Akeso's AK157D1 Cleared For Phase I Trial In Solid Tumors

(RTTNews) - Akeso, Inc. (9926.HK) announced that its next-generation antibody-drug conjugate (ADC), AK157D1 targeting B7-H3, has received clinical trial clearance from China's National Medical Products Administration (NMPA).

The clearance enables initiation of a Phase 1 study in patients with advanced malignant solid tumors. B7-H3 is highly expressed across a wide range of cancers— including lung, prostate, esophageal, colorectal, breast and glioblastoma— while showing limited presence in normal tissues, making it a promising broad-spectrum target.

AK157D1 is Akeso's third differentiated ADC candidate to enter clinical development, following AK146D1 (TROP2/Nectin-4 ADC) and AK138D1 (HER3 ADC). The company plans to explore AK157D1 in combination with its proprietary bispecific antibodies Ivonescimab and Cadonilimab, further advancing its IO2.0+ ADC2.0 strategy.

Preclinical studies demonstrated potent antitumor activity and a favorable safety profile, suggesting potential to overcome limitations of existing ADCs such as hematologic toxicity and interstitial lung disease.

Akeso continues to expand its innovative oncology pipeline, positioning AK157D1 as part of its broader effort to establish next-generation standards of care in cancer treatment.

9926.HK has traded between HKD 80.20 and HKD 179 over the past year. The stock is currently trading at HKD 90.45, down 3.67%.

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