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DELIVERING A NEW CLASS OF ONCOLYTIC VIRUS THERAPEUTICS




ABOUT THERIVA

Theriva Biologics is a clinical-stage immuno-oncology company developing
oncolytic viruses intended to overcome the protective barrier surrounding solid
tumors and selectively kill tumor cells. Our therapies are designed to enable
systemic delivery and have the potential to enhance current standard-of-care
therapies, offering patients with difficult-to-treat cancers the chance of a
longer life.

Led by a team of experienced leaders with a vision for clinical innovation, we
are committed to offering new therapeutic modalities that improve the way cancer
is treated.


OUR SCIENCE


THE THERIVA DIFFERENCE

Theriva is developing highly differentiated oncolytic adenoviruses that are
designed to overcome the challenges of accessibility, availability, and
administration and can potentially enable multiple dosing to improve efficacy.
The unique therapeutic properties of Theriva’s oncolytic viruses represent a new
class of cancer therapies that are designed to selectively destroy tumor cells
and enhance the effects of current standard-of-care therapies. Engineered for
systemic delivery, Theriva’s oncolytic viruses can be administered intravenously
or as a direct injection into the tumor or tumor compartment (intravitreal,
intratumoral).

To improve efficiency, Theriva’s oncolytic viruses are designed for:

 * Systemic delivery, which eliminates the need for invasive surgeries and
   permits the oncolytic virus to reach both the target tumor and metastases
   throughout the body
 * Selective replication in tumor cells, which minimizes toxicity and destroys
   the tumor while avoiding damage to healthy tissues
 * Stroma-Degrading, intended to break down the tumor’s protective barrier,
   improve tumor access by the oncolytic virus and other cancer therapies, and
   expose the tumor to robust and persistent attack by the patient’s immune
   system

This unique combination of features means that Theriva’s oncolytic viruses are
particularly well-positioned to work alongside other cancer therapies
(chemotherapy, immunotherapy, etc.) and may enhance the efficacy of both
standard-of-care and developmental cancer therapies.




LEAD CANDIDATE

Theriva’s leading systemic, selective, and stroma-degrading oncolytic virus
clinical candidate is VCN-01, which will be evaluated in the VIRAGE trial, an
upcoming phase 2 clinical trial in patients with pancreatic ductal
adenocarcinoma (PDAC) and in a planned Company Sponsored multicenter trial in
patients with retinoblastoma.

VCN-01 is characterized by four interconnected advancements in oncolytic virus
design that enable intravenous delivery at higher doses than have been feasible
for other oncolytic viruses:

 * High replication rate, which increases manufacturing yields and is expected
   to enable an antitumor effect even if low levels of the oncolytic virus are
   delivered to the tumor
 * Tumor-selective replication, which is intended to maximize antitumor effects,
   minimize potential off-target effects, and limit damage to healthy tissues
 * Liver detargeting, which is intended to reduce the loss of VCN-01 through
   hepatic clearance and avoid potential liver toxicities
 * Expression of hyaluronidase (PH20), which will degrade tumor stromal
   hyaluronic acid, a substance that has been strongly associated with reduced
   tumor immunogenicity and poor prognosis in patients with PDAC and ovarian
   cancer

VCN-01 has been uniquely engineered to ensure that PH20 expression occurs only
after VCN-01 has entered the tumor and undergone a viral replication cycle. This
feature ensures a tumor-focused release of PH20 and provides a powerful
biomarker for measuring VCN-01 tumor delivery and activity.


CLINICAL EVIDENCE TO DATE

To date, more than 76 subjects have been dosed with VCN-01 in Phase 1 clinical
trials in patients with a broad range of cancers, including PDAC,
retinoblastoma, colorectal cancer, and head and neck squamous cell carcinoma
(HNSCC). Additional investigator-sponsored studies are ongoing in patients with
brain cancers and ovarian cancers. 

VCN-01 has demonstrated an acceptable safety profile at the doses used, and
accumulated data support the proposed VCN-01 mode of action and Phase 2 dosing
regimen. Although these were not randomized controlled trials, there were
encouraging observations in VCN-01-treated patients with respect to tumor
response and patient survival.

 



A PIPELINE WITH EXPANSIVE POTENTIAL

Theriva’s oncolytic viruses have the potential to treat a broad range of
difficult-to-treat tumor types and may be combined with a variety of cancer
therapies.

In an upcoming VIRAGE Phase 2 clinical trial in patients with PDAC, VCN-01 will
be tested in combination with standard-of-care chemotherapy
gemcitabine/nab-paclitaxel. VCN-01 was also administered with the checkpoint
inhibitor durvalumab in a Phase 1 study in patients with HNSCC and is currently
being evaluated in combination with huCART-meso cells in an
investigator-sponsored study in patients with either pancreatic cancer or
ovarian cancer.

The diversity of tumor types and coadministered cancer treatments highlight the
broad anticipated utility of Theriva’s systemic, selective, and stroma-degrading
oncolytic viruses.

Building on the clinical advancement of VCN-01, Theriva developed the Albumin
Shield™ technology to protect oncolytic viruses from circulating anti-oncolytic
virus antibodies after systemic administration. We anticipate that this
technology will enable multiple oncolytic virus doses to be administered in
therapeutic cycles to treat particularly refractory tumors. Preclinical proof of
concept for the Albumin Shield™ technology has been demonstrated with the
archetype VCN-11, and a range of Albumin Shield™ oncolytic viruses with
different therapeutic payloads are currently under consideration. Other
technologies in earlier stages of development are also being explored by our
experienced scientific team.

Pre-IND
Phase 1
Phase 2
Collaborators
Status*
Oncolytic Virus Portfolio
Stroma Degrading Oncolytic Virus
VCN-01
VIRAGE trial Pancreatic Cancer (IV) ± Gem/nab-P
Pre-IND
Phase 1
Phase 2
Collaborators
Status*


Ph2 trial ongoing
Retinoblastoma (IVit)
Pre-IND
Phase 1
Phase 2
Collaborators
Status*


Trial Initiation Expected H2’23 (ODD US)
HNSCC (IV) + CPI
Pre-IND
Phase 1
Phase 2
Collaborators
Status*


Enrollment Complete, Initial Data H2’22
Solid Tumors – Brain, Ovarian, PDAC (IV)
Pre-IND
Phase 1
Phase 2
Collaborators
Status*


Ph 1 Investigator Sponsored Studies Initiated
Oncolytic Virus Albumin Shield
VCN-11
Solid Tumors (IV)
Pre-IND
Phase 1
Phase 2
Collaborators
Status*


Preclinical studies are on-going
Antibiotic Degrading Enzyme Portfolio
Oral β-lactamase
SYN-004
Prevention of aGVHD in allo-HCT
Pre-IND
Phase 1
Phase 2
Collaborators
Status*


Ph 1b/2a Cohort 2 dosing expected Q4’22
Aligned with our oncology focus, our oral β-lactamase product SYN-004
(ribaxamase) continues clinical evaluation as a means of preventing critical
adverse outcomes in patients who undergo allogeneic hematopoietic cell
transplantation (HCT) to treat hematologic cancers. 80-90% of these patients
will be treated with an IV β-lactam antibiotic and this antibiotic use has been
strongly associated with increased incidence and severity of acute
graft-versus-host disease (aGVHD), infection by vancomycin resistant enterococci
(VRE), and Clostridioides difficile infection (CDI). Prevention of one or all of
these outcomes by SYN-004 coadministration may significantly improve treatment
outcomes and reduce patient mortality.



LEADERSHIP

Our team is comprised of determined and experienced leaders who are committed to
offering patients with difficult-to-treat cancers the chance of a longer life.
We are fueled by our deep desire to change outcomes by working to enhance the
current standard of care and transform the cancer therapy landscape.
Steven Shallcross
Chief Executive Officer,
Chief Financial Officer,
Director
Manel Cascallo, PhD
General Director,
EU Subsidiary
Frank Tufaro, PhD
Chief Operating Officer
Vince Wacher, PhD
Head of Corporate &
Product Development


SCIENTIFIC ADVISORY BOARD

Ramon Alemany, Ph.D.
Chair
Mark S. Blumenkranz, M.D., MMS

Ennio Antonio Chiocca, M.D., Ph.D

Daniel DiMaio, M.D., Ph.D.

Tom Dubensky, Ph.D.

Josep Tabernero, M.D., Ph.D.



BOARD OF DIRECTORS

Jeffrey J. Kraws
Chairman
Jeffrey Wolf, JD
Director
John Monahan, Ph.D.
Director
Steven Shallcross
Chief Executive Officer,
Chief Financial Officer,
Director




WORK AT THERIVA

As we grow, we continue to seek talented and driven scientists, marketers,
analysts, and engineers who share in our mission. We are a collaborative,
generous, and committed team devoted to leveraging the unique perspectives of
every team member in our efforts to develop first-in-class cancer therapies.
Please reach out to info@therivabio.com to share your resume and hear about open
positions.
Interested in learning more? We’d love to hear from you – info@therivabio.com

9605 Medical Center Dr.
Suite 270
Rockville, MD 20850
info@therivabio.com


INVESTORS

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