Transgene included last patient in Phase 2 trial testing TG4010 in combination with Opdivo

May 28, 2019 Off By BusinessWire

Clinical Trial in Collaboration with Bristol-Myers Squibb

Trial has Enrolled Patients whose Tumor Expresses Low or Undetectable
Levels of PD-L1

Results for the Primary Endpoint (ORR) Expected in Q4 2019

STRASBOURG, France–(BUSINESS WIRE)—-Regulatory News:

Transgene (Paris:TNG), a biotech company that designs and develops
virus-based immunotherapies for the treatment of solid tumors, today
announces that the last patient has been included in the Phase 2 trial
evaluating TG4010 in combination with Opdivo® (nivolumab) and
chemotherapy as a first-line treatment for advanced non-squamous
non-small cell lung cancer (NSCLC) with low or no expression of PD-L1 by
the tumor cells.
Transgene confirms that the study’s primary
endpoint (objective response rate – ORR) on a minimum of 35 evaluable
patients will be reported in Q4 2019.

The Phase 2 clinical trial is exploring the tolerability and efficacy of
the combination regimen of Transgene’s TG4010, an investigational active
immunotherapy against MUC1 tumor-associated antigen, with Bristol-Myers
Squibb’s immune checkpoint inhibitor, Opdivo® (nivolumab), which acts by
overcoming immune suppression, and standard platinum doublet
chemotherapy.

This multi-center single-arm trial has enrolled patients both in the USA
and Europe.

The trial has overall ORR as primary endpoint. The study will also
assess the safety and tolerability of the regimen together with other
efficacy and immunological parameters. More information on the trial can
be found on clinicaltrials.gov (NCT03353675).

This trial is being conducted by Transgene under a clinical
collaboration agreement with Bristol-Myers Squibb, which is supplying
nivolumab.

“We are looking forward to reporting the first efficacy data of our
active immunotherapy TG4010, with nivolumab and chemotherapy as a
first-line treatment of advanced lung cancer for patients whose tumors
express low or undetectable levels of PD-L1”, said Maud Brandely,
Chief Medical Officer of Transgene. “Today anti-PD-1 therapy is
relatively less effective in this large subset of NSCLC patients. With
this triple combination regimen, we aim to significantly improve
treatment outcomes in this major oncology indication.”

The combination of TG4010 immunotherapy and chemotherapy has
demonstrated significant efficacy in terms of increased response rate,
progression-free survival and overall survival in a randomized,
double-blind, placebo-controlled Phase 2b trial in first-line treatment
of patients with advanced non-squamous NSCLC (Quoix et al. Lancet
Oncol. 2015).

About TG4010
TG4010 is an active immunotherapy that
has been designed to express the coding sequences of the MUC1
tumor-associated antigen and the cytokine, Interleukin-2 (IL2). It is
based on a modified Vaccinia virus (MVA) and has been shown to
induce an immune response against MUC1 expressing tumors, such as
non-small cell lung cancer (NSCLC). Its mechanism of action and
excellent safety profile make TG4010 a very suitable candidate for
combinations with other therapies, including immune checkpoint
inhibitors and chemotherapy. 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 being investigated for the first-line
treatment of NSCLC in combination with nivolumab and chemotherapy in
patients whose tumors express low or undetectable levels of PD-L1 (NCT03353675).

About Non-Small Cell Lung Cancer (NSCLC)
Lung cancer
is one of the most common malignancies worldwide with an estimated
2.1 million new cases annually. It is also a leading cause of
cancer-related deaths, accounting for an estimated 1.7 million deaths
(Source: GLOBOCAN 2018). Advanced lung cancer remains one of the cancer
types with the worst prognosis (five-year survival rate for advanced
NSCLC of less than 5%), underlining the still unmet need in this disease
despite recent progress.

About Transgene
Transgene (Euronext: TNG) 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 (a therapeutic
vaccine for the treatment of chronic hepatitis B) and TG6002 (an
oncolytic virus for the treatment of solid tumors).
With its
proprietary Invir.IO^TM, Transgene builds on its expertise in
viral vectors engineering to design a new generation of multifunctional
oncolytic viruses.
myvac^TM, an
individualized MVA-based immunotherapy platform designed to integrate
neoantigens, completes this innovative research portfolio. TG4050, the
first candidate selected from the myvac^TM platform,
will enter the clinic for the treatment of ovarian cancer and head and
neck cancer.
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
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perspectives, financial situation, results, regulatory authorities’
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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
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which could cause the Company’s actual results, financial condition,
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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
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