- Late-stage biopharma companies, Advaxis and Sellas Life Sciences are combining forces to develop an immuno-oncology agent using Advaxis' antigen delivery technology and Sellas' galinpepimut-S, a peptide-antigen mixture. The aim is to create an immunotherapy that targets the WT1 antigen, found in many tumors and triggers a local immune response as well as reducing immune tolerance.
- Advaxis will carry out pre-clinical studies and all IND-enabling activities, with Sellas taking on responsibility for clinical development and all commercial activities from that point on.
- In return for reaching development, regulatory and commercial milestones, Advaxis will get payments of up to $358 million, followed by single- to low double-digit royalties on any sales.
Cancer immunotherapy is a growing field, as researchers discover new ways to pit the human immune system against cancers, and it could be worth as much as $34 billion by 2024, according to GlobalData. This deal is designed to slot into this market, creating a product that could be effective across a wide range of cancers.
"WT1 is one of the most widely expressed cancer antigens and was named a top target for cancer immunotherapy by the National Cancer Institute," said Daniel J. O’Connor, president and CEO of Advaxis. "Sellas’ proprietary galinpepimut-S therapy has already demonstrated clinical benefit and a strong immune response against WT1 expressing cancer cells. We believe that the use of our proprietary Lm-based antigen delivery technology with SELLAS’ proprietary technology could result in a very compelling WT1-targeted cancer immunotherapy."
Sellas Life Sciences' lead product, galinpepimut-S, is a mixture of peptides that trigger a response against WT1 antigen, which is found on cancers and cancer stem cells. This should begin Phase 3 trials in acute myeloid leukemia (AML) in the first half of 2017, and in mesothelioma in late 2017. It has orphan drug designation and fast track designation for both indications.
Sellas isn't the only company targeting WT1. Inovio's SynCon WT1 cancer immunotherapy has been shown to break immune tolerance in pre-clinical trials, and will be added to the company's INO-5401, a cancer product expected to begin clinical trials in 2017. Formula Pharmaceuticals' FPI-01, a WT1 peptide vaccine, is in Phase 2 development for maintenance of first remission in acute myeloid leukemia (AML) and in mesothelioma, and could have potential in combination with other therapies, including checkpoint inhibitors. Atara Bio also has a WT1-targeted T-cell program in Phase 1 in plasma cell leukemia and multiple myeloma. This would be an off-the-shelf donor-derived product.