At­las, F-Prime pro­vide launch mon­ey for Akre­via — a lit­tle biotech with big plans to de­sign bet­ter drugs

Tim Clack­son

A cou­ple of vet­er­an drug de­vel­op­ers are guid­ing a stealthy start­up dubbed Akre­via Ther­a­peu­tics out in­to the open to­day af­ter a pair of high-pro­file biotech in­vestors blessed the op­er­a­tion with a $30 mil­lion launch round.

Akre­via is head­ed by sci­en­tist Tim Clack­son, whose last role was run­ning the R&D shop at Ari­ad un­til Take­da came in and bought it, and ex­ec­u­tive chair­man Nes­san Berming­ham, whose last gig was CEO of the gene edit­ing com­pa­ny In­tel­lia.

The tech­nol­o­gy they’re us­ing was in-li­censed from Thomas Jef­fer­son Uni­ver­si­ty and City of Hope, where John Williams, a pro­fes­sor of mol­e­c­u­lar med­i­cine, has been play­ing with the atom­ic struc­tures of mol­e­cules. That is be­ing built in­to the plat­form.

Nes­san Berming­ham

The big idea at lit­tle Akre­via — a 13-per­son shop with plans to quick­ly bring that num­ber up to 20 — is that their found­ing sci­en­tists’ work on drug struc­tures gave them the in­sights they need­ed to take a set of an­ti­bod­ies, cy­tokines and chemokines that are ei­ther too dan­ger­ous to be used or plagued with tox­i­c­i­ty is­sues and re­design them so they can be made in­to best-in-class drugs.

“We have been in full work­ing mode for just a few months af­ter hav­ing built the seed­ed ver­sion of the com­pa­ny,” Clack­son tells me.

One of their first projects will be on CT­LA-4, the orig­i­nal im­muno-on­col­o­gy drug that has a well un­der­stood ef­fi­ca­cy pro­file and a big prob­lem with side ef­fects. They won’t be the on­ly play­er in this field, though, as Cy­tomX has al­so been at work with Bris­tol-My­ers Squibb on re­mak­ing Yer­voy in­to a much safer drug with­out los­ing its po­ten­cy.

“There are some in­ter­est­ing echoes of Ari­ad here,” says Clack­son. His for­mer em­ploy­er al­so liked “val­i­dat­ed, high val­ue tar­gets.” And imm­no-on­col­o­gy makes a lot of sense if you con­sid­er the hand­ful of pi­o­neers that have made it to the mar­ket de­spite be­ing ham­pered with some se­vere safe­ty is­sues.

Ro­nan O’Ha­gan

The team’s main goal now is to start prep­ping for the clin­i­cal work ahead, while build­ing a pipeline of pre­clin­i­cal ther­a­pies and con­tin­u­ing the hunt for part­ners who want to come in and join Akre­via on its quest.

Says Clack­son: “Giv­en the breadth and num­ber of tar­gets, we do see our­selves en­gag­ing with one or more part­ners who would share that vi­sion.”

At­las and F-Prime have bought in, pro­vid­ing the launch mon­ey while lead­ing the round. 

Mar­garet Karow

Mer­ck vet Ro­nan O’Ha­gan is SVP of Dis­cov­ery while Mar­garet Karow — with stints at Am­gen and Re­gen­eron — is SVP of Pre­clin­i­cal De­vel­op­ment. Thomas Beck and Ben Aus­pitz of F-Prime Cap­i­tal will serve on the board along­side David Grayzel and Michael Glad­stone of At­las Ven­ture. 

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

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

As FDA buck­les un­der the strain of a pan­dem­ic work­load, 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.”

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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David Berry (Flagship)

Flag­ship's next big tech­no­log­i­cal bet? The cloud

Earlier this month, Flagship announced their big bet on the software half the industry is talking about, launching the AI and machine learning startup. Now, they and a couple other investors are gambling $100 million on a software that much of the public generally thinks of as a cool, IT afterthought: cloud computing.

The idea, says founder and Flagship partner David Berry, is one of scale: The sheer magnitude of biological data that you can store on cloud technology is unprecedented. And that size, when leveraged properly, can allow you to ask questions and form insights that are similarly unprecedented.

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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.

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.

New York governor Andrew Cuomo (AP Images)

An­drew Cuo­mo says New York will un­der­take its own vac­cine re­view process, and wouldn’t rec­om­mend trust­ing the fed­er­al gov­ern­ment

The concerns keep mounting over President Donald Trump’s politicization of the FDA and other federal agencies guiding the development of a safe and effective vaccine. And today, the telegenic New York governor Andrew Cuomo appeared to introduce even more politics into the matter — latest in an ongoing series of incidents that have cast the proudly independent FDA in starkly political terms.

During his daily press conference Cuomo said that the state will review any coronavirus vaccines approved by the federal government, citing a lack of trust in the Trump administration. The announcement comes one day after Trump accused the FDA of making an “extremely political” move in proposing stricter vaccine guidance.