A Triangle drugmaker working to advance a portfolio of cancer treatments has announced the first human patient has been treated with its antibody treatment for tumors.
Morrisville-based Heat Biologics (Nasdaq: HTBX) this month began Phase 1 trials of its antibody treatment PTX-35.
The study is expected to enroll as many as 30 patients with “advanced solid tumors.” The selected patients will receive the drug every two weeks until an optimal or maximum dose of the drug can be determined. Once safety and dose are determined, the company plans to launch a larger Phase 2 study as well as a “exploratory analyses of clinical benefit and immunological effect of PTX-35” possibly for other uses.
The drug was developed by the company’s subsidiary Pelican Therapeutics. The newest trial of the drug is financed in part by the Cancer Prevention and Research Institute of Texas, which provided a $15.2 million grant. That funding, according to Heat, supported the pre-clinical development, manufacturing and Phase 1 trial of the drug.
“This is an important milestone as we advance our first antibody product candidate into clinical development,” said Jeff Wolf, the company’s CEO. “I am very pleased with our team’s effort in accelerating the development of PTX-35 as well as the speed of execution to initiate our first-in-human study following FDA clearance of our [application.]”
The move into clinical trials for the drug is more momentum for the company, which has seen its stock value steadily increase since the beginning of the year.
Near the beginning of the pandemic, the company announced it was working on a Covid-19 vaccine especially designed for elderly patients and others in vulnerable populations, including those with underlying health conditions. In late May, it announced it landed a deal with Wisconsin-based Waisman Biomanufacturing to produce the vaccine for human trials.
Company shares closed at $0.76 per share on Monday after beginning 2020 at around $0.47 cent per share.
Original Post By: Triangle Business Journal