CAR-T play­er Po­sei­da march­es on with $30.5M Se­ries B; Kymera inks dis­cov­ery deal with GSK

→ In­vestors have in­fused $30.5 mil­lion in Se­ries B cash in­to Po­sei­da Ther­a­peu­tics’ pipeline of au­tol­o­gous T cell and NK cell ther­a­pies. Us­ing its gene en­gi­neer­ing tech, the San Diego com­pa­ny has iden­ti­fied sev­er­al CAR-T and gene ther­a­pies, with the lead pro­gram, P-BC­MA-101 for mul­ti­ple myelo­ma, cur­rent­ly in a Phase I tri­al. The new round of fi­nanc­ing will go to­wards that study, and push Po­sei­da to­ward INDs for two pro­grams in PS­MA CAR-T and al­lo­genic BC­MA CAR-T. Lon­gi­tude Cap­i­tal led the round, flanked by fel­low new in­vestors Vi­vo Cap­i­tal and the Tavi­s­tock Group, and David Hirsch — its man­ag­ing di­rec­tor — will join Po­sei­da’s board of di­rec­tors.

→ Glax­o­SmithK­line is team­ing up with Cam­bridge, MA-based Kymera Ther­a­peu­tics on a dis­cov­ery pact re­lat­ed to pro­tein degra­da­tion, a hot field that’s seen a va­ri­ety of star­tups come along. The 2-year deal cov­ers new small mol­e­cules and E3 lig­as­es – the en­zymes that do trig­ger the degra­da­tion of pro­teins that cause dis­eases.

→ Bay Area Stan­ford spin­out Sur­rozen, which re­cent­ly grabbed a $33M Se­ries A, just ap­point­ed a new CEO and sci­en­tif­ic co-founder. Craig Park­er, the for­mer SVP of cor­po­rate de­vel­op­ment at Jazz Phar­ma­ceu­ti­cals, is com­ing on board as the com­pa­ny’s new chief ex­ec­u­tive. He’s tak­ing the reins from Tim Kutzkey, a man­ag­ing part­ner at The Col­umn Group, who’s in­stead tak­ing up the role of chair­man of the board. The com­pa­ny, found­ed in 2016, is re­search­ing the Wnt path­way and the role it plays in re­gen­er­a­tive med­i­cine. In the same news re­lease, Sur­rozen al­so ap­point­ed a new sci­en­tif­ic co-founder in Hans Clevers, a pro­fes­sor of mol­e­c­u­lar ge­net­ics at the Hubrecht In­sti­tute. “The chal­lenge of pro­duc­ing Wnt has been a great source of frus­tra­tion in the field, im­ped­ing the ad­vance­ment of organoid tech­nol­o­gy and a deep­er dis­sec­tion of Wnt sig­nal­ing,” Clevers said in a state­ment. “Sur­rozen’s abil­i­ty to gen­er­ate po­tent and se­lec­tive Wnt path­way ag­o­nists with drug-like prop­er­ties is a re­al break­through.  I’m thrilled to join an es­teemed group of co-founders as Sur­rozen con­tin­ues its rapid pace of dis­cov­ery and fur­ther in­no­vates with its tech­nol­o­gy plat­forms.”

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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ITeos nabs $125M as they prep Keytru­da com­bi­na­tion tri­al — if Covid-19 will let them

For iTeos, it turned out, $75 million could only last so long.

Two years after announcing their eye-catching Series B raise, the Belgian biotech is back with an even larger Series B-2: $125 million.

The now $200 million financing illustrates the vast capital available for those with promising new immuno-oncology compounds, particularly those that might be used in combination with existing therapies. In December, iTeos announced a collaboration with Merck to test its lead compound with Keytruda this year. The proceeds will push forward that trial and help fund the ongoing Phase I/II trials for that compound, EOS-850, and a second one, EOS-448.

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).