Appclon is expanding development of AC101, a cancer drug candidate licensed to China’s Henlius, beyond stomach cancer to colorectal cancer and breast cancer that has progressed after treatment with antibody-drug conjugates (ADCs).

With a global Phase 3 trial underway in metastatic stomach cancer and two new Phase 2 trials added, the overall clinical program has grown to nine trials. The expansion is also broadening the potential applications of the licensed asset.

According to industry sources on the 2nd, Appclon is a biotechnology company developing antibody-based drugs, including cancer treatments and immune cell therapies, based on its proprietary antibody discovery technology. AC101 is a human epidermal growth factor receptor 2 (HER2)-targeted antibody drug candidate developed by Appclon and licensed to China’s Henlius.

Henlius, which acquired the technology, is currently leading development and clinical trials. Under the agreement, Appclon is eligible to receive milestone payments tied to development stages as well as royalties after commercialization.

Henlius recently added a Phase 2 trial involving 180 patients with advanced or metastatic HER2-positive colorectal cancer. The trial, involving 47 medical institutions including Sun Yat-sen University Cancer Center in China, will evaluate AC101 in combination with chemotherapy and other treatments as a first-line therapy in patients who have not previously received treatment.

For patients who have failed standard treatment, the trial will assess AC101’s potential as a subsequent treatment in combination with trastuzumab.

The clinical program for AC101, also known as HLX22, a HER2-targeted antibody drug candidate being developed by Henlius, has grown to nine trials. From development in stomach cancer and HER2-low breast cancer at the end of last year, seven additional clinical programs have been added in about a year.

Expanding Applications Into New Indications

A Phase 2 trial has also been added for breast cancer patients whose disease has progressed after ADC treatment. Henlius plans to evaluate the efficacy and safety of AC101 in 90 patients whose disease has progressed despite treatment with HER2-targeted ADCs such as Enhertu. The development scope is being expanded to patients who continue to have unmet treatment needs after existing HER2-targeted therapies.

The key development program for AC101 is the global Phase 3 trial in metastatic stomach cancer. While conducting the trial, Henlius is also expanding the indications into colorectal and breast cancer. The strategy is to establish the drug’s commercialization potential through its lead trial while broadening its applications through development in additional indications.

For Appclon, progress in AC101’s clinical development is a key factor in converting the licensing deal into revenue. If clinical development succeeds and the drug receives regulatory approval and is commercialized, Appclon can secure milestone payments and royalty revenue under the agreement.

However, the actual scale and timing of revenue will depend on clinical results and subsequent development and regulatory approval procedures.

An Appclon official said, “It is significant that AC101’s development scope has expanded from stomach and breast cancer to colorectal cancer as well,” adding, “In addition to metastatic stomach cancer, we expect royalty revenue under the licensing agreement depending on future clinical results, regulatory approvals and commercialization.”

Appclon is expanding development of AC101, a cancer drug candidate licensed to China’s Hen …

Appclon Expands Cancer Drug Candidate’s Potential Beyond Stomach Cancer to Colorectal and Treatment-Resistant Breast Cancer