Anthony DeBoer, Synaffix VP of business development

Synaf­fix ex­pands ADC deal from 2022 with Macro­Gen­ics

The Dutch biotech Synaf­fix, which has been ac­tive in the deal space out of the gate in 2023, is build­ing on a deal it made with Macro­Gen­ics last year.

Synaf­fix an­nounced Tues­day it has ex­pand­ed an agree­ment with the biotech Macro­Gen­ics to li­cense out its an­ti­body con­ju­ga­tion plat­form, called Gly­co­Con­nect, along with oth­er pieces of Synaf­fix’s tech­nol­o­gy. The deal is de­signed to cre­ate sev­er­al ADC pro­grams. Both com­pa­nies inked the first in Feb­ru­ary 2022, which net­ted Synaf­fix $586 mil­lion in up­front and mile­stone pay­ments, with three pro­grams be­ing de­vel­oped. Synaf­fix is el­i­gi­ble for roy­al­ties on com­mer­cial sales.

The ex­pan­sion will now see Synaf­fix re­ceive a pos­si­ble $2.2 bil­lion, plus tiered roy­al­ties in the low to high sin­gle-dig­it range for pos­si­ble net sales on the prod­ucts. The ex­pand­ed deal will al­so al­low Macro­Gen­ics to have sev­en to­tal pro­grams, in­clud­ing the three from the orig­i­nal deal. How­ev­er, no de­tails on the time­line for the re­lease of ADC prod­ucts were im­me­di­ate­ly avail­able.

An­tho­ny De­Boer, the vice pres­i­dent of busi­ness de­vel­op­ment at Synaf­fix, told End­points News in an email that the deal was ex­pand­ed be­cause the part­ners want­ed to de­vel­op a larg­er num­ber of ADC prod­uct can­di­dates.

“The teams and tech­nolo­gies of both com­pa­nies work seam­less­ly to­geth­er and we want­ed to build on that mo­men­tum and broad­en our re­la­tion­ship,” De­Boer wrote. He al­so added no fur­ther ex­pan­sions of the deal are on the books for now.

Ac­cord­ing to a re­lease, there are now 13 com­pa­nies that are de­vel­op­ing more than 20 AD­Cs us­ing Synaf­fix tech­nol­o­gy, with five pro­grams hav­ing start­ed clin­i­cal de­vel­op­ment.

The news has al­so giv­en Macro­Gen­ics a small bump in its stock price $MGNX by 2% since open­ing on Tues­day.

Ezio Bon­vi­ni

“Macro­Gen­ics con­tin­ues to be ex­cit­ed about the promise of Synaf­fix’s nov­el drug-link­er tech­nol­o­gy that can help ad­vance mul­ti­ple po­ten­tial first and best-in-class AD­Cs for the treat­ment of can­cer,” Macro­Gen­ics chief sci­en­tif­ic of­fi­cer Ezio Bon­vi­ni said in a re­lease.

Synaf­fix has been busy on the deal front so far this year. In Jan­u­ary, the biotech struck a deal with Am­gen to de­vel­op new AD­Cs, with the phar­ma start­ing with one ADC pro­gram and promis­ing Synaf­fix up to $2 bil­lion if it opt­ed in­to four oth­ers.

Sin­ga­pore’s Hum­ming­bird Bio­science al­so en­tered in­to a li­cens­ing agree­ment with Synaf­fix at the be­gin­ning of this year, with the biotech el­i­gi­ble for up to $150 mil­lion, in­clud­ing an up­front and mile­stone pay­ment plus roy­al­ties on net sales. Hum­ming­bird ob­tained the rights to use Synaf­fix’s ADC tech­nolo­gies.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

Editor’s note: This is a live story and will be updated.

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

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See­los Ther­a­peu­tics 'tem­porar­i­ly' stops study in rare neu­ro dis­or­der for busi­ness rea­sons

Microcap biotech Seelos Therapeutics is halting enrollment of its study in spinocerebellar ataxia type 3 (also known as Machado-Joseph disease) because of “financial considerations,” and in order to focus on other studies, the company said today, adding that the pause would be temporary.

The study will continue with the patients who have already enrolled, and the data from them will be used to decide whether to continue enrolling others in the future.

Alec­tor cuts 11% of work­force as it dou­bles down on late-stage neu­ro pro­grams part­nered with GSK, Ab­b­Vie

A month after revealing plans to concentrate on its late-stage immuno-neurology pipeline, Alector is trimming its headcount by 11%.

The layoffs will impact around 30 employees across the organization, the company disclosed in an SEC filing, adding that the plan will “better align the company’s resources” with the new strategy. With $712.9 million in cash, cash equivalents and investments as of the end of 2022, Alector believes the reserves will now get it through 2025.

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Hugo Peris, Spiral Therapeutics CEO

Hear­ing-fo­cused biotech grabs trio of pro­grams from Oton­o­my's fire sale

Otonomy may be shutting down, but the lessons learned there will live on at another biotech working on new treatments for hearing loss.

San Francisco-based Spiral Therapeutics has bought certain assets related to three of Otonomy’s programs, ranging from data, patent rights, and know-how to inventory. That includes data around Otonomy’s twice-failed lead program, OTO-104 (Otividex), a sustained-exposure formulation of dexamethasone.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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J&J bows out of RSV vac­cine race, end­ing PhI­II study and ced­ing to Pfiz­er, GSK

Johnson & Johnson announced Wednesday morning it is ending development of its adult RSV vaccine that was in the middle of a 27,200-patient trial, giving up a big slice of what’s expected to be the next multibillion-dollar pharma market.

The decision came down to the shifting RSV “competitive landscape,” a company spokesperson tells Endpoints News, adding the “breadth of options” was much different than when J&J first started its pivotal study. The spokesperson declined to comment on the Phase III data, saying only the shot is undergoing an “ongoing assessment.”

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No longer ‘dead or just hi­ber­nat­ing,’ drug­mak­ers re­turn to heart med­i­cines

In 2015, now-FDA Commissioner Robert Califf joined industry, academic and regulatory representatives in Washington to discuss why more drugs weren’t in development for cardiovascular diseases, the leading US cause of death and once a mainstay of pharmaceutical industry blockbusters.

The group pointed to many reasons. Clinical trials could take years and testing was expensive. Wide availability of generic drugs made the commercial prospects uncertain. Their paper title summed up the mood: “Cardiovascular Drug Development: Is it Dead or Just Hibernating?”

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