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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): October 16, 2023
THERIVA 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(b) 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 |
TOVX |
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 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.
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 |
Exhibit 99.1
Theriva™ Biologics Announces Presentation
at ESMO Congress 2023 Featuring 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
-Results from investigator-sponsored study in
collaboration with the Institut Catala d’Oncologia (ICO) show enhanced patient survival, correlating with VCN-01 induced upregulation
of PD(L)-1-
-Key Opinion Leader (KOL) webinar featuring
expert oncologist Ricard Mesia M.D., Ph.D., to be held Monday, October 23, 2023 at 8:00 a.m. ET-
Rockville,
MD, 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, today announced
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). 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) Congress, being held both virtually and in Madrid, Spain from October 20-24, 2023.
“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 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 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 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).
About Theriva™ Biologics, Inc.
Theriva™
Biologics (NYSE American: TOVX), is a diversified clinical-stage company developing therapeutics designed to treat cancer and related
diseases in areas of high unmet need. The Company’s wholly-owned Spanish subsidiary Theriva Biologics, S.L., has been developing
a new oncolytic adenovirus platform designed for intravenous (IV), intravitreal and antitumoral delivery to trigger tumor cell death,
improve access of co-administered cancer therapies to the tumor, and promote a robust and sustained anti-tumor response by the patient’s
immune system. In addition to VCN-01, the Company’s clinical-stage candidates include: (1) SYN-004 (ribaxamase) which is designed
to degrade certain commonly used IV beta-lactam antibiotics within the gastrointestinal (GI) tract to prevent microbiome damage, thereby
limiting overgrowth of pathogenic organisms such as VRE (vancomycin resistant Enterococci) and reducing the incidence and severity of
acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients); and (2) SYN-020, a recombinant
oral formulation of the enzyme intestinal alkaline phosphatase (IAP) produced under cGMP conditions and intended to treat both local
GI and systemic diseases. For more information, please visit Theriva Biologics’ website at www.therivabio.com.
Forward-Looking Statement
This
release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases
forward-looking statements can be identified by terminology such as “may,” “should,” “potential,”
“continue,” “expects,” “anticipates,” “intends,” “plans,” “believes,”
“estimates,” and similar expressions, and include statements regarding the VCN-01-based combination approaches
transforming treatment for devastating cancers with high unmet needs and leveraging the findings as VCN-01 advances through clinical development. These
forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and are subject
to a number of risks and uncertainties, many of which are difficult to predict that could cause actual results to differ materially from
current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause
actual results to differ materially from current expectations include, among others, the Company’s ability to complete enrollment
in its trials when anticipated and anticipated results, the Company’s ability to address the unmet medical needs for treatment of
cancer and related diseases, the Company’s ability to take advantage of the potential benefits of orphan drug designation, the Company’s
ability to reach clinical milestones when anticipated, the Company’s ability to successfully operate the combined US and Spanish
business entities , the Company’s product candidates demonstrating safety and effectiveness, as well as results that are consistent
with prior results; the ability to complete clinical trials on time and achieve the desired results and benefits, continuing clinical
trial enrollment as expected; the ability to obtain regulatory approval for commercialization of product candidates or to comply with
ongoing regulatory requirements, regulatory limitations relating to the Company’s ability to promote or commercialize their product
candidates for the specific indications, acceptance of product candidates in the marketplace and the successful development, marketing
or sale of the Company’s products, developments by competitors that render such products obsolete or non-competitive, the Company’s
ability to maintain license agreements, the continued maintenance and growth of the Company’s patent estate, the ability to continue
to remain well financed and other factors described in the Company’s Annual Report on Form 10-K for the year ended December 31,
2022 and its other filings with the SEC, including subsequent periodic reports on Forms 10-Q and current reports on Form 8-K. The
information in this release is provided only as of the date of this release, and Theriva Biologics undertakes no obligation to update
any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required
by law.
For further information, please contact:
Investor Relations:
Chris Calabrese
LifeSci Advisors, LLC
ccalabrese@lifesciadvisors.com
917-680-5608
Exhibit 99.2
Abstract 6207
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
Type: Abstract
Category:Head and
neck cancer, excl. thyroid
Authors: M.
Jové1, I.
Braña2, M. Oliva Bernal1,
A. Hernando Calvo2, C. Erasun
Lecuona1, J.D. Assaf Pastrana2,
A. Mato-Berciano3, M.V. Maliandi3,
S. Torres-Manjon4, R. Moreno4,
C. Le5, P. Nuciforo6,
R. Alemany4, G. Capella7,
C. Blasco8, M. Cascallo Piqueras8,
R. Mesia Nin9; 1Medical
Oncology - Phase 1 Functional Unit, Catalan Institute of Oncology (ICO), Hospitalet De Llobregat, Spain, 2Medical
Oncology Dept., Vall d ´Hebron Hospital Universitari and Vall d´Hebron Institute of Oncology (VHIO), Barcelona,
Spain, 3R&D, Theriva Biologics,
Parets Del Valles, Spain, 4ProCure Program
ICO. Program in Molecular Mechanisms and Experimental Therapy in Oncology (Oncobell), IDIBELL, ICO -
Institut Català d'Oncologia - Hospital Duran i Reynals, Hospitalet De Llobregat, Spain, 5Statistics &
Analytics, Theriva Biologics, Rockville, United States of America, 6Molecular
Oncology Dept., Vall d'Hebron Institute of Oncology (VHIO)-Cellex Center, Barcelona, Spain, 7Program
in Molecular Mechanisms and Experimental Therapy in Oncology (Oncobell), IDIBELL, Hospitalet De Llobregat, Spain, 8Clinical
Operations, Theriva Biologics, Parets Del Valles, Spain, 9Medical
Oncology Department, ICO - Institut Català d'Oncologia. B-ARGO group, IGTP, Badalona, Spain
Background
VCN-01 is an oncolytic
adenovirus expressing hyaluronidase that increases immune check-point inhibitor uptake in preclinical models suggesting it could reduce
resistance to anti-PD(L)-1 therapies. Initial results from Phase 1 trial NCT03799744 showed that sequential administration of VCN-01
and Durvalumab is feasible with an acceptable safety profile. Here we present the clinical outcomes data
Methods
VCN-01 at 3,3E12 and 1E13 viral
particles [vp] were administered with a fixed dose of Durvalumab (1500 mg) in a 3+3 design in R/M HNSCC pts previously treated with
anti-PD(L)-1 agents. Concomitant (single dose VCN-01 + Durvalumab on day 1, CS), and sequential (single dose of VCN-01 on day -14 +
Durvalumab on day 1; SS) schedules were tested. Durvalumab continued q4 weeks until progression in both schedules. Fresh tumor
biopsies were taken at baseline, post-VCN-01 and post-Durvalumab
Results
20 patients were enrolled (median
prior lines: 4, range: 1-7), from which 6 in the CS (all 3.3E12 vp) and 12 in the SS (6 at 3,3E12vp and 6 at 1E13 vp) were evaluable
for response. Objective response rate (ORR), median PFS and OS (95% CI) in the CS at 3,3E12vp were 0% 1,7 months (1.6-NE) and 10.4 months
(8.9-NE), respectively. For SS patients at 3.3E12 vp, ORR, median PFS and OS were 16%, 3.7 months (2.2-NE) and 15.5 months (15.1-NE)
respectively. Values for SS patients at 1E13 vp were 0%, 2.1 months (1.4-NE) and 15+ months. 11 patients (61.1%) were alive >12 months
(2 in CS; 5 in SS at 3.3E12 vp, 4 in SS at 1E13 vp). Unexpectedly most of them appeared to benefit from subsequent treatment. The 3 patients
with the longest survival showed immune-mediated DLT. 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 both post-VCN-01 and post-Durvalumab. A correlation between OS and CPS at D8 was observed (p=0.005). Viral
genome analysis and other biologic markers confirmed sustained VCN-01 replication.
Conclusions
Encouraging survival was
observed in patients progressing to anti-PD(L)-1 agents after systemic VCN-01 with Durvalumab. VCN-01-induced upregulation of PD-L1,
which correlated with enhanced patient survival
Clinical trial
identification
NCT03799744
Editorial acknowledgement
Print
v3.23.3
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Theriva Biologics (AMEX:TOVX)
Gráfica de Acción Histórica
De Ene 2025 a Feb 2025
Theriva Biologics (AMEX:TOVX)
Gráfica de Acción Histórica
De Feb 2024 a Feb 2025
