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

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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Vicente Anido (University of West Virginia via YouTube)

Aerie fires CEO af­ter lead pro­gram flop, com­ments about pri­ma­ry end­points be­ing 'not re­quired'

Aerie Pharmaceuticals CEO Vicente Anido has left the company less than a week after trying to chart a Phase III study in the wake of a serious Phase IIb flop.

Anido’s last day at Aerie was Friday, the biotech announced in a news release Tuesday morning, and Benjamin McGraw is taking his place in an interim role. The now former CEO was terminated without cause, according to an SEC filing.

The board has started looking for a full-time chief to take his place.

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When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a specific market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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Take­da snaps up the Japan­ese rights to an old Shire cast-off; Boehringer In­gel­heim ac­quires Abexxa Bi­o­log­ics

A week before the FDA is set to decide on Mirum Pharmaceuticals’ lead liver disease drug — an old Shire cast-off called maralixibat — Takeda is swooping in to secure the rights in Japan.

Maralixibat’s roots trace back to Lumena, which was snapped up by Shire for $260 million-plus back in 2014. While the candidate had failed mid-stage studies at Shire, Mirum believes better trial design and patient selection will deliver the wins it needs. The drug is currently in development for Alagille syndrome (a condition called ALGS in which bile builds up in the liver), progressive familial intrahepatic cholestasis (PFIC, which causes progressive liver disease) and biliary atresia (a blockage in the ducts that carry bile from the liver to the gallbladder).

Covid-19 roundup: J&J boost­er shot da­ta show promise; CD­C's ACIP meet­ing this week to dis­cuss Pfiz­er boost­ers

J&J revealed a summary of new Covid-19 vaccine data today, including new results showing booster shots may help with protection.

A Phase III study (ENSEMBLE 2) looked at booster shots at two different points in time: a second shot 56 days after the first shot, or a second shot six months after the first. The eight-week shot showed increased protection against symptomatic Covid-19, with the following levels of protection: