Skip to main content
Press Releases

OncoNano Announces Positive Preclinical Data for ONM-400 Tumor Specific IL-2 Delivery at the 2020 Society for Immunotherapy of Cancer (SITC) Annual Meeting

Findings indicate proof of mechanism and strong antitumor efficacy in preclinical models

SOUTHLAKE, Texas – November 9, 2020 – OncoNano Medicine, Inc. today announced positive results from its preclinical study of ONM-400, a novel interleukin-2 (IL-2) encapsulating pHactivated nanoparticle that targets metabolic acidosis of cancer. ONM-400 employs OncoNano’s ON-BOARDTM platform designed to provide tumor specific delivery of a variety of cancer therapeutics. The data, presented today at the Society for Immunotherapy of Cancer (SITC) 35th Anniversary Annual Meeting, demonstrate successful tumor acidosis-driven accumulation that provides a high local concentration of IL-2 within tumors potentially resulting in an improved therapeutic index for this cancer therapeutic.

“While IL-2 is established as a highly effective solid tumor therapy for treatment of metastatic melanoma and renal cell cancers, the clinical application is greatly hindered by healthy tissue toxicity,” said Ravi Srinivasan, Ph.D., President of OncoNano Medicine. “Exploiting low pH relative to normal tissues as a common trait of all solid tumors, ONM-400 has the potential to deliver IL-2 directly to the tumor microenvironment. We are highly encouraged by these findings and look forward to evaluating ONM-400 in patients.”

Presentation Overview

TITLE: ONM-400, a Novel Approach for Interleukin-2 Therapy Using a pH-Activated Nanoparticle Targeting Metabolic Acidosis in Solid Cancers
LOCATION AND TIME: Virtual Poster Hall, 11/11/2020 – 11/14/2020, 9:00 am – 5:00 pm
PRESENTER: Qingtai Su, Ph.D.

The results announced today are based on in vitro characterization and in vivo demonstration in multiple mice models. Tumor accumulation and biodistribution following intravenous injection (I.V.) of ONM-400 were evaluated in mice bearing head and neck tumors and antitumor efficacy of ONM-400 after I.V. injection was studied in MC38 colon cancer-bearing mice and compared with unencapsulated IL-2 at the same dose. The findings indicate that ONM-400:

  • Showed high encapsulation efficiency and drug loading density of IL-2
  • Enabled pH-dependent IL-2 release and bioactivity
  • Demonstrated successful tumor acidosis-driven release and minimum normal tissue exposure
  • Allowed for a significantly higher tumor accumulation and lower renal elimination of IL-2 when compared to free IL-2 control
  • Induced strong antitumor efficacy with complete tumor regression as a monotherapy and a durable antitumor memory effect

About ONM-400

ONM-400 is a next-generation interleukin-2 (IL-2) program that has demonstrated a highly differentiated mechanism of action in preclinical studies. ONM-400 utilizes a proprietary pHsensitive micelle platform to encapsulate IL-2 and exploit a universal biomarker of all solid cancers – the low pH tumor microenvironment that is acidic relative to normal tissues – to deliver IL-2 directly to the tumor. ONM-400 micelles remain inactive at normal physiological pH until exposure to the acidic tumor microenvironment triggers micelle dissociation and IL-2 release. This has the potential to increase IL-2 accumulation within the tumor while avoiding healthy tissue toxicity, a common challenge of IL-2 therapy.

About OncoNano Medicine

OncoNano Medicine is developing a new class of products that exploit pH as a biomarker to diagnose and treat cancer with high specificity. Our product candidates are designed to help patients across the continuum of cancer care and include solid tumor therapeutics, agents for real-time image-guided surgery and a platform of product candidates that activate and guide the body’s immune system to target cancer. Learn more at


Lauren Arnold, 781-235-3060