Wilms Tumor

- Primary Endpoint of Safety and Efficacy Met with Clinical Activity and Increased Survival Observed - - 70.3 Weeks Median Overall Survival for Patients Treated with Combination Therapy; Median Overall Survival in Relapsed/Refractory Patients Treated with Standard of Care is Approximately 28 Weeks - - Median Overall Survival of Patients without GPS Immune Response was 9.0 Months vs. 27.8 Months for Patients with GPS-Specific Immune Response: a Three-fold or 208.3% Increase in Survival Time - Dec. 27, 2023-- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS” or the “Company”), a late-stage clinical biopharmaceutical company focused on developing novel therapies for a broad range of cancer indications, today announced follow-up clinical/immune-response data from a Phase 1 investigator-sponsored clinical trial of its lead clinical candidate, galinpepimut-S (GPS), combined with the checkpoint inhibitor nivolumab (Opdivo®) in patients with refractory/relapsed malignant pleural mesothelioma (MPM). As previously reported, ten patients were enrolled in the clinical study and nine of the ten patients enrolled received at least three doses of GPS, with the third GPS dose given in combination with nivolumab. Nine out of ten patients (90%) had sufficient samples collected to be analyzed for GPS-specific immune response. All enrolled patients had either received and progressed with or were refractory to frontline pemetrexed-based chemotherapy. Additional analyses for the correlation of immune response and survival benefit were performed. Immune response was defined as a measurable increase in activated Wilms Tumor 1 (WT1) specific T cells, both CD8 T+ cells (killer T cells) and CD4+ T cells (regulatory T cells). Of the 10 evaluable patients, eight were male and two were female, with a median age of 69 years. Sixty percent entered the study as Stage III or IV patients. Initial tumor stages were I (one patient), II (three patients), III (two patients) and IV (four patients). All patients had MPM epithelioid and/or sarcomatoid variant, a tumor that universally expresses WT1, one of the most widely expressed cancer antigens, ranked by the National Cancer Institute as the top priority among cancer antigens for immunotherapy. The key clinical efficacy and immune response study outcomes are as follows: 70.3 weeks (17.6 months) median overall survival (OS) was achieved in patients who received the combination therapy (9/10 patients) and 54.1 weeks (13.5 months) for all 10 patients (nine patients with combination therapy and one GPS-only patient). Median OS for patients who entered the study as Stage IV patients was 62.3 weeks (15.6 months). OS was calculated as the time from cessation of the most recent previous therapy until confirmed death or most recent data update for patients who are still alive (40% of patients). The median OS among patients who did not have an immune response to GPS was 9.0 months; the median OS for patients who had an immune response to GPS was 27.8 months, more than three times longer median OS (208.3% increase). Among the nine evaluable patients, four patients had a CD4+ immune response (44.4%) and three patients had a CD8+ immune response (33.3%) to GPS. Three patients had both CD4+ and CD8+ immune responses (33.3%). Among patients who had a full immune response (both CD4+ and CD8+) to GPS, two patients achieved an objective response (66.7%), while among the patients who did not have an immune response to GPS one patient achieved an objective response (14.3%). 11.9 weeks median progression-free survival (PFS) was observed for all patients. The disease control rate (DCR) was 30% with three patients achieving stable disease per RECIST criteria with a tumor volume decrease of up to 17%. DCR is the sum of the overall response rate and rate of stable disease. Angelos Stergiou, M.D., Sc.D. h.c., President and CEO, SELLAS commented: “We are excited that in a bulky, measurable disease setting, such as in this relapsed/refractory advanced mesothelioma study, we have observed yet again strong GPS-specific immune responses which appear to be correlated with significant survival benefit in patients when combined with checkpoint inhibitors, a more than 200% survival benefit. As we had hypothesized in the past, this increase in survival appears to be consistent with long-term immunity-mediated antitumor effect with our immunotherapy combination as we had seen in other studies with GPS, and, importantly, the positive survival outcomes seen in this study are accompanied with a safety profile which is similar to that of the checkpoint inhibitor alone. We believe that these observed survival benefits in the active disease setting further confirm the strong biological effect of GPS in even the most challenging settings where GPS seems to contribute to stopping the progression of extremely aggressive cancers and demonstrates its utility as a potentially effective combination therapy.” With approximately 3,300 cases in the United States each year, accompanied by a rising incidence in developing countries, MPM is notoriously difficult to treat and can lead to poor clinical outcomes with respect to both OS and PFS, especially for those patients with the sarcomatoid variant who show a median OS of approximately 4.0 to 5.0 months. In relapsed and refractory patients who progressed after the first line standard of care pemetrexed, a similar patient population to that in the GPS nivolumab combination trial, the common treatment regimen is vinorelbine and OS in those patients is reported to be between 4.5 and 6.2 months. In patients treated with other chemotherapy regimens, such as carboplatin and irinotecan, the median OS is reported to be approximately 7.0 months. 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, 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 the 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 SLS009 (formerly 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. Opdivo® is a registered trademark of Bristol Myers Squibb and is not a trademark of SELLAS. The manufacturer of this brand is not affiliated with and does not endorse SELLAS or its products. The content above comes from the network. if any infringement, please contact us to modify.

– FDA feedback indicates Company’s CMC plans are in alignment with FDA’s requirements and expectations towards a BLA – – CMC regulatory alignment is critical step in approval pathway for GPS – NEW YORK, Nov. 13, 2023 (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 it recently concluded a Type C meeting with the U.S. Food and Drug Administration (FDA) regarding the Company’s Chemistry, Manufacturing, and Controls (CMC) sections in a potential biologics license application (“BLA”) for SELLAS’ lead product candidate, galinpepimut-S (GPS). SELLAS submitted a CMC Briefing Package to the FDA which provided an up-to-date overview of the extensive work completed for the GPS CMC program and commercial manufacturing and regulatory plans. The FDA reviewed this package of data and accompanying questions to the agency and responded with favorable guidance. To date, the Company has successfully completed numerous clinical development and CMC objectives in advancing GPS monotherapy into its Phase 3 REGAL study in patients with acute myeloid leukemia (“AML”) in the maintenance setting after achievement of second complete remission. CMC activities in support of the clinical development leading to this Type C meeting include: Manufacturing lyophilized clinical GMP batches;Qualifying processes;Validating analytical methods; andMonitoring the stability program. The FDA also agreed on the Company’s proposed stability data generation plan for the commercial presentation of GPS. GPS is expected to be stored at 2-8 C (36 – 46 F) making it more accessible for end-users. Andrew Elnatan, Vice President of Regulatory Affairs, CMC & Quality at SELLAS, stated, “We are pleased with the positive outcome of the Type C meeting and FDA’s guidance on the advancement of the CMC plans as part of the GPS program development. The responses to questions regarding our proposed potency assay and manufacturing processes validation are aligned with our expectations and will help guide our plans towards a potential future successful BLA assuming positive data from the REGAL study.” “We look forward to completing our enrollment in the Phase 3 REGAL trial, outside of China, this month and working closely with the FDA as we continue to advance our GPS development program. GPS, through its unique mechanism of action and novel technology, has the potential to become the first immunotherapy, cancer vaccine to reach the market for AML. There are currently no FDA-approved drugs to address the high unmet medical need that exists in treating patients in the maintenance setting in second complete remission,” said Angelos Stergiou, MD, ScD hc, President and Chief Executive Officer at SELLAS. “Our off-the-shelf therapy, GPS, was precisely and deliberately designed to target Wilms Tumor 1 and the multivalent approach of GPS targets 25 carefully selected WT1 epitopes, allowing it to be maximally immunogenic by eliciting both CD4 and CD8 immune responses. GPS has the potential to offer clinical benefit to this population of leukemia patients and the positive CMC regulatory feedback is a critical step in its development.” 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, 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 SLS009 (formerly 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. 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 GPS clinical development program, including CMC data therefrom, regulatory strategy and future activities, including the potential filing of a BLA with the FDA. 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 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 16, 2023 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 MackleManaging DirectorLifeSci Advisors, LLCSELLAS@lifesciadvisors.com

Record-breaking 2023 Gift Brings the PMC's Total Contributions in Support of Cancer Research and Treatment within Reach of $1 Billion Fundraising Milestone in 2024 BOSTON, Nov. 13, 2023 /PRNewswire/ -- Today, the Pan-Mass Challenge (PMC), the world's single most successful athletic fundraiser, announced its largest gift ever for cancer research, treatment, and care at the world-renowned Dana-Farber Cancer Institute, a record-breaking $72 million. This impressive gift will bring the PMC's total contributions to $972 million since 1980, positioning the organization to cross a monumental $1 billion in cumulative fundraising for the Institute in 2024. Continue Reading On Sunday, November 12, 2023, the Pan-Mass Challenge announced a record-breaking $72 million gift to Dana-Farber Cancer Institute during a celebratory brunch for riders, volunteers, donors, and corporate partners who contributed to this year’s donation. Photo Credit: John Deputy "Our riders continue to expand the very definition of what a bike-a-thon, and a bicycle, was really meant to do! Their support of the PMC and Dana-Farber is unwavering," said Billy Starr, PMC founder and executive director. "The impact this year's gift has is unparalleled and, as we head towards $1 billion cumulatively raised, this is a proud moment to celebrate the progress that has been made in the fight against cancer thanks in large part to PMC fundraising efforts." When the PMC began in 1980, the five-year relative survival rate for cancer was 50 percent, and today, it's more than 65 percent. The organization continues to make a profound difference in the lives of patients worldwide, thanks to advances enabled by its robust support of cancer research, treatment, and care at Dana-Farber. In recent years, PMC funding has played a key role in enhancing early detection – for example, Dana-Farber scientists developed new blood tests that precisely detect tumor DNA in Wilms tumor, a rare pediatric kidney cancer, and in recurrent HPV-driven oropharyngeal cancer, a major advancement in finding these cancers early. This year's $72 million gift was revealed during a celebratory brunch for riders, volunteers, donors, and corporate partners at Legal Harborside in Boston, Massachusetts, on Sunday morning. Notably, and for the 17th consecutive year, the PMC donated 100 percent of every rider-raised dollar to support the lifesaving mission of Dana-Farber. The PMC remains Dana-Farber's largest single contributor, accounting for 62 percent of its Jimmy Fund's annual revenue. "Year after year, the PMC community's extraordinary support touches every aspect of our organization from our cancer research to the care we deliver to our patients," said Laurie H. Glimcher, MD, president and CEO of Dana-Farber. "As a proud eight-year PMC rider myself, I get to experience the joy of PMC weekend every August and then witness the impact of this extraordinary gift, which is immeasurable to cancer patients both at Dana-Farber and around the world." In August of this year, 6,500 riders and 3,100 volunteers joined together from across the globe for the 44th PMC, cycling up to 211 miles across the State of Massachusetts to raise this year's record gift. Looking ahead to 2024, the PMC is eager to reconvene its dedicated community of riders, volunteers, donors, and corporate sponsors to not only raise the fundraising bar for cancer research and treatment once again, but to achieve a significant milestone together: $1 billion contributed to fighting cancer. The PMC is presented by the Red Sox Foundation® and M&T Bank. To learn more or make a financial contribution to the cause, visit , or call (800) WE-CYCLE. Connect with #PMC2023 on Facebook, X, Instagram and LinkedIn. About Dana-Farber Cancer Institute Dana-Farber Cancer Institute is one of the world's leading centers of cancer research and treatment. Dana-Farber's mission is to reduce the burden of cancer through scientific inquiry, clinical care, education, community engagement, and advocacy. Dana-Farber is a federally designated Comprehensive Cancer Center and a teaching affiliate of Harvard Medical School. We provide the latest treatments in cancer for adults through Dana-Farber Brigham Cancer Center and for children through Dana-Farber/Boston Children's Cancer and Blood Disorders Center. Dana-Farber is the only hospital nationwide with a top 4 U.S. News & World Report Best Cancer Hospital ranking in both adult and pediatric care. As a global leader in oncology, Dana-Farber is dedicated to a unique and equal balance between cancer research and care, translating the results of discovery into new treatments for patients locally and around the world, offering more than 1,100 clinical trials. About the Pan-Mass Challenge The Pan-Mass Challenge (PMC) is a bike-a-thon that today raises more money for charity than any other single athletic fundraising event in the world. The PMC was founded in 1980 by Billy Starr, who remains the event's executive director, an annual cyclist, and a fundraiser. The PMC has since raised $972 million for adult and pediatric patient care and cancer research at Dana-Farber Cancer Institute through the Jimmy Fund. The event donates 100 percent of every rider-raised dollar directly to the cause, generating 62 percent of the Jimmy Fund's annual revenue as Dana-Farber's single largest contributor. The PMC has successfully melded support from committed cyclists, volunteers, corporate sponsors, and individual contributors, all of which are essential to the PMC's goal and model: to attain maximum fundraising efficiency while increasing its annual gift. The PMC's hope and aspiration is to provide Dana-Farber's doctors and researchers with the necessary resources to discover cures for all cancers. For more information on the Pan-Mass Challenge, visit . SOURCE Pan-Mass Challenge