Apexigen and the Nordic Society of Gynaecological Oncology – Clinical Trial Unit Announce Collaborative Phase 2 Study of Sotigalimab (APX005M)

SAN CARLOS, Calif. and COPENHAGEN, Denmark, June 16, 2021 (GLOBE NEWSWIRE) -- Apexigen, Inc., a clinical-stage biopharmaceutical company focused on discovering and developing a new generation of antibody therapeutics for oncology, and the Nordic Society of Gynaecological Oncology – Clinical Trial Unit (NSGO-CTU) today announced an agreement to initiate a collaborative Phase 2 clinical study evaluating sotigalimab, Apexigen’s monoclonal antibody targeting CD40, in combination therapy for patients with recurrent BRCA wild type ovarian cancer. Sotigalimab, Apexigen’s lead immuno-oncology therapeutic candidate, is a potentially first-in-class and best-in-class CD40 agonist, with unique epitope specificity and Fc receptor engagement for optimal therapeutic effect and tolerability.

“We are excited to collaborate with the NSGO-CTU and ENGOT, premier organizations with tremendous experience conducting gynaecological oncology clinical trials,” said Xiaodong Yang, M.D., Ph.D., President and CEO of Apexigen. “The poor survival in advanced ovarian cancer is due both to late diagnosis as well as a lack of effective second-line therapy. Robust preclinical and early clinical data underscore the utility of next-generation immune-modulating therapies, such as sotigalimab. We believe combining sotigalimab treatment with chemotherapy or chemotherapy plus radiation shows promise in offering new therapeutic options for patients with recurrent BRCA wild type ovarian cancer. We’re fortunate to have the opportunity to explore these combinations with the NSGO-CTU and ENGOT as we continue to address the greatest outstanding challenges in oncology.”

Our purpose at the NSGO-CTU and ENGOT is to improve management options in gynaecological cancer indications by conducting and coordinating clinical trial efforts across countries,” added Mansoor Raza Mirza, M.D., Medical Director of the NSGO-CTU and Chair of ENGOT. “The evaluation of sotigalimab, a novel and promising agent, in this Phase 2 randomized study is an important next step to improve the standard of care for patients with ovarian cancer. We look forward to working with Apexigen to reach our mutual goal.”

About Sotigalimab (APX005M)
Sotigalimab is a novel, humanized monoclonal antibody that stimulates the anti-tumor immune response. Sotigalimab targets CD40, a co-stimulatory receptor that is essential for activating both innate and adaptive immune systems. Binding of sotigalimab to CD40 on antigen presenting cells (i.e., dendritic cells, monocytes and B-cells) initiates a multi-faceted immune response bringing multiple components of the immune system (e.g., T cells, macrophages) to work in concert against cancer. Sotigalimab is currently in Phase 2 clinical development for the treatment of cancers such as esophageal and gastroesophageal junction cancers, melanoma, rectal cancer and sarcoma in various combinations with immunotherapy, chemotherapy, radiation therapy or a cancer vaccine. Additional information on clinical trials for sotigalimab can be found at www.clinicaltrials.gov.

About Apexigen
Apexigen is a clinical-stage biopharmaceutical company focused on discovering and developing a new generation of antibody therapeutics for oncology, with an emphasis on new immuno-oncology agents that may harness the patient’s immune system to combat and eradicate cancer. Sotigalimab and Apexigen’s other programs were discovered using Apexigen’s proprietary APXiMAB™ discovery platform. This platform has enabled Apexigen and its collaboration partners to discover and develop high-quality therapeutic antibodies against a variety of molecular targets, including targets that are difficult to drug with conventional antibody technologies. Seven product or product candidates discovered using APXiMAB are currently commercially available or in clinical development, either internally by Apexigen or by its licensees. For more information, please visit www.apexigen.com.


The Nordic Society of Gynaecological Oncology – Clinical Trial Unit is a non-profit organization aiming to improve the practice of prevention, diagnosis and treatment for gynaecological cancers by supporting research and conducting clinical trials across countries.


ENGOT is a platform that guarantees that the European spirit and culture is incorporated into the medical progress in gynaecological oncology, and that all European patients and countries can participate in an active way in clinical research and progress. The ultimate goal is to bring the best treatment to gynaecological cancer patients through the best science and enabling every patient in every European country to access a clinical trial.

Investor Contact:

Bruce Mackle
LifeSci Advisors

Apexigen Contact:

Mark Nevins
Sr. Vice President, Business Development

NSGO-CTU Contact:

Mansoor Raza Mirza, MD
Chief Oncologist, Rigshospitalet
Medical Director, NSGO-CTU
Chairman, ENGOT
+45 3545 9624


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