Randolf Kerschbaumer, Michael Thiele and Alexander Schinagl (OncoOne)

For­mer Shire ex­ecs set up shop to take a shot at 'un­der the radar' can­cer tar­get

In De­cem­ber 2016, Shire aban­doned a can­cer drug tar­get­ing oxMIF it had swal­lowed as part of its $32 bil­lion buy­out of Bax­al­ta ear­li­er that year. Now for­mer ex­ec­u­tives of the two com­pa­nies have set up their own shop in Aus­tria — bank­ing on that same tar­get.

The com­pa­ny, chris­tened On­coOne, has scored €13 mil­lion in a Se­ries A round. With 8 em­ploy­ees, in­clud­ing its 3 founders, the com­pa­ny will use the in­jec­tion to take its com­pounds — de­signed to ad­dress pan­cre­at­ic, col­orec­tal, lung and ovar­i­an can­cer — in­to the clin­ic by 2022.

Macrophage mi­gra­tion in­hibito­ry fac­tor, or MIF, is a cy­tokine ubiq­ui­tous across the hu­man body. The com­pa­ny is tar­get­ing a dis­ease-re­lat­ed iso­form of MIF, called oxMIF.

“OxMIF is quite tricky to han­dle, and it’s not so easy to work with — it’s a com­pli­cat­ed cy­tokine — so that might be one of the rea­sons why it’s still un­der the radar,” CEO Ran­dolf Ker­schbaumer, who has worked with Bax­ter and Shire, not­ed in an in­ter­view.

The pro­gram for the Shire com­pound, imalum­ab, was ter­mi­nat­ed af­ter ear­ly da­ta failed to con­vince re­searchers, On­coOne chief sci­en­tif­ic of­fi­cer (and for­mer Bax­ter, Bax­al­ta and Shire ex­ec) Michael Thiele not­ed.

“How­ev­er, we…do be­lieve in the po­ten­tial of this tar­get,” he said. “We have three dif­fer­ent modal­i­ties with very dis­tinct mech­a­nisms of ac­tion when com­pared to imalum­ab — in fact, our mode of ac­tion doesn’t have much to do or any­thing to do with imalum­ab.”

The ex­ec­u­tives de­clined to of­fer de­tails on their com­pounds and the mech­a­nism of ac­tion. In­vestors par­tic­i­pat­ing in the Se­ries A in­clud­ed the Aus­tri­an Re­search Pro­mo­tion Agency (FFG), the Aus­tria Wirtschaftsser­vice Gesellschaft (AWS), and two fam­i­ly of­fices.

As the coro­n­avirus cri­sis in­ten­si­fies, days ago Aus­tria’s chan­cel­lor put in place ma­jor re­stric­tions on move­ment in pub­lic places, urged cit­i­zens to self-iso­late and banned gath­er­ings of more than five per­sons.

On­coOne’s em­ploy­ees are large­ly work­ing from home, Ker­schbaumer said, with the ex­cep­tion of per­son­nel work­ing in the lab.

“Well, maybe we will have to close the lab in the next cou­ple of weeks,” he added. “But, I think we are well pre­pared to restart when the whole sit­u­a­tion im­proves.”

Bob Nelsen at the Milken Institute Global Conference on April 29, 2019 in Beverly Hills, California. (Photo by Michael Kovac/Getty Images)

ARCH chief Bob Nelsen has $1.5B to prove 2 sim­ple points: ‘We’re in the most in­no­v­a­tive time ever’ and in­vestors are stay­ing

ARCH co-founder and managing director Bob Nelsen has a well known yen for the home run swing, betting big on potentially transformative meds and tech and the biotech teams he helps bring together. He thrives and bleeds on the cutting edge. And now Nelsen and the ARCH group have debuted 2 big funds to prove that this is the time for the best of biotech to shine — deadly pandemic be damned.

Two new funds, ARCH Venture Fund X and ARCH Venture Fund X Overage, gathered a combined $1.46 billion. And that’s a record. ARCH Venture Fund IX and ARCH Venture Fund IX Overage closed in 2016 with a combined $1.1 billion. ARCH Venture Fund VIII and ARCH Venture Fund VIII Overage closed in 2014 with a combined $560 million.

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Covid-19 roundup: No­var­tis, In­cyte pitch Jakafi PhI­II to tack­le se­vere cas­es; Is coro­n­avirus spread­ing like measles?

Novartis, which has so far taken a supporting role in the global R&D campaign against Covid-19, is stepping up to launch its own clinical trial. Together with Incyte, the Swiss pharma giant will test their partnered Jakafi in patients who experience cytokine storm as a result of the coronavirus infection.

Marketed as Jakavi outside of the US, the JAK1/2 inhibitor is a blockbuster product that’s already approved for a number of cancers and graft versus host disease. Incyte noted that many Covid-19 patients with severe respiratory disease appear to have “increased activation of the JAK-STAT pathway.” Novartis added that preclinical evidence and preliminary reports form independent studies support their decision to go ahead with a Phase III.

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J&J gives pi­o­neer­ing stem cell biotech its first Big Phar­ma deal, part­ner­ing on iP­SC CAR-T and CAR-NK

Late last summer, one of the earliest stem cell therapy companies got two government decisions in the span of three weeks: The USPTO granted them a patent for iPSC-derived CAR-T cells, and then the FDA cleared them for their first-in-human CAR-NK trial.

Yesterday, the two technologies landed them an up-to $3.1 billion deal.

Fate Therapeutics and J&J announced a global collaboration that will pay Fate $100 million upfront and a trove of potential milestones to develop multiple CAR-T and CAR-NK therapies. It’s the first Big Pharma partnership Fate has announced in their 13-year existence and the largest, although at least one longtime follower thought they could have landed more.

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Drug dis­cov­ery in the age of coro­n­avirus

Developing new drugs is incredibly hard. That’s why, despite superhuman efforts from the industry, we’re still looking at 12-18 months minimum before we can realistically hope for a vaccine for Covid-19, and probably months before there’s a proven viable drug treatment.

But our increasing ability to begin to industrialize the drug discovery and development process through an engineering approach means that we have more hope for speeding up this process than ever before — and not just to defeat coronavirus, but to benefit the development of all new medicines in the future.

UP­DAT­ED: Have a new drug that promis­es to fight Covid-19? The FDA promis­es fast ac­tion but some de­vel­op­ers aren't hap­py

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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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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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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Noubar Afeyan, Flagship

Step­ping out along­side ARCH's record raise, Flag­ship adds a $1.1B mon­ster fund of its own

ARCH’s unveiling this morning of 2 new funds bulging with $1.5 billion in cash for biotech startups was just the first round of today’s venture news.

Right on its heels we have another monster fund debuting at Flagship Pioneering, another big venture group known for making huge bets on cutting-edge tech — the kind it brews up in its labs.

And this one weighs in at $1.1 billion, which will operate in tandem with the $1.1 billion in funds Flagship rolled out last year.

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