SAN DIEGO, May 14, 2018 /PRNewswire/ -- Tocagen Inc.
(Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy
company, today announced preclinical data on Toca 521, a retroviral
replicating vector (RRV) expressing a single-chain variable
fragment targeting PD-L1, will be presented at the 2018 Annual
Meeting of The American Society of Gene & Cell Therapy (ASGCT),
held May 16-19 in Chicago.
In a preclinical study, Toca 521 reversed PD-1/PD-L1 mediated immune
suppression, resulting in robust, durable and highly selective
anti-tumor activity that was
superior to systemically administered anti-PD-1 or anti-PD-L1
monoclonal antibodies. Tocagen expects to advance Toca 521 into
investigational new drug application (IND) enabling studies this
year.
In addition, previously disclosed clinical data and new
preclinical results from an ovarian cancer model will be
presented.
Summaries are provided below for new data sets, for which full
posters will be placed on Tocagen's website following the
presentation.
Presentation Type: Poster (Abstract: 111)
Title: PD-L1 Checkpoint Blockade Using a Single-Chain
Variable Fragment Targeting PD-L1 Delivered by Retroviral
Replicating Vector Enhances Anti-Tumor Effect in Cancer
Models
Presenter: Amy Lin, Ph.D.,
associate director of experimental virology at Tocagen
Date and Time: Wednesday, May
16, 5:30 p.m. CT
Summary:
- A RRV expressing a single-chain variable fragment targeting
PD-L1, called Toca 521, was developed using Tocagen's proprietary
cancer-selective gene therapy platform technology.
- Preclinical results demonstrated Toca 521 reversed PD-1/PD-L1
mediated immune suppression in a human in vitro cell culture
system, and conferred robust, durable and highly selective
anti-tumor activity compared to systemically administered anti-PD-1
or anti-PD-L1 monoclonal antibodies.
- These results indicate further development of Toca 521 is
warranted to investigate the potential for improved safety and
efficacy profiles compared to systemic monoclonal antibodies
against the same checkpoint target. Toca 521 could also be useful
in combination with other agents, including immuno-oncology
therapies.
Presentation Type: Oral presentation (Abstract: 344)
Title: Treatment of Recurrent HGG Patients with the
Retroviral Replicating Vector Toca 511 and Toca FC Resulted in
Durable Responses and Survival Lasting 3 Years or Longer: Immune
Mechanisms and Molecular Analyses of Tumors
Presenter: Douglas Jolly,
Ph.D., executive vice president of research and pharmaceutical
development at Tocagen
Date and Time: Thursday, May
17, 9:20-9:40 a.m. CT
Presentation Type: Poster (Abstract: 428)
Title: Toca 511-Mediated Prodrug Activator Gene Therapy: A
Promising Therapeutic Strategy for Ovarian Cancer
Presenter: Sara Collins,
Ph.D., assistant scientist in the department of cell biology at the
University of Miami Miller School of
Medicine. These studies were performed in the laboratory
of Noriyuki Kasahara, M.D., Ph.D., professor of cell biology
and pathology at the University of Miami.
Date and Time: Thursday, May
17, 5:15 p.m. CT
Summary:
- Preclinical studies evaluating Toca 511 and 5-FC in a mouse
model of ovarian cancer were conducted.
- Increased survival and reduced tumor burden was observed in
mice with pre-existing tumors receiving Toca 511 followed by 5-FC,
as compared to untreated controls.
About Toca 511 & Toca FC
Tocagen's lead product candidate is a two-part cancer-selective
immunotherapy comprised of an investigational biologic, Toca 511
and an investigational small molecule, Toca FC. Toca 511
(vocimagene amiretrorepvec) is a retroviral replicating vector
(RRV) that selectively infects cancer cells and delivers a gene for
the enzyme, cytosine deaminase (CD). Through this targeted
delivery, infected cancer cells carry the CD gene and produce CD.
Toca FC is an orally administered, extended-release formulation of
the prodrug, 5-fluorocytosine (5-FC), which is converted into an
anti-cancer drug, 5-fluorouracil (5-FU), when it encounters CD.
5-FU kills cancer cells and immune-suppressive myeloid cells in the
tumor microenvironment resulting in anti-cancer immune activation
and subsequent tumor killing.
About Tocagen Inc.
Tocagen is a clinical-stage, cancer-selective gene therapy
company developing first-in-class, broadly applicable product
candidates designed to activate a patient's immune system against
their own cancer. Tocagen's lead investigational product candidate,
Toca 511 & Toca FC, is under evaluation in a pivotal Phase 3
trial for recurrent high grade glioma (HGG), a disease with
significant unmet medical need. The U.S. Food and Drug
Administration (FDA) has granted Toca 511 & Toca FC
Breakthrough Therapy Designation for the treatment of recurrent HGG
and the European Medicines Agency (EMA) has granted Toca 511 PRIME
(PRIority MEdicines) designation for the treatment of glioma. For
more information about Tocagen, visit www.tocagen.com.
Forward-Looking Statements
Statements contained in this press release regarding matters
that are not historical facts are "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act
of 1995. Because such statements are subject to risks and
uncertainties, actual results may differ materially from those
expressed or implied by such forward-looking statements. Such
statements include, but are not limited to, statements regarding
our business plans and objectives, expectations regarding the
timing and success of our clinical trials and planned clinical
trials, activities related to development of our current and future
product candidates in additional indications and our plan to update
our regulatory plans. Risks that contribute to the uncertain nature
of the forward-looking statements include: the success, cost and
timing of our product candidate development activities and planned
clinical trials; our ability to execute on our strategy; regulatory
developments in the United States
and foreign countries; and our estimates regarding expenses, future
revenue and capital requirements. These and other risks and
uncertainties are described more fully under the caption "Risk
Factors" and elsewhere in Tocagen's filings and reports with the
United States Securities and Exchange Commission. All
forward-looking statements contained in this press release speak
only as of the date on which they were made. Tocagen undertakes no
obligation to update such statements to reflect events that occur
or circumstances that exist after the date on which they were
made.
Media Contact:
Monica May
Canale Communications
(619) 849-5383
monica@canalecomm.com
Investor Contact:
Elizabeth Broder
Endurance Advisors
(646) 206-1246
ebroder@enduranceadvisors.com
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SOURCE Tocagen Inc.