OR2805 / OncoResponse - LARVOL DELTA

Taking Clues from Patients to Target TAMS (PEGS 2023) - "OR2805 is a first-in-class clinical antibody directed against CD163 that reverses immunosuppression caused by TAMs and restores T cell function, both in vitro and in vivo. OR502 is a preclinical anti- LILRB2/IL4 antibody that rescues T cells from macrophage-mediated suppression and induces anti-tumor responses."

Clinical • Oncology • CD163 • IL4

OncoResponse Awarded $13 Million in Funding from CPRIT and Raises $14 Million in Added Funds from Investors to Advance Cancer Immunotherapy (PRNewswire) - "OncoResponse...announced it has been awarded a $13 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT). The Company concurrently raised $14 million in new funding from existing investors, led by RiverVest Venture Partners and including ARCH Venture Partners, Canaan Partners, 3B Future Health Fund, Bering Capital, Takeda Ventures, InterVest and others. The CPRIT award and investment will support the advancement of OR502, a best-in-class anti-LILRB2 antibody poised to move to IND and clinical studies. Funds from the existing syndicate will also support continued advancement of the Company's lead immunotherapy candidate OR2805, a fully human monoclonal antibody identified from an Elite Responder using OncoResponse's proprietary B-cell discovery platform. OR2805 is currently being evaluated in a Phase 1 clinical trial."

Financing • Breast Cancer • Head and Neck Cancer • Leiomyosarcoma • Liposarcoma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Sarcoma • Skin Cancer • Soft Tissue Sarcoma • Solid Tumor • Spindle Cell Sarcoma • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Thoracic Cancer • Triple Negative Breast Cancer

Interrogating Elite Responder humoral responses to identify novel targets and therapeutic antibodies for the treatment of cancer (SITC 2022) - P1/2 | "A phase 1–2 dose escalation-expansion study of OR2805 alone or in combination in subjects with advanced solid tumors is ongoing ( NCT05094804 ). Conclusions Interrogation of humoral responses in cancer Elite Responders is an attractive strategy for discovery of novel targets and therapeutic antibodies for the treatment of cancer."

IO biomarker • Oncology • Solid Tumor

A Phase 1-2 Study of OR2805 Alone and in Combination with other Anti-cancer Agents in Subjects with Advanced Malignancies (clinicaltrialsregister.eu) - P1/2 | N=140 | Ongoing | Sponsor: OncoResponse, Inc.

Combination therapy • Metastases • New P1/2 trial • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • PD-L1

OncoResponse Announces Preclinical Data Highlighting OR2805 Discovery from Elite Responder Platform and OR502 anti-LILRB2 Antibody at SITC 2022 (PRNewswire) - "OR2805 increases T cell activation and proliferation, amplifies anti-PD1 activity, and demonstrates robust anti-tumor activity. OR502 specifically binds and blocks LILRB2, relieves immunosuppression, and boosts anti-cancer immune response."

Preclinical • Oncology • Solid Tumor

A phase 1/2 dose escalation/expansion study of OR2805 alone or in combination in subjects with advanced solid tumors. (ASCO 2022) - P1/2 | "Exploratory biomarkers of OR2805-mediated pharmacodynamic effects and immune stimulation will be explored. The study was opened September 2021 and is enrolling at sites in the United States with planned expansion within the US and to Europe."

Clinical • IO biomarker • P1/2 data • Head and Neck Cancer • Liposarcoma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Sarcoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD163 • IFNG

A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents (clinicaltrials.gov) - P1/2 | N=172 | Recruiting | Sponsor: OncoResponse, Inc. | N=130 ➔ 172

Combination therapy • Enrollment change • Endometrial Cancer • Head and Neck Cancer • Leiomyosarcoma • Liposarcoma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Sarcoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • ALK • BRAF • EGFR • NTRK • PD-L1

OncoResponse Announces Clinical Supply Agreement with Regeneron to Evaluate OR2805 in Combination with Libtayo (cemiplimab) in Patients with Advanced Cancer (PRNewswire) - "OncoResponse...announced a clinical supply agreement with Regeneron for PD-1 inhibitor Libtayo^® (cemiplimab). The supply agreement will support the evaluation of Libtayo in combination with OR2805, a fully human monoclonal antibody identified from an elite cancer responder using OncoResponse's proprietary B-cell discovery platform."

Licensing / partnership • Oncology • Solid Tumor

Development of OR2805, an anti-CD163 antibody derived from an elite responder to checkpoint inhibitor therapy that relieves immunosuppression caused by M2c macrophages (SITC 2021) - "Methods Cocultures of immunosuppressive primary human polarized M2c macrophages with autologous CD8+ T cells or phytohemagglutinin (PHA)-T cell blasts (exhausted T cells) were used to interrogate OR2805-dependent immunomodulatory responses as single agent and in combination with pembrolizumab, an anti-PD1 antibody. OR2805-treatment resulted in significant anti-tumor activity in lung cancer xenograft models in humanized mice. The pharmacology, PK, and toxicokinetic data support further development of OR2805 as an anti-cancer therapy, both as a monotherapy and in combination with CPI therapy."

Checkpoint inhibition • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD163 • CD8 • IFNG • IL10 • IL1B • IL2 • IL4 • IL6 • TNFA

OncoResponse Presents Data on Multiple Immuno-oncology Agents at the Society for Immunotherapy of Cancer's 36th Annual Meeting (SITC 2021) (PRNewswire) - "Robust anti-tumor activity was demonstrated in lung cancer xenograft models in humanized NSG-SGM3 mice. Additionally, OR2805 reduces TAM mediated immunosuppression and enhances anti-tumor immune responses. Combination with OR2805 restores and amplifies anti-PD-1 and anti-PD-L1 activity in coculture assays. OR2805 toxicology predicts a tolerable safety profile...Preclinical characterization of humanized anti-Siglec-15 antibodies that rescue T cells from macrophage-mediated immune suppression...Rescue of T cell activation and proliferation from M2c macrophage-mediated immunosuppression in M2c/CD8 coculture assays. Restoration of effector function of activated and exhausted T cells from M2c-mediated immune suppression, with favorable half-life and anti-tumor activity in humanized mouse models."

Preclinical • Oncology

OncoResponse Announces Initiation of Phase 1 Trial of OR2805 - Human Monoclonal Antibody Derived from Elite Responder to Cancer Immunotherapy - in Patients with Advanced Cancer (PRNewswire) - "OncoResponse...announced initiation of a Phase 1/2 study of OR2805 in patients with advanced cancer...The study will evaluate the safety, pharmacokinetics and preliminary anti-cancer activity of OR2805 in patients with advanced solid tumors alone and in combination with anti-PD-1 therapy. The trial will include a dose escalation phase, followed by several expansion cohorts."

Trial status • Oncology

A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With a PD-1 Inhibitor (clinicaltrials.gov) - P1/2; N=130; Recruiting; Sponsor: OncoResponse, Inc.

Clinical • Combination therapy • IO biomarker • New P1/2 trial • Breast Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • ALK • BRAF • BRCA • EGFR • NTRK • PD-L1

OncoResponse Announces Presentations at the Society for Immunotherapy of Cancer 36th Annual Meeting (SITC 2021) (PRNewswire) - "OncoResponse...announced that it will present three abstracts at the upcoming Society for Immunotherapy of Cancer's (SITC) 36th Annual Meeting being held in Washington D.C. and virtually November 10-14, 2021. 'We are pleased to be highlighting several preclinical findings at the SITC conference demonstrating the application of our propriety immunotherapy platform we are utilizing to discover and develop therapeutic antibodies that modulate the tumor microenvironment. This includes preclinical findings for our lead therapeutic candidate, OR2805, which has entered clinical development...'"

Preclinical • Oncology

[VIRTUAL] OR2805, an anti-CD163 antibody derived from an elite responder to checkpoint inhibitor therapy relieves immunosuppression caused by tumor associated macrophages (AACR 2021) - "OR2805 reduces M2 macrophage-mediated immunosuppression and enhances anti-tumor immune responses. OR2805 treatment induces anti-tumor activity in lung cancer xenograft models in humanized mice. These data support further development of OR2805 as an anti-cancer therapy, both as a monotherapy and an addition to current CPI therapy."

Checkpoint inhibition • IO biomarker • Lung Cancer • Oncology • Solid Tumor • CD163 • CD8 • ITGAM

OncoResponse Raises $40.6 Million Series C Financing (GlobeNewswire) - “OncoResponse…announced that it has raised $40.6 million in a Series C financing. Proceeds will be used to advance the Company’s lead antibody, OR2805, into clinical development in multiple tumor types and fund a pipeline of preclinical assets to IND…We will be entering clinical studies in multiple tumor types later this year.”

Clinical • Financing • Oncology