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.

Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

Phase III read­outs spell dis­as­ter for Genen­tech’s lead IBD drug

Roche had big plans for etrolizumab. Eyeing a hyper-competitive IBD and Crohn’s market where they have not historically been a player, the company rolled out 8 different Phase III trials, testing the antibody for two different uses across a range of different patient groups.

On Monday, Roche released results for 4 of those studies, and they mark a decided setback for both the Swiss pharma and their biotech sub Genentech, potentially spelling an end to a drug they put over half-a-decade and millions of dollars behind.

Eli Lil­ly teams with Pieris on HER2+ tu­mors; Op­di­vo + Yer­voy best chemo in mesothe­lioma

Despite the FDA putting a partial clinical hold on its lead program only a few weeks ago, Boston-based Pieris Pharmaceuticals is plowing forward with a new collaboration.

Pieris will work with Eli Lilly to further advance studies on PRS-343, a 4-1BB/HER2 bispecific for HER2-positive tumors, in combination with the latter’s ramucirumab and paclitaxel for the second-line treatment of patients with HER2-positive gastric cancer in a single-arm, Phase II study.

DFC CEO Adam Boehler and Kodak CEO Jim Continenza (Kodak)

Covid-19 roundup: Cure­Vac beefs up its uni­corn IPO dreams as bil­lion­aire own­er takes this Covid-19 mR­NA play­er on a forced march to Nas­daq; Ko­dak's $765M deal is put on hold

When CureVac initially jotted down $100 million for its IPO raise a couple of weeks ago, it seemed small. The German mRNA player, after all, had jumped into a Covid-19 race that swelled the sails of Moderna and BioNTech by tens of billions. And after raising $640 million in a slate of deals, $100 million in a hot market like this seemed like a pittance in the bigger scheme of things.

Today, we got a look at a figure that probably comes closer to the game-changing number the top execs probably have in mind. Selling 15.3 million shares at the high end of their $14 to $16 range would net a $243 million bounty. Majority owner Dietmar Hopp is putting in another €100 million, bringing the total to around $350 million. And what are the chances they want to do even better than that?

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Eric Shaff (Seres)

UP­DAT­ED: Af­ter a 4-year so­journ, strug­gling mi­cro­bio­me pi­o­neer Seres claims a break­out PhI­II come­back. And shares re­spond in fren­zied spike

Almost exactly 4 years ago, Seres Therapeutics $MCRB experienced one of those soul-crunching failures that can raise big questions about a biotech’s future. Out front in their pursuit of a gut punch to C. difficile infection (CDI), the Phase II test was a flat failure, and investors wiped out a billion dollars of equity value that never returned in the years that followed.

Seres, though, pressed ahead, changing out CEOs a year ago — bidding Merck vet Roger Pomerantz farewell from the C suite — and pushing through a Phase III, hoping that amping up the dosage would make the key difference. And this morning, they unveiled a claim that they had aced the Phase III and positioned themselves for a run at a landmark FDA OK.

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Vi­da Ven­tures co-leads Dyne's $115M megaround for next-gen oli­go ther­a­pies aimed square­ly at mus­cles

Dyne Therapeutics started out last April with a modest $50 million to mine targeted muscle disease therapies from its in-house conjugate technology. The biotech has now convinced more investors that it’s got gems on its hands, closing $115 million in fresh financing to push its next-gen oligonucleotide drugs into the clinic.

Vida Ventures and Surveyor Capital led the round, joined by a group of other new backers including Wellington Management Company, Logos Capital and Franklin Templeton.

In­novent and Eli Lil­ly chal­lenge Mer­ck­'s mega-block­buster Keytru­da in non-small cell lung can­cer field

China-based Innovent Biologics and its multinational ally Eli Lilly shared Phase III evidence that their PD-1 inhibitor combo can delay the progression of nonsquamous non-small cell lung cancer.

But the drugmakers will face stiff competition in China from Merck’s Keytruda, the ruling PD-1 which is already approved to treat both squamous and nonsquamous NSCLC and boasts positive overall survival rates.

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Anap­tys­Bio's etokimab pro­vides more dis­ap­point­ing re­sults, rais­ing ques­tions about com­pound's fu­ture

The lead program for AnaptysBio’s in-house pipeline has hit another setback.

Etokimab, an IL-33 inhibitor, did not achieve statistically significant improvement in a Phase II trial for patients suffering from chronic rhinosinusitis with nasal polyps. Researchers measured the individuals’ bilateral nasal polyps score and sino-nasal outcome test, finding that neither improved upon a placebo after both four- and eight-week time markers, though they did demonstrate improvement over baseline levels of the examinations.

Gallia Levy, Spark CMO (Roche)

Spark Ther­a­peu­tics nabs new CMO from Genen­tech, fill­ing a ma­jor post-merg­er de­par­ture

Spark Therapeutics is getting a new CMO from their new owners.

The gene therapy company-turned-subsidiary has named Gallia Levy, who had been running rare blood disorders — including clinical development for their blockbuster-potential hemophilia antibody Hemlibra for Roche’s big biotech sub Genentech — to run medical affairs.

The appointment is a fitting one. Roche spent $4.8 billion to acquire Spark last year in large part to get their hands on their hemophilia gene therapy, SPK-8011, and expand the toe-hold Hemlibra gave them in an crowded hemophilia space.  It’s also a somewhat ironic appointment: The FTC held up the Spark acquistions for nearly a year, reportedly over concerns about the anti-trust implications of Roche owning both a top chronic treatment in Hemlibra and a top one-time treatment in Spark’s gene therapy.

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