Latest news with #TKI
Medscape
5 days ago
- Health
- Medscape
Fast Five Quiz: B-Cell Acute Lymphoblastic Leukemia
Though more common in pediatric populations, B-cell acute lymphoblastic leukemia (B-ALL) affects both children and adults, and it has several genetic subtypes that significantly affect prognosis and treatment decisions. Despite advances in treatment protocols, resistance mechanisms remain a significant challenge. However, some genetic subtypes are associated with more favorable prognosis, and the nuances of this disease are evident in the cascading treatment algorithm recommended by the National Comprehensive Cancer Network (NCCN) for pediatric and adult cases. What do you know about B-ALL? Check your knowledge with this quick quiz. The treatment of B-ALL involves a complex and intensive series of steps. In the induction phase, glucocorticoids are typically used to reduce tumor burden by clearing leukemic cells from the bone marrow. However, point mutations in the NR3C1 gene generally cause resistance to glucocorticoid therapy, which can significantly affect prognosis. Mutations in the CREBBP gene also cause resistance to glucocorticoids DHFR , FPGS , and TYMS genes have been shown to generally cause resistance to methotrexate, not glucocorticoids. Learn more about corticosteroids in B-ALL. In risk stratification for B-ALL, the NCCN notes that having a white blood cell count of > 30 x 109/L is considered a high-risk feature. This is consistent with European guidelines. The NCCN also states that age over 35 years is another high-risk feature for B-ALL. ETP phenotype is a high-risk feature for T-cell acute lymphoblastic leukemia rather than the B-ALL subtype. Hyperdiploidy (a molecular subtype of B-ALL with 51-65 chromosomes) is considered standard risk by the NCCN; data have shown better prognosis for pediatric patients with this subtype. Learn more about risk stratification for B-ALL. TKIs are an important component of induction, consolidation, and maintenance treatment for Ph+ B-ALL. They are recommended by the NCCN for use in conjunction with other drugs, such as corticosteroids, blinatumomab, and inotuzumab ozogamicin (depending on treatment phase and disease severity) and as a treatment post-HCT. They recommend continuing TKI therapy for at least 2 years after HCT, although they note that the 'optimal duration' is unknown for this population. A recent review, however, notes that despite their success in patients with Ph+ B-ALL, approximately 25% of cases will develop resistance to TKIs. Given this possibility, the NCCN notes that clinicians should consider prior TKI intolerance, dose used, BCR::ABL1 mutations, and disease-related features when choosing a specific TKI; they specifically recommend bosutinib, dasatinib, imatinib, nilotinib, or ponatinib as options for TKI therapy. Learn more about Ph+ B-ALL treatments. The DUX4-rearranged subtype of B-ALL is considered to have a favorable prognosis in adolescents and young adults, compared with MEF2D-rearranged, CDX2/UBTF, and IDH1/2; these subtypes generally have inferior prognosis in the same populations (although MEF2D-rearranged has intermediate prognosis in adults). Specifically, DUX4-rearranged B-ALL has been associated with 93% event-free survival and overall survival in pediatric patients, and adolescent and young-adult patients also see longer disease-free survival after complete remission is achieved. Learn more about B-ALL genomics. Several genetic subtypes of B-ALL are associated with varying prognoses, and the outcomes differences seen between pediatric and adult patients can be partly explained by the different subtypes expressed by these populations. Further, new therapies have enabled high survival rates among pediatric patients with B-ALL, with long-term survival of up to 90% in this population. Prognosis for B-ALL in adolescents and adults is comparatively poor. For example, a population-based study reported the following declining survival rates with age: 74% for patients 15-19 years old, 59% for patients 20-39 years old, and 43% for those 40-59 years old. However, the researchers explained that these percentages still demonstrate improvements, as survival rates were overall lower in the 1980s and 1990s. Learn more about B-ALL prognosis.
Yahoo
23-05-2025
- Business
- Yahoo
Great Novel Therapeutics Biotech & Medicals Corporation (GNTbm) Presented Preclinical Data on GNTnm-38, an Novel Epigenetic Immune Activator, at the 2025 ASCO Annual Meeting
TAIPEI, May 22, 2025 /PRNewswire/ -- GNTbm (stock code: 7427, Taiwan) announced the preclinical data on GNTbm-38, an novel epigenetic immune activator for cancer immunotherapy. GNTbm-38 was presented as posters at the 2025 American Association of Clinical Oncology (ASCO) Annual Meeting, which is held in Chicago, USA, from May 30 to Jun 04, 2025. Abstract: 2574 Title: Preclinical development of GNTbm-38, a novel class I histone deacetylase inhibitor, while combined with anti-VEGFR TKI or anti-PD-1 Ab: Assessment of immune activation and immune memory in cancer immunotherapy. Session Date/Time: 6/2/2025, 1:30 PM-4:30 PM CT Poster Board Number: 221 At present, there is no ICI-based drug combination for the treatment of advanced MSS colorectal cancer, which is a cold tumor. Studies have shown that epigenetic regulators such as class I HDAC inhibitors are an emerging and important drug component for combination therapy that can greatly increase the anti-cancer benefits of cancer immunotherapy. Therefore, rational drug combinations, containing class I HDACi, may provide opportunities in cancer immunotherapy. GNTbm-38 is a new drug candidate independently developed by GNTbm. GNTbm-38 acts as a TME reprogramming regulator in immunotherapy. When combined with TKI, GNTbm-38 significantly improved tumor response rate and survival rate through synergistic effect by normalizing tumor vessels, increasing tumor antigen presentation, increasing activated CD8+ T cell infiltration into tumors, inducing memory T cell persistence, and inhibiting mobilization of immunosuppressive cells into tumors. On the other hand, treatment with GNTbm-38 plus anti-PD-1 antibody in the CT-26 model showed greatly improved tumor response rate and survival rate with a strong synergistic effect. Furthermore, in B-hPD-1/hPD-L1 mice (humanized model) subcutaneously injected with B-hPD-L1 CT-26 cells, treatment of pembrolizumab and GNTbm-38 resulted in a 46.5% inhibition on tumor growth. Therefore, our data provided a strong rationale to explore the combination of GNTbm-38 with anti-VEGF TKI with or without ICI. From these data GNTm-38 has been shown to display powerful induction of immune activation and immune memory in combination therapy with TKI/ICI against colon CT-26 cold tumor. Based on the in vitro, in vivo and preclinical studies, these data show that GNTbm-38 exhibits markedly superior pharmacokinetics, tolerability, and efficacy in animal models. It is expected to complete the US IND application by the end of 2025 and enter the clinical study. About GNTbm-38 GNTbm-38 is a new chemical entity with potential as a pivotal drug component of a new generation of cancer immunotherapy independently developed by GNTbm. It is a drug candidate selected by an immuno-competent tumor-bearing animal testing platform, and has undergone many preclinical research studies to confirm that it has very outstanding anti-cancer activity in tumor microenvironment. GNTbm-38 is an oral drug with dual effects of epigenetic regulation of gene expression and immune activation, which is unique when compared to the mechanism of other epigenetic drugs. GNTbm-38 can remodel the tumor microenvironment (TME) through a unique epigenetic regulatory mechanism, including the cell composition and gene expression that affect the TME, so that "cold tumors" can be transformed into "hot tumors", which can attract CTL to infiltrate into the TME, and at the same time, it can also reduce the attraction of immunosuppressive cells (such as : TAM, Treg, and MDSCs) into the TME, so as to achieve the remodeling of the TME, which is more conducive to obtaining the therapeutic benefits of cancer immunotherapy. GNTbm-38 monotherapy can be used in the treatment of hematological tumors, and GNTbm-38 can also be combined with a unique multi-kinase inhibitor or immune checkpoint inhibitor for treatment of a variety of solid tumors, mainly through a unique anti-cancer immune-regulating mechanism to achieve anti-cancer treatment goals. About GNTbm GNTbm (stock code: 7427, Taiwan) is a company that has conducted clinical trials and developed a new drug against advanced breast cancer on the market in Taiwan. The GNTbm R&D team has the ability to independently develop new drugs, and has multiple anti-cancer drug candidates with global development rights, with the goal of meeting the unmet clinical needs of patients with advanced cancers. GNTbm mainly focuses on the development of drugs with innovative mechanisms for the new generation of cancer immunotherapy, conducts clinical validation, and hopes to successfully provide novel immunotherapy with excellent efficacy and safety for varieties of cancer indications, to fulfil the unmet medical needs of patients around the world and improve the quality of life of patients. View original content: SOURCE Great Novel Therapeutics Biotech & Medicals Corporation Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
14-03-2025
- Health
- Yahoo
Man files lawsuit against several individuals, county for allegedly denying chemo pill while in CJC
(EL PASO COUNTY, Colo.) — A man who was incarcerated at the El Paso Criminal Justice Center (CJC) in 2023 is now suing El Paso County, private medical provider Wellpath, LLC, and several other individuals for 'deliberately failing' to provide him his chemotherapy medicine while he was in jail, according to the lawsuit. Stuart Patrick McLaney was in custody at the CJC from March 23, 2023, until July 24, 2023. According to the lawsuit, McLaney has chronic myeloid leukemia, a type of cancer that involves the uncontrolled, irregular production of white blood cells in an individual's blood marrow. He's had cancer for over three years and takes a tyrosine kinase inhibitor (TKI) chemotherapy pill, which he had been prescribed, to keep his cancer from progressing and becoming life-threatening. According to the lawsuit, McLaney notified the CJC and its staff from the moment of his arrival. 'But that day, and every day after, Defendant El Paso County sheriff's deputies andDefendant Wellpath staff consciously and intentionally denied Mr. McLaney his medication,' the lawsuit states. 'They denied Mr. McLaney his medication despite his numerous pleas communicating both about his immense pain and long-term health risks, and their own documentation thereof.' According to the lawsuit, McLaney reached out to multiple people at CJC several times about his declining health, including Wellpath staff at the jail. On May 18, 2023, he was taken for an appointment outside of the CJC where a medical professional noted McLaney needed to continue taking his TKI pill, among other medications to continue the treatment plan his doctor had provided him. Around that time, McLaney also allegedly heard Wellpath staff discussing the situation and heard an individual say that it was just too expensive. However, documents say that even after that, none of the defendants took any actions to ensure McLaney was provided his medication. Weeks later, on June 13, 2023 a defendant acknowledged that she knew McLaney's CML needed to be treated, but there was an insurance problem while he was at CJC and noted that it was a different daily oral pill than he had been on in the past. The lawsuit stated that it might require special monitoring that they were unequipped to provide at the CJC. 'Despite his continued communications to Defendant Dobyns and other Defendant El Paso County sheriff's deputies and Defendant Wellpath staff about his CML and the immediate and long-term consequences of it going untreated, Mr. McLaney was still not given his medication.' To read the full lawsuit: 1-McLaney-ComplaintDownload Four months later, he was released and the lawsuit states that he was not given his 'life-saving daily oral TKI chemotherapy pill or other critical medicine while he was at the CJC.' The lawsuit also states that McLaney experienced 'immense physical pain and severe emotional distress' while at the CJC. Upon his release, McLaney immediately resumed taking the TKI pill, but the four months without it have had devastating impacts, per the lawsuit. Furthermore, lapses in the treatment of CML are associated with a shorter life expectancy, in the context of cancer. 'Stuart was in pain for months in the CJC because his suffering was the price El Paso County and Wellpath were willing to pay to pad their pockets,' said Attorney Madeline Leibin. 'And now he faces devastating long-term consequences. What happened to Stuart is not only illegal, it's inhumane and immoral.' When asked for a comment, El Paso County, El Paso County Sheriff's Office, and Wellpath said they do not comment on pending litigation. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
Yahoo
10-02-2025
- Business
- Yahoo
Ocean Biomedical Announces Breakthrough Findings in EGFR-Mutant Lung Cancer and Plans for FDA Alignment on Next-Stage Development
Company Poised to Enter Booming Bispecific Antibody Market Amid Growing Pharma Interest Providence, RI, Feb. 10, 2025 (GLOBE NEWSWIRE) -- Ocean Biomedical (NASDAQ: OCEA) today announced newly published research findings demonstrating the ability of its proprietary cancer immunotherapy candidates to favorably interact with tyrosine kinase inhibitors (TKI), such as osimertinib that are used to treat non-small cell lung cancer (NSCLC). Specifically, they demonstrate that Ocean's immunotherapy candidates provide synergy with the TKI therapies (gefitinib and osimertinib) to suppress tumor growth and progression. In addition, the paper's findings demonstrate that its proprietary cancer immunotherapy candidates have a remarkable ability to restore treatment sensitivity following development of osimertinib resistance. This breakthrough offers a potential paradigm shift in the treatment of Epidermal Growth Factor Receptor (EGFR)-mutant NSCLC and could expand treatment options for patients whose tumors are no longer responding to tyrosine kinase inhibitors. These findings, led by Ocean Biomedical's Scientific Co-founder Dr. Jack A. Elias in collaboration with researchers at Yale University and Brown University, were published in Translational Oncology and mark the first description of the role of chitinase 3-like-1 (CHi3L1) in EGFR-mutant cancers. The research underscores the ability of Ocean Biomedical's novel antibody to suppress CHi3L1 activity, leading to significant tumor reduction and, crucially, the reversal of drug resistance in preclinical models. As part of its continued commitment to developing next-generation cancer therapeutics, Ocean Biomedical is initiating preclinical studies to advance its immunotherapy program and will engage with the FDA this year to align on a regulatory pathway for first-in-human trials. Industry Momentum: Bispecific Antibodies Leading a 'Gold Rush' in Oncology Ocean Biomedical's advancements come at a time when the oncology field is shifting its focus towards bispecific antibodies, an innovative therapeutic class designed to target multiple cancer mechanisms simultaneously. Bispecific antibodies that target PD-1/PD-L1 and VEGF have shown remarkable efficacy in recent clinical studies, with leading biotech and pharmaceutical companies rapidly investing in this space. Merck's recent $588 million acquisition of LaNova's LM-299, a PD-1/VEGF bispecific antibody currently in early-stage clinical trials, underscores the high-value potential of this technology. Industry experts suggest that this wave of investments mirrors the early days of checkpoint inhibitors, highlighting the significant opportunity for Ocean Biomedical to position itself at the forefront of the next major oncology breakthrough. Ocean has also developed bispecific antibodies that combine its anti-CHI3L1 antibody and anti-PD-1 or anti-CTLA4. Studies with these bispecific antibodies have highlighted their impressive efficacy in suppressing tumor growth and progression in preclinical models of NSCLC, malignant melanoma and glioblastoma. Ocean's Board Chair and Co-Founder Statement on Market Potential and Investor Opportunity 'Our latest findings open an exciting new avenue in lung cancer treatment by demonstrating a potential solution to osimertinib resistance, a critical unmet need for patients worldwide,' said Dr. Chirinjeev Kathuria, Ocean's Board Chair and Co-Founder. 'With the industry shifting towards next-generation bispecific antibodies, Ocean Biomedical is strategically positioned to capitalize on this momentum in a variety of diseases including NSCLC, malignant melanoma and glioblastoma. The recent $588 million acquisition of LaNova's LM-299 validates the enormous market potential in this space, and we believe our innovative immunotherapy platform could drive significant value for both patients and investors.' Expanding Therapeutic Applications The company's lead oncology program is poised for multiple therapeutic applications: As a standalone therapy for EGFR-mutant NSCLC, In combination with existing TKIs to extend therapeutic response duration, As a salvage therapy to restore treatment efficacy in resistant tumors. Next Steps: FDA Alignment and Preclinical Advancements With plans to initiate preclinical studies this year, Ocean Biomedical is actively preparing for discussions with the FDA to determine the regulatory pathway for clinical development. This milestone marks a significant step toward bringing its innovative cancer therapy to patients in need. About Ocean Biomedical Ocean Biomedical, Inc. is a Providence, Rhode Island-based biopharma company with an innovative business model that accelerates the development and commercialization of scientifically compelling assets from research universities and medical centers. Ocean Biomedical deploys the funding and expertise to move new therapeutic candidates efficiently from the laboratory to the clinic, to the world. Ocean Biomedical is currently developing five promising discoveries that have the potential to achieve life-changing outcomes in lung cancer, brain cancer, pulmonary fibrosis, and the prevention and treatment of malaria. The Ocean Biomedical team is working on solving some of the world's toughest problems, for the people who need it learn more, visit Forward-Looking Statements The information included herein and in any oral statements made in connection herewith include 'forward-looking statements' within the meaning of the 'safe harbor' provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as 'estimate,' 'plan,' 'project,' 'forecast,' 'intend,' 'will,' 'expect,' 'anticipate,' 'believe,' 'seek,' 'target' or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters, although not all forward-looking statements contain such identifying words. These forward-looking statements include, but are not limited to, statements regarding estimates and forecasts of financial and performance metrics and expectations. These statements are based on various assumptions, whether or not identified herein, and on the current expectations of the Company's management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by any investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. The announced discoveries were based solely on laboratory and animal studies. Ocean Biomedical has not conducted any studies that show similar efficacy or safety in humans. There can be no assurances that this treatment will prove safe or effective in humans, and that any clinical benefits of this treatment is subject to clinical trials and ultimate approval of its use in patients by the FDA. Such approval, if granted, could be years away. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside the control of the Company that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. Important factors, among others, that may affect actual results or outcomes include (i) the outcome of any legal proceedings that may be instituted against the Company; (ii) changes in the markets in which the Company competes, including with respect to its competitive landscape, technology evolution, or regulatory changes; (iii) changes in domestic and global general economic conditions; (iv) risk that the Company may not be able to execute its growth strategies; (v) risks related to the ongoing COVID-19 pandemic and response, including supply chain disruptions; (vi) risk that the Company may not be able to develop and maintain effective internal controls; (vii) the risk that the Company may fail to keep pace with rapid technological developments to provide new and innovative products and services or make substantial investments in unsuccessful new products and services; (viii) the ability to develop, license or acquire new therapeutics; (ix) the risk that the Company will need to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all; (x) the risk that the Company experiences difficulties in managing its growth and expanding operations; (xi) the risk of product liability or regulatory lawsuits or proceedings relating to the Company's business; (xii) the risk of cyber security or foreign exchange losses; (xiii) the risk that the Company is unable to secure or protect its intellectual property. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties that are described in the Company's Annual Report on Form 10-K for the year ended December 31, 2023 and its Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, and which are described in the 'Risk Factors' section of the Company's definitive proxy statement filed by the Company on January 12, 2023, and other documents to be filed by the Company from time to time with the SEC and which are and will be available at These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements. These forward-looking statements should not be relied upon as representing the Company's assessments as of any date subsequent to the date of this filing. Accordingly, undue reliance should not be placed upon the forward-looking statements. Ocean Biomedical Investor Relations info@ Biomedical Media Relations connect@ Source: Ocean Biomedical, Inc.
