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

Sanofi brings in 4 new ex­ec­u­tives in con­tin­ued shake-up, as vac­cines and con­sumer health chief head out the door

In the middle of Sanofi’s multi-pronged race to develop a Covid-19 vaccine, David Loew, the head of their sprawling vaccines unit, is leaving – part of the final flurry of moves in the French giant’ months-long corporate shuffle that will give them new-look leadership under new CEO Paul Hudson.

The company also said today that Alan Main, the head of their consumer healthcare unit, is out, and they named 4 executives to fill new or newly vacated positions, 3 of whom come from both outside both Sanofi and from Pharma.

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Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

Cap­i­tal­iz­ing Pablo: The world’s biggest drug roy­al­ty buy­er is go­ing pub­lic. And the low-key CEO di­vulges a few se­crets along the way

Pablo Legorreta is one of the most influential players in biopharma you likely never heard of.

Over the last 24 years, Legorreta’s Royalty Pharma group has become, by its own reckoning, the biggest buyer of drug royalties in the world. The CEO and founder has bought up a stake in a lengthy list of the world’s biggest drug franchises, spending $18 billion in the process — $2.2 billion last year alone. And he’s become one of the best-paid execs in the industry, reaping $28 million from the cash flow last year while reserving 20% of the cash flow, less expenses, for himself.

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As­traZeneca trum­pets the 'mo­men­tous' da­ta they found for Tagris­so in an ad­ju­vant set­ting for NSCLC — but many of the ex­perts aren’t cheer­ing along

AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

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Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: Gilead leas­es part­ner rights to TIG­IT, PD-1 in a $2B deal with Ar­cus. Now comes the hard part

Gilead CEO Dan O’Day has brokered his way to a PD-1 and lined up a front row seat in the TIGIT arena, inking a deal worth close to $2 billion to align the big biotech closely with Terry Rosen’s Arcus. And $375 million of that comes upfront, with cash for the buy-in plus equity, along with $400 million for R&D and $1.22 billion in reserve to cover opt-in payments and milestones..

Hotly rumored for weeks, the 2 players have formalized a 10-year alliance that starts with rights to the PD-1, zimberelimab. O’Day also has first dibs on TIGIT and 2 other leading programs, agreeing to an opt-in fee ranging from $200 million to $275 million on each. There’s $500 million in potential TIGIT milestones on US regulatory events — likely capped by an approval — if Gilead partners on it and the stars align on the data. And there’s another $150 million opt-in payments for the rest of the Arcus pipeline.

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Paul Hudson, Sanofi CEO (Getty Images)

Sanofi CEO Paul Hud­son has $23B burn­ing a hole in his pock­et. And here are some hints on how he plans to spend that

Sanofi has reaped $11.1 billion after selling off a big chunk of its Regeneron stock at $515 a share. And now everyone on the M&A side of the business is focused on how CEO Paul Hudson plans to spend it.

After getting stung in France for some awkward politicking — suggesting the US was in the front of the line for Sanofi’s vaccines given American financial support for their work, versus little help from European powers — Hudson now has the much more popular task of managing a major cash cache to pull off something in the order of a big bolt-on. Or two.

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Ab­b­Vie wins an ap­proval in uter­ine fi­broid-as­so­ci­at­ed heavy bleed­ing. Are ri­vals My­ovant and Ob­sE­va far be­hind?

Women expel on average about 2 to 3 tablespoons of blood during their time of the month. But with uterine fibroids, heavy bleeding is typical — a third of a cup or more. Drugmakers have been working on oral therapies to try and stem the flow, and as expected, AbbVie and their partners at Neurocrine Biosciences are the first to make it across the finish line.

Known chemically as elagolix, the drug is already approved as a treatment for endometriosis under the brand name Orilissa. It targets the GnRH receptor to decrease the production of estrogen and progesterone.

As tislelizum­ab gains trac­tion in Chi­na, BeiGene pulls the cur­tain on NSCLC da­ta sup­port­ing the PD-1 drug

In a world now brimming with checkpoint inhibitors, companies often struggle to make a mark given a raft of therapies have already captured a considerable portion of the vast oncology market.

BeiGene’s tislelizumab was the fourth PD(L)-1 inhibitor to secure approval in China — and as it works on expanding its share the company has put out detailed data on the use of the drug in certain patients with lung cancer.

David Chang, Allogene CEO (Jeff Rumans)

Head­ed to PhII: Al­lo­gene CEO David Chang com­pletes a pos­i­tive ear­ly snap­shot of their off-the-shelf CAR-T pi­o­neer

Allogene CEO David Chang has completed the upbeat first portrait of the biotech’s off-the-shelf CAR-T contender ALLO-501 at virtual ASCO today, keeping all eyes on a drug that will now try to go on to replace the first-wave personalized pioneers he helped create.

The overall response rate outlined in Allogene’s abstract for treatment-resistant patients with non-Hodgkin lymphoma slipped a little from the leadup, but if you narrow the patient profile to treatment-naïve patients — removing the 3 who had previous CAR-T therapy who didn’t respond, leaving 16 — the ORR lands at 75% with a 44% complete response rate. And 9 of the 12 responders remained in response at the data cutoff, offering a glimpse on durability that still has a long way to go before it can be completely nailed down.

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Pfiz­er, Mer­ck KGaA ce­ment Baven­cio blad­der can­cer win with OS da­ta — while carv­ing an­oth­er niche in rare can­cer

Pfizer and Merck KGaA have detailed the Phase III data that inspired FDA regulators to designate Bavencio a “breakthrough” for first-line advanced bladder cancer and offered an early glance at how the PD-L1 can help patients with a rare gynecological cancer — carving out niches in the checkpoint space for itself after being shut out of numerous others.

In JAVELIN Bladder 100, Bavencio led to a 31% reduction in risk of death compared to standard care alone. It also extended median survival by more than seven months — a historic feat in this setting, according to investigators at Queen Mary University of London.