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.”

Dan Skovronsky, Eli Lilly CSO

UP­DAT­ED: An­a­lysts are quick to pan Eli Lil­ly's puz­zling first cut of pos­i­tive clin­i­cal da­ta for its Covid-19 an­ti­body

Eli Lilly spotlighted a success for one of 3 doses of their closely-watched Covid-19 antibody drug Wednesday morning. But analysts quickly highlighted some obvious anomalies that could come back to haunt the pharma giant as it looks for an emergency use authorization to launch marketing efforts.

The pharma giant reported that LY-CoV555, developed in collaboration with AbCellera, significantly reduced the rate of hospitalization among patients who were treated with the antibody. The drug arm of the study had a 1.7% hospitalization rate, compared to 6% in the control group, marking a 72% drop in risk.

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#ES­MO20: Alk­er­mes of­fers their first snap­shot of a ben­e­fit for their next-gen IL-2 drug. But why did 1 pa­tient starve to death?

Everyone in the cancer R&D arena is looking to build new franchises around better drugs and combos. And one busy pocket of that space is centered entirely on creating an IL-2 drug that can be as effective as the original without the toxicity that damned it to the sidelines.

Alkermes $ALKS formally tossed its hat into the ring of contenders at virtual ESMO today, highlighting the first glimpse of efficacy for their candidate, ALKS 4230, as both a monotherapy as well as in combination with Merck’s Keytruda.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

Pfiz­er match­es Mod­er­na with their full Covid-19 tri­al blue­print — As­traZeneca says it will un­veil its pro­to­col 'short­ly'

Yesterday, after sustained public pressure as Moderna released its Phase III Covid-19 trial blueprint, Pfizer released its own full trial design for their vaccine trials. The move was designed to boost transparency and shore up public trust in the vaccines, but it also revealed differences in how the two companies are approaching the much-watched studies while failing to satisfy the demands of the fiercest advocates for transparency.

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Stronger to­geth­er? Boehringer and Mi­rati team to put first KRAS-KRAS com­bo in the clin­ic

Researchers are still waiting to see how much any of the vaunted KRAS drugs now in the clinic can, after decades of preclinical research and some early human studies, help patients. But while they do, two of the leading developers will look to see whether a KRAS-KRAS combo might pose a better shot than any KRAS alone.

Boehringer Ingelheim and Mirati have signed a collaboration to combine Mirati’s closely-watched lead KRAS inhibitor, MRTX849, in a clinical trial with the pan-KRAS blocker that Boehringer has quietly developed with high expectations behind their flashier contenders.

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#ES­MO20: Re­gen­eron, Sanofi eye an­oth­er first for their PD-1 con­tender Lib­tayo with promis­ing da­ta for on­col­o­gy niche

Regeneron and Sanofi took another step forward in the long march towards a greatly expanded market for their late-bloomer PD-1 checkpoint Libtayo.

The two occasional allies posted an objective response rate of 31% for Libtayo among 84 patients suffering from advanced cases of basal cell carcinoma at virtual ESMO. That spotlights progress for 26 patients, 5 of whom had a complete response. The data also reflect a boost in the number of responses seen from the last cut of the numbers.

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Albert Bourla, Pfizer CEO (Steven Ferdman/Getty Images)

Pfiz­er ex­ecs con­fi­dent­ly tap their top 10 block­busters-to-be. But what are the chances of sur­viv­ing PhI­II, let alone hit­ting these big peak sales es­ti­mates?

Pfizer’s top executive team doesn’t lack for confidence.

Where many Big Pharmas would be reluctant to put a peak sales figure on their late-stage drugs, Pfizer CEO Albert Bourla has shrugged off the usual diffidence to outline where the pharma giant expects to get $15 billion-plus.

The list, outlined this week during their investor presentations, is topped by 3 drugs in the $3 billion-plus peak sales category. They are:

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Christian Itin, Autolus CEO (Autolus)

#ES­MO20: Au­to­lus pro­vides glimpse of next-gen­er­a­tion CAR-T pro­gram, show­ing ear­ly pos­i­tive safe­ty da­ta

CAR-T therapies were hailed as a breakthrough when Novartis received the first FDA approval for Kymriah back in 2017. Though highly effective at treating certain types of blood cancers, CAR-Ts are also associated with severe and potentially deadly side effects, including lethal instances of cytokine release syndrome.

With this in mind, Autolus Therapeutics is looking to take a crack at a safer CAR-T and presented Phase II cohort data for its AUTO3 program at virtual ESMO 2020. The data showed that, among the 35 patients in the cohort being treated for r/r diffuse large B cell lymphoma, there were no instances of Grade 3 or higher CRS. Eight individuals saw Grade 1 inflammation while another four patients reached Grade 2.

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A long­time Cy­tomX ex­ec re-emerges at Syn­thekine, an $82M Stan­ford spin­out

Debanjan Ray apparently had big plans when he quietly left his long-held CFO spot at CytomX back in March 2019. He had gotten his own biotech.

Still in its early stages at the time, that biotech, known as Synthekine, is now ready to start talking. They are breaking out of stealth mode today with $82 million in Series A funding led by Canaan Partners, Samsara BioCapital and The Column Group, and plans to rapidly bring a handful of engineered cytokines, including a rejigged IL-2, into the clinic.

Sean Bo­hen's break from bio­phar­ma is over. The ex-As­traZeneca CMO has re­tired his Big Phar­ma jer­sey and is now — hap­pi­ly — run­ning a lit­tle biotech

The last I had heard about Sean Bohen, he had stepped out of his high-profile job as chief medical officer at AstraZeneca at the beginning of 2019 as CEO Pascal Soriot triggered a broad-ranging R&D shakeup. And then, earlier this week, I got a chance to catch up.

It turns out that Bohen decided at the time that he would not just jump into a new job in the booming biopharma business. As an oncologist, he had worked on the big programs at AstraZeneca, and before that he was at Genentech. That was good for a ticket to just about anyplace in the big biopharma world. But he felt it was time to stop and think things through.

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