Childhood Rhabdomyosarcoma

Company expands capabilities of its Precision Orthopaedics platform PARSIPPANY, N.J., July 19, 2023 /PRNewswire/ -- Onkos Surgical, a leading innovator of solutions for musculoskeletal oncology and complex orthopaedic procedures, announced its launch of the JTS Extendible Prosthesis, a novel growing implant designed for pediatric patients with bone cancer, and unveiled its new, state-of-the-art manufacturing and R&D innovation center at its Parsippany, NJ headquarters to support the integration and growth of the technology. Continue Reading Onkos Surgical manufacturing facility in Parsippany, NJ The JTS Extendible Prosthesis is a growing implant with a significant body of clinical evidence for pediatric patients with bone cancer. With the use of magnetic technology, the implant expands non-invasively to accommodate the patients natural growth curve, preserving lower limb length equality for young patients with bone loss due to cancer. The addition of the JTS technology expands the company's access and ability to provide solutions for pediatric patients. Patrick Treacy, Onkos Founder and CEO said, "This is a transformative time for our company, which was founded on serving this group of surgeons treating complex orthopaedic procedures and the patients they care for. Pediatric sarcoma patients, who are candidates for the JTS growing prosthesis, often have complex treatment cycles in which we need to deliver precision designs in a very specific treatment window. Our investment in manufacturing innovation and design expertise will make a big difference in the future for these surgeons, patients, and families and we couldn't be more proud to serve their needs." "This milestone reflects an exciting evolution for Onkos as the company accelerates our investments to serve the pediatric musculoskeletal oncology space and broaden our Precision Orthopaedics portfolio. The new manufacturing facility and innovation center will enable a more agile production environment and provide a world-class experience for our customers. Everything about the design of the facility is geared toward increasing speed, capacity and ownership of the supply chain to optimize our ability to deliver personalized devices," said Gary Thomas, Onkos VP of Manufacturing. For more information on Onkos Surgical and its products and services, please visit . About Onkos Surgical Onkos Surgical is a leader in innovative solutions for musculoskeletal oncology and complex orthopaedic procedures. With its Precision Orthopaedics approach, surgeons are better informed about patient-specific clinical challenges and are able to plan and implement a more precise reconstruction. Onkos' personalized approach supports improved patient outcomes and experiences using the latest innovations in virtual surgical planning, 3D modeling and printing, implant design, and workflow optimization. More than 350 of the leading academic medical institutions in the US choose Onkos Surgical Precision Orthopaedics. Forward Looking Statements Certain statements made in this release that are not statements of historical or current facts are forward-looking statements which involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance, or achievements of the company to be materially different from historical results or from any future results or projections expressed or implied by such forward-looking statements. In many cases, forward-looking statements can be identified by terms such as "future," "believes," "expects," "may," "will," "should," "potential," "estimates," "intends," "anticipates" or "plans" or the negative of these terms or other comparable terminology. Forward-looking statements are based upon management's beliefs, assumptions and current expectations but are subject to known and unknown risks and uncertainties including, without limitation, market trends and demand, supply chain interruptions, the availability of skilled labor, equipment failures, and property damage. Although management believes that the expectations reflected in the forward-looking statements are reasonable, forward-looking statements are not, and should not be relied upon as a guarantee of future performance or results. The forward-looking statements included are made only as the date of this release. The company assumes no obligation to update any information or forward-looking statement contained herein, save for any information required to be disclosed by law. Media Contacts: Sean Curry SVP, Commercial Operations Onkos Surgical [email protected] 973.264.5400 SOURCE Onkos Surgical

NEW YORK, Dec. 06, 2022 (GLOBE NEWSWIRE) -- 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, today announced 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. 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 About SELLAS Life Sciences Group, Inc. SELLAS is a late-stage clinical biopharmaceutical company focused on the development of novel therapeutics for a broad range of cancer indications. SELLAS’ lead product candidate, galinpepimut-S (GPS), is licensed from Memorial Sloan Kettering Cancer Center and targets the WT1 protein, which is present in an array of tumor types. GPS has potential as a monotherapy and combination with other therapies to address a broad spectrum of hematologic malignancies and solid tumor indications. The Company is also developing GFH009, a small molecule, highly selective CDK9 inhibitor, which is licensed from GenFleet Therapeutics (Shanghai), Inc., for all therapeutic and diagnostic uses in the world outside of Greater China. For more information on SELLAS, please visit www.sellaslifesciences.com.

Studies are Supported and Funded ThroughCooperative Agreement Grants from the National Cancer Institute GFH009 to be Evaluated Against Pediatric Solid Tumors and Leukemia Models at Eight Participating Research Institutions NEW YORK, Dec. 06, 2022 (GLOBE NEWSWIRE) -- 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, today announced 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. 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 About SELLAS Life Sciences Group, Inc. SELLAS is a late-stage clinical biopharmaceutical company focused on the development of novel therapeutics for a broad range of cancer indications. SELLAS’ lead product candidate, galinpepimut-S (GPS), is licensed from Memorial Sloan Kettering Cancer Center and targets the WT1 protein, which is present in an array of tumor types. GPS has potential as a monotherapy and combination with other therapies to address a broad spectrum of hematologic malignancies and solid tumor indications. The Company is also developing GFH009, a small molecule, highly selective CDK9 inhibitor, which is licensed from GenFleet Therapeutics (Shanghai), Inc., for all therapeutic and diagnostic uses in the world outside of Greater China. For more information on SELLAS, please visit . Forward-Looking Statements This press release contains forward-looking statements. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, forward-looking statements can be identified by terminology such as “plan,” “expect,” “anticipate,” “may,” “might,” “will,” “should,” “project,” “believe,” “estimate,” “predict,” “potential,” “intend,” or “continue” and other words or terms of similar meaning. These statements include, without limitation, statements related to the pre-clinical development of GFH009 and the potential for GFH009 as a drug development candidate. These forward-looking statements are based on current plans, objectives, estimates, expectations and intentions, and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the COVID-19 pandemic and its impact on the Company’s clinical plans and business strategy, risks and uncertainties associated with oncology product development and clinical success thereof, the uncertainty of regulatory approval, and other risks and uncertainties affecting SELLAS and its development programs as set forth under the caption “Risk Factors” in SELLAS’ Annual Report on Form 10-K filed on March 31, 2022 and in its other SEC filings. Other risks and uncertainties of which SELLAS is not currently aware may also affect SELLAS’ forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof. SELLAS undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward-looking statements were made. Investor Contact Bruce Mackle Managing Director LifeSci Advisors, LLC SELLAS@lifesciadvisors.com