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.

UP­DAT­ED: Have a new drug that promis­es to fight Covid-19? The FDA will see you now — maybe

After providing an emergency approval to use malaria drugs against coronavirus with little actual evidence of their efficacy or safety in that setting, the FDA has already proven that it has set aside the gold standard when it comes to the pandemic. And now regulators have spelled out a new approach to speeding development that promises immediate responses in no uncertain terms — promising a program offering the ultimate high-speed pathway to Covid-19 drug approvals.

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In a stun­ning set­back, Amarin los­es big patent fight over Vas­cepa IP. And its high-fly­ing stock crash­es to earth

Amarin’s shares $AMRN were blitzed Monday evening, losing billions in value as reports spread that the company had lost its high-profile effort to keep its Vascepa patents protected from generic drugmakers.

Amarin had been fighting to keep key patents under lock and key — and away from generic rivals — for another 10 years, but District Court Judge Miranda Du in Las Vegas ruled against the biotech. She ruled that:
(A)ll the Asserted Claims are invalid as obvious under 35 U.S.C.§ 103. Thus, the Court finds in favor of Defendants on Plaintiff’s remaining infringementclaim, and in their favor on their counterclaims asserting the invalidity of the AssertedClaims under 35 U.S.C. § 103.

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Once fu­ri­ous over No­var­tis’ da­ta ma­nip­u­la­tion scan­dal, the FDA now says it’s noth­ing they need to take ac­tion on

Back in the BP era — Before Pandemic — the FDA ripped Novartis for its decision to keep the agency in the dark about manipulated data used in its application for Zolgensma while its marketing application for the gene therapy was under review.

Civil and criminal sanctions were being discussed, the agency noted in a rare broadside at one of the world’s largest pharma companies. Notable lawmakers cheered the angry regulators on, urging the FDA to make an example of Novartis, which fielded Zolgensma at $2.1 million — the current record for a one-off therapy.

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Covid-19 roundup: GSK, Am­gen tai­lor R&D work to fit the coro­n­avirus age; Doud­na's ge­nomics crew launch­es di­ag­nos­tic lab

You can add Amgen and GSK to the list of deep-pocket drug R&D players who are tailoring their pipeline work to fit a new age of coronavirus.

Following in the footsteps of a lineup of big players like Eli Lilly — which has suspended patient recruitment for drug studies — Amgen and GSK have opted to take a more tailored approach. Amgen is intent on circling the wagons around key studies that are already fully enrolled, and GSK has the red light on new studies while the pandemic plays out.

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Dai­ichi Sankyo sinks $200M in­to new gene ther­a­py tech from Ul­tragenyx

In a leap to the gene therapy space, Daiichi Sankyo has dropped $200 million to access Ultragenyx’s manufacturing technology, providing the rare disease biotech with plenty of cash and a stock boost amid a general cash crunch.

For $125 million in cash and a $75 million equity investment, Daiichi Sankyo has bought a non-exclusive license to the IP around two platforms with which it plans to develop AAV-based gene therapy products. The Japanese pharma is purchasing the stock $RARE at $60 per share, more than a third above its current price of $44.43.

Arie Belldegrun, Endpoints @ JPM20 Breakfast Panel. Photography by Jeff Rumans.

Mo­tion de­nied: Gilead still on the hook for $1.5B in dam­ages over CAR-T patent dis­pute with Bris­tol My­ers Squibb

Gilead’s bid to overturn a jury verdict that ordered it to pay Bristol Myers Squibb about $752 million for CAR-T patents owned by its subsidiary Juno Therapeutics has ended in vain.

The ruling leaves Gilead vulnerable to an even bigger $1.5 billion payment that Bristol is now demanding — adding fuel to the fiery criticism some analysts are already heaping on its $11.9 billion Kite buyout.

In a 30-page document unsealed on Monday, Judge James Otero of the district court in Los Angeles struck down several different arguments for a new decision. Here are Morgan Stanley analysts’ takeaways:
The court, in particular, denied Kite’s contentions (1) that Juno’s patent is invalid, (2) the damages award was unreasonable, and (3) that a new trial should take place. The court also denied Kite’s argument that its infringement was not willful.
Gilead is likely to appeal to the federal circuit, they noted, but the odds are not in their favor as the same standard for evidence will be applied in that court. Appeals typically take 16 months.

A quiver of ar­rows for im­mune dis­or­ders: Pan­dion scores $80M in fresh fund­ing

Scientists began with making recombinant versions of naturally-occurring human proteins, then graduated to monoclonal antibodies. Now, rather than replicating moieties within the body, researchers are modifying these molecules to have precise biology in a functional manner.

This technology, referred to as bispecific antibodies, is already being employed to fight cancer. In early 2018, Pandion Therapeutics was born to reverse-engineer the science into the realm of autoimmune and inflammatory disorders.

It is 'kind of a proven tech­nol­o­gy': Hep B vac­cine mak­er joins glob­al hunt for coro­n­avirus vac­cine

Using lab-grown proteins that are engineered to mimic the architecture of viruses to induce an immune response, VBI Vaccines is joining the hunt for a coronavirus vaccine — harnessing technology that has initially been proved safe in early trials as a prophylactic for cytomegalovirus (CMV) infection.

Unlike the raft of the companies in the Covid-19 vaccine race — including Moderna, CureVac and J&J — VBI is taking a pan-coronavirus approach, by developing a vaccine that will encompass Covid-19, severe acute respiratory syndrome (SARS), and Middle East respiratory syndrome (MERS).

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As­traZeneca says its block­buster Farx­i­ga proved to be a game-chang­er in CKD — wrap­ping PhI­II ear­ly

If the FDA can still hold up its end of the bargain, AstraZeneca is already on a short path to scooping up a cutting-edge win with a likely approval for their SGLT2 drug Farxiga in cutting the risk of heart failure. Now the pharma giant says it can point to solid evidence that the drug — initially restricted to diabetes — also works for chronic kidney disease, potentially adding a blockbuster indication for the franchise.

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