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.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

What lured Hal Bar­ron away?; Top FDA minds on ac­cel­er­at­ed ap­proval re­forms; ‘Dead wrong’ Aduhelm ad blitz; 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.

Nothing can really compete with Hal Barron’s departure from GlaxoSmithKline as the news of the week, but we do have plenty of original reporting and analysis from the Endpoints team in this edition. Enjoy and have a nice weekend.

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Mer­ck wins le­gal bat­tle over in­sur­ance cov­er­age af­ter ran­somware at­tack

Merck has emerged victorious from a years-long legal battle with insurers over the coverage of more than a billion dollars in losses from the malware NotPetya, with a New Jersey Superior Court judge concluding that the responsibility is on insurers to clarify their policies around cyber attacks.

The pharma giant was one of several victims of a global cyber attack back in 2017 that also hit Danish shipping company Maersk, American food company Mondelēz, French construction giant Saint-Gobain and even the systems monitoring the Chernobyl nuclear power stations, Bloomberg reported back in 2019.

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Crit­ics push back on Alzheimer’s As­so­ci­a­tion ad blitz to get Medicare to change its Aduhelm rul­ing: 'Dead wrong'

The latest Alzheimer’s Association advertising campaign encourages people to fight.

Not against the disease or for more research or treatments, but against the Centers for Medicare and Medicaid Services. More specifically, CMS’ recent reimbursement decision to only pay for Biogen and Eisai’s controversial Alzheimer’s drug Aduhelm for patients in clinical trials.

With CMS’ preliminary decision now in a 30-day comment period, patient advocates’ goal is to convince CMS to reverse its decision with a marketing blitz and public pressure.

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Dan O'Day, Gilead CEO (Jim Watson/AFP via Getty Images)

Fail­ing to con­firm clin­i­cal ben­e­fit, Gilead pulls 2 ac­cel­er­at­ed ap­proval in­di­ca­tions for can­cer drug

Gilead recently decided to pull two indications for its cancer drug Zydelig — in relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic leukemia (SLL) — after failing to complete the confirmatory trials required as part of the accelerated approvals from 2014.

“As the treatment landscape for FL and SLL has evolved, enrollment into the confirmatory study has been an ongoing challenge,” Gilead said in a statement, noting it formally notified the FDA of its decision to voluntarily withdraw these indications.

Richard Pazdur (via AACR)

Time lim­its on ac­cel­er­at­ed ap­provals? FDA's on­col­o­gy chief Rick Paz­dur eyes po­ten­tial re­forms via in­ter­na­tion­al ap­proach­es

The spotlight on the accelerated approval pathway continues to shine bright, with the FDA’s top oncology official writing in an opinion that the pathway may be strengthened with bits and pieces of what other regulators in Europe and elsewhere have done with their expedited approval pathways, such as adding expiration dates for these faster approvals to ensure they confirm clinical benefit in a timely manner.

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Hal Barron, Endpoints UKBIO20 (Jeff Rumans)

'Al­tos was re­al­ly a once-in-a-life­time op­por­tu­ni­ty': Hal Bar­ron re­flects on his big move

By all accounts, Hal Barron had one of the best jobs in Big Pharma R&D. He made more than $11 million in 2020, once again reaping more than his boss, Emma Walmsley, who always championed him at every opportunity. And he oversaw a global R&D effort that struck a variety of big-dollar deals for oncology, neurodegeneration and more.

Sure, the critics never let up about what they saw as a rather uninspiring late-stage pipeline, where the rubber hits the road in the Big Pharma world’s hunt for the next big near-term blockbuster, but the in-house reviews were stellar. And Barron was firmly focused on bringing up the success rate in clinical trials, holding out for the big rewards of moving the dial from an average 10% success rate to 20%.

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Executive Director of the EMA Emer Cooke (AP Photo/Geert Vanden Wijngaert)

Eu­ro­pean Par­lia­ment signs off on strength­en­ing drug reg­u­la­tor's abil­i­ty to tack­le short­ages

The European Parliament on Thursday endorsed a plan to increase the powers of the European Medicines Agency, which will be better equipped to monitor and mitigate shortages of drugs and medical devices.

By a vote of 655 to 31, parliament signed off on a provisional agreement reached with the European Council from last October, in which the EMA will create two shortage steering groups (one for drugs, the other for devices), a new European Shortages Monitoring Platform to facilitate data collection and increase transparency, and on funding for the work of the steering groups, task force, working parties and expert panels that are to be established.

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FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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