Advaxis has licensed its proprietary Lm-based antigen delivery technology to Sellas, under a cancer immunotherapy collaboration that could generate up to $358 million for Advaxis, the companies said today.

Sellas plans to develop a cancer immunotherapy that combines the Advaxis technology with Sellas’ patented Wilms Tumor antigen 1 (WT1)-targeted heteroclitic peptide antigen mixture (galinpepimut-S).

Galinpepimut-S is a cancer immunotherapeutic agent licensed from Memorial Sloan Kettering Cancer Center that targets a broad spectrum of hematologic cancers and solid tumor indications.

Sellas said galinpepimut-S is poised to enter Phase III clinical trials in patients with acute myeloid leukemia (AML) and malignant pleural mesothelioma (MPM) in the first and second half of 2017, respectively.

Galinpepimut-S has shown positive Phase II clinical results in AML and MPM, as well as positive early clinical data in multiple myeloma, with a median overall survival (OS) in AML of 61.8 months vs. ~12 to 15 months for best standard treatment—and a median OS in MPM of 24.8 months vs.16.6 months in the control arm.

In addition to multiple myeloma, galinpepimut-S is also in development for ovarian cancer, where it is in Phase I and Phase II studies assessing a combination therapy with the Bristol-Myers Squibb cancer immunotherapy Opdivo® (nivolumab).

The immunotherapy candidate will soon enter the clinic in other indications as monotherapy or in combination with other immuno-oncology agents, Sellas said.

Galinpepimut-S has also been shown to induce strong immune responses (CD4+/CD8+) against the WT1 antigen and to access a broad range of human leukocyte antigen (HLA) types, the company added. Sellas recently received orphan drug designations for galinpepimut-S in AML and MPM from the FDA and European Medicines Agency; as well as the FDA’s Fast Track Designation for AML and MPM.

Advaxis says its Lm-based antigen delivery technology has shown the potential to induce enhanced innate immune stimulation and generate specific T cells while reducing immune tolerance in the tumor microenvironment.

Sellas reasons that the combination of its WT1 antigens with Advaxis’ technology—which has generated innate immune stimulation alongside potent and sustained T-cell responses—has the potential to yield improved clinical activity against many cancer types that express WT1 by precisely directing an immune response.

“The delivery afforded by the Advaxis technology expands upon our current programs and should substantially enhance the clinical utility seen with galinpepimut-S, and eventually, the cancer immunotherapy armamentarium for a variety of tumors,” Angelos Stergiou, M.D., Sc.D. h.c., Sellas vice chairman and CEO, said in a statement.

Future clinical studies, Sellas said, will investigate that capability in the presence of measurable residual or recurrent disease.

“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,” Advaxis president and CEO Daniel J. O'Connor said today in a statement.

Advaxis will conduct all preclinical activities required for an IND filing, with Sellas agreeing to oversee all clinical development and commercial activities.

In return for the license, Sellas has agreed to pay Advaxis up to $358 million tied to achieving development, regulatory, and commercial milestones. Should the cancer immunotherapy candidate receive regulatory approval, Sellas has agreed to pay Advaxis single-digit to low double-digit royalties based on worldwide net sales upon commercialization.








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