FDA Fast Tracks Novel Dendritic Cell Vaccine for Pancreatic Cancer

Pancreatic cancer anatomy concept, malignant tumor of pancreas: © Лилия Захарчук - stock.adobe.com

• The FDA has granted a fast track designation for DOC1021 for the treatment of pancreatic ductal adenocarcinoma (PDAC).
• DOC1021 is a dendritic cell vaccine that also has a fast track designation for the treatment of glioblastoma multiforme (GBM).
• Fast track designation aims to speed the development and review of drugs that show promise in treating severe or life-threatening diseases.

DOC1021, a novel dendritic cell vaccine, has been granted FDA fast track designation in PDAC.¹

"This second FDA fast track designation of our autologous dendritic cell vaccines for pancreatic cancer is another acknowledgement of the incredible potential of this innovative immunotherapy for treating the most deadly cancers," said Mike Wicks, chief executive officer of Diakonos, in a press release.

FDA fast track designation is intended to speed up the development and review of agents that show early clinical promise in treating life-threatening conditions.

DOC1021 is an autologous vaccine made with a patient’s dendritic cells and tumor sample. The vaccine is able to activate cytotoxic cell signaling pathways to stimulate a natural immune response. There is no genetic modification to the patient’s immune cells, which helps to streamline the manufacturing process and lower treatment costs.

The phase 1 DECIST trial (NCT04157127) is investigating the dendritic cell immunotherapy in patients with PDAC.² The study is currently enrolling at 2 sites in Houston, Texas, at the Baylor College of Medicine. The primary end points of the study are the maximum tolerated dose and number of dose-limiting toxicities. Secondary end points include time to recurrence and overall survival (OS).

Six cohorts are included, and doses ranging from 0.5 million to 8 million cells are being tested. DOC1021 is given in 3 doses, and patients are receiving 1 dose every 14 days. Patients are also being treated with peginterferon alfa-2a at 180 mcg/week during the course of vaccination.

Adult patients with pancreatic adenocarcinoma that is deemed to be potentially resectable and considered good candidates for adjuvant or neoadjuvant chemotherapy are eligible for enrollment in the trial. Patients also must have an adequate tissue sample, adequate laboratory functions, negative hepatitis B and C serology, and an ECOG performance status of less than or equal to 2. Patients with reproductive potential must agree to use effective contraception.

Additionally, a phase 1 study (NCT05799612) is looking at the agent for the treatment of cutaneous angiosarcoma.¹

About DOC1021 in GBM

DOC1021 was previously given fast track and orphan drug designations for the treatment of patients with GBM.³ Interim data from the phase 1 open-label study were presented in a poster at the 2024 American Association for Cancer Research Annual Meeting in April 2024. With an average of 12.9 months of follow-up among 16 patients with newly diagnosed GBM, the median OS had yet to be reached. The median 12-month survival among the evaluable patients was 88%. Comparatively, the median OS for patients with GBM receiving the standard of care is 12.7 months.

REFERENCES:

1. Diakonos Oncology receives FDA fast track designation for pancreatic cancer dendritic cell vaccine; names Daniel D. Von Hoff, M.D. to scientific advisory board. News release. Diakonos Oncology. July 15, 2024. Accessed July 16, 2024. https://tinyurl.com/yx8s42dm

2. Th-1 dendritic cell immunotherapy plus standard chemotherapy for pancreatic adenocarcinoma. ClinicalTrials.gov. Updated November 18, 2023. Accessed July 16, 2024. https://clinicaltrials.gov/study/NCT04157127

3. Diakonos Oncology’s unique dendritic cell vaccine (DOC1021) improves survival compared to standard of care in phase 1 trial for glioblastoma. News release. Diakonos Oncology. April 9, 2024. Accessed July 16, 2024. https://tinyurl.com/45j37yfa