A Triumph Unveiled: CanariaBio Attains FDA’s Orphan Drug Designation for MAb-AR20.5, a Beacon of Hope in the Fight Against Pancreatic Cancer

A Triumph of Science: Breaking Barriers in Cancer Research as CanariaBio’s Innovator, MAb-AR20.5, Achieves Landmark Orphan Drug Designation for Pancreatic Cancer

PYEONGTAEK, South Korea, Aug. 21, 2023 /PRNewswire/ — A symphony of progress echoes through the halls of CanariaBio Inc., a beacon of hope in the realm of cancer therapy innovation. With a drumroll of anticipation, the curtain rises on a monumental achievement: the U.S. Food and Drug Administration (FDA) bestows the coveted orphan drug designation (ODD) upon their brainchild, MAb-AR20.5.

This remarkable monoclonal antibody, an IgG1k type murine masterpiece, has the power to unlock the secrets of Mucin 1 (MUC1)—a code embedded in pancreatic cancer cells. In a breathtaking breakthrough, CanariaBio conquers uncharted territories, becoming the first to claim this distinction. As the world watches, science takes its triumphant leap forward, and the battle against pancreatic cancer enters a new era.

“In the labyrinth of medical challenges, pancreatic cancer stands as a formidable adversary, its resilience testing the limits of our medical arsenal. Amid this battle, a beacon of hope emerges—MAb-AR20.5. Like a silent hero, it has whispered promises of change through early studies, sparking MUC-1-specific immune responses in even the most advanced stages of this relentless disease. This novel warrior wields specificity as its sword, promising a renewed offensive against the aggressor that is pancreatic cancer.

As the sun rises on this new era, Mike Na, the visionary at the helm of CanariaBio Inc., shares the sentiment of triumph. “Orphan Drug Designation for MAb-AR20.5 is a testament to our unwavering dedication,” he declares. A glimmer of hope shines through his words—a lifeline woven from innovation, destined to reach those who have been affected by the shadow of pancreatic cancer.

In the intricate dance of medical progress, Orphan Drug Designation takes center stage—a coveted honor bestowed upon therapies that dare to tread where few have ventured. A web of benefits unfurls—tax credits, user fee waivers, and the promise of seven years of exclusivity. It’s a recognition of the bravery it takes to face the rarest of challenges.

With a gaze fixed on the horizon, CanariaBio Inc. lays the groundwork for a new chapter—a chapter of trials that will define the future of pancreatic cancer treatment. Clinical trials beckon, offering a stage to showcase the potential and promise of MAb-AR20.5. A symphony of hope and healing plays on, promising a crescendo that will resonate through the corridors of medicine.”

About CanariaBio Inc.

Imagine a horizon where cancer is met with innovative and potent biotherapeutics, leading the charge is Canariabio Inc., a dynamic clinical-stage biopharmaceutical pioneer. Their mission? To revolutionize cancer treatment through cutting-edge technology. Picture a powerful arsenal of tumor antigen-specific monoclonal antibodies setting their sights on CA-125, MUC1, PSA, and Her2/neu.

But here’s the twist – these antibodies aren’t fighting alone. They’re joining forces with immune-modulating wonders to create a symphony of healing. At the heart of their triumphs is oregovomab, a majestic monoclonal antibody centered on MUC16. It’s not just a treatment; it’s a saga.

In the grand arena of Phase 3, it partners with chemotherapy champions paclitaxel and carboplatin to combat ovarian cancer. Canariabio isn’t just a company; it’s a legacy in the making, a realm where skill, innovation, and determination redefine the landscape of cancer care.”

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