FOR IMMEDIATE RELEASE
Vancouver, BC — June 16, 2025 — Andira Pharmaceuticals Inc., a therapeutics company developing synergistic, cannabinoid-based treatments for oncology and infectious disease, today announced the successful completion of pre-clinical efficacy studies for AND-259, a first-in-class transdermal cannabinoid treatment for ductal carcinoma in situ (DCIS)—a highly prevalent, early-stage form of breast cancer for which no FDA-approved pharmacological treatment currently exists.
Key Pre-Clinical Results
Conducted with the University of British Columbia’s Faculty of Pharmaceutical Sciences and Canada Research Chair in Oncology, Professor K. Williams, the study demonstrated:
- Significant and reproducible tumor regression after localized treatment with AND-259 in vivo
- Synergistic enhancement of standard breast cancer chemotherapies
- Superior efficacy compared to a library of molecular analogs and active agents
- Optimized therapeutic window, matched to Andira’s targeted delivery system
“Our results on the use of AND-259 are highly promising,” said Dr. Williams. “We are very excited about its potential therapeutic application.”
Reimagining the Standard of Care
DCIS, often referred to as “stage 0” breast cancer, affects 20–25% of breast cancer patients. Although it is non-invasive, DCIS can progress to invasive cancer in up to 60% of cases. Standard treatment includes lumpectomy or mastectomy surgery, sometimes paired with radiation or hormone therapy—all of which carry substantial side effects and long-term consequences, including chronic post-surgical pain.
AND-259 aims to replace surgery with a non-invasive, localized therapy, offering the potential for improved outcomes and quality of life.
A Novel Targeted Delivery Platform
AND-259 is delivered through Andira’s patented transdermal technology, which demonstrated a 225% increase in skin penetration compared to conventional transdermal methods. This allows for precise, localized delivery directly to the tumor, improving the likelihood of therapeutic success while also minimizing the possibility for side effects.
Accelerated Path to Market
The company is preparing AND-259 for clinical trials under the FDA’s 505(b)(2) regulatory pathway, which allows the use of existing safety data for previously characterized drug substances—significantly reducing development time and cost. Given the drug’s novelty and the unmet need in DCIS, AND-259 may also qualify for Breakthrough Therapy Designation, enabling priority review and increased FDA engagement.
“AND-259 addresses a large clinical gap in breast cancer care with a completely novel, non-invasive approach,” said Dana Lambert, PhD, CEO & Founder of Andira Pharmaceuticals. “Our delivery platform unlocks the immense potential of targeted cannabinoid therapy for cancer.”
Market Opportunity
Breast cancer is the most common cancer globally, with 2.3 million new diagnoses in 2022 according to the World Health Organization. DCIS accounts for up to a quarter of these cases, representing a significant and underserved market.
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About Andira Pharmaceuticals
Andira Pharmaceuticals is a biotechnology company developing synergistic cannabinoid therapeutics and novel drug delivery platforms for oncology and infectious disease. The company’s lead programs focus on non-invasive, targeted treatments for early-stage cancers, post-surgical care, and hospital-acquired infections.
Media Contact:
Nishi Whiteley
Manager of Communications
Andira Pharmaceuticals
info@andira.ca
www.andira.ca