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ePoster Display

1032TiP - A phase I, first-in-human, study of TILT-123, a tumor-selective oncolytic adenovirus encoding TNFa and IL-2, in participants with advanced melanoma receiving adoptive T-cell therapy with tumor-infiltrating lymphocytes

Date

16 Sep 2021

Session

ePoster Display

Presenters

Inge-Marie Svane

Citation

Annals of Oncology (2021) 32 (suppl_5): S829-S866. 10.1016/annonc/annonc705

Authors

I. Svane1, J.M. Santos2, V. Cervera-Carrascon2, R. Havunen2, S. Sorsa2, E. Ellebæk1, T. Monberg1, M. Donia1, A. Khammari3, B. Dréno3, A. Hemminki4

Author affiliations

  • 1 Department Of Oncology, National Center for Cancer Immune Therapy (CCIT-DK), Copenhagen University Hospital, 2730 - Herlev/DK
  • 2 Tilt Biotherapeutics Ltd, TILT Biotherapeutics Ltd, 00290 - Helsinki/FI
  • 3 Department Of Dermatology, Cic, CRCINA INSERM, CHU Nantes, Nantes/FR
  • 4 Tilt Biotherapeutics Ltd, TILT Biotherapeutics Ltd, Helsinki/FI
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Abstract 1032TiP

Background

Adoptive T-cell therapy using tumor-infiltrating lymphocytes (TIL) has demonstrated that potent and long-lasting antitumor responses can be achieved with cellular cancer immunotherapy in solid tumor patients. Yet, the therapy yields various toxicities, due to toxic lymphodepleting preconditioning and IL-2 postconditioning. With the intent of decreasing conditioning-related toxicities, while retaining efficacy, we developed TILT-123 (Ad5/3-E2F-D24-hTNFa-IRES-hIL2), a novel oncolytic adenovirus designed to reinvigorate antitumor T-cells. Preclinical data indicates that TILT-123 modulates the tumor milieu, leading to increased activity and trafficking of antitumor T-cells. TILT-123 enhances the efficacy of adoptive T-cell therapy, without conditioning regimens, curing 100% of tumor-bearing test animals and inducing tumor-specific immunological memory. This warrants clinical investigation.

Trial design

An open-label, dose-escalation, phase I clinical trial (NCT04217473) is assessing the safety of the approach in refractory or recurrent stage III/IV melanoma patients, which cannot be treated with curative intent with available therapies and are eligible for TIL therapy. Patients receive TILT-123 intravenously and intratumorally, and TIL therapy without pre- or postconditioning. Patients must have at least one biopsiable/operable tumor for TIL generation and another injectable lesion for intratumoral TILT-123 administration. The primary endpoint of the trial is safety of TILT-123 by day 36 (prior to TIL administration), based on the incidence of serious and non-serious adverse events, vital signs, ECG, and safety laboratory results. Secondary endpoints include evaluation of safety and tolerability for the duration of the trial, antitumor efficacy, antitumor responses, and biological effects against tumors. Enrollment began in 2020 and, at the time of submission, cohort 1 was completed without DLTs, and cohort 2 enrolment is in progress. Interim safety, efficacy, biological, immunological, and biosafety data will be presented.

Clinical trial identification

NCT04217473.

Editorial acknowledgement

Legal entity responsible for the study

TILT Biotherapeutics Ltd.

Funding

TILT Biotherapeutics Ltd.

Disclosure

I. Svane: Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Writing Engagements: MSD; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Advisory Board: Pierre Fabre; Financial Interests, Personal, Invited Speaker: Pierre Fabre; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Other, Cofounder and Founder Warrents: IO Biotech; Financial Interests, Personal, Stocks/Shares: IO Biotech; Non-Financial Interests, Institutional, Research Grant: Adaptimmune; Non-Financial Interests, Institutional, Research Grant: Enara Bio; Non-Financial Interests, Institutional, Funding: Evaxion; Non-Financial Interests, Institutional, Research Grant: Lytix Biopharma; Non-Financial Interests, Institutional, Research Grant: TILT Biotherapeutics; Non-Financial Interests, Principal Investigator: BMS; Non-Financial Interests, Principal Investigator: Lytix Biopharma; Non-Financial Interests, Principal Investigator: Novartis; Non-Financial Interests, Principal Investigator: Roche; Non-Financial Interests, Principal Investigator: TILT Biotherapeutics. J.M. Santos: Financial Interests, Institutional, Full or part-time Employment: TILT Biotherapeutics Ltd; Financial Interests, Personal, Stocks/Shares: TILT Biotherapeutics Ltd. V. Cervera-Carrascon: Financial Interests, Institutional, Full or part-time Employment: TILT Biotherapeutics Ltd; Financial Interests, Personal, Stocks/Shares: TILT Biotherapeutics Ltd. R. Havunen: Financial Interests, Institutional, Full or part-time Employment: TILT Biotherapeutics Ltd. S. Sorsa: Financial Interests, Institutional, Full or part-time Employment: TILT Biotherapeutics Ltd. E. Ellebæk: Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Invited Speaker: Pierre Fabre; Financial Interests, Personal, Invited Speaker: Kyowa Kirin; Financial Interests, Personal, Other, Travel/conference expenses: MSD. T. Monberg: Non-Financial Interests, Other, Study site coordinator in clinical trial: BMS; Non-Financial Interests, Other, Study site coordinator in clinical trial: Lytix Biopharma. M. Donia: Financial Interests, Personal, Invited Speaker, Teaching: Novartis; Financial Interests, Personal, Invited Speaker, Teaching: Roche; Non-Financial Interests, Other, Sub-investigator of clinical trial with connected translational research: Bristol Myers Squibb. A. Hemminki: Financial Interests, Institutional, Full or part-time Employment, Chief Executive Officer: TILT Biotherapeutics Ltd; Financial Interests, Personal, Other, Founder: TILT Biotherapeutics Ltd; Financial Interests, Institutional, Member of the Board of Directors: TILT Biotherapeutics Ltd; Financial Interests, Personal, Stocks/Shares: Targovax ASA; Financial Interests, Personal, Stocks/Shares: TILT Biotherapeutics Ltd. All other authors have declared no conflicts of interest.

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