(Boursier.com) — Transgene a biotechnology company that designs and develops viral-based cancer immunotherapies, and BioInvent International AB (“BioInvent”) (Nasdaq Stockholm: BINV), a biotechnology company focused on discovering and developing innovative immunomodulatory antibodies for cancer, will present a poster on the first clinical results from the Phase I portion of the randomized Phase I/IIa trial evaluating BT-001 as monotherapy and in combination with KEYTRUDA (pembrolizumab), the anti-PD-1 therapy made available by MSD (Merck & Co. Inc. Rahway, NJ, USA).
Phase I data will be presented at the European Society for Medical Oncology (ESMO) Annual Conference to be held in Barcelona, Spain, September 13-17, 2024.
Key points of the abstract include:
In monotherapy, in terms of overall response, disease stabilization was observed in 4 of 18 patients with advanced solid tumors receiving BT-001. Tumor reduction was also observed in 2 of 20 injected lesions.
In combination, partial responses were observed in 2 out of 6 patients with advanced solid tumors receiving BT-001 in combination with pembrolizumab. This includes one patient with PD(L)-1-resistant melanoma and one patient with leiomyosarcoma after five lines of treatment. Patient response profiles and updated results will be presented at ESMO.
BT-001 is well tolerated, with no dose-limiting toxicity (DLT) observed. Two grade 3 adverse events related to BT-001 were observed (one skin ulcer and one decreased lymphocyte count). No DLT was observed despite repeated intratumoral injections of BT-001 alone (in 18 patients) or in combination with pembrolizumab (in 6 patients).
The oncolytic virus BT-001 replicates in tumors and expresses its anti-CTLA-4 antibody (mAb) payload with rare and sporadic dissemination, in line with translational data.
Dr. Stéphane Champiat, Medical Oncologist at Gustave Roussy, Head of the Hospitalization Unit, Department of Drug Development (DITEP) and clinical investigator of the study, adds: “Many cancer patients do not respond to existing treatments, which underlines the significant need for new approaches. BT-001 is a potentially very promising new immunotherapy that elicits a strong immune response, enhanced by the local expression of the anti-immune checkpoint inhibitor antibody CTLA-4 and the cytokine GM-CSF. The first clinical data from this study provide an important proof of principle and demonstrate the relevance of this oncolytic virus approach. Alone or in combination with pembrolizumab, BT-001 offers the possibility of improving treatment options with a better safety profile for patients in many types of cancer.”
Dr. Alessandro Riva, Chairman and Chief Executive Officer of Transgene, commented: “The promising initial clinical results from the ongoing Phase I/IIa clinical study evaluating BT-001 demonstrate its full potential. Within Transgene’s portfolio of oncolytic viruses, it further confirms the ability of our invir.IO(R) platform to generate tumor-specific targeted immunotherapies. BT-001 shows preliminary efficacy without dose-limiting toxicity, both as a monotherapy and in combination with pembrolizumab, while modulating the tumor microenvironment. We look forward to presenting further results as this study progresses.”
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Breakthrough in Cancer Immunotherapy: BT-001 Oncolytic Virus Shows Promising Results
Cancer treatment has long been a complex and multifaceted challenge, with many patients failing to respond to existing therapies. However, a breakthrough in oncolytic virus research has brought new hope to the medical community and patients alike. BT-001, a novel oncolytic virus developed by Transgene and BioInvent, has shown promising results in its Phase I clinical trial, offering a potentially game-changing approach to cancer immunotherapy.
What is BT-001?
BT-001 is the first oncolytic virus from Invir.IO™, a proprietary platform developed by Transgene. This innovative immunotherapy approach has been designed to act as a Trojan horse, leveraging the body’s natural immune response to target and destroy cancer cells [1[1[1[1[1[1[1[1]. The virus is optimized to replicate in tumors and express a human CTLA4-specific antibody, which enhances the local immune response and promotes the destruction of cancer cells <a href="https://jitc.bmj.com/content/8/Suppl3/A356.1″>[2[2[2[2[2[2[2[2].
Phase I Clinical Trial Results
The Phase I clinical trial of BT-001, conducted in collaboration with BioInvent, has yielded promising results. According to the trial data, BT-001 has demonstrated a favorable safety profile, with no dose-limiting toxicity observed. In terms of efficacy, disease stabilization was observed in 4 out of 18 patients with advanced solid tumors receiving BT-001 monotherapy, while tumor reduction was seen in 2 out of 20 injected lesions. Moreover, partial responses were observed in 2 out of 6 patients with advanced solid tumors receiving BT-001 in combination with pembrolizumab, including one patient with PD(L)-1-resistant melanoma and one patient with leiomyosarcoma after five lines of treatment.
The Future of Cancer Immunotherapy
The results of the Phase I clinical trial of BT-001 are highly encouraging, suggesting that this novel oncolytic virus has the potential to provide a safe and effective treatment option for patients with advanced solid tumors. As Dr. Stéphane Champiat, Medical Oncologist at Gustave Roussy, notes, “BT-001 is a potentially very promising new immunotherapy that elicits a strong immune response, enhanced by the local expression of the anti-immune checkpoint inhibitor antibody CTLA-4 and the cytokine GM-CSF.”
The success of BT-001 in its Phase I trial has paved the way for further research and development, with the potential to improve treatment options for patients with various types of cancer. As the medical community continues to explore the possibilities of oncolytic virus research, one thing is clear: BT-001 has the potential to be a game-changer in the fight against cancer.
References
1 Transgene. (n.d.). BT-001. Retrieved from
<a href="https://jitc.bmj.com/content/8/Suppl3/A356.1″>2 Semmrich, M. (2020). 594 BT-001, an oncolytic vaccinia virus armed with a Treg-depleting antibody, induces systemic tumor regression in combination with pembrolizumab. Journal for ImmunoTherapy of Cancer, 8(Suppl 3), A356.1. doi: 10.1136/jitc-2020-SITC2020.0356.1
3 BioInvent. (2023, October 10). BioInvent and Transgene: First patient treated in Part B of Phase 1 trial assessing novel oncolytic virus BT-001. Retrieved from
Transgene’s BT-001: A Promising New Immunotherapy for Cancer Treatment
Transgene, a biotechnology company specializing in immunotherapies, has made significant progress in the development of BT-001, a novel oncolytic virus designed to treat advanced solid tumors. In collaboration with BioInvent International AB, Transgene has presented promising clinical results from the Phase I portion of the randomized Phase I/IIa trial evaluating BT-001 as monotherapy and in combination with KEYTRUDA (pembrolizumab) [[1]].
Key Findings from the Phase I Trial
The Phase I trial demonstrated that BT-001 is well tolerated, with no dose-limiting toxicity (DLT) observed in patients receiving the oncolytic virus as monotherapy or in combination with pembrolizumab [[1]]. In terms of overall response, disease stabilization was observed in 4 of 18 patients with advanced solid tumors receiving BT-001, and tumor reduction was observed in 2 of 20 injected lesions [[1]]. Additionally, partial responses were observed in 2 out of 6 patients with advanced solid tumors receiving BT-001 in combination with pembrolizumab, including one patient with PD(L)-1-resistant melanoma and one patient with leiomyosarcoma after five lines of treatment [[1]].
Mechanism of Action
BT-001 is an oncolytic virus that replicates in tumors and expresses its anti-CTLA-4 antibody (mAb) payload with rare and sporadic dissemination, in line with translational data [[1]]. The oncolytic virus approach has shown promise in eliciting a strong immune response, enhanced by the local expression of the anti-immune checkpoint inhibitor antibody CTLA-4 and the cytokine GM-CSF [[1]].
Expert Insights
Dr. Stéphane Champiat, Medical Oncologist at Gustave Roussy, commented: “Many cancer patients do not respond to existing treatments, which underlines the significant need for new approaches. BT-001 is a potentially very promising new immunotherapy that elicits a strong immune response, enhanced by the local expression of the anti-immune checkpoint inhibitor antibody CTLA-4 and the cytokine GM-CSF. The first clinical data from this study provide an important proof of principle and demonstrate the relevance of this oncolytic virus approach [[1]].”
Dr. Alessandro Riva, Chairman and Chief Executive Officer of Transgene, added: “The promising initial clinical results from the ongoing Phase I/IIa clinical study evaluating BT-001 demonstrate its full potential. Within Transgene’s portfolio of oncolytic viruses, it further confirms the ability of our invir.IO(R) platform to generate tumor-specific targeted immunotherapies. BT-001 shows preliminary efficacy without dose-limiting toxicity, both as a monotherapy and in combination with pembrolizumab, while modulating the tumor microenvironment [[1]].”
Previous Studies
Earlier this year, Transgene reported favorable results from the Phase Ia trial of BT-001, with the oncolytic virus showing promising activity in advanced solid tumors [[3]]. The results demonstrated that BT-001 was able to stabilize lesions in 11 patients, with an objective antitumor activity defined by a reduction in tumor size [[3]].
About Transgene
Transgene is a biotechnology company that designs and develops viral-based cancer immunotherapies [[2]]. The company’s portfolio includes a range of oncolytic viruses, including BT-001, which is being developed in collaboration with BioInvent International AB.
the promising clinical results from the Phase I trial of BT-001 suggest that this oncolytic virus may offer a new and effective treatment option for patients with advanced solid tumors. As the study continues, further results are eagerly anticipated to confirm the potential of BT-001 in the treatment of cancer.
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