Todd Harris and Daniel Bensen. Tyra

RA Cap­i­tal, Canaan help in­fuse $50M in­to Al­ta-in­cu­bat­ed biotech bat­tling ac­quired re­sis­tance to TKIs

Since Gleevec was ap­proved in 2001, over 40 oth­er ty­ro­sine ki­nase in­hibitors have come on­to the mar­ket to treat var­i­ous types of can­cer. But with the pro­lif­er­a­tion of the class al­so came a surge of ac­quired re­sis­tance, where pa­tients’ tu­mors mu­tate around the drug tar­get and stop re­spond­ing to the ther­a­pies.

Tyra Bio, a Carls­bad, CA-based biotech “pur­pose built” to ad­dress that prob­lem, has just raised $50 mil­lion from Al­ta Part­ners, RA Cap­i­tal Man­age­ment, Box­er Cap­i­tal of Tavi­s­tock Group, and Canaan.

“It’s not en­tire­ly clear what type of ac­quired re­sis­tance might emerge re­al­ly un­til you get these drugs in­to pa­tients,” co-founder and CEO Todd Har­ris told End­points News. “In some in­stances, the first gen­er­a­tion drugs couldn’t have en­tire­ly pre­dict­ed what might come along.”

Bob More

But with some class­es of TKIs now in their third gen­er­a­tion, there is an in­creas­ing amount of clin­i­cal ev­i­dence and bet­ter tools to crunch them for in­sights in­to the pre­cise mu­ta­tions — in­sights that Tyra would take right back to the start of drug dis­cov­ery and de­vel­op­ment. In the long run, the goal is for their drugs to not just be de­ployed when re­sis­tance emerges but to move to the front­line set­ting with the hope of a longer du­ra­tion of re­sponse.

Har­ris added that the strat­e­gy has shown some promise in ALK and EGFR, but re­mained tight-lipped about the ex­act tar­gets they are start­ing with, though it’s a safe bet they would first go af­ter the most well-known ones.

Daniel Bensen, COO and co-founder, will be steer­ing a small team along­side CSO Ronald Swan­son, CFO Es­ther van den Boom, and Robert Hud­kins, VP of chem­istry, as well as Jane Ar­bole­da, as­so­ciate di­rec­tor of cell bi­ol­o­gy, to bring their first can­di­dates to the clin­ic. An army of biotechs are in the game, many fo­cus­ing on par­tic­u­lar nich­es with­in the vast TKI space. Tyra will be look­ing to out­pace some of them.

Ja­son Sheltzer of Cold Spring Har­bor Lab­o­ra­to­ry, William Hahn of Dana Far­ber, and Jef­frey Hager, for­mer­ly of Ideaya Bio, have come on board as sci­en­tif­ic ad­vi­sors.

“Our strength is re­al­ly in a nim­ble and high­ly ex­pe­ri­enced drug dis­cov­ery and drug de­vel­op­ment team,” Har­ris said, lever­ag­ing tried and true tech­nolo­gies such as struc­tured-based drug de­sign, and patch­ing in self-built pre­clin­i­cal mod­els when­ev­er nec­es­sary.

Har­ris al­so co-found­ed what even­tu­al­ly be­came Si­en­na Bio­phar­ma, a skin drug de­vel­op­er that count­ed Arch Ven­tures and Part­ner Fund Man­age­ment as back­ers but nev­er­the­less was forced to file for Chap­ter 11 af­ter a bruis­ing tri­al fail­ure. The en­tre­pre­neur­ial les­son he learned: Fi­nance your com­pa­ny for the ups and downs along the biotech road.

Al­ta Part­ners, which in­cu­bat­ed Tyra, is ready for the long haul. The in­clu­sion of crossover firm RA Cap­i­tal al­so gives Har­ris more con­fi­dence that this one will stick. Each in­vestor in the Se­ries A is send­ing a rep­re­sen­ta­tive to the board: Bob More of Al­ta Part­ners, Jake Sim­son of RA Cap­i­tal, Sid Sub­ra­mo­ny of Box­er Cap­i­tal and Ni­na Kjell­son of Canaan. Mi­rati CMO Isan Chen and for­mer Gates foun­da­tion ex­ec Gilla Ka­plan are the oth­er two di­rec­tors.

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).