TuHURA Biosciences, Inc.
Phase‑3 stage immuno‑oncology company developing tumor‑directed nucleic acid vaccines, monoclonal antibodies that inhibit myeloid checkpoint pathways, and Delta opioid receptor‑targeted bi‑functional conjugates to modulate the tumor microenvironment and address primary and acquired resistance to cancer immunotherapies. Advancing a lead intratumoral plasmid DNA innate immune agonist in a randomized Phase 3 registration trial under an FDA Special Protocol Assessment and developing antibody and conjugate programs for solid tumors and hematologic malignancies.
Industries
Nr. of Employees
small (1-50)
Patents
Products
Intratumoral plasmid DNA innate immune agonist (lead clinical candidate)
Intratumoral plasmid DNA construct designed to express an immunogenic protein within tumor cells to trigger innate immune recognition and antigen presentation; evaluated as an adjunctive therapy to checkpoint inhibition in a randomized Phase 3 registration trial.
Tumor‑targeted mRNA LNP vaccine candidate (CD22‑directed)
mRNA vaccine formulated in lipid nanoparticles and targeted using an antibody fragment against CD22 to direct payload expression in malignant B cells; positioned for IND‑enabling development toward hematologic malignancies.
VISTA‑inhibiting monoclonal antibody (clinical‑stage)
Monoclonal antibody that blocks VISTA, a checkpoint predominantly expressed on myeloid cells and MDSCs; evaluated in early clinical dose‑escalation studies and planned for randomized Phase 2 development in combination with other targeted agents for hematologic malignancies.
Delta opioid receptor‑targeted bi‑specific ADC/APC (preclinical)
Preclinical program developing antibody‑drug and antibody‑peptide conjugates that target Delta opioid receptor on tumor‑associated myeloid cells to inhibit suppressive functions and localize immune effectors to the tumor microenvironment.
Intratumoral plasmid DNA innate immune agonist (lead clinical candidate)
Intratumoral plasmid DNA construct designed to express an immunogenic protein within tumor cells to trigger innate immune recognition and antigen presentation; evaluated as an adjunctive therapy to checkpoint inhibition in a randomized Phase 3 registration trial.
Tumor‑targeted mRNA LNP vaccine candidate (CD22‑directed)
mRNA vaccine formulated in lipid nanoparticles and targeted using an antibody fragment against CD22 to direct payload expression in malignant B cells; positioned for IND‑enabling development toward hematologic malignancies.
VISTA‑inhibiting monoclonal antibody (clinical‑stage)
Monoclonal antibody that blocks VISTA, a checkpoint predominantly expressed on myeloid cells and MDSCs; evaluated in early clinical dose‑escalation studies and planned for randomized Phase 2 development in combination with other targeted agents for hematologic malignancies.
Delta opioid receptor‑targeted bi‑specific ADC/APC (preclinical)
Preclinical program developing antibody‑drug and antibody‑peptide conjugates that target Delta opioid receptor on tumor‑associated myeloid cells to inhibit suppressive functions and localize immune effectors to the tumor microenvironment.
Expertise Areas
- Immuno‑oncology drug development
- Clinical development and regulatory strategy (Phase 1–3, SPA/accelerated pathways)
- Nucleic‑acid cancer vaccine platforms (plasmid DNA, mRNA LNP)
- Monoclonal antibody discovery and translation
Key Technologies
- Plasmid DNA tumor‑directed vaccine constructs
- mRNA vaccines formulated in lipid nanoparticles (LNPs)
- Intratumoral injection delivery
- Monoclonal antibodies targeting myeloid checkpoint pathways (e.g., VISTA)
News & Updates
Management presentation and one‑on‑one meetings at the 27th Annual H.C. Wainwright Global Investment Conference.
Report of Q2 2025 financial results, initiation of a Phase 3 trial of the lead innate immune agonist, completion of an acquisition adding a VISTA‑targeting antibody to the pipeline, and financing updates.
Announcement of corporate rebranding and overview of platform focus on personalized cancer vaccines and bi‑functional conjugates targeting the tumor microenvironment.
Started a randomized placebo‑controlled Phase 3 registration trial of the lead intratumoral plasmid DNA innate immune agonist as adjunctive therapy in first‑line advanced/metastatic Merkel cell carcinoma under an FDA SPA.
Completed acquisition of an asset that added a VISTA‑inhibiting monoclonal antibody program to the development pipeline.
Company added to the Russell 3000® and Russell 2000® indexes as part of the 2025 reconstitution.
Management presentation and one‑on‑one meetings at the 27th Annual H.C. Wainwright Global Investment Conference.
Report of Q2 2025 financial results, initiation of a Phase 3 trial of the lead innate immune agonist, completion of an acquisition adding a VISTA‑targeting antibody to the pipeline, and financing updates.
Announcement of corporate rebranding and overview of platform focus on personalized cancer vaccines and bi‑functional conjugates targeting the tumor microenvironment.
Started a randomized placebo‑controlled Phase 3 registration trial of the lead intratumoral plasmid DNA innate immune agonist as adjunctive therapy in first‑line advanced/metastatic Merkel cell carcinoma under an FDA SPA.
Completed acquisition of an asset that added a VISTA‑inhibiting monoclonal antibody program to the development pipeline.
Company added to the Russell 3000® and Russell 2000® indexes as part of the 2025 reconstitution.