CureLab Oncology receives pre-IND response from the FDA
Feedback from FDA was constructive and includes recommendations to test cumulative toxicity and clinical benefits progression; this has led the company to consider a shorter trial design for Phase II.
BOSTON: CureLab Oncology, a clinical-stage pre-IPO biotech company, announced receipt of written feedback from the U.S. Food and Drug Administration (FDA) that was helpful and clearly defines the necessary path forward for the company’s planned clinical trial for Elenagen-3NBC, an experimental DNA vaccine that consists of a plasmid encoding the human gene for p62. The company has been testing the product ex-US for the treatment of triple-negative breast cancer and other types of cancer.
The pre-IND (investigational new drug) briefing package and key questions were centered around a proposed Phase II US clinical trial that will use the experimental DNA vaccine as an adjuvant to three types of chemotherapy for late-stage progressing triple-negative breast cancer patients. The company is working with Dr. Virginia G. Kaklamani, professor of medicine in the division of hematology and oncology at UT Health San Antonio, and the leader of the Breast Cancer Program at UT Health San Antonio MD Anderson Cancer Center, who is intended be the primary investigator for the US trial.
“We are really thankful to the FDA examiners — their comments will help us strengthen our IND application. The additional data they have requested are reasonable. Importantly, the pre-IND feedback includes recommendations that are leading us to consider a shorter Phase II trial and possibly a much faster path to Phase III.”
CureLab proposed a Phase II clinical trial expected to take 36 months to test the safety and clinical benefits of its DNA vaccine. Now, in consideration of the FDA feedback, the company is considering a shorter duration trial to focus on the assessment of safety and cumulative toxicity being the primary end point of the study, and progression-free disease and partial response identified as secondary endpoints.
“We are very enthusiastic to receive this feedback from the FDA and look forward to submitting our IND application,” said Charles Legg, COO of CureLab Oncology. “It is encouraging to get this first feedback from the FDA, which is important both in setting our course toward IND approval for triple negative breast cancer and in supporting a second program for platinum-resistant ovarian cancer. This feedback is very helpful and supportive as we consider our expanding portfolio.”
About Elenagen
CureLab’s lead investigational compound is code-named Elenagen. It is a DNA vaccine that consists of a circular piece of DNA called a plasmid that includes a gene for a human protein called p62/SQSTM1. In animal studies and Phase I/II human trials conducted ex-US, Elenagen has shown promise in reversing tumor grade, changing the tumor microenvironment, and enhancing the anti-cancer effects of chemotherapy. Experimental results indicate a mitigation of chronic inflammation and stimulation of an immune response to the tumor.
About CureLab Oncology
CureLab Oncology Inc. is a clinical-stage immuno-oncology biotech company headquartered in the greater Boston area. CureLab is dedicated to advancing new and safer therapeutics for solid tumors and other oncology and inflammatory indications. To learn more, visit curelaboncology.com.
Media contact: Tim Cox, ZingPR, tim@zingpr.com
