IO-108 / Immune-Onc Therap - LARVOL DELTA

Immune-Onc Therapeutics Announces First Patient Dosed with IO-108 in a Randomized Global Phase 1b/2 Study of First-Line Treatment of Advanced Liver Cancer in Clinical Collaboration with Roche (Businesswire) - "Immune-Onc Therapeutics...announced that the first patient has been dosed with IO-108 in a global clinical collaboration with Roche. The Phase 1b/2 trial is designed to evaluate IO-108, a first-in-class antibody targeting LILRB2 (also known as ILT4), in combination with Roche’s atezolizumab and bevacizumab as a potential first-line treatment for patients with locally advanced or metastatic and/or unresectable hepatocellular carcinoma (HCC)....The trial, sponsored by Roche, is expected to enroll 40 patients across 25 sites worldwide in the IO-108-containing arm. This arm will be compared to an active control arm of the atezolizumab and bevacizumab combination."

Trial status • Hepatocellular Cancer

A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver) (clinicaltrials.gov) - P1/2 | N=518 | Recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Aug 2026 ➔ Dec 2026 | Trial primary completion date: Aug 2026 ➔ Dec 2026

Metastases • Trial completion date • Trial primary completion date • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor • PD-L1

Phase I dose escalation study of IO-108, an anti-LILRB2 antibody, in patients with advanced solid tumors. (PubMed, J Immunother Cancer) - P1 | "IO-108 is well tolerated and has led to objective response as monotherapy and in combination with pembrolizumab. The complete response and the pharmacodynamic changes in the monotherapy cohort demonstrate single agent activity of IO-108 and provide proof of concept that targeting myeloid-suppressive pathways through LILRB2 inhibition may potentiate the clinical efficacy of anti-PD-1 immune checkpoint inhibitors."

IO biomarker • Journal • Metastases • P1 data • Merkel Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor

Immune-Onc Therapeutics Announces Positive Results from Phase 1 Dose Escalation Study of IO-108 in Advanced Solid Tumors Published in the Journal for ImmunoTherapy of Cancer (Firstwordpharma Press Release) - P1 | N=91 | NCT05054348 | Sponsor: Immune-Onc Therapeutics | "Immune-Onc Therapeutics...today announced the publication of Phase 1 dose-escalation study results of IO-108, its first-in-class antibody targeting LILRB2 (also known as ILT4), in the Journal for ImmunoTherapy of Cancer (JITC), the peer-reviewed, online journal of the Society for Immunotherapy of Cancer (SITC)....In the IO-108 monotherapy cohort, the overall response rate was 9%, with one patient achieving a durable complete response (CR) for over two years. The CR was observed in a patient with treatment-refractory Merkel cell carcinoma whose prior treatment included two lines of immunotherapy (pembrolizumab, followed by a combination of nivolumab (anti-PD-1) and ipilimumab (anti-CTLA-4))."

P1 data • Solid Tumor

First-in-human Study of IO-108 as Single Agent and in Combination With a PD-1 Immune Check Point Inhibitor in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=91 | Completed | Sponsor: Immune-Onc Therapeutics | Active, not recruiting ➔ Completed | N=309 ➔ 91

Combination therapy • Enrollment change • Metastases • Monotherapy • Trial completion • Oncology • Solid Tumor

Dose Confirmation and Dose Expansion Phase 1 Study of IO-108 and IO-108 + Anti-PD-1 in Solid Tumors (clinicaltrials.gov) - P1 | N=38 | Completed | Sponsor: Immune-Onc Therapeutics | Recruiting ➔ Completed | N=89 ➔ 38

Enrollment change • Trial completion • Oncology • Solid Tumor

First-in-human Study of IO-108 as Single Agent and in Combination With a PD-1 Immune Check Point Inhibitor in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=309 | Active, not recruiting | Sponsor: Immune-Onc Therapeutics | Phase classification: P1b ➔ P1 | Trial completion date: Dec 2024 ➔ Apr 2024 | Trial primary completion date: Dec 2023 ➔ Mar 2024

Combination therapy • Metastases • Monotherapy • Phase classification • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Immune-Onc Therapeutics Announces Clinical Trial Collaboration to Evaluate IO-108 in a Randomized Global Phase 1b/2 Study for First-Line Treatment of Advanced Liver Cancer (Businesswire) - "Immune-Onc Therapeutics...announced a Phase 1b/2 clinical trial collaboration with Roche to evaluate Immune-Onc’s IO-108, a first-in-class antibody targeting LILRB2 (also known as ILT4), in combination with Roche’s atezolizumab and bevacizumab for the first-line treatment of patients with locally advanced or metastatic and/or unresectable hepatocellular carcinoma (HCC)....Under the collaboration, Roche will sponsor and conduct the global, randomized Phase 1b/2 trial to evaluate the safety, efficacy and pharmacodynamics of IO-108 in combination with atezolizumab and bevacizumab compared to atezolizumab and bevacizumab....Initially, 40 patients will be enrolled across 25 sites worldwide in the IO-108 triplet combination....Under the terms of the clinical collaboration agreement, Roche will manage the study operations, and Immune-Onc will supply IO-108 to support the trial while retaining global rights to IO-108."

Licensing / partnership • New P1/2 trial • Hepatocellular Cancer

First-in-human Study of IO-108 as Single Agent and in Combination With a PD-1 Immune Check Point Inhibitor in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1b | N=309 | Active, not recruiting | Sponsor: Immune-Onc Therapeutics | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Metastases • Monotherapy • Oncology • Solid Tumor

Novel Myeloid Checkpoint Inhibitors Targeting the LILRB (ILT) Family Members (PEGS 2023) - "These include IO-108, an antagonist antibody targeting LILRB2 (ILT4), in Phase I clinical development for solid tumors and IO-202; an antagonist antibody targeting LILRB4 (ILT3), in Phase I clinical development for the treatment of acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), and solid tumors. Additional assets in Immune-Onc’s pipeline include IO-106, a first-in-class antagonist antibody targeting LAIR1; IO-312, a novel bispecific antibody targeting LILRB4 and CD3 (LILRB4 x CD3); and multiple undisclosed programs."

Checkpoint inhibition • Acute Myelogenous Leukemia • Chronic Myelomonocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • Solid Tumor • LAIR1 • LILRB4

Taylor Highlights Safety and Efficacy of IgG4 Monoclonal Antibody IO-108 in Advanced Solid Tumors (OncLive) - P1 | N=309 | NCT05054348 | Sponsor: Immune-Onc Therapeutics | "As of the March 13, 2023, data cutoff, 1 patient with Merkel cell carcinoma achieved a complete response (CR). Additionally, 36.4% vs 30.8% of patients had stable disease in the monotherapy and combination arms, respectively, and 54.5% vs 46.1% of patients had disease progression....Any-grade treatment-related adverse events (AEs) occurred at rates of 50.0% in the monotherapy group and 46.2% in the combination arm, including grade 1/2 pruritus, myalgia, and diarrhea."

P1 data • Oncology • Solid Tumor

A first-in-human phase 1 trial of IO-108, an antagonist antibody targeting LILRB2 (ILT4), as monotherapy and in combination with pembrolizumab in adult patients with advanced relapsed or refractory solid tumors: Dose escalation study (AACR 2023) - P1b | "The initial encouraging data support further development of IO-108, both as monotherapy and in combination with anti-PD-(L)1 for patients with advanced solid tumors."

Clinical • Combination therapy • IO biomarker • Metastases • Monotherapy • P1 data • Biliary Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Merkel Cell Carcinoma • Neuroendocrine Tumor • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor

Immune-Onc Therapeutics to Present Encouraging Phase 1 Data for IO-108 at AACR Annual Meeting 2023 (Businesswire) - P1b | N=309 | NCT05054348 | Sponsor: Immune-Onc Therapeutics | "Immune-Onc Therapeutics...announced encouraging Phase 1 dose escalation data for IO-108, a novel myeloid checkpoint inhibitor targeting Leukocyte Immunoglobulin-Like Receptor B2 (LILRB2, also known as ILT4). The data will be presented in an oral session at the American Association for Cancer Research (AACR) Annual Meeting....Preclinical data for IO-312, a novel bispecific antibody targeting LILRB4 (ILT3) and CD3 (LILRB4 x CD3) will also be presented on April 18 as a late-breaking poster at AACR 2023....The trial enrolled 25 advanced cancer patients with relapsed/refractory solid tumors....Among 23 evaluable patients (11 monotherapy, 12 combination therapy plus 1 crossover), results showed 1 complete response and 4 stable disease patients in the monotherapy cohorts and 3 partial responses and 4 stable disease patients in the combination cohorts."

Late-breaking abstract • P1 data • Preclinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • Solid Tumor

Immune-Onc Therapeutics to Present Encouraging Phase 1 Data for IO-108 at AACR Annual Meeting 2023 (Businesswire) - "'Treating patients who are refractory to treatment with T-cell immune checkpoint inhibitors remains an ongoing challenge across many tumor types,' said IO-108 Phase 1 investigator, Matthew H. Taylor, M.D..."

Media quote

Immune-Onc Therapeutics Announces IO-108 Phase I Clinical Trial Results Selected for Oral Presentation at AACR Annual Meeting 2023 (Businesswire) - P1 | N=309 | NCT05054348 | Sponsor | Immune-Onc Therapeutics | "Immune-Onc Therapeutics...announced that Phase 1 dose escalation data for IO-108, a novel myeloid checkpoint inhibitor targeting Leukocyte Immunoglobulin-Like Receptor B2 (LILRB2, also known as ILT4) is selected for oral presentation at the American Association for Cancer Research (AACR) Annual Meeting being held April 14 - 19, 2023 in Orlando, Florida. In addition, preclinical data for IO-312, a novel bispecific antibody targeting LILRB4 (ILT3) and CD3 (LILRB4 x CD3) will be presented as a late-breaking poster at AACR 2023."

P1 data • Preclinical • Oncology • Solid Tumor

IO-108, A fully human therapeutic antibody blocking the myeloid checkpoint LILRB2/ILT4, promotes innate and adaptive anti-cancer immunity in preclinical studies (AACR 2022) - P1 | "Importantly, IO-108 presents a favorable pharmacokinetic and safety profile in preclinical models. Collectively, the preclinical characterization of IO-108 enabled a comprehensive clinical biomarker plan and lends rationale to the clinical study (NCT05054348) of IO-108 as a novel immunotherapy for multiple solid tumor types, including those relapsed/refractory to standard of care therapies."

IO biomarker • Preclinical • Oncology • Ovarian Cancer • Solid Tumor • CD4 • STING

Phase 1b Study of IO-108 as Monotherapy and in Combination With a PD-1 Inhibitor in Solid Tumors (clinicaltrials.gov) - P1b | N=309 | Recruiting | Sponsor: Immune-Onc Therapeutics | Phase classification: P1 ➔ P1b | N=36 ➔ 309 | Trial completion date: Nov 2023 ➔ Dec 2024 | Trial primary completion date: May 2022 ➔ Dec 2023

Combination therapy • Enrollment change • Monotherapy • Phase classification • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

A first-in-human phase 1 trial of IO-108, an antagonist antibody targeting LILRB2 (ILT4), as monotherapy and in combination with pembrolizumab in adult patients with advanced relapsed or refractory solid tumors (NCT05054348) (AACR 2022) - P1 | "Response to treatment as assessed by RECIST v1.1 will be tabulated. To date, five patients have been dosed without DLT."

Clinical • Combination therapy • IO biomarker • Monotherapy • P1 data • Oncology • Solid Tumor

Dose Confirmation and Dose Expansion Study of IO-108 and IO-108 + Pembrolizumab in Solid Tumors (clinicaltrials.gov) - P1 | N=89 | Recruiting | Sponsor: Immune-Onc Therapeutics | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Monotherapy • Oncology • Solid Tumor

Immune-Onc Therapeutics Initiates Expansion Cohorts for IO-108 and Enters into Clinical Supply Agreement with Regeneron (Businesswire) - "Immune-Onc Therapeutics, Inc...announced the dosing of the first patient in the expansion cohorts of its ongoing Phase 1 study for IO-108. The Company also entered into a clinical supply agreement with Regeneron Pharmaceuticals, Inc...to evaluate IO-108 in combination with Regeneron’s anti-PD-1 therapy, Libtayo® (cemiplimab), as part of its ongoing clinical development program....The Phase 1 expansion phase includes IO-108 monotherapy cohorts and IO-108 combination cohorts with anti-PD-1 antibodies (pembrolizumab or cemiplimab, depending on tumor types). Under the terms of the agreement, Immune-Onc will sponsor and fund the planned clinical trials and Regeneron will provide cemiplimab (Libtayo®). Immune-Onc retains global development and commercial rights to IO-108."

Licensing / partnership • Trial status • Oncology • Solid Tumor

Immune-Onc Therapeutics Enters into Clinical Collaboration with BeiGene in China (Businesswire) - "Immune-Onc Therapeutics, Inc...announced it has entered into a clinical trial collaboration and supply agreement with BeiGene to evaluate Immune-Onc’s first-in-class myeloid checkpoint inhibitors, IO-108 and IO-202, in combination with BeiGene’s anti-PD-1 antibody, tislelizumab, as part of its clinical development programs in China....Under the terms of the collaboration, Immune-Onc will sponsor and fund the IO-108 and IO-202 clinical trials in China, and BeiGene will provide tislelizumab. Immune-Onc retains global development and commercial rights to IO-108 and IO-202."

Licensing / partnership • Oncology • Solid Tumor

Dose Confirmation and Dose Expansion Study of IO-108 and IO-108 + Pembrolizumab in Solid Tumors (clinicaltrials.gov) - P1 | N=89 | Not yet recruiting | Sponsor: Immune-Onc Therapeutics

Combination therapy • Monotherapy • New P1 trial • Oncology • Solid Tumor

Immune-Onc Therapeutics Announces Appointment of Christopher Whitmore as Chief Financial Officer and Provides Clinical Progress Update (Businesswire) - P1 | N=36 | NCT05054348 | Sponsor: Immune-Onc Therapeutics Inc | "Immune-Onc also announced successful completion of dose escalation in the first-in-human clinical trial (NCT05054348) of IO-108, a novel antagonist antibody targeting the myeloid checkpoint Leukocyte Immunoglobulin-Like Receptor B2 (LILRB2, also known as ILT4), for the treatment of solid tumors...IO-108 has been well-tolerated at up to 1,800 mg, either as a monotherapy or in combination with pembrolizumab, without dose-limiting toxicity so far. Additionally, early signals of clinical activity were observed in multiple tumor types with demonstrated monotherapy efficacy."

P1 data • Trial status • Oncology • Solid Tumor

Immune-Onc Therapeutics to Participate in the Raymond James LILRB/ILT Symposium on Myeloid Checkpoint Therapeutics in Cancer (Businesswire) - "Immune-Onc Therapeutics, Inc...announced the Company will present at the virtual LILRB/ILT Symposium: A Deep Dive into Myeloid Checkpoint Therapeutics in Cancer on Tuesday, April 26, 2022, at 2:00 PM EDT...will provide a corporate overview, including recent clinical development progress and anticipated milestones for 2022 and beyond. Dr. Chengcheng (Alec) Zhang, Professor of Physiology at UT Southwestern Medical Center and Scientific Founder of Immune-Onc, will give an expert presentation on the LILRB/ILT family of receptors as myeloid checkpoint targets in immuno-oncology at 2:30 PM EDT...Immune-Onc’s focused platform approach has led to the development of several promising therapeutics across various stages of development, including IO-108...in Phase 1 clinical development for solid tumors and IO-202....in Phase 1 clinical development for the treatment of acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), and solid tumors."

Clinical • Acute Myelogenous Leukemia • Chronic Myeloid Leukemia • Chronic Myelomonocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • Solid Tumor

Immune-Onc Therapeutics Makes Two Presentations of IO-108, a Novel Clinical-Stage Myeloid Checkpoint Inhibitor Targeting LILRB2 (ILT4), at the American Association for Cancer Research (AACR) 2022 Annual Meeting (Businesswire) - "IO-108 enhances the effect of PD-1 blocking antibodies in CD4+ T cell activation by allogeneic macrophages. Moreover, IO-108 monotherapy inhibits the growth of solid tumors in a preclinical model, which is associated with immune cell activation. Importantly, IO-108 presents a favorable pharmacokinetic and safety profile in preclinical models."

Preclinical • Oncology • Solid Tumor