Current Report Filing (8-k)
12 Septembre 2022 - 03:17PM
Edgar (US Regulatory)
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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 |
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001-12584 |
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13-3808303 |
(State or other jurisdiction of
incorporation)
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(Commission File No.) |
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(IRS Employer Identification
No.)
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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):
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¨ |
Written communications pursuant to Rule 425 under
the Securities Act (17 CFR 230.425) |
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¨ |
Soliciting material pursuant to Rule 14a-12 under
the Exchange Act (17 CFR 240.14a-12) |
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¨ |
Pre-commencement communications pursuant to Rule
14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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¨ |
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:
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· |
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). |
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o |
The most common treatment-related adverse events (TRAEs) were
pyrexia, flu-like symptoms and increases in liver
transaminases. |
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o |
TRAEs were dose-dependent, reversible and consistent with TRAEs
previously described for other adenovirus-based products. |
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· |
Pharmacokinetics (PK) and pharmacodynamics (PD): Based
on toxicology and PK/PD analysis the recommended Phase 2 dose is
1x1013 viral particles (vp)/patient. |
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· |
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. |
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By: |
/s/
Steven A. Shallcross |
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Name: |
Steven
A. Shallcross |
|
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Title: |
Chief Executive Officer
and Chief Financial Officer |
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