OrienX010 / Seven and Eight BioPharma - LARVOL DELTA

Neoadjuvant oncolytic virus orienx010 and toripalimab in resectable acral melanoma: a phase Ib trial. (PubMed, Signal Transduct Target Ther) - P1 | "Cytokines and chemokines analysis showed the combination therapy significantly increases the secretion of proinflammatory cytokines and chemokines in both responders and non-responders. Therefore, neoadjuvant ori and tori demonstrated promising antitumor activity with high response rates and high 2-year RFS/EFS for AM with acceptable tolerability."

Journal • Oncolytic virus • P1 data • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor

Analysis of overall survival (OS) and progression-free survival (PFS) in the phase 1b clinical trial of anti–PD-1 ab (toripalimab) plus intrahepatic injection of OrienX010 in stage IV melanoma with liver metastases. (ASCO 2023) - P1 | "Systemic toripalimab combined with intrahepatic OrienX010 injection has shown remarkable long PFS, OS and ORR in melanoma pts with liver metastases with manageable toxicity. Clinical trial information: Clinical trial information: NCT04206358."

Clinical • IO biomarker • Metastases • P1 data • Cardiovascular • Cutaneous Melanoma • Eye Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Melanoma • Ocular Melanoma • Oncology • Pulmonary Embolism • Respiratory Diseases • Solid Tumor • CSF2

Phase Ic trial of intralesional OrienX010 oncolytic viral therapy into liver metastases among melanoma patients (ESMO Asia 2017) - P1; "This is the first trial for evaluating intralesional oncolytic virus injection into liver metastases among melanoma pts- It is tolerable with a potentially beneficial effect. Phase 2 and combination trials are pending."

Clinical • Oncolytic virus • Hepatocellular Cancer • Melanoma

A phase Ib trial of neoadjuvant oncolytic virus OrienX010 (ori) and anti-PD-1 toripalimab (tori) combo in patients (pts) with resectable stage IIIb-IV (M1a) acral melanoma (ESMO 2022) - P1 | "Conclusions Neoadjuvant ori/tori achieved a high pathologic response rate, an impressive 1-y RFS rate, and was well-tolerated in patients with resectable stage IIIB-IV (M1a) acral melanoma. Although longer follow-up is in need, this combo warrants further evaluation in this melanoma subtype."

Clinical • Oncolytic virus • P1 data • Melanoma • Oncology • Solid Tumor

Analysis of overall survival (OS) and relapse-free-survival (RFS) in the phase 1b clinical trial of anti–PD-1 ab (toripalimab) plus intralesional injection of OrienX010 in stage Ⅳ melanoma with liver metastases. (ASCO 2022) - P1 | "Systemic toripalimab combined with intrahepatic OrienX010 injection has shown remarkable long PFS and OS in melanoma pts with liver metastases."

Clinical • IO biomarker • P1 data • Eye Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Melanoma • Ocular Melanoma • Oncology • Solid Tumor • BRAF • CSF2 • NRAS

OrienX010, an oncolytic virus, in patients with unresectable stage IIIC-IV melanoma: a phase Ib study. (PubMed, J Immunother Cancer) - "OrienX010 oncolytic virotherapy has a tolerable safety profile with antitumor effects in both injected and non-injected metastases and warrants further evaluation in patients with melanoma. Based on these results, the higher cohort 09 dose (up to 10 mL of 8×10 pfu/mL every 2 weeks) was selected as the recommended phase II dose for ongoing trials."

Journal • Oncolytic virus • P1 data • Herpes Simplex • Melanoma • Mucosal Melanoma • Oncology • Solid Tumor

[VIRTUAL] A phase Ib clinical trial of neoadjuvant OrienX010, an oncolytic virus, in combination with toripalimab in patients with resectable stage IIIb to stage IVM1a acral melanoma. (ASCO 2021) - P1 | "Neoadjuvant treatment with OrienX010 and toripalimab in resectable stage IIIB-IVM1a acral melanoma was well tolerated and produced a high pathologic response rate . To date, no patients have recurred, and recurrence-free survival evaluation is ongoing . This combination therapy warrants further evaluation in acral melanoma."

Clinical • Combination therapy • IO biomarker • Oncolytic virus • P1 data • Cutaneous Melanoma • Fibrosis • Herpes Simplex • Immunology • Infectious Disease • Melanoma • Oncology • Solid Tumor • BRAF • NRAS

[VIRTUAL] A phase 1b clinical trial of anti-PD-1 ab (Toripalimab) plus intralesional injection of OrienX010 in stage Ⅳ melanoma with liver metastases. (ASCO 2021) - P1 | "Systemic toripalimab combined with intrahepatic OrienX010 injection has shown remarkable pathological responses with good tolerance in melanoma liver metastases . Survival is still in follow-up . Clinical trial information: NCT04206358"

Clinical • IO biomarker • P1 data • Eye Cancer • Fatigue • Fibrosis • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Immunology • Melanoma • Ocular Melanoma • Oncology • Solid Tumor • BRAF • CD8 • CSF2 • NRAS

Current status of intralesional agents in treatment of malignant melanoma. (PubMed, Ann Transl Med) - "This review focuses on the current status of IT agents currently under clinical trials in melanoma. Reviewed therapies include T-VEC, T-VEC with immune checkpoint inhibitors including ipilimumab and pembrolizumab or other agents, RP1, OrienX010, Canerpaturev (C-REV, HF10), CAVATAK (coxsackievirus A21, CVA21) alone or in combination with checkpoint inhibitors, oncolytic polio/rhinovirus recombinant (PVSRIPO), MAGE-A3-expressing MG1 Maraba virus, VSV-IFNbetaTYRP1, suicide gene therapy, ONCOS-102, OBP-301 (Telomelysin), Stimulation of Interferon Genes Pathway (STING agonists) including DMXAA, MIW815 (ADU-S100) and MK-1454, PV-10, toll-like receptors (TLRs) agonists including TLR-9 agonists (SD-101, CMP-001, IMO-2125 or tilsotolimod, AST-008 or cavrotolimod, MGN1703 or lefitolimod), CV8102, NKTR-262 plus NKTR-214, LHC165, G100, intralesional interleukin-2, Daromun (L19IL2 plus L19TNF), Hiltonol (poly-ICLC), electroporation including calcium electroporation and plasmid..."

Journal • Review • Gene Therapies • Immune Modulation • Inflammation • Melanoma • Oncology • Solid Tumor • CD40 • IL12A • MAGEA3 • TYRP1

Clinical Study to Evaluate OrienX010 in Combination With Toripalimab as Neoadjuvant Treatment in Advanced Melanoma (clinicaltrials.gov) - P1; N=33; Active, not recruiting; Sponsor: Beijing Cancer Hospital; Recruiting ➔ Active, not recruiting

Clinical • Combination therapy • Enrollment closed • Melanoma • Oncology • Solid Tumor

Study to Evaluate OrienX010 in Combination With JS001 in the Treatment of Stage IV (M1c) Liver Metastasis From Melanoma (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: Beijing Cancer Hospital

Clinical • Combination therapy • New P1 trial

A Clinical Study to Evaluate the Safety and Efficacy of OrienX10 in Unresectable Malignant Melanoma Patients (clinicaltrials.gov) - P2; N=165; Recruiting; Sponsor: OrienGene Biotechnology Ltd.

Clinical • New P2 trial

Clinical Study to Evaluate OrienX010 in Combination With Treprizumab Injection as Neoadjuvant Treatment in Melanoma (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: Beijing Cancer Hospital

Clinical • Combination therapy • New P1 trial