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. 

UP­DAT­ED: Clay Sie­gall’s $614M wa­ger on tu­ca­tinib pays off with solid­ly pos­i­tive piv­otal da­ta and a date with the FDA

Back at the beginning of 2018, Clay Siegall snagged a cancer drug called tucatinib with a $614 million cash deal to buy Cascadian. It paid off today with a solid set of mid-stage data for HER2 positive breast cancer that will in turn serve as the pivotal win Siegall needs to seek an accelerated approval in the push for a new triplet therapy.

And if all the cards keep falling in its favor, they’ll move from 1 drug on the market to 3 in 2020, which is shaping up as a landmark year as Seattle Genetics prepares for its 23rd anniversary on July 15.

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Med­ical an­i­ma­tion: Mak­ing it eas­i­er for the site and the pa­tient to un­der­stand

Medical animation has in recent years become an increasingly important tool for conveying niche information to a varied audience, particularly to those audiences without expertise in the specialist area. Science programmes today, for example, have moved from the piece-to-camera of the university professor explaining how a complex disease mechanism works, to actually showing the viewer first-hand what it might look like to shrink ourselves down to the size of an ant’s foot, and travel inside the human body to witness these processes in action. Effectively communicating a complex disease pathophysiology, or the novel mechanism of action of a new drug, can be complex. This is especially difficult when the audience domain knowledge is limited or non-existent. Medical animation can help with this communication challenge in several ways.
Improved accessibility to visualisation
Visualisation is a core component of our ability to understand a concept. Ask 10 people to visualise an apple, and each will come up with a slightly different image, some apples smaller than others, some more round, some with bites taken. Acceptable, you say, we can move on to the next part of the story. Now ask 10 people to visualise how HIV’s capsid protein gets arranged into the hexamers and pentamers that form the viral capsid that holds HIV’s genetic material. This request may pose a challenge even to someone with some virology knowledge, and it is that inability to effectively visualise what is going on that holds us back from fully understanding the rest of the story. So how does medical animation help us to overcome this visualisation challenge?

As­traZeneca's Farx­i­ga scores FDA nod to cut risk of hos­pi­tal­iza­tion for heart fail­ure in di­a­bet­ics

While the FDA recently spurned an application to allow AstraZeneca’s blockbuster drug Farxiga for type 1 diabetes that cannot be controlled by insulin, citing safety concerns — the US regulator has endorsed the use of the SGLT2 treatment to reduce the risk of hospitalisation for heart failure in patients with type-2 diabetes and established cardiovascular disease or multiple CV risk factors.

IM­brave150: Roche’s reg­u­la­to­ry crew plans a glob­al roll­out of Tecen­triq com­bo for liv­er can­cer as PhI­II scores a hit

Just weeks after Bristol-Myers Squibb defended its failed pivotal study pitting Opdivo against Nexavar in liver cancer, Roche says it’s beat the frontline challenge with a combination of their PD-L1 Tecentriq with Avastin. And now they’re rolling their regulatory teams in the US, Europe and China in search of a new approval — badly needed to boost a trailing franchise effort.
Given their breakthrough and Big Pharma status as well as the use of two approved drugs, FDA approval may well prove to be something of a formality. And the Chinese have been clear that they want new drugs for liver cancer, where lethal disease rates are particularly high.
Researchers at their big biotech sub, Genentech, say that the combo beat Bayer’s Nexavar on both progression-free survival as well as overall survival — the first advance in this field in more than a decade. We won’t get the breakdown in months of life gained, but it’s a big win for Roche, which has lagged far, far behind Keytruda and Opdivo, the dominant PD-1s that have captured the bulk of the checkpoint market so far.
Researchers recruited hepatocellular carcinoma — the most common form of liver cancer — patients for the IMbrave150 study who weren’t eligible for surgery ahead of any systemic treatment of the disease.
Roche has a fairly low bar to beat, with modest survival benefit for Nexavar, approved for this indication 12 years ago. But they also plan to offer a combo therapy that could have significantly less toxicity, offering patients a much easier treatment regimen.
Cowen’s Steven Scala recently sized up the importance of IMbrave150, noting:

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Alex­ion clinch­es aHUS ap­proval for Ul­tomiris as the clock ticks on Soliris con­ver­sion

Alexion has racked up a second approval for Ultomiris, the successor therapy to Soliris, as its mainstay blockbuster therapy faces a patent review process that could drastically shorten its patent exclusivity.

The FDA OK for atypical hemolytic uremic syndrome (aHUS) on Friday was widely expected after Alexion posted a full slate of positive Phase III data in January. But regulators also flagged concerns about serious meningococcal infections, slapping a black box warning on the label and mandating a REMS.

FDA ap­proval lets Foamix set its maid­en ac­ne ther­a­py on course for US mar­ket launch

Months ago, Foamix leaned on its biggest shareholders — Perceptive Advisors and OrbiMed — to financially grease its wheels, ahead of the FDA decision date for its acne therapy. On Friday, that approval came in — and the topical formulation of the antibiotic minocycline is set for a January launch.

The therapy, Amzeeq (formerly known as FMX101), was approved to treat inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in patients aged 9 and older.

Hal Barron, GSK's president of R&D and CSO, speaks to Endpoints News founder and editor John Carroll in London at Endpoints' #UKBIO19 summit on October 8, 2019

[Video] Cel­e­brat­ing tri­al fail­ures, chang­ing the cul­ture and al­ly­ing with Cal­i­for­nia dream­ers: R&D chief Hal Bar­ron talks about a new era at GSK

Last week I had a chance to sit down with Hal Barron at Endpoints’ #UKBIO19 summit to discuss his views on R&D at GSK, a topic that has been central to his life since he took the top research post close to 2 years ago. During the conversation, Barron talked about changing the culture at GSK, a move that involves several new approaches — one of which involves celebrating their setbacks as they shift resources to the most promising programs in the pipeline. Barron also discussed his new alliances in the Bay Area — including his collaboration pact with Lyell, which we covered here — frankly assesses the pluses and minuses of the UK drug development scene, and talks about his plans for making GSK a much more effective drug developer.

This is one discussion you won’t want to miss. Insider and Enterprise subscribers can log-in to watch the video.

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Christine Bunt, Robert Langer. Verseau

Armed with Langer tech and $50M, Verseau hails new check­point drugs un­leash­ing macrophages against can­cer

The rising popularity of CD47 has propelled the “don’t-eat-me” signal to household name status in the immuno-oncology world: By blocking that protein, the theory goes, one can stop cancer cells from fooling macrophages. But just as PD-(L)1 merely represents the most fruitful of all checkpoints regulating T cells, Verseau Therapeutics is convinced that CD47 is one of many regulators one can modulate to stir up or tame the immune system.

Alice Shaw, Lung Cancer Foundation of America

Top ALK ex­pert and can­cer drug re­searcher Al­ice Shaw bids adieu to acad­e­mia, hel­lo to No­var­tis

Jay Bradner has recruited a marquee oncology drug researcher into the ranks of the Novartis Institutes for BioMedical Research. Alice Shaw is jumping from prestigious posts intertwined through Mass General, Harvard and Dana-Farber to take the lead of NIBR’s translational clinical oncology group.

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