by Ryu Hyunseok
Published 01 Feb.2021 08:20(KST)
[Asia Economy Reporter Yoo Hyun-seok] BioX announced on the 1st that OncoPep, Inc. has received approval from the U.S. Food and Drug Administration (FDA) to start Phase 2 clinical trials for a treatment for metastatic triple-negative breast cancer. OncoPep is a U.S.-based cancer treatment development company in which BioX is the largest shareholder.
OncoPep is expected to actively proceed with Phase 2 clinical trials combining its immuno-oncology vaccine pipeline ‘PVX-410’ with chemotherapy agents such as Merck’s Keytruda.
OncoPep plans to enroll a total of 56 patients for the Phase 2 clinical trial of metastatic triple-negative breast cancer. The company intends to select a CRO in February, when the ongoing pre-IPO funding is completed, and then commence the Phase 2 trial.
Breast cancer is classified based on the presence (positive) or absence (negative) of ▲estrogen receptor (ER) ▲progesterone receptor (PR) ▲epidermal growth factor receptor (HER2). Triple-negative breast cancer lacks all three receptors (negative). It accounts for approximately 12?20% of all breast cancers and is particularly more likely to occur in younger age groups (under 40). It is known to be aggressive in nature, with rapid cancer progression, high risks of metastasis and recurrence, and the highest mortality rate among breast cancers.
Early-stage triple-negative breast cancer (stages 1?3) can be treated with surgery, radiation therapy, and chemotherapy before and after surgery. However, for patients with metastatic triple-negative breast cancer (stage 4), surgery and radiation therapy are not options, making it a fatal condition and highlighting the urgent need for treatment development, according to the company.
OncoPep is already conducting clinical trials for triple-negative breast cancer and multiple myeloma using the immuno-oncology vaccine ‘PVX-410’ in collaboration with global pharmaceutical companies such as Merck, AstraZeneca, and Celgene (BMS). In earlier Phase 1 trials, sufficient safety and strong immune responses were confirmed.
Doris Peterkin, CEO of OncoPep, stated, “With the FDA’s approval to start Phase 2 clinical trials, OncoPep has taken the first major step in developing a treatment for metastatic triple-negative breast cancer. We plan to begin patient enrollment soon for this important Phase 2 trial and hope to deliver effective treatment options quickly.”
A company representative explained, “OncoPep has secured approximately $10 million in LOC (Letter of Commitment) from various investment and pharmaceutical companies and expects to complete the pre-IPO around mid-February.”
Meanwhile, detailed information about OncoPep’s Phase 2 clinical trial has been published on the U.S. government-operated clinical data site under the reference NCT#03362060.
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