Third ADC with Synaffix's Technology Enters Clinical Development

- Partner Shanghai Miracogen (fully owned by LEPU BIOPHARMA CO., LTD) commences US Phase I/II trial with ADC designed to treat solid tumors

- MRG004A selected for clinical development based on highly competitive efficacy and tolerability in preclinical studies compared to conventional ADC technology

- Over 10 ADCs currently being developed by Synaffix licensees

AMSTERDAM, Sept. 29, 2021 /PRNewswire/ -- Synaffix B.V., a biotechnology company focused on commercializing its clinical-stage platform technology for the development of antibody-drug conjugates (ADCs) with best-in-class therapeutic index, today announces that its partner Shanghai Miracogen has commenced a Phase I trial in the US with MRG004A, an ADC designed to treat solid tumors.  This is the 3^rd ADC built with GlycoConnect™ ADC technology to enter the clinic.

Synaffix signed a licensing agreement with Shanghai Miracogen (now fully owned by LEPU BIOPHARMA CO., LTD), a Chinese biotechnology company with a clinical-stage pipeline of ADCs, in 2019. This major development has triggered a milestone payment to Synaffix.

MRG004A is an ADC targeting human Tissue Factor (TF), conjugated using GlycoConnect™ site specific conjugation technology. In preclinical studies, MRG004A exhibited significantly improved stability in circulation, enhanced efficacy and tolerability compared to the conventional ADC technology.

Mary Hu, CEO of Miracogen and Co-CEO of Lepu Biopharma said:

"We have been very pleased with our collaboration with Synaffix and the data that we generated with ADCs built with its outstanding ADC technology. MRG004A has demonstrated the potential to become a best-in-class TF-targeted ADC and to address high unmet medical need for patients."

Peter van de Sande, CEO of Synaffix, said:

"This is an important milestone in our collaboration and we look forward to continuing our successful partnership as Miracogen develops multiple best-in-class ADC product candidates using our technology.

There are now 3 ADCs that were built with Synaffix's ADC technology in clinical development. We have now announced 6 collaborations that we have established with biotech and pharma partners around the world and more than 10 ADCs are being developed under those license agreements. We look forward to announcing further progress and additional partnerships in the coming months."

In the last few months, Synaffix has signed significant agreements with Kyowa Kirin, a global specialty pharmaceutical company; ProfoundBio, an emerging oncology biotherapeutics company; and Innovent Biologics, a leading biopharmaceutical company developing innovative medicines for the treatment of major diseases. These come in addition to preexisting collaborations with ADC Therapeutics, Mersana Therapeutics and Shanghai Miracogen.

About Synaffix B.V.

Synaffix B.V. is a biotechnology company that enables ADC product candidates using its clinical-stage, site-specific ADC technology platform. In addition to GlycoConnect™ and HydraSpace™ technology, the toxSYN™ linker-payload platform rounds out a fully complementary technology platform that enables any company with an antibody to develop proprietary best-in-class ADC products under a single license from Synaffix.

The Synaffix platform enables a rapid timeline to clinic due to the established supply chain of technology components. Granted patents covering Synaffix' technology provide end-to-end protection of the manufacturing technology as well as the resulting products through at least 2035. The business model of Synaffix is target-specific technology out-licensing, as exemplified through its existing deals with ADC Therapeutics, Mersana Therapeutics, Shanghai Miracogen, Innovent Biologics, ProfoundBio and Kyowa Kirin.

Synaffix is backed by a top tier, European, life science-focused investor syndicate that includes Aravis, BioGeneration Ventures, BOM Capital and M Ventures. 

For more information, please visit the website at www.synaffix.com.

About Shanghai Miracogen and Lepu Biopharma

Shanghai Miracogen is a clinical stage biotech company fully owned by Lepu Biopharma. Lepu Biopharma is an innovation-driven biopharmaceutical company focusing on oncology therapeutics. There are currently eight clinical stage drug candidates in the pipeline including five ADC drugs, two immune check point inhibitors and one oncolytic virus. The ADC drug candidates are currently in the phase I and phase II clinical studies conducted in both China and US. These targeted ADC drugs have been developed mainly in the treatments of head and neck cancer, nasopharyngeal cancer, lung cancer, breast cancer, gastric cancer, urothelial cancer, biliary tract cancer, cervical cancer and lymphoma.

Lepu Biopharma is committed to become a leading innovative company serving the unmet medical needs of cancer patients with first-in-class and best-in-class drugs. The company strives to continuously develop a market differentiating pipeline by combining in-house research and development, and strategic collaborations in China as well as via partnerships internationally.

For more information, please visit the website at www.lepubiopharma.com.

About The Synaffix ADC Platform Technology

Synaffix' proprietary ADC technology platform consists of GlycoConnect™, HydraSpace™ and toxSYN™ technologies.  Both GlycoConnect™ and HydraSpace™ are clinical-stage technologies that enable best-in-class ADCs with significantly enhanced efficacy and tolerability. 

GlycoConnect™ is a conjugation technology that exploits the native antibody glycan for site-specific and stable payload attachment and is tunable to DAR1, DAR2 or DAR4 formats. 

HydraSpace™ is a compact and highly polar spacer technology that is designed to further enhance therapeutic index, particularly with hydrophobic payloads. toxSYN™ is a linker-payload platform that spans key, validated MOAs for ADC product development, including SYNtecan E™ and SYNeamicin G™, among other linker-payloads.

The combination of these three technologies provides developers with a "one stop" and easy-to-use ADC technology platform, allowing any antibody developer to develop its own proprietary ADC and any ADC developer to expand its pipeline further and increase its competitive position.

At the most recent World ADC US event, Synaffix was recognized with first place in the "Best ADC Platform Technology" award category at the World ADC Awards ceremony following a global review of technologies, voting by industry peers and final evaluation by a panel of independent industry experts.