Zai Lab finds lat­est tar­get in Re­gen­eron’s bis­pe­cif­ic, pay­ing up to $190M for Chi­nese rights

Nine months af­ter hint­ing they might have bis­pe­cif­ic an­ti­bod­ies in the works, Shang­hai-based Zai Lab has signed on to help com­mer­cial­ize one of biotech’s most promis­ing can­di­dates.

Zai Lab and Re­gen­eron have signed a deal to de­vel­op and com­mer­cial­ize REGN1979, their CD20XCD3 bis­pe­cif­ic now be­ing test­ed in a range of blood can­cers, in main­land Chi­na, Hong Kong, Tai­wan and Macau. Zai Lab will pay Re­gen­eron $30 mil­lion and up to $160 mil­lion in de­vel­op­men­tal and sales mile­stones.

The deal rep­re­sents the promi­nent Chi­nese biotech’s first for­ay in­to the in­creas­ing­ly heat­ed race to de­vel­op bis­pe­cif­ic an­ti­bod­ies — mol­e­cules that grab im­mune cells and a tu­mor to smash them to­geth­er — as a next step in im­munother­a­py.

REGN1979 made a huge splash at the Amer­i­can So­ci­ety for Hema­tol­ogy meet­ing two years ago, when the New York biotech an­nounced that its Phase I proof-of-con­cept study had led to a 100% re­sponse rate and an 80% com­plete re­sponse rate across 10 pa­tients with re­lapsed or re­frac­to­ry B-cell non-Hodgkin’s lym­phoma. Sub­se­quent re­sults have mud­died the pic­ture — in­clud­ing with the rev­e­la­tion last year that in one tri­al, two pa­tients died from from cy­tokine re­lease syn­drome — but broad­ly point­ed to an im­munother­a­py that could be ef­fec­tive in sev­er­al blood can­cers, and even shows ac­tiv­i­ty in pa­tients whose can­cers pro­gressed af­ter CAR-T ther­a­py.

The lat­est da­ta, un­veiled at ASH’s Eu­ro­pean ri­val last June, showed 13 re­spons­es and 10 com­plete re­spons­es in 14 pa­tients with fol­lic­u­lar lym­phoma and 4 re­spons­es out of 7 pa­tients with dif­fuse large b-cell lym­phoma, al­though all 4 were com­plete re­spons­es.

“The fol­lic­u­lar lym­phoma da­ta don’t look as stel­lar as the pri­or da­ta cut but the DL­B­CL da­ta im­prove,” Baird’s Bri­an Sko­r­ney wrote in re­sponse to the June da­ta. “We think this bis­pe­cif­ic pro­gram looks like a strong next-gen B-cell lym­phoma ther­a­py that could yield a fair­ly sig­nif­i­cant mar­ket op­por­tu­ni­ty.”

Zai Lab has made a near­ly $4 bil­lion biotech in large part by in-li­cens­ing the right ex­per­i­men­tal drugs from top Amer­i­can biotechs. They grabbed Chi­nese rights for ni­ra­parib from Tesaro months be­fore its US ap­proval, and last June signed on to a De­ci­phera ki­nase in­hibitor for sol­id tu­mors, be­fore get­ting rights to an In­cyte PD-1 the fol­low­ing month.

They’re plan­ning to test the lat­ter in sev­er­al new com­bi­na­tions, in­clud­ing with mar­ge­tux­imab, a HER2-tar­get­ing drug li­censed from Macro­gen­ics.

Re­gen­eron has of­fered lit­tle time­line for fil­ing with the FDA, but 2020 was shap­ing up to be a big year for bis­pe­cif­ic an­ti­bod­ies. Am­gen and Bris­tol My­ers Squibb have each post­ed promis­ing ear­ly batch­es, and ap­peared like­ly to give fur­ther up­dates. Al­ready, in March, Astel­las promised Cy­tomx up to $1.6 bil­lion in a deal cen­tered large­ly around bis­pe­cif­ic an­ti­bod­ies.

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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Alan Hirzel, Abcam

Drug sup­pli­er Ab­cam brings a long­time col­lab­o­ra­tor in house as part of $340M buy­out pact

BioVision has supplied Abcam with research tools since 1999, and now the two are making it official as part of a merger unveiled Monday.

Abcam will buyout BioVision as part of a $340 million acquisition deal to bring aboard the supplier’s biochemical and cell-based assays for biological research, as well as recombinant proteins, antibodies and enzymes.

The deal will give Abcam control of BioVision’s portfolio and allow for both the expansion of research existing areas of focus such as oncology, neuroscience and epigenetics and preparation to expand into new products. As a part of the deal, Abcam will develop and supply products and services to NKY, the previous owner of BioVision and receive support for ongoing development and commercialization of in vitro diagnostic products.

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.

Tib­so­vo clears an­oth­er hur­dle for Servi­er, but can it make Agios' old drug prof­itable?

When European regulators saw the data Agios used to win US approval for their AML drug Tibsovo, they sent the more than decade-old biotech back to the drawing board. A single, single-armed trial was not going to cut it.

On Monday, though, the drug’s new owners announced it had cleared a more rigorous study. In a randomized, Phase III trial of certain newly diagnosed patients, those who received a combination of Tibsovo and chemotherapy lived longer than those who received a combination of placebo and chemotherapy. Those patients also had higher response rates and complete remission rates.

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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