Mer­ck-part­nered biotech hands Roche its half-life ex­ten­sion tech as it piv­ots to im­muno-on­col­o­gy

It seems few can re­sist the rev­enue that can await a can­cer treat­ment.

Af­ter over a decade ex­tend­ing the half-life of med­i­cines for J&J, Genen­tech and oth­er large play­ers, Amu­nix is piv­ot­ing to de­vel­op el­e­ments of its plat­form in­to two ap­proach­es to im­muno-on­col­o­gy, one of which is an off-the-shelf al­ter­na­tive to CAR–T treat­ments. And they’re li­cens­ing a por­tion of the old­er tech­nol­o­gy to Roche for $40 mil­lion and $1.5 bil­lion in po­ten­tial mile­stones.

“Roche had been play­ing around with the tech for a tech as­sess­ment for quite a bit of time pri­or to my join­ing and they ob­vi­ous­ly like what they saw,” Ang­ie You, Amu­nix’s new CEO, told End­points News. 

Ang­ie You

Roche isn’t dis­clos­ing what drugs it will use on Amu­nix’s old plat­form, known as XTEN, for, but You said it will be for a “very cir­cum­scribed in­di­ca­tion and a very cir­cum­scribed tar­get.” It al­so won’t be in on­col­o­gy. The Swiss gi­ant had toyed with the half-life-ex­tend­ing plat­form for 4 or 5 years be­fore re­cent­ly giv­ing Amu­nix word they want­ed to li­cense it, You said.

Amu­nix will fun­nel that mon­ey in­to their emerg­ing im­muno-on­col­o­gy ap­proach. They first piv­ot­ed over a year ago, bring­ing in You as a new CEO and Rich Hey­man as chair­man, and soon ro­tat­ing out the rest of the C-suite.

That pe­ri­od al­so saw the biotech li­cense the new im­muno-on­col­o­gy plat­form to Mer­ck. With a sim­i­lar ap­proach to the one em­ployed by the re­cent­ly launched Were­wolf Ther­a­peu­tics, Amu­nix will try to get the body’s T cells to at­tack sol­id tu­mors with­out trig­ger­ing the tox­i­c­i­ty T cell en­gage­ment has caused in oth­er stud­ies. It takes the polypep­tide chains it once used to ex­tend half-lives and com­bines them with pro­teas­es to es­sen­tial­ly “mask” the drugs un­til they reach the tu­mor.

“We’re solv­ing the prob­lem of tox­i­c­i­ty,” You said.

Amu­nix lim­it­ed the Roche deal so it could con­tin­ue to li­cense its old­er plat­form for oth­er tar­gets and in­di­ca­tions, You said, part of an ef­fort to con­tin­ue draw­ing funds for the im­muno-on­col­o­gy ef­fort.

“We want­ed to make sure we had oth­er deals to col­lab­o­rate with big phar­ma,” she said.

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.