MedPath

Sanofi Expands Oncology Pipeline with CD73 Inhibitor Ulelimumab Collaboration

• Sanofi partners with I-Mab to develop ulelimumab, a monoclonal antibody targeting CD73, for cancer treatment. • A pivotal study in China is evaluating ulelimumab with Loqtorzi in first-line NSCLC patients with PD-L1 and CD73-positive tumors. • Phase 1/2 trials showed a 63% ORR in NSCLC patients with high CD73 and PD-L1 expression when ulelimumab was combined with Loqtorzi. • The collaboration marks Sanofi's third oncology deal recently, focusing on innovative approaches in a competitive CD73-targeting landscape.

Sanofi has entered into a collaboration with I-Mab to develop ulelimumab, a monoclonal antibody targeting CD73, marking Sanofi's latest move to bolster its oncology pipeline. This collaboration aims to explore ulelimumab's potential, particularly in combination with other therapies, for treating various cancers. The deal comes shortly after Otsuka's licensing of Arcus’s CD73 inhibitor quemliclustat, highlighting the growing interest in CD73 as a therapeutic target.

Ulelimumab's Clinical Development

Currently, a pivotal study is underway in China, assessing ulelimumab in conjunction with Coherus/Shanghai Junshi’s anti-PD-1 antibody, Loqtorzi, as a first-line treatment for non-small cell lung cancer (NSCLC) patients whose tumors are positive for both PD-L1 and CD73. Data from this trial are expected next year. I-Mab has also conducted trials in the US, raising questions about Sanofi’s potential plans for ulelimumab's development beyond China.

Competitive Landscape of CD73 Inhibitors

The CD73-targeting space is becoming increasingly crowded, with 24 projects currently in clinical development. Among these, 15 are monoclonal antibodies, with AstraZeneca's oleclumab being the most advanced. I-Mab believes that ulelimumab could offer improved efficacy compared to other monoclonal antibodies, a claim that will need to be substantiated through clinical trials.

Early Clinical Data

Data from a phase 1/2 trial conducted in both the US and China in first-line NSCLC showed that the combination of ulelimumab and Loqtorzi resulted in an overall response rate (ORR) of 31%. Notably, this ORR increased to 63% in patients with tumors deemed to have high CD73 and PD-L1 expression. These early results suggest a potential benefit in a specific subset of NSCLC patients.

Sanofi's Expanding Oncology Portfolio

This collaboration represents Sanofi's third oncology-focused deal in recent times, signaling a strategic effort to expand its presence in the cancer therapeutics market. While the financial details of these deals have been relatively modest, they reflect a targeted approach to incorporating innovative assets into Sanofi’s development pipeline.
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

CEL-SCI's Multikine Demonstrates Promising Tumor Regression, Advances to Confirmatory Phase 3 Trial for Head and Neck Cancer

CEL-SCI's Multikine showed significant pre-surgical tumor regression in head and neck cancer patients within three weeks, a finding confirmed by pathology.
The FDA has approved CEL-SCI's plan to use PD-L1 as a biomarker for patient selection in the confirmatory Phase 3 trial, focusing on patients with low PD-L1 expression.

Sanofi Announces Breakthroughs in Multiple Myeloma and MS Treatments

Sanofi has made significant progress in the treatment of multiple myeloma and multiple sclerosis, with new formulations and therapies receiving positive feedback and designations from regulatory bodies.

China Approves Zorifer for NSCLC with Brain Metastases, Addressing Critical Treatment Gap

China's NMPA has approved Zorifer (zorifertinib), a novel EGFR-TKI developed by Alpha Biopharma and AstraZeneca, for treating non-small cell lung cancer (NSCLC) with CNS metastases. The drug demonstrated significant efficacy in the EVEREST trial, showing a 37% reduction in intracranial progression risk and 17.9-month progression-free survival compared to first-generation EGFR-TKIs.

Sanofi and SK bioscience's 21-Valent Pneumococcal Vaccine Enters Phase III Trials

Sanofi and SK bioscience have initiated global Phase III trials for their 21-valent pneumococcal conjugate vaccine candidate, GBP410, targeting individuals aged six weeks to 17 years.
The Phase III program will enroll over 7,700 participants across multiple regions, assessing the vaccine's safety and immunogenicity with varying doses based on age.

Sanofi's Tolebrutinib Meets Primary Endpoint in Phase 3 Relapsing MS Trial

Sanofi's oral treatment, tolebrutinib, achieved its primary endpoint in a Phase 3 study for relapsing multiple sclerosis (MS).
The positive results may pave the way for regulatory approval of tolebrutinib as a treatment option for MS patients.

Sanofi to Present New Oncology Data at ASCO 2023

Sanofi will showcase new data from its oncology pipeline at the ASCO 2023 Annual Meeting, including a first-in-human study of SAR443579, a novel NK cell engager for hematological malignancies, which has received Fast Track Designation by the U.S. FDA.

I-Mab's Uliledlimab Plus Toripalimab Shows Promise in NSCLC Combination Therapy

I-Mab reported encouraging Phase Ib/II trial data for uliledlimab combined with toripalimab in treatment-naïve advanced non-small cell lung cancer (NSCLC).
The combination therapy demonstrated a 31.3% objective response rate (ORR) in the efficacy evaluable population, regardless of PD-L1 and CD73 expression.

Immutep's INSIGHT-003 Trial Reaches Enrollment Target in First-Line NSCLC

The INSIGHT-003 trial, evaluating eftilagimod alpha in combination with anti-PD-1 therapy and chemotherapy, has reached its enrollment target of 20 patients with 1L NSCLC.
Initial results from the triple combination therapy showed a 72.7% objective response rate and a 90.9% disease control rate in 1L NSCLC patients.

Uliledlimab Shows Promise in Advanced NSCLC with High CD73 Expression

Uliledlimab, a CD73 antibody, demonstrates a favorable safety profile both as a monotherapy and in combination with toripalimab in Phase 2 trials.
In NSCLC patients ineligible for standard care, uliledlimab combined with toripalimab achieved a 26% ORR and a 73.7% disease control rate.

Sorrento's License Partner, Lee's Pharm, Announces Full Enrollment in Phase III Trial of Socazolimab for ES-SCLC

Lee's Pharmaceutical Holdings Limited, a subsidiary of Sorrento Therapeutics, has completed the enrollment of 498 patients for a Phase III clinical trial of Socazolimab, an anti-PD-L1 monoclonal antibody, combined with chemotherapy for the first-line treatment of extensive-stage small-cell lung cancer (ES-SCLC). The trial, involving 54 centers across China, is led by Prof. Shun Lu from Shanghai Chest Hospital, with an interim analysis expected in April 2023.

Reference News

[1]
Sanofi sees promise in CD73 | ApexOnco - Clinical Trials news and analysis
oncologypipeline.com · Sep 26, 2024

Sanofi partners with I-Mab for ulelimumab, a monoclonal antibody targeting CD73, focusing on China for NSCLC treatment a...

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy