CanWell Pharma Announces FDA Clearance of the IND for CAN016, a Dual-Payload ADC Targeting HER2, for ADC Pre-Treated Solid Tumors

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WOBURN, Mass.--(BUSINESS WIRE)--Apr 2, 2026--

CanWell Pharma Inc. today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for CAN016, a HER2-targeting dual-payload ADC. The company will initiate a Phase I clinical study to evaluate CAN016 in solid tumor patients who have experienced disease progression following prior ADC therapies.

About CAN016

CAN016 is an ADC in development by CanWell Pharma Inc. for ADC pre-treated solid tumors. Developed using CanWell’s StarLinker platform, CAN016 is distinguished by its integration of two distinct MoA cytotoxic agents within a single antibody construct, leading to enhanced anti-tumor activity through complementary mechanisms. This design is expected to counter the resistance mechanisms that limit the efficacy of conventional single payload ADCs.

In preclinical studies, CAN016 effectively delivered dual cytotoxic payloads into tumor cells leading to synergistic tumor cell killing, inhibition of proliferation, and apoptosis. CAN016 has demonstrated potent anti-tumor activity in multiple CDX and PDX models, including those resistant to currently approved HER2-targeted ADC therapies.

The Phase I study will assess the safety, tolerability, and pharmacokinetics of CAN016, determine the recommended dose for subsequent clinical development, and explore preliminary anti-tumor efficacy across a range of HER2-expressing ADC pre-treated solid tumors.

About CanWell

CanWell Pharma is a clinical-stage biotechnology company dedicated to the discovery and development of first-in-class and best-in-class oncology therapies using its multi-payload ADC and small molecule drug conjugate (SMDC) platforms. CanWell is advancing a pipeline comprised of several candidates and two SMDC clinical candidates. The company’s leadership team has extensive experience in global drug development, having successfully advanced multiple programs through regulatory filings, clinical trials, and product approvals.

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CONTACT: [email protected]

www.canwellpharma.com

KEYWORD: MASSACHUSETTS CHINA UNITED STATES NORTH AMERICA ASIA PACIFIC

INDUSTRY KEYWORD: ONCOLOGY HEALTH FDA RESEARCH SCIENCE PHARMACEUTICAL BIOTECHNOLOGY

SOURCE: CanWell Pharma Inc.

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PUB: 04/02/2026 06:48 AM/DISC: 04/02/2026 06:49 AM

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