Alteogen Unveils Preclinical Results for ADC Subcutaneous Formulation
Quick Summary (Spoiler)
Alteogen has demonstrated that integrating its recombinant human hyaluronidase (ALT-B4) with ADCs for subcutaneous delivery results in faster drug absorption and milder side effects compared to traditional intravenous methods.
Alteogen said Tuesday it has unveiled preclinical results for the subcutaneous (SC) formulation of an antibody-drug conjugate (ADC) using its recombinant human hyaluronidase "ALT-B4." The announcement was made by Kim Tae-hwan, a professor at the College of Pharmacy at Daegu Catholic University, at "World ADC Korea 2026," held from June 9 to 11.
Preclinical Findings: SC vs. IV Administration
In the preclinical study, "ALT-P7," an ADC developed in-house by Alteogen, was administered to minipigs via intravenous (IV) injection, subcutaneous injection, and subcutaneous injection combined with ALT-B4, and the results were compared. The study found that the ALT-B4 combined SC administration group showed a faster drug absorption rate after dosing compared with the group not using ALT-B4, with improved systemic drug exposure and bioavailability.
An improvement effect was also confirmed in skin toxicity at the local site where the ADC was administered when combined with ALT-B4. This effect tended to become more pronounced as the dose of ALT-B4 increased.
Differences were also confirmed in hematological indicators such as absolute neutrophil count, triglycerides, and liver enzymes. While the IV administration group showed a significant decrease in neutrophil count and increases in triglyceride and liver enzyme levels, the ALT-B4 combined SC administration group showed a smaller decrease in neutrophils and milder increases in triglycerides and liver enzymes. Accordingly, the company explained that it confirmed the potential to improve the hematological side effects of ADC therapies.
Future Potential of ALT-B4 in the ADC Field
"These preclinical results show that SC formulation can serve as a starting point for optimizing both the pharmacokinetics and safety profile of ADC therapies, going beyond simply improving administration convenience," said Jung Tae-yun, CEO of Alteogen. "The Phase 1 clinical trial of an Enhertu SC formulation using ALT-B4 by our partner Daiichi Sankyo is a case demonstrating that the expansion potential of ALT-B4 in the ADC field has been confirmed and is leading to actual clinical development stages."
Meanwhile, ALT-B4 is the core material of Alteogen's SC formulation conversion platform, an enzyme that breaks down hyaluronic acid within subcutaneous tissue to create space for drug administration. Using it allows intravenous therapies to be converted into SC formulations, which is utilized to extend the lifecycle of existing drugs and improve patient convenience.
