Akamis Bio

What Akamis Bio does

Akamis Bio is a clinical-stage oncology company developing systemically administered, tumor-specific oncolytic immunotherapies based on its proprietary T-SIGn (Tumor-Specific Immuno-Gene) platform. The platform uses a replication-competent chimeric group B adenovirus backbone, optimized via directed evolution, to selectively target epithelial-cell-derived solid tumors after intravenous delivery while sparing healthy tissue, and to deliver immunotherapeutic transgene payloads — including antibodies, bispecifics, chemokines, cytokines, and synthetic constructs — directly into the tumor microenvironment.

The company's lead candidate, NG-350A, drives intratumoral expression of a secreted CD40 agonist monoclonal antibody to activate antigen-presenting cells and recruit T cells, and is currently being evaluated in the Phase 1b FORTRESS trial (NCT06459869) in patients with mismatch repair-proficient (pMMR) locally advanced rectal cancer (LARC). NG-348, a second clinical-stage T-SIGn candidate, expresses membrane-bound CD80 and an anti-CD3 scFv for direct T-cell engagement in metastatic colorectal cancer. In April 2026 the company reported preliminary FORTRESS data showing a 50% composite response rate in the first 10 patients treated with NG-350A plus chemoradiotherapy versus a 25% benchmark for chemoradiotherapy alone, with no new safety signals.

Akamis Bio is pre-revenue with no commercialized products. Its business model relies on advancing pipeline assets through clinical proof-of-concept, securing regulatory designations such as the FDA Fast Track Designation received in October 2025 for NG-350A, and monetizing through regional licensing partnerships — most notably the December 2024 deal granting Xuanzhu Biopharma Greater China rights to NG-350A in exchange for undisclosed upfronts, regulatory and sales milestones, and tiered royalties in the high single- to low double-digit range. The company is led by CEO Howard Davis, PhD, is headquartered in Cambridge, Massachusetts, and has approximately $90 million in cumulative funding as of late 2024.

Name

Akamis Bio

Legal name

Akamis Bio, Inc.

Website

https://akamisbio.com

Company type

Private

Founded year

2022

Operating status

Operating

Headcount range

11–50 employees

Short description

Akamis Bio is a clinical-stage oncology company developing intravenously delivered, tumor-specific oncolytic immunotherapies based on its proprietary T-SIGn platform, targeting colorectal cancer and other solid tumors through its lead candidate NG-350A and pipeline programs.

Ownership category

akta.pro rank

Product category

Oncolytic Immunotherapy / Clinical-Stage Biopharmaceuticals

NAICS

Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Oncology Gene Therapies (incl. oncolytic vectors & gene-modified approaches) (HLAAACAF)

Keywords

• Oncolytic immunotherapy
• Tumor-specific gene therapy
• Clinical-stage oncology
• Transgene payload delivery
• Colorectal cancer therapeutics

Headquarters

HQ city

Cambridge

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales

Revenue model

1. Licensing Royalties: Akamis Bio receives licensing fees, regulatory and sales milestones, and tiered royalties (high single- to low double-digit range) on Greater China Region NG-350A sales from Xuanzhu Biopharma partnership
2. Clinical-stage Product Development: Pre-revenue clinical stage company developing oncolytic immunotherapies for colorectal cancer. No commercialized products yet; revenue dependent on successful clinical development and potential future product launches or additional licensing deals.

Go-to-market motion2 records

Distribution channels1 record

Marketing channels5 records

Core offering

Akamis Bio develops systemically administered, tumor-specific oncolytic immunotherapies using its proprietary T-SIGn (Tumor-Specific Immuno-Gene) platform, which is built on a replication-competent chimeric group B adenovirus backbone optimized via directed evolution to selectively replicate within epithelial-cell-derived solid tumors following intravenous delivery. Its lead clinical-stage candidate, NG-350A, drives intratumoral expression of a CD40 agonist monoclonal antibody to treat pMMR locally advanced rectal cancer, while NG-348 expresses membrane-bound CD80 and anti-CD3 scFv for metastatic colorectal cancer. The company monetizes the platform through licensing deals with pharmaceutical partners (e.g., Xuanzhu Biopharma for Greater China rights) and pursues further co-development partnerships.

Product overview

Akamis Bio is a clinical-stage oncology company developing a portfolio of oncolytic immunotherapies based on its proprietary T-SIGn (Tumor-Specific Immuno-Gene) platform. The platform delivers immunotherapeutic transgene payloads via systemically administered, tumor-specific adenoviral vectors. The company's lead clinical-stage product is NG-350A, which drives intratumoral expression of a CD40 agonist monoclonal antibody for treating pMMR locally advanced rectal cancer (with FDA Fast Track Designation). NG-348 is a second clinical-stage candidate expressing CD80 and anti-CD3 scFv for metastatic colorectal cancer. The T-SIGn platform has also been used in partnership collaborations including with Xuanzhu Biopharma (Greater China licensing agreement) and earlier collaborations with Merck and Cancer Research Institute.

Differentiator

Problem solved

Functional benefit

Products and services

• NG-350A Clinical-stage, intravenously delivered T-SIGn therapeutic designed to drive intratumoral expression of a secreted CD40 agonist monoclonal antibody, activating antigen-presenting cells to recruit T cells for anti-tumor immune response. Currently in Phase 1b FORTRESS study for pMMR locally advanced rectal cancer; granted FDA Fast Track Designation in October 2025.
• NG-348 Clinical-stage, intravenously delivered T-SIGn therapeutic designed to drive intratumoral expression of two membrane-bound T cell activators (CD80 and anti-CD3 scFv) for direct tumor cell killing and anti-tumor immune response in metastatic colorectal cancer.
• T-SIGn (Tumor-Specific Immuno-Gene) Platform Virus-based, systemically administered, tumor-specific oncolytic immunotherapy platform built on replication-competent, chimeric group B adenovirus backbone, optimized via directed evolution to exclusively attack epithelial-cell derived solid tumors following intravenous delivery. Capable of delivering immunotherapeutic transgene payloads directly to tumor microenvironment; offered to pharmaceutical partners via licensing and co-development arrangements.

Quantifiable outcome

• 50% composite response rate in FORTRESS study (first 10 patients) vs 25% benchmark for standard chemoradiotherapy alone
• +2 more outcomes

Named customers1 record

Segments2 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Seven partnerships are on record, tiered major, core and minor.

• Xuanzhu BiopharmamajorOEM/ Whitelabel/ Licensing Partner · 17 December 2024Licensing agreement granting Xuanzhu Biopharma the Greater China Region rights to NG-350A. Akamis Bio eligible to receive undisclosed upfront payments plus regulatory and sales milestones, as well as tiered royalties in the high single- to low double-digit range on Greater China Region NG-350A sales.
• MerckcoreStrategic or Co-development PartnerT-SIGn platform-focused collaboration with leaders in the immuno-oncology field.
• Cancer Research Institute (CRI)coreStrategic or Co-development PartnerT-SIGn platform-focused collaboration with leaders in the immuno-oncology field.
• Cancer Research UKcoreStrategic or Co-development PartnerCo-sponsored the CEDAR Phase 1 study of Enadenotucirev (EnAd) in combination with chemoradiotherapy for locally advanced rectal cancer.
• Undisclosed CAR-T PartnerminorStrategic or Co-development PartnerCollaboration using T-SIGn therapeutics to drive local expression of synthetic CAR to increase efficacy and safety of CAR-T therapy for solid tumors.
• Bristol-Myers Squibb (BMS)coreStrategic or Co-development PartnerT-SIGn platform-focused collaboration with leaders in the immuno-oncology field.
• Parker Institute for Cancer Immunotherapy (PICI)coreStrategic or Co-development PartnerT-SIGn platform-focused collaboration with leaders in the immuno-oncology field.

Scale indicators4 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Replimune Group: Clinical-stage oncology company developing a portfolio of oncolytic immunotherapies (RP1, RP2, RP3) based on a proprietary herpes simplex virus platform. Most direct peer to Akamis Bio given overlapping oncolytic virus modality, transgene-payload delivery approach, and clinical-stage solid tumor focus.
• CG Oncology: Clinical-stage immuno-oncology company developing oncolytic adenovirus therapies (cretostimogene grenadenorepvec) for bladder cancer. Directly comparable as an oncolytic virus developer with late-stage clinical assets and a focus on urologic/solid tumor indications.
• Turnstone Biologics: Clinical-stage biotech developing oncolytic virus immunotherapies (TBio-6517, TBio-5167) using vaccinia and other viral platforms for solid tumors. Comparable clinical-stage peer working in the same oncolytic immunotherapy modality.
• Targovax: Norwegian clinical-stage immuno-oncology company developing oncolytic virus therapies (ONCOS-102) for solid tumors including mesothelioma and colorectal cancer. Closely matches Akamis Bio's platform modality and colorectal cancer indication.
• Transgene: French clinical-stage biotech developing oncolytic virus immunotherapies (TG6002, TG4050) using poxvirus and adenovirus platforms. Comparable viral immunotherapy modality with clinical-stage assets across solid tumors.

Emerging players

• Oncorus: Clinical-stage biotech developing oncolytic virus immunotherapies using both herpesvirus and synthetic viral platforms for solid tumors. Comparable modality with a more recent platform expansion to synthetic viruses.
• DNAtrix: Clinical-stage company developing oncolytic adenovirus therapies (DNX-2401) for glioblastoma and other solid tumors. Directly comparable adenovirus-based oncolytic platform targeting hard-to-treat cancers.

Others

• PsiOxus Therapeutics (historical): Akamis Bio was formerly PsiOxus Therapeutics before its 2023 corporate relaunch. Listed for historical reference, not as a current peer.

Broad incumbents

• Merck & Co. Large-cap pharma with Keytruda dominating immuno-oncology; existing T-SIGn collaboration partner. Relevant as a strategic partner and as the dominant incumbent in immuno-oncology combinations that Akamis aims to combine with.
• Bristol-Myers Squibb: Large-cap pharma with Opdivo in immuno-oncology; existing collaboration partner with Akamis Bio. Relevant as a strategic partner and as a broader incumbent in the colorectal cancer immunotherapy space.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/psioxus
• LinkedInlinkedin.com/company/akamisbio

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 records

Funding overview

Funding rounds10 records

Investors13 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A1 record

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Akamis Bio