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
CAMBRIDGE, Mass.--(BUSINESS WIRE)--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-10), 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.
Results from Part one of the Phase 1 FIH study are being presented on Monday, April 28, 2025 at the American Association of Cancer Research (AACR) Annual Meeting in Chicago, IL.
Abstract Title: Results of a first-in-human phase 1 trial of anchored IL-12 drug conjugate (ANK-101).
Session Title: Phase 0 and Phase I Clinical Trials
Session End: 4/28/2025 12:00:00 PM
Location: Poster Section 49
Poster Board Number: 18
Abstract Presentation Number: CT039
The poster will be available on the publications section of Ankyra's website after the meeting at https://ankyratx.com/news/
Key Study Findings
Fifteen (15) patients with metastatic solid tumors who had progressed on standard therapy and had accessible lesions for injection were enrolled across four study sites in the U.S. and Canada
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
Initial results suggest clinical activity with 2 PRs and a disease control rate of 80% by modified RECIST v1.1
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 but does not diffuse into the systemic circulation, thereby avoiding systemic toxicity. Treatment with ANK-101 in animal models has been associated with recruitment and retention of CD8+ T cells, NK cells and M1 macrophages activating innate and adaptive anti-tumor immunity. 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, open-label clinical trial of ANK-101 as a monotherapy (NCT:06171750) consists of a dose escalation portion that will evaluate the safety and tolerability of ANK-101, followed by dose expansion cohorts. Additional clinical trials are being planned in different cancer types.
ANK-101 will be prominently featured on an upcoming documentary 'The Cancer Pioneers' as part of the Public Broadcasting System (PBS) series 'Shelter Me'. The program will air nationally on local PBS television stations on May 1, 2025 and more information can be found at https://www.facebook.com/ShelterMeTV/videos/coming-soon-to-pbs-shelter-me-the-cancer-pioneersthis-film-is-about-groundbreaki/1342447700302755/.
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 was founded in 2019 and is headquartered in Cambridge, Massachusetts. For more information, please visit www.ankyratx.com.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Business Wire
3 hours ago
- Business Wire
Securonix Acquires ThreatQuotient to Deliver Industry's Broadest and Deepest Threat Detection Investigation and Response
PLANO, Texas--(BUSINESS WIRE)--Today, Securonix, a five-time Leader in the Gartner® Magic Quadrant™ for Security Information and Event Management (SIEM), announced the acquisition of ThreatQuotient, a four-time leader in threat intelligence based on QKS Group Spark Matrix report and the force behind ThreatQ, the most innovative external threat intelligence platform. This combination will create a comprehensive, modular, and fully integrated AI-driven platform for threat detection, investigation, and response (TDIR), leveraging advanced analytics and insights across both internal and external threats. This acquisition accelerates the modernization of security operations by uniting internal and external threat intelligence with real-time analytics and agentic AI. Unlike external threat intelligence bolt-on solutions with disconnected management interfaces, the integrated platform from Securonix and ThreatQuotient will deliver unified visibility, faster response, and greater operational clarity. "Bringing threat intelligence management and SIEM together in a unified platform is a game changer. We've already seen the value of deeply enriched advanced analytics and detection in our Securonix SIEM environment—but coupling that with integrated threat curation, prioritization, and response should help customers move even faster. It means fewer swivel-chair investigations, more accurate triage, and greater confidence that security analysts are working with the most relevant threats. This kind of integration has the potential to accelerate the ability to detect, respond, and stay ahead," said Marcel Jonker, Director of Cybersecurity Operations at Cambia Health Systems. The integration of Securonix and ThreatQuotient promises to deliver up to a 70% reduction in Mean Time to Respond (MTTR), enabling security teams to detect, investigate, and remediate threats significantly faster. By combining curated threat intelligence with AI-driven automation, the solution will deliver exponential improvements in filtering out false positives, enriching alerts with actionable context, and automating historical threat sweeps and incident response. This reduces alert overload, speeds up root cause analysis, and minimizes manual handoffs—cutting investigation time from hours to minutes and enabling automated containment before threats escalate. 'Security teams are drowning in noise and struggling to keep up with evolving threats,' said Kash Shaikh, CEO and President of Securonix. 'This acquisition brings together Securonix's Agentic AI-driven Platform with ThreatQuotient's deep threat intelligence to deliver clarity, speed, and automated workflows to our customers, reducing false positives by up to 90%. Together, we're building the modern SOC Platform—proactive, intelligent, and built for what's next.' Kash added, 'Securonix and ThreatQuotient bring together complementary strengths—deep innovation across internal and external threat domains, and a shared commitment to innovation and customer service. Both companies serve enterprise and government customers as well as managed security service providers (MSSPs), and we're excited to welcome the talented ThreatQuotient team and their customers to Securonix.' Purpose-Built for Analysts. Proven Against Real-World Threats. ThreatQuotient's Threat Intelligence Platform (TIP) strength lies in delivering curated, contextualized threat intelligence that drives smart, timely decisions. When combined with Securonix's EON Agentic AI-based SIEM, SOAR, UEBA and Data Pipeline Manager, customers can accelerate their migration from reactive threat hunting-based defense to proactive, real-time, behavior-driven, open-agentic security operations. With this integration, Securonix customers and partners will enjoy the following benefits: Gain clear visibility: Integrate deep enriched real-time analytics from Securonix with curated external intelligence from ThreatQuotient to create a single, high-context stream of alerts. Eliminate blind spots and accelerate threat identification with confidence. Stay ahead of risk: Auto-enrich Indicator of compromise (IoCs) and preemptively respond to repeat attacks, blocking 90 percent before they start. Act smarter: Automate repetitive tasks, reduce false positives, and streamline investigations. Teams can stay focused on high-priority threats and reduce time spent on manual triage. Deploy your way: Continue to use ThreatQ as a standalone threat intelligence platform or as part of the fully integrated Securonix solution. Deploy on-premise or SaaS in a way that fits the current architecture and scales with needs. Accelerated Roadmap: Combined R&D synergies will accelerate upcoming roadmap innovations, including Agentic AI and ThreatQuotient's innovation priorities. With this acquisition, ThreatQuotient customers and partners will enjoy the following benefits: Increased Scale: ThreatQ customers can take advantage of Securonix's global R&D scale and GTM reach, including access to Securonix's Threat Labs Intelligence. Deeper Integrations: Gain access to an enriched roadmap and integration between Securonix's best-in-class SIEM, SOAR, and UEBA portfolio and ThreatQ, including extension of Agentic AI advancements. Continued Focus: Zero interruption of their existing service, as ThreatQuotient will continue to operate as a standalone offering, with no disruption to existing roadmap and workflows. 'Enterprises, government institutions and managed security service providers rely on ThreatQuotient to protect their mission critical businesses. Joining Securonix marks a powerful new chapter for ThreatQuotient. By uniting our strengths, we can accelerate innovation, expand our reach, and deliver greater value to our customers. I'm proud of what we've built and excited for what's ahead,' said John Czupak, CEO of ThreatQuotient. BTIG, LLC served as exclusive financial advisor, and King & Spalding LLP served as legal advisor to ThreatQuotient. Vinson & Elkins LLP served as legal advisor to Securonix. About Securonix Securonix is leading the transformation of cybersecurity with the industry's first Unified Defense SIEM powered by agentic AI, purpose-built to decide and act across the threat lifecycle with a human-in-the-loop philosophy. Built for scale, precision, and speed, our cloud-native platform empowers global enterprises to shift from reactive security to proactive, autonomous operations. Recognized as a Leader in the Gartner® Magic Quadrant™ for SIEM and a Customers' Choice by Gartner Peer Insights™, Securonix is driving the next era of intelligent, autonomous security operations. Learn more at About ThreatQuotient ThreatQuotient improves security operations by fusing disparate data sources, tools, and teams to accelerate threat detection, investigation, and response (TDIR). ThreatQ is the first purpose-built, data-driven threat intelligence platform that helps teams prioritize, automate, and collaborate on security incidents; enables more focused decision-making; and maximizes limited resources by integrating existing processes and technologies into a unified workspace. The result is reduced noise, clear priority threats, and the ability to automate processes with high-fidelity data. ThreatQuotient's leading integration marketplace, data management, orchestration, and automation capabilities support multiple use cases including threat intelligence management and sharing, incident response, threat hunting, spear phishing, alert triage, and vulnerability management. For more information, visit
Business Wire
3 hours ago
- Business Wire
Specialities Inc. Introduces Hollandic
MILLINGTON, N.J.--(BUSINESS WIRE)-- Hollandic is how we say Gouda cheese! We are thrilled to introduce Hollandic, our exquisite Gouda cheese that brings a slice of the Netherlands to your table! Revered as one of the world's oldest cheeses, Hollandic is crafted from premium cow's milk, resulting in a semi-hard cheese that is rich in flavor and boasts a wonderfully creamy texture. Dutch Gouda stands out for its exceptional quality and rich heritage, making it a beloved choice for cheese aficionados around the globe. Our Hollandic Gouda selection features a delightful variety, ranging from young and mild to intensely aged, each showcasing its distinct taste and character. Perfect on its own or as the star of a vibrant charcuterie board, Hollandic Gouda is the ideal addition to your culinary adventures! Since 1991, Specialities Inc. has been at the forefront of importing, distributing, and elevating specialty food products across U.S. Deli and Specialty Markets, along with select food service distributors. Our 'Best of Class' offerings originate from both domestic and international artisans. Please join us on June 28-30, 2025, at the New York Fancy Food Show Booth 468 to learn more about these all-natural and innovative products.
Yahoo
3 hours ago
- Yahoo
Specialities Inc. Introduces Hollandic
MILLINGTON, N.J., June 14, 2025--(BUSINESS WIRE)--Hollandic is how we say Gouda cheese! We are thrilled to introduce Hollandic, our exquisite Gouda cheese that brings a slice of the Netherlands to your table! Revered as one of the world's oldest cheeses, Hollandic is crafted from premium cow's milk, resulting in a semi-hard cheese that is rich in flavor and boasts a wonderfully creamy texture. Dutch Gouda stands out for its exceptional quality and rich heritage, making it a beloved choice for cheese aficionados around the globe. Our Hollandic Gouda selection features a delightful variety, ranging from young and mild to intensely aged, each showcasing its distinct taste and character. Perfect on its own or as the star of a vibrant charcuterie board, Hollandic Gouda is the ideal addition to your culinary adventures! Since 1991, Specialities Inc. has been at the forefront of importing, distributing, and elevating specialty food products across U.S. Deli and Specialty Markets, along with select food service distributors. Our "Best of Class" offerings originate from both domestic and international artisans. Please join us on June 28-30, 2025, at the New York Fancy Food Show Booth 468 to learn more about these all-natural and innovative products. View source version on Contacts Ron Schinbeckler, Specialities Inc. (908) 294-3200, (908) 647.6485fromo1@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
