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Therapeutic vaccines

TG4050

One patient, one cancer, one vaccine

With TG4050, Transgene is developing an individualized immunotherapy based on multiple advanced genetic engineering technologies and cutting-edge artificial intelligence capabilities, together with NEC.

Each treatment is based on an optimized viral vector, that is customized and manufactured by Transgene for each patient. It integrates the most relevant tumor targets (patient-specific neoantigens) selected by NEC’s AI.

Once injected into the patient, the vaccine induces a specific immune response, enabling individualized targeted destruction of tumor cells.

Two clinical trials are including patients in the USA, in the UK and in France.

myvac® video

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TG4001

Target HPV-induced cancers (HPV-16, E6 & E7 + IL-2)

TG4001, an innovative therapy capable of combating papillomavirus-induced cancers. The concept behind TG4001 is to teach the immune system to recognise and destroy the cancer cells expressing HPV-16 antigens, specifically E6 and E7 antigens.

We have selected typical papillomavirus sequences that code for these antigens and have incorporated them into the DNA of another virus (the MVA virus) previously rendered harmless. We have also introduced a gene that codes for a molecule (interleukin 2, IL-2) that will stimulate the immune system at the injection site.

TG4001 triggers a specific immune response that supports the recognition and destruction of cancer cells carrying the HPV viral antigens. This approach enables the body to destroy the tumours.

Based on promising Phase Ib/II data, Transgene is conducting a randomized Phase II trial of TG4001 in combination with avelumab. This study is being conducted with the alliance of Merck KGaA, Darmstadt, Germany, and Pfizer, which is supplying avelumab.

TG4001 in action

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ONCOLYTIC VIRUSES (OV)

TG6002

Deliver chemotherapy directly in the tumor

TG6002 is an oncolytic virus that allows the production of a chemotherapy agent directly in the tumor.

It is based on the patented viral backbone (VVcop TK-RR-) behind Transgene’s Invir.IO™ platform and TG6002 has the FCU1 gene incorporated into its DNA. The expression of FCU1 in tumor cells enables the local conversion of 5-FC, administered orally, into 5-FU, a chemotherapeutic agent commonly used to treat certain cancers.

TG6002, when administered intravenously or via the hepatic artery, replicates selectively in tumor cells, resulting in the local production of 5-FU.

This specific mechanism of action allows for the targeted destruction of the tumor while stimulating the patient’s immune response locally. With its selective mechanism of action, TG6002 could offer a real alternative to chemotherapeutic agents, which due to their systemic administration, have many associated side effects.

Two Phase I/II clinical trials are enrolling patients in Europe.

TG6002 video

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BT-001

BT-001 is the first oncolytic virus from Invir.IO™ and is optimized to act as a Trojan horse.

This novel immunotherapy approach has been designed to be highly targeted and is based on the patented viral backbone (VVcop TK-RR-). Two specific “weapons” have been integrated into the Vaccinia viral DNA: an anti-CTLA4 antibody, which was developed by BioInvent, and the cytokine GM-CSF, which triggers the body’s immune response.

Once injected into the tumor, BT-001 replicates in the cancer cells leading to their targeted destruction by oncolysis and generating local production of its two therapeutic weapons. The resulting anti-CTLA4 antibody produced in the tumor neutralizes the regulatory T-cells that inhibit the immune system, thereby activating the immune defenses within the tumor itself.

The destruction of cancer cells also triggers an immune cascade that will enable the body’s systemic immune system to fight the tumour and its metastases. BT-001, given its multiple modes of action, could be developed to combat many different types of cancers.

Phase I/IIa clinical trial is enrolling patients in France and in Belgium; it has been granted an IND by the US FDA.

Public Information (ENNLFR)

BT-001 in action

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Invir.IO

A cutting-edge platform to develop novel viral immunotherapeutics

As a pioneer in immunotherapy, Transgene is using its Invir.IO™ platform to develop innovative treatments that can attack cancer cells directly: oncolytic viruses.

Invir.IO™-based oncolytic viruses are optimized to act as a Trojan horse; they are called “armed” or multifunctional viruses.

To design these therapies, Transgene integrates into the genome of a patented virus the genetic sequences encoding the therapies that will be produced during viral replication, directly in the tumor. The objective is to improve therapeutic efficacy while limiting side effects for the patient.

In addition to BT-001 and its collaboration with AstraZeneca, Transgene has built a portfolio of preclinical candidates.

Invir.IO™ in action

AstraZeneca

Transgene and AstraZeneca have entered into a collaboration agreement under which Transgene designs five innovative oncolytic viruses based on the Invir.IO™ platform.

AstraZeneca can exercise an option on each of these candidates.

Patients

Important information

Please note that the Transgene TG4050, TG4001 drug candidates are currently only in the clinical testing phase, subject to regulations set by the competent authorities. Transgene is not legally authorized to decide on the eligibility of patients to be included in the clinical studies of which it is a sponsor. Only the investigating physicians responsible for the clinical study centers have the competence to decide whether a patient meets the inclusion and exclusion criteria with regard to the corresponding clinical study protocol. Please also note that Transgene cannot communicate or interact with patients on the progress or progress of the studies. You will find all publicly available information on clinicaltrials.gov.

What is a clinical trial?

Clinical trials are designed to evaluate new treatments, including their safety and efficacy. They are mandatory before approval and commercialization of new treatments.

Who can participate in a clinical trial?

Each clinical trial is conducted according to a protocol defined upstream and validated by the health authorities and various committees to protect the interest of patients. To be included in a clinical trial, the patient must meet a number of criteria that are specific to each trial and contained in the protocol.

Participate in a clinical study: what are the benefits and risks?

The risks and benefits of participating in a clinical trial are described in the research protocol and the informed consent document. The medical team also explains them to the patient, who is free to ask questions.

Participating in a clinical trial gives access to an innovative treatment before it is potentially widely available. Clinical trials also provide a specific frame of care and support, as well as an appropriate and rigorous follow-up during and after the completion of the treatment.

As with any treatment, drug candidates used in clinical trials can cause side effects. In some clinical trials, it is also possible to be part of the control group and not receive innovative treatment.

How to participate in a clinical trial?

First, the patients should discuss this topic with their physician and oncologist. He can then get closer to the doctors in charge of the clinical trial (investigator).

Can Transgene put me in contact with the investigators of the clinical trial?

When possible, Transgene provides the clinical trial number (NCT) of the www.clinicaltrials.gov database, that lists the sites where studies are active (refer to the “products” page on the website).

Transgene cannot respond to inquiries about participation in its clinical trials. Patients should discuss treatment options with their physician who, if relevant, may connect them with the doctors in charge of clinical trials.

More information

More information on the website of the French National Cancer Institute (INCa) website or on the US National Cancer Institute website.

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