dri­ving can­cer to de­vel­op in­hibitors that are tu­mor ag­nos­tic.

Eliz­a­beth Buck

As in­creas­ing ge­nom­ic pro­fil­ing of can­cer pa­tients iden­ti­fies clus­ters of un­char­ac­ter­ized ge­nom­ic al­ter­ations, the biotech’s tech­nol­o­gy is de­signed to iso­late “drug­gable mu­ta­tion bas­kets” to cre­ate pre­ci­sion med­i­cines. The com­pa­ny cur­rent­ly has two pro­grams: al­losteric HER2 and EGFR dri­ver mu­ta­tions that oc­cur across a range of tis­sue type tu­mors, and oth­er undis­closed pro­grams brew­ing in its pipeline.

Black Di­a­mond’s Ep­stein and fel­low co-founder Eliz­a­beth Buck — who were in­volved in the de­vel­op­ment of can­cer drug Tarce­va — re­ceived $20 mil­lion in Se­ries A fi­nanc­ing ex­clu­sive­ly from found­ing in­vestor Ver­sant Ven­tures. The fresh B round of fund­ing, an­nounced on Wednes­day, was co-led by New En­ter­prise As­so­ci­ates and RA Cap­i­tal Man­age­ment. The mon­ey will be used to de­vel­op Black Di­a­mond’s pipeline and help es­tab­lish its new cor­po­rate head­quar­ters in Cam­bridge, Mass­a­chu­setts. 

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

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 73,100+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 73,100+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 73,100+ biopharma pros reading Endpoints daily — and it's free.

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.

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%.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 73,100+ biopharma pros reading Endpoints daily — and it's free.

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.

Anthony Fauci (AP Images)

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 73,100+ biopharma pros reading Endpoints daily — and it's free.

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.