On October 23, 2023 Theriva Biologics (NYSE American: TOVX), ("Theriva" or the "Company"), a clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, reported new clinical data from the Phase 1 investigator-sponsored study with the Institut Catala d’Oncologia (ICO) evaluating VCN-01 in combination with durvalumab for patients with recurrent/metastatic squamous cell carcinoma of the head and neck (R/M HNSCC) (Press release, Theriva Biologics, OCT 23, 2023, View Source [SID1234636270]). These data were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, held both virtually and in Madrid, Spain from October 20-24, 2023.

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"Results presented at ESMO (Free ESMO Whitepaper) further validate VCN-01’s unique mechanism of action for devastating cancers with high unmet need," said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. "We are encouraged by the data generated to date, highlighted by the enhanced patient survival, correlating with VCN-01 mediated increases in the CPS score, a key determinant of outcomes with anti-PD-(L)1 checkpoint inhibitor therapies. These results build on the previously reported acceptable safety profile seen with sequential dosing of VCN-01 and durvalumab. Taken together, we believe VCN-01 based combinations may address the need for improved treatments with the potential to overcome previous resistance to anti-PD-(L)1 therapies in patients with R/M HNSCC."

The poster (#937P) titled "Survival Outcomes in Phase I Trial Combining VCN-01 and Durvalumab (MEDI4736) in Subjects with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma Refractory to Previous Immunotherapy Treatment," was presented by Maria Jové (Hospitalet de Llobregat, Spain).

Presentation Highlights:
Key Takeaway: VCN-01 combined with durvalumab showed encouraging overall survival (OS) in patients who previously progressed on anti-PD(L)-1 therapy.

Survival: VCN-01 induced upregulation of PD-L1, which correlated with enhanced patient survival.
In the concomitant (CS) cohort at the 3.3×1012 viral particles (vp) dose, overall survival (OS) was 10.4 months and progression free survival (PFS) was 1.7 months.
In the sequential (SS) cohort at the 3.3×1012vp dose OS was 15.5 months and PFS was 3.7, whereas in the SS cohort at the 1×1013 vp dose OS was 17.3 months and PFS was 2.1 months.
VCN-01 induces changes in the immune status of tumors
VCN-01 combined with durvalumab increased CD8 T cells, a marker of tumor inflammation and the expression of PD(L)-1 in tumors. An increase of PD(L)-1 CPS (8/11 at day 8; 8/10 at day 28) and CD8 T cells (7/11 at day 8; 5/10 at day 28) from baseline were found in tumor biopsies.
VCN-01 alone increased the CPS score of tumor biopsies at day 8 after administration by 62.5% in the sequential arm.
VCN-01 induced PD(L)-1 upregulation with enhanced patient survival. A statistical correlation was observed between CPS on day 8 and patient OS (p=0.005).
Pharmacodynamics and shedding of VCN-01
PH20 expression from VCN-01 peaked on day 3-8 and remained elevated in some patients up to day 42. Quantification of VCN-01 genomes in stool demonstrated viral shedding that peaked at day 8.
KOL Webinar on Monday, October 23, 2023 at 8:00 a.m. ET (2:00 p.m. CEST)

The webinar will feature KOL, Ricard Mesia, M.D., Ph.D., head of Medical Oncology Department at Catalan Institut of Oncology in Barcelona. Dr. Mesia will discuss the unmet medical need in the head and neck cancer treatment landscape, the current limitations, and the need for new approaches, along with the key takeaways from Theriva’s ESMO (Free ESMO Whitepaper) poster presentation. A live Q&A session will follow the formal discussion. To register for the event, please click here. An archived webcast will also be accessible in the "Events" section of the company’s website at www.therivabio.com.

About VCN-01

VCN-01 is a systemically administered oncolytic adenovirus designed to selectively and aggressively replicate within tumor cells and degrade the tumor stroma that serves as a significant physical and immunosuppressive barrier to cancer treatment. This unique mode-of-action enables VCN-01 to exert multiple antitumor effects by (i) selectively infecting and lysing tumor cells; (ii) enhancing the access and perfusion of co-administered chemotherapy products; and (iii) increasing tumor immunogenicity and exposing the tumor to the patient’s immune system and co-administered immunotherapy products. Systemic administration enables VCN-01 to exert its actions on both the primary tumor and metastases. VCN-01 has been administered to over 80 patients in Phase 1 and investigator-sponsored clinical trials of different cancers, including PDAC (in combination with chemotherapy), head and neck squamous cell carcinoma (with an immune checkpoint inhibitor), ovarian cancer (with CAR-T cell therapy), colorectal cancer, and retinoblastoma (by intravitreal injection).