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Alteogen Presents the First-in-Human Data on ALT-P7, a HER2-targeting Antibody-Drug Conjugate (ADC) at ASCO 2020

DAEJEON, South Korea--(BUSINESS WIRE)--#ALTB4--Alteogen Inc. (KOSDAQ:196170) has today presented at ASCO results from the First-in-Human (FIH), phase 1 study of ALT-P7, a HER2-targeting antibody-drug conjugate (ADC), in patients with HER2-positive advanced breast cancer.

This is a FIH clinical trial of ALT-P7, a HER2-targeting ADC, and is a single-group, dose-escalation study designed to determine the maximum tolerated dose (MTD) and evaluate the safety of ALT-P7. For patients with HER2-positive breast cancer, the MTD of ALT-P7 was determined to be 4.5 mg/kg and was confirmed as the recommended dose for Phase II clinical trials (RP2D). Patients with HER2-positive breast cancer who participated in this clinical trial had received 6 types of systemic chemotherapy, including 4 types of HER2-targeted therapy. In this trial, a total of 27 patients received study drug. The most common grade 3/4 adverse event (AE) was neutropenia. Other common treatment-related AEs of any grade were myalgia, fatigue, sensory neuropathy, alopecia, pruritus, and neutropenia. The dose limit toxicities (DLTs) were observed at 4.8 mg/kg with a single case of febrile neutropenia, hyperbilirubinemia, myalgia, and hyponatremia. The disease control rate (DCR) of ALT-P7 was 72%, and the median progression-free survival (PFS) was 6.2 months (95% CI: 2.5-9.9 months).

“Compared with other ADC therapeutics which have microtubule-targeting payloads, ALT-P7 exhibited substantial tolerability,” said Dr. Jae Hyeon Juhn, director of Regulatory Affair and Clinical Development of Alteogen. “The high tolerability together with a high disease control rate has the potential to offer a great benefit to patients, especially for those previously treated with several systemic & target therapeutics."

Based on the RP2D determined in this trial, Alteogen plans to evaluate the efficacy of ALT-P7 with RP2D in Phase 2 and also will evaluate its applicability for other HER2-positive carcinomas such as urethral epithelial cell cancer, or biliary tract cancer as well.

About Alteogen Inc.

Alteogen Inc. is a Korea-based biopharmaceutical company that focuses on the development and commercialization of novel biologics. Alteogen’s portfolio includes clinical-stage long-acting therapeutic proteins and next-generation ADCs, developed by its proprietary NexPTM-fusion and NexMabTM platform technology, respectively. It also develops Herceptin SC and Eylea biosimilars. The company was founded in 2008 and listed in KOSDAQ (196170.KQ).

Contacts

For Media and Investors

Alteogen Inc.

Arun Swaminathan, Ph.D.

Chief Business Officer and Senior Vice President

phone: +16099378767

[email protected]

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