6 Di­men­sions backs Lyv­gen's $30M B round; No­var­tis hands off glob­al rights to IL-2 drug

→ Shang­hai’s im­muno-on­col­o­gy drug­mak­er Lyv­gen Bio­phar­ma has scored a $30 mil­lion B round led by one of Chi­na’s most ac­tive biotech VCs — 6 Di­men­sions Cap­i­tal. Join­ing the round are new in­vestors Win­fair Glob­al and Run­ling Cap­i­tal, along with ex­ist­ing back­ers from the A round Morn­ing­side Ven­tures. Lyv­gen has an an­ti­body plat­form and an ear­ly pipeline, in­clud­ing a PD-1 an­ti­body and a set of pro­pri­etary ag­o­nist an­ti­bod­ies.

→ Clin­i­cal and com­mer­cial ser­vice provider Clin­i­gen has picked up ex-US glob­al rights to No­var­tis’ Pro­leukin, a re­com­bi­nant in­ter­leukin-2 ther­a­py pri­mar­i­ly in­di­cat­ed for use in metasta­t­ic re­nal cell car­ci­no­ma, and for metasta­t­ic melanoma in some of the 20 mar­kets it’s li­censed in. Fi­nan­cial de­tails of the deal deal were not dis­closed; Clin­i­gen said it will in­ves­ti­gate po­ten­tial com­bos for the drug and seek to re­vi­tal­ize sales — a fig­ure around $80 mil­lion for the past cou­ple of years. “This ac­qui­si­tion strength­ens our of­fer­ing in Com­mer­cial Med­i­cines and brings our spe­cial­ty phar­ma prod­uct port­fo­lio to six,” said CEO Shaun Chilton.

→ In yet an­oth­er ef­fort to stave off gener­ic com­pe­ti­tion for its block­buster Hu­mi­ra, Ab­b­Vie $AB­BV has struck a deal with My­lan, which has agreed to be­gin sell­ing its biosim­i­lar in the US on Ju­ly 31, 2023 — a month af­ter Sam­sung Bioepis and Mer­ck will un­veil theirs, and six months af­ter Am­gen’s knock­off will hit the mar­kets. Based on the deal, My­lan will pay roy­al­ties to Ab­b­Vie for li­cens­ing the Hu­mi­ra patents once its biosim­i­lar is launched.

→ Seat­tle biotech Presage Bio­sciences added some fresh cap­i­tal to its cof­fers Tues­day, al­low­ing the can­cer com­pa­ny to work on the de­sign of a de­vice it cre­at­ed to con­duct its ear­ly clin­i­cal work. The com­pa­ny makes a mi­croin­jec­tor and drug load­ing de­vice, cou­pled with flu­o­res­cent track­ing mi­cros­pheres, that they use to in­ject pa­tients with small dos­es of in­ves­ti­ga­tion­al drugs. The de­vice is de­signed to al­low the dos­ing to be high­ly lo­cal­ized on a pa­tient’s tu­mor. Presage is call­ing it the CI­VO plat­form, and they say this small $6 mil­lion Se­ries D round — led by Take­da and Cel­gene — will push its de­vel­op­ment for­ward.

At the same time, Presage an­nounced its CSO Rich Kling­hof­fer is tak­ing over as CEO, while for­mer CEO Nathan Caf­fo steps in­to an ad­vi­so­ry role. “When Nathan and I joined Presage as the first two em­ploy­ees of the com­pa­ny, it was be­cause we rec­og­nized the trans­for­ma­tive po­ten­tial of the CI­VO plat­form to en­able faster proof-of-con­cept stud­ies for ear­ly stage drug can­di­dates,” Kling­hof­fer said in a state­ment. “Giv­en the well-known lack of trans­la­tion of an­i­mal mod­els to the hu­man clin­ic, we are ex­cit­ed to pro­vide an ap­proach that al­lows our part­ners to test as­sets in the con­text where they are ul­ti­mate­ly in­tend­ed to be used – the hu­man can­cer pa­tient.”

Aque­s­tive Ther­a­peu­tics, the man­u­fac­tur­er-turned drug de­vel­op­er mak­ing oral film for­mu­la­tions of CNS dis­ease treat­ments, set­tled on a price range of $14 to $16 for its IPO. All told, the War­ren, NJ-based com­pa­ny ex­pects to raise $60 mil­lion to fund com­mer­cial­iza­tion of sev­er­al late-stage prod­ucts as well as clin­i­cal tri­als for two pre­clin­i­cal as­sets. Among them Sym­pa­zan (AQST-120), a for­mu­la­tion of clobazam used to treat Lennox-Gas­taut syn­drome, has been filed for ap­proval and will po­ten­tial­ly join the group of two prod­ucts that Aque­s­tive is al­ready mar­ket­ing with part­ners. The com­pa­ny plans to list un­der the sym­bol $AQST.

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.

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.

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.

Clin­i­cal tri­al spon­sors have to dis­close decade’s worth of un­re­leased da­ta, fed­er­al judge rules

A decade’s worth of unreleased trial data may soon see the light of day.

A New York federal judge ruled this week that the FDA and the NIH have for years misinterpreted a law that would require companies, universities and other clinical trial sponsors to release trial data from studies completed between 2007 and 2017. The ruling covers drugs and medical devices that were experimental when the study was completed but have since been approved, potentially putting hundreds of sponsors out of compliance if they don’t put their results on clinicaltrials.gov.

Laurie Glimcher and Ansbert Gadicke (Justin Knight, Dana-Farber Cancer Institute)

Ty­ing ba­sic sci­ence to spin­outs, Dana-Far­ber de­buts sis­ter funds to­tal­ing $126M with MPM Cap­i­tal

As one of the most prestigious cancer institutes in the US, Dana-Farber has enjoyed considerable support for its entrepreneurial pursuits, spinning out about 30 companies in the past 12 years.

“Now where we’ve always struggled — where every cancer center struggled — is support of basic science,” Barrett Rollins, chief scientific officer emeritus, told Endpoints News.

And then two of its trustees had an idea. What if they tied philanthropy to investment in Dana-Farber startups, requiring a donation to basic science as a condition for accessing its brightest biotech venture ideas?