On September 7, 2022 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported its financial results for the six-month period ended June 30, 2022 and provides an update on the progress of its portfolio of clinical-stage drug candidates (Press release, Transgene, SEP 7, 2022, View Source [SID1234619181]).
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"Our goal is to transform the outlook for cancer patients with solid tumors by developing immunotherapies that can become vital components of the therapeutic arsenal. To achieve this, Transgene has created two highly innovative technology platforms that have delivered multiple therapeutic vaccine and oncolytic drug candidates now being evaluated in clinical trials," commented Hedi Ben Brahim, CEO of Transgene.
"We have made remarkable progress in the first half of 2022, with initial results in patients reinforcing my confidence that we are on track to progress through the clinic successfully. With several further important clinical milestones to be announced before the end of the year, we are approaching a critical moment to become a world leader in innovative cancer therapies."
Highlights and expected news flow
TG4001 – Result of the Phase II interim analysis to be released in Q4 2022
Just over 50 patients have been enrolled in the randomized Phase II trial evaluating the combination of TG4001 and avelumab in HPV-induced anogenital cancers. Transgene expects to report the results of the interim analysis in Q4 2022.
The objective of this trial is to demonstrate the superiority of the combination of TG4001 + avelumab versus avelumab as a single agent to improve progression-free survival (primary endpoint of the trial) and, in the longer term, overall patient survival.
In this Q4 2022 communication, Transgene will specify, based on the results of the interim analysis, the total number of patients that must be included in the trial to confirm the efficacy of the therapy and achieve statistically significant progression-free survival improvement. Indeed, the design of the trial allows for the total number of patients to be adjusted according to the results obtained in the interim analysis and based on the recommendations of the IDMC (independent data monitoring committee).
TG4050 – Patients treated with our neoantigen vaccine show a robust, vaccine specific immune response
Transgene presented new positive preliminary data from TG4050, its proprietary cancer vaccine based on the myvac platform, at the AACR (Free AACR Whitepaper) (April 2022) and ASCO (Free ASCO Whitepaper) (June 2022) meetings. These data show good safety and robust immunogenicity. The induction of immune responses is particularly efficient (100% of patients evaluated at the data cut-off date showed a specific cellular response) and is associated with disease regression.
Transgene has also produced data on circulating tumor DNA (ctDNA); signals of this increasingly validated surrogate marker of efficacy are particularly encouraging. Combined with the first signs of clinical activity, these results suggest that the individualized TG4050 vaccine has the potential to extend the period of remission, potentially offering a new treatment option for cancer patients.
Additional data from the two ongoing Phase I trials (ovarian cancer and head and neck cancers) are expected in the second half of 2022. The information generated will be key to designing the Phase II trial of TG4050, which could start as early as 2023.
In addition, Transgene has completed patient inclusion in the two Phase I trials. These patients are now being monitored until they become eligible for treatment per study protocol.
An article on Transgene’s personalized vaccine technology was published in the Journal for ImmunoTherapy of Canceri. The publication demonstrated that Transgene successfully developed a patient specific vaccine within a few weeks for a study case patient with a low tumor mutational burden (TMB).
TG6002 – Phase I trials completed – Confirms the strong potential of IV administration of the Invir.IO oncolytic viruses
Patient enrollment has been completed in the Phase I trial evaluating the intravenous (IV) route of administration: 51 patients received TG6002 at different doses and with different schedules.
This route of administration has considerable therapeutic and market potential as it allows targeting many types of internal lesions and metastases inaccessible by intratumoral injection (injection of the oncolytic virus directly into the tumor) which is currently the only approved route of administration for an oncolytic virus.
New data from this trial will be presented in a poster at the ESMO (Free ESMO Whitepaper) Congress on September 11, 2022 at 12:00 pm CET. The data confirm the safety and feasibility of the IV route for TG6002 and support the potential of IV administration of Invir.IO-based oncolytic viruses, extending the use of these therapies to a broad range of solid tumors.
In the TG6002 Phase I trial evaluating the intrahepatic artery route of administration (IHA), enrollment has been completed. Data are currently being analyzed and will be presented at a conference in the first half of 2023.
BT-001 – Good safety and first signs of antitumor activity as a monotherapy
Transgene and BioInvent provided an update on the progress of the clinical trial of BT-001, an oncolytic Vaccinia virus encoding an anti-CTLA-4 antibody and GM-CSF, in June 2022. Initial data from Part A of the Phase I trial demonstrated that BT-001 as a single-agent is well tolerated, with first signs of anti-tumor activity observed in a hard-to-treat patient population. The mechanism of action for BT-001, as a single agent, was also confirmed: the virus replicates in the tumor and the anti-CTLA-4 antibody is expressed in the tumor.
A clinical collaboration and supply agreement for KEYTRUDA (pembrolizumab) was signed with MSD (Merck & Co) at the end of June 2022. The Phase Ib part of the clinical trial (combination with pembrolizumab) is expected to start in the second half of 2022.
Promising preclinical data with BT-001 were presented at AACR (Free AACR Whitepaper) 2022 and published in the Journal for ImmunoTherapy of Cancerii demonstrating the broad and robust antitumor activity of this Invir.IO oncolytic virus.
Change in governance and appointment within the executive committee
Transgene reinforced its corporate governance by separating the roles of Chairman and CEO. Dr. Alessandro Riva, MD, became Non-Executive Chairman of the Company (May 25, 2022). With 30 years’ experience in the Life Sciences industry, Dr. Riva is closely working with Transgene’s CEO Hedi Ben Brahim to realize the potential of the Company’s technology platforms and products to benefit cancer patients.
Prof. Jean‑Yves Blay, MD, PhD, and Laurence Espinasse were appointed as members of the board of directors.
Steven Bloom joined Transgene as Vice President, Chief Business Officer (CBO). In this position, he has become a member of the executive committee, leading global business development strategy, alliance management and program management. In particular, he is focused on building the profile of Transgene in the USA, where he is based, as part of establishing the Company as a world leader in virus-based immunotherapies.
R&D Day
Transgene is organizing an R&D Day intended for the financial community, in particular analysts and institutional investors. It will be accessible to investment professionals in person and, online to everyone on Transgene’s website (via webcast). It will take place on September 27, from 2 p.m. to 6 p.m. CET (8 a.m. EST to 12 p.m. EST).
The event will include presentations by several Key Opinion Leaders, independent and active in Transgene’s clinical trials, as well as a review of Transgene’s immunotherapy portfolio and its positioning in the immuno-oncology landscape. In particular, Transgene will disclose new data on TG4050 and provide insights on the progress of the Invir.IO platform.
Summary of key ongoing clinical trials
TG4001
+ avelumab
Phase II
NCT03260023
Targets: HPV16 E6 and E7 oncoproteins
Recurrent/metastatic anogenital HPV-positive – 1st (patients ineligible for chemotherapy) and 2nd lines
Randomized Phase II trial comparing the combination of TG4001 with avelumab versus avelumab alone
Active patient enrollment in Europe (France and Spain) and in the USA
Results of the interim analysis expected in Q4 2022 (N≈50)
myvac
TG4050
Phase I
NCT03839524
Targets: tumor neoantigens
Codeveloped with NEC
New positive data in first patients demonstrating the immunogenicity of the vaccine as well as first signs of clinical activity presented at AACR (Free AACR Whitepaper) and ASCO (Free ASCO Whitepaper) 2022
Additional data on the 2 trials expected in H2 2022
Ovarian cancer – after surgery and first-line chemotherapy
Trial ongoing in the USA and in France
Patient enrollment completed
TG4050
Phase I
NCT04183166
HPV-negative head and neck cancer – after surgery and adjuvant therapy
Trial ongoing in the UK and in France
Patient enrollment completed
TG6002
Phase I/IIa
NCT03724071
Payload: FCU1 for the local production of a 5-FU chemotherapy
Advanced gastro-intestinal cancer (colorectal cancer for Phase II) – Intravenous (IV) administration
Multicenter trial ongoing in France, Belgium and Spain
Proof-of-concept data of the IV administration presented in 2021 (ESMO & AACR (Free AACR Whitepaper))
Patient enrollment completed in Phase I part
Poster to be presented at ESMO (Free ESMO Whitepaper) 2022 (September 11, 2022)
TG6002
Phase I/IIa
NCT04194034
Colorectal cancer with liver metastasis – Intrahepatic artery (IHA) administration
Multicenter trial ongoing in the UK and in France
Patient enrollment completed in Phase I part
Data to be presented in H1 2023
Invir.IO
BT-001
Phase I/IIa
NCT04725331
Payload: anti-CTLA4 antibody and GM-CSF cytokine
Solid tumors
Co-development with BioInvent
Trial ongoing in France, Belgium and approved in the USA
Initial data showing safety and first signs of clinical activity
Collaboration agreement with MSD, supplying pembrolizumab for the trial
Start of part B of the Phase I trial in H2 2022
Key financials
The Board of Directors of Transgene met on September 7, 2022 and approved the financial statements for the six-month period ended June 30, 2022. 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, www.transgene.fr.
Key elements of the income statement
Operating income amounted to €6.1 million for the first six months of 2022 compared to €5.0 million for the same period in 2021.
In 2019, the Company entered into a collaboration agreement with AstraZeneca, which included exclusive licensing options to co-develop oncolytic immunotherapies derived from the Invir.IO platform. As a result, in the first half of 2019 Transgene received €8.9 million (US$10 million) in fees for access to its platform. This initial payment is recognized as revenue based on the stage of completion of the related activities. In the first half of 2022, the income recognized under this collaboration agreement was €2.3 million (€1.3 million in the first half of 2021). Of this amount €0.4 million reflects recognition of the initial payment for work done during the period and €1.9 million in respect of the supply of candidates and the performance of R&D services.
The research tax credit amounted to €3.7 million for the first half of 2022, compared to €3.5 million for the first half of 2021.
Research and Development (R&D) expenses amounted to €17.0 million in the first half of 2022 compared to €15.3 million for the same period in 2021, reflecting the acceleration of clinical trials.
General and administrative expenses amounted to €3.9 million for the first half of 2022 compared to €3.1 million for the same period in 2021.
Financial income is a loss of €0.4 million in the first half of 2022 compared to a gain of €1.6 million for the same period in 2021.
As a consequence, the net loss amounted to €15.3 million for the first half of 2022 compared to a loss of €11.8 million for the same period in 2021.
Transgene’s cash burn amounted to €6.8 million in the first half of 2022 compared with €11.9 million for the same period in 2021.
As of June 30, 2022, the Company’s cash, cash equivalents and other financial assets amounted to €42.8 million (€49.6 million as of December 31, 2021).
The Company has financial visibility until the end of 2023.
A conference call in English is scheduled today, on September 7, 2022, at 6 p.m. CET / 12 p.m. EST.