Childhood Germ Cell Tumor

VANCOUVER, British Columbia, Jan. 26, 2023 (GLOBE NEWSWIRE) -- Rakovina Therapeutics Inc. (TSX-V: RKV) (“the Company”), is pleased to announce a scientific presentation at the 6th Annual DDR Inhibitors Summit in Boston, MA. The 6th Annual DDR Inhibitors Summit, held in Boston January 24-26, 2023, brought together academic and pharmaceutical industry researchers to share progress across the preclinical and clinical DDR inhibitor landscape. The conference aims to provide an up-to-date overview of the field across both novel and established targets, utilizing inhibitors in combination studies and improving patient selection through novel biomarkers. Conference organizers highlighted that DNA damage response (DDR) inhibition has amassed significant interest over the last decade through its potential to treat many types of tumors such as breast and colorectal cancers, and even notoriously difficult-to-treat tumors. Professor Mads Daugaard, president & chief scientific officer of Rakovina Therapeutics Inc. presented an address intitled “Exploring a Novel Dual PARP-HDAC Inhibitor for the Treatment of Ewing Sarcoma,” in which he described the company’s research results with its novel kt-3000 series in pre-clinical models of Ewing sarcoma, a rare childhood tumor. The data demonstrated that co-inhibition of PARP and HDAC amplifies DNA damage and cytotoxicity in cancer cells. An FDA approved PARP inhibitor has previously been tested in a phase II clinical study in Ewing sarcoma where it failed to produce durable responses. Prof. Daugaard reported that Ewing sarcoma cancer cells are highly sensitive to treatment with combination PARP-HDAC inhibition exhibited by kt-3000 drug candidates. “It was an honor to present work to the distinguished audience at today’s summit,” said Prof. Daugaard. “We look forward to continuing to share our continued progress with the medical and pharmaceutical community as we seek to advance a kt-3000 lead candidate toward human clinical trials.” Development of Rakovina Therapeutics’ novel kt-3000 bi-functional DNA-damage response inhibitors is supported, in part, by the St. Baldrick’s Foundation Martha’s BEST Grant for All, which is aimed at developing new treatments for Ewing sarcoma, an aggressive bone and soft tissue cancer in children and young adults. About Rakovina Therapeutics Inc. Rakovina Therapeutics Inc. is focused on the development of new cancer treatments based on novel DNA-damage response (DDR) technologies. The Company has established a pipeline of novel DNA-damage response inhibitors with the goal of advancing one or more drug candidates into human clinical trials and obtaining marketing approval for new cancer therapeutics from Health Canada, the United States Food and Drug Administration and similar international regulatory agencies. Further information may be found at . Additional Information The TSXV has neither approved nor disapproved the content of this press release. Neither the TSXV nor its Regulation Services Provider (as that term is defined in policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release. Notice regarding forward-looking statements: This release includes forward-looking statements regarding the Company and its respective business, which may include, but is not limited to, statements with respect to the proposed business plan of the Company and other statements. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “is expected”, “expects”, “scheduled”, “intends”, “contemplates”, “anticipates”, “believes”, “proposes” or variations (including negative variations) of such words and phrases, or state that certain actions, events, or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Such statements are based on the current expectations of the management of the Company. The forward-looking events and circumstances discussed in this release may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including risks regarding the medical device industry, economic factors, regulatory factors, the equity markets generally and risks associated with growth and competition. Although the Company has attempted to identify important factors that could cause actual actions, events, or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events, or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and the Company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise. The reader is referred to the Company’s most recent filings on SEDAR for a more complete discussion of all applicable risk factors and their potential effects, copies of which may be accessed through the Company’s pro at . Contact: Rakovina Therapeutics Inc. David Hyman Chief Financial Officer Email: info@rakovinatherapeutics.com Investor Relations Contact IR@rakovinatherapeutics.com Media Contact MEDIA@rakovinatherapeutics.com

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