Preclinical data demonstrate enhanced systemic exposure and bioavailability, reduced dermal toxicity, and improved safety profile in ALT-B4-enabled ADC therapy
Key Points
- Superior PK: Subcutaneous administration of ADCs combined with ALT-B4 demonstrated rapid absorption, enhanced systemic exposure, and improved bioavailability compared to SC administration without ALT-B4
- Reduced local toxicity: The ALT-B4 combination SC group showed a notable, dose-dependent reduction in local dermal toxicity at the injection site
- Improved hematologic safety: Compared to IV infusion, the ALT-B4 combination SC group exhibited lower reductions in absolute neutrophil count (ANC) and mitigated elevations in triglycerides and AST, indicating a favorable safety profile
DAEJEON, South Korea, June 10, 2026 /PRNewswire/ -- Alteogen Inc. (KOSDAQ: 196170), a leading biopharmaceutical company specializing in platform technologies, announced today that it presented preclinical data at the World ADC Summit South Korea on the subcutaneous (SC) formulation of antibody-drug conjugates (ADCs) using its proprietary hyaluronidase ALT-B4 (berahyaluronidase alfa).
During the oral presentation session, Associate Professor Tae Hwan Kim of the College of Pharmacy at Daegu Catholic University presented findings on the pharmacokinetics (PK) and local tolerability of ADC therapies administered subcutaneously with ALT-B4. In the subsequent poster presentation session, Alteogen's scientists further demonstrated that subcutaneous administration of ADC combined with ALT-B4 showed improved absorption and reduced toxicity. (Poster title: Enabling Subcutaneous Delivery of ADCs with Berahyaluronidase Alfa: Improved Absorption and Reduced Toxicity)
In this preclinical study, Alteogen evaluated its proprietary ADC, ALT-P7 (anti-HER2 ADC), in minipigs, comparing intravenous (IV) infusion, subcutaneous (SC) administration, and SC administration in combination with ALT-B4. The results showed that the ALT-B4 combination SC group exhibited rapid absorption after administration, leading to enhanced systemic exposure and bioavailability compared to the SC group without ALT-B4. In addition, the ALT-B4 combination SC group showed a notable reduction in local dermal toxicity, with a clear dose-dependent trend.
In terms of hematologic parameters — including absolute neutrophil count (ANC), triglycerides, and aspartate aminotransferase (AST) — the IV infusion group showed a significant decrease in neutrophil counts along with increases in triglyceride and AST levels. In contrast, the ALT-B4 combination SC group exhibited a lower reduction in neutrophils and mitigated elevations in triglycerides and AST compared to the IV infusion group, demonstrating an improved hematologic safety profile over conventional intravenous ADC therapy.
Based on these findings, Alteogen demonstrated the potential of combining ALT-B4 to enhance drug absorption, injection-site tolerability, and systemic safety in the subcutaneous delivery of ADCs. In the highly competitive ADC landscape, Alteogen expects that ALT-B4-enabled SC formulations could represent a meaningful breakthrough, creating new opportunities for strategic partnerships.
"In this preclinical study, combining ALT-B4 reduced injection-site skin reactions and showed improvements in PK parameters including AUC, and hematologic safety markers including absolute neutrophil count. These findings suggest that ALT-B4-enabled subcutaneous formulations go beyond improving dosing convenience, and may serve as a starting point for a paradigm shift in optimizing the PK and safety profile of ADC therapies. We believe these study results further validate the potential of ALT-B4 as a platform to enhance the competitiveness of ADC therapies, and we anticipate that this will support the expansion of ADC partnerships going forward."
— Tae-Yon Chun, Ph.D., CEO of Alteogen
About ALT-B4
ALT-B4 (berahyaluronidase alfa) is a proprietary recombinant human hyaluronidase developed using Alteogen's Hybrozyme® platform technology. ALT-B4 enables the conversion of biologics typically administered via intravenous (IV) infusion into more convenient and rapid subcutaneous (SC) formulations. By temporarily depolymerizing hyaluronan in the extracellular matrix, ALT-B4 facilitates the rapid and efficient dispersion and absorption of co-administered therapeutics.
About Alteogen
Alteogen Inc. is a South Korea-based biopharmaceutical company that focuses on the development and commercialization of novel biologics such as antibody-drug conjugates (ADCs), biobetters, and biosimilars. Alteogen's portfolio includes clinical-stage long-acting therapeutic proteins and next-generation ADCs, developed by its proprietary NexP®-fusion and NexMab® platform technologies, respectively. The company also developed a proprietary recombinant human hyaluronidase enzyme utilizing Hybrozyme® technology, which enables the large-volume subcutaneous administration of drugs typically given as IV infusions. Alteogen was founded in 2008 and is listed on KOSDAQ (196170.KQ).
Media Contact:
Junseok Jang, Director, Investor Relations and Corporate Communications
E-mail: jsjang@alteogen.com
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