|Advaxis CEO Daniel O'Connor|
Following up on data from a Phase I study in canines with osteosarcoma, Advaxis ($ADXS) is taking its HER2 cancer vaccine into human trials.
The Princeton, NJ-based company said on Monday that the first patient has started treatment in a Phase Ib dose-escalation study of ADXS-HER2 in patients with metastatic HER2-expressing solid tumors. The study will seek to investigate the safety and tolerability of the candidate as a monotherapy and to determine the maximum tolerated dose (MTD). Once the MTD and a recommended Phase II dose are established, a subsequent phase could enroll 80 patients in up to 4 HER2 tumor cohorts.
HER2 cancers are associated with more aggressive disease, increased relapse risk and decreased overall survival, Advaxis said, with its vaccine having received the FDA's orphan drug designation for the treatment of osteosarcoma.
With the news, Advaxis has three clinical constructs in development and 7 ongoing trials--including partnerships with Merck ($MRK), AstraZeneca ($AZN) and Incyte ($INCY)--testing the company's platform across a range of tumor types. To support all of the work, Advaxis raised $23 million in February through a securities purchase with institutional investors.
And, when it learns more about the MTD for ADXS-HER2, Advaxis may be looking to build on that total. It said in its statement that it could launch a pivotal trial for the jab next year in pediatric osteosarcoma in conjunction with the Children's Oncology Group, an NCI-sponsored clinical trials group and the world's largest dedicated to cancer research for children and adolescents.
Monday's announcement comes more than a week after Advaxis reported "encouraging" results for its ADXS-HPV: 38.5% of cervical cancer patients who failed at least one line of therapy were alive after 12 months. The patients were previously given 4 to 7 months to live, and the results represented "a meaningful step" for those afflicted, according to one expert.
- here's the release