NG-350A

I.V.-Delivered Vector Core to Akamis Bio T-SIGn® Therapeutics; Phase 1 Study Data to be Presented at the 2023 American Society for Radiation Oncology (ASTRO) Annual Meeting CAMBRIDGE, Mass. & OXFORD, England--(BUSINESS WIRE)-- Akamis Bio, a clinical-stage oncology company using a proprietary Tumor-Specific Immuno-Gene (T-SIGn®) therapy platform to deliver novel immunotherapeutic proteins, biomolecules and transgene combinations to treat solid tumors, shared data today from a Phase 1 study of its adenovirus vector technology in combination with radiotherapy that showed improved response rates relative to expectations for radiation alone in patients with locally advanced rectal cancer. The CEDAR study, sponsored by Cancer Research UK and Akamis Bio, found that Enadenotucirev (EnAd), a tumor selective, I.V.-administered oncolytic adenovirus (on which T-SIGn therapeutics are based), in combination with chemoradiotherapy, showed significantly higher response rates by MRI assessed tumor regression grade (mrTRG – 41.6%) and pCR/cCR (41.6%) than expected rates (~20%) for standard chemoradiation. In the two dose schedules with administration pre-CRT and post-CRT, mrTRG of 1 or 2 was observed in 5 out of 10 (50%) of the treated patients. Further, hexon staining of patient samples suggested EnAd localization in both the primary tumor and in metastatic sites. The combined therapy was well tolerated with an acceptable safety profile. “These data are compelling given the higher-than-expected pCR/cCR rate, and the low adverse event rate highlights the ability to deliver the oncolytic virus concurrently with chemoradiation. This demonstrates the potential of a more reliable systemic administration compared to intratumoral injection,” said Dr. Maria A. Hawkins, Chair of Radiation Oncology at University College in London and the principal investigator of the study. “We are further encouraged by the potential of this systemic treatment to reach micro-metastatic cancer sites and we believe this approach should be pursued in additional studies as we look to improve the efficacy of chemoradiation for a wide range of solid tumors.” EnAd is a group B adenovirus designed for the systemic treatment of metastatic or advanced epithelial tumors. It is a precursor to Akamis Bio’s clinical-stage Tumor-Specific Immuno-Gene (T-SIGn®) therapeutics platform, which selectively delivers multiple transgene combinations, such as cytokines, chemokines, and antibodies for expression by tumor cells. The primary objective of the Phase 1 CEDAR study was to determine the optimal dose and frequency that EnAd can be administered with chemoradiation for rectal cancer, with secondary objectives focused on demonstrating the ability to deliver EnAd with chemoradiation and to measure the local response rate to combined therapy compared to pre-treatment status. “These results are very encouraging as they demonstrate the acceptable safety pro potent efficacy achievable with our first-generation adenovirus vector, EnAd,” said Dr. Oliver Rosen, Akamis Bio’s Chief Medical Officer. “As our T-SIGn therapeutics combine the EnAd backbone with an ability to selectively deliver transgenes to solid tumors, we look forward to building upon the clinical insights from the CEDAR study and demonstrating the potential of T-SIGn in conjunction with chemoradiation to positively impact the lives of patients living with rectal cancer and other solid tumors.” Data from the CEDAR study will be presented today at the 2023 American Society for Radiation Oncology Annual Meeting in San Diego, CA. Details of the presentation are as follows: Poster Presentation Title: A Phase 1 Trial of the Safety, Tolerability, and Biological Effects of Intravenous Enadenotucirev (EnAd), a Novel Oncolytic Virus, in Combination with Chemoradiotherapy in Locally Advanced Rectal Cancer (CEDAR) Poster Session: Gastrointestinal Cancer and Sarcoma Date and Time: October 3 at 12:45 - 2:00 p.m. ET Presenter: Dr Séan M. O’Cathail, MSc DPhil MRCPI FRCP FRCR, Senior Research Fellow, School of Cancer Sciences, University of Glasgow About T-SIGn Akamis Bio’s T-SIGn® therapeutics are based on a replication competent, chimeric group B adenovirus backbone which has been adapted via directed evolution to home specifically to both primary and metastatic epithelial-derived solid tumor tissue following intravenous delivery. Once at the tumor site, T-SIGn therapeutics can drive the intratumoral expression of multiple transgene payloads, turning solid tumor cells into “drug factories” while leaving healthy tissue unaltered and intact. The intratumoral expression of immunologically active biomolecules and therapeutic proteins can result in the remodeling of the solid tumor microenvironment, triggering robust antitumor immune responses. T-SIGn therapeutics have the potential to be used in the monotherapy setting, as well as in combination with other immuno-oncology agents to target the key mechanisms that tumors use to evade the immune system. About Akamis Bio Akamis Bio is a clinical-stage oncology company using a proprietary Tumor-Specific Immuno-Gene Therapy (T-SIGn®) platform to deliver novel immunotherapeutic proteins, biomolecules and transgene combinations to treat solid tumors. The company is developing a portfolio of solid tumor-targeted T-SIGn therapeutics which aim to enable a patient’s own immune system to recognize, attack, and clear their cancer. Akamis Bio has a growing pipeline of T-SIGn therapeutics anchored by its lead clinical-stage program, NG-350A (an immuno-stimulatory tumor gene therapy driving intratumoral expression of a CD40 agonist monoclonal antibody) being investigated in ongoing Phase 1 clinical studies in patients with metastatic or advanced epithelial tumors. In addition to internal pipeline development efforts, Akamis Bio has a number of T-SIGn platform-focused collaborations with leaders in the immuno-oncology field including BMS, Merck, and the Parker Institute for Cancer Immunotherapy (PICI). To learn more, please visit .

Company Names Dr. Oliver Rosen Chief Medical Officer and Peter Kosa Chief Business Officer; Samantha Bailey-Bucktrout Promoted to Senior Vice President, Head of Research CAMBRIDGE, Mass. & OXFORD, England--(BUSINESS WIRE)-- Akamis Bio, a clinical-stage oncology company using a proprietary Tumor-Specific Immuno-Gene Therapy (T-SIGn®) platform to deliver novel immunotherapeutic proteins, biomolecules and transgene combinations to treat solid tumors, today announced the appointment of Oliver Rosen, M.D. as Chief Medical Officer (CMO), Peter Kosa, Ph.D. as Chief Business Officer (CBO), and Samantha Bailey-Bucktrout, Ph.D. as Senior Vice President, Head of Research. Drs. Rosen and Kosa will be based in the Company’s Cambridge, MA office and Dr. Bailey-Bucktrout will continue to lead Research from the Oxford, UK site. “We are thrilled to welcome these experienced leaders to our team at this important point in the Company’s evolution as we work to deliver on the potential of our platform and expand our pipeline of therapeutic candidates for patients with intractable solid tumors,” said Howard Davis, Ph.D., Chief Executive Officer of Akamis Bio. “As CMO, Oliver’s decades of experience in oncology drug development will be critical as we advance our lead program, NG-350A, toward clinical proof-of-concept studies. Peter’s track record of leading corporate strategy and business development will be invaluable as we seek to leverage our platform with collaborators, and we are excited to have Samantha drive our discovery and preclinical efforts building upon her contributions to date which have been instrumental in establishing our pipeline of tumor gene therapies. With several anticipated clinical data readouts and new strategic partnerships on the horizon, we believe we are now well-positioned to accelerate our internal pipeline progress while continuing to explore the potential combination of our T-SIGn therapeutics with current and emerging immuno-oncology approaches to potentially address a broad range of cancers.” NG-350A is an intravenously delivered T-SIGn therapeutic candidate capable of driving intratumoral expression of a secreted CD40 agonist monoclonal antibody. Currently being studied in two Phase 1 clinical trials, NG-350A may potentially be used as both a monotherapy and in combination with other immuno-oncology agents. Dr. Oliver Rosen, M.D.: As CMO, Dr. Rosen will be responsible for driving the company’s overall clinical development and regulatory strategy. An experienced drug developer, he most recently served as President and CMO at DynamiCure and was previously CMO of SQZ Biotechnologies and Deciphera Pharmaceuticals. At SQZ, his work led to achieving proof of concept in the clinic for an autologous PBMC-based antigen presenting cell platform and a red blood cell-based cancer vaccine. At Deciphera, he led clinical development efforts resulting in the approval of QINLOCK™ (repritinib) for advanced gastrointestinal tumors. Before joining Deciphera, Dr. Rosen held senior clinical development and medical affairs roles at Takeda Oncology and Genentech. Dr. Rosen received his medical training in oncology and hematology at the University Hospital Charité in Berlin, participated in a post-doctoral program in molecular and cellular biology at the University of Hamburg, and holds an M.D. from the University of Cologne, Germany. Peter Kosa, Ph.D.: Dr. Kosa will serve as CBO, leading corporate strategy, business development, and partnerships. Dr. Kosa was formerly the Managing Director of the Myeloma Investment Fund, a non-profit venture capital fund created by the Multiple Myeloma Research Foundation to support research and development for new therapeutics. Previously, he served as the Senior Director of Business Development at bluebird bio and was Director of Oncology Strategic Alliances at Novartis Institutes for Biomedical Research, where he had global responsibility for search and evaluation of oncology partnerships. Dr. Kosa has also held leadership positions at XOMA, Bayer Healthcare, and Connecticut Innovations. He earned his B.A. in biochemistry from Swarthmore College, a Ph.D. in molecular biophysics from Yale University, and was a Damon Runyan Cancer Research Postdoctoral Fellow at Harvard Medical School. He also earned an MBA from the Sloan School of Management at MIT. Samantha Bailey-Bucktrout, Ph.D.: Dr. Bailey-Bucktrout joined Akamis Bio in 2022 as Vice President of Research Strategy before her recent promotion to Senior Vice President and Head of Research, where she will lead all discovery and preclinical programs. She joined Akamis Bio from the Parker Institute for Cancer Immunotherapy in San Francisco where she was Senior Director of Research and Development. She previously served as Associate Director at Pfizer’s Cancer Immunotherapy Research Unit. Dr. Bailey-Bucktrout earned a B.S. degree at the University of Aberdeen and a Ph.D. in immunology from the University of Edinburgh. She was a postdoctoral fellow at the University of California, San Francisco and a postdoctoral scholar at the Feinberg School of Medicine at Northwestern University. About T-SIGn® Akamis Bio’s Tumor-Specific Immuno-Gene (T-SIGn®) therapeutics are chimeric group B adenoviral vector-based, tumor gene therapies which are capable of homing specifically to primary and metastatic solid tumors following intravenous delivery. Once at the tumor site, T-SIGn therapeutics can drive intratumoral expression of multiple immunologically active biomolecules and therapeutic proteins encoded by the vector to remodel the tumor microenvironment and trigger robust antitumor immune responses. T-SIGn therapeutics have potential for use in the treatment of solid tumors as monotherapy, as well as in combination with other immuno-oncology agents (e.g., checkpoint inhibitors, antibody drug conjugates, bispecific T-cell engagers, and cell therapies) to enable and/or enhance the efficacy of those modalities in the solid tumor setting. Akamis Bio has an extensive and growing body of clinical experience with T-SIGn therapeutics with more than 200 patients treated across both the monotherapy setting, as well as in combination with checkpoint inhibitors. Across clinical studies, T-SIGn therapeutics have demonstrated a consistent safety and tolerability profile, as well as promising preliminary evidence of clinical activity. About Akamis Bio Akamis Bio is a clinical-stage oncology company using a proprietary Tumor-Specific Immuno-Gene Therapy (T-SIGn®) platform to deliver novel immunotherapeutic proteins, biomolecules and transgene combinations to treat solid tumors. The company is developing a portfolio of solid tumor-targeted T-SIGn therapeutics which aim to enable a patient’s own immune system to recognize, attack, and clear their cancer. Akamis Bio has a growing pipeline of T-SIGn therapeutics anchored by its lead clinical-stage program, NG-350A (an immuno-stimulatory tumor gene therapy driving intratumoral expression of a CD40 agonist monoclonal antibody) being investigated in ongoing Phase 1 clinical studies in patients with metastatic or advanced epithelial tumors. In addition to internal pipeline development efforts, Akamis Bio has a number of T-SIGn platform-focused collaborations with leaders in the immuno-oncology field including BMS, Merck, and the Parker Institute for Cancer Immunotherapy (PICI). To learn more, please visit .