John Oyler, BeiGene CEO (Endpoints News, PharmCube)

BeiGene dives in on nat­ur­al killer cells with dis­cov­ery pact for small biotech's stem cell-based plat­form

Chi­na’s BeiGene has been busy on the on­col­o­gy front in re­cent years, look­ing to keep up with the pack with one late-stage PD-1 on the way to a fil­ing and a slate of small deals flesh­ing out the pipeline. Now, with its eyes on the hori­zon, the drug­mak­er has snared an ear­ly-stage pact for a clutch of next-gen cell ther­a­pies.

BeiGene will shell out $45 mil­lion in cash and an undis­closed amount in fu­ture biobucks and roy­al­ties for up to four of Shore­line Bio­sciences’ in­duced pluripo­tent stem cell-based nat­ur­al killer ther­a­pies for can­cer, the part­ners said Wednes­day.

The mul­ti-year pact will ini­tial­ly tar­get four po­ten­tial ther­a­pies with the op­tion to ex­pand in fu­ture years, the com­pa­nies said. BeiGene will lead glob­al clin­i­cal de­vel­op­ment with Shore­line pick­ing up com­mer­cial-scale man­u­fac­tur­ing du­ties. In re­turn for its in­vest­ment, BeiGene will hold glob­al com­mer­cial rights to any ap­proved ther­a­py with Shore­line re­serv­ing the op­tion for US and Cana­di­an rights for two of those tar­gets.

BeiGene al­so re­served the op­tion to buy up an eq­ui­ty stake in Shore­line in the biotech’s next fi­nanc­ing round, the com­pa­ny said.

“We are ex­cit­ed to col­lab­o­rate with Shore­line as BeiGene looks to ex­pand our pipeline of trans­for­ma­tive med­i­cines from small mol­e­cule and an­ti­body ther­a­peu­tics to off-the-shelf cell ther­a­pies, a com­pelling area of re­search that has been pri­mar­i­ly out of reach for many of the world’s pa­tients,” CEO John Oyler said in a state­ment.

Shore­line spe­cial­izes in off-the-shelf ad­vanced can­cer im­munother­a­pies, in­clud­ing iP­SC NK cells and macrophages for var­i­ous tu­mors. Where the San Diego-based com­pa­ny hopes to set it­self apart in that rapid­ly grow­ing field is in man­u­fac­tur­ing, where it main­tains a “strate­gic man­u­fac­tur­ing re­la­tion­ship” with UC San Diego’s Ad­vanced Cell Ther­a­py Lab­o­ra­to­ry. The biotech is backed by a slew of big-name in­vestors, head­lined by Gilead’s Kite and Box­er Cap­i­tal.

The push in­to next-gen cell ther­a­pies comes as Chi­na’s BeiGene looks to rein­vent it­self around on­col­o­gy R&D, most no­tably in its on­go­ing race to bring its own PD-1 check­point in­hibitor tislelizum­ab to mar­ket. That drug was out-li­censed to No­var­tis in Feb­ru­ary, bring­ing a Big Phar­ma part­ner on board amid late-stage read­outs.

In May, the part­ners read out topline re­sults show­ing the drug met its pri­ma­ry end­point of pro­gres­sion-free sur­vival in first-line re­cur­rent or metasta­t­ic na­sopha­ryn­geal can­cer as a com­bi­na­tion with chemo. The drug topped chemother­a­py alone at a sta­tis­ti­cal­ly sig­nif­i­cant rate, BeiGene said, po­ten­tial­ly set­ting up a Chi­nese ap­proval in the in­di­ca­tion.

Mean­while, de­spite its stat­ed in­tent to ex­pand be­yond an­ti­bod­ies, BeiGene has looked to grow in that space as well. In Feb­ru­ary, the com­pa­ny signed off on a $120 mil­lion-plus deal with Boston Im­mune Tech­nolo­gies and Ther­a­peu­tics to de­vel­op and com­mer­cial­ize their tu­mor necro­sis fac­tor re­cep­tor 2 (TN­FR2) an­tag­o­nist an­ti­bod­ies in Asia (ex­clud­ing Japan), Aus­tralia and New Zealand. That move was all part of BeiGene’s play to take more shots on goal to build its on­col­o­gy brand, SVP of ex­ter­nal in­no­va­tions Lu­song Luo told End­points News at the time.

“The com­mon de­nom­i­na­tor is we are try­ing to bring ex­ter­nal in­no­va­tions in, and al­so bring our in­no­va­tions out to oth­er ge­o­graph­i­cal re­gions,” Luo said.

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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