On March 20, 2019 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies to transform the fight against solid tumors and infectious diseases, publishes its financial results for 2018 and provides an update on its clinical and preclinical portfolio, and its technology platforms (Press release, Transgene, MAR 20, 2019, View Source [SID1234534517]).
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Philippe Archinard, Chairman and Chief Executive Officer of Transgene, commented:
"2018 was a year of intense activity for Transgene resulting in significant progress across all aspects of the business. We continued to advance our promising clinical assets and look forward to announcing data from our key clinical trials in the second half of 2019.
Our R&D efforts were focused on our two cutting-edge technology platforms: oncolytic viruses and therapeutic vaccines, engineered to deliver a step change improvement in the treatment of solid tumors.
With the Invir.IOTM platform, we design a new virus with a more potent oncolytic effect and are arming it with strong immune-modulating agents to treat tumor which are today resistant to existing therapies. Positive data were presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting 2018. We have an ambitious program and we are currently evaluating several preclinical Invir.IOTM candidates which we expect to bring to the clinic in H1 2020.
In September we launched myvacTM, a highly innovative viral vector-based, individualized immunotherapy approach combining the use of the tumor’s neoantigens with Transgene’s viral Page 2 / 13 vector expertise to create a completely novel patient specific treatment option for solid tumors. We signed a strategic collaboration with NEC to leverage its artificial intelligence capabilities to identify candidate neoantigen targets. With the know-how and highly skilled experts at NEC as well as Institut Curie, HalioDx and Traaser, we are targeting to initiate two clinical trials in H2 2019 with our lead myvacTM candidate TG4050.
This is an exciting time for Transgene as we advance our viral-vector based immunotherapies to transform the fight against solid tumors."
Clinical Pipeline Review
Transgene has made significant progress with its key clinical trials, the majority of which are designed to produce proof-of-concept clinical data. Positive results from these trials would create significant value and partnering opportunities.
TG4010 + Opdivo (ICI) (nivolumab) +chemotherapy Phase 2 Non-small cell lung cancer (NSCLC) – 1 st line Trial of TG4010 in combination with nivolumab and chemotherapy in patients whose adenocarcinoma cells express low or undetectable levels of PD-L1. ✓ Recruitment is progressing well in US and EU with the opening of additional centers in EU; recruitment completion expected in Q2 2019 ✓ Bristol-Myers Squibb supplying nivolumab through a clinical collaboration Data on the study’s primary endpoint (ORR) on all evaluable patients(n=35) expected in H2 2019 Pexa-Vec + sorafenib (PHOCUS) Phase 3 Advanced liver cancer (hepatocellular carcinoma-HCC) – 1 st line ✓ Clinical trial being conducted by Transgene’s partner, SillaJen, Inc. (sponsor) ✓ Ongoing global recruitment Futility analysis expected mid-2019 First efficacy readout expected in 2020 Pexa-Vec + Opdivo (ICI) (nivolumab) Phase 1/2 Advanced liver cancer (hepatocellular carcinoma-HCC) – 1 st line ✓ Several active trial sites in France and Italy ✓ Safety confirmed by Safety Review Committee (SRC) in February 2019, Phase 2 part on-going ✓ US sites to be activated in Q2 2019 Interim analysis on 15 patients expected 2H 2019 (primary endpoint: ORR) ✓ TG4001 + Bavencio (ICI) (avelumab) Phase 1/2 HPV-positive cancers including oropharyngeal head and neck cancer – 2 nd line ✓ Clinical collaboration agreement with Merck KGaA and Pfizer, for the supply of avelumab ✓ Following positive SRC the Phase 2 part is ongoing and additional sites are being activated in Europe Next clinical readout expected in H2 2019 Page 3 / 13 TG6002 Phase 1/2a TG6002 is the first candidate from Transgene’s next generation oncolytic platform which is based on an improved viral backbone. This oncolytic virus, given in combination with the prodrug 5-FC, has been designed to produce the cytotoxic 5-FU locally in the tumor Gastro-intestinal adenocarcinoma (colon cancer for Phase 2) – IV route ✓ Multi-center trial on-going in Belgium, France and Spain First clinical readout expected in H2 2019 Metastatic colon cancer (liver metastasis) – IHA route ✓ Coordinating investigator: Adel Samson, St James’s Hospital, Leeds (UK) ✓ Multi-center trial in UK; INDs submitted in UK First patient expected to be treated in Q4 2019 TG1050 + Standard of care Phase 1 Chronic hepatitis B ✓ Trial completed Positive results from Phase 1 clinical trial of TG1050 in Chronic Hepatitis B presented at the AASLD Liver Meeting 2018: confirmation of safety, and immunogenicity Transgene is looking for partner to further advance this product TG4050 Two Phase 1 in preparation ✓ TG4050 is a therapeutic vaccine developed for individual patients, based on the specific mutations identified in the patient’s own tumor ✓ Collaboration with NEC; Transgene and NEC will co-finance 2 trials in: Ovarian cancer (after first line surgery and adjuvant therapy) First patient expected Q4 2019 (evaluation of safety and immunogenicity) Trial will be conducted in the US and France HPV-negative head & neck cancer (after surgery and adjuvant therapy) First patient expected in Q4 2019 (evaluation of safety and immunogenicity) Trial will be conducted in the UK and France
Transgene’s Cutting-edge Oncolytics and Vaccine Platforms Poised to Change the Treatment of Solid Tumors In 2018, Transgene significantly reinforced its preclinical capabilities, capitalizing on its global leading viral vector expertise in two of the most attractive fields of onco-immunotherapy: oncolytic viruses (OV) and therapeutic vaccines.
With Invir.IO, its new and more potent oncolytic virus platform Transgene is designing multi-functional OVs that it believes will deliver a step change in the treatment of advanced solid tumors. This is still an area of significant medical need despite the rapid growth in the use of immune checkpoint inhibitors either alone or in combination with other anti-cancer agents.
With myvacTM its individualized immunotherapy platform, Transgene is developing therapeutic vaccines designed for each individual patient which are expected to deliver improved outcomes in patients with less advanced solid tumors, as an adjuvant therapy following surgery for the first proof of concept trials. The lead candidates from both platforms are expected to enter clinical development in the next 12 months. Page 4 / 13 Invir.IOTM: the next generation of multifunctional oncolytic viruses to treat advanced solid tumors With Invir.IOTM, Transgene is making good progress in the increasingly attractive field of novel oncolytic viruses (OVs). Oncolytic viruses are an emerging class of targeted anticancer therapies designed to selectively infect, replicate in, and lyse malignant cells without causing harm to normal, healthy tissues. In addition to direct oncolytic activity, OVs have shown dual promise as immunotherapeutic agents: the viral infection leads to an immunogenic tumor cell death, triggers innate and adaptive immune responses that mediate further tumor destruction and these viruses can also deliver very potent immunotherapeutic agents selectively in the tumor micro environment. Transgene expects its Invir.IO viruses to deliver a step change on these two fronts.
The Invir.IO platform is designed to generate novel multifunctional oncolytic virus that has a more potent oncolytic viral backbone and incorporate several transgenes encoding for a range of specific anticancer weapons that are capable of better modulating the tumor micro-environment, with the aim of improving the treatment outcomes of patients with solid tumors.
In November 2018, Transgene presented positive data of its antibody-armed oncolytic vaccinia virus at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper). This oncolytic vaccinia virus has demonstrated its ability to ensure the expression of BioInvent’s anti-CTLA-4 antibody in the tumor with low systemic exposure. It also showed improved efficacy and a better safety profile compared to the combination of the antibody and the non-armed corresponding oncolytic virus in pre-clinical models.
The Company is progressing very well in developing its large preclinical portfolio of candidates. We are committed and on track to bring to the clinic the OV encoding an anti-CTLA-4 antibody (collaboration with BioInvent), as well as at least one other OV encoding for an anti-cancer agent in H1 2020.
myvacTM: New generation of individualized immunotherapy using Transgene’s unique MVA based platform
In September 2018, Transgene announced the launch of its myvacTM platform, which has been designed to produce individualized, MVA-based immunotherapies that stimulate and educate the immune system of patients to recognize and destroy tumor cells.
The personalized immunotherapy product is based on the mutations that are identified in the patient’s own tumor. These mutations are highly relevant targets since they lead to the expression of tumor neoantigens which are known to trigger a stronger immune response than tumor associated antigens.
In March 2019, Transgene formalized its strategic collaboration with NEC aimed at treating cancer patients. NEC’s artificial intelligence algorithms will be used to predict which of the tumor neoantigens identified by sequencing in a given patient’s solid tumor are the most appropriate neoantigens to integrate into the genome of the viral vector (MVA). Transgene will design and manufacture a personalized vaccine for the treatment of this specific patient using the myvacTM technology.
NEC will co-finance the first two clinical studies that Transgene will conduct with the lead myvac vaccine TG4050. These two clinical trials will be conducted in Europe and in US, in patients with HPV-negative head and neck cancers and ovarian cancer. Both trials are expected to start in Q4 2019.
Transgene has developed and validated its PilotClin manufacturing unit in order to efficiently produce GMP batches of its personalized vaccines. Several research tracks are also being pursued to optimize further the immunogenicity of the myvacTM therapeutic vaccines. Page 5 / 13
In March 2019, the NEOVIVA project which supports the industrial development of the myvacTM platform, was awarded a grant from Bpifrance’s ‘Investments for the Future’ program. Under the agreement, Transgene will receive €2.6 million over the five-year duration of the program from Bpifrance. The NEOVIVA project aims to further develop this innovative technology in collaboration with its three partners: HalioDx, Traaser and the Curie Institute. The NEOVIVA project complements the already existing collaboration between Transgene and NEC.
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. (‘Tasly’) under which Transgene sold both the T101 Greater China patent rights and its entire 50% stake in the Transgene Tasly (Tianjin) joint venture which already owned the T601 Greater China patent rights. Following these
agreements, Tasly now holds all rights to research, develop and commercialize T601 and T101 in Greater China.
In return, Transgene received a total of 27.4 million new Tasly shares valued at $48 million (€41 million) based on the subscription price in pre-IPO financing round of Tasly, which took place concurrently with the transaction with Transgene. Transgene’s stake represents 2.53% of Tasly’s expanded share capital. Tasly 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.
€20 million revolving credit facility secured with Natixis Transgene has recently secured a €20 million loan (revolving credit) facility with Natixis, the French Corporate and Investment bank. The interest-bearing facility will have a 30-month term and Transgene will be able to draw and reimburse the facility at its discretion during the term. Transgene has used its shares in the Chinese biotech company Tasly as collateral for this loan.
Key Financials-
Net profit of €8.0 million in 2018, compared to a loss of €32.3 million in 2017. The net profit that Transgene achieved in 2018 was mainly generated by the transaction with Tasly Biopharmaceuticals Co., Ltd.-Net operating expenses of €35.5 million in 2018, compared to €36.1 million in 2017-Net cash burn for 2018 was reduced to €24.5 million compared to €28.1 million in 2017-Cash available at year-end 2018: €16.9 million, compared to €41.4 million at the end of 2017 "In 2018 we were able to continue a high level of investment in our clinical and per-clinical programs while at the same time reducing our cash burn via prudent financial management. Operating costs remain under good control and following the recent financing agreement with Natixis we now have extended our financial visibility until mid-2020." said Jean-Philippe Del, Vice President, Finance.
The financial statements for 2018 as well as management’s discussion and analysis are attached to this press release (Appendices A and B). Page 6 / 13
Financial Outlook 2019 Transgene expects its cash burn for 2019 to be between €25 million and €30 million. The Company has the financial resources to execute its strategy through to mid-2020.
The Board of Directors of Transgene met on March 20, 2019, under the chairmanship of Philippe Archinard and closed the 2018 financial statements. Audit procedures have been performed by the statutory auditors and the delivery of the auditors’ report is ongoing. The Board will convene Transgene’s annual general meeting of shareholders for May 22, 2019 and proposes to renew all four directors whose terms are set to expire at that meeting. The Board of directors was informed of the decision of Mr Alain Mérieux to retire from his board seat effective as of the AGM on May 22, 2019. The Board thanks Mr Mérieux for his long-time continued support of Transgene and has named Mr Mérieux Honorary President of Transgene in recognition of his contributions. The Board has proposed the nomination of Mr Hedi Ben Brahim, Vice President for immunotherapy at Institut Mérieux, to fill the seat vacated by Mr Mérieux.
The Company’s registration document, which includes the annual financial report, will be available in April 2019 on Transgene’s website, www.transgene.fr.
A conference call in English is scheduled today, on March 20th at 6:30 p.m. CET Webcast link to English language conference call: View Source Participant telephone numbers: France: +33 (0) 1 7099 4740 UK (Toll Free): 0808 109 0700 US (Toll Free): +1 866 966 5335 Password: Transgene A replay of the call will be available on the Transgene website (www.transgene.fr) following the live event. Contacts Transgene: Jean-Philippe Del +33 (0)3 88 27 91 04 [email protected] Media contacts: Citigate Dewe Rogerson EU : David Dible/ Sylvie Berrebi US : Marine Perrier-Barthez + 44 (0)20 7638 9571 / +1 424 341 9140 [email protected]