Neoanti­gens beck­on Mer­ck in­to a $200M can­cer col­lab­o­ra­tion with Mod­er­na

Now that Gale­na has added fresh ev­i­dence that first-gen can­cer vac­cines make for a poor R&D pro­gram, Mer­ck is bet­ting $200 mil­lion up­front that the next-gen neoanti­gen ap­proach to per­son­al­ized can­cer vac­cines can suc­ceed where all else has failed.

Mer­ck is ty­ing up with the mR­NA spe­cial­ists at Cam­bridge, MA-based Mod­er­na, which has inked a long line­up of mar­quee part­ner­ships. The big idea here is that each per­son’s can­cer cells present unique “neoanti­gens” that can be used to tai­lor a can­cer vac­cine for each pa­tient.

That’s a rad­i­cal idea that has gained con­sid­er­able steam in re­cent months, with Grit­stone and Neon Ther­a­peu­tics — paired now with Bris­tol-My­ers on Op­di­vo — round­ing up sig­nif­i­cant ven­ture cash. Biotech bil­lion­aire Patrick Soon-Sh­iong has al­so jumped in­to the game, in­clud­ing it in its grow­ing slate of can­cer R&D work in a group of star­tups.

Mod­er­na says it has al­ready set up a man­u­fac­tur­ing sys­tem that can be used to cre­ate these per­son­al­ized vac­cines in a mat­ter of weeks. And Mer­ck will use the part­ner­ship to ad­vance new com­bi­na­tion ther­a­pies that in­clude its check­point in­hibitor Keytru­da.

The way the deal works, Mod­er­na notes in its state­ment, is that Mer­ck can step up af­ter it sees some ev­i­dence in hu­mans that the tech is work­ing as planned. Af­ter hu­man proof-of-con­cept, if Mer­ck wants to opt in they can pay a sig­nif­i­cant mile­stone and then both com­pa­nies can share the cost on Phase III and com­mer­cial­iza­tions, prof­it­ing equal­ly.

Mod­er­na CEO Stéphane Ban­cel says they can jump in­to the clin­ic next year.

The deal marks an­oth­er rare pact by Mer­ck R&D chief Roger Perl­mut­ter, who’s been care­ful­ly

Roger Perl­mut­ter, Pres­i­dent, Mer­ck Re­search Lab­o­ra­to­ries

fo­cused on mak­ing Keytru­da a foun­da­tion fran­chise that can sus­tain the com­pa­ny for years to come. While Mer­ck has been a cou­ple of steps be­hind Bris­tol-My­ers in gain­ing mar­ket share, Perl­mut­ter’s not set­tling for a sec­ond place fin­ish.

“Com­bin­ing im­munother­a­py with vac­cine tech­nol­o­gy may be a new path to­ward im­prov­ing out­comes for pa­tients,” said Perl­mut­ter, pres­i­dent, Mer­ck Re­search Lab­o­ra­to­ries. “While the area of per­son­al­ized can­cer vac­cine re­search has faced chal­lenges in the past, there have been many re­cent ad­vances, and we be­lieve that work­ing with Mod­er­na to com­bine an im­muno-on­col­o­gy ap­proach, us­ing KEYTRU­DA, with mR­NA-based per­son­al­ized can­cer vac­cines may have the po­ten­tial to trans­form the treat­ment of can­cer.”

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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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.”

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.

Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.