Orionis Biosciences Announces First Patient Dosed in Phase 1 Clinical Trial of ORB-011 in Patients with Advanced Solid Tumors

BOSTON & GHENT, Belgium--(BUSINESS WIRE)-- Orionis Biosciences, a life sciences company pioneering the creation of highly selective and tunable therapeutics for cancer and other diseases, today announced that the first patient has been dosed in a Phase 1 clinical trial of ORB-011, an attenuated, cis-targeted interferon immunotherapy based on the company’s A-Kine® platform. ORB-011 is the first clinical candidate to emerge from the platform, which engineers cytokines to be highly selective for specific cellular targets while avoiding the broad systemic activity and associated toxicities observed with traditional cytokine therapies. The company is also announcing the appointment of Tony Fadell to its Board of Directors.

ORB-011 is a first-in-class modified interferon designed to act with a high level of precision on cDC1 dendritic immune cells, potent activators of tumor cell killing CD8+ T cells. Preclinical research has shown that selective activation of cDC1s with such conditionally active interferon molecules translates into effective antitumor activity. Targeted activation of cDC1 was also well tolerated in non-human primate studies.

“The beginning of this clinical study represents a major milestone for Orionis and our A-Kine® protein engineering platform, which combines a range of redesigned immune-modulatory cytokines with targeting modules aimed at cell types of therapeutic relevance. ORB-011 has the potential to harness the therapeutic activity of interferon in a new way,” said Nikolai Kley, Ph.D., Founder, President, and Chief Executive Officer of Orionis Biosciences. “Interferons and other cytokines in our pipeline are powerful immune-activating agents. By localizing their activity to specific target cells, and exploiting communication networks across immune cells, we are evolving immunotherapies with unique translational potential.”

Tony Fadell, Principal at Build Collective has joined the Orionis Board of Directors. He is the founder and former CEO of Nest, the company that pioneered the “Internet of Things.” Tony was the SVP of Apple’s iPod Division and led the team that created the first 18 generations of the iPod and the first three generations of the iPhone. Tony holds more than 300 patents and is the author of the New York Times Best-Seller “BUILD – An Unorthodox Guide to Making Things Worth Making.”

“Tony is a tremendously supportive and collaborative investor, bringing a broad range of expertise and insights to countless topics important to the strategic growth and vision of our business,” said Dr. Kley. “His increased involvement will help us take Orionis to the next level and execute on our mission to bring new breakthrough medicines to patients in need.”

“Orionis deploys the most powerful new foundational technologies available: Robotics plus Assay-on-Chip for high-throughput screening, generative AI for structure-based drug design...to name only a few,” said Fadell. “This is what’s needed to combat the toughest, currently undruggable diseases. I’m excited about Orionis’s focus on immunotherapies: activating and directing our natural immune system to go after cancer. I can’t think of a more worthwhile endeavor.”

About ORB-011

ORB-011 is a clinical-stage, targeted interferon that is designed to specifically activate cDC1 dendritic cells, immune cells that are specialized in presenting tumor antigens to, and activating, tumor cytotoxic CD8 T cells. It achieves localized activity by a unique mechanism of induced proximity on the cell surface of cDC1s. Orionis is evaluating ORB-011 in a Phase 1 open-label dose-escalation study (NCT05947474) for patients with recurrent or refractory solid tumors amenable to medically safe serial biopsies, including, but not limited to, colorectal cancer, HR+ or triple-negative breast cancer, non-small cell lung cancer, pancreatic cancer, head and neck squamous cell carcinoma, metastatic melanoma, bladder/urothelial, gastric cancers, esophageal, renal cell, hepatic and ovarian cancers. The Phase 1 clinical trial will provide initial safety, pharmacokinetic and pharmacodynamic readouts, and identify a dose of ORB-011 for use in future studies. It is being conducted at this time at the M.D. Anderson Cancer Center in Houston, Texas and at Honor Health Research Institute in Scottsdale, Arizona.

About the A-Kine® Platform

Orionis’s A-Kine® platform is designed to harness the intrinsic function and therapeutic potential of cytokines as key immune system regulators and natural defenders against cancer and infections. A-Kines® are designed to be highly selective for intended cell targets, such as immune cells, and to avoid broad systemic activity and associated toxicities observed with traditional cytokine therapies. The platform covers multiple cytokine classes, including interferons, interleukins, and tumor necrosis factors, to generate a diversified pipeline of targeted immunotherapy candidates. These redesigned cytokines are leveraged to restart a stalled Cancer Immunity Cycle at multiple different positions to elicit natural mechanisms of immune attack against a variety of cancers.

About Orionis Biosciences

Orionis Biosciences is a life sciences company pioneering the discovery of conditionally active drug modalities for life threatening diseases. These operate by leveraging induced molecular proximity and cooperativity mechanisms in unique fashion to gain novel target access, drug potency and precision. The company applies its design concepts and technological innovations to the discovery of small molecules, with a focus on monovalent molecular glues with its Allo-Glue™ platform, and to the design and engineering of novel classes of precision biologics and cytokine-based immunotherapies with its A-Kine® platform. The company is advancing a deep and diversified pipeline of drug modalities, including agents that engage components of the adaptive and innate immune systems, creating new avenues for the development of single agent-effective therapies for patients with cancer or other diseases. To learn more, please visit www.orionisbio.com.

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