Stéphane Bancel, AP Images

Mod­er­na takes on a low-risk pact with CAR-T play­er Au­to­lus for mR­NA-based can­cer drugs

Mod­er­na’s Covid-19 vac­cine has trans­formed the once-back­wa­ter biotech in­to one of the most high­ly val­ued drug­mak­ers in the world in the span of a year. But what does the fu­ture hold for Mod­er­na’s star turn? A small-scale dis­cov­ery pact could of­fer a clue.

Mod­er­na will hold ex­clu­sive rights to four mR­NA-based im­muno-on­col­o­gy can­di­dates us­ing pro­pri­etary bind­ing tech from Au­to­lus, a biotech best known for its work on “off-the-shelf” CAR-T ther­a­pies, the part­ners said Mon­day.

Un­like some oth­er dis­cov­ery pacts in­volv­ing big-name drug­mak­ers, the deal doesn’t come with up­front cash straight away. Au­to­lus will be due an up­front pay­ment for each can­di­date if Mod­er­na choos­es to opt-in with down­stream reg­u­la­to­ry and com­mer­cial mile­stones and roy­al­ty rights.

De­spite the scanty de­tails, shares of $AUTL were trad­ing up about 17% be­fore the bell.

It’s a low risk en­deav­or for Mod­er­na, which un­der the watch­ful eye of CEO Stéphane Ban­cel has seen its mar­ket cap ex­plode to near­ly $142 bil­lion amid the rise of its Covid-19 vac­cine and its plat­form po­ten­tial in oth­er in­di­ca­tions.

The pact, while mea­ger, could al­so of­fer some in­sight in­to how Mod­er­na is think­ing about its next steps, look­ing for out­side part­ners to help de­vel­op bet­ter ways to traf­fic mR­NA-based ther­a­peu­tics in­to tu­mor cells.

The linch­pin of the deal is the binders that Au­to­lus has tout­ed as a key tech­nol­o­gy. Al­though it didn’t dis­close the binders it’ll ex­plore with Mod­er­na, the com­pa­ny us­es a CAT binder in its CAR-T can­di­dates, a syn­thet­ic an­ti­body the biotech be­lieves has a short­er half-life than the stan­dard FMC63 binder used in oth­er ther­a­pies, po­ten­tial­ly lim­it­ing the se­ri­ous side ef­fects as­so­ci­at­ed with the class. In a note to clients, Mizuho an­a­lysts called the deal a “broad val­i­da­tion” of Au­to­lus’ plat­form if, ul­ti­mate­ly, a heav­i­ly qual­i­fied one.

But the tie-up will like­ly come as cold so­lace for mar­ket watch­ers wait­ing for if, or when, Mod­er­na will use its grow­ing cash po­si­tion to start ink­ing re­search deals or po­ten­tial­ly add a small­er biotech to the fold out­right. Dri­ven by grow­ing sales for its Covid-19 vac­cine and the val­i­da­tion of its mR­NA vac­cine plat­form writ large, Mod­er­na has seen its mar­ket cap sky­rock­et in re­cent days — now sur­pass­ing no less a light than old stal­wart Am­gen — with no end in sight to the growth.

How Mod­er­na will cap­i­tal­ize on that suc­cess to set it­self up in the fu­ture is still yet to be seen.

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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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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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.”

invoX Pharma CEO Ben Toogood (L) and F-star CEO Eliot Forster

F-star bought out in $161M all-cash deal as Hong Kong's Sino Bio­pharm looks to­ward in­ter­na­tion­al ex­pan­sion

After more than a decade and a half of charting its own course, F-star Therapeutics will now settle under a new umbrella company.

The UK biotech will be acquired by invoX Pharma, a subsidiary of Hong Kong’s Sino Biopharm, in a roughly $161 million all-cash deal, the companies announced Thursday morning. F-star’s buyout will value its shares $FSTX at $7.12 apiece, nearly an 80% premium above Wednesday’s closing price.

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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.

FDA un­veils new draft guid­ance to help with oligonu­cleotide ther­a­peu­tics de­vel­op­ment

While oligonucleotides, a wide variety of synthetically modified RNA or RNA/DNA hybrids that bind to a target RNA sequence to alter RNA and/or protein expression, have been winning approvals in recent years (e.g. Novartis’ cholesterol drug Leqvio), the regulatory agency is offering new draft guidance for those looking to follow a similar path.

The non-binding guidance, titled “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics Guidance for Industry” deals with pharmacokinetic, pharmacodynamic, and safety assessments required as part of oligonucleotide therapeutics R&D.

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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.