On December 6, 2022 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported that SELLAS’ highly selective CDK9 inhibitor, GFH009, will be evaluated in pediatric solid tumors and leukemia models through the National Cancer Institute (NCI) Pediatric Preclinical in Vivo Testing (PIVOT) Program (Press release, Sellas Life Sciences, DEC 6, 2022, View Source [SID1234624847]).

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GFH009 testing through the program involves a two-phase research plan for pharmacokinetics (PK) and efficacy in pediatric tumors. In the first phase, PIVOT principal investigators will conduct PK experiments to confirm the appropriate dose and route administration for GFH009. In the second phase, monotherapy in vivo efficacy testing for GFH009 will be performed by PIVOT investigators. Studies will be supported through cooperative agreement grants from the NCI to the seven PIVOT research programs performing the testing and a centralized coordinating center.

"Participation in the NCI PIVOT Program provides an extensive and invaluable level of expertise in preclinical pediatric cancer testing and we are excited that we were granted this program after a diligent review process. In addition to being a source of non-dilutive funding for our GFH009 program, we also believe this discovery work could ultimately support a path to a rare disease pediatric voucher," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "We are optimistic that the significant anti-tumor activity of GFH009 recently demonstrated in in vitro and in vivo models will be mirrored in PIVOT’s pediatric studies, allowing us to further expand our GFH009 clinical development program to include pediatric tumor types," continued Dr. Stergiou.

The NCI-supported PIVOT program is a comprehensive program to systematically evaluate novel agents against genomically characterized pediatric solid tumor and leukemia models at eight participating research institutions. By supporting a more reliable agent prioritization process, the PIVOT program contributes to the goal of accelerating discovery of more effective treatments for children with cancer.

Each PIVOT principal investigator has expertise in preclinical testing of childhood cancer in vivo models. These models utilize patient derived xenografts, many of which are refractory to current standard of care treatments, from high-risk childhood cancers and have undergone comprehensive genomic characterization to demonstrate close resemblance to genetic alterations seen in the respective human cancers. Research strategies are based on a substantial body of data showing that preclinical testing in the appropriate pediatric cancer models, combined with expertise on relative drug exposures tolerated in mice and humans, provides powerful insights into likely clinical utility of investigational agents.

PIVOT Program participating institutions and relevant pediatric cancer models are as follows:

Jackson Laboratory which serves as PIVOT Coordinating Center
St. Jude Children’s Research Hospital for soft tissue sarcomas including rhabdomyosarcoma
MD Anderson Cancer Center for osteosarcoma
University of Texas Health Science Center San Antonio for Ewing sarcoma rhabdomyosarcoma, kidney, and liver cancers
Memorial Sloan Kettering Cancer Center for pediatric sarcomas and other solid tumors
Children’s Hospital of Chicago for orthotopic CNS tumors
Children’s Cancer Inst Australia for acute lymphoblastic leukemia
Children’s Hospital of Philadelphia for neuroblastoma