Blaine McKee (file photo)

Laid off from Im­muno­Gen, an ex-Gen­zyme and Shire ex­ec heads to an ARCH up­start

Im­muno­Gen CBO Blaine Mc­K­ee got laid off af­ter the com­pa­ny had a big Phase III fail­ure last March, but by the time his of­fi­cial ex­it came around in De­cem­ber, he al­ready land­ed a plum new gig. ARCH Ven­ture Part­ners had tapped the long­time ex­ec­u­tive to run a biotech will­ing to spend a lot of cash in an area that had gone un­der-in­vest­ed: kid­ney dis­ease.

Now that biotech is emerg­ing from stealth mode with 12 em­ploy­ees, $51 mil­lion in Se­ries A fund­ing from ARCH and UCB Ven­ture and two new meth­ods of di­rect­ly at­tack­ing a dis­ease and an or­gan that drug de­vel­op­ers have long on­ly tried to mit­i­gate from the side. They’ve al­so got a new name: Walden Bio­sciences.

“It’s hor­ri­bly served, poor­ly served, there hasn’t been much in­no­va­tion for years,” Mc­K­ee told End­points News. “We’re not look­ing to slow the pro­gres­sion of re­nal dis­eases, we’re not look­ing to make a mod­est im­pact on re­nal dis­ease, we want to full on stop or re­verse the pro­gres­sion of re­nal dis­ease.”

Alex Dun­can

Al­though a cou­ple re­cent up­starts have al­tered the pic­ture, for years the ma­jor­i­ty of drugs in biotech pipelines have treat­ed the chron­ic con­di­tions that of­ten trig­ger kid­ney dis­eases, CSO Alex Dun­can not­ed. That’s been on par­tic­u­lar­ly acute dis­play over the past year, as As­traZeneca grad­u­al­ly rolled out what they’ve billed as “un­prece­dent­ed” da­ta on their SGLT2 di­a­betes drug Farx­i­ga. Those da­ta showed a 40% re­duc­tion in risk of kid­ney pro­gres­sion or car­dio­vas­cu­lar death, but that was in pa­tients re­gard­less of di­a­betes sta­tus and in some ways an out­lier.

“Phar­ma has tend­ed to fo­cus on, well, let’s treat the di­a­betes and we should be able to treat the kid­ney dis­ease,” Dun­can, a Med­im­mune and As­traZeneca vet who last worked at the can­cer biotech Agenus, told End­points. “Well, that hasn’t hap­pened.”

Jochen Reis­er

Mc­K­ee, a long­time Gen­zyme ex­ec­u­tive who ran cor­po­rate de­vel­op­ment for Shire be­fore the Take­da buy­out, will di­rect a plat­form culled from the labs of Jochen Reis­er and San­ja Sev­er at Mass­a­chu­setts Gen­er­al Hos­pi­tal and Har­vard. Al­though they have yet to nom­i­nate lead can­di­dates, their ap­proach can be split in­to two dif­fer­ent bi­o­log­i­cal mech­a­nisms.

In one path, they’ll look to tar­get a pro­tein known as sol­u­ble uroki­nase plas­mino­gen ac­ti­va­tor re­cep­tor, or sim­ply: su­PAR. Re­searchers have known for years that the pro­tein, when over­pro­duced else­where in the body, can flow through the blood and cause harm­ful in­flam­ma­tion in the kid­ney. They’ve sub­se­quent­ly large­ly used it as a bio­mark­er. But Walden says they can use an­ti­bod­ies to ba­si­cal­ly neu­tral­ize su­PARs be­fore they reach the kid­ney, re­turn­ing it to nor­mal lev­els — an ap­proach akin to the an­ti­bod­ies now be­ing de­vel­oped to neu­tral­ize SARS-CoV-2 be­fore it en­ters cells.

In the sec­ond path, they’ll look to ac­ti­vate a pro­tein called dy­namin. The pro­tein helps sup­port the phys­i­cal struc­ture of the kid­ney it­self, and in a 2015 Na­ture Med­i­cine pa­per, Sev­er and Reis­er de­scribe how a small mol­e­cule that con­tin­u­al­ly ac­ti­vates the re­cep­tor can help main­tain the kid­ney’s struc­ture and ame­lio­rate dis­ease in an­i­mals. The ap­proach, Dun­can said, could al­low pa­tients to keep on meds they would have dis­con­tin­ued be­cause of re­nal side ef­fects.

“Even with the dam­age that might be be­ing caused from con­di­tions out­side of the kid­ney, we can make the prop­er fil­tra­tion ap­pa­ra­tus in­side,” Dun­can said.

As they look to push the two pro­grams, Walden will be boost­ed by a key reg­u­la­to­ry change, Mc­K­ee said. The FDA in 2018 changed their guide­lines to al­low com­pa­nies to use the re­duc­tion of pro­tein in the urine as an ac­cept­able end­point for ac­cel­er­at­ed ap­proval. That, he said, could shave off years of de­vel­op­ment time.

He said that’s what helped oth­er VCs en­ter the field over the last 5 years, in­clud­ing Third Rock with GoldFinch in 2016 and Ver­sant with Chi­nook in 2019.

They’ll be look­ing to put their first drug in­to the clin­ic in 2022.

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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Paul Sekhri

The next big biotech su­per­star? Paul Sekhri has some thoughts on that

It occasionally occurs to Paul Sekhri that if they pull this off, his company will be on the front page of the New York Times and a lead story in just about every major news outlet on the planet. He tries not to dwell on it, though.

“I just want to be laser-focused on getting to that point,” Sekhri says, before acknowledging, “Yes, it absolutely crossed my mind.”

Sekhri, a longtime biopharma executive with tenures at Sanofi and Novartis, is now entering year three as CEO of eGenesis, the biotech that George Church protégé Luhan Yang founded to genetically alter pigs so that they can be used for organ transplants. He led them through one megaround and has just closed another, raising $125 million from 17 different investors to push the first-ever (humanized) pig to human transplants into the clinic.

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Michael Shpigelmacher

Khosla joins bet on un­con­ven­tion­al start­up look­ing to send drug de­liv­er­ing ro­bots in­to the brain

When Michael Shpigelmacher started the project, he knew he’d have to fund it himself. Every other effort of its kind was academic, rejected as too risky by investors.

Shpigelmacher, a robotics geek and entrepeneur who had drifted into consulting for pharma, wanted to build the real-life equivalent of technology from the 1960s film Fantastic Voyage, the one where a submarine crew is shrunk to “about the size of a microbe” and sent on a mission to repair a scientist’s brain. He scanned the literature, found the lab that was working on the most advanced project — at the Max Planck Institute in Germany, it turned out — and started funding them with money from his own account, along with some seed cash from friends and family.

Bob Nelsen (Photo by Michael Kovac/Getty Images)

With stars aligned and cash in re­serve, Bob Nelsen's Re­silience plans a makeover at 2 new fa­cil­i­ty ad­di­tions to its drug man­u­fac­tur­ing up­start

Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape.

Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling.

The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.

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Or­biMed, bio­phar­ma's biggest in­vestor, clos­es $3.5B in three new pri­vate funds

One of the world’s leading biopharma investors has pulled in its next rounds of cash, with the funds planned to go to dozens of companies around the world.

OrbiMed raised $3.5 billion across three private investment funds, it announced Monday, as it continues building on its long track record in healthcare and biopharma. All in all, the firm expects to invest in at least 60 companies across the US, Asia and Europe.

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Af­ter bail­ing on Covid-19 vac­cines, Mer­ck will team up with J&J to pro­duce its shot as part of un­usu­al Big Phar­ma pact

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

Ab­b­Vie tees up a biotech buy­out af­ter siz­ing up their Parkin­son's drug spun out of Ke­van Shokat's lab

AbbVie has teed up a small but intriguing biotech buyout after looking over the preclinical work it’s been doing in Parkinson’s disease.

The company is called Mitokinin, a Bay Area biotech spun out of the lab of UCSF’s Kevan Shokat, whose scientific explorations have formed the academic basis of a slew of startups in the biotech hub. One of Shokat’s PhD students in the lab, Nicholas Hertz, co-founded Mitokinin using their lab work on PINK1 suggesting that amping up its activity could play an important role in regulating the mitochondrial dysfunction contributing to Parkinson’s disease pathogenesis and progression.

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Fi­bro­Gen shares skid low­er as a sur­prise ad­comm rais­es risks on roxa OK

FibroGen will likely have to delay its US rollout for roxadustat once again.

In an unexpected move, the FDA is convening its Cardiovascular and Renal Drugs Advisory Committee to review the NDA in an advisory committee meeting. The date is yet to be confirmed.

Just a few weeks ago, SVB Leerink analyst Geoffrey Porges predicted that the roxa approval could come ahead of the PDUFA date on March 20 — effusive despite already being let down once by the FDA’s extension of its review back in December. AstraZeneca, which is partnered with FibroGen on the chronic kidney disease-related anemia drug, disclosed regulators had requested further clarifying analyses of clinical data.

In­tro­duc­ing End­pointsF­DA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.