AM-Phar­ma gath­ers €116M for PhI­II pro­gram on kid­ney drug Pfiz­er passed on

Erik van den Berg AM-Phar­ma

Back in 2015, Pfiz­er put a spot­light on Dutch biotech AM-Phar­ma and its drug can­di­date for sep­sis-as­so­ci­at­ed acute kid­ney in­jury, an­te­ing up $87.5 mil­lion for a mi­nor­i­ty stake in ad­di­tion to an op­tion to gob­ble the whole op­er­a­tion up. The Phase II tri­al that the gi­ant part­ner had bet on end­ed up de­liv­er­ing a mixed win, and Pfiz­er walked away from the deal cit­ing “in­ter­nal strate­gic rea­sons” — leav­ing the small play­er on its own to pull off a large Phase III study and pon­der com­mer­cial­iza­tion.

A year and a half af­ter that da­ta read­out, AM-Phar­ma is go­ing for it. In lieu of one deep-pock­et­ed al­ly, it’s as­sem­bled a group of top-tier Eu­ro­pean in­vestors to back its fi­nal stretch in the clin­ic.

LSP and An­dera Part­ners co-led the €116 mil­lion ($133 mil­lion) round, join­ing found­ing in­vestor For­bion and oth­er ex­ist­ing sup­port­ers: Ys­ios Cap­i­tal, Kur­ma Part­ners, ID In­vest Part­ners, BB Pure­os Bioven­tures and Gilde Health­care.

The Phase III pro­gram will re­cruit 1,400 pa­tients across 12 coun­tries to test whether AM-Phar­ma’s re­com­bi­nant hu­man al­ka­line phos­phatase (re­cAP) can in­deed re­duce the mor­tal­i­ty rate due to kid­ney dam­age in­duced by the body’s over­whelm­ing re­sponse to in­fec­tions.

The 40% re­duc­tion not­ed in the pre­vi­ous Phase II was what gave van den Berg con­fi­dence de­spite the drug not hit­ting the pri­ma­ry end­point of im­prov­ing kid­ney func­tion in 7 days.

“Short term kid­ney func­tion im­prove­ment was re­al­ly more a de­sign for the Phase II study to be able to pick the most op­ti­mal dose,” he said. “It’s kind of a bio­mark­er if you like. For Phase III one has to choose hard clin­i­cal end­points, and the most pre­ferred end­point by the reg­u­la­tors is the mor­tal­i­ty in this set­ting.”

And it’s not hard to see why. With mil­lions of pa­tients suf­fer­ing from acute kid­ney in­jury each oth­er — half of which are as­so­ci­at­ed with sep­sis — and 700,000 deaths around the world an­nu­al­ly, mak­ing a dent in that would mean a block­buster op­por­tu­ni­ty.

Re­cAP works by de­phos­pho­ry­lat­ing sub­stances that can trig­ger the im­mune sys­tem in­to dev­as­tat­ing the kid­ney, thus dex­o­ti­fy­ing them and re­duc­ing the in­flam­ma­tion.

“From our in­ter­ac­tions with FDA and EMA last year, we just need to con­duct one sin­gle pos­i­tive piv­otal study to file for mar­ket ap­proval,” he tells me, adding that the drug has se­cured fast track des­ig­na­tion in the US.

He plans to bring the com­pa­ny’s head­count up from 15 to as many as 30 to com­plete the clin­i­cal work and per­haps be­gin lay­ing some ground­work for launch.

Fol­low­ing the fi­nanc­ing the board will al­so ex­pand, com­pris­ing Mar­ti­jn Klei­jwegt and Fe­lice Ver­duyn van Wee­gen from LSP, Raphael Wis­niews­ki from An­dera, Re­mi Droller from Kur­ma and Geert-Jan Mul­der from For­bion.

Dan Skovronsky, Eli Lilly CSO

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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?

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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.

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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.

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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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