Hummingbird Bioscience CEO Piers Ingram (L) and Synaffix CEO Peter van de Sande

Hum­ming­bird and Synaf­fix agree to an­ti­body-drug con­ju­gate deal worth up to $150M

The Dutch biotech Synaf­fix has been ac­tive on the deal front for the past few years. And it’s not show­ing signs of stop­ping, hit­ting the ground run­ning in 2023 by ink­ing a deal with Sin­ga­pore’s Hum­ming­bird Bio­science.

In an an­nounce­ment Mon­day, Hum­ming­bird and the an­ti­body-drug con­ju­gate biotech said they will en­ter in­to a li­cens­ing agree­ment, open­ing the door for Hum­ming­bird to de­vel­op an ADC pro­gram us­ing Synaf­fix’s tech­nol­o­gy.

Synaf­fix will be el­i­gi­ble for up to $150 mil­lion, which in­cludes both an up­front and mile­stone pay­ment plus roy­al­ties on net sales. Hum­ming­bird, mean­while, will get the rights to use Synaf­fix’s ADC tech­nolo­gies, one of which us­es gly­cans as an an­chor­ing point in an­ti­bod­ies while the oth­er ex­tends the drugs’ half-lives. The biotech the­o­rizes they can then re­move them to cre­ate space for the drug pay­load.

In a state­ment from Hum­ming­bird CEO Piers In­gram, the com­pa­ny plans to com­bine the tech­nolo­gies from Synaf­fix with its ef­forts in gen­er­at­ing an­ti­bod­ies on its RAD, or ra­tio­nal an­ti­body dis­cov­ery plat­form.

How­ev­er, no de­tails on the can­di­date or when the deal would close were pro­vid­ed. End­points News reached out to Hum­ming­bird for more in­for­ma­tion.

“By com­bin­ing our cut­ting-edge ADC tech­nol­o­gy plat­form with Hum­ming­bird Bio’s next-gen­er­a­tion port­fo­lio of pre­ci­sion ther­a­peu­tics we can fur­ther con­tribute to­wards the trans­for­ma­tion of can­cer treat­ment.” Synaf­fix CEO Pe­ter van de Sande said in a state­ment.

This is not the first ef­fort by Synaf­fix to li­cense out its tech­nol­o­gy. In Feb­ru­ary of last year, the biotech signed a deal with Macro­Gen­ics for $586 mil­lion in up­front and mile­stone pay­ments across the three pro­grams and was el­i­gi­ble for roy­al­ties on com­mer­cial sales.

In 2021, Synaf­fix al­so signed a deal with Ky­owa Kirin and in 2019, it al­so se­cured a $125 mil­lion li­cens­ing pact with Chi­na’s Miraco­gen.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to clinicaltrials.gov, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Zhi Hong, Brii Biosciences CEO

Brii Bio­sciences stops man­u­fac­tur­ing Covid-19 an­ti­body com­bo, plans to with­draw EUA re­quest

Brii Biosciences said it will stop manufacturing its Covid-19 antibody combination, sold in China, and is working to withdraw its emergency use authorization request in the US, which it started in October 2021.

The Beijing and North Carolina biotech commercially launched the treatment in China last July but is now axing the work and reverting resources to other “high-priority programs,” per a Friday update. The focus now is namely hepatitis B viral infection, postpartum depression and major depressive disorders.

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Geoff McDonough, Generation Bio president and CEO

Mod­er­na part­ners on non-vi­ral gene ther­a­py with Gen­er­a­tion Bio af­ter swing­ing gene edit­ing deals

Moderna has inked a five-year partnership with gene therapy biotech Generation Bio, it announced Thursday morning, wading deeper into the genetic medicines space as it navigates beyond its vaccine work.

Moderna will pay Generation Bio $40 million upfront and invest another $36 million into the gene therapy biotech. In exchange, Moderna can license Generation Bio’s non-viral gene therapy platforms for two immune cell programs and two liver programs, with an option for a fifth program. Moderna will fund all the research work under the partnership, and could be on the hook for milestone, fee and royalty payments totaling up to $1.8 billion, a company spokesperson tells Endpoints News.

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Sijmen de Vries, Pharming CEO

FDA ap­proves Pharm­ing drug for ul­tra-rare im­mun­od­e­fi­cien­cy dis­ease

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.

Stuart Peltz, former PTC Therapeutics CEO

Stu­art Peltz re­signs as PTC Ther­a­peu­tics CEO af­ter 25 years

Stuart Peltz, the longtime CEO of PTC Therapeutics who’s led the rare disease drug developer since its founding 25 years ago, is stepping down.

Succeeding him in the top job is Matthew Klein, who joined PTC in 2019 and was promoted to chief operating officer in 2022. In a call with analysts, he said the CEO transition has been planned for “quite some time” — in fact, as part of it, he gave the company’s presentation at the JP Morgan healthcare conference earlier this year.

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