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.

The Advance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

How Aus­tralia De­liv­ers Rapid Start-up and 43.5% Re­bate for Ear­ly Phase On­col­o­gy Tri­als

About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

BREAK­ING: Mer­ck makes a triple play on Covid-19: buy­ing out a vac­cine biotech, part­ner­ing on an­oth­er pro­gram and adding an an­tivi­ral to the mix

Merck is making a triple play in a sudden leap into the R&D campaign against Covid-19.

Tuesday morning the pharma giant simultaneously announced plans to buy an Austrian biotech that has been working on a preclinical vaccine candidate, added a collaboration on another vaccine with the nonprofit IAVI and inked a deal with Ridgeback Biotherapeutics on an early-stage antiviral.

The deal with IAVI covers recombinant vesicular stomatitis virus (rVSV) technology that is the basis for Merck’s successful Ebola Zaire virus vaccine. That’s going into the clinic later this year.

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Af­ter de­cou­pling from Re­gen­eron, Sanofi says it’s time to sell the $13B stake picked up in the mar­riage

With Regeneron shares going for a peak price — after doubling from last fall — Sanofi is putting a $13 billion stake in their longtime partner on the auction block. And Regeneron is taking $5 billion of that action for themselves.

Sanofi — which has been decoupling from Regeneron for more than a year now — bought in big in early 2013, back when Regeneron’s stock was going for around $165 a share. Small investors flocked to the deal, buzzing about an imminent takeover. The buyout chatter wound down long ago.

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Andrew Hopkins, Exscientia founder and CEO (Exscientia)

Af­ter years of part­ner­ships, AI biotech Ex­sci­en­tia lands first ma­jor fi­nanc­ing round at $60M

After years racking up partnerships with biotechs and Big Pharma, the AI drug developer Exscientia has landed its first large financing round.

The UK-based company raised $60 million in a Series C round led by Novo Holdings — more than double the $26 million it garnered in a Series B 18 months ago. The round will help further the company’s expansion into the US and further what it calls, borrowing a term from the software world, its “full-stack capabilities,” i.e. its ability to develop drugs from the earliest stage to the market.

Piv­otal myas­the­nia gravis da­ta from ar­genx au­gur well for FcRn in­hibitors in de­vel­op­ment

Leading the pack of biotechs vying for a piece of the generalized myasthenia gravis (gMG) market with an FcRn inhibitor, argenx on Tuesday unveiled keenly anticipated positive late-stage data on its lead asset, bringing it one step closer to regulatory approval.

Despite steroids, immunosuppressants, acetylcholinesterase inhibitors, and Alexion’s Soliris, patients with the rare, chronic neuromuscular disorder (more than 100,000 in the United States and Europe) don’t necessarily benefit from these existing options, leaving room for the crop of FcRn inhibitors in development.

Covid-19 roundup: Janet Wood­cock steps aside — for now — as FDA drug czar; WHO hits the brakes on hy­droxy study af­ter lat­est safe­ty alarm

The biopharma industry will soon get a look at what the FDA will look like once CDER’s powerful chief Janet Woodcock retires from her post.

Long considered one of the most influential regulators in the agency, if not its single most powerful official when it counts, Woodcock is being detached to devote herself full-time to the White House’s special project to fast-forward new drugs and vaccines for the pandemic. The move comes a week after some quick reshuffling as Woodcock and CBER chief Peter Marks joined Operation Warp Speed. Initially they opted to recuse themselves from any FDA decisions on pandemic treatments and vaccines, after consumer advocates criticized the move as a clear conflict of interest in how the agency exercises oversight on new approvals.

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Janet Woodcock, director of the Center for Drug Evaluation and Research (AP Images)

Covid-19 roundup: Hit with new con­flict ac­cu­sa­tions, Janet Wood­cock steps out of the agen­cy's Covid-19 chain of com­mand

Two weeks ago, FDA drug chieftain Janet Woodcock was assuring a top Wall Street analyst that any vaccine approved for combating Covid-19 would have to meet high agency standards on safety and efficacy before it’s approved. But over the weekend, after she and Peter Marks took top positions with the public-private operation meant to speed a new vaccine to lightning-fast approvals — they both recused themselves from the review process after an advocacy group argued their roles close to the White House could pose a conflict of interest.

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Eric Edwards, Phlow president and CEO (PR Newswire)

BAR­DA of­fers a tiny start­up up to $812M to cre­ate a US-based drug man­u­fac­tur­er — and the CEO comes with a price goug­ing con­tro­ver­sy on his ré­sumé

BARDA has tapped a largely unknown startup to ramp up production of a list of drugs that may be at risk of running short in the US. And the deal, which comes with up to $812 million in federal funds, was inked by a CEO who found himself in the middle of an ugly price gouging controversy a few years ago.

The feds’ new partner — called Phlow — won a 4-year “base” contract of $354 million, with another $458 million that’s on the table in potential options to sustain the outfit. That would make it one of the largest awards in BARDA’s history.

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Re­searchers de­fine ex­act­ly what they saw in the first pos­i­tive remde­sivir study for Covid-19. But what's that worth to Gilead?

Remdesivir can work in fighting Covid-19, particularly for patients with less severe cases, but this is just a first step in the journey to finding combos that can do the job much better.

That’s the bottom line from Gilead’s randomized study published in the New England Journal of Medicine. Analysts were quick to draw conclusions about how the big biotech could turn this into a profitable advantage — with widespread expectation of considerable pricing restraint on Gilead’s part. Anyone looking for a new mountain of cash to count as the world grapples with the pandemic is likely to come away disappointed.