Articles from Ankyra Therapeutics

Ankyra Therapeutics, a leading clinical-stage company developing anchored drug conjugates for the treatment of cancer, today presented preliminary data highlighting the safety and biologic activity of their lead asset, tolododekin alfa (ANK-101), an anchored interleukin-12 (IL-12) drug conjugate. The data was derived from Part 1 of the first-in-human (FIH) ANCHOR Phase 1 clinical trial. The study was designed to evaluate the safety and feasibility of tolododekin alfa, as monotherapy in patients with advanced solid tumors. Dr. Howard Kaufman, Ankyra President and CEO stated that “We are extremely pleased with the data which provided support for the potential of the anchored drug conjugate platform.” He added “The study demonstrates for the first time that IL-12 can be delivered to tumors at therapeutic doses higher than previously achievable without systemic toxicity.” Systemic delivery of IL-12 has been evaluated in previous clinical studies, but development was halted after a maximum tolerated dose of 500 ng/kg prevented further dose escalation of IL-12 in cancer patients. Dr. Joe Elassal, Ankyra Chief Medical Officer added that tolododekin alfa “Phase 1 data are encouraging and we have seen that IL-12 anchoring has resulted in 6-fold higher local IL-12 delivery to established cancers compared with what has been achieved with systemic administration.” Furthermore, biomarker analysis of tumor-treated biopsies showed increased CD8+ T cell infiltration and induction of local PD-L1 expression. Dr. Elassal added “The high levels of PD-L1 seen provide strong justification for our expansion cohort combining tolododekin alfa with immune checkpoint blockade.” Ankyra reports that on March 25, 2025 the first patient with advanced cutaneous squamous cell carcinoma was treated with a combination of tolododekin-alfa and Regeneron’s PD-1 inhibitor, Libtayo® (cemiplimab), in an expansion cohort to the current Phase 1 trial.

Ankyra Therapeutics, a clinical stage biotechnology company pioneering anchored therapy to treat cancer, today announced the first patient dosed in a visceral tumor in Part 2 of their dose escalation Phase 1 study. The ANCHOR study is a first-in-human Phase 1 study being conducted in two parts. Part 1 is enrolling patients with superficially accessible tumors and is expected to complete enrollment by December 2024. Part 2 is now open to patients with solid tumors located in deep viscera accessed by interventional radiologic or endoscopic procedures for injection.

Ankyra is pleased to announce the appointment of Dr. Julia G. Butchko and Ms. Tara Withington to the Board of Directors effective September 25, 2024. They will both serve as independent board members and their appointment brings the total board composition to seven directors. “We are delighted to welcome Dr. Butchko and Ms. Withington to the Board”, stated Tillman Gerngross, PhD, Chairman of the Ankyra Board of Directors. “These accomplished individuals bring a fresh perspective to Ankyra at a critical time in the company’s growth.” Howard L. Kaufman, MD, President and Chief Executive Officer at Ankyra added “I am especially enthusiastic about working with Dr. Butchko and Ms. Withington since they bring considerable strengths in research and development as well as representing the patient perspective as we pursue our mission of delivering new drugs to patients with cancer.”

Ankyra Therapeutics, a clinical-stage oncology company developing anchored immunotherapies to improve the therapeutic window for immuno-oncology drugs, announced today that it is presenting a Trial in Progress poster for the phase 1 ANCHOR clinical trial at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting being held May 31 – June 4, 2024 in Chicago, IL.

Ankyra Therapeutics and Jenga Biosciences are pleased to announce today an exclusive license agreement to develop and commercialize JEN-101 (formerly known as cANK-101). JEN-101 is a first-in-class, pre-clinical immuno-oncology agent based on Ankyra’s anchored platform. JEN-101 is composed of a fully canine interleukin-12 (IL-12) complexed with aluminum hydroxide. The drug is designed to be retained within tumors for an extended period and provide therapeutic activity with limited systemic toxicity.

Ankyra Therapeutics, a clinical stage biotechnology company pioneering anchored immunotherapies to treat cancer, today announced the first patient dosed in the dose escalation cohort in a Phase 1 clinical study evaluating ANK-101, a tumor-directed, anchored immune medicine for solid tumors.

Ankyra Therapeutics, an emerging clinical-stage biotechnology company pioneering anchored immunotherapies to treat cancer, today announced results from a preclinical study demonstrating potent anti-tumor activity of its lead program ANK-101 were published in the December issue of the Journal of Clinical Investigation Insight (JCI Insight). The research paper is titled “Intratumoral aluminum hydroxide-anchored IL-12 drives potent antitumor activity by remodeling the tumor microenvironment.”

Ankyra Therapeutics, a clinical stage biotechnology company developing a new form of local immunotherapy termed “anchored immunotherapy,” today announced a clinical trial supply agreement with Regeneron to evaluate ANK-101 in combination with Regeneron’s anti-PD-1 therapy, Libtayo® (cemiplimab).

Ankyra Therapeutics, an emerging clinical stage biotechnology company pioneering anchored immunotherapies to treat cancer, today announced data from a preclinical study using ANK-101, an IL-12 anchored therapeutic, in combination with cytotoxic chemotherapy and immune checkpoint blockade, to treat head and neck squamous cell carcinoma, modeled by murine oral carcinoma (MOC1). The study was conducted jointly by Ankyra Therapeutics and the Center for Immuno-Oncology, part of the National Institute of Health’s National Cancer Institute Center for Cancer Research. The findings are being presented during the Society for Immunotherapy of Cancer Annual Meeting November 1-5, 2023 in San Diego, CA.

Ankyra Therapeutics, a clinical stage biotechnology company pioneering anchored immunotherapies to treat cancer, today announced approval of its investigational new drug (IND) application by the U.S. Food & Drug Administration (FDA) and clinical trial application (CTA) by Health Canada for its lead agent, ANK-101, a novel tumor-directed anchored immune medicine. The Company plans to initiate a first-in-human Phase I clinical trial of ANK-101 as a single agent in early 2024 at a limited number of clinical sites in the U.S. and Canada in patients with advanced solid tumors who have failed standard of care treatments.

Ankyra Therapeutics, a pre-clinical stage biotechnology company developing a new class of anchored immunotherapies to treat cancer, today presented preliminary data from an exploratory Phase 1 canine clinical study evaluating cANK-101, a canine IL-12 anchored therapeutic, to treat advanced malignant melanoma. The study is being conducted at the University of Illinois College of Veterinary Medicine. Timothy Fan, DVM, PhD, a professor of veterinary clinical medicine and Associate Director for Translation and Development at the Cancer Center at the University of Illinois, is the principal investigator. Dr. Fan presented findings in an oral session during the annual Veterinary Cancer Society conference in Reno, NV.

Ankyra Therapeutics, a clinical biotechnology company developing a new form of local immunotherapy termed “anchored immunotherapy,” today announced a clinical trial collaboration and supply agreement with Merck (known as MSD outside of the US and Canada) to evaluate ANK-101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) following the completion of a first-in-human phase I study of ANK-101 alone in patients with advanced solid tumors.

Ankyra Therapeutics, a pre-clinical biotechnology company developing targeted immune potentiating agents for the treatment of cancer, today announced the appointment of Robert V. Tighe, as chief scientific officer. He joined the team on July 10, 2023 and brings considerable immuno-oncology drug development experience to the company.

Ankyra Therapeutics, a pre-clinical-stage oncology company developing anchored immunotherapies to improve the therapeutic window for cytokine drugs, announced today that it will be presenting data from a canine clinical trial of cANK-101 at the American Association for Cancer Research (AACR) Annual Meeting being held April 14-19, 2023, in Orlando, FL. 

Ankyra Therapeutics, a biotech company developing targeted immune activating agents for the treatment of cancer, today announced the appointment of Stephen Gorgol as chief financial officer. Mr. Gorgol, a proven financial leader within the biotech industry, joins Ankyra from Replimune Inc., where he served as chief accounting officer.

Ankyra Therapeutics, a biotech company developing targeted immune activating agents for the treatment of cancer, today announced that is has entered into a strategic collaboration with the Lung Cancer Initiative (LCI) at Johnson & Johnson*. The collaboration will focus on the advancement of Ankyra’s lead product candidate, ANK-101, an IL-12-based locally administered immunotherapy, as a potential treatment for lung cancer. Ankyra is currently advancing ANK-101 through Investigational New Drug (IND) enabling studies for the treatment of solid tumors and plans to submit an IND to the U.S. Food and Drug Administration in the third quarter of 2023.

Ankyra Therapeutics, a biotech company developing targeted immune activating agents for the treatment of cancer, today announced that Leisha A. Emens, M.D., Ph.D., has been appointed as senior vice president, translational research. Dr. Emens is an experienced oncologist who joins Ankyra after an extensive career in academia, most recently holding positions at the University of Pittsburgh Medical Center.

Ankyra Therapeutics, a biotech company developing targeted immune activating agents for the treatment of cancer, today announced that new, preclinical data highlighting the potential of the company’s lead program, ANK-101, an IL-12-based treatment, to deliver potent anti-tumor responses following intratumoral administration will be presented during a poster presentation at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting. SITC is being held November 10-13, 2022, virtually and in Boston.

Ankyra Therapeutics, a company developing targeted immune potentiating agents for the treatment of cancer, today announced the appointment of Joseph J. Elassal, M.D., as chief medical officer. Dr. Elassal will fill the role formerly served by Howard Kaufman, M.D., who was recently promoted to president and chief executive officer of Ankyra Therapeutics.

Ankyra Therapeutics is pleased to announce that it has entered into a formal research collaboration with the College of Veterinary Medicine at the University of Illinois Urbana-Champaign. Ankyra is developing a novel anchored immunotherapy platform that allows retention of immune-oncology drugs in the tumor microenvironment for several weeks. This promotes local immune-mediated tumor regression while limiting systemic toxicity. Ankyra has developed a canine IL-12 drug designated cANK-101. The collaboration with the U. of I. will evaluate the safety and effectiveness of cANK-101 in dogs with oral malignant melanoma. Dr. Timothy Fan, DVM, PhD, a veterinary oncologist, Professor of Veterinary Clinical Medicine at the U. of I. and program leader for the Cancer Center at Illinois, will lead the project. Dr. Fan’s lab will also conduct biomarker research designed to better understand the mechanism of action of cANK-101 in dogs with melanoma.

Ankyra Therapeutics is pleased to announce that it has established a formal Cooperative Research and Development Agreement with the National Cancer Institute (NCI) to pursue basic, translational and clinical research using Ankyra Therapeutics’ emerging anchored immunotherapy pipeline in collaboration with NCI’s Center for Cancer Research (CCR). CCR is located within the National Institutes of Health (NIH) in Bethesda, Maryland, and it has made many contributions to cancer therapy. CCR includes intramural investigators focused on understanding cancer biology and developing new therapeutic strategies for the treatment of cancer. The primary NCI investigators include Dr. Jeffrey Schlom, Chief of the Laboratory of Tumor Immunology and Biology in CCR, NCI, and Dr. James Gulley, Chief of the Genitourinary Malignancies Branch, Director of the Medical Oncology Service, and Deputy Director of the CCR, NCI.

Ankyra Therapeutics, a company developing cancer therapies based on tumor localized immune potentiating agents, announced today that the Board of Directors has appointed Howard L. Kaufman, MD as Chief Executive Officer effective March 22, 2022. He will be the first CEO for the company and previously served as the Chief Medical Officer at Ankyra. Co-founder Tillman Gerngross, PhD will remain as Chairman of the Board at Ankyra Therapeutics.

Ankyra Therapeutics, a company developing cancer therapies based on tumor localized immune potentiating agents that boost anti-tumor immune responses, today announced the closing of a $45 million Series B financing. Proceeds from the financing will be used to progress Ankyra’s lead molecule, ANK-101 through Investigational New Drug (IND) enabling studies and into Phase 1 clinical trials, as well as advance additional cytokine programs.