On May 6, 2020 Transgene (Euronext Paris: TNG) (Paris:TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported its business update for the quarter ending March 31, 2020, and provides an update on its progress of clinical trial portfolio taking into account the impact of the Covid-19 pandemic (Press release, Transgene, MAY 6, 2020, View Source [SID1234557154]).
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Operating revenue
The following table summarizes the first quarter operating revenue for 2020 compared to the same period in 2019:
During the first quarter of 2020, revenue from collaborative and licensing agreements was mainly composed of the revenue under the collaboration with AstraZeneca.
As of March 31, 2020, government financing for research expenditures mainly consisted of 25% of the research tax credit expected for 2020 (€1.5 million in the first quarter of 2020, as in 2019).
Cash, cash equivalents and other financial assets
In the first quarter of 2020, Transgene’s cash burn was €8.0 million, compared to €7.8 million for the same period in 2019. Cash, cash equivalents and other financial assets stood at €35.3 million as of March 31, 2020, compared to €43.3 million as of December 31, 2019.
This cash position does not include the €20 million credit facility available for the Company until June 2022.
Summary of key ongoing clinical trials and expected milestones
Transgene continues to monitor the development of the of Covid-19 pandemic and its potential consequences on its activities. To-date the pandemic has had limited impact.
Transgene’s teams have been mostly working from home to ensure business continuity. The commitment of our employees and the measures taken to provide a safe environment have allowed Transgene to maintain activity in the labs in order to ensure the progress of our strategic research projects and to operate our pilot manufacturing unit. Encouragingly, we expect our labs to be operating at close to normal levels starting next week.
As of today, we do not anticipate significant delays to our clinical readouts.
Some key congresses, such as AACR (Free AACR Whitepaper), have been rescheduled as virtual events. Transgene and its partners intend to present preclinical data on myvac and BT-001 at "virtual" AACR (Free AACR Whitepaper) (Session II). The abstracts of the posters to be presented will be available on May 15, 2020.
TG4001
+ Bavencio
(avelumab)
Phase 2
Targets: HPV16 E6 and E7 oncoproteins
HPV-positive cancers including oropharyngeal head and neck cancer – 2nd line
Clinical collaboration with Merck KGaA and Pfizer, for the supply of avelumab
All patients required to perform the interim analysis have been enrolled
Interim Phase 2 results on track for 2Q 2020
myvac
TG4050
Phase 1
Targets: tumor neoantigens
Ovarian cancer – after first-line surgery and adjuvant therapy
Trial authorized in the United States and in France
Principal investigator: Matthew Block (Mayo Clinic)
First patient enrolled in January 2020
First data on track for 1H 2021
myvac
TG4050
Phase 1
HPV-negative head and neck cancer – after surgery and adjuvant therapy
Trial authorized in the United Kingdom and in France
Principal investigator: Christian Ottensmeier (Southampton University)
First patient enrolled in January 2020
First data on track for 1H 2021
Data demonstrating high accuracy of AI-based neoantigen prediction for the design of TG4050 will be presented at AACR (Free AACR Whitepaper)
TG6002
Phase 1/2a
Payload: FCU1 for the local production of a 5-FU chemotherapy
Gastro-intestinal adenocarcinoma (colorectal cancer for Phase 2) – Intravenous (IV) route
Multicenter trial ongoing in Belgium, France and Spain
Last dose cohorts currently being evaluated (Phase 1 part)
First results of the Phase 1 part expected for late of 2Q / early 3Q 2020
TG6002
Phase 1/2a
Colorectal cancer with liver metastasis – Intrahepatic artery (IHA) route
Multicenter trial authorized in the United Kingdom
First patient treated in February 2020; enrollment paused for several weeks due to Covid-19
The Company will provide an update in September 2020 on the expected timing of the release of the first Phase 1 data
Invir.IO
BT-001
Phase 1/2
Payload: anti-CTLA4 antibody and GM-CSF cytokine
Solid tumors
Collaboration with BioInvent
First clinical trial application submitted
Presentation of very encouraging preclinical results at AACR (Free AACR Whitepaper)
First clinical trial expected to start before the end of 2020
Outlook
Transgene expects its cash burn for 2020 to be around €25 million, based on its current development plan.
Post-closing events
On May 4, 2020, Transgene announced the sale of its proprietary DuckCelt-T17 cell line to Vaxxel, a French biotech start up focused on respiratory vaccines. As a result of this transaction, Transgene has become a significant shareholder in Vaxxel. Vaxxel will use the DuckCelt-T17 cell line to enable the production of prophylactic vaccines against respiratory viruses (Metapneumovirus and Respiratory Syncytial Virus).
On April 9, 2020, Transgene sold its entire 8.25% holding in ElsaLys Biotech in a private operation.