AkamisBio

Akamis Bio announced today that it will present encouraging preliminary data from the ongoing Phase 1b FORTRESS study of NG-350A in mismatch repair proficient (pMMR) locally advanced rectal cancer (LARC) at AACR 2026. Data from the first ten patients to complete the 12-week active treatment period showed that the company’s oncolytic immunotherapy, NG-350A, combined with chemoradiotherapy demonstrated a composite response rate (clinical complete response and near clinical complete response) of 50%. This represents a significant increase over the benchmark composite response rate of 25% expected with CRT alone in pMMR LARC. These early FORTRESS data provide the first key evidence of clinical proof of concept for NG-350A plus CRT in pMMR LARC and highlight the potential to advance the standard of care, offering more patients access to a non-operative approach to management of their disease, as well as the opportunity for organ preservation – a critically important treatment goal as LARC continues to impact increasingly younger patient populations. See today’s news here: akamisbio.com/news/akamis-bi… See the AACR poster here: akamisbio.com/science-pipeli…

We are pleased to announce our upcoming poster at the American Association for Cancer Research (AACR) Annual Meeting 2026 which will disclose initial data from the Phase 1b FORTRESS study of NG-350A in patients with mismatch repair-proficient (pMMR) locally advanced rectal cancer (LARC). Read today's full release here: akamisbio.com/news/akamis-bi… #AACR2026 #Colorectalcancer #FORTRESSStudy

💙 March 6 is Dress in Blue Day for Colorectal Cancer Awareness. At Akamis Bio, our mission is to transform the standard of care for people living with colorectal cancer – starting with our therapeutic candidate for patients with mismatch repair proficient (pMMR) locally advanced rectal cancer (LARC), which accounts for ~95% of all LARC cases. There’s an urgent need for new LARC treatment options that eliminate tumors and reduce the need for surgery so patients can preserve colorectal organ function and have an improved quality of life. On March 6, we’ll be wearing blue to honor the patients and families impacted by rectal cancer, reaffirm our commitment to advancing the field, and help address a disease that continues to rise at an alarming rate – particularly among individuals under 50. Learn more about the unmet need in LARC here: akamisbio.com/patient-commun… #DressInBlueDay #ColorectalCancerAwareness #RectalCancer #Fortressstudy

Colorectal cancer (CRC) is the second leading cause of cancer-related death in the U.S. - and the leading cause among people under 50. Alarmingly, the incidence of CRC in younger adults continues to rise. At Akamis Bio, we’re working to advance the standard of care in CRC by developing the next generation of oncolytic immunotherapies designed to bring new options, and new hope, to patients. This week, we’re proud to launch our updated website (akamisbio.com) where we detail our science, clinical approach, and the unmet needs in CRC that we aim to address. Our initial clinical focus is mismatch repair–proficient (pMMR) locally advanced rectal cancer (LARC), which represents ~95% of all LARC cases. New treatments are urgently needed not only to eliminate tumors, but also to help patients potentially avoid life-altering surgery and preserve organ function - particularly important goals of treatment as the incidence of CRC continues to rise in younger populations. Our lead candidate, NG-350A, is being developed with those goals in mind and our ongoing Phase 1b FORTRESS study, evaluating NG-350A + chemoradiotherapy in patients with pMMR LARC, continues to enroll. We invite you to explore akamisbio.com and to learn more about the FORTRESS study at fortressstudy.org, as we work to advance new therapeutic approaches to treating this devastating disease. #ColorectalCancer #CRC #LARC

We’re pleased to stand with @FightCRC in their commitment to provide patients, families, and caregivers with clear, accessible information about colorectal cancer research and clinical study options. Fight CRC's latest newsletter highlights why bringing science to everyone and improving access to clinical studies is so important — and we’re grateful that our FORTRESS study for patients with mismatch repair-proficient (pMMR) locally advanced rectal cancer (LARC) is part of that conversation. The Phase 1b FORTRESS clinical study is designed to assess whether our investigational oncolytic immunotherapy, NG-350A, combined with chemoradiotherapy, can improve treatment responses for patients with pMMR LARC compared with expected outcomes from chemoradiotherapy alone. Our overarching mission with FORTRESS is to help patients achieve better outcomes and quality of life, while potentially avoiding surgical interventions. If you or someone you know would like to learn more, read the Fight CRC blog and listen to their podcast episode discussing NG-350A and the FORTRESS study here: fightcolorectalcancer.org/blog/science-f… For additional information about FORTRESS study eligibility and participation, please visit fortressstudy.org We’re deeply grateful to the CRC patient community for their strength, partnership, and commitment to advancing important new treatment options through participation in clinical studies. #ColorectalCancer #ClinicalTrials #FORTRESSStudy #FightCRC

We share the Colorectal Cancer Alliance’s belief that understanding all treatment options, including clinical trials, empowers patients facing colorectal cancer to make the most informed decisions possible. At Akamis Bio, we’re advancing that mission through the Ph1b FORTRESS clinical trial, which is designed to assess whether our investigational oncolytic immunotherapy, NG-350A, in combination with chemoradiotherapy can improve treatment responses for patients with mismatch repair-proficient (pMMR) locally advanced rectal cancer (LARC) relative to expected response levels with chemoradiotherapy alone. This work represents more than science. It represents hope. Our aim is to help patients achieve better outcomes and quality of life, while potentially avoiding surgical interventions. We’re grateful to every patient, clinician, and partner contributing to this effort. Together, we’re working to redefine what’s possible in cancer treatment. Learn more at: fortressstudy.org #FORTRESSStudy #RectalCancer #ColorectalCancer #Immunotherapy #CancerAwareness

Congratulations to our partner Xuanzhu Biopharma on a successful Hong Kong stock exchange IPO, highlighting the strength of its programs, pipeline and team. We’re proud of our collaboration on NG-350A, Akamis' lead oncolytic immunotherapy, currently being studied in our Phase 1b FORTRESS trial in locally advanced rectal cancer. We look forward to working closely with Xuanzhu as they prepare to move the candidate into clinical studies in the greater China region.

Akamis Bio today announced FDA Fast Track designation for NG-350A in mismatch-repair–proficient (pMMR) locally advanced rectal cancer (LARC). This is an important recognition of the significant unmet need in pMMR LARC as we advance NG-350A through our Ph1b FORTRESS study (enrolling). Learn more: akamisbio.com/items/akamis-b…

We’re pleased to welcome C4 Therapeutics CEO Andrew Hirsch to our Board of Directors. His extensive industry leadership, as well as his strategic and operational expertise in advancing novel therapies will be invaluable as we unlock the full potential of our immunotherapeutic platform across a range of oncology indications, beginning with colorectal cancer. See today's announcement: businesswire.com/news/home/2025…

We are thrilled to announce the appointment of three experienced biopharma executives to the Akamis Bio team to lead our Finance, CMC and Business Development/Alliance Management functions. Read today’s announcement here: akamisbio.com/items/akamis-b…

We are pleased to announce enrollment of the first patient in our Phase 1b FORTRESS trial of NG-350A for the treatment of locally advanced rectal cancer (LARC), a key milestone toward advancing a novel immunotherapy and potentially transforming standard of care. Learn more: akamisbio.com/items/akamis-b…

Thrilled to announce the completion of Akamis Bio’s Series A Prime financing and new strategic partnership which provide funding to support the advancement of our lead oncology candidate, NG-350A, into a clinical proof-of-concept study in patients with locally advanced rectal cancer (LARC). bit.ly/49G841g #oncology #immunotherapy #innovation

Tune in to the Careers in Discovery #podcast with @Tom_Froggatt to hear Samantha Bailey-Bucktrout discuss her #career and current role leading research at Akamis Bio, and the potential of systemically delivered T-SIGn therapeutics to treat solid tumors: bit.ly/3uzQlYV

Samantha Bailey-Bucktrout will be speaking at the #PEGSEurope Conference to discuss how we use our T-SIGn platform to express novel antibody combinations, recent advances in our lead program NG-350A, and new transgene combinations to boost CAR-T activity: bit.ly/3Szx1F8

Akamis Bio CEO Howard Davis, Ph.D., was featured on The Bio Report podcast with @dslevine where they discussed the potential of T-SIGn therapeutics to treat solid tumors both as monotherapies and in combination with a range of cell therapies. Listen now: bit.ly/3M55NSO

Akamis Bio will share data at #ASTRO2023 from the Phase 1 CEDAR study which showed improved responses in patients with locally advanced rectal #cancer treated with radiotherapy in combination with our adenovirus vector #technology, over radiation alone bit.ly/3Q0Axqr

Learn more about Akamis Bio’s lead program, NG-350A, a Phase 1 immuno-stimulatory #genetherapy that aims to safely drive intra-tumoral expression of a potent CD-40 agonist to treat solid #cancer tumors: bit.ly/3pPRxoR

Akamis Bio is working to enhance #immunotherapy by addressing the safety and efficacy challenges of treating #solidtumors. Learn how our T-SIGn® therapeutics aim to drive a powerful tumor-specific immune response while avoiding systemic toxicity: bit.ly/3pPRxoR

Check out this recent article from @_CellandGene featuring our CEO, Howard Davis, Ph.D., who discusses Akamis Bio’s portfolio of T-SIGn #therapeutics, our NG-350A clinical trial, and how T-SIGn is broadening the impact of cell therapy in #solidtumors: bit.ly/45QO3T2