A study of tolododekin alfa (also known as ANK-101) administered prior to surgery in kidney transplant participants that also have high-risk cutaneous squamous cell carcinoma (CSCC).

Start Date15 Dec 2025

Sponsor / Collaborator

Ankyra Therapeutics, Inc.

NCT07027514

/ RecruitingPhase 1

A Phase 1b, Two-Part 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

A study of tolododekin alfa (also known as ANK-101) administered in combination with an anti-programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) antibody in participants with advanced or metastatic non-small cell lung cancer (NSCLC). Cohort A will enroll participants who have progressed on prior standard of care treatment with an anti-PD-1/PD-L1 antibody and a platinum-based chemotherapy regimen. Cohort B will enroll participants who are treatment-naïve for locally advanced or metastatic NSCLC.

Start Date22 Oct 2025

Sponsor / Collaborator

Ankyra Therapeutics, Inc.

NCT06171750

/ RecruitingPhase 1

A Phase I Open-Label, Dose Escalation Study of the Safety and Tolerability of Tolododekin Alfa (ANK-101) in Advanced Solid Tumors

This is a Phase 1, multicenter, open-label dose escalation study to determine the safety and tolerability of intratumoral (IT) injection of tolododekin alfa (ANK-101) in participants with advanced solid tumors who have progressed during or after receiving standard of care (SOC) therapy or who will not benefit from such therapy. The study will be conducted in three parts; in Part 1, participants with superficial lesions will receive ANK-101 as a single agent; in Part 2, participants with visceral lesions will receive ANK-101 as a single agent; and in Part 3, participants with cutaneous squamous cell carcinoma (CSCC) will receive ANK-101 in combination with cemiplimab.

Start Date19 Jan 2024

Sponsor / Collaborator

Ankyra Therapeutics, Inc.

100 Clinical Results associated with Tolododekin Alfa

100 Translational Medicine associated with Tolododekin Alfa

100 Patents (Medical) associated with Tolododekin Alfa

Literatures (Medical) associated with Tolododekin Alfa

02 Jul 2025·MOLECULAR CANCER THERAPEUTICS

A Pharmacokinetic and Pharmacodynamic Model of an IL-12 Anchored-Drug Conjugate for the Treatment of Solid Tumors

Article

Author: Battula, Sailaja ; Hodson, David ; Tighe, Robert ; Kaufman, Howard L. ; Mistry, Hitesh B. ; Schmidt, Michael M. ; Chassagnole, Christophe

Abstract:

IL-12 mediates innate and adaptive immune responses and has demonstrated therapeutic antitumor activity, but clinical development has been hindered by a narrow therapeutic window. We generated a novel IL-12–anchored drug conjugate by physiochemical linking of murine IL-12 to aluminum hydroxide (alum). The complex was designed to utilize alum as a scaffolding for durable retention of IL-12 within the tumor microenvironment as a strategy to increase the therapeutic window. To better define the systemic pharmacokinetic (PK) profile of the anchored IL-12 (mANK-101), a model-based assessment tool was developed to describe the systemic PK profile and downstream signaling factors following intratumoral injection of mANK-101. When compared with nonanchored IL-12, mANK-101 exhibited a distinct PK profile. Specifically, mANK-101 treatment was associated with a significant ninefold increase in the systemic terminal volume of distribution (Vd). Furthermore, linear mixed-effects models provided evidence that CD8+ T-cell infiltration and increased serum IFN-γ levels were correlated with tumor regression after a single dose of mANK-101. In addition, PK/pharmacodynamic modeling confirmed a link between systemic IL-12 and serum IFN-γ. The model also suggests that the anchored IL-12 drug conjugate is expected to prolong the absorption half-life (115 hours vs. 8 hours for the unanchored drug) with durable local retention and limited systemic absorption. In addition, serum IFN-γ may be a surrogate marker for drug activity. The PK modeling predictions may also contribute to determining the optimal clinical dose and schedule of mANK-101 and other anchored drug conjugates in patients with solid tumors.

01 Oct 2024·Journal for ImmunoTherapy of Cancer

Alum-anchored IL-12 combined with cytotoxic chemotherapy and immune checkpoint blockade enhanced antitumor immune responses in head and neck cancer models

Article

Author: Battula, Sailaja ; Lassoued, Wiem ; Kaufman, Howard ; Fabian, Kellsye P ; Hodge, James W ; Allen, Clint Tanner ; Padget, Michelle R ; Santiago-Sanchez, Ginette

Background:

First-line treatment with pembrolizumab plus chemotherapy in recurrent and metastatic head and neck squamous cell carcinomas (HNSCC) has improved survival. However, the overall response rate with this standard of care regimen (SOC) remains limited. Interleukin (IL)-12 is a potent cytokine that facilitates the crosstalk between innate and adaptive immunity, making it crucial in the antitumor response. Alum-anchored murine IL-12 (mANK-101) has been demonstrated to elicit robust antitumor responses in diverse syngeneic models, which were correlated with increased immune effector functions and prolonged local retention of IL-12. This study investigates the therapeutic benefit of combining mANK-101 with SOC in the MOC1 and MOC2 murine HNSCC tumor models.

Methods:

MOC1 and MOC2 tumor-bearing C57BL/6 mice were administered with a single intratumoral injection of mANK-101 and weekly intraperitoneal injections of cisplatin and α-programmed death 1 (PD-1) for 3 weeks. For MOC1, flow cytometry and cytokine array were performed to assess the immune effector functions associated with the combinational treatment. Multiplex immunofluorescence was employed to characterize the influence of the treatment on the immune architecture in the tumors. RNA analysis was implemented for in-depth examination of the macrophage and effector populations.

Results:

In the MOC1 and MOC2 models, combination therapy with mANK-101, cisplatin, and α-PD-1 resulted in superior tumor growth inhibition and resulted in the highest rate of tumor-free survival when compared with treatment cohorts that received mANK-101 monotherapy or SOC treatment with α-PD-1 plus cisplatin. Furthermore, the combination therapy protected against tumor re-growth on rechallenge and controlled the growth of distal tumors. The improved therapeutic effect was associated with increased CD8+ T-cell recruitment, increased CD8+ and CD4+ activity, and repolarization of the macrophage population from M2 to M1 at the tumor site. Elevated and prolonged interferon-γ expression is central to the antitumor activity mediated by the combination therapy. In addition, the combination therapy with mANK-101+cisplatin+α-PD-1 induced the formation of tertiary lymphoid structure-like immune aggregates in the peritumoral space.

Conclusion:

The current findings provide a rationale for the combination of alum-tethered IL-12 with cisplatin and α-PD-1 for HNSCC.

08 Dec 2023·JCI insight

Intratumoral aluminum hydroxide–anchored IL-12 drives potent antitumor activity by remodeling the tumor microenvironment

Article

Author: Kaufman, Howard L. ; Battula, Sailaja ; Schmidt, Michael M. ; Papastoitsis, Gregory ; Wittrup, K. Dane

IL-12 is a potent cytokine that can promote innate and adaptive anticancer immunity, but its clinical development has been limited by toxicity when delivered systemically. Intratumoral (i.t.) administration can expand the therapeutic window of IL-12 and other cytokines but is in turn limited by rapid drug clearance from the tumor, which reduces efficacy, necessitates frequent administration, and increases systemic accumulation. To address these limitations, we developed an anchored IL-12 designated ANK-101, composed of an engineered IL-12 variant that forms a stable complex with the FDA-approved vaccine adjuvant aluminum hydroxide (Alhydrogel). Following i.t. administration of murine ANK-101 (mANK-101) in early intervention syngeneic mouse tumors, the complex formed a depot that was locally retained for weeks as measured by IVIS or SPECT/CT imaging, while unanchored protein injected i.t. was cleared within hours. One or 2 i.t. injections of mANK-101 induced single-agent antitumor activity across a diverse range of syngeneic tumors, including models resistant to checkpoint blockade at doses where unanchored IL-12 had no efficacy. Local treatment with mANK-101 further induced regressions of noninjected lesions, especially when combined with systemic checkpoint blockade. Antitumor activity was associated with remodeling of the tumor microenvironment, including prolonged IFN-γ and chemokine expression, recruitment and activation of T and NK cells, M1 myeloid cell skewing, and increased antigen processing and presentation. 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.

News (Medical) associated with Tolododekin Alfa

27 May 2026

·www.biospace.com

Ankyra Therapeutics Announces Presentations on Novel IL-12 Anchored Immunotherapy at 2026 ASCO

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Ankyra Therapeutics, a clinical-stage biotechnology company pioneering anchored immunotherapy to deliver better outcomes for people with cancer and other serious diseases, announced two poster presentations will be featured at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 29 to June 2 in Chicago. The presentations highlight ongoing Phase 1 clinical trials of tolododekin alfa, a novel IL-12 anchored immunotherapy, including a trial-in-progress poster describing its evaluation in combination with an anti-PD-1/PD-L1 antibody in people with advanced non-small cell lung cancer (NSCLC), as well as baseline quality-of-life data from a separate Phase 1 trial of tolododekin alfa in people with advanced or metastatic solid tumors. These presentations underscore Ankyra’s commitment to advancing anchored immunotherapy as a practical platform design that retains high-dose therapeutics, like IL-12, at the tumor site to deliver enhanced efficacy with lower systemic toxicity. Presentation details: Title: A Phase 1b, Two-Arm 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 (NSCLC) Type: Poster Session Session: Developmental Therapeutics – Immunotherapy Abstract: #TPS2678 Poster: #461b Date / time : Saturday, May 30, 2026; 1:30 – 4:30 pm CDT; Hall A Lead author: Thomas Marron, MD, PhD, Division of Hematology and Medical Oncology, Tisch Cancer Institute, Icahn School of Medicine, Mount Sinai, New York Title: Quality-of-Life in Cancer Patients Treated with Anchored Interleukin-12 (IL-12) Immunotherapy: Results from a First-in-Human Phase 1 Trial of Tolododekin Alfa (ANK-101) Type: Poster Session Session: Developmental Therapeutics – Immunotherapy Abstract: #2593 Poster: #383 Date / time : Saturday, May 30, 2026; 1:30 – 4:30 pm CDT; Hall A Lead author: Jong Chul Park, MD, Mass General Brigham, Harvard Medical School, Boston About tolodoken alfa Tolododekin alfa is an investigational, first-in-class interleukin-12 (IL-12)-anchored immunotherapy. IL-12 is a highly potent proinflammatory cytokine, but its therapeutic use has been limited by toxicity. With Ankyra’s anchoring technology, tolododekin alfa has been shown to deliver and retain high doses of IL-12 in the tumor microenvironment. Early results from an ongoing Phase 1 study show durable retention within tumors, encouraging clinical activity, and a favorable safety profile, with no dose-limiting toxicities across multiple difficult-to-treat solid tumor types. Ankyra is also evaluating tolododekin alfa for the treatment of non-small cell lung cancer and cutaneous squamous cell carcinoma. About Ankyra Therapeutics Ankyra Therapeutics is a clinical-stage biotechnology company pioneering anchored immunotherapy to deliver better outcomes for people with cancer and other serious immune-mediated diseases. Powered by its novel anchoring platform, Ankyra engineers therapies that unlock the full therapeutic potential of immune-modulating drugs once limited by toxicity. Anchored immunotherapies are designed to stay precisely at the disease site, allowing higher doses for greater therapeutic impact while limiting systemic exposure. Ankyra is advancing a robust pipeline of first-in-class therapies and strategic collaborations to shape the next generation of immunotherapy. For more information, please visit . Contacts For Investor and Media Inquiries: Howard L. Kaufman, MD President and CEO, Ankyra Therapeutics, Inc. info@ankyratx.com

Phase 1ImmunotherapyASCOClinical Result

16 Apr 2026

·www.businesswire.com

Ankyra Therapeutics Announces Clinical Presentations on Novel IL-12 Anchored Immunotherapy at AACR 2026

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Ankyra Therapeutics, a clinical-stage biotechnology company pioneering anchored immunotherapy to deliver better outcomes for people with cancer and other serious diseases, announced two poster presentations will be featured at the American Association for Cancer Research (AACR) Annual Meeting, taking place April 17-22 in San Diego. The presentations cover data from the ongoing Phase 1 clinical trial of tolododekin alfa, a novel IL-12 anchored immunotherapy, and preclinical data on anchored immunotherapy in combination with HDAC for the treatment of checkpoint-refractory solid tumors. Patients interested in enrolling in the Phase 1 clinical trial at the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), may contact the toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615) and/or visit the web site: https://trials.cancer.gov and/or email NCIMO_referrals@mail.nih.gov. Presentation details: Title: Immune Escape via Myeloid-Derived Suppressor Cells in Solid Tumor Cancer Patients Treated with Anchored IL-12 (Tolododekin Alfa)? Type: Poster Presentation Session: First-in-Human Phase 1 Clinical Trials Date and time: April 20, 2:00-5:00pm PST Abstract number: CT123 Lead author: Wiem Lassoued, Ph.D., Center for Immuno-oncology, National Cancer Institute Title: Intratumoral IL-12 in combination with HDAC inhibition overcomes checkpoint-refractory tumors Type: Poster Presentation Session: Combination Immunotherapies Date and time: April 20, 9:00am-12:00pm PST Abstract number: 1563 Lead author: Ainara Meler, Ph.D., Center for Immuno-oncology, National Cancer Institute About tolodoken alfa Tolododekin alfa is an investigational, first-in-class interleukin-12 (IL-12)-anchored immunotherapy. IL-12 is a highly potent proinflammatory cytokine, but its therapeutic use has been limited by toxicity. With Ankyra’s anchoring technology, tolododekin alfa has been shown to deliver and retain high doses of IL-12 in the tumor microenvironment. Early results from an ongoing Phase 1 study show durable retention within tumors, encouraging clinical activity, and a favorable safety profile, with no dose-limiting toxicities across multiple difficult-to-treat solid tumor types. Ankyra is also evaluating tolododekin alfa for the treatment of non-small cell lung cancer and cutaneous squamous cell carcinoma. About Ankyra Therapeutics Ankyra Therapeutics is a clinical-stage biotechnology company pioneering anchored immunotherapy to deliver better outcomes for people with cancer and other serious immune-mediated diseases. Powered by its novel anchoring platform, Ankyra engineers therapies that unlock the full therapeutic potential of immune-modulating drugs once limited by toxicity. Anchored immunotherapies are designed to stay precisely at the disease site, allowing higher doses for greater therapeutic impact while limiting systemic exposure. Ankyra is advancing a robust pipeline of first-in-class therapies and strategic collaborations to shape the next generation of immunotherapy. For more information, please visit www.ankyratx.com.

ImmunotherapyPhase 1AACR

18 Feb 2026

·www.businesswire.com

Ankyra Therapeutics Presents First Preclinical Data on ANK-203, a Novel CD137-Anchored Immunotherapy Candidate, in Oral Session at AACR IO

ANK-203 is a first-in-class anchored immunotherapy designed to unlock the full therapeutic potential of monoclonal antibody CD137 through localized delivery and retention In preclinical studies, ANK-203 activated the CD137 (4-1BB) immune pathway and showed strong anti-tumor activity with no observed systemic toxicity; additional studies are underway Ankyra’s pipeline also includes tolododekin alfa, an IL-12 anchored immunotherapy with promising Phase 1 clinical activity and favorable tolerability as monotherapy in advanced solid tumors CAMBRIDGE, Mass.--(BUSINESS WIRE)--Ankyra Therapeutics, a clinical-stage biotechnology company pioneering anchored immunotherapy to deliver better outcomes for people with cancer and other serious diseases, announced preclinical data on ANK-203, a first-in-class anchored immunotherapy using monoclonal antibody CD137 (4-1BB). The data were presented today in an oral session, “Agonistic CD137 (4-1BB) anchored immunotherapy (ANK-203) elicits potent 4-1BBL signaling in vitro and therapeutic responses against established tumors without systemic toxicity in vivo” (abstract # 64034) at the American Association of Cancer Research (AACR) Immuno-Oncology Conference in Los Angeles, CA. ANK-203 extends our platform’s application beyond cytokines to monoclonal antibodies and expands our pipeline, reinforcing its versatility and underscoring the potential to realize the promise of therapeutics that have been shelved due to toxicity. “Our anchored immunotherapy platform has already demonstrated promising clinical activity with tolododekin alfa, validating our approach to improving the therapeutic index of potent immune modulators, like IL-12,” said Howard Kaufman, MD, and Chief Executive Officer at Ankyra Therapeutics. “ANK-203 extends our platform’s application beyond cytokines to monoclonal antibodies and expands our pipeline, reinforcing its versatility and underscoring the potential to realize the promise of therapeutics that have been shelved due to toxicity.” ANK-203 is designed to activate the CD137 (4-1BB) immune pathway through localized delivery and retention at the tumor site. In preclinical studies, ANK-203 demonstrated robust activation of the CD137 (4-1BB) immune pathway and regression of established tumors following localized administration. Treatment was well tolerated, with no significant safety signals observed. In addition to local tumor control, ANK-203 induced anti-tumor responses in distant, untreated tumors, suggesting the induction of a systemic immune response. “CD137 has long been recognized as a powerful immune costimulatory molecule with a high potential for cancer immunotherapy, but safety challenges have constrained its clinical potential,” said Sailaja Battula, PhD, Chief Scientific Officer at Ankyra Therapeutics. “By anchoring CD137 locally, ANK-203 enables focused immune activation where it matters most – at the tumor site – while minimizing systemic exposure, offering a differentiated approach to maximize clinical benefit.” Based on these findings, Ankyra plans to advance ANK-203 through additional preclinical studies to further characterize immune mechanisms and support potential clinical development. About Ankyra Therapeutics Ankyra Therapeutics is a clinical-stage biotechnology company pioneering anchored immunotherapy to deliver better outcomes for people with cancer and other serious immune-mediated diseases. Powered by its novel anchoring platform, Ankyra engineers therapies that unlock the full therapeutic potential of immune-modulating drugs once limited by toxicity. Anchored immunotherapies are designed to stay precisely at the disease site, allowing higher doses for greater therapeutic impact while limiting systemic exposure. Ankyra is advancing a robust pipeline of first-in-class therapies and strategic collaborations to shape the next generation of immunotherapy. For more information, please visit www.ankyratx.com.

ImmunotherapyAACR

100 Deals associated with Tolododekin Alfa

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D13096	-	-	-

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Solid tumor	Phase 1	-	Ankyra Therapeutics, Inc.	15 Dec 2025
Advanced Lung Non-Small Cell Carcinoma	Phase 1	United States	Ankyra Therapeutics, Inc.	22 Oct 2025
Advanced Malignant Solid Neoplasm	Phase 1	United States	Ankyra Therapeutics, Inc.	19 Jan 2024
Advanced Malignant Solid Neoplasm	Phase 1	Canada	Ankyra Therapeutics, Inc.	19 Jan 2024
Cutaneous Squamous Cell Carcinoma	Phase 1	United States	Ankyra Therapeutics, Inc.	19 Jan 2024
Cutaneous Squamous Cell Carcinoma	Phase 1	Canada	Ankyra Therapeutics, Inc.	19 Jan 2024
metastatic non-small cell lung cancer	Phase 1	United States	Ankyra Therapeutics, Inc.	19 Jan 2024
metastatic non-small cell lung cancer	Phase 1	Canada	Ankyra Therapeutics, Inc.	19 Jan 2024
Metastatic Solid Tumor	Phase 1	United States	Ankyra Therapeutics, Inc.	19 Jan 2024
Metastatic Solid Tumor	Phase 1	Canada	Ankyra Therapeutics, Inc.	19 Jan 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06171750 (ASCO2026)	Phase 1	Advanced Malignant Solid Neoplasm	39	ANK-101	fpxkzcglte(egyokkyznf) = 5 cases raifxhusim (ycahkmbctw ) View more	Positive	29 May 2026
NCT07027514 (ASCO2026)	Phase 1	Advanced Lung Non-Small Cell Carcinoma	32	ANK-101+cetrelimab	gdwpphrjop(vpovqhauow) = lmystumitk ncumjwfzps (suixjcywvi ) View more	Positive	29 May 2026
NCT07027514 (ASCO2026)	Phase 1	Advanced Lung Non-Small Cell Carcinoma	32	tolododekin alfa + investigator's choice of ICB (with a PD-L1 tumor proportion score (TPS) ≥ 50%)	wbzhvchxqo(fnoviajnyb) = amluninvyb dwmtgbyhgz (tggfrgecmx, 2.8 - 11.4) View more	Positive	29 May 2026
NCT06171750 (AACR2026)	Phase 1	Solid tumor	10	Tolododekin alfa (ANK-101)	npryqwgofs(jnolpcling) = tmhvtebwot wqgcsffxoo (defpyyoofz ) View more	Positive	20 Apr 2026
NCT06171750 (SITC2025)	Phase 1	Solid tumor NKT cells	15	ANK-101 (solid tumors)	tibxvtydyo(ybgksbuyij) = vmnhuejbli gomcbqezww (fzkwbuwuko )	Positive	05 Nov 2025
NCT06171750 (Pubmed \| Nat Commun)	Phase 1	Advanced Malignant Solid Neoplasm	15	Tolododekin alfa	cybooolwdg(qknzkgayyf) = alclmewieg syayviefpv (jpwnhvqewf, 3.6 - 7.6) View more	Positive	29 Sep 2025

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