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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.

 

(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

 

 

 

 

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.

 

TherivaBiologics (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

 

 

 

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Oct. 16, 2023
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Entity File Number 001-12584
Entity Registrant Name THERIVA BIOLOGICS, INC.
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Entity Address, Address Line One 9605 Medical Center Drive
Entity Address, Address Line Two Suite 270
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Title of 12(b) Security Common stock, par value $0.001 per share
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