On September 19, 2018 Transgene (Paris:TNG) (Euronext Paris: TNG), Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapeutics against cancers and infectious diseases, reported its financial results for the six-month period ended June 30, 2018, and provides an update on its clinical and preclinical portfolio (Press release, Transgene, SEP 19, 2018, View Source [SID1234529493]).

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Philippe Archinard, Chairman and Chief Executive Officer of Transgene, commented:

"2018 is a period of intense activity for Transgene. We obtained $48 million in the form of Tasly Biopharmaceuticals shares following the sale of TG1050 and TG6002 rights in Greater China. We presented new results on our oncolytic virus Pexa-Vec at ASCO (Free ASCO Whitepaper) that benefitted from a positive reception. We have continued to make progress with our clinical and preclinical programs.

Looking ahead we expect to announce more comprehensive clinical results from our strategic studies before the end of 2018 and over the course of 2019.

Our research efforts are focused on our world-leading viral vector expertise applied to our two core technologies: oncolytic viruses and therapeutic vaccines. With our Invir.IOTM platform, we are designing new viruses to provide a better modulation of the tumor micro-environment. We are also about to present our ambitious approach in neoantigen-based therapeutic vaccines at a scientific congress in the coming weeks.

The progress that we have made in 2018 further confirms Transgene’s strategic position as leading innovator in the fight against cancer."

Clinical Pipeline Review

1. Update on company-sponsored strategic trials

Transgene has been making significant progress with its key clinical trials, which are aimed at generating proof-of-concept clinical data. Positive results from these trials would create significant partnering opportunities.

TG4010
+ Opdivo (ICI)
(nivolumab)
+ chemotherapy
Phase 2

Non-small cell lung cancer (NSCLC) – 1st line

Trial of TG4010 in combination with nivolumab and with chemotherapy in patients whose tumor cells express low or undetectable levels of PD-L1.

✓ Collaboration deal signed with Bristol-Myers Squibb, for the supply of nivolumab.

✓ Centers open in Europe and the US.

✓ First patient treated in January 2018. Recruitment is progressing with the opening of additional centers; expected completion in 2Q 2019.

→ Evaluation of the primary endpoint (ORR) on all patients (n=35) expected in 2H 2019.

Pexa-Vec
+ sorafenib
(PHOCUS)
Phase 3

Advanced liver cancer (hepatocellular carcinoma – HCC) – 1st line

✓ Clinical trial being conducted by Transgene’s partner, SillaJen, Inc. (sponsor).

✓ Ongoing global recruitment. First patient treated in China (September 2018).

→ First data readout expected in 2019.

Pexa-Vec
+ Opdivo (ICI)
(nivolumab)
Phase 1/2

Advanced liver cancer (hepatocellular carcinoma – HCC) – 1st line

✓ Several active trial sites in France and Italy.

→ Safety review committee expected before year-end 2018.

→ Interim analysis on 15 patients expected mid-2019 (primary endpoint: ORR).

TG4001
+ Bavencio (ICI)
(avelumab)
Phase 1/2

HPV-positive cancers including oropharyngeal 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).

✓ Following positive safety evaluation of the combination regimen, Phase 2 part is ongoing and additional sites are being activated in Europe.

→ Phase 1 part results in 4Q 2018 (n=9 patients).

→ Next clinical readout expected in 2H 2019.

TG6002
Phase 1/2a

Gastro-intestinal adenocarcinoma (colon cancer)

✓ TG6002 is an oncolytic virus that produces chemotherapy (5-FU) in the tumor.

✓ Principal investigator: Prof. Philippe Cassier, Centre Léon Bérard, Lyon (France).

✓ Multi-center trial; INDs granted in Belgium, France and Spain.

→ First patient to be treated in the coming weeks.

TG1050
+ Standard of care
Phase 1

Chronic hepatitis B

✓ Trial completed.

→ Full results to be presented at a major liver conference in 4Q 2018.

2. Update on investigator-sponsored trials evaluating Transgene’s products

Transgene is collaborating with leading physicians at world-renowned clinical centers to identify and evaluate novel treatment regimens based on the initiative of the clinicians. These trials are designed to generate further clinical data demonstrating the value of Transgene’s products in exploratory clinical settings. These trials also contribute to strengthening the data packages and increase the visibility of the products amongst the medical community.

TG4010
+ Opdivo (ICI)
(nivolumab)
Phase 2

Non-small cell lung cancer (NSCLC) – 2nd line

Trial of TG4010 in combination with nivolumab (supplied by Bristol-Myers Squibb) in a collaborative agreement with UC Davis Medical Center (USA); principal investigator: Dr. Karen Kelly; sponsor: UC Davis.

✓ The prevailing use of ICIs in first-line therapy in the USA has led to a very significant slowdown in the recruitment of this trial, as patients previously treated with ICIs are excluded per protocol.

✓ Based on Dr. Kelly’s recommendation, the trial will be discontinued due to poor patient accrual.

✓ No unexpected safety issues have been observed.

Pexa-Vec
Neo-adjuvant

Solid tumors

✓ Principal investigator: Prof. Alan Anthoney; sponsor: University of Leeds (UK).

✓ Completion of the recruitment (9 patients).

✓ First positive results presented at the ASCO (Free ASCO Whitepaper) conference in June 2018, confirming strong anti-tumor immunity after intravenous administration. Of the four evaluable patients with liver metastases, one showed complete tumor pathological response at the time of surgery.

✓ The final data from this trial will be published in an upcoming paper and will be presented at a future scientific conference.

✓ Data support ongoing development of Transgene’s Vaccinia virus-based oncolytics.

Pexa-Vec
+ Yervoy (ICI)
(ipilimumab)
Phase 1

Solid tumors (ISI-JX)

✓ Coordinating investigator: Dr. Aurélien Marabelle; sponsor: Centre Léon Bérard, Lyon.

✓ The combination regimen was well tolerated to-date.

✓ Additional sites are being activated.

Pexa-Vec
+ metronomic
cyclophosphamide
Phase 1/2a

HER2 negative breast cancer and soft tissue sarcoma (METROmaJX)

✓ Principal investigator: Prof. Antoine Italiano (Institut Bergonié, Bordeaux); sponsor: INCa (French national cancer institute).

✓ The combination regimen was well tolerated.

✓ At the interim analysis of the patients treated for soft tissue sarcoma, the pre-specified primary endpoint was not reached; enrolment for this indication has been discontinued.

TG6002
Phase 1/2a

Glioblastoma

✓ Principal investigator: Prof. Ahmed Idbahi (AP-HP, Paris), with the support of INCa; sponsor: AP-HP.

✓ Single-center trial.

✓ No safety issues have been observed to-date.

Sale of the Rights of TG1050 and TG6002 in Greater China

On July 10, 2018, Transgene entered into a set of agreements with Tasly Biopharmaceuticals Co., Ltd. under which Transgene sold both the T101 Greater China patent rights and its entire 50% stake in the Transgene Tasly (Tianjin) BioPharmaceuticals Co. Ltd. joint venture which already owned the T601 Greater China patent rights. Following these agreements, Tasly Biopharmaceuticals now holds all rights to research, development and commercialization for T601 and T101 in Greater China.

In return, Transgene received a total of 27.4 million new Tasly Biopharmaceuticals shares valued at $48 million based on the subscription price in pre-IPO financing round of Tasly Biopharmaceuticals, which took place concurrently with the transaction with Transgene. Transgene’s stake represents 2.53% of Tasly Biopharmaceutical’s expanded share capital. Tasly Biopharmaceuticals has announced its intention to list its shares on the Hong Kong Stock Exchange.

The transactions were finalized in August 2018.

NB: T601 and T101 are products developed in China and respectively incorporating Transgene’s TG6002 and TG1050 patented technologies.

Research and preclinical portfolio

In the first half of 2018, Transgene significantly reinforced its preclinical capabilities, capitalizing on its leading viral vectors expertise in the most attractive fields of onco-immunotherapy.

With Invir.IOTM, Transgene is making progress in the increasingly attractive field of novel oncolytic viruses (OVs). The Invir.IOTM platform aims at generating multifunctional novel oncolytic viruses that incorporate several transgenes encoding for a range of specific anticancer weapons and that are capable of better modulating the tumor micro-environment.
The Company is currently evaluating several preclinical Invir.IOTM OV candidates to identify the most attractive one to progress into clinical development. Current candidates include OVs encoding an anti-CTLA-4 antibody in a collaboration with BioInvent, as well as other anti-cancer agents (ligands, cytokines, chemokines, enzymes, etc.). Transgene is on track to initiate the first clinical trial with the first Invir.IOTM designed virotherapy in 2019.

Transgene will shortly be presenting an ambitious personalized immunotherapy approach that will allow the Company to enter the promising field of personalized medicine. This approach combines the Company’s expertise in therapeutic vaccines with neoantigen vectorization and artificial intelligence.
Transgene will provide further updates on preclinical activities in the coming months, including at key upcoming immunotherapy congresses.

Key Financials

Operating revenues amounted to €3.6 million for the first six months of 2018 compared to €3.9 million for the same period in 2017.

Revenues from collaboration and licensing agreements amounted to €0.6 million for the first six months of 2018 versus €0.5 million in the same period in 2017.
The research tax credit amounted to €2.8 million for the first half of 2018, compared to €3.0 million for the first half of 2017.
Research and Development (R&D) expenses amounted to €13.8 million in the first half of 2018 compared to €16.9 million for the same period in 2017. This decrease was mainly due to the 2017 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 trial). External expenses for clinical projects increased by €0.5 million to €3.7 million as we continued to progress the development of all our products.

General and administrative expenses were stable at €3.0 million for the first half of 2018 compared to €3.1 million for the same period in 2017.

Net loss amounted to €14.9 million for the first half of 2018 compared to €18.3 million for the same period in 2017.

As of June 30, 2018, the Company’s cash, cash equivalents, available-for-sale financial assets and other financial assets amounted to €33.1 million versus €41.4 million as of December 31, 2017.

Transgene’s cash burn amounted to €8.4 million in the first half of 2018, compared with €12.3 million for the same period in 2017 (mainly due to the milestone payment of €3.8 million ($4 million) to SillaJen, Inc. in 2017).

Transgene confirms its net cash burn target of approximately €25 million for 2018.

"Our results for the first six months of 2018 are in line with our expectations. We confirm our financial visibility for the next 12 months, excluding the monetization of the Tasly Biopharmaceuticals shares," commented Jean-Philippe Del, Chief Financial Officer of Transgene.

The Board of Directors of Transgene met on September 19, 2018 and adopted the financial statements for the six-month period ended June 30, 2018. The Statutory Auditors have conducted a limited review of the interim consolidated financial statements. The half-year financial report is available on Transgene’s website, View Source