Gilead wa­gers $109M — cash — that this biotech can il­lu­mi­nate a drug dis­cov­ery path point­ed straight in­to the kid­ney

By any ob­jec­tive mea­sure, Gilead has learned as much or more than vir­tu­al­ly any oth­er bio­phar­ma play­er about the liv­er. Now they’re go­ing deep­er, much deep­er, in­to the kid­ney with the help of a Cam­bridge, MA-based biotech you may have for­got­ten about.

Ab­bie Cel­niker

In a new dis­cov­ery pact be­ing un­veiled Wednes­day morn­ing, the big biotech $GILD is com­mit­ting $109 mil­lion — in cash — to start work with a biotech few in the glob­al in­dus­try will like­ly re­call off hand. Goldfinch Bio, a clas­sic Third Rock start­up craft­ed un­der the lead­er­ship of Ab­bie Cel­niker, has been build­ing what it rather grand­ly calls the Kid­ney Genome At­las to gath­er to­geth­er a trea­sure trove of ge­net­ics and clin­i­cal da­ta de­vot­ed en­tire­ly to the kid­ney. And they’ve added a bi­ol­o­gy plat­form of kid­ney cells and “organoids” to find drugs that can hit the pre­ci­sion tar­gets they’ve iden­ti­fied.

Tony John­son

Now helmed by Tony John­son, an As­traZeneca vet­er­an who had worked with Mene Pan­ga­los’ group in the UK, this is Goldfinch’s first big re­search al­liance. Af­ter get­ting $55 mil­lion in A round mon­ey close to 3 years ago, the com­pa­ny qui­et­ly added $29 mil­lion more to ex­tend the run­way through the tech build­out. 

They are aim­ing at the clin­ic, us­ing their ge­net­ics ex­per­tise and bi­ol­o­gy to avoid the mul­ti­ple mishaps that have oc­curred with kid­ney drug R&D in the past.

“We an­tic­i­pate val­i­dat­ing the first tar­get next year,” John­son tells me, then it’s on to the first mol­e­cule and in­to the clin­ic.

Gilead’s cash com­mit­ment — $50 mil­lion up­front, $5 mil­lion for eq­ui­ty and $54 mil­lion for re­search sup­port to flesh out its work specif­i­cal­ly on di­a­bet­ic kid­ney dis­ease — is an un­usu­al­ly large cash com­mit­ment for a dis­cov­ery deal, which helps ex­plain the over­sized $1.95 bil­lion in biobucks on the ta­ble for up to 5 pro­grams. 

The deal doesn’t cap the work at 5 drugs, but it’s a handy way to out­line the up­side.

For Gilead, it’s a way to build out a seg­ment of the pipeline that hasn’t re­ceived a lot of at­ten­tion. John­son notes a mid-stage pro­gram for an ASK1 drug in fi­bro­sis, where the com­pa­ny has been cen­tered on a va­ri­ety of ther­a­pies. A Gilead spokesman tells me:

We have been study­ing kid­ney dis­ease pre­clin­i­cal­ly and clin­i­cal­ly for sev­er­al years. Our pipeline builds up­on our ex­per­tise in the fields of in­flam­ma­tion and fi­bro­sis bi­ol­o­gy. These are process­es in­volved in a num­ber of kid­ney dis­eases in­clud­ing DKD, lu­pus nephri­tis and oth­er con­di­tions. Our aim is to de­vel­op nov­el dis­ease mod­i­fy­ing ther­a­pies for pa­tients with kid­ney dis­eases as we grow our pres­ence in in­flam­ma­tion and fi­bro­sis.

Gilead’s $5 mil­lion for eq­ui­ty makes it part of the syn­di­cate now. John­son says they’ll be think­ing more about the right time for an IPO as they get clos­er to proof of con­cept da­ta on new drugs. In the mean­time, they’ve been build­ing some strength on the AI side, look­ing to cre­ate a com­pu­ta­tion­al group that can plumb the da­ta they’ve been gath­er­ing to help spot­light tar­gets and drugs. 

If this all works out, the next 3 years at Goldfinch will be a lot more noisy than the last 3.

FDA chief Stephen Hahn on Capitol Hill earlier this week (Getty Images)

As FDA’s work­load buck­les un­der the strain, Trump again ac­cus­es the agency of a po­lit­i­cal hit job

Peter Marks appeared before a virtual SVB Leerink audience yesterday and said that his staff at FDA’s CBER is on the verge of working around the clock. Manufacturing inspections, policy work and sponsor communications have all been pushed down the to-do list so that they can be responsive to Covid-related interactions. And the agency’s objective right now? “To save as many lives as we can,” Marks said, likening the mortality on the current outbreak as equivalent to “a nuclear bomb on a small city.”

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

PhII Alzheimer's fail­ure deals new blow to Roche, AC Im­mune — but the tau hy­poth­e­sis is far from dead

The leading anti-tau antibody has failed its first Phase II testing, casting a shadow on a popular target (just trailing amyloid beta) for Alzheimer’s disease.

Roche and AC Immune are quick to acknowledge disappointment in the topline readout, which suggested that semorinemab did not reduce cognitive decline among patients with early Alzheimer’s disease, who are either just starting to have symptoms or have mild manifestations.

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The win­dow is wide open as four more biotechs join the go-go IPO class of 2020

It’s another day of hauling cash in the biopharma world as four more IPOs priced Friday and a fifth filed its initial paperwork.

The biggest offering comes from PMV Pharma, an oncology biotech focusing on p53 mutations, which raised $211.8 million after pricing shares at $18 apiece. Prelude Therapeutics, developing PRMT5 inhibitors for rare cancers, was next with a $158 million raise, pricing shares at $19 each. Graybug Vision raised $90 million after pricing at $16 per share for its wet AMD candidates, and breast cancer biotech Greenwich Lifesciences brought up the rear with a small, $7 million raise after pricing shares at $5.75.

J&J of­fers PhI/IIa da­ta show­ing its sin­gle-dose vac­cine can stir up suf­fi­cient im­mune re­sponse

Days after J&J dosed the first participants of its Phase III ENSEMBLE trial, the pharma giant has detailed the early-stage data that gave them confidence in a single-dose regimen.

Testing two dose levels either as a single dose or in a two-dose schedule spaced by 56 days in, the scientists from Janssen, the J&J subsidiary developing its vaccine, reported that the low dose induced a similar immune response as the high dose. The interim Phase I/IIa results were posted in a preprint on medRxiv.

Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

Play-by-play of Gilead­'s $21B Im­munomedics buy­out de­tails a fren­zied push — and mints a new biotech bil­lion­aire

Immunomedics had not really been looking for a buyout when the year began. Excited by its BLA for Trodelvy, submitted to the FDA in late 2019, executive chairman Behzad Aghazadeh started off looking for potential licensing deals and zeroed in on four potential partners, including Gilead, following January’s JP Morgan Healthcare Conference in San Francisco. Such talks advanced throughout the year, with discussions advancing to the second round in mid-August.

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President Donald Trump reacts after signing an executive order following his remarks on his healthcare policies yesterday in Charlotte, North Carolina (Getty Images)

Op-ed: Will phar­ma re­al­ly pay for Trump’s lat­est law­less promise to 33 mil­lion Medicare ben­e­fi­cia­ries? Not like­ly

Sitting atop the executive branch, President Donald Trump is the ultimate authority at the FDA. He can fast track any vaccine to approval himself. If it came to that, of course.

What he can’t do is unilaterally order the legislative branch to loosen the Treasury’s coffers for $6.6 billion. Nor can he command pharmaceutical companies to pay for $200 vouchers sent to 33 million Medicare beneficiaries for prescription drugs before the election.

Pal­la­dio bags $20 mil­lion Se­ries B to top­ple a prob­lem­at­ic kid­ney dis­ease drug

Palladio Biosciences just took one step further in its quest to topple Otsuka’s Samsca with its own — it hopes safer — autosomal dominant polycystic kidney disease (ADPKD) drug.

The Pennsylvania-based biotech announced a $20 million Series B on Friday, which will fund a 10-person Phase III trial of its vasopressin V2 receptor agonist, lixivaptan. CEO Alex Martin expects to read out data in the first half of next year, then launch straight into a larger pivotal Phase III study with about 1,200 participants.

Samit Hirawat (Bristol Myers Squibb)

Af­ter bruis­ing re­jec­tion, blue­bird and Bris­tol My­ers Squibb land ide-cel pri­or­i­ty re­view. But will it mat­ter for the CVR?

With the clock all but up, the FDA accepted and handed priority review to Bristol Myers Squibb and bluebird bio’s BCMA CAR-T, keeping a narrow window open for Celgene investors to still cash in on the $9 CVR from the $63 billion Celgene merger.

The acceptance comes five months after the two companies weres slammed with a surprise refuse-to-file that threatened to foreclose the CVR entirely. Today’s acceptance sets the FDA decision date for March 27, 2021 – or precisely 4 days before the CVR deadline of March 31. Given the breakthrough designation and strong pivotal data — 81.5% response rate, 35.2% complete response rate — priority review was largely expected.

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