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

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alteogen
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2023-01-06 10:29
[BusinessWire Link]  https://www.businesswire.com/news/home/20200529005170/en/Alteogen-Presents-the-First-in-Human-Data-on-ALT-P7-a-HER2-targeting-Antibody-Drug-Conjugate-ADC-at-ASCO-2020

May 29, 2020 08:00 AM Eastern Daylight Time

DAEJEON, South Korea--(BUSINESS WIRE)--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).





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For Media and Investors
Alteogen Inc.

US: Vivek Shenoy, PhD, MBA
Chief Business Officer
Phone: +18055708998
E-mail: vivek_shenoy@alteogen.com

ROW: Tae-Yon Chun, Ph.D., J.D.
Corporate Alliance Officer
Phone: +820428678861
E-mail: alliance@alteogen.com