On November 7, 2024 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, and NEC Corporation (NEC; TSE: 6701), a leader in IT, network and AI technologies, reported 24.1 month median follow-up data from the ongoing randomized Phase I trial of TG4050 in the adjuvant treatment of head and neck cancers (Press release, NEC, NOV 8, 2024, View Source [SID1234647967]). The data will be presented in a poster at the Society for ImmunoTherapy of Cancer (SITC) (Free SITC Whitepaper) 2024 Annual Meeting, November 9.

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TG4050 is an individualized immunotherapy being developed for solid tumors that is based on Transgene’s myvac platform and powered by NEC’s cutting-edge AI capabilities designed to optimize antigen selection.

After a median follow up of 24.1 months, all 16 patients who received TG4050 as adjuvant immunotherapy after completion of an adjuvant standard of care remain disease-free and have not relapsed. Out of the 16 patients in the control observation arm, 3 patients have relapsed. There remains a high medical need for these head and neck cancer patients, as approximately 30% of them are expected to experience a relapse within 24 months after standard surgery and adjuvant chemoradiotherapy.

Immune responses targeting selected neoantigens were identified in 100% of patients who received TG4050, demonstrating the strong immunogenicity of the cancer vaccine, with both de novo and amplified responses. An analysis over 7 months also shows that immune responses are sustained, during the induction and boost periods.

All treatment-related adverse events continue to be mild to moderate.

Pr. Le Tourneau, Head of the Department of Drug Development and Innovation (D3i) at Institut Curie, and Principal Investigator, said: "It is highly encouraging to see confirmation of TG4050’s clinical and immune response data after a median follow-up of 24.1-months. There remains a significant unmet need in head and neck cancer patients in the adjuvant setting. TG4050 has demonstrated its potential to prime an adaptive immune response against tumor antigens and prevent relapse in patients with locally advanced resected head and neck squamous cell carcinoma."

Dr. Emmanuelle Dochy, Chief Medical Officer of Transgene, added: "We are very encouraged to observe that all the patients treated with our neoantigen cancer vaccine TG4050 remain disease-free after a median follow-up of 24.1 months. Looking at these results and at the long-lasting immune response, we are confident that TG4050 has the potential to benefit these patients, who still face a significant risk of relapse with current therapies. A Phase II part of our trial is currently enrolling patients internationally, with the aim of further confirming these promising findings."

Motoo Nishihara, Corporate EVP, and CTO, at NEC, added: "These results illustrate the power of our collaboration with Transgene and our ability to develop a personalized approach to cancer patient treatment using our proprietary artificial intelligence and machine learning models. We have built a strong and compelling clinical data set to support the benefits of TG4050 as an individualized immunotherapy, and we remain committed to bringing novel AI-based treatments to patients across the globe."

The SITC (Free SITC Whitepaper) poster can be viewed in-person during the poster presentation at the new windowSITC 2024 meeting and can be accessed on PDFTransgene’s website on November 9.

Building on these promising data, the randomized Phase I trial has been expanded to a randomized Phase I/II trial in the adjuvant setting of head and neck cancer (new windowNCT04183166), which is currently enrolling patients in a Phase II part.

Poster details

Abstract Number: 650
Title: Randomized phase I trial of adjuvant individualized TG4050 vaccine in patients with locally advanced resected HPV-negative head and neck squamous cell carcinoma (HNSCC)
Presenting Author: C. Le Tourneau – Institut Curie
Poster Presentation Day: November 9

On November 7, 2024 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported its business update and financial position for the quarter ending September 30, 2024 (Press release, Transgene, NOV 7, 2024, View Source [SID1234655851]).

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Key events and upcoming milestones
TG4050: Neoantigen therapeutic cancer vaccine
Transgene and NEC will present promising new data from the ongoing randomized Phase I trial of the neoantigen individualized therapeutic cancer vaccine, TG4050 at SITC (Free SITC Whitepaper) 2024 on November 9, 2024 (see press release here). These data provide robust clinical proof of principle for Transgene’s lead candidate in the adjuvant head and neck cancer setting, a patient population at high risk of relapse.

Compelling 24.1-month median follow-up data presented showed that all 16 patients treated with TG4050 after completion of adjuvant standard of care remain disease-free and have not relapsed, comparing favorably to the observational arm which saw 3 out of 16 patients relapse. All patients treated with TG4050 developed specific immune responses against the selected personalized antigen targets, demonstrating the strong immunogenicity of the cancer vaccine, with both de novo and amplified responses. Additionally, immune responses are sustained over a 7-month period, covering the induction and boost periods.

In Q2 2024, Transgene started enrolling patients in the Phase II part of the expanded randomized Phase I/II trial investigating TG4050 in the adjuvant treatment of head and neck cancer (NCT04183166). Patient enrollment continues to progress at a good pace.

TG4050 is the only individualized neoantigen cancer vaccine currently being developed in a randomized trial in the adjuvant treatment of head and neck cancer.

TG4050 has potential applicability across a range of solid tumors where there remains a significant unmet medical need, despite the existing therapeutic options, including immunotherapies. As a result, Transgene is conducting preliminary work on a potential new Phase I trial in a further undisclosed indication.

TG4001 – Shared antigen cancer vaccine
In October 2024, Transgene announced that its randomized Phase II study evaluating TG4001 in combination with avelumab versus avelumab alone in patients with recurrent or metastatic HPV16- positive cervical and anogenital tumors did not meet its primary objective (improvement in progressionfree survival).

However, analysis of a pre-planned subgroup showed a positive efficacy trend in favor of the TG4001 containing regimen in cervical cancer patients, which requires further confirmation through additional analyses, including by PD-L1 status. These patients account for approximately half of the patients enrolled in the study. Transgene is currently evaluating the full study results in detail to determine the best way forward for this program and will communicate further once this is completed.

Oncolytic Viruses
BT-001 (intratumoral administration):
In September 2024, Transgene and its partner BioInvent presented preliminary Phase I/IIa data (NCT04725331) at ESMO (Free ESMO Whitepaper) (see press release here) showing that BT-001 induced tumor regression in patients unresponsive to prior anti PD(L)-1 treatment, both as monotherapy and in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA (pembrolizumab).

BT-001 replicated in the tumor and expressed the encoded GM-CSF and anti-CTLA-4 transgenes. Notably, BT-001 in combination with pembrolizumab showed first signs of efficacy in 2 out of 6 patients, with shrinkage of injected and non-injected lesions. In a reported case study, BT-001 treatment was able to modulate the tumor microenvironment, converting "cold tumors" into "hot tumors", and inducing T cell infiltration.

Transgene and BioInvent are finalizing the second cohort in the part B of the Phase I/IIa trial, to inform on the further development strategy.

TG6050 (intravenous administration):
The Phase I Delivir trial (NCT05788926), evaluating TG6050 in patients with advanced non-small cell lung cancer who have failed standard therapeutic options, completed the first two dose levels. Dose-limiting toxicity was observed in one patient in the third cohort and additional patients are being enrolled according to the protocol to complete this trial. Initial data are now expected in H1 2025.

Preclinical data, recently published in the Journal for ImmunoTherapy of Cancer (JITC), were awarded with the JITC Best Oncolytic and Local Immunotherapy Paper Award. The article on TG6050 demonstrates that it induces tumor regression in numerous "hot" and "cold" murine tumor models investigated in these studies. This antitumoral activity was further amplified when TG6050 was combined with an immune checkpoint inhibitor (article available here).

Cash, cash equivalents and other financial assets
Cash, cash equivalents and other financial assets stood at €14.0 million as of September 30, 2024, compared to €15.7 million as of December 31, 2023.

In the first nine months of 2024, Transgene’s cash burn amounted to €31.3 million compared to a cash burn of €13.8 million in the same period of 2023. The difference is explained by the July 2023 sale of Transgene’s remaining shares held in Tasly BioPharmaceuticals for a total amount of US$15.3 million (€14.3 million).

At of the end of July 2024, Transgene announced the conversion into shares of €33 million debt drawn down from the current account advance granted by the Company’s major shareholder TSGH (Institut Merieux), in accordance with the terms of an agreement signed for the first time in 2023. As a result, the share capital of Transgene held by TSGH increased from 59.7% to 69.1% of the outstanding shares. In carrying out this transaction, Transgene has strengthened its balance sheet, reduced its debt levels and its debt burden as a result of lower interest payments.

As of September 30, 2024, Transgene had the capacity to draw down €23.5 million from the current account advance provided by TSGH.

Transgene confirms financial visibility into Q4 2025, enabling the Company to deliver news flow on its portfolio progress over the next 12 months.

On November 7, 2024 Oncopeptides reported third quarter financial results (Presentation, Oncopeptides, NOV 7, 2024, View Source [SID1234654164]).

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On November 7, 2024 Orion reported interim financial report for January to September 2024 (Presentation, Orion, NOV 7, 2024, View Source [SID1234649455]).

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On November 7, 2024 Moderna, Inc. (NASDAQ:MRNA) reported financial results and provided business updates for the third quarter of 2024 (Press release, Moderna Therapeutics, NOV 7, 2024, View Source [SID1234649412]).

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"During the third quarter, we focused on execution with the launch of our updated COVID-19 and RSV vaccines in markets across the globe. I am pleased with the cost efficiency we achieved in the quarter, tracking ahead of where we planned to be at this time," said Stéphane Bancel, Chief Executive Officer of Moderna. "Looking into the fourth quarter and preparing for 2025, we remain focused on driving sales growth, delivering 10 product approvals over the next three years, and continuing to reduce our cost structure."