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Poster Discussion – Developmental therapeutics

6587 - Immune activation with a novel immune switch anti-macrophage antibody (anti-Clever-1 mAb; FP-1305) in phase I/II first-in-human MATINS trial in patients with advanced solid tumors

Date

28 Sep 2019

Session

Poster Discussion – Developmental therapeutics

Presenters

Petri Bono

Citation

Annals of Oncology (2019) 30 (suppl_5): v851-v934. 10.1093/annonc/mdz394

Authors

P. Bono1, M. Hollmen2, P. Jaakkola3, S. Shetty4, A. Thibault5, M.J.A. de Jonge6, A.R. Minchom7, Y.T. Ma4, C. Yap8, D. Robbrecht6, A. Pasanen3, S. Jalkanen2, R. Cruz5, A. Pal7, M.K. Karvonen9, J. Mandelin10, J. Koivunen11

Author affiliations

  • 1 Terveystalo Finland, Terveystalo Helsinki Kamppi, 00100 - Helsinki/FI
  • 2 Medicity Research Laboratory, University of Turku, 20520 - Turku/FI
  • 3 Comprehensive Cancer Center, Helsinki University Central Hospital (HUCH), Helsinki/FI
  • 4 Institute Of Immunology And Immunotherapy, University of Birmingham, Birmingham/GB
  • 5 Simbec-orion, Simbec-Orion Group Limited, Slough/GB
  • 6 Erasmus University Medical Center, Erasmus MC Daniel den Hoed Cancer Center, 3075EA - Rotterdam/NL
  • 7 Drug Development Unit, The Institute of Cancer Research/Royal Marsden NHS Foundation Trust, SM2 5PT - Sutton/GB
  • 8 Icr Clinical Trials And Statistics Unit, The Institute of Cancer Research, London, United Kingdom, London/GB
  • 9 Medical, Faron Pharmaceuticals Ltd, Turku/FI
  • 10 Preclinical Development, Faron Pharmaceuticals Ltd, 20520 - Turku/FI
  • 11 Department Of Oncology, Oulu University Hospital, Oulu/FI

Resources

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Abstract 6587

Background

CLEVER-1 is a scavenger receptor that is highly expressed on tumor associated macrophages (TAMs) and mediates the clearance of “unwanted” self-components. Pre-clinical studies demonstrate that CLEVER-1 inhibition switches TAMs to a pro-inflammatory phenotype and reactivates CD8+ T-cell responses with a robust anti-tumour activity (Viitala et al. Clin Cancer Res 2019). Targeting CLEVER-1 could overcome the immunosuppressive tumour microenvironment and has led to the development of FP-1305, a humanized anti-CLEVER-1 IgG4-antibody.

Methods

MATINS (Macrophage Antibody To INhibit immune Suppression) trial is a multicenter first-in-human phase I/II study (NCT03733990) to assess the tolerability, safety and preliminary efficacy of FP-1305 in patients (pts) with advanced, IO-refractory melanoma, cholangiocarcinoma, hepatocellular, colorectal, and pancreatic ductal adenocarcinoma (PDAC)

Results

11 pts (median age 57) were enrolled in four cohorts (0.3, 1.0, 3.0 or 10 mg/kg) and received 1-8 cycles (median 3) of FP-1305 every three weeks. FP-1305 has been well tolerated without dose-limiting toxicities. Most frequent treatment-emergent adverse events (AEs; ≥20%) were fatigue and raised ALT and AST levels. Initial FP-1305 dosing led to an increase in blood NK cells (median 154 %), CD8+/CD4+ T cell ratio (median 121 %), B cells (median 143 %) and a decrease in regulatory T cells (median 65 % from baseline). Clinical benefits have been observed in two colorectal cancer pts. One with an ongoing partial response (-52%) and another with disease stabilization along with a decline in Carcinoembryonic antigen (CEA). The updated safety and efficacy results will be reported.

Conclusions

FP-1305 is the first macrophage checkpoint candidate promoting immune switch with promising tolerability and clinical anti-tumor activity. Analysis of circulating immune cells after administration of FP-1305 demonstrates Th1 activation as well as mobilization of NK cells and B cells.

Clinical trial identification

EudraCT: 2018-002732-24 (obtained 09 Jul 2018).

Editorial acknowledgement

Legal entity responsible for the study

Faron Pharmaceuticals Ltd.

Funding

Faron Pharmaceuticals Ltd.

Disclosure

P. Bono: Full / Part-time employment, Employment: Terveystalo; Advisory / Consultancy, Shareholder / Stockholder / Stock options, Stock owenership and Scientific Board member: TILT Biotherapeutics; Spouse / Financial dependant, Family member’s stock ownereship: Faron pharmaceuticals; Advisory / Consultancy: Faron pharmaceuticals; Advisory / Consultancy, Scientific Board member: Oncorena; Advisory / Consultancy: Pfizer; Advisory / Consultancy: BMS; Advisory / Consultancy: MSD; Advisory / Consultancy: Orion Pharma; Advisory / Consultancy: Ipsen ; Honoraria (self), Data safety monitoring Board member: Herantis Pharma. M. Hollmen: Advisory / Consultancy, Shareholder / Stockholder / Stock options, patent holder: faron pharmaceuticals. P. Jaakkola: Advisory / Consultancy: Faron Pharmaceuticals. S. Shetty: Advisory / Consultancy: Faron Pharmaceuticals. A. Thibault: Full / Part-time employment: Simbec-Orion. M.J.A. de Jonge: Advisory / Consultancy: Faron Pharmaceuticals. A.R. Minchom: Advisory / Consultancy: Faron Pharmaceuticals. Y.T. Ma: Advisory / Consultancy: Faron Pharmaceuticals. C. Yap: Advisory / Consultancy: Faron Pharmaceuticals. D. Robbrecht: Advisory / Consultancy: Faron Pharmaceuticals. S. Jalkanen: Shareholder / Stockholder / Stock options: Faron Pharmaceuticals. M.K. Karvonen: Shareholder / Stockholder / Stock options, Full / Part-time employment: Faron Pharmaceuticals. J. Mandelin: Shareholder / Stockholder / Stock options, Full / Part-time employment: Faron Pharmaceuticals. J. Koivunen: Advisory / Consultancy: Novartis; Advisory / Consultancy: Pfizer; Advisory / Consultancy: AstraZeneza; Advisory / Consultancy: Boehringer Ingelheim; Advisory / Consultancy: KaikuHealth; Research grant / Funding (self): Roche. All other authors have declared no conflicts of interest.

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