ANK-101

CAMBRIDGE, Mass.--( BUSINESS WIRE )--Ankyra is pleased to announce the appointment of Dr. Julia G. Butchko and Ms. Tara Withington to the Board of Directors effective September 25, 2024. They will both serve as independent board members and their appointment brings the total board composition to seven directors. “We are delighted to welcome Dr. Butchko and Ms. Withington to the Board”, stated Tillman Gerngross, PhD, Chairman of the Ankyra Board of Directors. “These accomplished individuals bring a fresh perspective to Ankyra at a critical time in the company’s growth.” Howard L. Kaufman, MD, President and Chief Executive Officer at Ankyra added “I am especially enthusiastic about working with Dr. Butchko and Ms. Withington since they bring considerable strengths in research and development as well as representing the patient perspective as we pursue our mission of delivering new drugs to patients with cancer.” Julia G. Butchko, Ph.D. brings 25 years of industry experience and most recently served as Chief Development Officer at Immunovant (NASDAQ: IMVT), a biopharmaceutical company focused on developing therapies for patients with autoimmune disease. Dr. Butchko joined Immunovant in October 2019 and has co-led Research and Development to advance batoclimab (IMVT-1401) from early development to multiple, global registration trials and IMVT-1402 from candidate identification through registration trial planning. Prior to Immunovant, Dr. Butchko held various leadership roles at Eli Lilly and Company where she most recently served as the Chief of Staff, Strategy and Operations for Lilly’s Immunology and Neuroscience businesses and Vice President, Lilly Oncology Portfolio Management and Clinical Development. Dr. Butchko earned a B.S. in Chemistry from the State University of New York at Fredonia, a Ph.D. in Chemistry from Pennsylvania State University, and a Business Certificate from Indiana University, Kelly School of Business. Dr. Butchko stated that “I am delighted to be joining Ankyra’s Board of Directors at this exciting time. This year will be an impactful one for the Company as the ANK-101 Phase 1 program expands, and the Company advances discovery and early development efforts. I believe Ankyra’s anchoring technology holds a breadth of potential to improve the treatment for cancer patients and look forward to working with the senior leadership team as the Company continues to grow.” Tara Withington has over 40 years’ executive experience serving the nonprofit sector. Currently she is a principal and Vice President with Executive Director, Incorporated (EDI), an association management company that manages more than 40 scientific organizations and professional boards. She takes special interest in improving organizational excellence, including board development and infrastructure improvement. She also has a keen ability to forecast influences impacting associations and offers innovative ideas and an entrepreneurial mindset to position organizations to take advantage of opportunities and identify challenges allowing organizations to pivot for optimal outcomes. She has previously served as executive director or consulting partner for over 20 organizational boards. Ms. Withington served as a member of the Board of Directors for the AMC Institute and is a member in good standing in the American Society of Association Executives (ASAE), where she currently serves as a member of the Foresight Advisory Task Force. In 2001, the Society for Immunotherapy of Cancer (SITC) joined EDI and Ms. Withington began her tenure as the Executive Director and principal staff member. Tara has been instrumental in positioning the society as a universally respected organization known for its dedication to advancing the science and application of cancer immunotherapy both in the US and abroad. Ms. Withington holds a degree in Business Management as well as the Certified Association Executive (CAE) designation. In 2020 she received the Society for Immunotherapy of Cancer inaugural Lifetime Achievement Award. She currently serves as the Executive Director Emeritus of SITC Ms. Withington states “I am especially pleased to be joining the Board at Ankyra at this exciting time in their development.” She added that immunotherapy “offers a chance for durable responses and better patient experience, and I share the Ankyra team’s vision of providing new drugs for patients with cancer while ensuring broad access to the drug for patients who may benefit.” Dr. Howard L. Kaufman, President and CEO at Ankyra added “I am delighted to welcome Dr. Butchko and Ms. Withington to the Ankyra Board of Directors. They bring valuable expertise to the company and will add diversity and new perspectives on our goal of advancing the research and development of our anchoring platform and our commitment to doing so in a patient-focused manner.” Ankyra’s lead asset, ANK-101, is an anchored IL-12 that entered phase I clinical trials earlier this year and now over 10 patients with advanced solid cancers have been treated at multiple study sites in the United States and Canada (NCT:06171750). About Ankyra Therapeutics Ankyra Therapeutics is a biotechnology company that has developed a highly differentiated technology platform that expands the therapeutic window of cytokine drugs by forming a stable depot in the tumor 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

Ankyra Therapeutics will provide an update on the status of the ANK-101 Phase 1 ANCHOR clinical trial at ASCO 2024 and has received approval by FDA and Health Canada to amend the Phase I study to include patients with solid tumors in visceral organs CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Ankyra Therapeutics, a clinical-stage oncology company developing anchored immunotherapies to improve the therapeutic window for immuno-oncology drugs, 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. Ankyra Therapeutics has developed an anchored drug-delivery platform based on linking immunotherapy drugs to aluminum hydroxide. The linked compounds are delivered locally to the tumor, where they are retained for several weeks promoting anti-tumor activity without systemic toxicity. Ankyra’s lead asset, ANK-101, is comprised of interleukin-12 with an alum-binding peptide that enables direct linkage with aluminum hydroxide. The ANCHOR study is a multi-institution, first-in-human, phase I clinical trial of ANK-101 in patients with superficially accessible solid tumors who have progressed after standard therapy was initiated 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, OR; University of Pittsburgh in Pittsburgh, PA; Princess Margaret Hospital in Toronto, ON; and the National Cancer Institute (NCI), part of the National Institutes of Health, in Bethesda, MD. 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. “We are delighted with the progress in the current phase I study which will help establish the initial safety pro dosing selection for ANK-101,” stated Howard L. Kaufman, MD, CEO of Ankyra Therapeutics. Dr. Kaufman also stated that “this study is the first step to realize the potential for anchored immunotherapy to deliver high doses of immunotherapy without systemic toxicity, which could represent an important advance in how we deliver effective cancer treatment in a safer manner.” Joe Elassal, MD, Chief Medical Officer at Ankyra added “the recent approval to extend ANK-101 to visceral tumors is especially exciting as we can now study a broader patient population that could extend the potential indications for ANK-101 treatment”. For patients interested in enrolling in this clinical trial at NCI, please call NCI’s toll-free number: 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615); visit the website: ; and/or email: NCIMO_referrals@mail.nih.gov. Title: A phase 1, open-label, dose escalation study on the safety and tolerability of ANK-101 in advanced solid tumors Session Type: Poster Session Session Title: Developmental Therapeutics – Immunotherapy Track: Developmental Therapeutics – Immunotherapy Sub Track: New Targets and New Technologies (IO) Session Date and Time: Saturday June 1, 2024 9:00 AM CDT Location: Hall A Poster Board Number: 158a Published Abstract Number: TPS2689 Citation: J Clin Oncol. 42, 2024 (suppl 16; abstr TPS2689) The poster will be available on the publications section of Ankyra’s website after the meeting at . About ANK-101 ANK-101 is an anchored drug complex 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 Phase 1 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. About Ankyra Therapeutics Ankyra Therapeutics is a biotechnology company that has developed a highly differentiated technology platform that expands the therapeutic window of cytokine drugs by forming a stable depot in the tumor 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 View source version on businesswire.com: Contacts For Investor and Media Inquiries: Howard L. Kaufman, MD President and CEO info@ankyratx.com Source: Ankyra Therapeutics View this news release online at: