Strug­gling On­colyt­ics Biotech signs $86.6M Asia deal with Chi­na's Ad­lai Nortye

Cal­gary, Cana­da-based On­colyt­ics Biotech has struck an $86.6 mil­lion li­cens­ing deal with Chi­na’s Ad­lai Nortye for its IV im­muno-on­colyt­ic virus. Pay­ing $5.3 mil­lion up­front with the prospect of an­oth­er $16 mil­lion in short-term cash avail­able, Ad­lai gained de­vel­op­ment and com­mer­cial­iza­tion rights to Re­olysin (pelare­o­rep) in Chi­na, Hong Kong, Macau, Sin­ga­pore, South Ko­rea and Tai­wan.

The Hangzhou-based bio­phar­ma agreed to two po­ten­tial­ly quick pay­outs, with $8 mil­lion for eq­ui­ty and then an­oth­er $7.9 mil­lion if On­colyt­ics can hit its marks on cer­tain reg­u­la­to­ry ad­vance­ments. Up­on achieve­ment of the full slate of clin­i­cal, reg­u­la­to­ry and com­mer­cial­iza­tion mile­stones, On­colyt­ics can re­ceive up to an ad­di­tion­al $65.4 mil­lion.

Matt Cof­fey

On­colyt­ics $ON­CYF could use the cash. Its share price soured bad­ly over the past few years on mixed da­ta for its lead drug, with the stock falling in­to pen­ny stock ter­ri­to­ry — which forced a shift to the OTC mar­ket. The found­ing CEO left a year ago and in its most re­cent quar­ter­ly re­port On­colyt­ics re­port­ed that it had $14 mil­lion in cash on hand. Co-founder Matt Cof­fey is now in charge.

More re­cent­ly re­searchers have been up­beat about Re­olysin da­ta, but the strug­gling is far from over.

Li­cens­ing deals for the Chi­na mar­ket have pro­lif­er­at­ed in the past cou­ple years. While some big phar­ma com­pa­nies are start­ing to pull out or low­er ex­pec­ta­tions, oth­er bio­phar­mas are pil­ing in, look­ing to Chi­na’s enor­mous mar­ket in hopes of ex­pand­ing their sales.

That said, this par­tic­u­lar deal ap­pears to be a first for both com­pa­nies. Re­olysin, an en­gi­neered virus de­signed to trig­ger in­nate and adap­tive im­mune re­spons­es, will be Ad­lai’s first late-stage drug (with six oth­ers in the pipeline, some li­censed from with­in Chi­na).

“Giv­en its po­ten­tial in mul­ti­ple on­co­log­i­cal in­di­ca­tions and its abil­i­ty to be used in com­bi­na­tion with mul­ti­ple chemother­a­pies and im­munother­a­pies, Re­olysin will help to broad­en fu­ture ther­a­pies made avail­able by Ad­lai Nortye and ad­vance us to­wards com­mer­cial­iza­tion,” CEO Carsten Lu said in a state­ment.

For On­colyt­ics, which places all its hopes in this sole prod­uct, this is hope­ful­ly just the be­gin­ning.

Fol­low­ing an FDA fast track des­ig­na­tion in May and a re­cent meet­ing with the reg­u­la­tor, On­colyt­ics has hur­ried up to find part­ners in oth­er re­gions such as Eu­rope or Japan. The plan is to start a 400-pa­tient PhI­II study fo­cused on 400 paHR+/HER2- metasta­t­ic breast can­cer. If the EMA hands down its for­mal guid­ance by the end of the year as ex­pect­ed, the com­pa­ny will be­gin en­rolling pa­tients in mid-2018 — thanks in part to the mon­ey gained in this re­gion­al agree­ment with Ad­lai.

Nick Leschly via Getty

UP­DAT­ED: Blue­bird shares sink as an­a­lysts puz­zle out $1.8M stick­er shock and an un­ex­pect­ed de­lay

Blue­bird bio $BLUE has un­veiled its price for the new­ly ap­proved gene ther­a­py Zyn­te­glo (Lenti­Glo­bin), which came as a big sur­prise. And it wasn’t the on­ly un­ex­pect­ed twist in to­day’s sto­ry.

With some an­a­lysts bet­ting on a $900,000 price for the β-tha­lassemia treat­ment in Eu­rope, where reg­u­la­tors pro­vid­ed a con­di­tion­al ear­ly OK, blue­bird CEO Nick Leschly said Fri­day morn­ing that the pa­tients who are suc­cess­ful­ly treat­ed with their drug over 5 years will be charged twice that — $1.8 mil­lion — on the con­ti­nent. That makes this drug the sec­ond most ex­pen­sive ther­a­py on the plan­et, just be­hind No­var­tis’ new­ly ap­proved Zol­gens­ma at $2.1 mil­lion, with an­a­lysts still wait­ing to see what kind of pre­mi­um can be had in the US.


Glob­al Blood Ther­a­peu­tics poised to sub­mit ap­pli­ca­tion for ac­cel­er­at­ed ap­proval, with new piv­otal da­ta on its sick­le cell dis­ease drug

Global Blood Therapeutics is set to submit an application for accelerated approval in the second-half of this year, after unveiling fresh data from a late-stage trial that showed just over half the patients given the highest dose of its experimental sickle cell disease drug experienced a statistically significant improvement in oxygen-wielding hemoglobin, meeting the study's main goal.

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Gene ther­a­pies seize the top of the list of the most ex­pen­sive drugs on the plan­et — and that trend has just be­gun

Anyone looking for a few simple reasons why the gene therapy field has caught fire with the pharma giants need only look at the new list of the 10 most expensive therapies from GoodRx.

Two recently approved gene therapies sit atop this list, with Novartis’ Zolgensma crowned the king of the priciest drugs at $2.1 million. Right below is Luxturna, the $850,000 pioneer from Spark, which Roche is pushing hard to acquire as it adds a gene therapy group to the global mix.

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News­mak­ers at #EHA19: Re­gen­eron, Ar­Qule track progress on re­sponse rates

Re­gen­eron’s close­ly-watched bis­pe­cif­ic con­tin­ues to ring up high re­sponse rates

Re­gen­eron’s high-pro­file bis­pe­cif­ic REGN1979 is back in the spot­light at the Eu­ro­pean Hema­tol­ogy As­so­ci­a­tion sci­en­tif­ic con­fab. And while the stel­lar num­bers we saw at ASH have erod­ed some­what as more blood can­cer pa­tients are eval­u­at­ed, the re­sponse rates for this CD3/CD20 drug re­main high.

A to­tal of 13 out of 14 fol­lic­u­lar lym­phomas re­spond­ed to the drug, a 93% ORR, down from 100% at the last read­out. In 10 out of 14, there was a com­plete re­sponse. In dif­fuse large B-cell lym­phoma the re­sponse rate was 57% among pa­tients treat­ed at the 80 mg to 160 mg dose range. They were all com­plete re­spons­es. And 2 of these Cars were for pa­tients who had failed CAR-T ther­a­py.

Search­ing for the next block­buster to fol­low Darza­lex, J&J finds a $150M an­ti-CD38 drug from part­ner Gen­mab

Now that J&J and Genmab have thrust Darzalex onto the regulatory orbit for first-line use in multiple myeloma, the partners are lining up a deal for a next-gen follow-on to the leading CD38 drug.

Janssen — J&J’s biotech unit — has its eyes on HexaBody-CD38, a preclinical compound generated on Genmab’s tech platform designed to make drugs more potent via hexamerization.

Genmab is footing the bill on studies in multiple myeloma and diffuse large B-cell lymphoma; once it completes clinical proof of concept, Janssen has the option to license the drug for a $150 million exercise fee. There’s also $125 million worth of milestones in play.

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J&J gains an en­thu­si­as­tic en­dorse­ment from Pres­i­dent Don­ald Trump for their big new drug Spra­va­to

Pres­i­dent Don­ald Trump has lit­tle love for Big Phar­ma, but there’s at least one new drug that just hit the mar­ket which he is en­am­ored with.

Trump, ev­i­dent­ly, has been read­ing up on J&J’s new an­ti-de­pres­sion drug, Spra­va­to. And the pres­i­dent — who of­ten likes to break out in­to a full-throat­ed at­tack on greedy drug­mak­ers — ap­par­ent­ly en­thused about the ther­a­py in a meet­ing with of­fi­cials of Vet­er­ans Af­fairs, which has long grap­pled with de­pres­sion among vet­er­ans.

Savara shares are crushed as PhI­II tri­al flunks pri­ma­ry, key sec­on­daries — but they can’t stop be­liev­ing

In­vestors are in no mood to hear biotechs tout the suc­cess of a “key” sec­ondary end­point when the piv­otal Phase III flunks the pri­ma­ry goal. Just ask Savara. 

The Texas biotech $SVRA went look­ing for a sil­ver lin­ing as com­pa­ny ex­ecs blunt­ly con­ced­ed that Mol­gradex, an in­haled for­mu­la­tion of re­com­bi­nant hu­man gran­u­lo­cyte-macrophage colony-stim­u­lat­ing fac­tor (GM-CSF), failed to spur sig­nif­i­cant­ly im­proved treat­ment out­comes for pa­tients with a rare res­pi­ra­to­ry dis­ease called au­toim­mune pul­monary alve­o­lar pro­teinosis, or aPAP.

As an­oth­er an­tibi­otics biotech sinks in­to a cri­sis, warn­ings of a sec­tor ‘col­lapse’

Another antibiotics company is scrambling to survive today, forcing the company’s founding CEO to exit in a reorganization that eliminates its research capabilities as the survivors look to improve on minuscule sales of their newly approved treatment. And the news — on top of an alarming series of failures — spurred at least one figure in the field to warn of a looming collapse of the antimicrobial resistance research field.

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In a boost to Rit­ux­an fran­chise, Roche nabs quick ap­proval for po­latuzum­ab ve­dotin

Roche’s lat­est an­ti­body-drug con­ju­gate has crossed the FDA fin­ish line, gain­ing an ac­cel­er­at­ed ap­proval a full two months ahead of sched­ule.

Po­livy, or po­latuzum­ab ve­dotin, is a first-in-class drug tar­get­ing CD79b — a pro­tein promi­nent in B-cell non-Hodgkin lym­phoma. It will now be mar­ket­ed for dif­fuse large B-cell lym­phoma as part of a reg­i­men that al­so in­cludes the chemother­a­py ben­damus­tine and a ver­sion of rit­ux­imab (Rit­ux­an).