Australian biotech Imugene says its HER2 vaccine hit the mark in a part 1b trial, establishing a part 2 examine that may start recruiting sufferers in the brand new yr.
The first tranche of data from the 14-patient trial comes from the primary 10 evaluable topics who got the HER-Vaxx vaccine at three doses on high of normal chemotherapy with cisplatin and fluorouracil or capecitabine.
Of these, 5 had a partial response—with a 30% lower or extra in tumor dimension from baseline scans—whereas 4 confirmed illness stabilization. Imugene CEO Leslie Chong said (PDF) she is “cautiously encouraged” by the data, though the part 1b examine is just actually meant to present a security readout. On that rating, HER-Vaxx additionally appeared to be well-tolerated.
“With these early results from the HER-Vaxx clinical study, Imugene’s B-cell active immunotherapy approach is showing positive signs which provides us with further confidence in our … pipeline,” she added. The vaccine carried out finest on the highest dose (50 mcg), which might be taken ahead into part 2.
HER-Vaxx grew out of labor on the Medical University of Vienna in Austria and is designed to induce a affected person’s personal immune system to provide antibodies that may assault tumor cells. Imugene’s hope is that vaccination might be an alternative choice to common use of monoclonal antibodies similar to Roche’s Herceptin, which made gross sales of virtually $7.5 billion final yr.
The vaccine relies on B-cell epitope peptides, which when injected trigger sufferers’ B cells to generate antibodies towards HER2 receptors, slowing the expansion of HER2-positive cancer cells and inflicting them to be destroyed by the immune system. HER-Vaxx has beforehand been proven to stimulate a polyclonal antibody response—primarily based on a number of antibody sorts—in preclinical research in addition to a part 1 trial in HER2-positive breast cancer.
The part 2 gastric cancer examine, which is anticipated to enroll 68 HER2-positive gastric cancer sufferers, will examine HER-Vaxx plus chemo to chemo alone and be carried out in websites throughout Asia, Eastern Europe and India, the place HER2 therapies similar to Herceptin and Roche’s follow-up drug Perjeta will not be available to sufferers. Imugene’s HER2 vaccine is seen because the key to exhibiting proof of idea for its B-cell epitope platform, however analysts at Edison assume the packages on the firm with the best potential rewards are its PD-1 (KEY-Vaxx) and mixed PD-1/HER2 vaccines.
Imugene has in-house PD-1 candidates in early-stage improvement however minimize two years off its timelines in June after licensing expertise from the Ohio State University Wexner Medical Center and Mayo Clinic, in line with Edison, which says that deal may very well be “transformational” for the biotech. Clinical trials of KEY-Vaxx are due subsequent yr and if profitable might make the vaccine a rival to blockbuster checkpoint inhibitors similar to Merck & Co.’s Keytruda and Bristol-Myers Squibb’s Opdivo.
“One of the key appeals of KEY-Vaxx is that if it demonstrates efficacy in clinical studies with acceptable tolerability, then the convenient sub-cutaneous dosing schedule and low cost of goods could make it well suited for use in combination with other therapies in a wide range of cancers,” stated Edison in a current analysis word.