Pier Vincenzo Colli, Alfasigma CEO (C. Romagnoli, Alfasigma archive)

Al­fasig­ma snares EU rights to blood clot­ting an­ti­body on the hunt for pa­tients tak­ing As­traZeneca's Bril­in­ta

Two years af­ter Phase I da­ta gen­er­at­ed promise for ben­tracimab as the first drug to stop bleed­ing in pa­tients that were pre­scribed As­traZeneca’s much-hyped stroke and heart at­tack drug Bril­in­ta, Phase­Bio has li­censed it out to a Eu­ro­pean part­ner.

Phase­Bio sold Eu­ro­pean rights for the un­con­trolled bleed­ing mon­o­clon­al an­ti­body to Ital­ian biotech Al­fasig­ma. That com­pa­ny will mar­ket the drug in 49 coun­tries across Eu­rope and oth­er mar­kets, Phase­Bio said in a press re­lease.

Ben­tracimab has shown the abil­i­ty in ear­ly hu­man stud­ies to re­verse the an­tiplatelet ef­fects of Bril­in­ta, a drug from As­traZeneca that is pre­scribed to pre­vent stroke, heart at­tack and oth­er acute coro­nary syn­drome.

Phase­Bio will get $20 mil­lion up front and an­oth­er $35 mil­lion af­ter ob­tain­ing reg­u­la­to­ry ap­proval, and the deal in­cludes up to $190 mil­lion in sales mile­stones. Al­fasig­ma is re­spon­si­ble for gain­ing ap­proval from the EMA and MHRA. The pri­vate­ly owned Ital­ian com­pa­ny is known for its fo­cus­es on gas­troen­terol­o­gy and vas­cu­lar health that em­ploys around 3,000 peo­ple. It boasts sev­er­al pro­duc­tion plants and in-house R&D ca­pa­bil­i­ties.

Phase­Bio was giv­en break­through des­ig­na­tion from the FDA based off its Phase I re­sults af­ter it achieved “im­me­di­ate and sus­tained re­ver­sal,” and the com­pa­ny moved to hus­tle the drug to the mar­ket. Its Phase IIa tri­al test­ed the drug in both el­der­ly sub­jects on an an­tiplatelet ther­a­py of Bril­in­ta and as­pirin, and healthy younger sub­jects, and achieved “im­me­di­ate and sus­tained re­ver­sal of the an­ti platelet ef­fects.” There are not cur­rent­ly any ap­proved re­ver­sal agents for any an­ti platelet drugs, the com­pa­ny said in a re­lease.

Phase­Bio li­censed ben­tracimab from Med­Im­mune, the bi­o­log­ics arm of As­traZeneca, in 2017 for an up­front fee of $100,000, with $68 mil­lion in po­ten­tial mile­stones. A lit­tle over a year lat­er, Phase­Bio rode that deal to an IPO with Med­Im­mune own­ing 5% of the stock.

Ben­tricimab is cur­rent­ly in late-stage Phase III clin­i­cal de­vel­op­ment. The drug is fo­cused on the pre­ven­tion of bleed­ing, a com­mon ef­fect of Bril­in­ta in pa­tients who re­quire ur­gent surgery, life-threat­en­ing bleed­ing or in­va­sive pro­ce­dures.

Adap­tive De­sign Meth­ods Of­fer Rapid, Seam­less Tran­si­tion Be­tween Study Phas­es in Rare Can­cer Tri­als

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Matt Gline (L) and Pete Salzmann

UP­DAT­ED: Roivant bumps stake in Im­muno­vant with a $200M deal. But with M&A off the ta­ble, shares crater

Roivant has worked out a deal to pick up a chunk of stock in its majority-owned sub Immunovant $IMVT, but the stock buy falls far short of its much-discussed thoughts about buying out all of the 43% of shares it doesn’t already own.

Roivant, which recently inked a SPAC move to the market at a $7 billion-plus valuation, has forged a deal to boost its ownership in Immunovant by 6.3 points, ending with 63.8% of the biotech’s stock following a $200 million injection. That cash will bolster Immunovant’s cash reserves, giving it a $600 million war chest to fund a slate of late-stage studies for its big drug: the anti-FcRn antibody IMVT-1401.

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Sanofi preps a multi­bil­lion-dol­lar buy­out of an mR­NA pi­o­neer af­ter falling be­hind in the race for a Covid-19 jab — re­port

It looks like Sanofi CEO Paul Hudson is dead serious about his intention to vault directly into contention for the future of mRNA vaccines.

A year after paying Translate Bio a whopping $425 million in an upfront and equity payment to help guide the pharma giant to the promised land of mRNA vaccines for Covid-19, Sanofi is reportedly ready to close the deal with a buyout.

Translate’s stock $TBIO soared 78% after the market closed Monday. A spokesperson for Sanofi declined to comment on the report, telling Endpoints News that the company doesn’t comment on market rumors.

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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.

UP­DAT­ED: Watch out Glax­o­SmithK­line: As­traZeneca's once-failed lu­pus drug is now ap­proved

Capping a roller coaster journey, AstraZeneca has steered its lupus drug anifrolumab across the finish line.

Saphnelo, as the antibody will be marketed, is the only treatment that’s been approved for systemic lupus erythematosus since GlaxoSmithKline’s Benlysta clinched an OK in 2011. The British drugmaker notes it’s also the first to target the type I interferon receptor.

Mirroring the population that the drug was tested on in late-stage trials, regulators sanctioned it for patients with moderate to severe cases who are already receiving standard therapy — setting up a launch planned for the end of August, according to Ruud Dobber, who’s in charge of AstraZeneca’s biopharmaceuticals business unit.

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Ipsen con­tin­ues its shop­ping spree with a $1B-plus deal for Ex­i­cure's next-gen oligonu­cleotides

Ipsen has been on a deal-making spree the last few weeks, shelling out more than a billion dollars in two separate deals to work on a mid-stage levodopa-induced dyskinesia (LID) candidate and a preclinical BAX inhibitor in several cancers. But on Monday, the company inked its largest collaboration deal yet.

Ipsen is putting down $20 million upfront and up to $1 billion in biobucks for exclusive options to two of Exicure’s discovery-stage spherical nucleic acid (SNA) treatments for Huntington’s disease and Angelman syndrome.

Not all mR­NA vac­cines are cre­at­ed equal. Does it mat­ter?; Neu­ro is back; Pri­vate M&A af­fair; and more

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As part of our broader and deeper drive, Endpoints has been pairing webinars with our special reports to cover more angles on a given topic. In conjunction with Max Gelman’s neuroscience feature, Kyle Blankenship moderated an insightful panel to discuss where the field is headed. You can register to watch it on demand here.

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Bris­tol My­ers pulls lym­phoma in­di­ca­tion for Is­to­dax af­ter con­fir­ma­to­ry tri­al falls flat

Amid an industrywide review of cancer drugs with accelerated approval, Bristol Myers Squibb had to make the tough call last month to yank an approval for leading I/O drug Opdivo after flopping a confirmatory study. Now, a second Bristol Myers drug is on the chopping block.

Bristol Myers has pulled aging HDAC inhibitor Istodax’s indication in peripheral T cell lymphoma after a Phase III confirmatory study for the drug flopped on its progression-free survival endpoint, the drugmaker said Monday.

Rick Pazdur (via AACR)

FDA's on­col­o­gy head Rick Paz­dur de­fends the ac­cel­er­at­ed ap­proval path­way, claim­ing it is 'un­der at­tack'

The FDA is sounding the alarm over its accelerated approval pathway as backlash continues over the recent nod in favor of Biogen’s Alzheimer’s drug Aduhelm, and an ODAC meeting on six such approvals that could potentially be pulled from the market — two of which already have.

“Do you think accelerated approval is under attack? I do,” Rick Pazdur, head of FDA’s Oncology Center of Excellence, said at a Friends of Cancer Research webinar on Thursday.

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