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.

A cancer-fighting concept from the inventor of the first cancer vaccine is nearing prime time, and its biotech developer has received a significant new infusion of cash to get it there.

Bolt Biotherapeutics announced a $93.5 million Series C round led by Sofinnova Investments and joined by more than 9 others, including Pfizer Ventures and RA Capital Management. That money will go toward pushing the San Francisco biotech’s platform of innate immune-boosting warheads through its first trial on metastatic solid tumors and into several more.

Four years after announcing themselves to the biotech world with a new idea for drugging neurodegeneration, backing by the late Henri Termeer and $5 million from Morningside Venture, the young entrepreneurs at Amylyx are back for round 2.

Morningside continued to lead the $30 million Series B, with participation from Termeer’s widow, Belinda, and other unnamed investors. Having celebrated a topline Phase II win for its lead program in amyotrophic lateral sclerosis, Amylyx expects the cash to fund talks with regulators as well as a separate trial for the same drug in Alzheimer’s — for which they had just finished enrolling.

The breakthrough therapy designation Pfizer and Merck KGaA notched for Bavencio in bladder cancer has quickly paved way for a full approval.

The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”

A year after landing $109 million in cash for an early-stage discovery deal with Gilead, Goldfinch Bio has scored a similar bounty from investors, raising $100 million in the biotech’s first financing round since its 2016 launch.

The new round, led by Eventide Asset Management and joined by 8 other firms, confirms that last year’s Gilead deal began a new, busier, more vocal era for the company. After launching out of Third Rock with $55 million and a plan to tackle kidney disease, they focused on preclinical research and made few material announcements. But the latest press release is full of plans, including their first Phase II study and a new therapy scheduled to enter the clinic next year.