\nRegulatory News:\n<\/p>\n
Transgene (Paris:TNG) (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer<\/strong>, and BioInvent International AB<\/b>(\u201cBioInvent\u201d) (OMXS: BINV)<\/b>, a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, today announced they have received regulatory approval in Belgium for a clinical trial application (CTA) for a Phase 1\/2a study of the novel oncolytic Vaccinia virus<\/i> BT-001.<\/b><\/p>\n BT-001 is a best-in-class oncolytic Vaccinia virus. <\/i>It has been generated using Transgene\u2019s Invir.IO\u2122 platform and its patented large-capacity VVcop<\/sub>TK–<\/sup>RR– <\/sup>oncolytic virus, which has been engineered to encode both a Treg-depleting human recombinant anti-CTLA4 antibody generated by BioInvent\u2019s proprietary n-CoDeR\u00ae\/F.I.R.S.T\u2122 platforms, and the human GM-CSF cytokine.<\/b> By selectively targeting the tumor microenvironment, BT-001 is expected to elicit a much stronger and more effective antitumoral response. Delivering the anti-CTLA4 antibody directly to the tumor microenvironment will allow a local therapeutic activity and will thus greatly increase the safety and tolerability profile of the monoclonal antibody by reducing systemic exposure. BT-001 is being co-developed through a 50\/50 collaboration between BioInvent and Transgene.\n<\/p>\n Philippe Archinard, PhD, Chairman and CEO of Transgene<\/b>, said: \u201cWe are pleased that we have received a first approval to initiate the Phase 1\/2a trial of BT-001. This oncolytic virus has induced long-lasting antitumor immune responses and abscopal effects in several tumor models, and its activity is further enhanced through combination with an anti-PD-1 antibody treatment. Thanks to its unique mode of action and the results seen so far, we believe it has the potential to make a significant difference to cancer patients.\u201d<\/i><\/p>\n \n\u201cThis clinical trial approval sets the stage to further broaden BioInvent\u2019s promising clinical pipeline. BT-001 will soon be our fourth product in clinical development. We are very excited to move forward this unique oncolytic virus which combines multiple, clinically proven mechanisms of action into a single drug. This clinical study will allow us to test BT-001\u2019s potential to treat a range of solid cancer indications. Regulatory approval of this agent demonstrates the excellent performance of our teams.<\/i>\u201d added Martin Welschof, CEO of BioInvent<\/b>.\n<\/p>\n \nThis multicenter, open-label, dose-escalation Phase 1\/2a trial evaluating BT-001 alone or in combination with pembrolizumab will first be including patients in several countries in Europe and then in the USA. The Phase 1, which is expected to begin within the next few weeks, will be divided into two parts. Part A will enroll up to 36 patients with metastatic\/advanced solid tumors, who have already been pretreated, including with immunotherapies. Patients will receive single agent, intra-tumoral administrations of BT-001, in cutaneous or palpable subcutaneous lesions or easily injectable lymph nodes, to select the recommended dose and best regimen. Part B will explore the combination of intra-tumoral injections of BT-001 with pembrolizumab, an anti-PD1 targeting agent in 12 patients. The Phase 2a will evaluate the combination regiment in several patient cohorts with different tumors types. These expansion cohorts will offer the exciting possibility of exploring the activity of this approach to treat other malignancies not traditionally addressed with this type of treatment.\n<\/p>\n \n***\n<\/p>\n About Transgene About BioInvent Disclaimer – BioInvent Disclaimer Transgene View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20201220005003\/en\/<\/a><\/span><\/p>\n For further information, please contact: \nMedia: Citigate Dewe Rogerson \nMary-Ann Chang, LifeSci Advisors BioInvent: BioInvent International AB (publ) KEYWORDS:<\/b> Europe Sweden France<\/p>\n INDUSTRY KEYWORDS:<\/b> Health Genetics Pharmaceutical Clinical Trials Oncology<\/p>\n
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<\/i><\/b>Transgene (Euronext: TNG) is a publicly traded French biotechnology company focused on designing and developing targeted immunotherapies for the treatment of cancer. Transgene\u2019s programs utilize viral vector technology with the goal of indirectly or directly killing cancer cells.
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The Company\u2019s clinical-stage programs consist of two therapeutic vaccines (TG4001 for the treatment of HPV-positive cancers, and TG4050, the first individualized therapeutic vaccine based on the myvac<\/i>\u00ae platform) as well as two oncolytic viruses (TG6002 for the treatment of solid tumors, and BT-001, the first oncolytic virus based on the Invir.IO\u2122 platform).
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With Transgene\u2019s myvac<\/i>\u00ae platform, therapeutic vaccination enters the field of precision medicine with a novel immunotherapy that is fully tailored to each individual. The myvac<\/i>\u00ae approach allows the generation of a virus-based immunotherapy that encodes patient-specific mutations identified and selected by Artificial Intelligence capabilities provided by its partner NEC.
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With its proprietary platform Invir.IO\u2122, Transgene is building on its viral vector engineering expertise to design a new generation of multifunctional oncolytic viruses. Transgene has an ongoing Invir.IO\u2122 collaboration with AstraZeneca.
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Additional information about Transgene is available at: www.transgene.fr
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Follow us on Twitter: @TransgeneSA<\/a><\/p>\n
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<\/i><\/b>BioInvent International AB (OMXS: BINV) is a clinical stage company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapies, with four programs in clinical development. The Company\u2019s validated, proprietary F.I.R.S.T\u2122 technology platform simultaneously identifies both targets and the antibodies that bind to them, generating many promising new drug candidates to fuel the Company\u2019s own clinical development pipeline or for additional licensing and partnering.
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The Company generates revenues from research collaborations and license agreements with multiple top-tier pharmaceutical companies, as well as from producing antibodies for third parties in the Company\u2019s fully integrated manufacturing unit. More information is available at www.bioinvent.com<\/a>.\n<\/p>\n
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<\/i><\/b>The press release contains statements about the future, consisting of subjective assumptions and forecasts for future scenarios. Predictions for the future only apply as the date they are made and are, by their very nature, in the same way as research and development work in the biotech segment, associated with risk and uncertainty. With this in mind, the actual outcome may deviate significantly from the scenarios described in this press release.<\/i><\/p>\n
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<\/i><\/b>This press release contains forward-looking statements, which are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. There can be no guarantee that (i) the results of pre-clinical work and prior clinical trials will be predictive of the results of the clinical trials currently underway, (ii) regulatory authorities will agree with the Company\u2019s further development plans for its therapies, or (iii) the Company will find development and commercialization partners for its therapies in a timely manner and on satisfactory terms and conditions, if at all. The occurrence of any of these risks could have a significant negative outcome for the Company\u2019s activities, perspectives, financial situation, results and development. For a discussion of risks and uncertainties which could cause the Company\u2019s actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (\u201cFacteurs de Risques\u201d) section of the Universal Registration Document, available on the AMF website (http:\/\/www.amf-france.org<\/a>) or on Transgene\u2019s website (www.transgene.fr<\/a>). Forward-looking statements speak only as of the date on which they are made, and Transgene undertakes no obligation to update these forward-looking statements, even if new information becomes available in the future.<\/i><\/p>\n<\/p>\n
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Transgene:
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Lucie Larguier
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Director Corporate Communications & IR
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+33 (0)3 88 27 91 04
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investorrelations@transgene.fr <\/a><\/p>\n
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David Dible\/Sylvie Berrebi
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+ 44 (0)20 7638 9571
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transgene@citigatedewerogerson.com<\/a><\/p>\n
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+44 7483 284 853
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mchang@lifesciadvisors.com<\/a><\/p>\n
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Martin Welschof, CEO
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+46 (0)46 286 85 50
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martin.welschof@bioinvent.com<\/a><\/p>\n
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Co. Reg. No. Org nr: 556537-7263
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Visiting address: Ideongatan 1
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Mailing address: 223 70 LUND
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Phone: +46 (0)46 286 85 50
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www.bioinvent.com<\/a><\/p>\n
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