Woburn, Mass. & Guangzhou, China — CanWell Pharma today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for CAN016, a novel HER2-targeting dual-payload antibody-drug conjugate (ADC). The company plans to initiate a Phase I clinical study to evaluate CAN016 in patients with advanced solid tumors, including those who have experienced disease progression following prior ADC therapies.
About CAN016
CAN016,a new generation of ADC therapeutics and is designed to address resistance mechanisms associated with conventional single-payload ADCs. Leveraging CanWell’s proprietary StarLinkerTM platform, CAN016 integrates two distinct MoA cytotoxic agents within a single antibody construct, enabling enhanced anti-tumor activity through complementary mechanisms.
Preclinical studies have demonstrated that CAN016 is capable of delivering dual cytotoxic payloads into tumor cells, resulting in synergistic tumor cell killing, inhibition of proliferation, and induction of apoptosis. Notably, CAN016 has shown potent anti-tumor activity in multiple CDX and PDX models, including those resistant to currently approved HER2-targeted ADC therapies.
Clinical Development Plan
The upcoming Phase I study will assess the safety, tolerability, and pharmacokinetics of CAN016, as well as determine the recommended dose for subsequent clinical development. The study will also explore preliminary anti-tumor efficacy across a range of HER2-expressing advanced solid tumors.
Technological Innovation
The successful IND of CAN016 underscores the potential of CanWell’s StarLinkerTM platform, which enables the precise conjugation of multiple payloads onto a single antibody. This approach is designed to enhance therapeutic efficacy, overcome drug resistance, and expand the clinical applicability of ADC-based treatments.
In addition to CAN016, the company is advancing a pipeline of next-generation ADC candidates utilizing dual- and multi-payload technologies, several of which are currently in preclinical or IND-enabling stages.
About CanWell
CanWell Pharma is a clinical-stage biotechnology company dedicated to the discovery and development of innovative oncology therapies. The company’s leadership team brings extensive experience in global drug development, having successfully advanced multiple programs through regulatory filings, clinical trials, and product approvals.
With a strong focus on FIC and BIC therapeutics, CanWell aims to deliver transformative treatment options that improve outcomes and quality of life for patients with cancer. The company has established integrated technology platforms, including its ADC multi-payload conjugation platform and SMDC platform, to support a robust and diversified pipeline.