SHR-2005 / Jiangsu Hengrui Pharma - LARVOL DELTA

SHR-2005, an FcγR-Dependent CD40 Agonistic Antibody with Potent Antitumor Activities and Favorable Safety Profile. (PubMed, Mol Cancer Ther) - "Notably, SHR-2005 induced significantly lower IL-6 secretion than the APX005M analogue in human peripheral blood mononuclear cells, indicating a favorable safety profile. In conclusion, the CD40 agonistic antibody SHR-2005 was highly reliant on FcγR for agonistic activation and exhibited promising potential for clinical development as monotherapy or in combination with the anti-PD-L1 antibody for the treatment of solid tumors. Based on promising efficacy and tolerance in preclinical studies, SHR-2005 is currently being evaluated in an ongoing phase I clinical trial for the intravesical treatment of high-risk non-muscle-invasive bladder cancer."

Journal • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • CD40 • CD40LG • IL6

SHR-1501 Combined With SHR-2005 for High-Risk Non-Muscle Invasive Bladder Cancer Which is Not Completely Resectable by TURBt (clinicaltrials.gov) - P1/2 | N=58 | Not yet recruiting | Sponsor: Fudan University

New P1/2 trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

A Phase I Clinical Study of SHR-2005 Intravesical Instillation in the Treatment of High-risk Non-muscle Invasive Bladder Cancer (NMIBC) (clinicaltrials.gov) - P1 | N=150 | Recruiting | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

A Phase I Clinical Study of SHR-2005 Intravesical Instillation in the Treatment of High-risk Non-muscle Invasive Bladder Cancer (NMIBC) (clinicaltrials.gov) - P1 | N=150 | Not yet recruiting | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

New P1 trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Hengrui Medicine’s two new anti-tumor drugs have been approved for clinical trials. No similar products have been launched at home or abroad. [Google translation] (163.com) - "...On the evening of September 20, Hengrui Pharmaceuticals issued two announcements. Two new anti-tumor drugs, SHR-2005 injection and SHR-5495 for injection, were approved for clinical trials....SHR-2005...The approved clinical trial is for single-agent use in bladder cancer. Up to now, Hengrui Medicine has invested a total of approximately 37.93 million yuan in research and development expenses on SHR-2005 injection-related projects...SHR-5495...The approved clinical trial is for single-agent use in advanced malignant tumors....Hengrui Medicine has invested a total of approximately 24 million yuan in research and research and development expenses for this drug."

Commercial • New trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor