On October 16, 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 a presentation of Phase 1 data from the investigator-sponsored study 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 16, 2023, View Source [SID1234636021]). Encouraging survival was observed in patients progressing to anti-PD(L)-1 agents after systemic VCN-01 in combination with durvalumab. Data will be featured in a poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, being held both virtually and in Madrid, Spain from October 20-24, 2023.

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"We are encouraged by the biological activity observed in R/M HNSCC patients previously treated with anti-PD(L)-1 agents, where new options are urgently needed to offer patients the best chance of long-term survival," said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. "Results show enhanced patient survival, which correlated with VCN-01 induced upregulation of PD(L)-1 and underscores the promise of VCN-01-based combination approaches that may transform treatment for devastating cancers with high unmet needs. We look forward to leveraging our findings as we advance VCN-01 through clinical development."

Key data and conclusions featured in the ESMO (Free ESMO Whitepaper) presentation include:

20 patients were enrolled with a median of 4 prior lines of therapy, from which six in the concomitant (CS) (single dose of VCN-01 in combination with durvalumab on day 1) and 12 in the sequential (SS) (single dose of VCN-01 on day -14 and durvalumab on day 1) were evaluable for response.
In the CS cohort at the 3.3×1012 viral particles (vp) dose, overall survival (OS) was 10.4 months.
In the SS cohort at the 3.3×1012vp dose OS was 15.5 months, whereas in the SS cohort at the 1×1013 vp dose OS was 17.3 months.
11 patients (61.1%) were alive >12 months (2 in CS; 5 in SS at 3.3×1012vp, 4 in SS at 1×1013 vp).
In spite of the advanced stage of the disease and objective response rate of 0%, most of the patients appeared to benefit from subsequent treatment.
Biological activity: Patients showed VCN-01 replication and increased serum hyaluronidase levels were maintained for over six weeks.
Observed an increase in CD8 T cells, a marker of tumor inflammation and an upregulation of PD-L1 in tumors.
Increase of PDL1-CPS (16/21; p=0.013) and CD8 T-cells (12/21; p=0.007) from baseline were found in tumor biopsies.
CPS score of tumor biopsies was increased by administration of VCN-01 at day 8 after administration in the sequential group.
A statistical correlation was observed between CPS on day 8 and patient OS (p=0.005).
The full abstract for the presentation (#937P) is accessible on the ESMO (Free ESMO Whitepaper) Congress portal and the poster will be available starting Sunday, October 22, 2023 at 9:00 a.m. CEST. Additional details of the poster are provided below.

Title: 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
Presenting Author: Maria Jové (Hospitalet de Llobregat, Spain)
Poster Session Date and Time: Sunday, October 22 from 12:00-1:00 p.m. CEST
Location: Hall 8 of the IFEMA Madrid, Spain
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).