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

Ankyra Therapeutics Announces First Patient Dosed in Phase 1b Trial Evaluating First-in-Class Anchored Immunotherapy in Combination with Immune Checkpoint Blockade in Patients with Lung Cancer (Businesswire) - "This study will evaluate the combination of Ankyra’s tolododekin alfa (ANK-101), an anchored IL-12 drug conjugate with the anti-PD1 agent, cetrelimab, in patients who have progressed after initial treatment of metastatic, non-mutated non-small cell lung cancer (NSCLC). In addition, the study will evaluate tolododekin alfa in combination with standard of care immune checkpoint blockade in first-line treatment of patients with metastatic, non-mutated NSCLC and a tumor proportion score (TPS) of ≥ 50%."

Trial status • Non Small Cell Lung Cancer

Intratumoral IL-12 in combination with HDAC inhibition overcomes checkpoint-refractory tumors (SITC 2025) - "In this study, we investigated the anti-tumor activity and mechanism of action of murine ANK-101 (mANK-101) delivered intratumorally in combination with the class I histone deacetylase (HDAC) inhibitor entinostat, in different ICB-refractory murine tumor models, including CT26 (colorectal) and MOC-1 (HPV16neg head and neck).Methods Mice receiving Entinostat diet and/or mANK-101 were monitored for anti-tumor activity, survival and protective memory. Notably, spatial analysis of tumor architecture indicates the development of B-cell rich stemness hubs exclusive to combination therapy. Ongoing in-depth studies including single cell transcriptomics in the tumor and tDLN, and investigation of the role of immune stemness hubs in the observed anti-tumor activity will allow for an in-depth understanding of the synergistic effect of mANK-101 with HDAC inhibition.Conclusions Collectively, these findings provide a rationale for the combination of intratumoral delivery of anchored..."

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

Baseline NKT cells as a potential predictive biomarker for treatment with an anchored IL-12 drug conjugate in patients with solid tumors (SITC 2025) - P1 | "ANK-101 (tolododekin alfa) is an alum-anchored IL-12 drug conjugate designed to deliver and retain high doses of IL-12 in solid tumors...Higher baseline NKT cells were associated with disease control. Further studies are warranted to better define if NKT cells may serve as a predictive biomarker for IL-12 immunotherapy."

Biomarker • Clinical • IO biomarker • Oncology • Solid Tumor • CD8 • IFNG • IL12A • NCAM1 • PTPRC

Ankyra Announces Publication of Phase 1 Clinical Data, and Will Present at the Society for Immunotherapy of Cancer (SITC) Annual Meeting (Businesswire) - "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...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...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."

P1 data • Preclinical • Solid Tumor

ANK-101, an anchored IL-12 drug conjugate, induces immune responses and therapeutic activity in patients with HPV negative squamous cell carcinoma of the head and neck (HNSCC): A subset analysis of the Phase 1 ANCHOR clinical trial [WITHDRAWN] (ESMO 2025) - No abstract available

Clinical • P1 data • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • IL12A

ANK-101-004: A Study of Tolododekin Alfa (ANK-101) in Combination With an Anti-PD-1/PD-L1 Antibody in Participants With Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Ankyra Therapeutics, Inc | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Interleukin-12 anchored drug conjugate (tolododekin alfa) in patients with advanced solid tumors: first-in-human Phase 1 trial. (PubMed, Nat Commun) - P1 | "These findings support continued clinical development of tolododekin alfa. ClinicalTrials.gov registration: NCT06171750."

First-in-human • IO biomarker • Journal • P1 data • Oncology • Solid Tumor • CD8 • IL12A • PD-L1

A Study of Tolododekin Alfa (ANK-101) in Renal Allograft Recipients With High Risk Cutaneous Squamous Cell Carcinoma (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: Ankyra Therapeutics, Inc

New P1 trial • Non-melanoma Skin Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer • Transplantation

ANCHOR: Phase I Study of Tolododekin Alfa (ANK-101) in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=97 | Recruiting | Sponsor: Ankyra Therapeutics, Inc | Trial completion date: Jan 2026 ➔ Jun 2027 | Trial primary completion date: Jul 2025 ➔ Apr 2027

Trial completion date • Trial primary completion date • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer • IL12A

A Study of Tolododekin Alfa (ANK-101) in Combination With an Anti-PD-1/PD-L1 Antibody in Participants With Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: Ankyra Therapeutics, Inc

New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

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 Registry NCT06171750. Research Sponsor: Ankyra Therapeutics."

Clinical • Combination therapy • IO biomarker • P1 data • Hematological Disorders • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer • IL12A

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

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

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