Akamis Bio

Market position

Akamis Bio is a clinical-stage, privately held oncology company with no approved products, competing in tumor-directed gene therapy and oncolytic immunotherapy for solid tumors. It cites colorectal cancer as the second leading cause of cancer deaths globally with rising incidence in adults under 50 as the unmet need it targets. Backers include Sedgwick Yard, ARCH Venture Partners, the Parker Institute for Cancer Immunotherapy and Westlake Village BioPartners.

The T-SIGn platform is positioned around systemic, intravenous administration of tumor-selective replicating viral vectors, in contrast to intratumoral injection. Reported first-in-human findings cited by the company and press include sustained persistence of NG-350A for up to seven weeks after intravenous dosing, dose-dependent vector DNA detection in biopsies nearly two months after treatment, detection of transgene mRNA from replicating vector in nearly half of intravenously treated patients versus one intratumorally treated patient, and sustained increases in inflammatory cytokines at higher intravenous doses. The stated therapeutic positioning is an alternative that may reduce reliance on surgery in rectal cancer.

Technology

The core technology is the T-SIGn (Tumor-Specific Immuno-Gene Therapy) platform: viral vector-based, tumor-selective gene therapies capable of replicating within primary and metastatic solid tumors following intravenous delivery, then driving intratumoral expression of immunologically active molecules to remodel the tumor microenvironment and enhance antitumor immune responses. NG-350A is a transgene-armed vector expressing a CD40 agonist monoclonal antibody; a second disclosed program is a stromal-targeted vector encoding a FAP-CD3 bispecific antibody, CXCL-9, CXCL-10 and interferon alpha.

Go-to-market

As a pre-commercial clinical-stage developer, the company's route to market is clinical development of NG-350A through a Phase 1b proof-of-concept study, supported by regional out-licensing (Greater China rights to Xuanzhu Biopharma) and platform collaborations with larger pharmaceutical companies. Its website directs prospective trial participants to eligibility information for the FORTRESS study.

People living with colorectal cancer, specifically adults with locally advanced rectal cancer (including mismatch repair-proficient disease) and patients with metastatic or advanced epithelial-derived solid tumors, together with the oncologists and clinical trial sites treating them; pharmaceutical partners such as Xuanzhu Biopharma, BMS and Merck are counterparties for licensing and platform collaborations.

Geography

The company originated as an Oxford, UK-based business (as PsiOxus Therapeutics) and established US operations in Cambridge, Massachusetts in Q4 2022, with a US-based CEO. Commercial rights for NG-350A in the Greater China Region have been licensed to Xuanzhu Biopharma.

History

The business was previously known as PsiOxus Therapeutics, an Oxford-based company backed by SR One, IP Group, Hambro Perks, Lundbeckfonden, Sedgwick Yard, Mercia Asset Management and Rosetta Capital. It relaunched as Akamis Bio, appointing Howard Davis, PhD as US-based CEO in Q3 2022 and establishing US operations in Cambridge, Massachusetts in Q4 2022. In January 2023 the renaming was reported alongside a $30 million convertible note financing led by ARCH Venture Partners, the Parker Institute for Cancer Immunotherapy and Westlake Village BioPartners. In January 2025 the company closed a Series A Prime round led by Sedgwick Yard and simultaneously licensed Greater China rights to NG-350A to Xuanzhu Biopharma, together raising up to $60 million. In April 2026 it reported preliminary results from the Phase 1b FORTRESS study.

Risks & controversies

The company is pre-approval and dependent on a single lead clinical asset, NG-350A, whose value hinges on the Phase 1b FORTRESS proof-of-concept readout; management stated an aim of delivering proof-of-concept data within 12-18 months of the January 2025 financing. Financial terms of the Xuanzhu Biopharma license, including upfront payments and milestones, are undisclosed. No controversies are reported in the available sources.