On September 13, 2017 Transgene (Paris:TNG), a biotechnology company focused on designing and developing viral-based immune-targeted therapies, reported its financial results for the six-month period ended June 30, 2017, and reviews the progress of it products portfolio since the beginning of the year (Press release, Transgene, SEP 13, 2017, View Source [SID1234520500]).
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Philippe Archinard, Chairman and Chief Executive Officer of Transgene said: "Transgene is continuing to successfully execute its strategy. We are making progress with our clinical development plans with seven active trials as of today, and in parallel we are continuing to advance our cutting edge research program.
Four of the clinical trials are aiming to confirm the potential of TG4010 or Pexa-Vec in combination with immune checkpoint inhibitors (ICIs), including in two high unmet need indications, lung and liver cancer.
We have signed two collaborations, one with Bristol-Myers Squibb (BMS) covering a combination study with TG4010 in the first-line treatment of lung cancer, and one with Servier for the design of an optimized production process of allogenic CAR-T cells using our viral vectorization technology. These new deals build on our existing collaborations with BMS for TG4010 in the 2nd-line treatment of lung cancer and with Merck KGaA/Pfizer for TG4001 in head and neck cancers. We believe these agreements provide strong validation of the potential of our immunotherapy approach.
With our current funding, Transgene is well placed to progress its programs through to the end of 2018. We will continue to focus all of our energy to advance our multiple clinical trials and to seize the development opportunities that they could create for Transgene."
Product pipeline review
1. Therapeutic Vaccines
TG4010: combination trial with nivolumab (ICI); collaborations with Bristol-Myers Squibb
TG4010 is a therapeutic vaccine being developed in advanced-stage non-squamous non-small cell lung cancer (NSCLC). TG4010’s mechanism of action, excellent safety profile and existing clinical data make it a very suitable candidate for combinations with other therapies.
The clinical trials aim to confirm the synergies that are expected to result from the combination of a therapeutic vaccine and an ICI. The expected clinical benefits of the combination are an increase in the response rate, in the quality and in the duration of the response to current and future standards of care.
TG4010
+ Opdivo (ICI)
(nivolumab)
+ chemotherapy
Phase 2
Non-small cell lung cancer (NSCLC) – 1st-line
Collaboration deal signed in April 2017 with Bristol-Myers Squibb, that will supply nivolumab
Preparation of a Phase 2 clinical trial combining TG4010 with nivolumab and with chemotherapy in patients with tumor cells expressing low or undetectable levels of PD-L1
FDA IND approval granted to begin the clinical trial in the USA
First patient expected to be enrolled at the end of 2017
TG4010
+ Opdivo (ICI)
(nivolumab)
Phase 2
Non-small cell lung cancer (NSCLC) – 2nd-line
Trial of TG4010 in combination with nivolumab, that will be provided by Bristol-Myers Squibb, within a collaborative agreement with UC Davis Medical Center (USA) – Principal investigator: Dr. Karen Kelly
First patient treated in March 2017; the trial’s 4 sites are now open
First results expected beginning of 2018
TG4001: trial in combination with avelumab (ICI), based on a collaboration agreement with Merck KGaA and Pfizer
TG4001 is a therapeutic vaccine that has already been administered to more than 300 subjects in previous clinical trials. TG4001 has demonstrated good tolerability, a significant HPV clearance rate and promising efficacy results. Its mechanism of action and good safety profile make TG4001 an appropriate candidate for combinations with other therapies.
TG4001
+ Bavencio (ICI)
(avelumab)
Phase 1/2
HPV positive head and neck cancer – 2nd-line
Clinical collaboration agreement with Merck KGaA and Pfizer, for the supply of avelumab for the trial
Principal investigator: Prof. Christophe Le Tourneau (Institut Curie, Paris); multi-center trial
First patient expected to be treated shortly
TG1050: results expected in 2H 2017
TG1050 is a therapeutic vaccine for the treatment of chronic hepatitis B. At the end of 2015, Transgene started a study evaluating the safety and tolerability of TG1050 in patients who are currently being treated for chronic HBV infection with standard-of-care antiviral therapy. The technology of TG1050 is also being developed in China, where Transgene operates a joint-venture with Tasly Biopharmaceutical Technology.
TG1050
+ Standard-of-
Care Antiviral
Phase 1/1b
Chronic hepatitis B
Results from the first part of the study to be presented at AASLD (October 2017)
Several patents granted, extending protection to 2032
2. Oncolytic viruses
Pexa-Vec: ongoing Phase 3 trial, initiation of the Phase 2 clinical combination trials
Pexa-Vec is an oncolytic virus designed to selectively target and destroy cancer cells through intracellular viral replication (oncolysis), and by stimulating the body’s immune response against cancer cells. Its mechanism of action and tolerability profile make it an appropriate candidate for use in combinations.
Pexa-Vec
+ sorafenib
(PHOCUS)
Phase 3
Advanced liver cancer (hepatocellular carcinoma – HCC) – 1st-line
Clinical trial being conducted by SillaJen, Inc., Transgene’s partner
Ongoing recruitment. First patient treated in Europe in April 2017
Trial recruitment authorized in China (July 2017)
First data readout expected in 2019
Pexa-Vec
+ Opdivo (ICI)
(nivolumab)
Phase 2
Advanced liver cancer (hepatocellular carcinoma – HCC) – 1st-line
Principal investigator: Prof. Olivier Rosmorduc (Pitié Salpêtrière, Paris)
First patient treated in July 2017; several active trial sites
First data readout expected in 2018
Pexa-Vec
+ metronomic
cyclophosphamide
Phase 1/2
HER2 negative breast cancer et soft tissue sarcoma (METROmaJX)
Principal investigator: Prof. Antoine Italiano (Institut Bergonié, Bordeaux); Sponsor : INCa
Positive results of the Phase 1 part presented at ESMO (Free ESMO Whitepaper) 2017 (Sept. 2017)
First patient of the Phase 2a part treated in April 2017
Pexa-Vec
+ Yervoy (ICI)
(ipilimumab)
Phase 1
Solid tumors (ISI-JX)
Principal investigator: Dr. Aurélien Marabelle, MD, PhD (Centre Léon Bérard, Lyon)
First patient treated in February 2017
First readout expected around the end of 2017
TG6002: preparation of first-in-human trial
TG6002 is a next generation oncolytic immunotherapy. It has been designed to induce the breakdown of cancer cells (oncolysis) and express the FCU1 gene in the cancer cells it has infected leading to the local production of 5-FU, a widely-used chemotherapy. TG6002 could potentially be used both in combination or as monotherapy in recurrent cancers.
TG6002
Phase 1
Glioblastoma
Principal investigator: Prof. J-Y Delattre (AP-HP, Paris), with the support of INCa (French national cancer institute)
First patient expected in the coming weeks
3. Research and preclinical portfolio
Research and preclinical highlights during the first half were:
The signing of a collaboration agreement with Servier in June 2017 aimed at designing an original process for the production of allogenenic CAR-T cells which would provide better yield and a reduced number of steps. This collaboration highlights Transgene’s expertise in viral vectorization;
A poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) meeting in April 2017 and the publication of preclinical data supporting the clinical development of TG6002 in Cancer Research in July 2017;
The filing of several patent applications ensuring the protection of the innovative technologies developed by Transgene for new products (therapeutic vaccines and oncolytic viruses).
A R & D Day for investors on 22 June 2017 in Paris. At this meeting, Transgene presented its new generation of immunotherapies based on multifunctional (armed) oncolytic viruses aimed at improving the treatment of cancer.
Key financials
The Board of Directors of Transgene met on September 12, 2017, and reviewed the financial statements for the six-month period ended June 30, 2017. The Statutory Auditors have conducted a review of the interim consolidated financial statements. The half-year financial report is available on Transgene’s website, View Source
Key elements of the income statement
(in thousands of euros) June 30, 2017 June 30, 2016
Operating revenues 3,898 5,339
Research and development expenses (16,855) (12,504)
General and administrative expenses (3,066) (3,406)
Other revenue and (expenses), net (107) (128)
Operating expenses (20,028) (16,038)
Operating income / (loss) (16,130) (10,699)
Net income / (loss) (18,346) (11,639)
Net income / (loss) from discontinued operations - (514)
Comprehensive net income (18,346) (12,153)
Operating revenues amounted to €3.9 million for the first six months of 2017 compared to €5.3 million for the same period in 2016. Excluding the €1.3 million one-off revenue received from Sanofi Chimie in 2016, Transgene’s revenues remained stable compared to the first half of 2016.
Revenues from collaboration and licensing agreements amounted to €0.5 million for the first six months of 2017 versus €1.9 million in the same period in 2016, that included €1.3 million from Sanofi Chimie. Under the collaboration agreement with Servier signed in June 2017, Transgene invoiced an initial amount of €1.0 million. Revenue recognition of this amount will be spread over the initial term of the contract, i.e. 3 years.
Government financing of research expenditures amounted to €3.0 million for the first half of 2017, stable compared to the first half of 2016. These figures included a research tax credit of €3.0 million for the first six months of 2017 compared to €2.9 million for the same period in 2016.
Research and Development (R&D) expenses amounted to €16.9 million for the first half of 2017 compared to €12.5 million for the same period in 2016. This increase was mainly due to the milestone payment of €3.8 million ($4 million) to SillaJen, Inc. triggered by the first patient being recruited in Europe in the Phase 3 trial of Pexa-Vec (Phocus). External expenses for clinical projects also increased by €0.4 million with the development plan progressing notably with our products TG4010, Pexa-Vec and TG1050.
General and administrative expenses decreased to €3.1 million for the first half of 2017 compared to €3.4 million for the same period in 2016.
Net loss amounted to €18.4 million for the first half of 2017 compared to €12.2 million for the same period in 2016.
As of June 30, 2017, the Company’s cash, cash equivalents, available-for-sale financial assets and other financial assets amounted to €43.9 million versus €56.2 million as of December 31, 2016.
Cash burn was €12.3 million for the first half of 2017 compared to €8.2 million for the same period in 2016. This cash burn increase was mainly explained by the milestone payment to Sillajen in H1 2017.
Transgene confirms that it expects 2017 cash burn to be around €30 million, which includes an increase of expenses linked to clinical trials due to the acceleration of the clinical development plan and the milestone payment to SillaJen, Inc.
"Our results for the first six months of 2017 are in line with our expectations. We confirm our financial visibility through to the end of 2018", commented Jean-Philippe Del, Chief Financial Officer of Transgene.
As a reminder, the Company still benefits from access to further additional funding that can be activated in 2017: namely the second tranche of the European Investment Bank (EIB) loan (€10 million).