BMS and Apexigen collaborate to evaluate Opdivo in combination with APX005M in advanced solid tumours
Study to evaluate potential of APX005M plus Opdivo to activate antigen-presenting cells in the tumour micro-environment to demonstrate enhanced anti-tumour activity.
Bristol-Myers Squibb (BMS) and Apexigen have announced a clinical trial collaboration to evaluate BMS’s Opdivo (nivolumab) in combination with Apexigen’s APX005M in patients with advanced solid tumours. APX005M is an investigational compound that is designed to activate CD40, a key immune co-stimulatory receptor essential to regulating the activation of both innate and adaptive immune responses against cancer.
The proposed collaboration will evaluate the safety, tolerability and preliminary efficacy of APX005M in combination with Opdivo in second-line metastatic NSCLC patients who have failed prior chemotherapy, and in metastatic melanoma patients who have failed prior Immuno-Oncology (I-O) therapy.
Preclinical data suggest that APX005M mimics the endogenous immune activation process through activation of CD40. A receptor on the surface of antigen presenting cells of the immune system, CD40 plays a fundamental role in the activation of both innate and adaptive immune system mechanisms. Opdivo is designed to overcome PD-1 pathway related immune suppression. The companies will explore the potential of combining these two agents with the goal of effectively activating antigen presenting cells (APC) in the tumour micro-environment, thus driving a more productive and sustained immune response against the tumour.
“Targeting the tumour micro-environment through activation of antigen-presenting cells is a novel approach that we are excited to add to our I-O strategy as we continue to advance research for cancers with limited treatment options,” stated Fouad Namouni, head of Oncology Development, BMS. “Our agreement with Apexigen builds on our continued focus to bring forward potential novel combination treatment options for patients with cancer.”
“APX005M has demonstrated immune stimulation in patients with solid tumors in a Phase 1 study,” said Xiaodong Yang, President and CEO of Apexigen. “Based on scientific rationale and demonstrated data, we are excited about the new combination studies with Opdivo and APX005M.”
Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world in July 2014, and currently has regulatory approval in 57 countries including the US, Japan, and in the European Union.
APX005M is a novel, humanized investigational monoclonal antibody designed to reverse the systemic immune suppression that typically affects cancer patients. APX005M is designed to activate CD40, a co-stimulatory receptor that is essential for activating both innate and adaptive immune systems.
Related News
-
News Patients vs Pharma – who will the Inflation Reduction Act affect the most?
The Inflation Reduction Act brought in by the Biden administration in 2022 aims to give better and more equitable access to healthcare in the USA. However, pharma companies are now concerned about the other potential costs of such legislation. -
News CPHI Podcast Series: What does the changing US Pharma market mean for industry and patients alike?
In this week's episode of the CPHI Podcast Series Lucy Chard, Digital Editor for CPHI Online is joined by James Manser to discuss the political and market changes in the US pharma field. -
News CPHI Barcelona Annual Report illuminates industry trends for 2024
The CPHI Annual Survey comes into it’s 7th year to report on the predicted trends for 2024. Over 250 pharma executives were asked 35 questions, with their answers informing the industry landscape for the next year, spanning all major pharma marke... -
News Which 10 drugs are open to price negotiation with Medicare in the USA?
The Centres for Medicare & Medicaid Services, under the Biden administration in the USA, has released a list of the 10 drugs that will be open to price negotiations as part of the new legislation under the Inflation Reduction Act (IRA). -
News EU Medical Devices Regulation causes unintended disappearances of medical devices for children, doctors state
Doctor groups and associations have appealed to the EU to correct the EU Medical Devices Regulation law that may cause unintended shortages of essential drug and medical devices for children and rare disease patients. -
News 10 Major Drug Approvals So Far in 2023
Last year, 37 novel drugs were approved by the FDA, this was a high number for such a category, and covered many fields including oncology, demonstrating how promising further research is, and how it is only continuing to build. To date, there are alre... -
News Detecting Alzheimer's disease with a simple lateral flow test
A novel rapid diagnostic test for early-stage Alzheimer's disease has been developed using a biomarker binder from Aptamer Group along with technology from Neuro-Bio, the neurodegenerative disease experts. -
News CPHI Podcast Series: outsourcing and manufacturing trends
Listen to the CPHI Podcast Series this June to hear Gil Roth of the PBOA speak with Digital Editor Lucy Chard about the biggest trends and topics to watch in pharma outsourcing and manufacturing at the minute.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance