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.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Fangliang Zhang (Imaginechina via AP Images)

The big mon­ey: Poised to make drug R&D his­to­ry, a Chi­na biotech un­veils uni­corn rac­ing am­bi­tions in a bid to raise $350M-plus on Nas­daq

Almost exactly three years after Shanghai-based Legend came out of nowhere to steal the show at ASCO with jaw-dropping data on their BCMA-targeted CAR-T for multiple myeloma, the little player with Big Pharma connections is taking a giant step toward making it big on Wall Street. And this time they want to seal the deal on a global rep after staking out a unicorn valuation in what’s turned out to be a bull market for biotech IPOs — in the middle of a pandemic.

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Gilead re­leas­es an­oth­er round of murky remde­sivir re­sults

A month after the NIH declared the first trial on remdesivir in Covid-19 a success, Gilead is out with new results on their antiviral. But although the study met one of its primary endpoints, the data are likely to only add to a growing debate over how effective the drug actually is.

In a Phase III trial, patients given a 5-day dose of remdesivir were 65% more likely to show “clinical improvement” compared to an arm given standard-of-care. The trial, though, gave little indication for whether the drug had an impact on key endpoints such as survival or time-to-recovery. And in a surprising twist, a 10-day dosing arm of remdesivir didn’t lead to a statistically significant improvement over standard of care.

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Len Schleifer (left) and George Yancopoulos, Regeneron (Vimeo)

Eyes on he­mo­phil­ia prize, Re­gen­eron adds a $100M wa­ger on joint de­vel­op­ment cam­paign with In­tel­lia

When George Yancopoulos first signed up Intellia to be its CRISPR/Cas9 partner on gene editing projects 4 years ago, the upstart smartly ramped up its IPO at the same time. Today, Regeneron $REGN is coming back in, adding $100 million in an upfront fee and equity to significantly boot up a whole roster of new development projects.

And they’re highlighting some clinical hemophilia research plans in the process.

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Iterum's fu­ture looks un­cer­tain, af­ter lead an­tibi­ot­ic fails con­sec­u­tive piv­otal stud­ies

While the market for antibiotics remains in tatters — unlike many of its bankrupt (or at the brink of bankruptcy) peers — Iterum is suffering not because its antibiotic isn’t selling, but because the compound has now failed back-to-back late-stage studies.

The experimental drug, sulopenem, was designed to tackle drug-resistant infections with an outpatient focus (in addition to hospitals), to avert those reimbursement challenges that incentivize hospitals to prescribe cheaper, generic broad-spectrum antibiotics.

Covid-19 roundup: Did in­sid­ers cash in on pos­i­tive news re­port about Gilead be­fore pub­li­ca­tion?

A series of bullish trades on Gilead options just before the release of a favorable news story is raising questions among regulatory experts, Reuters reported.

On April 16, just hours before STAT published anecdotes from a Chicago hospital that served as one of the clinical sites to test Gilead’s remdesivir in Covid-19 patients, the California-based company’s shares were trading at around $75. Four large blocks of options were purchased for about $1.5 million each, betting that the stock would rise beyond that to as much as $87.5 by mid-August.

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IPOs abound in the time of coro­n­avirus, as For­ma Ther­a­peu­tics pen­cils in $150M Nas­daq de­but

The IPO engine is thriving, never mind the rampage of the coronavirus crisis on R&D timelines.

On Friday, along with synthetic lethality-focused biotech Repare Therapeutics, another Bristol Myers partner Forma Therapeutics also unveiled its plans to vault on to the Nasdaq — penciling in a target of $150 million.

The Watertown, Massachusetts-based company — which poached senior Genentech executive Frank Lee to take over the reins last year after more than a decade under founder Steve Tregay — raised a plump $100 million late last year, while shepherding its sickle cell disease (SCD) drug through an early-stage trial.

Jean-Jacques Bienaimé, BioMarin chairman and CEO

Bio­Marin holds the line on bleeds with 4-year val­rox up­date on he­mo­phil­ia A — but what's this about an­oth­er de­cline in Fac­tor 8 lev­els?

BioMarin has posted some top-line results for their 4-year followup on the most advanced gene therapy for hemophilia A — extending its streak on keeping a handful of patients free of bleeds and off Factor VIII therapy, but likely stirring fresh worries over a continued drop in Factor VIII levels.

We just don’t know how big a drop.

We’ll see more data when the results are presented at the World Federation of Hemophilia in a couple of weeks. But in a statement out Sunday night, BioMarin $BMRN reported that none of the patients required Factor VIII treatment, adding:

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Roche nabs front­line OK for Avastin/Tecen­triq in com­mon liv­er can­cer, best­ing an old Bay­er drug

For the first time in 12 years, the FDA has approved a new frontline treatment for the most common form of liver cancer.

The agency okayed a combination of Roche’s anti-VEGF antibody Avastin and their immunotherapy Tecentriq for patients with unresectable or metastatic hepatocellular carcinoma (HCC). The approval comes two weeks after Roche and their big biotech sub Genentech published Phase III results showing the combo improved both progression-free survival and, crucially, helped patients live longer than the long-running standard-of-care, Bayer’s Nexavar.