Transgene Stories Enterprise Replace And Q3 2022 Monetary Place

• Optimistic end result from interim evaluation and discount of the scale of the Section II trial evaluating TG4001 + avelumab vs avelumab in HPV-positive anogenital cancers

• Optimistic scientific knowledge on TG4050 have been introduced throughout a R&D Day in Sept. 2022

• €36.3 million in money and money equivalents as of September 30, 2022

• Monetary visibility till the tip of 2023

STRASBOURG, France, November 07, 2022–(BUSINESS WIRE)–Regulatory Information:

Transgene (Euronext Paris: TNG) (Paris:TNG), a biotech firm that designs and develops virus-based immunotherapies for the therapy of most cancers, right now pronounces its enterprise replace and its monetary place for the quarter ending September 30, 2022.

Optimistic end result from interim evaluation of Section II trial evaluating TG4001 + avelumab vs avelumab in HPV-positive anogenital cancers

On November 2, 2022, Transgene introduced that following a prespecified interim evaluation of its randomized, managed Section II scientific research evaluating TG4001 together with avelumab to avelumab alone in sufferers with HPV16-positive anogenital tumors (NCT: 03260023), the Impartial Information Monitoring Committee (IDMC) has really useful the research continues.

Based mostly on progression-free survival (PFS) and optimistic efficacy indicators noticed within the interim evaluation, the trial is now anticipated to enroll a complete of 120 sufferers in comparison with the preliminary forecast of 150 sufferers. Transgene anticipates the final affected person to be randomized within the trial in H1 2024. Ultimate outcomes might be communicated subsequently when they’re out there.

Ultimate optimistic outcomes from this trial would permit Transgene to launch a registration trial to additional affirm the advantage of its therapeutic vaccine. TG4001 goals at bringing a brand new resolution to sufferers who at the moment have very restricted therapy choices.

The optimistic interim evaluation end result highlights the potential of Transgene’s platform of therapeutic vaccines primarily based on the MVA viral vector. Alongside TG4001, Transgene can also be growing TG4050, an individualized, MVA-based therapeutic vaccine. TG4050 is at the moment being evaluated in two Section I trials and has additionally delivered preliminary optimistic knowledge, together with in a randomized trial (see under).

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Key occasions of the third quarter 2022 and anticipated information circulate

Throughout an R&D day, held on September 27, 2022, Transgene’s administration workforce, main clinicians and scientists from all over the world, supplied insights on TG4001, TG4050 and the progress of the Invir.IO™ platform.

TG4001: New optimistic scientific knowledge from earlier trial in HPV16+ most cancers sufferers

In a earlier single-arm Section Ib/II, Transgene generated robust scientific knowledge in superior HPV16-positive most cancers sufferers who acquired TG4001 + avelumab. The Firm additionally recognized a affected person inhabitants that derived elevated profit from the therapy: metastatic sufferers with lesions situated in organs aside from the liver.

In these sufferers, an total response price (ORR) of 32%, a median PFS of 5.6 months and a median total survival (OS) of 13.3 months have been achieved on this earlier trial. These outcomes examine favorably with checkpoint inhibitors administered alone.

The therapy induced HPV16-specific T-cell responses and was related to elevated ranges of immune cell infiltration within the tumors and expression of genes related to activation of the immune system.

The present randomized, managed Section II trial was launched primarily based on these very encouraging knowledge.

TG4050: New updates from the 2 ongoing Section I trials affirm the robust potential of this individualized most cancers vaccine

Within the head and neck most cancers trial, 20 of the 30 deliberate sufferers have been randomized on the finish of August 2022. All 10 evaluable sufferers who instantly acquired vaccination with TG4050 (arm A) stay steady and in full response on the cutoff date. Out of the ten sufferers of the management arm, who’re monitored and didn’t obtain the vaccine (arm B), 3 have skilled relapse.

Within the ovarian most cancers trial (n=5), one affected person handled after an elevation of CA-125 skilled a normalization of CA-125 with out scientific development for 9 months till loss of life from an unrelated power sickness. One other affected person was handled upon onset of radiological proof of relapse and remained steady for 11.4 months.

Thus far, the vaccine has been effectively tolerated and no associated Critical Adversarial Occasions have been reported throughout the 2 research.

Within the two scientific research, enrollment has been accomplished. Enrolled sufferers are being randomized or handled in step with research protocols. Total, Transgene plans to deal with 13 sufferers within the ovarian most cancers trial and 30 sufferers within the head and neck most cancers trial.

Transgene plans to speak an replace on these doubtlessly panorama altering trials at a scientific convention within the first half of 2023.

Important progress on oncolytic viruses, together with knowledge demonstrating the potential of the Invir.IO™ platform oncolytic viruses to be administered intravenously

Transgene introduced a poster on TG6002 on the ESMO congress (September 11, 2022). The Firm mentioned optimistic confirmatory knowledge from the Section I trial evaluating TG6002 administered intravenously (IV) together with oral 5-FC in sufferers with superior gastrointestinal carcinomas. These up to date knowledge generated on 37 sufferers handled on the highest dose ranges of the Section I demonstrated that the remedy is effectively tolerated and confirmed the mechanism of motion of TG6002 administered IV.

These findings help the potential of IV administration of Invir.IO™-based oncolytic viruses, extending using these therapies to a broad vary of stable tumors. Extra knowledge might be produced from the Section I program and might be introduced at a scientific congress within the first half of 2023.

In June 2022, Transgene and BioInvent launched optimistic progress and security knowledge within the ongoing Section I/IIa trial evaluating BT-001 in sufferers with stable tumors. The preliminary knowledge generated within the Section I half A demonstrated that BT-001 alone is effectively tolerated, with first indicators of anti-tumor exercise in a hard-to-treat inhabitants and confirmed the mechanism of motion of BT-001 as a single agent. A scientific collaboration and provide settlement for KEYTRUDA® (pembrolizumab) was signed with MSD (Merck & Co) on the finish of June 2022. The Section Ib a part of the scientific trial (mixture with pembrolizumab) is anticipated to begin within the first half of 2023.

On the R&D day, Transgene launched a novel oncolytic virus vectorizing human IL-12 that has been designed to be administered intravenously. This Invir.IO™ candidate is anticipated to enter scientific improvement in 2023.

AstraZeneca will current a poster at SITC 2022 (November 8–12, 2022), on a assemble that was designed throughout the body of its collaboration with Transgene. The preclinical knowledge that might be introduced spotlight oncolysis and tumor-specific immunity induced by the oncolytic virus.

Abstract of key ongoing scientific trials

Working revenue

Through the first 9 months of 2022, working revenue amounted to €8.4 million in comparison with €6.8 million in the identical interval in 2021.

Income from collaborative and licensing agreements amounted to €3 million within the first 9 months of 2022, in contrast with €1.6 million in the identical interval in 2021. These revenues are primarily derived from Transgene’s collaboration settlement with AstraZeneca on the Invir.IO™ program, whose acknowledged revenue represents €3 million as of September 30, 2022. Of this quantity, €0.5 million displays recognition of the preliminary fee for work carried out throughout the interval and €2.5 million in respect of the provision of candidates and the efficiency of R&D companies.

Through the first 9 months of 2022, authorities financing for analysis expenditures, primarily within the type of a analysis tax credit score, amounted to €5.2 million, in comparison with €4.9 million for a similar interval in 2021.

Money, money equivalents and different monetary property

Money, money equivalents and different monetary property stood at €36.3 million as of September 30, 2022, in comparison with €49.6 million as of December 31, 2021. Within the first 9 months of 2022, Transgene’s money burn amounted to €13.3 million (together with the receipt of an $8 million fee for the primary license choice exercised by AstraZeneca finish of 2021) in comparison with a money burn of €18.7 million for a similar interval in 2021 (excluding capital enhance).

Transgene has monetary visibility till the tip of 2023.

Publish-closing occasion

On October 11, 2022, Transgene notified Tasly Holding Group and its subsidiary Tianjin Fuhade Know-how Growth Co. the train of its choice underneath the Tasly BioPharmaceuticals Shareholder Settlement, requiring them to repurchase Transgene’s stake in Tasly BioPharmaceuticals.

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About Transgene

Transgene (Euronext: TNG) is a biotechnology firm centered on designing and growing focused immunotherapies for the therapy of most cancers. Transgene’s applications make the most of viral vector know-how with the aim of not directly or immediately killing most cancers cells.

The Firm’s clinical-stage applications include two therapeutic vaccines (TG4001 for the therapy of HPV-positive cancers, and TG4050, the primary individualized therapeutic vaccine primarily based on the myvac® platform) in addition to two oncolytic viruses (TG6002 for the therapy of stable tumors, and BT-001, the primary oncolytic virus primarily based on the Invir.IO™ platform).

With Transgene’s myvac® platform, therapeutic vaccination enters the sphere of precision drugs with a novel immunotherapy that’s totally tailor-made to every particular person. The myvac® strategy permits the era of a virus-based immunotherapy that encodes patient-specific mutations recognized and chosen by Synthetic Intelligence capabilities supplied by its companion NEC.

With its proprietary platform Invir.IO™, Transgene is constructing on its viral vector engineering experience to design a brand new era of multifunctional oncolytic viruses. Transgene has an ongoing Invir.IO™ collaboration with AstraZeneca.

Extra details about Transgene is out there at: www.transgene.fr

Observe us on Twitter: @TransgeneSA

Disclaimer

This press launch comprises forward-looking statements, that are topic to quite a few dangers and uncertainties, which may trigger precise outcomes to vary materially from these anticipated. The incidence of any of those dangers may have a big damaging final result for the Firm’s actions, views, monetary state of affairs, outcomes, regulatory authorities’ settlement with improvement phases, and improvement. The Firm’s capability to commercialize its merchandise is determined by however is just not restricted to the next elements: optimistic pre-clinical knowledge is probably not predictive of human scientific outcomes, the success of scientific research, the flexibility to acquire financing and/or partnerships for product manufacturing, improvement and commercialization, and advertising and marketing approval by authorities regulatory authorities. For a dialogue of dangers and uncertainties which may trigger the Firm’s precise outcomes, monetary situation, efficiency or achievements to vary from these contained within the forward-looking statements, please seek advice from the Danger Elements (“Facteurs de Risque”) part of the Common Registration Doc, out there on the AMF web site (http://www.amf-france.org) or on Transgene’s web site (www.transgene.fr). Ahead-looking statements communicate solely as of the date on which they’re made, and Transgene undertakes no obligation to replace these forward-looking statements, even when new info turns into out there sooner or later.

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Contacts

Transgene:
Lucie Larguier
Director Company Communications & IR
+33 (0)3 88 27 91 04
investorrelations@transgene.fr

Media: MEDiSTRAVA Consulting
David Dible/Sylvie Berrebi/George Underwood
+44 (0)203 928 6900
transgene@medistrava.com