• Initial Phase 1 data, recently published in Nature Communications, demonstrated clinical activity with no dose limiting toxicity in heavily pre-treated patients with solid tumors
• Ankyra will be presenting clinical biomarker data at the annual SITC meeting
• 3 additional abstracts were accepted for poster presentation at SITC

Ankyra Therapeutics, a clinical-stage biotechnology company pioneering anchored drug conjugate technology for cancer and other diseases, today announced the publication online of Part 1 results from its Phase 1 first-in-human study of tolododekin alfa in Nature Communications in the September 29, 2025, issue. Ankyra recently completed dose escalation of a phase 1 first-in-human study of monotherapy tolododekin alfa, the first anchored IL-12 designed for local tumor retention. The study was conducted at several centers in the United States and Canada in patients with progressive solid tumors. Data from Part 1 of the study focused on patients with superficially accessible tumors. “Tolododekin alfa demonstrated a tolerable safety profile and treatment was associated with monotherapy clinical activity in several types of cancers”, said Howard L. Kaufman, MD. “This data opens the door for realizing the therapeutic potential of interleukin-12 for patients with cancer.”

“The emerging data supports the proposed mechanism action for tolododekin alfa”, stated Joe Elassal, MD, chief medical officer at Ankyra Therapeutics, “and provides initial proof of concept for the anchored drug conjugate platform”. The company has an emerging pipeline and will be presenting initial data with their ANK-201 at the Society for Immunotherapy of Cancer annual meeting on November 7, 2025.

Ankyra Therapeutics Announces Multiple Scientific Presentations at SITC Meeting

Highlights include:

• NKT Cells as Predictive Biomarkers of Response to IL-12 Conjugate Immunotherapy Abstract# 189 (oral presentation)
  
  Exploratory analysis of phase 1 solid tumor patients treated demonstrates baseline levels of circulating natural killer T (NKT) cells may serve as predictive biomarkers of response to anchored IL-12 treatment.
• First-in-Class ANK-201 Data Abstract # 999
  
  Preclinical results from Ankyra’s next-generation candidate, ANK-201, will be presented for the first time, highlighting the expansion of the company’s pipeline beyond cytokines.
• Combination anchored IL-12 and HDAC inhibitor therapy improves therapeutic responses Abstract #631
  
  Results from an ongoing collaboration with the National Cancer Institute Center for Immuno-Oncology will report on anchored murine IL-12 in combination with a histone deacetylase (HDAC) inhibitor in checkpoint-refractory tumor models.
• Pharmacologic evaluation of a canine anchored IL-12 (JEN-101) in dogs with melanoma Abstract #1195
  
  In collaboration with Timothy M. Fan, DVM, PhD from the Department of Veterinary Clinical Medicine and Cancer Center at Illinois, University of Illinois at Urbana-Champaign and Jenga Biosciences, new data will be presented from a clinical trial of weight-based versus volume-based dosing of JEN-101, a canine anchored IL-12 conjugate, in dogs with melanoma.

“We are pleased with the data to be presented at the SITC meeting showing the therapeutic potential of anchored immunotherapy”, stated Howard Kaufman, MD.

About Tolododekin alfa (ANK-101)

Tolododekin alfa (ANK-101) is an anchored drug conjugate composed of interleukin-12 (IL-12) linked to aluminum hydroxide. ANK-101 enables local delivery of functional IL-12 to the tumor microenvironment where it remains biologically active for several weeks with transient exposure to the systemic circulation, thereby avoiding systemic toxicity. Treatment with ANK-101 in animal models has been associated with immune activation and rapid tumor regression. ANK-101 is being evaluated for the treatment of advanced solid tumors alone and in combination with anti-PD-1 agents. The first-in-human clinical trial of ANK-101 (NCT06171750) consists of monotherapy dose escalation, dose expansion in combination with cemiplimab, and dose optimization cohorts. The ANK-101-004 clinical trial (NCT07027514) will focus on non-mutated metastatic non-small cell lung cancer.

About Ankyra Therapeutics

Ankyra Therapeutics is a biotechnology company that has developed a highly differentiated technology platform that expands the therapeutic window of therapeutic drugs by forming a stable depot after local administration leading to prolonged immune activation and potent local and systemic immunity with reduced systemic toxicity. Ankyra is headquartered in Cambridge, Massachusetts. For more information, please visit www.ankyratx.com.

About Jenga Biosciences

Jenga Biosciences is an early-stage veterinary biotherapeutics company, utilizing breakthroughs from human biopharmaceuticals to enhance animal health. Specializing in pioneering immunotherapies for canine oncology, we are dedicated to extending and enhancing the quality of dogs’ lives. Our goal is to set new standards of care for canine cancer through cutting-edge therapies that are both accessible and affordable. Discover more at www.jengabio.com.

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