UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Item 7.01. Regulation FD Disclosure.
On October 16, 2023, Theriva Biologics, Inc. (the “Company”) issued a press release announcing the presentation of survival outcomes in Phase 1 study evaluating VCN-01 in combination with durvalumab in patients with recurrent/ metastatic squamous cell carcinoma of the head and neck. These data will be featured in a poster presentation at the European Society for Medical Oncology (ESMO) Congress, being held both virtually and in Madrid, Spain from October 20-24, 2023.
Key data and conclusions featured in the ESMO 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). |
A copy of the abstract titled “Survival outcomes in Phase 1 trial combining VCN-01 and Durvalumab (MED14736) in Subjects With Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma refractory to previous immunotherapy treatment” is filed as Exhibit 99.2 to this Current Report on Form 8-K.
The information in this Item 7.01 and in the press release furnished as Exhibit 99.1 to this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended and shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
The press release furnished as Exhibit 99.1 to this Current Report on Form 8-K includes “safe harbor” language pursuant to the Private Securities Litigation Reform Act of 1995, as amended, indicating that certain statements contained therein are “forward-looking” rather than historical.
Item 8.01. Other Events.
On October 16, 2023, the Company presented survival outcomes in Phase 1 study evaluating VCN-01 in combination with durvalumab in patients with recurrent/ metastatic squamous cell carcinoma of the head and neck These data will be featured in a poster presentation at the European Society for Medical Oncology (ESMO) Congress, being held both virtually and in Madrid, Spain from October 20-24, 2023.
Key data and conclusions featured in the ESMO 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 between OS observed in patients and CPS on day 8 (p=0.005). |
Item 9.01. Financial Statements and Exhibits.
| (d) | Exhibits. |
| Exhibit Number |
Description | |
| 99.1 | Press Release issued by Theriva Biologics, Inc., dated October 16, 2023 | |
| 99.2 | Abstract titled “Survival outcomes in Phase 1 trial combining VCN-01 and Durvalumab (MED14736) in Subjects With Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma refractor to previous immunotherapy treatment” | |
| 104 | Cover Page Interactive Data File (embedded within the XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Dated: October 17, 2023 | THERIVA BIOLOGICS, INC. | ||
| By: | /s/ Steven A. Shallcross | ||
| Name: | Steven A. Shallcross | ||
| Title: | Chief Executive Officer and Chief Financial Officer | ||