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April 2, 2019

Apexigen reports positive Phase Ib APX005M clinical trial data

Apexigen has presented positive Phase Ib clinical trial data of its lead immuno-oncology (I-O) therapeutic, APX005M, in patients with metastatic pancreatic cancer.

Apexigen has presented positive Phase Ib clinical trial data of its lead immuno-oncology (I-O) therapeutic, APX005M, in patients with metastatic pancreatic cancer.

APX005M is a monoclonal antibody targeting CD40, a co-stimulatory receptor, and is being evaluated in multiple clinical trials in different types of solid tumours.

Apexigen noted that in an interim analysis of the ongoing clinical trial, 20 of 24 evaluable patients with metastatic pancreatic cancer demonstrated tumour shrinkage after treatment with APX005M in combination with standard-of-care chemotherapy, with or without Bristol-Myers Squibb’s PD-1 inhibitor nivolumab.

After one year of treatment, several patients remained on therapy.

“We are committed to advancing a broad clinical development programme for APX005M in multiple types of cancer as we work toward transforming the standard of care.”

Apexigen Clinical Development chief medical officer and senior vice-president Ovid Trifan said: “Our CD40 agonist APX005M is critical for activating the body’s innate and adaptive immunity, potentially enabling the immune system to fight even the most difficult-to-treat forms of cancer.

“We are committed to advancing a broad clinical development programme for APX005M in multiple types of cancer as we work toward transforming the standard of care for patients across a wide range of cancer indications.”

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In the Phase 1b portion of the clinical trial, patients with metastatic pancreatic ductal adenocarcinoma who were earlier untreated received APX005M in combination with gemcitabine and nab-paclitaxel.

Half of patients also received Bristol-Myers Squibb’s PD-1 inhibitor nivolumab.

Several patients who remained on treatment for about a year had a durable response and 20 of 24 evaluable participants demonstrated tumour shrinkage.

The trial has currently progressed to the Phase II portion.

The humanised monoclonal antibody APX005M has been designed to stimulate the anti-tumour immune response.

APX005M is currently in Phase II clinical development for the treatment of pancreatic cancer, melanoma, oesophagal and gastroesophageal junction cancers, non-small cell lung cancer, renal cell carcinoma, sarcomas, and pediatric brain cancer in various combinations.

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