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Pipeline
iOnctura is developing a pipeline of next generation, differentiated molecules that are at the forefront of pioneering new therapies for the treatment of cancer.
Target Product Candidate Indication Development Phase ABCDEFPreclinicalIND Enabling StudiesCTA/IND SubmissionPhase IPhase Ib/IIPhase II/IIIPI3Kδ IOA-244 Selected Solid Tumors Phase Ib/IINon-Hodgkin's Lymphoma Phase IAutotaxin IOA-289 Selected Solid Tumors Phase ICD73 IOA-237 Selected Solid Tumors PreclinicalIOA-244
Target Indication Development Phase PreclinicalIND Enabling StudiesCTA/IND SubmissionPhase IPhase Ib/IIPhase II/IIIPI3Kδ Selected Solid Tumors Phase Ib/IINon-Hodgkin's Lymphoma Phase IIOA-289
Target Indication Development Phase PreclinicalIND Enabling StudiesCTA/IND SubmissionPhase IPhase Ib/IIPhase II/IIIAutotaxin Selected Solid Tumors Phase IIOA-237
Target Indication Development Phase PreclinicalIND Enabling StudiesCTA/IND SubmissionPhase IPhase Ib/IIPhase II/IIICD73 Selected Solid Tumors PreclinalIOA-244 (PI3Kδ Inhibitor)
Indication Combination Agent Development Phase PreclinicalIND Enabling StudiesCTA/IND SubmissionPhase IPhase Ib/IIPhase II/IIICombination Partners Cutaneous Melanoma N Preclinical— Y Phase Ib/II— Uveal Melanoma N IND Enabling Studies - Fast Track— Mesothelioma Y Phase Ib/II— Y CTA/IND Submission— Myelofibrosis N Phase II/III— NSCLC Y Phase Ib/II— Y Phase Ib/II— Non-Hodgkin's Lymphoma N Phase Ib/II - Fast Track— Y Phase Ib/II— Y Phase Ib/II— IOA-289 (Autotaxin Inhibitor)
Indication Combination Agent Development Phase ABCDEFPreclinicalIND Enabling StudiesCTA/IND SubmissionPhase IPhase Ib/IIPhase II/IIICombination Partners Pancreatic Cancer N Phase Ib/II— Y Phase Ib/II— Myelofibrosis Y Phase Ib/II— IOA-237 (CD73 Inhibitor)
Indication Combination Agent Development Phase PreclinicalIND Enabling StudiesCTA/IND SubmissionPhase IPhase Ib/IIPhase II/IIICombination Partners Solid Tumors N Phase Ib/II— IOA-359 (Undisclosed Target)
Indication Combination Agent Development Phase PreclinicalIND Enabling StudiesCTA/IND SubmissionPhase IPhase Ib/IIPhase II/IIICombination Partners Solid Tumors N Phase Ib/II— Each of iOnctura’s programs target core mechanisms of resistance and relapse at the tumor-stroma-immune interface.
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IOA-244
The only semi-allosteric PI3Kδ inhibitor, with a unique chemical structure and binding mode
IOA-244 is currently in Phase I/II clinical development in indications burdened by immune mediated resistance and a high intrinsic expression of PI3Kδ in both the cancer cells and in the tumor immune landscape.
The phosphatidylinositol 3-kinase (PI3K) signalling pathway is one of the most dysregulated pathways in cancer. We are developing a novel PI3Kδ inhibitor (IOA-244) with exquisite selectivity over PI3Kγ, translating into a new first in class mechanism in solid tumors and a class-leading safety and PK profile.
IOA-244 is an orally dosed molecule that modifies the balance of immune cells to harness a natural and sustained anti-tumor response.
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IOA-289
The only Autotaxin inhibitor being developed in oncology
IOA-289 is currently in a Phase Ia healthy volunteer study and is being developed as a first-in-class therapy for indications that over express ATX and are burdened with by stroma mediated resistance.
Autotaxin (ATX) is an extracellular enzyme that generates lysophosphatidic acid (LPA). LPA is a bioactive phospholipid that stimulates the proliferation, migration and survival of many cell types and has been implicated in a wide range of diseases, including cancer. We are developing a novel ATX inhibitor (IOA-289) with superior potency compared to clinical-stage ATX inhibitors.
IOA-289 is an orally dosed molecule that inhibits the growth and proliferation of cancer cells, stimulates immune cell infiltration into tumors and inhibits the development of fibrosis.
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IOA-237
The immune modifying mAb with combination potential
IOA-237 is in preclinical studies and is being developed as a combination therapy with IOA-244 and IOA-289 in indications burdened by stroma and immune mediated resistance.
CD73 is an enzyme that generates adenosine. Adenosine is a potent immunosuppressive factor contributing to tumor growth and survival. We are developing a selective CD73 monoclonal antibody (IOA-237) that has superior potency on cell surface and soluble CD73 compared to clinical stage competitors.
IOA-237 is a fully human mAb that disrupts CD73-mediated adenosine production. It is cross-reactive to mouse and human CD73, enabling a rapid development pathway.
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Clinical trials
IOA-244-101 STUDY NCT04328844
IOA-244-101 is a Phase 1a/1b, open label, dose escalation and expansion multicentre study of IOA-244, an orally bioavailable, selective PI3Kδ inhibitor in patients with metastatic Uveal Melanoma, Cutaneous Melanoma and Mesothelioma. This is a two-part First-in-Human study in approximately 60 participants, where Part A is a dose-escalation study with IOA-244 and Part B is a dose-expansion in parallel cohorts.
The dose-escalation phase (Part A) evaluates the safety and tolerability of IOA-244 as monotherapy and documents preliminary signs of clinical efficacy of IOA-244 as single agent.
The dose-expansion phase (Part B) evaluates the safety and tolerability of IOA-244 as monotherapy at the biological effective dose and in combination with pemetrexed/cisplatin. Preliminary signs of clinical efficacy including overall response rate [ORR], progression-free survival [PFS], duration of response [DOR] and overall survival [OS] will be evaluated.
Additional study information can be found on clinicaltrials.gov
IOA-289-101 STUDY NCT05027568IOA-289-101 is a Phase 1a randomized, double-blind, placebo-controlled, dose escalation study for the assessment of safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses (SAD) of IOA-289, an orally bioavailable, selective ATX inhibitor, approximately Healthy Volunteers.
Additional study information can be found on clinicaltrials.gov
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Publications
- Poster presentation at ESMO-IO 2021 (8-11 December 2021) entitled “Translating a novel autotaxin inhibitor from preclinical proof of concept in pancreatic cancer to a biomarker response in human subjects”. View
- Poster presentation at ESMO-IO 2021 (8-11 December 2021) entitled “First-in-human (FIH), pharmacokinetic (PK) and pharmacodynamic (PD) study of IOA-244, a phosphoinositide 3-kinase delta (PI3Kδ) inhibitor, in patients with advanced metastatic mesothelioma, uveal and cutaneous melanoma”. View
- "Autotaxin impedes anti-tumor immunity by suppressing chemotaxis and tumor infiltration of CD8+ T cells". Cell Reports 37, 110013, November 16, 2021. View
- Poster presentation at SITC 2021 (10-14 November 2021) entitled “A novel autotaxin inhibitor, IOA-289, modulates tumor, immune and stromal cell function and has monotherapy activity in fibrotic cancer models”. View
- Poster presentation at ATS 2021 (14-19 May 2021) entitled “IOA-289 - a Novel, Clinical Stage Autotaxin Inhibitor for the Treatment of Fibrotic Lung Disease”. View
- Poster presentation at AACR 2021 (10-15 April 2021) entitled “IOA-237 - A potent anti-CD73 mAb demonstrates monotherapeutic and combination efficacy in solid tumour models”. View
- Poster presentation at ICCS 2020 (27-31 July 2020) entitled “The modulatory effects of a PI3Kδ specific small molecule inhibitor (IOA-244) on basophil degranulation measured by flow cytometry”. View
- Poster presentation at AACR 2020 Virtual Meeting II (22-24 June 2020) entitled “Characterisation of novel CD73 antibodies as a therapeutic method of adenosine regulation”. View
- Poster presentation at AACR 2020 Virtual Meeting II (22-24 June 2020) entitled “A novel, highly selective PI3Kδ inhibitor for the treatment of solid malignancies that express high levels of target protein as assessed by immunohistochemistry”. View
- Poster Presentation at MAP 2019 (7-9 November 2019, London, UK) entitled “Preclinical development of a novel, highly selective PI3Kδ inhibitor, IOA-244 for the treatment of solid malignancies”. View
- Oral Presentation at the PI3K/PTEN pathway: from basic science to clinical translation (18-20 July 2019, Bruxton UK) entitled “Preclinical development of a novel, highly selective PI3Kδ inhibitor, IOA-244, for the treatment of solid malignancies”. View
- Poster Presentation at FASEB 2019 (July 7-12, 2019, Lisbon, Portugal) entitled “Autotaxin as an emerging target in immunotherapy”. View
- Oral Presentation at 3rd Annual Next-Gen Immuno-Oncology Congress (14-15 March 2019, London, UK) entitled “PI3Kδ: A New Era in Immuno-Oncology”. View
- Oral Presentation at AACR 2019 (29 March - 3 April 2019, Atlanta, USA) entitled “Preclinical development of a novel, highly selective PI3Kδ inhibitor, IOA-244, for the treatment of solid malignancies”. View
- Oral Presentation at 4th Annual ICI Europe (27-29 November 2018, Berlin, DE) entitled “PI3Kδ: A New Era in Immuno-Oncology”. View
- Poster presentation at ECI 2018 (2-5 September 2018, Amsterdam NL) entitled “Characterisation of novel CD73 antibodies as a therapeutic method of adenosine regulation”. View
