Lonza’s Synaffix is adding another manufacturing licensing partnership by securing a $740 million deal with Sotio Biotech, which would allow Sotio to use the Dutch company’s three-pronged ADC tech.

It’s been a busy year for Synaffix: It was acquired by Lonza in June and the Sotio deal is its fifth new licensing deal of the year. Synaffix CEO Peter van de Sande told Endpoints News the Lonza acquisition will allow the company to bolster its ADC services. This includes plans to increase its personnel count from 35 to 50 in the next year, as well as expand its facilities and increase its manufacturing R&D capacity.

Since its inception in 2014, Synaffix has had at least 15 licensing deals in total and, according to its website, has its hands on three Phase I assets and nine preclinical programs.

In the Sotio deal, the biotech will lead the R&D for one unnamed bioconjugate program, with Synaffix manufacturing relevant assets. The $740 million deal includes signature, target nomination and milestone payments, as well as the potential for royalties once the asset hits the market. The deal has the potential to expand to two more programs.

Sotio chief business officer Jens Hennecke told Endpoints it chose Synaffix as it is “a recognized player” in the ADC field. “We see them as a perfect fit to what we try to achieve to really lead the forefront of the ADC field,” he added in an interview.

On Friday, Sotio signaled it is increasing its focus on ADC products — what Hennecke described as the company’s “internal darling” — and dumped three clinical trials that studied its interleukin-15 superagonist called nanrilkefusp alfa.

Aside from Sotio, Synaffix also licensed its tech to ABL Bio on Sept. 13 for an undisclosed amount. Earlier, On Feb. 6, Synaffix also licensed its tech to South Korea-based Chong Kun Dang Pharm and, on Jan. 5, partnered with Amgen through a $2 billion licensing deal. This year started with a $150 million partnership with Hummingbird Bioscience, which was announced on Jan. 4.

Last week, Lonza revealed it is boosting its in-house ADC manufacturing by extending its partnership with an unnamed “major biopharmaceutical partner.”

Despite Lonza’s reduced CDMO sales outlook for 2023, van de Sande said Synaffix remains largely unaffected, as highlighted by its licensing deals. “We have more deals up our sleeve as well. You see, the funding landscape for ADCs is still good,” he added.

Synaffix’s ADC platform houses three technology products: GlycoConnect converts monoclonal antibodies into ADCs, HydraSpace stabilizes the linker, which attaches the antibody to the drug of choice or payload, and toxSYN provides six linkers with different payloads that have alternative mechanisms of action.

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Pfizer’s write-offs for its Covid-19 vaccine are having a ripple effect on partner BioNTech, which is expecting to write off up to €900 million ($950 million) related to the shot, Comirnaty.

BioNTech’s Monday update follows Pfizer’s late Friday announcement that it is launching a $3.5 billion company-wide cost-cutting program and writing off some of its inventory because of “lower-than-expected utilization” of its Covid products, including both Comirnaty and the antiviral Paxlovid.

In response to an Endpoints News inquiry about any cost cuts, a BioNTech spokesperson noted the company has been “actively managing our costs,” and pointed to statements from its second-quarter report in August. Notably, Pfizer also made write-offs in Q2, which “significantly reduced” BioNTech’s gross profit share.

“With some uncertainty on the revenue line, we are also carefully watching our spending by revisiting our cost base while remaining focused on executing against our strategic goals and providing value to the public and our shareholders,” CFO Jens Holstein said at the time.

Three years into the availability of Covid vaccines and drugs, companies — particularly those who earned the most at the height of the pandemic — have been scrambling to assess the extent of their revenue drop and recalibrate expectations. In the US, September marked the first vaccine season in which private payers, rather than the government, are footing the bill for Comirnaty. Earlier in the year, Pfizer and BioNTech also revised a contract with the European Union, leading to a smaller commitment to purchase doses.

The majority of Pfizer’s $900 million write-offs on Comirnaty has to do with raw materials, according to BioNTech, “mainly formulation-related lipids, purchased during the pandemic, as well as Covid-19 vaccine doses adapted to other, non-XBB.1.5 variants produced at risk.”

The biotech added that the updated Covid vaccine designed to address the XBB.1.5 variant, which has been approved and distributed on major markets, isn’t part of Pfizer’s write-offs.

It’s still evaluating the exact impact of Pfizer’s new calculations on its own financial results, BioNTech said, noting the €900 million figure is its “current expectation” and represents its half under a gross profit-sharing agreement with Pfizer. The write-offs will reduce the revenues to be reported in its third quarter, although it didn’t specify by how much.

The company previously forecast vaccine revenue of €5 billion for the full year of 2023, after reporting around €1.4 billion for the first half. It is expected to provide an updated estimate in November.

BioNTech shares on the Nasdaq $BNTX are down 5.8% to $97.6 in premarket trading.

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Lonza’s Synaffix is adding another manufacturing licensing partnership by securing a $740 million deal with Sotio Biotech, which would allow Sotio to use the Dutch company’s three-pronged ADC tech.

It’s been a busy year for Synaffix: It was acquired by Lonza in June and the Sotio deal is its fifth new licensing deal of the year. Synaffix CEO Peter van de Sande told Endpoints News the Lonza acquisition will allow the company to bolster its ADC services. This includes plans to increase its personnel count from 35 to 50 in the next year, as well as expand its facilities and increase its manufacturing R&D capacity.

Since its inception in 2014, Synaffix has had at least 15 licensing deals in total and, according to its website, has its hands on three Phase I assets and nine preclinical programs.

In the Sotio deal, the biotech will lead the R&D for one unnamed bioconjugate program, with Synaffix manufacturing relevant assets. The $740 million deal includes signature, target nomination and milestone payments, as well as the potential for royalties once the asset hits the market. The deal has the potential to expand to two more programs.

Sotio chief business officer Jens Hennecke told Endpoints it chose Synaffix as it is “a recognized player” in the ADC field. “We see them as a perfect fit to what we try to achieve to really lead the forefront of the ADC field,” he added in an interview.

On Friday, Sotio signaled it is increasing its focus on ADC products — what Hennecke described as the company’s “internal darling” — on the back of dumping three clinical trials studying its interleukin-15 superagonist called nanrilkefusp alfa.

Aside from Sotio, Synaffix also licensed its tech to ABL Bio on Sept. 13 for an undisclosed amount. Earlier, On Feb. 6, Synaffix also licensed its tech to South Korea-based Chong Kun Dang Pharm and, on Jan. 5, partnered with Amgen through a $2 billion licensing deal. This year started with a $150 million partnership with Hummingbird Bioscience, which was announced on Jan. 4.

Last week, Lonza revealed it is boosting its in-house ADC manufacturing by extending its partnership with an unnamed “major biopharmaceutical partner.”

Despite Lonza’s reduced CDMO sales outlook for 2023, van de Sande said Synaffix remains largely unaffected, as highlighted by its licensing deals. “We have more deals up our sleeve as well. You see, the funding landscape for ADCs is still good,” he added.

Synaffix’s ADC platform houses three technology products: GlycoConnect converts monoclonal antibodies into ADCs, HydraSpace stabilizes the linker, which attaches the antibody to the drug of choice or payload, and toxSYN provides six linkers with different payloads that have alternative mechanisms of action.

Read More