Ankyra Therapeutics Announces Ongoing Trial Poster Presentation at ASCO 2024 Meeting and Approval of Phase 1 ANK-101 Protocol Amendment

Ankyra Therapeutics will provide an update on the progress of the ANK-101 ANCHOR Phase 1 clinical trial at ASCO 2024 and has received approval from the FDA and Health Canada to amend the study phase I to include patients with solid tumors in visceral organs.

CAMBRIDGE, Mass., June 1, 2024–(BUSINESS WIRE)–Ankyra Therapeutics, a clinical-stage oncology company developing anchored immunotherapies to improve the therapeutic window of immuno-oncology drugs, today announced that it is introducing a trial poster underway for the ANCHOR Phase 1 clinical trial at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting to be held May 31 – June 4, 2024 in Chicago, Illinois.

Ankyra Therapeutics has developed an anchored drug delivery platform based on the binding of immunotherapy drugs to aluminum hydroxide. The bound compounds are delivered locally to the tumor, where they are retained for several weeks, promoting antitumor activity without systemic toxicity. Ankyra’s main active, ANK-101, is composed of interleukin-12 with an alum-binding peptide that allows direct binding with aluminum hydroxide. The ANCHOR study is a multi-institutional, first-in-human Phase I clinical trial of ANK-101 in patients with superficially accessible solid tumors that have progressed after initiation of standard therapy in February 2024. The primary objectives of the study are to determine the safety, tolerability, and recommended dose of ANK-101 for further studies. The trial is active at five clinical study sites: Massachusetts General Hospital in Boston, MA; Providence Cancer Institute in Portland, Oregon; University of Pittsburgh in Pittsburgh, Pennsylvania; Princess Margaret Hospital in Toronto, Ontario; and the National Cancer Institute (NCI), part of the National Institutes of Health, in Bethesda, MD. The poster presentation will include trial rationale, study objectives, clinical trial design, and an update on accrual. The study will also assess pharmacokinetics, immune biomarkers and quality of life.

Additionally, Ankyra received approval from the U.S. Food and Drug Administration (FDA) and Health Canada to modify the Phase I clinical trial to include a second part of increase and expansion of dose to evaluate ANK-101 for injection in solid tumors located in the United States. visceral organs. This portion will run concurrently with the ongoing Phase I study, with dosing beginning once patients in the superficial portion complete a 21-day dose-limiting toxicity (DLT) observation period.

“We are pleased with the progress made in the ongoing Phase I study, which will help establish the initial safety profile and dosage selection of ANK-101,” said Howard L. Kaufman, MD, CEO of ANK-101. ‘Ankyra Therapeutics. Dr. Kaufman also stated that “this study is the first step in realizing the potential of anchored immunotherapy to deliver high doses of immunotherapy without systemic toxicity, which could represent an important advancement in how we deliver treatment.” effective against cancer in a safer way. Joe Elassal, MD, Chief Medical Officer of Ankyra, added that “the recent approval to expand ANK-101 to visceral tumors is particularly exciting because we can now study a broader patient population that could expand the potential indications of the treatment with ANK-101”.

For patients interested in enrolling in this clinical trial at NCI, please call the NCI toll-free number: 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615) ; visit the website: https://trials.cancer.gov; and/or email: [email protected].

Title: A Phase 1, Open-Label, Dose-Escalation Study of the Safety and Tolerability of ANK-101 in Advanced Solid Tumors
Type of session: Poster session
Session title: Developmental Therapeutics – Immunotherapy
Track: Developmental Therapeutics – Immunotherapy
Subtrack: New Targets and New Technologies (IO)
Date and time of the session: Saturday June 1, 2024, 9:00 a.m. CDT
Location: Room a
Billboard number: 158a
Published abstract number: TPS2689
Quote: J Clin Oncol. 42, 2024 (suppl. 16; abstract TPS2689)

The poster will be available in the publications section of the Ankyra website after the meeting at https://ankyratx.com/#science.

About the ANK-101

ANK-101 is an anchored drug complex composed of interleukin-12 (IL-12) bound to aluminum hydroxide. ANK-101 allows 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. ANK-101 treatment in animal models was associated with the recruitment and retention of CD8+ T cells, NK cells, and M1 macrophages activating innate and adaptive antitumor immunity. ANK-101 is being evaluated for the treatment of advanced solid tumors, alone or in combination with anti-PD-1 agents. The first-in-human, open-label, phase 1 clinical trial of ANK-101 monotherapy (NCT: 06171750) consists of a dose escalation portion that will evaluate the safety and tolerability of ANK-101, followed by dose expansion cohorts.

About Ankyra Therapeutics

Ankyra Therapeutics is a biotechnology company that has developed a highly differentiated technology platform that expands the therapeutic window of cytokine-based drugs by forming a stable depot in the tumor after local administration, leading to prolonged immune activation and potent local immunity and systemic with reduced systemic toxicity. Ankyra was founded in 2019 and is headquartered in Cambridge, Massachusetts. For more information, please visit www.ankyratx.com

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Contacts

For investor and media inquiries:
Howard L. Kaufman, MD
President and CEO
[email protected]