Transgene: Peer Reviewed Scientific Publications Highlight TG4010’s Ability to Induce Broad CD8+ Responses and its Synergistic Effects in Combination with Immune Checkpoint Inhibitors

Transgene Is Currently Developing TG4010 in Advanced Lung Cancer
(NSCLC) in Combination Regimens with Immune Checkpoint Inhibitors (ICIs)

STRASBOURG, France–(BUSINESS WIRE)–#NSCLC–Regulatory News:

Transgene (Paris:TNG), a biotech company that designs and develops
viral-based immunotherapies, recently published two papers supporting
the efficacy and mechanism of action of its therapeutic vaccine TG4010.
After successful completion of the phase 2b TIME trial for combination
of TG4010 and chemotherapy (Quoix et al. Lancet Oncol., 2015),
these two peer-reviewed articles support the ongoing development of the
product in combination with immune checkpoint inhibitors (ICIs) in
advanced NSCLC. More generally, they confirm the interest in viral
vectors as immunotherapeutics.

“Viral based vaccine TG4010 induces broadening of specific immune
response and improves outcome in advanced NSCLC.”
By Tosch et al., Journal
for ImmunoTherapy of Cancer
, 2017, 5, 70

In this paper, based on samples from 78 patients of the TIME trial,
Transgene provides the first data linking directly the development of
a specific cellular immune response with an improved clinical benefit in
patients with advanced NSCLC upon vaccination with a viral vector
.
It
was shown that the significantly longer overall survival (OS) of
patients treated with TG4010 is correlated with the diversity and
intensity of CD8+ T cell responses against the MUC1 antigen.
Treatment
with TG4010 also led to a broadening of immune response to other
tumor-associated antigens that were not targeted by the vaccine. This is
the first report of such a mechanism of epitope spreading for a
virus-based immunotherapeutic product. This spreading might contribute
to the enrichment of the diversity of the anti-cancer response.
These
results support the causality of T-cell response in improved survival in
NSCLC, and strengthen the rationale for combination with ICIs to exploit
the broad CD8+ T cell repertoire induced by TG4010 vaccination.

“Sequential administration of MVA-based vaccines and
PD-1/PD-L1-blocking antibodies confers measurable benefits on tumor
growth and survival: preclinical studies with MVA-βGal and MVA-MUC1
(TG4010) in a murine tumor model.”
By Remy-Ziller et al., Human
Vaccines & Immunotherapeutics
, 2017 Sep (19:0), doi:
10.1080/21645515.2017.1373921. epub ahead of print

Transgene further demonstrates the benefit of administration of
MVA-vaccines, and ICIs in a preclinical metastatic model. Treatment with
MVA vectors showed increased survival rates, and led to the accumulation
of CD3dimCD8dim T cells in the lung and an
upregulation of PD-1 was observed on these T cells.
Targeting
the PD-1/PD-L1 pathway with ICIs in association with TG4010 treatment,
at late stage of tumor development, enhanced the therapeutic activity
induced by the vaccine, supporting the two ongoing clinical evaluation
of TG4010 in combination with nivolumab.

All publications on TG4010 can be accessed via www.transgene.fr,
Pipeline>Publications.

About TG4010
TG4010 is an immunotherapy that has been
designed to express the coding sequences of the MUC1 tumor-associated
antigen and the cytokine, Interleukin-2 (IL2) in a modified vaccinia
virus (MVA).
The combination of TG4010 immunotherapy and
chemotherapy has demonstrated significant efficacy in terms of
progression-free survival and overall survival in patients with advanced
stage NSCLC (Quoix et al. Lancet
Oncol
. 2015). TG4010 is currently being investigated in combination
with nivolumab (ICI) for the 2nd-line treatment of advanced
NSCLC (NCT02823990).
A trial in 1st-line treatment of NSCLC is expected to begin
at the end of 2017, evaluating the combination regimen of TG4010 +
nivolumab + chemotherapy in patients whose tumors express low or
undetectable levels of PD-L1.

About Transgene
Transgene (Euronext: TNG), part of
Institut Mérieux, is a publicly traded French biotechnology company
focused on designing and developing targeted immunotherapies for the
treatment of cancer and infectious diseases. Transgene’s programs
utilize viral vector technology with the goal of indirectly or directly
killing infected or cancerous cells. The Company’s lead clinical-stage
programs are: TG4010, a therapeutic vaccine against non-small cell lung
cancer, Pexa-Vec, an oncolytic virus against liver cancer, and TG4001, a
therapeutic vaccine against HPV-positive head and neck cancers. The
Company has several other programs in clinical development, including
TG1050 (chronic hepatitis B) and TG6002 (solid tumors). Transgene is
based in Strasbourg, France, and has additional operations in Lyon, as
well as a joint venture in China. Additional information about Transgene
is available at www.transgene.fr.
Follow
us on Twitter: @TransgeneSA

Disclaimer
This press release contains
forward-looking statements, which are subject to numerous risks and
uncertainties, which could cause actual results to differ materially
from those anticipated. The occurrence of any of these risks could have
a significant negative outcome for the Company’s activities,
perspectives, financial situation, results, regulatory authorities’
agreement with development phases, and development. The Company’s
ability to commercialize its products depends on but is not limited to
the following factors: positive pre-clinical data may not be predictive
of human clinical results, the success of clinical studies, the ability
to obtain financing and/or partnerships for product manufacturing,
development and commercialization, and marketing approval by government
regulatory authorities. For a discussion of risks and uncertainties
which could cause the Company’s actual results, financial condition,
performance or achievements to differ from those contained in the
forward-looking statements, please refer to the Risk Factors (“Facteurs
de Risque”) section of the Document de Référence, available on the AMF
website (
http://www.amf-france.org)
or on Transgene’s website (
www.transgene.fr).
Forward-looking statements speak only as of the date on which they are
made and Transgene undertakes no obligation to update these
forward-looking statements, even if new information becomes available in
the future.

Contacts

Transgene:
Lucie Larguier
Director Corporate
Communications & IR
+33 (0)3 88 27 91 04
investorrelations@transgene.fr
or
Media
contacts:

Citigate Dewe Rogerson
David Dible/Marine
Perrier
+ 44 (0)20 7638 9571
transgene@citigatedr.co.uk