tolododekin alfa (ANK-101) / Ankyra Therap - LARVOL DELTA

Ankyra Therapeutics Announces Phase 1 Clinical Data at the 2025 AACR Annual Meeting and the first patient has been dosed with tolododekin alfa and cemiplimab (Businesswire) - P1 | N=107 | ANCHOR (NCT06171750) | Sponsor: Ankyra Therapeutics, Inc | "The data was derived from Part 1 of the first-in-human (FIH) ANCHOR Phase 1 clinical trial...Key Study Findings...Primary tumor histology included melanoma (n=7), head and neck cancer (n=4), breast cancer (n=2), bladder cancer (n=1), and apocrine adenocarcinoma (n=1); ANK-101 monotherapy was well-tolerated at doses up to 250 µg/mL with no DLTs or Grade 3 or greater treatment-related treatment-emergent adverse events (TEAEs); Highly efficient tumor retention with low (generally <1%) systemic IL-12-ABP; ANK-101 induced CD8+ T cell recruitment, PD-L1 expression, and inflammatory gene signatures consistent with biologic IL-12 activity.... 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."

P1 data • Trial status • Bladder Cancer • Breast Cancer • Head and Neck Cancer • Melanoma • Skin Cancer • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Results of a first-in-human phase 1 trial of anchored IL-12 drug conjugate (ANK-101) (AACR 2025) - P1 | "ANK-101 is well tolerated at doses tested, demonstrated biologic activity, and was associated with durable disease control across different tumors in a heavily pretreated population. Further investigation is warranted."

IO biomarker • P1 data • Bladder Cancer • Breast Cancer • Head and Neck Cancer • Melanoma • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD8 • IFNG • IL12A • PD-L1

A phase 1, open-label, dose expansion cohort of the tolerability of tolododekin alfa (ANK-101) in combination with cemiplimab in cutaneous squamous cell carcinoma. (ASCO 2025) - P1 | "Clinical Trial Registration Number: NCT06171750 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • Combination therapy • P1 data • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

A pharmacokinetic and pharmacodynamic model of an interleukin-12 (IL-12) anchored-drug conjugate for the treatment of solid tumors. (PubMed, Mol Cancer Ther) - "In addition, serum IFNG may be a surrogate marker for drug activity. The PK modeling predictions may also contribute to determining the optimal clinical dose and schedule of ANK-101 and other anchored drug conjugates in patients with solid tumors."

Journal • PK/PD data • Oncology • Solid Tumor • CD8 • IFNG • IL12A

A phase 1, open-label, dose escalation study of the safety and tolerability of ANK-101 in advanced solid tumors (SITC 2024) - P1 | "Clinical trial information: Clinical Trial Registry NCT06171750. Research Sponsor: Ankyra Therapeutics."

Clinical • IO biomarker • Metastases • P1 data • Oncology • Solid Tumor • CD68 • CD8 • IL12A • PD-L1

Ankyra Therapeutics Announces First Visceral Tumor Patient Dosed in Phase 1 ANCHOR Clinical Trial of ANK-101, an Anchored Interleukin-12 (IL-12) (Businesswire) - "Ankyra Therapeutics...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."

Trial status • Oncology • Solid Tumor

A phase 1, open-label, dose escalation study on the safety and tolerability of ANK-101 in advanced solid tumors. (ASCO 2024) - P1 | "PD assessments will include serum cytokines and circulating immune cells, and local levels of PD-L1, CD8+ T cells, and CD68+ macrophages, and changes in gene expression within the TME. This clinical trial is in progress."

Clinical • IO biomarker • Metastases • P1 data • Hematological Disorders • Immunology • Oncology • Solid Tumor • CD68 • CD8 • IL12A • PD-L1

Ankyra Therapeutics Announces Trial in Progress Poster Presentation at 2024 ASCO Meeting and Approval of ANK-101 Phase 1 Protocol Amendment (Businesswire) - "Ankyra Therapeutics...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...The poster presentation will include the rationale for the trial, study objectives, clinical trial design, and an update on accrual. The study will also evaluate pharmacokinetics, immune biomarkers, and quality of life....In addition, Ankyra has received clearance from both the U.S. Food and Drug Administration (FDA) and Health Canada to amend the phase I clinical trial to include a second dose-escalation and expansion part to evaluate ANK-101 for injection into solid tumors located in visceral organs. This part will run concurrently with the current Phase I study with dosing to begin once patients in the superficial part have cleared a 21-day dose-limiting toxicity (DLT) observation period."

Clinical protocol • Trial status • Oncology • Solid Tumor

ANCHOR: Phase I Study of ANK-101 in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=92 | Recruiting | Sponsor: Ankyra Therapeutics, Inc | N=46 ➔ 92

Enrollment change • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Anchored IL-12 synergizes with an epigenetic modulator to promote immune remodeling and overcome anti-PD1-refractory murine tumors (AACR 2024) - "Significant decrease in CD4+ Tregs and increased CD8/Treg ratio were also observed. Ongoing functional studies, proteomic and immune cell analysis at the tumor site, tdLN, and periphery, including single cell transcriptomics and epigenetic studies, will allow for a deeper understanding of the synergistic effect of mANK-101 with the epigenetic modulator Entinostat.Conclusions Collectively, these findings form a rationale for the clinical combination of intralesional delivery of ANK-101 with entinostat for patients with ICB-refractory malignancies, including colorectal and HPV16neg head and neck cancers."

Preclinical • Head and Neck Cancer • Oncology • Solid Tumor • CD4 • CD8 • IFNG • IL12A • KRAS • TNFA

Ankyra Therapeutics Announces First Patient Dosed in Phase 1 Clinical Trial Dose Escalation Cohort Evaluating ANK-101, an Anchored Immune Medicine, for Solid Tumors (Businesswire) - "Ankyra Therapeutics...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....The dose escalation cohort portion of the study will assess the safety of ANK-101 and determine the recommended dose for expansion in people with cutaneous, subcutaneous, soft tissue, or nodal malignancies, with an additional 10 participants ultimately dosed at the recommended dose for expansion (RDE)."

Trial status • Solid Tumor

ANCHOR: Phase I Study of ANK-101 in Advanced Tumors (clinicaltrials.gov) - P1 | N=46 | Recruiting | Sponsor: Ankyra Therapeutics, Inc | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Oncology • Solid Tumor

ANCHOR: Phase I Study of ANK-101 in Advanced Tumors (clinicaltrials.gov) - P1 | N=46 | Not yet recruiting | Sponsor: Ankyra Therapeutics, Inc

Metastases • New P1 trial • Oncology • Solid Tumor

Intratumoral aluminum hydroxide-anchored IL-12 drives potent antitumor activity by remodeling the tumor microenvironment. (PubMed, JCI Insight) - "Subcutaneous administration of ANK-101 in cynomolgus macaques was well tolerated. Together, these data demonstrate that ANK-101 has an enhanced efficacy and safety profile and warrants future clinical development."

Biomarker • Journal • Tumor microenvironment • Oncology • IFNG • IL12A

Ankyra Therapeutics Announces Pre-Clinical Research Published in December JCI Insight Demonstrating Potent Anti-Tumor Activity of Anchored IL-12 in Multiple Murine Cancer Models (Businesswire) - "Ankyra Therapeutics...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)...Ankyra’s anchored immunotherapy platform achieves retention of the drug ANK-101 at the injected site for approximately four weeks...Anti-tumor activity mediated by the drug was associated with recruitment of immune cells and remodeling the tumor microenvironment....Human ANK-101, when tested in cynomolgus macaques, was well tolerated."

Preclinical • Oncology • Solid Tumor

Ankyra Therapeutics Announces Clinical Trial Supply Agreement with Regeneron to Evaluate ANK-101 in Combination with Libtayo (cemiplimab) in Patients with Cutaneous Squamous Cell Carcinoma (Businesswire) - "Ankyra Therapeutics...today announced a clinical trial supply agreement with Regeneron to evaluate ANK-101 in combination with Regeneron’s anti-PD-1 therapy, Libtayo^® (cemiplimab)....The combination study will proceed following Ankyra’s first-in-human phase I clinical trial, which is starting in the first quarter of 2024."

Licensing / partnership • New P1 trial • Melanoma • Oncology • Skin Cancer • Solid Tumor

Ankyra Therapeutics Announces Promising Preclinical Data on ANK-101, a Novel Anchored Immune Medicine, in Combination with Cytotoxic Chemotherapy in Head and Neck Cancer Model (Businesswire) - "Ankyra Therapeutics...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 findings are being presented during the Society for Immunotherapy of Cancer Annual Meeting November 1-5, 2023....Data presented showed that a single dose of mANK-101 was associated with a significant delay in tumor growth in the MOC1 model, while anti-PD-1 and cisplatin alone, or in combination, had minimal impact on tumor growth."

Preclinical • Head and Neck Cancer • Oral Cancer

Improved immunologic and therapeutic activity of anchored interleukin (IL-12) immunotherapy in combination with cytotoxic chemotherapy and immune checkpoint inhibitor in a head and neck cancer model (SITC 2023) - "Murine ANK-101 is a novel anchored form of IL-12 that persists in the tumor microenvironment for up to 30 days without systemic toxicity...Conclusions Anchored IL-12 improves therapeutic responses to cis-platinum chemotherapy and immune checkpoint blockade in the murine PD-1-refractory MOC1 head and neck cancer model. These preliminary data demonstrate that combining local IL-12 with cytotoxic chemotherapy and/or immune checkpoint blockade merits investigation in other tumor models."

Checkpoint inhibition • Combination therapy • Preclinical • Head and Neck Cancer • Oncology • Oral Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD8 • IL12A

Ankyra Therapeutics Receives FDA IND and Health Canada CTA Approval to Advance First-In-Class Selective Anchored Immunotherapy Agent, ANK-101, into Human Trials in Solid Tumors (Businesswire) - "Ankyra Therapeutics...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."

IND • New P1 trial • Solid Tumor

Ankyra Therapeutics Presents Preliminary Phase 1 Canine Clinical Data Evaluating cANK-101 to Treat Advanced Malignant Melanoma in Dogs (Businesswire) - "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....'We are highly encouraged by the safety and tolerability profile of our anchored IL-12 in canines and plan to initiate a Phase 1 clinical study in humans in early 2024...'"

New P1 trial • Preclinical • Melanoma • Oncology • Skin Cancer • Solid Tumor

Ankyra Therapeutics Announces Clinical Trial Collaboration and Supply Agreement with Merck to Evaluate ANK-101 in Combination with KEYTRUDA (pembrolizumab) in Patients with Advanced Solid Tumors (Businesswire) - '"ANK-101 has demonstrated therapeutic activity in several preclinical models and has been shown to strongly induce expression of PD-1 within the tumor microenvironment,' said Robert Tighe..."

Media quote

Ankyra Therapeutics Announces Clinical Trial Collaboration and Supply Agreement with Merck to Evaluate ANK-101 in Combination with KEYTRUDA (pembrolizumab) in Patients with Advanced Solid Tumors (Businesswire) - "Ankyra Therapeutics...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. Pending completion of a first-in-human phase I study, ANK-101 would advance to KEYNOTE-E56, a clinical trial designed to evaluate ANK-101 in combination with pembrolizumab in patients with advanced solid tumors. The study is anticipated to begin enrollment in 2024."

Licensing / partnership • New trial • Solid Tumor

Ankyra Therapeutics Announces Collaboration to Evaluate ANK-101 in Early Clinical Trials Focused on Lung Cancer (Businesswire) - "Ankyra Therapeutics...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."

IND • Licensing / partnership • Lung Cancer • Oncology • Solid Tumor

Anchored immunotherapy with intratumorally administered aluminum hydroxide-tethered IL-12 induces potent anti-tumor immune response (SITC 2022) - "Methods Human or murine IL-12 was genetically fused to a phosphorylated alum-binding peptide (IL-12-ABP) and mixed with aluminum hydroxide to form the therapeutic complexes ANK-101 (human) or mANK-101 (mouse)...Conclusions Anti-tumor activity of locally retained IL-12/alum is mediated by recruitment and activation of lymphocytes and myeloid immune cells. Anchored immunotherapy may represent a general approach to improve the therapeutic potential of immuno-oncology agents."

IO biomarker • Oncology • CD8 • IFNG • IL12A

Ankyra Therapeutics Presents Positive Preclinical Data Supporting Advancement of ANK-101 into Clinical Studies for Treatment of Solid Tumors (Businesswire) - "Ankyra Therapeutics...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....Administration of mANK-101 was efficacious in diverse syngeneic tumor models, including large tumors, leading to substantial reductions in tumor volume after one or two injections....Ankyra is currently advancing ANK-101 through Investigational New Drug (IND) enabling studies and plans to submit an IND to the U.S. Food and Drug Administration in the second quarter of 2023."

IND • Preclinical • Oncology • Solid Tumor