Team­ing up with NIH, Vi­iV buys in­to the next big thing in HIV: an­ti­bod­ies

Weeks af­ter tak­ing over from John Pot­tage, Kim Smith — Vi­iV Health­care’s new­ly mint­ed head of R&D — has found a new HIV treat­ment ap­proach to cham­pi­on and do some heavy lift­ing around.

Kim Smith Vi­iV

The GSK sub­sidiary has li­censed a “broad­ly neu­tral­iz­ing an­ti­body” from the NIH that promis­es to rec­og­nize and block the en­try of mul­ti­ple HIV strains in­to healthy CD4+ T cells. By bind­ing to a spe­cif­ic site known as gp120 on the sur­face of the virus, N6LS is en­gi­neered to keep them out and an­nul any chance of repli­ca­tion in­side cells — which can work as ei­ther pro­phy­lax­is or ther­a­py.

Based on “ini­tial ev­i­dence that bN­Abs can tar­get dor­mant copies of HIV that may be hid­ing in hu­man cells and avoid­ing an­ti-retro­vi­ral treat­ment,” a spokesper­son added, “this re­search could have im­pli­ca­tions for ef­forts to cure HIV.”

The Na­tion­al In­sti­tute of Al­ler­gy and In­fec­tious Dis­eases has been work­ing on adding this spe­cif­ic type of an­ti­bod­ies to its ar­se­nal of HIV ther­a­pies along­side oth­er next-gen ap­proach­es such as im­plants and even a vac­cine. Here’s why they are im­por­tant, ac­cord­ing to NI­AID di­rec­tor An­tho­ny Fau­ci:

An­ti­retro­vi­ral ther­a­py sup­press­es HIV to very low lev­els, nor­mal­izes life ex­pectan­cy, and pre­vents sex­u­al trans­mis­sion of the virus. How­ev­er, these ben­e­fits are lost if an in­di­vid­ual stops tak­ing the med­ica­tions as pre­scribed. If proven safe and ef­fec­tive, pe­ri­od­ic in­fu­sions of po­tent, broad­ly neu­tral­iz­ing HIV an­ti­bod­ies may be a po­ten­tial al­ter­na­tive to dai­ly an­ti­retro­vi­ral ther­a­py.

An­tho­ny Fau­ci NI­AID

But an­ti­bod­ies are still not im­mune to con­cerns about re­sis­tance, which looms large in an­ti­retro­vi­ral ther­a­pies. As Vi­iV pro­gress­es in the clin­ic with N6LS, they plan to com­bine it with an­oth­er long-act­ing mol­e­cule to form a 2-drug reg­i­men — pitch­ing less fre­quent dos­ing than ex­ist­ing op­tions.

The NI­AID Vac­cine Re­search Cen­ter will now be pro­vid­ing the ma­te­r­i­al — a prod­uct of a re­search and de­vel­op­ment pact be­tween GSK and the NIH — for Vi­iV to con­duct a Phase IIa study. The deal al­so comes with mile­stones and roy­al­ties.

“We are ex­cit­ed to ad­vance N6LS from its cur­rent proof of con­cept stage to the next step in its de­vel­op­ment by study­ing this bNAb as a long-act­ing med­i­cine that could po­ten­tial­ly be used for both treat­ment and pre­ven­tion of HIV,” Smith said in a state­ment.

Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

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Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen scores a pri­or­i­ty re­view for its Alzheimer's drug ad­u­canum­ab, mov­ing one gi­ant leap for­ward in its con­tro­ver­sial quest

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application earlier in the year.

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Levi Garraway, Roche CMO (Source: Genentech)

UP­DAT­ED: FDA hands out a quick OK for po­ten­tial SMA block­buster ris­diplam, giv­ing Genen­tech and Roche a chance to chal­lenge ri­vals on the price

US regulators handed Roche and Genentech a big win Friday afternoon, one that has market-shaping potential for its high-priced rivals from Novartis and Biogen.

The FDA has green-lit the companies’ spinal muscular atrophy drug risdiplam, which will be marketed as Evrysdi in the US, for use in patients two months and older. It’s the first SMA drug that can be taken orally, as Biogen’s Spinraza is injected into the spine while Novartis’ Zolgensma is a gene therapy.

Moncef Slaoui, Getty Images

When will it end? Big Phar­ma's top vac­cine ex­pert at OWS of­fers a speedy time­line for a Covid-19 vac­cine — ei­ther be­fore or right af­ter the elec­tion

Moncef Slaoui hasn’t started making plans for his summer vacation next year. But he offers high odds that all Americans will be able to do that in the not too distant future.

In an interview with a pair of sympathetic podcasters at the conservative American Enterprise Institute, Slaoui provides an education to listeners on how any drug or vaccine can be sped through trials. And he leaves the door wide open to the notion that the leading vaccine developers can demonstrate efficacy and safety in a compelling fashion as early as October — or as late as the end of this year.

Bio­haven adds near­ly $1B in Nurtec deals with Roy­al­ty Phar­ma, Sixth Street

Biohaven just added nearly $1 billion to their balance sheet.

On Friday morning, the neuroscience biotech announced a pair of creative agreements with Royalty Pharma and the investment firm Sixth Street to bolster the commercial launch of their new migraine drug, Nurtec. Biohaven will sell a sliver of its royalties on Nurtec and 3% of the royalties on their experimental migraine drug zavegepant to Royalty Pharma as part of a larger agreeement that will pay $450 million. At the same time, the company announced they took out a $500 million loan from Sixth Street.

Covid-19 roundup: Gates Foun­da­tion pours $150M in­to In­dia’s Serum In­sti­tute; Pfiz­er teams with Gilead on remde­sivir

By CEO and scion Adar Poonawalla’s estimation, the Serum Institute in India has already poured hundreds of millions of dollars into scaling up the unproven Covid-19 vaccine being developed by AstraZeneca and Oxford for use in low and middle income countries. It’s meant taking on a risk that other companies, including AstraZeneca, have mitigated with huge amounts of government funding.

Now, for the first time, Poonawalla is getting some outside help. The Gates Foundation has agreed to pay the institute $150 million to supply 100 million vaccines to India and other emerging economies next year, Reuters reported. That includes both the vaccine being developed by AstraZeneca and the one being developed by Novavax. Those vaccines will be available in 92 countries and be priced at $3 per dose.

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UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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Ab­b­Vie set­tles in­sur­ance fraud suit, agrees to tweak nurse am­bas­sador pro­gram; CStone aims for NSCLC OK with pos­i­tive PhI­II da­ta

AbbVie has resolved a California lawsuit alleging insurance fraud in the promotion of its cash cow Humira, paying $24 million to settle things with the state’s insurance regulator.

The settlement comes almost four years after a whistleblower first reported AbbVie’s practice of deploying registered nurses to visit patients at home or call them by phone to ensure that Humira prescriptions are filled. AbbVie was also charged with providing illegal kickbacks to doctors in an attempt to encourage them to prescribe Humira for a range of anti-inflammatory diseases.

Per­cep­tive fields SPAC #3 as an­oth­er group of biotechs scoops up $364M in lat­est Nas­daq romp

There’s no sign that the windfall of cash dropping biotech’s way on Wall Street is abating. Three more biopharmas priced IPOs on Thursday and Friday morning, riding a historic boom with a $364 million payoff.

London-based biotech Freeline Therapeutics took home the lion’s share of the cash with $159 million after pricing 8,823,529 shares at $18 a pop. Checkmate Pharmaceuticals, of Cambridge, MA, raised $75 million with an offer of 5 million shares at $15 — right at the midpoint of its range. And Arya Sciences Acquisition Corp III, the third in a series from Perceptive, priced 13,000,000 shares at $10 per share.