SELLAS Life Sciences Group Signs Exclusive License Agreement for Global Rights on Development and Commercialization of WT1 Cancer Vaccine with Memorial Sloan Kettering Cancer Center
Unique Multivalent WT1 Vaccine to be developed across hematological malignancies
and solid tumors
Innovative Regulatory Strategy to be initiated in the US and Europe to accelerate development program
September 4, 2014 – New York, NY — SELLAS Life Sciences Group (SELLAS), a Swiss-based development-stage biopharmaceutical company today announced that it has signed an exclusive global collaboration and license agreement with Memorial Sloan Kettering Cancer Center (MSK) for the development, marketing, and commercialization of MSK’s proprietary WT1 cancer vaccine.
“This collaboration underscores SELLAS’ commitment to innovative therapies for major unmet medical needs and is of paramount importance and a significant milestone for us,” said Angelos M. Stergiou, MD, SELLAS Chairman and Chief Executive Officer. “We believe this will enable us to accelerate the development of the WT1 vaccine, and we would like to congratulate the Memorial Sloan Kettering research team for their superb work identifying very effective peptide sequences for this vaccine.”
Initially, work will focus on the development of the WT1 vaccine in leukemia, mesothelioma, and multiple myeloma, followed by additional solid tumor indications. SELLAS has initiated a development and regulatory strategy with an expert group in the United States and Europe to assure the vaccine clears the FDA and EMA regulatory process. There are also plans to begin phase 2 clinical studies in early 2015.
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. MSK researchers have already shown the potential of this vaccine to safely immunize patients against the WT1 antigen in several clinical trials. SELLAS will now further develop the drug in other, larger studies.
Under the license agreement, SELLAS will have certain rights to future MSK findings in this field.
“We are confident in SELLAS’ ability and expertise to make the WT1 vaccine a treatment option for various hematologic and solid tumor indications,” said David Scheinberg, MD, PhD, Chairman of MSK’s Center for Experimental Therapeutics, and inventor of WT1 vaccine. “The current treatment options for these difficult and most often lethal cancers are poor and advancing this vaccine to market will allow a new treatment tool for physicians. SELLAS has assembled a team with proven expertise in cancer vaccine development.”
“We are indeed delighted to enter into this strategic partnership with Memorial Sloan Kettering,” said Gerald L. Messerschmidt, MD, FACP, SELLAS’ Chief Medical Officer. “We believe the WT1 vaccine, one of the most promising cancer vaccines currently available, is a novel target to teach the cellular immune system to specifically attack cancer cells and to potentially improve patient survival.
In order to understand our WT1 vaccine multivalent peptide sequence technology the peptide sequence interacts with various directing that teach or stimulate the specific immune system cells to recognize the cancer as foreign fight to kill the cancer cells that may be in the body. This license agreement epitomizes the fact of SELLAS building a strong cancer therapeutics pipeline.”
About the WT1 Vaccine
WT1 protein is a transcription factor that is not generally expressed in adult tissues, but reappears in a large number of cancers, as well as in certain cancer stem cells. The WT1 protein is not drugable by traditional approaches, but it can be targeted by the immune system, in particular by CD4 T cells and CD8 T cells. A number of different peptide sequences from the WT1 protein have been identified as being immunogenic and capable of stimulating cytotoxic T cells that will kill WT1 expressing cancer cells. The WT1 vaccine was assembled from a set of immunogenic peptides that are capable of stimulating both CD4 and CD8 T cells. In addition, key amino acids from some of these peptides have been modified to improve their immunogenicity. The WT1 peptides in the vaccine are administered in combination with an immunologic adjuvant and an immune stimulant to improve the immune response to the target. Initial studies with the vaccine were conducted in patients with myeloid leukemias and thoracic cancers, such as lung cancer and mesothelioma. Based on encouraging results in these initial studies, additional phase 2 trials were launched in hematopoietic cancers and solid tumors. Results of these initial studies have shown the vaccine is well-tolerated and capable of inducing an immune response to the peptide. Patients enrolled in the acute myeloid leukemia trials have shown prolonged survival following vaccination.
About SELLAS Life Sciences Group
SELLAS Life Sciences is a Swiss-based development-stage biopharmaceutical company that acquires and develops innovative products for the treatment of various indications in cancer and the central nervous system (CNS), including orphan indications. The headquarters of the company are located near Zurich, Switzerland. Being a healthcare-oriented global group of companies, SELLAS has embraced all major aspects of the healthcare industry. Our core team is highly experienced in developing drugs and vaccines throughout all stages of the product’s life cycle to the point of approval, marketing, and commercialization, pricing, and reimbursement, as well as third party out-licensing deals.
Our management team has a proven track record of drug discovery and development, and successful clinical trial coordination. In addition, the team has been involved in bringing previous companies to the German DAX and US NASDAQ stock markets, successful out-licensing of drug candidates, co-development, R&D partnership with big pharma, and creating multiple alliances with centers of excellence to accelerate drug discovery and development. The management team has also developed cost-effective and time efficient ways of developing drug candidates to value inflection points.
Presently, there are two phase 2 products to enter clinical trials in Europe and the USA in 2014 and 2015 across five indications in cancer and CNS.
Next to the WT1 vaccine for hematological malignancies and solid tumors, in-licensed by Memorial Sloan Kettering, SELLAS has the zolpidem asset for various CNS basal ganglia disorders, including Parkinson’s Disease (PD) and the orphan indication Progressive Supranuclear Palsy (PSP), which SELLAS intends to develop via the expedited 505 (b)(II) regulatory path and as a fast-track product. The phase two program will be initiated around Q4 2014 for the orphan indication Progressive Supranuclear Palsy (PSP) and followed thereafter for Parkinsons Disease (PD). Due to high efficacy doses, SELLAS will implement a REMS (Risk Mitigation Safety) program. Numerous peer-reviewed journals have already published data supporting that the use of this drug is indeed highly effective and safe in patients with PD as well as with PSP.
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