Axplora

In a statement earlier today, Lonza*, a global manufacturing partner to the pharmaceutical, biotech and nutraceutical markets, confirmed that it has acquired Netherlands-based Synaffix, a biotechnology company focused on commercializing its clinical-stage technology platform for the development of antibody-drug conjugates (ADCs).

Synaffix revenues and margins will be recognized within the Lonza business from the date of acquisition.

Development and manufacturing challenges
While ADCs offer widespread and targeted treatment potential against cancer, they present a range of complex development and manufacturing challenges. Supported by a team of scientific experts, the Synaffix technology platform, which includes payload and site-specific linker technologies, will enhance and extend Lonza’s integrated ADC services, including its early-phase offering.

The award-winning Synaffix ADC technology platform comprises proprietary GlycoConnect™, HydraSpace™ and toxSYN™ technologies that can considerably enhance the efficacy and tolerability of ADCs.

Advertisement #3 
Axplora
 
  • GlycoConnect™ is a clinical-stage conjugation technology designed to exploit the native antibody for site specific and stable payload attachment, allowing development of an ADC with a drug-to antibody-ration of (DAR) 1 to DAR4 formats.[1][2][3]
  • HydraSpace™ is a clinical-stage compact and highly polar spacer technology designed to further enhance the therapeutic index of ADCs with hydrophobic payloads, further differentiating the efficacy and tolerability of ADCs developed using this proprietary technology versus other site-specific ADC approaches. It forms an integral part of every toxSYN™ linker/payload, bears a negative charge at physiological pH and improves the therapeutic efficacy, tolerability, PK and manufacturability of ADCs. [4]
  • toxSYN™ is a linker/payload platform technology that includes potent topoisomerase 1 inhibitor (SYNtecan E™), DNA damaging agents (SYNeamicin D™ and SYNeamicin G™), α-Microtibule (SYNtansine™) and β-microtubule (SYNstatin E™ and SYNstatin F™) inhibitors as well as several other, not yet launched, proprietary linker-payloads.

The combined technologies provide developers a ‘one-stop’ and easy-to-use technology platform.

Linker-Payload (toxSYN™)Mode-of-ActionPayload
(Active Catabolite)
SYNtecan E™Topoisomerase inhibitionExatecan
SYNeamicin D™DNA damagingCalicheamicin γ1I
SYNeamicin G™N-glycyl calicheamicin γ1I
SYNstatin E™Microtubule inhibitionMonomethyl auristatin E (MMAE)
SYNstatin F™Monomethyl auristatin F (MMAF)
SYNtansine™Maytansinoid (N-6-aminohexanoyl-maytansine also known as ahx-maytansine)

 

Comprehensive service
Combining Lonza’s development and manufacturing capabilities with the Synaffix ADC technology platform is expected to offer customers and licensees with a comprehensive service to rapidly discover, develop, scale up and commercialize novel and differentiated ADCs. These enhanced capabilities will streamline the path to clinic and commercialization.

“The Synaffix ADC technology is the gold standard, helping clinical-stage developers to design potentially curative therapies in areas of high unmet medical need,” noted Ulrich Osswald, Vice President, Licensing, at Lonza.

“The acquisition of Synaffix underlines the strategic position of bioconjugates within Lonza’s portfolio, expands our offering in this fast-growing market and enhances our value proposition for clinical customers. With Synaffix, our combined industry-leading knowledge and capabilities have the capacity to support both clinical and commercial needs,” Osswald added.

Synergies
“On our mission to bring Synaffix’s ADC technologies to patients, we are excited to become part of Lonza and thus, through strong and immediate synergies, ensure a robust technology and manufacturing platform for our licensees as they progress into the late stage clinical and commercial development phase,” said Peter van de Sande, Chief Executive Officer of Synaffix.

“We can now also leverage the potential offered by Lonza to fast-track technology innovations in bioconjugates beyond cytotoxic ADCs. We look forward to working closely with our colleagues at Lonza for the continued enablement of promising potential medicines for patients in need,” Van de Sande added

As a Lonza company, Synaffix will continue to operate under the Synaffix name and further expand its operations in Oss, the Netherlands to cater for further innovation and growth.

The acquisition reflects Lonza’s strategy to differentiate through technology and innovation. From its leading bioconjugation offering, to the commercial manufacture of cell and gene therapies and support in producing live biotherapeutics, Lonza’s manufacturing technologies help customers deliver innovative new therapies to patients.

Reference
[1] Van Geel R, Wijdeven MA, Heesbeen R, Verkade JM, Wasiel AA, van Berkel SS, van Delft FL. Chemoenzymatic Conjugation of Toxic Payloads to the Globally Conserved N-Glycan of Native mAbs Provides Homogeneous and Highly Efficacious Antibody-Drug Conjugates. Bioconjug Chem. 2015 Nov 18;26(11):2233-42. doi: 10.1021/acs.bioconjchem.5b00224. Epub 2015 Jun 10. PMID: 26061183.
[2] Dommerholt J, Schmidt S, Temming R, Hendriks LJ, Rutjes FP, van Hest JC, Lefeber DJ, Friedl P, van Delft FL. Readily accessible bicyclononynes for bioorthogonal labeling and three-dimensional imaging of living cells. Angew Chem Int Ed Engl. 2010 Dec 3;49(49):9422-5. doi: 10.1002/anie.201003761. PMID: 20857472; PMCID: PMC3021724.
[3] Van Berkel SS, van Delft FL. Enzymatic strategies for (near) clinical development of antibody-drug conjugates. Drug Discov Today Technol. 2018 Dec;30:3-10. doi: 10.1016/j.ddtec.2018.09.005. Epub 2018 Oct 11. PMID: 30553518.
[4] Verkade JMM, Wijdeven MA, Van Geel R, Janssen BMG, Van Berkel SS, Van Delft FL. A Polar Sulfamide Spacer Significantly Enhances the Manufacturability, Stability, and Therapeutic Index of Antibody-Drug Conjugates. Antibodies (Basel). 2018 Feb 20;7(1):12. doi: 10.3390/antib7010012. Erratum in: Antibodies (Basel). 2018 Aug 30;7(3): PMID: 31544864; PMCID: PMC6698870.

Note: *in 2013, Lonza was the founding sponsor of ADC Review | Journal of Antibody-drug Conjugates.

Advertisement #4