THERIVA BIOLOGICS S.L.
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- Biodrugs
- Gene Therapy
- Oncology
- Blood and lymphatic system
- Digestive system and hepatology
Theriva™ Biologics (TOVX) is a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need.
The company´s transformed pipeline includes lead candidate, VCN-01, a systemically administered oncolytic adenovirus (OV) engineered to break down the stroma barrier, which protects tumors from cancer therapies and hides them from the patient´s immune system.
These unique and differentiated mechanisms are intended to improve the anti-tumor effect of the OV with co-administered chemotherapy and immune-oncology products. Importantly, degrading the stroma can also expose tumor antigens, turning “cold” tumors to “hot” and enabling a sustained anti-tumor response by the patient´s immune system.
VCN-01 is Theriva’s lead clinical-stage candidate, designed to replicate selectively and aggressively within tumor cells, and to degrade the tumor stroma barrier that serves as a significant physical and immunosuppressive barrier to cancer treatment.
- VCN-01 is currently being evaluated in a phase 2 clinical trial in patients with pancreatic ductal adenocarcinoma (PDAC) and in investigator sponsored studies in a number of indications.
- VCN-01 is characterized by 4 interconnected evolutions in oncolytic virus design that enable intravenous delivery at higher doses than have been feasible for other oncolytic viruses:
- HIGH REPLICATION RATE. Increases manufacturing yields and is expected to enable an antitumor effect even if low levels of the oncolytic virus are delivered to the tumor.
- TUMOR-SELECTIVE REPLICATION. Intended to maximize antitumor effects, minimize potential off-target effects, and limit damage to healthy tissues.
- EXPRESSION OF HYALURONIDASE (PH20). Degrades tumor stromal hyaluronic acid, a substance that has been strongly associated with reduced tumor immunogenicity and poor prognosis in patients with PDAC and ovarian cancer.
- LIVER DETARGETING. Intended to reduce the loss of VCN-01 through hepatic clearance and avoids potential liver toxicities.
- HIGH REPLICATION RATE. Increases manufacturing yields and is expected to enable an antitumor effect even if low levels of the oncolytic virus are delivered to the tumor.
- VCN-01 clinical advancement is strongly supported by > 84-patient phase 1 clinical program that has provided encouraging safety and clinical data in patients with diverse types of cancer, including PDAC.
- VCN-01 development and commercialization are expected to benefit from Orphan Drug Designation granted by the EMA and FDA for pancreatic cancer and for retinoblastoma by FDA.
- VCN-01 has been successfully co-administered with chemotherapies, checkpoint inhibitors, and CAR-T cells and is expected to have brad potential utility in treatment regimens for multiple cancer types.
VCN-11 is the archetype product from the Albumin ShieldTM technology platform that is designed to improve systemic administration and may allow repeated OV dosing to improve potential efficacy.
- VCN-11 is a version of VCN-01 engineered to express Albumin Binding Domain (ABD) in the virus’ outer shell, which allows the virus to coat itself with human serum albumin, preventing inactivation of the OV by neutralizing antibodies in circulation.
- Strong preclinical proof-of-concept for the Albumin ShieldTM technology has been demonstrated with VCN-11 and the company is exploring additional ABD modified OVs with different potential therapeutic payloads.
- The unique Albumin ShieldTM technology provides a platform for the development of a sustainable pipeline of next-generation products and may also enable revenue generation through licensing and/or partnerships.
We are interested in Collaboration Agreements with Pharma companies looking to improve the efficacy of their Immuno Oncologic (IO) pipeline in PDAC and other cold tumors. Our systemically delivered oncolytic viruses are designed to improve accessibility of current standard-of-care therapies and IO products and boost immune responses by changing the extracellular matrix.
Biotech Sanitaria
Product / Service | Type | Therapeutic area | Development phase |
---|---|---|---|
VCN-11 | Cell Therapy, Gene Therapy | Oncología | Preclinical |
VCN-02 | Cell Therapy, Gene Therapy | Oncología | R&D |
VCN-01 | Cell Therapy, Gene Therapy | Oncología | P II |
VCN-01 | Cell Therapy, Gene Therapy | Oncología | P I |
VCN-01 | Cell Therapy, Gene Therapy | Oncología | P I |
VCN-01 | Cell Therapy, Gene Therapy | Oncología | P I |
VCN-01 | Cell Therapy, Gene Therapy | Oncología, Sistema nervioso central | P I |