ALT-B4-based subcutaneous ADC formulation demonstrates rapid absorption, improved injection-site tolerability, and potential reduction in systemic side effects.
Alteogen offers a strategic solution for the fast-growing next-generation ADC market by combining therapeutic efficacy with the convenience of subcutaneous delivery.
Alteogen has announced promising preclinical results for its proprietary antibody-drug conjugate (ADC) applied with subcutaneous (SC) delivery technology, showing bioavailability comparable to intravenous (IV) administration alongside a reduction in adverse effects in animal models. The study evaluated whether the subcutaneous route could enhance patient convenience while mitigating injection-site skin damage and systemic toxicity.
Alteogen announced on the 26th that it presented a poster detailing its research on subcutaneous ADC formulation utilizing ALT-B4 at the European Society for Medical Oncology (ESMO) Congress 2026 held in Madrid, Spain.
ADCs are targeted cancer therapies that link potent cytotoxic drugs to antibodies designed to home in on cancer cells. While engineered to deliver payloads selectively to tumor sites, the use of highly potent agents necessitates rigorous toxicity management. Alteogen focused on the potential of subcutaneous delivery to smooth out the sharp spikes in blood drug concentration typically observed following intravenous infusion, all while maintaining high bioavailability.
In this study, the company evaluated drug absorption, tolerability, and safety profiles by subcutaneously administering its proprietary HER2-targeting ADC, ALT-P7, combined with its recombinant human hyaluronidase, ALT-B4.
According to the company, ALT-B4 facilitated rapid ADC absorption, achieving systemic bioavailability comparable to intravenous administration. Co-administration of ALT-B4 also enabled uniform drug dispersion within subcutaneous tissue, thereby reducing injection-site skin lesions.
Furthermore, indicators of reduced systemic toxicity were observed. While the intravenous administration group exhibited neutropenia and hepatotoxicity, these adverse effects were significantly attenuated in the group receiving subcutaneous administration alongside ALT-B4. The maximum plasma concentration (Cmax) in the subcutaneous group was lower than that of the intravenous group, which Alteogen noted demonstrates the potential to minimize toxicity by blunting peak plasma concentration spikes.
At the congress, Alteogen shared these findings with leading European and global oncology experts and discussed prospective collaborations for the clinical development of subcutaneous ADC formulations.
Park Tae-yeon, CEO of Alteogen, noted that a partner company is currently conducting clinical development for an ALT-B4-utilizing subcutaneous ADC formulation, adding, "This study is significant as it confirms the feasibility of simultaneously enhancing therapeutic convenience and safety." He further stated that the company plans to leverage global academic platforms to showcase the advantages and developmental potential of ALT-B4 in the ADC space.
ALT-B4 is a recombinant human hyaluronidase utilized to convert intravenous biologic therapies into subcutaneous formulations. In 2024, Alteogen entered into a licensing agreement with Daiichi Sankyo for the development of subcutaneous ADC therapeutics.
