survivin

NEW YORK, April 28, 2025 (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 preclinical efficacy of SLS009 in TP53 mutated Acute Myeloid Leukemia (AML) cells are being presented in a poster session at the American Association for Cancer Research (AACR) taking place from April 25th – 30th at McCormick Place Convention Center, Chicago, IL. Patients with TP53–mutated AML continue to face extremely poor outcomes, even with intensive chemotherapy or the addition of stem cell transplantation. Preclinical data suggest that SLS009, a highly selective CDK9 inhibitor, can induce apoptosis downstream of p53 by targeting critical proteins such as MCL-1 and survivin, regardless of p53 status. Immunoblot analysis reveals near-complete removal of these proteins in treated cells within 8 hours of exposure to SLS009. Furthermore, the treatment reduced TP53-mutated leukemia cell populations by up to 97% in combination with azacitidine–venetoclax, and by up to 80% as monotherapy. “These findings are an exciting step forward in addressing one of the most challenging subsets of AML,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “The ability of SLS009 to overcome TP-53 driven resistance in preclinical models, combined with the positive data we have seen in our ongoing Phase 2 AML program, including a response in a patient with a TP53 mutation, gives us hope that we may one day offer an effective therapeutic option to patients with AML who have long been underserved.” SLS009 is currently in Phase 2 clinical trials in patients with relapsed or refractory (r/r) AML following venetoclax-based regimens, including patients with TP53-mutated leukemia. Recently announced data revealed that r/r AML patients receiving 30 mg of SLS009 BIW achieved a mOS of 8.8 months for all patients, while the mOS in AML myelodysplasia-related-changes (MRC) patients reached 8.9 months - far surpassing the historical benchmark of 2.5 months. Among patients with mutation ASXL1, 4/6 (67%) responded; among those with RUNX1 3/5 (60%) responded, and among those with TP53 1/3 (33%) responded. In addition, there were 3 patients with adverse karyotypes, and 1 responded. “Over the past decade we’ve seen significant progress in the treatment of AML, particularly with the introduction of the venetoclax/azacitidine regimen, the use of targeted agents, and safer application of haploidentical stem cell transplants,” said Dr Phillip Amrein, MD, Clinical Investigator, Massachusetts General Hospital, Assistant Professor of Medicine Harvard Medical School, the senior author of the study. “Yet, leukemias characterized by TP53 remain a major area of unmet need, with poor outcomes even with bone marrow transplantation. The preclinical findings suggest that CDK9 inhibition might have the potential to overcome this resistance and restore sensitivity to existing therapies, offering a promising new path forward for high-risk patient populations.” Poster presentation details: Title: CDK9 inhibition enhances apoptosis of TP53 mutated AML when combined with standard chemotherapy Session Date and Time: Monday, April 28, 20025, 9:00 AM to 12:00 noon Session Title: CDK9 inhibition enhances apoptosis of TP53 mutated AML when combined with standard chemotherapy Location: Poster Section 17 Poster Board #: 1626 The poster will be available on SELLAS websites following the session. SLS009 is currently being investigated in a Phase 2 open-label, single-arm, multi-center study designed to evaluate the safety, tolerability, and efficacy of SLS009 in combination with venetoclax and azacitidine, including AML patients with ASXL1 mutations. Initial clinical safety and efficacy data are available. In addition, the study aims to identify biomarkers for the target patient population and enrichment for further trials. For more information on the study, visit clinicaltrial.gov identifier NCT04588922. 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 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 (tambiciclib) - potentially the first and best-in-class differentiated small molecule CDK9 inhibitor with reduced toxicity and increased potency compared to other CDK9 inhibitors. Data suggests that SLS009 demonstrated a high response rate in AML patients with unfavorable prognostic factors including ASXL1 mutation, commonly associated with poor prognosis in various myeloid diseases. 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 the REGAL study and the timing of future milestones related thereto. 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 20, 2025 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

Highlights: Ongoing clinical trial of SurVaxM in glioblastoma [SURVIVE] has successfully progressed following an interim analysis of trial data The clinical trial is designed to evaluate the safety, efficacy, and overall benefit of SurVaxM in patients with newly diagnosed glioblastoma who receive standard-of-care treatment combined with SurVaxM The fully enrolled Phase 2b SURVIVE study will continue as planned to collect more data BUFFALO, N.Y., Feb. 12, 2025 /PRNewswire/ -- MimiVax, Inc., a leader in clinical-stage pharmaceutical research, today announced that its now fully enrolled Phase 2b clinical trial of SurVaxM in glioblastoma, [SURVIVE] (NCT05163080), has successfully progressed following the first interim analysis of trial data. The analysis, conducted as part of the company's rigorous clinical development program, has provided valuable insights that support the continued advancement of the trial. The purpose of this study is to determine whether adding SurVaxM to standard-of-care (resection, radiation/chemotherapy) is better than standard treatment alone for patients with newly diagnosed glioblastoma. Continue Reading While the company is unable to disclose specific details about the interim analysis due to regulatory requirements set forth by the U.S. Food and Drug Administration (FDA), MimiVax remains confident in the potential of SurVaxM and is committed to advancing the study as planned. Clinical trial of SurVaxM in glioblastoma has successfully progressed following interim analysis Post this "We are encouraged by the progress of our clinical trial and remain focused on our goal to develop innovative therapies that can address glioblastoma and other cancers. Although we are unable to provide detailed information at this stage, we are excited about the continued advancement of this important program," said Dr. Michael Ciesielski, CEO of MimiVax. "We are working closely with the FDA to ensure compliance with regulatory guidelines as we move forward with the trial." Based on the results of the recent interim futility analysis, and ongoing review by the study's Independent Data Safety Monitoring Committee, the SURVIVE trial will continue as designed without modification. The clinical trial is designed to evaluate the safety, efficacy, and overall benefit of SurVaxM in patients with newly diagnosed glioblastoma who receive standard-of-care treatment combined with SurVaxM at 11 participating major Cancer Centers in the United States. The company will provide updates at appropriate milestones, in accordance with regulatory requirements. MimiVax thanks all participants, healthcare professionals, clinical support teams and investigators involved in the study for their continued support and commitment to the advancement of SurVaxM. About SurVaxM: SurVaxM is a peptide mimic immunogen that targets 'survivin', a cell-survival protein present in most glioblastomas and in many other cancers. SurVaxM stimulates a patients' own immune response to control tumor growth and prevent disease recurrence. Because survivin is present in most cancers, SurVaxM could potentially have applicability in many other forms of cancer. About MimiVax, Inc.: MimiVax, Inc. is a Delaware-incorporated, clinical-stage biotechnology company focused on immunotherapy research and clinical translation of new agents for cancer treatment. MimiVax was formed as a spin-off from Roswell Park Comprehensive Cancer Center to develop and commercialize its lead candidate SurVaxM and has been graciously supported by private investors and donations to Roswell Park. For more information, visit Forward-Looking Statements: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based on the company's current expectations, estimates, and projections about the company's business and industry, and involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the forward-looking statements. SOURCE MimiVax, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

VANCOUVER, BC, Jan. 16, 2025 /PRNewswire/ -- BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) ("BioVaxys" or the "Company") highlights the potential for its DPX™ non-systemic immune educating platform to address the inherent limitations of lipid nanoparticles ("LNPs") for packaging and delivering mRNA and other polynucleotides. Continued development of DPX-mRNA formulations is one of the Company's objectives, with BioVaxys pursuing collaborations with companies and academic institutions that possess pipelines of promising tumor and virus-specific polynucleotide antigens. BioVaxys' DPX™ technology ("DPX") is a patented delivery platform that can incorporate a range of bioactive molecules, such as mRNA/polynucleotides, peptides/proteins, virus-like particles, and small molecules, to produce targeted, long-lasting immune responses enabled by various formulated components. The DPX platform facilitates antigen delivery to regional lymph nodes and has been demonstrated to induce robust and durable T cell and B cell responses in pre-clinical and clinical studies for both cancer and infectious disease. Data from proof-of-concept studies of DPX-mRNA formulations conducted in collaboration with leading RNA technology company Etherna and PCI Biotech demonstrate that DPX provides enhanced in vitro and in vivo stability of packaged mRNA, attracts a therapeutically unique subset of Antigen Presenting Cells (APCs) to the injection site for targeted uptake of mRNA by the immune system, and that immunization with DPX containing mRNA induces specific immune responses towards encoded antigens. mRNA vaccines have emerged as a major scientific breakthrough in the development of immuno-therapeutics and have become the foundation for many new vaccine programs as the Covid pandemic accelerated the development of mRNA vaccines. The genetic sequence in mRNA vaccines instructs host cells to produce proteins to elicit immunological responses and prepare the immune system to fight infections or cancer cells. During the pandemic, mRNA vaccines were proven to be highly effective, with billions of doses administered worldwide. However, their rapid development has led to challenges, particularly concerning relatively strong adverse reactions, including severe ones. Adverse reactions associated with current mRNA vaccines are primarily attributed to the LNPs that carry the mRNA. LNPs possess immunostimulatory properties and can spill out of the injection site, leading to systemic inflammatory responses. While these adverse reactions may be considered acceptable for a limited number of doses during a pandemic, a safer platform that allows multiple doses over a lifetime is desirable for the extension of mRNA vaccine applications to other applications. For instance, mRNA that is packaged using LNP- based vaccine delivery systems enters cells through endocytosis and faces several limitations and challenges such as systemic delivery leading to rapid degradation by nucleases, macrophage phagocytosis removal, and renal filtration clearance. Due to their relatively short half-life, LNPs can show instability under in vivo conditions. Endosomal escape and removal through macrophages of lipid nanoparticles is possible without proper cellular uptake. Their instability and degradation affect their storage, delivery, and overall efficiency, compared with prior studies demonstrating that DPX™ recruits and activates unique subsets of antigen presenting cells ("APCs") to drive immunogenicity of antigens, exhibiting superior immune activation compared to aqueous and emulsion-based antigen delivery systems. The studies with Etherna and PCI Biotech demonstrated a preliminary, non-optimized, mRNA formulated in DPX with shelf-life integrity maintained for over the 14 days of the study, with mRNA formulated in DPX demonstrated to be stable for up to 14 days in vivo. It was also seen that DPX attracts a unique subset of antigen presenting cells (APCs) to site of injection for targeted uptake of mRNA, with immunization with DPX containing mRNA inducing a specific immune response towards encoded antigens. BioVaxys President and Chief Operating Officer Kenneth Kovan says "The DPX platform is essentially a 'pipeline from a product' and will play a significant commercial role for the Company as an enabling technology for delivering nucleic acids and other antigens. DPX is ideal for mRNA delivery, as it remains localized and does not spill out from the injection site and has superior stability than LNPs. With better manufacturing economics than LNPs, it is generating interest from potential partners in the mRNA vaccine field." BioVaxys has several issued patents related to DPX-mRNA formulations. * mRNA Vaccine Market Size And Forecast, Verified Market Research About BioVaxys Technology Corp. BioVaxys Technology Corp. () is a clinical-stage biopharmaceutical company dedicated to improving patient lives with novel immunotherapies based on its DPX™ immune-educating technology platform and its HapTenix© 'neoantigen' tumor cell construct platform, for treating cancers, infectious disease, antigen desensitization for food allergy, and other immunological diseases. Through a differentiated mechanism of action, the DPX™ platform delivers instruction to the immune system to generate a specific, robust, and persistent immune response. The Company's clinical stage pipeline includes maveropepimut-S (MVP-S), based on the DPX™ platform, and is in Phase IIB clinical development for advanced Relapsed-Refractory Diffuse Large B Cell Lymphoma (DLBCL) and platinum resistant Ovarian Cancer. MVP-S delivers antigenic peptides from survivin, a well-recognized cancer antigen commonly overexpressed in advanced cancers, and also delivers an innate immune activator and a universal CD4 T cell helper peptide. MVP-S has been well tolerated and has demonstrated defined clinical benefit in multiple cancer indications as well as the activation of a targeted and sustained, survivin-specific anti-tumor immune response. BioVaxys is also developing DPX™+SurMAGE, a dual-targeted immunotherapy combining antigenic peptides for both the survivin and MAGE-A9 cancer proteins to elicit immune responses to these two distinct cancer antigens simultaneously, DPX™-RSV for Respiratory Syncytial Virus, DPX+rPA for peanut allergy prophylaxis, and BVX-0918, a personalized immunotherapeutic vaccine using its proprietary HapTenix© 'neoantigen' tumor cell construct platform for refractive late-stage ovarian cancer. BioVaxys common shares are listed on the CSE under the stock symbol 'BIOV', trade on the Frankfurt Bourse (FRA: 5LB), and in the US (OTCQB: BVAXF). For more information, visit and connect with us on X and LinkedIn. ON BEHALF OF THE BOARD Signed "James Passin" James Passin, Chief Executive Officer Phone: +1 740 358 0555 Cautionary Statements Regarding Forward Looking Information This press release includes certain "forward-looking information" and "forward-looking statements" (collectively "forward-looking statements") within the meaning of applicable Canadian and United States securities legislation including the United States Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, included herein, without limitation, statements relating the future operating or financial performance of the Company, are forward looking statements. Forward-looking statements are frequently, but not always, identified by words such as "expects", "anticipates", "believes", "intends", "estimates", "potential", "possible", and similar expressions, or statements that events, conditions, or results "will", "may", "could", or "should" occur or be achieved. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those expressed or implied in such forward-looking statements. These forward-looking statements reflect the beliefs, opinions and projections on the date the statements are made and are based upon a number of assumptions and estimates, primarily the assumption that BioVaxys will be successful in developing and testing vaccines, that, while considered reasonable by the Company, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies including, primarily but without limitation, the risk that BioVaxys' vaccines will not prove to be effective and/ or will not receive the required regulatory approvals. With regards to BioVaxys' business, there are a number of risks that could affect the development of its biotechnology products, including, without limitation, the need for additional capital to fund clinical trials, its lack of operating history, uncertainty about whether its products will complete the long, complex and expensive clinical trial and regulatory approval process for approval of new drugs necessary for marketing approval, uncertainty about whether its autologous cell vaccine immunotherapy can be developed to produce safe and effective products and, if so, whether its vaccine products will be commercially accepted and profitable, the expenses, delays and uncertainties and complications typically encountered by development stage biopharmaceutical businesses, financial and development obligations under license arrangements in order to protect its rights to its products and technologies, obtaining and protecting new intellectual property rights and avoiding infringement to third parties and their dependence on manufacturing by third parties. The Company does not assume any obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law. Investors are encouraged to read BioVaxys continuous disclosure documents and audited annual consolidated financial statements which are available on SEDAR at . Logo: SOURCE BioVaxys Technology Corp. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED