Vir­tu­al biotech An­ti­va sets out on a big R&D quest, armed with a $22M round for an HPV ther­a­py

Gail Maderis, An­ti­va

For a vir­tu­al biotech with one drug just en­ter­ing the clin­ic, lit­tle South San Fran­cis­co-based An­ti­va Bio­sciences has carved out a very big mis­sion for it­self.

Led by ex-Bay­Bio chief Gail Maderis, the biotech is tar­get­ing pre­can­cer­ous le­sions caused by HPV with an ex­per­i­men­tal top­i­cal ther­a­py. They’ve mapped out a clin­i­cal de­vel­op­ment plan that can, in a rel­a­tive­ly short pe­ri­od of time, of­fer some sol­id ev­i­dence of its po­ten­tial. And this morn­ing their ven­ture syn­di­cate has come up with a $22 mil­lion round de­signed to pro­vide enough sup­port to land key da­ta read­outs.

An­ti­va’s ABI-1968 be­gan its first hu­man study just days ago, on its way to tack­ling cer­vi­cal in­traep­ithe­lial neo­pla­sia, a pre­can­cer­ous con­di­tion that con­fronts mil­lions of women world­wide.

“It is a top­i­cal cream that is de­liv­ered in­trav­agi­nal­ly with two mech­a­nisms of ac­tion: an­tivi­ral and an an­tipro­lif­er­at­ing agent,” says Maderis. It’s de­signed to tack­le all forms of pre­can­cer­ous ab­nor­mal cell growth that lead to cer­vi­cal can­cer.

The mol­e­cule was in­vent­ed by a pro­fes­sor at UCSD, Karl Hostetler, an in­fec­tious dis­ease ex­pert who has a long and dis­tin­guished track record in an­tivi­rals.

“We are con­duct­ing a Phase Ia in healthy vol­un­teers in Aus­tralia,” says Maderis, fo­cus­ing on safe­ty and tol­er­a­bil­i­ty. If all goes well, the com­pa­ny will move for­ward in­to a Ib tri­al in the sum­mer, which will be in high grade dis­ease. And while safe­ty is still a big fo­cus, the biotech be­lieves it can get a sol­id look at ef­fi­ca­cy that should be a like­ly pre­dic­tor of larg­er da­ta read­outs.

“The Phase Ib study will be treat­ing pa­tients with FDA ap­proval end­points,” she adds. “We should get some good da­ta on the ef­fi­ca­cy of the drug. We are al­so de­vel­op­ing the same drug for anal neo­pla­sia, with a Phase I al­so in the sum­mer.”

A Phase II tri­al will like­ly have to wait un­til 2019.

Canaan Part­ners and Sofinno­va Ven­tures, two big play­ers on the West Coast, got the com­pa­ny up and run­ning, pro­vid­ing the ear­ly fi­nanc­ing need­ed for much of the pre­clin­i­cal work. They are in the C round an­nounced this morn­ing. But Maderis says its new back­ers al­so il­lus­trate the busi­ness plan at An­ti­va.

Brace Phar­ma Cap­i­tal, the ven­ture arm of Brazil’s largest phar­ma com­pa­ny, EMS, led the round. An­oth­er new in­vestor, NS In­vest­ment, is based in Ko­rea. Os­age Uni­ver­si­ty Part­ners and Alexan­dria Ven­ture In­vest­ments al­so joined in.

The in­ter­na­tion­al sig­na­ture in the syn­di­cate un­der­scores An­ti­va’s in­ter­est in form­ing re­gion­al part­ner­ships in Latin Amer­i­ca and Asia as they be­gin to lay the glob­al ground­work that will be need­ed to pave out what they hope will one day be a very large roll­out.

Says Maderis: “We are start­ing to plant the seed to look to ge­o­gra­phies in the world where HPV dis­ease has the most preva­lence.”

If their top­i­cal ther­a­py works, An­ti­va will look to de­liv­er a new ther­a­py that can be eas­i­ly ap­plied, at home.

An­ti­va was left with a very large open­ing, says Canaan’s Wende Hut­ton, af­ter the in­tro­duc­tion of new HPV vac­cines a decade ago seemed to an­swer this par­tic­u­lar un­met med­ical need. But the vac­cines proved to be a com­mer­cial let­down, and the threat of HPV re­mains a ma­jor threat to women – and men – around the world. Sur­gi­cal in­ter­ven­tions, adds Hut­ton, are not al­ways fea­si­ble.

“HPV is an epi­dem­ic and it’s a sad thing that women, even if screened, don’t have ac­cess to sur­gi­cal ther­a­py,” says Hut­ton.

I sug­gest­ed to Maderis that in most cas­es like this, a small, ven­ture backed biotech would even­tu­al­ly look to ei­ther a buy­out or a li­cens­ing pact with a big play­er which would be able to mar­ket a ther­a­py to a big group like this.

“Those are two good op­tions,” she said with a cheer­ful laugh.

It’s ear­ly days for An­ti­va. But there are a few short­cuts that could be avail­able to the com­pa­ny. One in par­tic­u­lar would be look­ing for an ac­cel­er­at­ed ap­proval on anal neo­pla­sia, where there’s a big un­met need for men. The cer­vi­cal side of the equa­tion would like­ly need to go all the way through a big Phase III.

The sev­en staffers at An­ti­va have a big job ahead.

2019 Trin­i­ty Drug In­dex Eval­u­ates Ac­tu­al Com­mer­cial Per­for­mance of Nov­el Drugs Ap­proved in 2016

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This report, the fourth in our Trinity Drug Index series, outlines key themes and emerging trends in the industry as we progress towards a new world of targeted and innovative products. It provides a comprehensive evaluation of the performance of novel drugs approved by the FDA in 2016, scoring each on its commercial performance, therapeutic value, and R&D investment (Table 1: Drug ranking – Ratings on a 1-5 scale).

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For start-up biotechnology companies and resource stretched pharmaceutical organisations, launching a novel product can be challenging. Lean teams can make setting a launch strategy and achieving your commercial goals seem like a colossal undertaking, but can these barriers be transformed into opportunities that work to your brand’s advantage?
We spoke to Managing Consultant Frances Hendry to find out how Blue Latitude Health partnered with a fledgling subsidiary of a pharmaceutical organisation to launch an innovative product in a
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What does the launch environment look like for this product?
FH: We started working on the product at Phase II and now we’re going into Phase III trials. There is a significant unmet need in this disease area, and everyone is excited about the launch. However, the organisation is still evolving and the team is quite small – naturally this causes a little turbulence.

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A $1B-plus drug stum­bles in­to an­oth­er big PhI­II set­back -- this time flunk­ing fu­til­i­ty test -- as FDA hold re­mains in ef­fect for Ipsen

David Meek

At the time Ipsen stepped up last year with more than a billion dollars in cash to buy Clementia and a late-stage program for a rare bone disease that afflicts children, then CEO David Meek was confident that he had put the French biotech on a short path to a mid-2020 launch.

Instead of prepping a launch, though, the company was hit with a hold on the FDA’s concerns that a therapy designed to prevent overgrowth of bone for cases of fibrodysplasia ossificans progressiva might actually stunt children’s growth. So they ordered a halt to any treatments for kids 14 and under. Meek left soon after to run a startup in Boston. And today the Paris-based biotech is grappling with the independent monitoring committee’s decision that their Phase III had failed a futility test.

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Roche's check­point play­er Tecen­triq flops in an­oth­er blad­der can­cer sub­set

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UP­DAT­ED: Eli Lil­ly’s $1.6B can­cer drug failed to spark even the slight­est pos­i­tive gain for pa­tients in its 1st PhI­II

Eli Lilly had high hopes for its pegylated IL-10 drug pegilodecakin when it bought Armo last year for $1.6 billion in cash. But after reporting a few months ago that it had failed a Phase III in pancreatic cancer, without the data, its likely value has plunged. And now we’re getting some exact data that underscore just how little positive effect it had.

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“I kind of look at 2019 as a transformational year,” report author Glen Hunzinger told Endpoints News. 

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Stephen Hahn, AP

The FDA has de­val­ued the gold stan­dard on R&D. And that threat­ens every­one in drug de­vel­op­ment

Bioregnum Opinion Column by John Carroll

A few weeks ago, when Stephen Hahn was being lightly queried by Senators in his confirmation hearing as the new commissioner of the FDA, he made the usual vow to maintain the gold standard in drug development.

Neatly summarized, that standard requires the agency to sign off on clinical data — usually from two, well-controlled human studies — that prove a drug’s benefit outweighs any risks.

Over the last few years, biopharma has enjoyed an unprecedented loosening over just what it takes to clear that bar. Regulators are more willing to drop the second trial requirement ahead of an accelerated approval — particularly if they have an unmet medical need where patients are clamoring for a therapy.

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