NIH un­veils a vac­cine can­di­date for uni­ver­sal flu jab as first-in-hu­man stud­ies get un­der­way

A lit­tle more than a year af­ter map­ping a path to de­vel­op­ing a uni­ver­sal flu vac­cine — one of the Holy Grails in med­i­cine — the NIH has a can­di­date in hand that it’s start­ing to test in healthy hu­man vol­un­teers.

H1ssF_3928 dif­fers from sea­son­al in­fluen­za vac­cines in that it dis­plays a dif­fer­ent part of hemag­glu­tinin (HA), one of two pro­teins that clas­si­fy flu virus­es (the oth­er is neu­raminidase, or NA). HA con­sists of a head and a stem re­gion, and while the head typ­i­cal­ly re­ceives most of the im­mune re­sponse, it al­so changes con­stant­ly. The new vac­cine ditch­es the head en­tire­ly in fa­vor of the stem, which is more con­stant among dif­fer­ent in­fluen­za strains.

The HA stem is tagged on­to a mi­cro­scop­ic nanopar­ti­cle made of non­hu­man fer­ritin, a plat­form that en­ables sci­en­tists to mim­ic the spiky pre­sen­ta­tion of HA on a nat­ur­al in­fluen­za virus.

For the Phase I tri­al, re­searchers at the Na­tion­al In­sti­tute of Al­ler­gy and In­fec­tious Dis­ease plan to en­roll at least 53 adults, strat­i­fied in­to four dif­fer­ent age groups be­tween 18 and 70. They will be­gin with five mem­bers of the youngest co­hort, who will re­ceive a sin­gle 20-mi­cro­gram in­jec­tion, where­as the rest will re­ceive two 60-mcg vac­ci­na­tions.

The main goal of the study is safe­ty, tol­er­a­bil­i­ty and abil­i­ty to in­duce an im­mune re­sponse. Re­sults are ex­pect­ed as ear­ly as 2020.

A uni­ver­sal flu vac­cine can re­duce de­vel­op­ers’ headache of up­dat­ing the shots — and the risks of tar­get­ing the wrong strains — every year, low­er­ing the chances for a pan­dem­ic. When the NI­AID un­veiled its plan last Feb­ru­ary, it list­ed four cri­te­ria for a suc­cess­ful can­di­date:

  • Be at least 75% ef­fec­tive
  • Pro­tect against group I and II in­fluen­za A virus­es
  • Have durable pro­tec­tion that lasts at least 1 year
  • Be suit­able for all age groups

Oth­er in­dus­try play­ers, in­clud­ing Ox­ford’s Vac­citech, have al­so lined up gov­ern­ment or non-prof­it part­ners to start their own hu­man stud­ies for a clin­i­cal ef­fort that still has years to play out.

Im­age: Shut­ter­stock

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; 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.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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David Loew (Ipsen)

Ipsen snags an ap­proved can­cer drug in $247M M&A deal as an­oth­er bat­tered biotech sells cheap

You can add Paris-based Ipsen to the list of discount buyers patrolling the penny stock pack for a cheap M&A deal.

The French biotech, which has had plenty of its own problems to grapple with, has swooped in to buy Epizyme $EPZM for $247 million in cash and a CVR with milestones attached to it. Epizyme shareholders, who had to suffer through a painfully soft launch of their EZH2a inhibitor cancer drug Tazverik, will get $1.45 per share along with a $1 CVR tied to achieving $250 million in sales from the drug over four consecutive quarters as well as an OK for second-line follicular lymphoma by 1 Jan. 2028.

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AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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GSK says its drug for chron­ic hep B could ‘lead to a func­tion­al cure’ — but will it be alone or in com­bi­na­tion?

GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”

At a presentation at the EASL International Liver Congress, GSK shared that in around 450 patients who received its hep B drug bepirovirsen for 24 weeks, just under 30% had hepatitis B surface antigen and viral DNA levels that were too low to detect.

Sanofi, GSK tout 72% Omi­cron ef­fi­ca­cy in PhI­II tri­al of next-gen, bi­va­lent shot — with an eye to year-end roll­out

Sometimes, being late can give you an advantage.

That’s what Sanofi and GSK are trying to say as the Big Pharma partners report positive results from a late-stage trial of their next-gen bivalent Covid-19 vaccine, which was designed to protect against both the original strain of the SARS-CoV-2 virus and the Beta variant. Specifically, against Omicron, they note, the vaccine delivered 72% efficacy in all adults and 93.2% in those previously infected.

Matt Kapusta, uniQure CEO

In trou­bled Hunt­ing­ton’s space, uniQure’s gene ther­a­py shows ear­ly promise

In randomized clinical trial data from a small number of patients, Dutch biotech uniQure shared that its gene therapy for Huntington’s disease seems to reduce the amount of the mutant protein responsible for the disease over the course of a year.

In seven patients with early-stage Huntington’s — four who got the treatment and three who got a placebo — mutant huntingtin protein levels in the cerebrospinal fluid decreased by an average of just over 50% in patients who got the gene therapy compared to around a 17% drop in patients who got the placebo after a year.

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De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”