Partnerships

Memorial Sloan Kettering Cancer Center (MSKCC)In September 2014, SELLAS announced an exclusive global collaboration and exclusive license agreement with Memorial Sloan Kettering Cancer Center (MSKCC) for the development, marketing and commercialization of MSKCC’s proprietary WT1 cancer immunotherapy.

WT1 is over-expressed in many human cancers, including most blood cancers and many solid tumors, including mesothelioma, and cancers of the ovary, lung, gastrointestinal tract, breast, and prostate. The National Cancer Institute recently ranked WT1 as the top target for cancer immunotherapy. MSKCC researchers have already shown the potential of this immunotherapy to safely immunize patients against the WT1 antigen in several clinical trials. SELLAS will now further develop the drug in other, larger studies.

CordenPharma CordenPharma International is a full-service partner in the contract development & manufacturing of APIs, drug products, and associated packaging services. Through a network of fully-inspected cGMP facilities across Europe and the US organized under five technology platforms – Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, Small Molecules, Antibiotics - CordenPharma experts translate complex ideas at any stage of development into high-value products.

PolyPeptide Group The PolyPeptide Group is a contract manufacturing organization for peptides and peptide related molecules. The group is one of the world’s largest independent contract manufacturers of therapeutic peptides for the cosmetic, pharmaceutical and veterinary markets employing more than 450 people in six manufacturing sites located in France, India, Scandinavia and the USA. The company manufactures over one third of all approved peptide drug substances (22 of 62 approved products worldwide) accounting for over 25% of the sales of outsourced peptide therapeutics worldwide.

Advaxis SELLAS has a license with Advaxis to develop a novel cancer immunotherapy agent using Advaxis’ Lm-based antigen delivery technology with SELLAS’ patented WT1 targeted heteroclitic peptide antigen mixture (galinpepimut-S).

Merck & Co., Inc.5 tumor indications
SELLAS entered into a Clinical Trial Collaboration and Supply Agreement for the conduct of a combination clinical trial Merck & Co., Inc., Kenilworth, N.J., USA (known as MSD outside the United States and Canada), whereby galinpepimut-S will be administered in combination with MSD's anti-PD-1 therapy pembrolizumab (Keytruda^®) in a Phase 1/2 trial enrolling patients with WT1-positive relapsed or refractory tumors in five cancer indications, including both hematologic malignancies and solid tumors. The study is expected to explore the following cancer indications: colorectal (arm enriched in but not exclusive to patients with microsatellite instability-low [MSI-L]), ovarian, small cell lung, triple-negative breast, and AML treated with hypomethylating agents.

Bristol-Myers Squibb (BMS) Galinpepimut-S plus nivolumab (ovarian cancer)
An investigator-sponsored trial (IST) is ongoing with galinpepimut-S in combination with nivolumab (Optivo^®; BMS). There is cogent immunobiological rationale supporting a study of the combination of nivolumab and GPS, seeking a signal of potential clinical synergy between the two agents. This Phase 1/2 clinical trial is an open label, single-center, investigator-sponsored, 10 patient study enrolling patients with ovarian cancer who have relapsed at least once and returned to complete clinical remission after additional (first or subsequent) salvage chemotherapy. Interval surgery is permitted. Eligible women harbor tumors that must be positive for WT1 protein expression, and will initially receive 6 GPS administrations over 12 weeks along with 7 infusions of nivolumab over 14 weeks. Non-progressors at the week 15 will receive 4 additional GPS doses every 8 weeks. The primary endpoint of the study is to assess the safety of the combination, with secondary endpoints being the evaluation of WT1-specific T- and B-cell immune responses, estimation of the 1-year progression-free survival (PFS) rate, and patient characterization by the targeted tumor sequencing test MSK-IMPACT™ (Integrated Mutation Profiling of Actionable Cancer Targets).

NeuVax^TM + trastuzumab, HER2 1+,2+ This investigator-sponsored trial is a clinical collaboration between Galena, Genentech/Roche, and the Henry M. Jackson Foundation. Genentech/Roche is providing the trastuzumab and partial funding for this trial.

NeuVax^TM + trastuzumab, HER2 3+ Funding for this trial was awarded through the Congressionally Directed Medical Research Program (CDMRP), funded through the Department of Defense (DoD), via a Breast Cancer Research Program (BCRP) Breakthrough Award.

Ductal Carcinoma in Situ (DCIS) This trial is being run in collaboration with the National Cancer Institute (NCI). The University of Texas M.D. Anderson Cancer Center (MDACC) Phase I and II Chemoprevention Consortium is the lead for this multi-center trial. The Consortium is funded through the Division of Cancer Prevention at NCI, which will provide financial and administrative support for the trial. Galena will provide NeuVax, as well as additional financial and administrative support.