STRASBOURG, France & LEEDS, United Kingdom--(BUSINESS WIRE)--
Regulatory News:
Transgene (Paris:TNG), a biotech company that designs and develops virus-based immunotherapies against cancers and infectious diseases, and University of Leeds, announce that new clinical data1 obtained with Pexa-Vec further demonstrate anti-tumor activity after intravenous (i. v.) infusion. These data were presented by Dr. Alan Anthoney (University of Leeds) in a poster presentation at the American Society for Clinical Oncology (ASCO) Annual Meeting, June 4, in Chicago.
These first clinical results confirm Pexa-Vec’s activation of anti-tumor immunity and targeted oncolytic activity. The key findings of the trial show:
- selective expression and replication of Pexa-Vec in the tumor tissues;
-
induction of a robust anti-tumor immune response:
- with the stimulation of an adaptive response (T cells) targeted to tumor specific antigens,
- the activation of innate immune response (NK cells), and
- an elevation of cytokines associated with immune stimulation;
- one partial and one complete necrosis of tumors among the patients with colorectal cancer and liver metastases (pathological responses);
- upregulation of PD-L1 and PD-1 signaling molecules, a finding that strongly supports the rationale for combining Pexa-Vec with anti-PD-1 inhibitors.
Dr Alan Anthoney, Consultant in Medical Oncology at Leeds Teaching Hospitals, Senior Lecturer in the Institute of Cancer & Pathology at the University of Leeds and principal investigator of the trial, said: “We are very encouraged to report that a single IV administration of Pexa-Vec displayed cytolytic activity at tumor sites, where it elicited a robust activation of tumor-antigen specific immune cells. In one patient with colorectal cancer liver metastasis a complete pathological response has been observed. These data clearly support the anti-tumor activity of Pexa-Vec. The final data from this trial will be published in an upcoming paper. Our decision to lead this clinical trial, investigating the potential of new weapons against cancers, testifies to our commitment at Leeds University and Leeds Teaching Hospitals NHS Trust to evaluate new innovative options that might improve the lives of our patients with cancer.”
Maud Brandely, Chief Medical Officer of Transgene, added: “These very positive translational data confirm the targeted oncolytic activity and the potential of Pexa-Vec in advanced stages cancers. The observed upregulation of PD-1 and PD-L1 positive pathways strongly supports the rationale for combining Pexa-Vec with anti-PD-1 immunotherapies, which is the focus of an ongoing Phase 1/2 trial in the first-line treatment of liver cancer (HCC). These data are also crucial for our next generation of multifunctional oncolytic viruses based on our Invir.IOTM platform: this trial clearly shows that Vaccinia virus based immunotherapeutics can reach the tumor sites after i. v. administration, and selectively replicate within cancer cells. This neoadjuvant trial is the first clinical trial led by Transgene to readout this year. We look forward to announcing additional clinical results this year, not only with Pexa-Vec, but also on our four other clinical-stage immunotherapeutics.”
About the Pexa-Vec “neo-adjuvant” trial:
This
clinical study is aimed at evaluating the biological effects of
pre-operative intravenous administration of Pexa-Vec prior to planned
surgical resection of locally advanced/poor prognosis or metastatic
cancers. This single center, open label, non-randomized trial recruited
9 patients including 8 evaluable patients (3 with metastatic melanoma
and 5 with colorectal cancer metastases to the liver). They received a
single intravenous dose of 1x109 pfu of Pexa-Vec, 14 days
prior to planned surgery. Up to 6 blood samples were collected pre- and
post- injection for each patient. Imaging was performed prior at
baseline and within 7 days prior to surgery. Tumor tissue was collected
at surgery for histologic and translational assessments.
University
of Leeds is the sponsor of the trial that was supported by Transgene and
run through the NIHR Clinical Research Facility at St James’ Hospital,
Leeds.
The poster is available on Transgene’s website.
- End -
Notes to editors
About Pexa-Vec
Pexa-Vec (JX594) is an oncolytic
immunotherapeutic based on an oncolytic vaccinia virus armed with a
GM-CSF gene that promotes an anti-tumor immune response. Pexa-Vec is
designed to selectively target and destroy cancer cells through three
different mechanisms of action: selectively destroy cancer cells through
the direct lysis (breakdown) of cancer cells through viral replication,
reduce the blood supply to tumors through vascular disruption, and
stimulate the body’s immune response against cancer cells.
Pexa-Vec
is currently being evaluated in a Phase 3 trial in hepatocellular
carcinoma (HCC, liver cancer) in combination with sorafenib (current
standard of care). Other trials evaluating the oncolytic virus in solid
tumors are underway and expected to readout in 2018, including a Phase 2
trial in combination with nivolumab (HCC).
Transgene has exclusive
rights to develop and commercialize Pexa-Vec for the treatment of solid
tumors in Europe. Its partner SillaJen, Inc. is focused on developing
Pexa-Vec for the North American market and has also granted exclusive
development and commercial rights to Pexa-Vec in Hong Kong and The
People’s Republic of China to Lee’s Pharmaceutical.
About University of Leeds
The University of Leeds is
one of the largest higher education institutions in the UK, with more
than 33,000 students from more than 150 different countries, and a
member of the Russell Group of research-intensive universities.
We are a top ten university for research and impact power in the UK, according to the 2014 Research Excellence Framework, and are in the top 100 for academic reputation in the QS World University Rankings 2018. Additionally, the University was awarded a Gold rating by the Government’s Teaching Excellence Framework in 2017, recognising its ‘consistently outstanding’ teaching and learning provision. Twenty-six of our academics have been awarded National Teaching Fellowships – more than any other institution in England, Northern Ireland and Wales – reflecting the excellence of our teaching. www.leeds.ac.uk
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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).
With its
proprietary Invir.IOTM, Transgene builds on its expertise in
viral vectors engineering to design a new generation of multifunctional
oncolytic viruses.
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. There can be no guarantee that (i) the results
of pre-clinical work and prior clinical trials will be predictive of the
results of the clinical trials currently underway, (ii) regulatory
authorities will agree with the Company’s further development plans for
its therapies, or (iii) the Company will find development and
commercialization partners for its therapies in a timely manner and on
satisfactory terms and conditions, if at all. The occurrence of any of
these risks could have a significant negative outcome for the Company’s
activities, perspectives, financial situation, results and development.
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 Risques”) 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.
1 n = 8; 3 patients with metastatic melanoma and 5 with colorectal cancer metastases to the liver
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