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.

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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Bo Cumbo, AavantiBio CEO (file photo)

Bo Cum­bo jumps from the top com­mer­cial post at Sarep­ta to the helm of a gene ther­a­py start­up with some in­flu­en­tial back­ers, big plans and $107M

After a 7-year stretch building the commercial team at Sarepta, longtime drug salesman Bo Cumbo is jumping to the entrepreneurial side of the business, taking the helm of a startup that’s got several deep-pocket investors. And he’s not just bringing his experience in selling drugs.

He tells me that when he told Sarepta CEO Doug Ingram about it, his boss got excited about the venture and opted to jump in with a $15 million investment from Sarepta to add to the launch money, alongside 3 of the busiest investors in biotech.

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A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

Covid-19 roundup: WSJ of­fers in­side look at Ox­ford-As­traZeneca deal, in­clud­ing fi­nan­cial terms; Lil­ly plant un­der scruti­ny again

Oxford scientists developing a Covid-19 vaccine are working with British drugmaker AstraZeneca, and together the pair have become one of the frontrunners in the race to end the pandemic. But a new Wall Street Journal report out Wednesday offered a behind-the-scenes look at how that deal came together in the wake of a scholar-led revolt over a potential collaboration with Merck, and included previously unreported financial terms of the AstraZeneca deal.

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Jean-Pierre Sommadossi, Atea president and CEO (file photo)

Roche wades deep­er in­to Covid-19 fight, ink­ing an­tivi­ral pact with $350M cash fol­low­ing Re­gen­eron deal

Roche is making its first bet on an antiviral against Covid-19 in style, shelling out $350 million in cash to grab ex-US rights.

The drug comes from Atea Pharmaceuticals, the 7-year-old biotech created by Pharmasset co-founder Jean-Pierre Sommadossi, which essentially rebranded itself as a Covid-19 fighter in May when it closed a whopping $215 million venture round. Over a dozen investors bought in, including marquee names like Bain Capital and RA Capital.

Peter Kolchinsky and Raj Shah (file photo)

Pe­ter Kolchin­sky and Raj Shah's RA Cap­i­tal has $461M more to play with, af­ter 'rapid' in­vest­ment in the last 15 months

Just over 15 months after launching its first venture fund, RA Capital Management is ready for more. And this time the firm is bringing an even bigger load of cash to the table.

Announcing the close of its Nexus II fund on Wednesday, RA said it raised $461 million for investments in private companies across the biotech industry. The first venture fund, which raised $300 million, has churned through roughly 80% of its capital already, a pace that managing partner Raj Shah called unusually quick.

Philipp Spycher, Araris CEO

Promis­ing bet­ter link­er tech to ADC field, Araris has 'very, very am­bi­tious' plans for the clin­ic

A couple months after raising CHF 2.5 million ($2.76 million) in initial seed funding, one-year-old Araris Biotech is topping off the round with another CHF 12.7 million ($14 million).

The Paul Scherrer Institute and ETH Zurich spinout now has CHF 15.2 million to work with, and CEO Philipp Spycher has big plans. He hopes to bring one of the company’s antibody-drug conjugates (ADC) to the clinic by late 2022 or early 2023. “It’s very, very ambitious, but we are very optimistic that we actually can make it,” he said.

Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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David Hung (file photo)

Mas­ter deal­mak­er David Hung re­tools a SPAC sedan in­to a fi­nanc­ing mus­cle ve­hi­cle that leaves his can­cer start­up with $850M and a place on Wall Street

It’s only right that one of the industry’s top dealmakers just completed one of the biggest SPAC-related deals in the pipeline.

David Hung, of Medivation fame, has completed a back flip into the market, merging with EcoR1 Capital’s SPAC Panacea and landing neatly on Wall Street with an $NUVB stock ticker after filling out the blank check in his name. In addition to the $144 million held in the SPAC — provided none of the investors opt out — Hung is getting ahold of $500 million more being chipped in by a slate of institutional investors who feel that Hung could have the keys to another Medivation-style success.

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