#USA #Los Angeles #Glioblastoma #Diakonos Oncology #DOC1021

Diakonos Oncology Starts Phase 2 Clinical Trial for Glioblastoma

In a significant advancement in cancer treatments, Diakonos Oncology Corp., a pioneering clinical-stage biotechnology firm, has announced that the first patient has been dosed in their Phase 2 clinical trial for DOC1021, an innovative immunotherapy designed to combat glioblastoma (GBM), one of the most aggressive types of brain cancer. This trial marks a critical phase in the evolution of targeted therapies aimed at improving outcomes for patients diagnosed with this formidable disease.

The initial dosing occurred at City of Hope's esteemed cancer center in Los Angeles, California, which is recognized nationally for its cutting-edge research and treatment capabilities. City of Hope has garnered accolades for its contributions to cancer therapy innovations, exemplified by the development of CAR T cell immunotherapy and several other treatments that are transforming the landscape of cancer care.

Jana Portnow, M.D., a leading medical oncologist at City of Hope and co-director of the Brain Tumor Program, expressed optimism about the potential impact of the trial. “Glioblastoma represents one of the toughest challenges within oncology due to its notoriously aggressive nature and resilience against conventional therapies. The urgency for novel treatments has never been higher. We are proud to take part in evaluating DOC1021 in this Phase 2 trial,” said Dr. Portnow.

About the Clinical Trial

The Phase 2 trial aims to evaluate the safety, tolerability, and efficacy of DOC1021 as it is used alongside the standard of care (SOC) treatment compared to SOC alone in adult patients who have recently received a glioblastoma diagnosis. The study, registered under ClinicalTrials.gov Identifier NCT06805305, is expected to expand to around 20 leading cancer centers across the United States, including the Atlantic Health System and UTHealth Houston.

Dr. Laura Aguilar, the Chief Medical Officer at Diakonos Oncology, shared her enthusiasm regarding the start of this trial. "We are incredibly proud to announce that the first patient has been dosed, signifying a key milestone for us. Glioblastoma treatments have historically yielded unsatisfactory patient outcomes, and we are striving to change this with our innovative approach. Our goal is to enhance the immune response to this aggressive disease,” stated Dr. Aguilar.

The trial's primary objective focuses on measuring overall survival (OS), with an additional emphasis on secondary measures such as 1-, 2-, and 3-year survival rates, progression-free survival (PFS), adverse event occurrences, and the quality of life related to health and neuro-cognitive function.

The Role of Cellipont Bioservices

Darren Head, CEO of Cellipont Bioservices, Diakonos' CDMO partner, shared his excitement about the collaboration. "Supporting the development of patient-specific cell therapies like DOC1021 demands precision and strong scientific cooperation. We are thrilled to be a part of this crucial initiative and look forward to our continued partnership as the trial unfolds," Head remarked.

Understanding Glioblastoma

Glioblastoma Multiforme (GBM) stands as the most prevalent and aggressive form of primary malignant brain tumor found in adults. Each year, approximately 15,000 new cases are diagnosed in the U.S. Standard therapies typically involve a combination of surgery, chemotherapy, and radiation; however, the prognosis remains grim, with patients averaging a survival duration of about 15 months post-diagnosis. The pressing need for innovative therapeutic solutions is evident.

A Closer Look at DOC1021

DOC1021 distinguishes itself as a first-in-class, patient-derived double-loaded dendritic cell therapy that merges tumor lysate with amplified tumor-derived mRNA. This groundbreaking immunotherapy harnesses the patient’s own dendritic cells combined with freshly prepared mRNA and proteins harvested from their tumors.

The novel double-loading technique, which simulates a viral infection, unleashes a powerful TH1 response, allowing for comprehensive targeting of the tumor's antigen pool, thus enhancing the body's ability to attack the cancer cells. Notably, this method circumvents the need for any molecular alterations to the patient's immune cells or preconditioning with chemotherapy, streamlining the treatment administration process.

In addition to the newly commenced Phase 2 glioblastoma trial, a complementary clinical study for DOC1021 in treating pancreatic cancer is currently ongoing. Diakonos has attained Fast Track designations from the FDA for both initiatives, further underscoring their commitment to addressing critical healthcare challenges. The company also received Orphan Drug Designation for the GBM trial in January 2024, signaling the potential of DOC1021 to make a substantial impact in oncology treatments.

Conclusion

Diakonos Oncology is on the cusp of exciting innovations in cancer therapy with its proprietary double-loaded dendritic cell platform. As they embark on the Phase 2 trial for DOC1021, the hope for more effective treatments for glioblastoma patients grows, reaffirming their dedication to revolutionizing cancer immunotherapy. For more details on Diakonos Oncology and their advancements, visit Diakonos Oncology.