Mcl-1

- All key study objectives regarding pharmacokinetic, pharmacodynamic, safety, and clinical activity were met - - Complete remission (CR) achieved after three months of treatment with duration of eight months and one year survival at the latest assessment - - First time achievement of CR with CDK9 inhibition monotherapy in relapsed/refractory (r/r) acute myeloid leukemia (AML) patient – - Phase 2a data in r/r AML patients expected in March and Q2 2024 - NEW YORK, March 01, 2024 (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 the delivery of an oral presentation of data for the cohort of patients with acute myeloid leukemia (AML) from the Phase 1 dose-escalation study of SLS009 (formerly GFH009) by Dr. Tapan Kadia, Professor at MD Anderson Cancer Center and the study’s primary investigator, at the 2024 European School of Haematology Acute Leukaemias (ESH) Conference: How to Diagnose and Treat Acute Leukaemias, taking place March 1-3, 2024, in Stockholm, Sweden. Positive topline data for the heavily pretreated AML patients showed evidence of anti-tumor activity increasing with higher dose levels and no significant safety issues. Treatment with SLS009 resulted in a complete remission (CR) with no minimal residual disease (MRD) after three cycles as a monotherapy in an AML patient who had failed prior venetoclax plus azacytidine (aza/ven) therapy. The CR lasted eight months with the patient achieving one year survival at the latest assessment. This is the first time that a relapsed/refractory (r/r) AML patient achieved a CR with CDK9 inhibition monotherapy. Notably, the median survival for patients relapsed after aza/ven therapy is approximately 2.5 months. All key study objectives regarding pharmacokinetic (PK), pharmacodynamic (PD), safety, and clinical activity were met. Presented findings included: No dose-limiting toxicities or significant off-target adverse events (AEs) at any dose level. Maximum tolerated dose was not reached due to a favorable safety profile. Dose-proportional anti-leukemic activity across all dose levels and administration regimens studied, including bone marrow blast reduction of greater than 50% in patients with high burdens of leukemic bone marrow blasts indicating a broad therapeutic index and meaningful cell killing activity. Durable CR was observed in one patient who had previously failed aza/ven therapy, after three months of treatment, lasting eight months and one-year survival at the most recent assessment. Strong inhibitory activity against key biomarkers with a dose-proportional response and universal decrease of MYC and MCL-1 in evaluable patients. Proportional and well-controlled pharmacokinetics at all dose levels and at different dosing regimens. The recommended phase two dose (RP2D) for AML was established at 60 mg. Favorable safety pro with a notable absence of higher-grade extramedullary toxicities which have been frequently observed with other CDK9 inhibitors in development. “SLS009 is a highly selective CDK9 inhibitor with high specificity, only low grade off-target toxicity, confirmed efficacy on relevant biomarkers and clinical outcomes in hematologic malignancies,” said Dragan Cicic, MD, Chief Development Officer at Sellas. “Its potential strong synergy with the standard regimen of venetoclax and hypomethylating agents could open up new avenues in the treatment of acute myeloid leukemia. We are looking forward to additional findings from the ongoing Phase 2a trial with the topline data from the initial 45 mg safety-dose level expected by the end of March and the 60 mg RP2D level in the second quarter of this year.” The ongoing Phase 2a trial is designed to assess the safety and efficacy of SLS009 in combination with aza/ven in AML patients who stopped responding to standard aza/ven therapy and other venetoclax- based regimens. Patients are dosed at two SLS009 dose levels of 45 mg once a week and 60 mg either as a once-weekly dose or divided into two 30 mg doses weekly. 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 SLS009 , 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 SLS009 clinical development program, including data therefrom, and the timing for release of additional data. 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 Mackle Managing Director LifeSci Advisors, LLC SELLAS@lifesciadvisors.com

NEW YORK, Feb. 21, 2024 /PRNewswire/ -- The DeGregorio Family Foundation with the support of the Esophageal Cancer Awareness Association has awarded $75,000 to R. Taylor Ripley, MD, Associate Professor at the Michael E. DeBakey Department of Surgery at Baylor College of Medicine and a thoracic surgeon. The Grant is named in memory of Michael F. Price, the noted value investor and philanthropist, who was an early supporter of the Foundation. Dr. Ripley, along with Yuan Xu, MD, PhD, Instructor at Baylor College of Medicine, will continue to evaluate whether targeting the portion of the tumor cell responsible for energy production will improve treatment responses in esophageal adenocarcinoma. This funding is in addition to $75,000 awarded in 2023 and could increase, depending on results. Continue Reading Dr. R. Taylor Ripley Normally, the tumor cell 'energy center', called the mitochondria, protect the tumor cell from treatment with either chemotherapy or immunotherapy. Dr. Ripley and Dr. Xu have reported that esophageal tumors resisted cancer cell death through a protein on the mitochondria called Myeloid Leukemia Cell-1 (McI-1). This protein increases in tumor mitochondria to further resist treatment so that treatment does not work well. They are evaluating whether targeting McI-1 will improve the effects of standard treatments. Importantly, Mcl-1 is part of a 'pathway' that may block treatment responses. Dr. Ripley's team found that certain proteins in that pathway are responsible for Mcl-1 production. Therefore, if these newer proteins are targeted, then Mcl-1 will not be present to prevent tumor cells from dying during treatment. To test the hypothesis that targeting Mcl-1 or its regulatory proteins will improve treatment response, Dr. Ripley and his team have established two models. In the first model, they generate 'patient-derived explants' in which a tumor is directly removed during surgery. This approach enables evaluation within three days, which is important to decide about treatment for each patient. In the second model, they developed 'patient-derived xenografts' in which tumors from patients were implanted in mice, which allows longer-term treatment evaluation. These mice are treated with drugs that block Mcl-1 in combination with chemotherapy. Together, these two models will confirm the new approach of targeting the mitochondria to help patients respond to therapy. In 2020, gastric and esophageal cancers combined killed over 1.3 million people worldwide. Patients continue to face poor prognoses following gastroesophageal cancer diagnoses due to their chemo-resistant behavior and ability to metastasize. "The support of the DeGregorio Family Foundation is critical to the success of our research; we very much appreciate it," said Dr. Ripley. "Esophageal adenocarcinoma has been growing exponentially in the last four decades in the U.S. and is the most common subtype of esophageal cancer found here," concluded Lynn DeGregorio, President and Founder. "We are proud of Dr. Ripley and his team for their pioneering research." The DeGregorio Family Foundation, founded in 2006 after a 10th member of the DeGregorio family died of stomach cancer, has raised more than $8 million to fund innovative research to cure gastric and esophageal cancers. It is the only public foundation focused on funding research grants for both of these cancers. Click here to donate. For high-res. images: SOURCE DeGregorio Family Foundation

SHANGHAI, Jan. 11, 2024 /PRNewswire/ -- GenFleet Therapeutics, a clinical-stage biotechnology company developing cutting-edge therapies in oncology and immunology, announced that U.S. Food and Drug Administration (FDA) has recently granted another two designations for SLS009 (GFH009). GFH009 (highly selective CDK9 inhibitor) so far has received both fast track and orphan drug designations from the FDA for the treatment of adult patients with relapsed/refractory (r/r) peripheral T-cell lymphomas (PTCL) and r/r acute myeloid leukemia (AML). At present, two phase II studies are actively underway in China and the US, focusing on the treatment of r/r PTCL and r/r AML respectively. Numerous subjects in GFH009 studies achieved complete or partial responses, and superior safety profile & efficacy of GFH009 was observed in previous studies. GenFleet is conducting a multi-center, open-label, single-arm study of GFH009 for the treatment of r/r PTCL in close to 40 sites in China. The study is currently progressing into Phase II, following the completion of safety confirmation in Phase Ib. During the dose escalation portion of Phase I, the data demonstrated significant reduction in expression of proto-oncogenes such as MYC, MCL1 among patients with hematological malignancies including PTCL; clinical responses were observed in four PTCL patients, and one of these PTCL patients has been under continuous treatment for over 66 weeks. GenFleet's partner Sellas Life Sciences is currently undertaking a Phase II trial in the US for SLS009 (GFH009) in combination with venetoclax and azacitidine for treating r/r AML patients. The first patient enrolled at the safety dose level has achieved complete response. No dose-limiting toxicities were observed; significant anti-leukemic effects, marked by a decrease of 50% or more in bone marrow blasts, were observed in a substantial number of subjects. "Leading projects in GenFleet's pipeline made significant strides in registrational efforts over the past year. GFH925 was granted with NDA acceptance, priority review and two breakthrough therapy designations in China; GFH009 received FDA fast track and orphan drug designations for two indications. The forward-thinking strategy in GenFleet's pipeline buildup brings immense challenge as well as opportunities for our innovation. We appreciate recognition of supervisory bodies and collaborative efforts of business partners both in China and the US. As we step into new year, we are looking forward to more registrational advancements of our pipeline." stated by Yu Wang, M.D.,Ph.D., Chief Medical Officer of GenFleet. Fast Track Designation is a process designed by the FDA to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Programs with FTD are eligible for more frequent interactions with FDA to discuss the candidate's development plan, as well as a rolling review of NDA or BLA to facilitate Accelerated Approval and Priority Review if relevant criteria are met. Besides, the benefits provided by ODD include assistance in the drug development process, tax credits for qualified clinical costs, exemptions from certain FDA fees and seven years of marketing exclusivity. About CDK9 and GFH009 As a family of serine & threonine kinases, the cyclin-dependent kinase (CDK) family plays an important role in cell cycle regulation and transcription; CDK9 activity is inversely correlated with the overall survival rate of patients with multiple tumors. Data from phase I trial and the preclinical research of GFH009 were posted at the 2002 Annual Meeting of the American Society of Hematology. GFH009 monotherapy is well tolerated with preliminary clinical activity in patients with relapsed/ refractory lymphomas. According to preclinical research, GFH009 reduces the expression of downstream oncogenes required for rapid cellular division and protein expression through specific, short-lived inhibition of CDK9. With more than 100 times selectivity over other CDK subtypes, this depletion via GFH009 inhibition of CDK9 likely deprives oncogene-addicted cancer cells of crucial survival signals, leading to senescence and death. GFH009 also exhibits strong anti-proliferative activities in multiple human cell lines, effectively inhibits the growth of tumor in various xenograft models and significantly improves survival of tumor bearing animals. GenFleet received IND approval in 2020 for the GFH009 monotherapy to proceed into phase I trial treating patients with r/r hematological malignancies. In 2022, GenFleet and SELLAS Life Sciences Group (Nasdaq: SLS) entered into an exclusive license agreement across all therapeutic and diagnostic uses worldwide outside of Greater China (the Chinese mainland, Hong Kong, Macau and Taiwan). SOURCE GenFleet Therapeutics