Chi­nese play­er joins a grow­ing group of biotechs buy­ing in­to Synaf­fix's ADC link­er tech

In de­vel­op­ing any an­ti­body-drug con­ju­gate, the link­er — the hy­phen be­tween the anti­gen-bind­ing an­ti­body and the can­cer-killing drug — is of ut­most im­por­tance. Link too much pay­load to the an­ti­body too loose­ly, and you risk trig­ger­ing off-site tox­i­c­i­ty while the ADC is cir­cu­lat­ing through blood; link too lit­tle, and it falls short of the goal to kill off can­cer cells from with­in. And while a host of drug­mak­ers have fol­lowed Seat­tle Ge­net­ics’ lead in­to new link­er tech­nol­o­gy, in some cas­es de­ploy­ing en­gi­neer­ing the an­ti­bod­ies, there’s still much to be learned about con­trol­ling the re­sult­ing AD­Cs.

Dutch biotech Synaf­fix be­lieves it has the tools to do pre­cise­ly that. Judg­ing from a $125 mil­lion li­cens­ing pact it just signed off on, Chi­na’s Miraco­gen does, too.

An­tho­ny De­Boer

“The first gen­er­a­tion of AD­Cs in the Chi­nese mar­ket were pre­dom­i­nant­ly biosim­i­lars or bio­bet­ters of Kad­cy­la,” Synaf­fix CEO Pe­ter van de Sande told me. But reg­u­la­to­ry re­forms have im­posed “pres­sure on more first-in-class and best-in-class prod­ucts in Chi­na that is dri­ving in­no­va­tion and dri­ving a need for in­creased ther­a­peu­tic in­dex” — the com­bined mea­sure of ef­fi­ca­cy and safe­ty.

Synaf­fix first got start­ed five months ago, tak­ing an an­ti­body from Miraco­gen and putting it through its two plat­forms, re­sult­ing in a pro­to­type ADC with­in a month. Hav­ing test­ed the can­di­date in pre­clin­i­cal mod­els, the Chi­nese part­ner is now ready to go for clin­i­cal tri­als — thus the need for a de­vel­op­ment and com­mer­cial li­cense, said An­tho­ny De­Boer, Synaf­fix’s di­rec­tor of busi­ness de­vel­op­ment.

Com­ing out of Rad­boud Uni­ver­si­ty, the Gly­co­Con­nect tech­nol­o­gy re­lies on gly­cans as an an­chor­ing point in an­ti­bod­ies, en­zy­mat­i­cal­ly re­mov­ing them to cre­ate space for the pay­load, which is at­tached through cop­per-free click chem­istry. Hy­dra­Space, mean­while, is Synaf­fix’s way of ex­tend­ing their AD­Cs’ half lives.

These are tech­nolo­gies that ADC Ther­a­peu­tics and Mer­sana have pre­vi­ous­ly bought in­to, van de Sande said, al­low­ing the com­pa­ny to re­fine the man­u­fac­tur­ing process­es for the en­zymes and small mol­e­cules in­volved in the process.

The part­ner­ship with Miraco­gen marks Synaf­fix’s first in­roads in­to Asia, added to key en­dorse­ments from some ADC ex­perts. Mary Hu, Miraco­gen’s CEO, was a for­mer ex­ec at Seat­tle Ge­net­ics along­side one of her VPs.

Synaf­fix does not yet have a pipeline of its own, but van de Sande is look­ing for more part­ner­ships — not just in the ADC field but for oth­er modal­i­ties such as cell ther­a­py and ra­dio­phar­ma­ceu­ti­cals as its tech is “per­fect­ly catered for in­cor­po­rat­ing any mol­e­cules of in­ter­est to a gly­can pro­tein in an an­ti­body” for tar­get­ed de­liv­ery.

Im­age: Pe­ter van de Sande. SYNAF­FIX

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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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.

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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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).

Fol­low­ing CAR-T pi­o­neer­s' foot­steps, Tes­sa launch­es Chi­na JV in $120M deal

These days just about every biotech se­ri­ous about glob­al de­vel­op­ment — and not just com­mer­cial­iza­tion — has a Chi­na strat­e­gy. Tes­sa Ther­a­peu­tics, a Bay­lor as­so­ci­at­ed out­fit based out of Sin­ga­pore, is no ex­cep­tion.

Tak­ing a page out of the CAR-T pi­o­neers’ play­book, Tes­sa is es­tab­lish­ing a joint ven­ture with Chi­na-Sin­ga­pore Guangzhou Knowl­edge City, which is ini­tial­ly putting down $40 mil­lion for a 13% stake with $40 mil­lion more to come in a sec­ond stage. The biotech, which now re­tains an 87% con­trol, is al­so rolling out its own con­tri­bu­tions in two phas­es, start­ing with $20 mil­lion and all its tech­nol­o­gy li­cense rights for Chi­na.

Neil Woodford, Woodford Investment Management via YouTube

Un­der siege, in­vest­ment man­ag­er Wood­ford faces an­oth­er in­vest­ment shock

Em­bat­tled UK fund man­ag­er Neil Wood­ford — who has con­tro­ver­sial­ly blocked in­vestors from pulling out from his flag­ship fund to stem the blood­let­ting, af­ter a slew of dis­ap­point­ed in­vestors fled fol­low­ing a se­ries of sour bets — is now pay­ing the price for his ac­tions via an in­vestor ex­o­dus on an­oth­er fund.

Har­g­reaves Lans­down, which has in the past sold and pro­mot­ed the Wood­ford funds via its re­tail in­vest­ment plat­form, has re­port­ed­ly with­drawn £45 mil­lion — its en­tire po­si­tion — from the in­vest­ment man­ag­er’s In­come Fo­cus Fund.

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.

An in­censed Cat­a­lyst Phar­ma sues the FDA, ac­cus­ing agency of bow­ing to po­lit­i­cal pres­sure and break­ing fed­er­al law

Af­ter hint­ing it was ex­plor­ing the le­gal­i­ty of the FDA’s ap­proval of a ri­val drug from fam­i­ly-run com­pa­ny Ja­cobus Phar­ma­ceu­ti­cals, Cat­a­lyst Phar­ma­ceu­ti­cals on Wednes­day filed a law­suit against the health reg­u­la­tor — ef­fec­tive­ly ac­cus­ing the agency of bow­ing to po­lit­i­cal pres­sure sur­round­ing sky­rock­et­ing drug prices.

Be­fore Cat­a­lyst’s Fir­dapse (which car­ries an av­er­age an­nu­al list price of $375,000) was sanc­tioned for use in Lam­bert-Eaton myas­thenic syn­drome (LEMS) by the FDA, hun­dreds of pa­tients had been able to ac­cess a sim­i­lar drug from com­pound­ing phar­ma­cies for a frac­tion of the cost, or Ja­cobus’ for free, as part of an FDA-rat­i­fied com­pas­sion­ate use pro­gram. But the ap­proval of the Cat­a­lyst drug — ac­com­pa­nied by mar­ket ex­clu­siv­i­ty span­ning sev­en years — ef­fec­tive­ly pre­clud­ed Ja­cobus and com­pound­ing phar­ma­cies from sell­ing their ver­sions.