Current Report Filing (8-k)
September 12 2022 - 9:17AM
Edgar (US Regulatory)
0000894158
false
0000894158
2022-09-12
2022-09-12
iso4217:USD
xbrli:shares
iso4217:USD
xbrli:shares
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event
reported): September 12, 2022
SYNTHETIC BIOLOGICS, INC.
(Exact name of registrant as specified in its charter)
| Nevada |
|
001-12584 |
|
13-3808303 |
|
(State or other jurisdiction of
incorporation) |
|
(Commission File No.) |
|
(IRS Employer Identification
No.) |
9605 Medical Center Drive, Suite 270
Rockville, Maryland 20850
(Address of principal executive offices and zip
code)
(301) 417-4364
Registrant’s telephone number, including
area code
N/A
(Former name or former address, if changed since
last report)
Check the appropriate box below if the Form 8-K
filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General
Instruction A.2. below):
| |
¨ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| |
¨ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| |
¨ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| |
¨ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b)
of the Act:
| Title of each class |
Trading Symbol(s) |
Name of each exchange on which
registered |
| Common stock, par value $0.001 per share |
SYN |
NYSE American |
Indicate by check mark whether the registrant
is an emerging growth company as defined in in Rule 405 of the Securities Act of 1933 (17 CFR §230.405 of this chapter) or Rule 12b-2
of the Securities Exchange Act of 1934 (17 CFR §240.12b-2 of this chapter).
Emerging growth company ¨
If an emerging growth company, indicate by checkmark
if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards
provided pursuant to Section 13(a) of the Exchange Act. ¨
Item
8.01. Other Events.
On September 12, 2022, a poster entitled “A Phase I Study to
Evaluate the Safety, Tolerability, and Efficacy of VCN-01 in Combination with Durvalumab (MEDI4736) in Subjects with Recurrent/ Metastatic
Squamous Cell Carcinoma of the Head and Neck (R/M HNSCC)” was presented at the European Society for Medical Oncology (ESMO) Congress
in Paris by Dr. Ricard Mesia, Head of the Medical Oncology Department at Institut Català d'Oncologia (Barcelona, Spain). A copy
of the Poster Presentation is filed as Exhibit 99.1.
Key data and conclusions featured in the Poster Presentation include:
| · | Safety: Treatment with VCN-01 had an acceptable safety profile when administered with durvalumab
in the sequential regimen (single dose of VCN-01 administered 14 days prior to the first dose of durvalumab; n=14).
|
| o | The most common treatment-related adverse events (TRAEs) were pyrexia, flu-like symptoms and increases in liver transaminases. |
| o | TRAEs were dose-dependent, reversible and consistent with TRAEs previously described for other adenovirus-based products. |
| · | Pharmacokinetics (PK) and pharmacodynamics (PD): Based on toxicology and PK/PD analysis the recommended Phase 2 dose is 1x1013
viral particles (vp)/patient. |
| · | Biological activity: Sustained blood levels of VCN-01 viral genomes and increased serum hyaluronidase levels were maintained
for over six weeks. |
| o | Observed an increase in CD8 T cells, a marker of tumor inflammation and an upregulation of PD-L1 in tumors. |
| o | Analysis of serial tumor biopsies revealed differential gene expression profiles and downregulation of matrix-related pathways after
VCN-01 administration. |
Item 9.01. Financial
Statements and Exhibits.
SIGNATURES
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this Current Report on Form 8-K to be signed on its behalf by the
undersigned hereunto duly authorized.
| Dated: September 12, 2022 |
SYNTHETIC BIOLOGICS, INC. |
| |
|
|
|
| |
By: |
/s/ Steven A. Shallcross |
| |
|
Name: |
Steven A. Shallcross |
| |
|
Title: |
Chief Executive Officer
and Chief Financial Officer |
Synthetic Biologics (AMEX:SYN)
Historical Stock Chart
From Nov 2024 to Dec 2024
Synthetic Biologics (AMEX:SYN)
Historical Stock Chart
From Dec 2023 to Dec 2024
