Lyn­parza se­cures third EU nod; Pro­tein degra­da­tion biotech grabs $16M launch round from Chi­nese VCs; Wave shares tum­ble on tri­al de­lay

Lyn­parza, the first PARP in­hibitor from As­traZeneca $AZN to win US ap­proval in 2014, has se­cured its third EU ap­proval. The drug won the EMA nod for use pa­tients with germline BR­CA1/2-mu­ta­tions and who have hu­man epi­der­mal growth fac­tor re­cep­tor 2 (HER2)-neg­a­tive lo­cal­ly ad­vanced or metasta­t­ic breast can­cer, part­ner Mer­ck $MRK said on Wednes­day.

→ A new pro­tein degra­da­tion biotech has raised a $16 mil­lion launch round from a pair of Chi­nese ven­ture groups. San Diego-based Cull­gen says it plans to put the mon­ey to use on its tech plat­form us­ing ubiq­ui­tin-me­di­at­ed, small mol­e­cule-in­duced pro­tein degra­da­tion to go af­ter can­cer, in­flam­ma­to­ry, and au­toim­mune dis­eases. Se­quoia Cap­i­tal Chi­na and High­light Cap­i­tal pro­vid­ed the cash. “Since our found­ing in ear­ly 2018 we have made sig­nif­i­cant ad­vance­ment of our tar­get­ed pro­tein degra­da­tion plat­form which has di­rect­ly led to the iden­ti­fi­ca­tion of sev­er­al pre-clin­i­cal as­sets that we are rapid­ly ad­vanc­ing to­wards the clin­ic,” notes Ying Luo, chair­man and pres­i­dent of Cull­gen.

→ Shares of Wave Life Sci­ences $WVE tum­bled 15% Wednes­day morn­ing af­ter the biotech re­vealed that it has to de­lay a top-line read­out from their Phase Ib/IIa study of 2 new Hunt­ing­ton’s dis­ease ther­a­pies un­til the end of the year. Re­searchers blamed the de­lay on slow­er than ex­pect­ed pa­tient re­cruit­ment.

→ Pfiz­er $PFE has joined forces with Con­cer­to HealthAI to col­lab­o­rate on us­ing re­al world da­ta to help de­vel­op as well as use can­cer ther­a­pies. Con­cer­to gath­ers da­ta from elec­tron­ic health records and in­sur­ance claims to cre­ate their data­base. This is the sec­ond new pact for Con­cer­to in a mat­ter of days, fol­low­ing an ear­li­er al­liance with Bris­tol-My­ers Squibb $BMY.

→ The transPa­cif­ic biotech Edi­GENE has raised $15 mil­lion in the first tranche of its B round. The com­pa­ny is work­ing with CRISPR on new gene edit­ing pro­grams for ge­net­ic dis­eases caused by mal­func­tion­ing pro­teins. UTokyo In­no­va­tion Plat­form joined a syn­di­cate that in­cludes SBI In­vest­ment, Fast Track Ini­tia­tive, SM­BC Ven­ture Cap­i­tal, Mizuho Cap­i­tal, CareNet Group. The com­pa­ny says it has de­vel­oped CRISPR-GNDM (Guide Nu­cleotide Di­rect­ed Mod­u­la­tion) to nor­mal­ize lev­els of gene ex­pres­sion with­out cut­ting the DNA or RNA. 

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

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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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.

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)

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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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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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.

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.