On June 5, 2019 Transgene (Paris:TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of solid tumors, reported the publication of two articles highlighting the potential of TG4001 and TG6002, two clinical-stage products, that are expected to generate new clinical data in H2 2019 (Press release, Transgene, JUN 5, 2019, View Source [SID1234536904]).
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TG4001 in Gynecologic Oncology
The data confirm the potential of TG4001 (Tipapkinogen Sovacivec), administered as a monotherapy, to treat precancerous HPV-induced lesions (cervical intraepithelial neoplasia – CIN2/3).
These clinical results, with a 30-month follow up, are highly supportive of the ongoing development of TG4001 in combination with avelumab in HPV-positive cancers, including head and neck carcinomas (NCT
03260023), for which efficacy data are expected in H2 2019.
Of the 129 women randomized to TG4001 and 63 to placebo, complete resolution1 was significantly higher in the vaccine group than placebo for CIN 2/3 regardless of the 13 high-risk HPV types assayed (24% vs. 10%, p < 0.05).
Irrespective of baseline HPV infection, viral DNA clearance2 was higher in the vaccine group compared to placebo (p < 0.01).
TG4001 was well tolerated with the most common adverse events being injection site reactions.
Ref: The efficacy and safety of Tipapkinogen Sovacivec therapeutic HPV vaccine in cervical intraepithelial neoplasia grades 2 and 3: Randomized controlled phase II trial with 2.5 years of follow-up, D.M. Harper, et al., Gynecologic Oncology –
TG6002 in Molecular Therapy Oncolytics
Transgene provides detailed preclinical data on its oncolytic virus TG6002. Based on an optimized Copenhagen strain of vaccinia virus, TG6002 displays a proprietary double gene deletion (TK-RR-) and a patented FCU1 gene, that allows the production of chemotherapy (5-FU) directly in the tumor.
TG6002 is currently being evaluated in a Phase 1/2 study patients with colorectal cancer (NCT
03724071).
TG6002 has an improved safety and efficacy profile and has shown to selectively replicate in tumor cells.
Several models highlight the promising activity of the oncolytic virus, particularly in colorectal carcinoma models.
Ref: The Enhanced Tumor Specificity of TG6002, an Armed Oncolytic Vaccinia Virus Deleted in Two Genes Involved in Nucleotide Metabolism, J. Foloppe, et al., Molecular Therapy Oncolytics –