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.

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His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

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Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.