Theriva™ Biologics and Sant Joan de Déu-Barcelona Children’s Hospital Advance Strategic Collaboration to Explore the Combination of VCN-01 with Topoisomerase Inhibitors to Treat Cancer

• Theriva signs exclusive option to license intellectual property from Sant Joan de Déu-Barcelona Children’s Hospital (SJD) to explore the therapeutic potential of VCN-01 in combination with topoisomerase I inhibitors -
• Strengthens long-term research collaboration with SJD and builds on ongoing trial evaluating VCN-01 in pediatric cancers -
• Emphasizes VCN-01’s potential for use in diverse chemotherapy combinations and cancer indications -

ROCKVILLE, Md. and BARCELONA, Spain, Nov. 02, 2023 (GLOBE NEWSWIRE) -- 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, and Sant Joan de Déu-Barcelona Children’s Hospital (“SJD”), a university hospital specializing in maternal, child and adolescent health care, today announced that Theriva has executed an exclusive worldwide option to negotiate an exclusive license certain SJD intellectual property rights related to the use of VCN-01 in combination with topoisomerase I inhibitor chemotherapies for the treatment of cancer. VCN-01 is Theriva’s systemic, selective, stroma-degrading oncolytic adenovirus.

The collaboration builds on growing data that suggests coadministration of VCN-01 with topoisomerase I inhibitors such as topotecan can enhance VCN-01 replication and antitumor activity in preclinical cancer models. Combination of VCN-01 with a topoisomerase I inhibitor is expected to provide a synergistic antitumor effect wherein a chemotherapy-mediated increase in tumor VCN-01 levels may enable greater degradation of the tumor stroma, significantly increasing chemotherapy access and tumor destruction.

“This option with SJD reinforces our strategy of employing VCN-01’s unique modes-of-action to improve patient outcomes by enabling effective use of VCN-01 with different classes of chemotherapies and immunotherapies in otherwise refractory cancers,” said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. “Topoisomerase I inhibitors are used to treat a range of challenging tumors, including lung, cervical, colorectal, and pancreatic cancers as well as retinoblastoma. Recent findings suggest that the combination of VCN-01 and topoisomerase I inhibitors may provide a synergistic antitumor effect to improve therapeutic outcomes in these indications. SJD has been a valuable, long-term, research partner with Theriva, and we are very pleased to advance our collaboration with SJD to refine the technology and potentially advance a VCN-01 and topoisomerase I inhibitor combination into advanced clinical trials.”

Angel Carcaboso, Ph.D., senior group leader at SJD, commented, “The new treatment combination shows a powerful synergy in preclinical human cancer models, including intraocular and leptomeningeal retinoblastoma, Ewing sarcoma and neuroblastoma. Synergy happens through the effect of topotecan increasing the susceptibility of cancer cells to VCN-01 infection. The main goal of our work is to bring new treatments to children with catastrophic diseases, and our smooth partnership with Theriva facilitates the translation of our laboratory results to phase 1 trials.”

Theriva will pay SJD an option fee of twenty-five thousand Euros (€25,000). Final license terms will be negotiated during a 12-month option period.

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 90 patients to date in 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). More information on these clinical trials is available at Clinicaltrials.gov.

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.

About Sant Joan de Déu – Barcelona Children’s Hospital

Sant Joan de Déu-Barcelona Children’s Hospital (SJD) is a university hospital specializing in maternal, child and adolescent health care. Founded in 1867, SJD belongs to the Hospitaller Order of Saint John of God and is a private, non-profit institution that has been integrated in the public network of the Spanish national health system since 1973. SJD is the largest children’s hospital in Spain and is one of the most recognized of its category across Europe. The hospital is accredited by the Spanish Ministry of Health as a reference centre for all Spain in a wide range of specialties such as Onco-haematology, Cardiology and Cardiac Surgery, Orthopedics, Neurosciences, Genetics, Rare Diseases, Ophthalmology and Reconstructive Surgery to name a few. The hospital is also accredited by the European Commission in 14 European Reference Networks for specialized care in rare diseases.

Associated with the University of Barcelona since 1994 and with the Hospital Clínic of Barcelona, a university adult hospital, SJD has a specialized pediatric research program managed by the Sant Joan de Déu Research Foundation. SJD together with the Hospital Clínic is one of the most well-known hospital alliances in Spain and an international reference for highly specialized hospital care, teaching and research. Thanks to numerous donors, on October 18, 2018 the hospital had the stone laying ceremony for the future SJD Pediatric Cancer Center Barcelona, which will be one of the largest pediatric oncology centers in Europe.

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 data suggesting coadministration of VCN-01 with topoisomerase I inhibitors such as topotecan can enhance VCN-01 replication and antitumor activity in preclinical cancer models; the combination of VCN-01 with a topoisomerase I inhibitor providing a synergistic antitumor effect to improve therapeutic outcomes in these indications; a chemotherapy-mediated increase in tumor VCN-01 levels enabling greater degradation of the tumor stroma, significantly increasing chemotherapy access and tumor destruction; the Company’s work bringing new treatments to children with catastrophic diseases and SJD’s smooth partnership with the Company facilitating the translation of laboratory results to phase 1 trials. 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, results of the research collaboration enhancing VCN-01 replication and antitumor activity in preclinical cancer models; the Company’s ability to complete enrollment in on-going and planned clinical trials when anticipated and anticipated results, the Company’s ability to address the unmet medical needs for treatment of PDAC and other refractory cancers, 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