On April 18, 2018 Heat Biologics, Inc. (NASDAQ: HTBX), a biopharmaceutical company developing drugs designed to activate a patient’s immune system against cancer, reported an upcoming clinical milestones for HS-110 in non-small cell lung cancer (NSCLC), its ComPACT platform, as well its Pelican subsidiary’s co-stimulator antibody, PTX-35 (Press release, Heat Biologics, APR 18, 2018, View Source [SID1234525496]).
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Anticipated Phase 2 NSCLC milestones include an interim data readout in Q4 2018 and a final Phase 2 data readout in Q2 2019, followed by a Phase 3-ready NSCLC program in Q3 2019. Expected PTX-35 milestones include receipt of $6.9 million in CPRIT grant funds to support the enrollment of the first patient in a Phase 1 clinical trial in Q1 2019 and an interim data readout in Q3 2019. Additionally, Heat plans on enrolling its first patient in its ComPACT trial in Q4 2018 and anticipates an interim data readout in Q2 2019.
Jeff Wolf, Heat’s CEO, commented, "The next four quarters are shaping up to be very exciting, with events that we believe will be transformational for our company. Earlier this year we reported positive interim results from the Phase 2 study investigating HS-110 in combination with Bristol-Myers Squibb’s anti-PD-1 checkpoint inhibitor, nivolumab (Opdivo), in patients with advanced NSCLC. We observed some potentially very exciting data with this combination that points to the opportunity to use this combined therapy in a very underserved population of NSCLC patients."
"Given all the recent progress, I am pleased to announce these upcoming milestones for the next 4 quarters. Importantly, we believe each of these milestones will help drive shareholder value. At the same time, we are witnessing advancements in the immuno-oncology landscape that are resulting in a growing interest in our technology across the industry, and, hence, we strongly believe our assets will play an important role in the future of combination immunotherapies."
Anticipated milestones:
Q3 2018:
Receive $6.9M in CPRIT (Cancer Prevention Research Institute of Texas) grant funds
Q4 2018:
Interim Phase 2 NSCLC data readout
IND filing for first ComPACT trial
Enroll first patient in ComPACT trial
Q1 2019:
PTX-35 IND filing
Enroll first patient in PTX-35 trial
Q2 2019:
Complete enrollment in Phase 2 NSCLC trial
Phase 2 NSCLC data readout
Interim ComPACT data readout
Q3 2019:
Interim PTX-35 data readout