Latest news with #FLT3
National Post
18-06-2025
- Health
- National Post
LabPMM® Receives New York State Approval for the NPM1 MRD Assay - Informing Therapy and Accelerating Targeted Trials
Article content SAN DIEGO — Invivoscribe is happy to announce that its wholly owned subsidiary, the Laboratory for Personalized Molecular Medicine ® (LabPMM) has received approval from New York State (NYS) for the NPM1 MRD Assay. This approval comes just two months after gaining NYS approval for our FLT3 ITD MRD Assay. Together these tests represent a critical tool for patients with acute myeloid leukemia (AML), clinicians and pharmaceutical companies. This new approval underscores Invivoscribe's ongoing commitment to providing the most accurate, standardized measurable residual disease (MRD) testing solutions worldwide. Article content The NPM1 MRD Assay is a pivotal development in the fight against AML, offering an ultra-sensitive DNA sequencing method to accurately measure trace levels of residual leukemia cells in patients with the NPM1 mutation variants. NPM1 mutations are considered an ideal target for MRD assessment because they are present in ~30% of adult AML cases, 1 stable over time, 2 and, if present in blood at allele fractions ≥0.01%, are associated with increased relapse and worse overall survival. 3 Recent studies show emerging evidence that pre-transplant MRD testing for NPM1 and FLT3 -ITD identifies AML patients in remission who are most likely to relapse or experience poor survival. 3,4,5 With this approval, LabPMM is helping to transform the landscape of AML research, treatment and drug development. By using MRD as a surrogate endpoint in clinical trials, instead of relying solely on overall survival (OS), pharmaceutical companies can accelerate their drug development timelines. This is particularly valuable in acute disease, where time is of the essence, and earlier intervention can dramatically improve patient outcomes. Article content 'We are proud to receive New York State approval for our NPM1 MRD Assay by NGS, marking our second assay approved by New York State this year,' said Jordan Thornes, V.P., Global Clinical Laboratory Operations at LabPMM. 'This milestone reflects our continued dedication to advancing precision diagnostics in cancer care. With this latest approval, we're further empowering clinicians with sensitive, reliable tools to detect residual disease and guide treatment decisions with confidence.' Article content LabPMM's NPM1 and FLT3 ITD MRD Assays are standardized next generation sequencing (NGS) tests that complement the LeukoStrat ® CDx FLT3 Mutation Assay, which is used to guide treatment selection for patients with AML. These services are offered in the U.S., European Union, and across Asia to ensure patients around the world have access to high-quality, standardized testing and to support the development of cutting-edge cancer treatments. LabPMM remains committed to advancing precision medicine and improving outcomes for patients worldwide. For more information about the NPM1 MRD Assay and LabPMM's full test menu, please visit or contact us at inquiry@ and follow us on LinkedIn. Article content About Invivoscribe Article content Invivoscribe ® is a global, vertically integrated biotechnology company dedicated to Improving Lives with Precision Diagnostics ®. For thirty years, Invivoscribe has improved the quality of healthcare worldwide by providing high quality standardized reagents, tests, and bioinformatics tools to advance the field of precision medicine. Invivoscribe has a successful track record of partnerships with pharmaceutical companies interested in clinical trial testing via our global lab network located in the U.S., Germany, Japan and China, and in developing and commercializing companion diagnostics, with our rigorous expertise in both regulatory and laboratory services. Providing distributable kits, as well as clinical trial services through its globally located clinical lab subsidiaries (LabPMM ®), Invivoscribe is an ideal partner from diagnostic development, through clinical trials, regulatory submissions, and commercialization. Article content Article content Article content Article content Article content Article content
Business Upturn
21-05-2025
- Business
- Business Upturn
CCM Biosciences Announces Presentation of Data on its First-In-Class AML Drug Program at ASCO 2025
By Business Wire Published on May 21, 2025, 14:15 IST Mount Laurel, N.J., United States: CCM Biosciences, a diversified pharmaceutical discovery and development company, today announced the upcoming presentation of its next-generation FLT3 inhibitor drug program for acute myeloid leukemia (AML) at the 2025 Annual Conference of the American Society of Clinical Oncology (ASCO), taking place May 30 to June 3 in Chicago. Acute Myeloid Leukemia (AML) is the most severe form of leukemia with few treatment options, and a malignancy frequently driven by mutations in the FMS-like tyrosine kinase 3 (FLT3) gene. The FLT3 internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations, particularly D835 and F691, appear in approximately 30% of AML patients, often leading to poor prognosis and resistance to existing therapies. Gilteritinib (Xospata®; Astellas Pharma, peak annual sales projection: $1.5 billion) and Quizartinib (Vanflyta®; Daiichi Sankyo) are two FDA-approved FLT3 inhibitors, with the former approved only for relapsed/refractory AML and the latter approved only for newly diagnosed AML. Quizartinib does not target TKD resistance mutations, whereas Gilteritinib's efficacy on FLT3-ITD-D835 mutations is limited and it is not effective against the FLT3-ITD-F691 gatekeeper mutation, both of which are very common. Crenolanib (AROG/Pfizer) is an FLT3 inhibitor whose NDA submitted to the FDA does not address the indications above, whose NDA was previously rejected by the FDA, and which binds to FLT3 mutants less tightly than Gilteritinib. Consequently, there is a critical need for next-generation FLT3 inhibitors that can address all of these mutations. At ASCO 2025, CCM Biosciences' presentation 'Novel, Potent and Selective Inhibitors Targeting FLT3 for AML Therapy' in the Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant session (Abstract #: 6542, will report novel FLT3 inhibitors have been identified that can both target FLT3-ITD and potentially overcome mutational resistance to FDA-approved FLT3 inhibitors. These agents are significantly more effective than Gilteritinib and have significant potential clinical applications. CCM Biosciences' novel, orally bioavailable FLT3 inhibitors (CCM-405 and CCM-445) are the first drug candidates to overcome both FLT3-ITD juxtamembrane domain and tyrosine kinase domain (TKD) mutational drug resistance (including D835Y, F691L), significantly outperforming the aforementioned current-generation inhibitors both in the absence and presence of resistance mutations. Other reported investigational drug candidates capable of addressing FLT3-ITD resistance mutations either have poor pharmacokinetics, significant off-target binding, or both. CCM Biosciences is advancing clinical candidates from its FLT3 inhibitor program to investigational new drug (IND) filing this year for entry into clinical trials for both newly diagnosed FLT3-positive AML and relapsed/refractory FLT3-positive AML. Multiple failures in AML clinical trials from competitors in 2024 present an attractive landscape for clinical trials of these drug candidates. The company is actively partnering with biotechnology and pharmaceutical companies for co-development rights in selected countries. CCM Biosciences, a sister company of the global chemical and pharmaceutical services company PMC Group, Inc., is also a Featured Exhibitor at ASCO 2025 — — and will be showcasing both its drug programs and the state-of-the-art platforms used to discover and develop them. About CCM Biosciences CCM Biosciences is a diversified biotechnology company dedicated to discovering and developing novel drugs, including small molecules, gene therapies, biologics, and nanomedicines within multiple corporate subsidiaries. CCM's patented drug discovery platforms were developed at Chakrabarti Advanced Technology, a privately funded R&D institute founded in 2010 with scientists in the US, France and India and with publications in leading scientific journals including PNAS, Nucleic Acids Research, Physical Review, American Chemical Society journals, Biophysical Society journals, and Nature Publishing Group journals. These platforms are complemented by the contract research, development, and manufacturing organizations (CRDMO) at PMC Group, the sister company of CCM Biosciences and a global chemical and pharmaceutical company with ~$1 billion in annual revenue. View source version on Disclaimer: The above press release comes to you under an arrangement with Business Wire. Business Upturn takes no editorial responsibility for the same. Business Wire is an American company that disseminates full-text press releases from thousands of companies and organizations worldwide to news media, financial markets, disclosure systems, investors, information web sites, databases, bloggers, social networks and other audiences.
Business Wire
20-05-2025
- Business
- Business Wire
CCM Biosciences Announces Presentation of Data on its First-In-Class AML Drug Program at ASCO 2025
MOUNT LAUREL, N.J.--(BUSINESS WIRE)-- CCM Biosciences, a diversified pharmaceutical discovery and development company, today announced the upcoming presentation of its next-generation FLT3 inhibitor drug program for acute myeloid leukemia (AML) at the 2025 Annual Conference of the American Society of Clinical Oncology (ASCO), taking place May 30 to June 3 in Chicago. Acute Myeloid Leukemia (AML) is the most severe form of leukemia with few treatment options, and a malignancy frequently driven by mutations in the FMS-like tyrosine kinase 3 (FLT3) gene. The FLT3 internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations, particularly D835 and F691, appear in approximately 30% of AML patients, often leading to poor prognosis and resistance to existing therapies. Gilteritinib (Xospata ®; Astellas Pharma, peak annual sales projection: $1.5 billion) and Quizartinib (Vanflyta ®; Daiichi Sankyo) are two FDA-approved FLT3 inhibitors, with the former approved only for relapsed/refractory AML and the latter approved only for newly diagnosed AML. Quizartinib does not target TKD resistance mutations, whereas Gilteritinib's efficacy on FLT3-ITD-D835 mutations is limited and it is not effective against the FLT3-ITD-F691 gatekeeper mutation, both of which are very common. Crenolanib (AROG/Pfizer) is an FLT3 inhibitor whose NDA submitted to the FDA does not address the indications above, whose NDA was previously rejected by the FDA, and which binds to FLT3 mutants less tightly than Gilteritinib. Consequently, there is a critical need for next-generation FLT3 inhibitors that can address all of these mutations. At ASCO 2025, CCM Biosciences' presentation 'Novel, Potent and Selective Inhibitors Targeting FLT3 for AML Therapy' in the Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant session (Abstract #: 6542, will report novel FLT3 inhibitors have been identified that can both target FLT3-ITD and potentially overcome mutational resistance to FDA-approved FLT3 inhibitors. These agents are significantly more effective than Gilteritinib and have significant potential clinical applications. CCM Biosciences' novel, orally bioavailable FLT3 inhibitors (CCM-405 and CCM-445) are the first drug candidates to overcome both FLT3-ITD juxtamembrane domain and tyrosine kinase domain (TKD) mutational drug resistance (including D835Y, F691L), significantly outperforming the aforementioned current-generation inhibitors both in the absence and presence of resistance mutations. Other reported investigational drug candidates capable of addressing FLT3-ITD resistance mutations either have poor pharmacokinetics, significant off-target binding, or both. CCM Biosciences is advancing clinical candidates from its FLT3 inhibitor program to investigational new drug (IND) filing this year for entry into clinical trials for both newly diagnosed FLT3-positive AML and relapsed/refractory FLT3-positive AML. Multiple failures in AML clinical trials from competitors in 2024 present an attractive landscape for clinical trials of these drug candidates. The company is actively partnering with biotechnology and pharmaceutical companies for co-development rights in selected countries. CCM Biosciences, a sister company of the global chemical and pharmaceutical services company PMC Group, Inc., is also a Featured Exhibitor at ASCO 2025 -- -- and will be showcasing both its drug programs and the state-of-the-art platforms used to discover and develop them. About CCM Biosciences CCM Biosciences is a diversified biotechnology company dedicated to discovering and developing novel drugs, including small molecules, gene therapies, biologics, and nanomedicines within multiple corporate subsidiaries. CCM's patented drug discovery platforms were developed at Chakrabarti Advanced Technology, a privately funded R&D institute founded in 2010 with scientists in the US, France and India and with publications in leading scientific journals including PNAS, Nucleic Acids Research, Physical Review, American Chemical Society journals, Biophysical Society journals, and Nature Publishing Group journals. These platforms are complemented by the contract research, development, and manufacturing organizations (CRDMO) at PMC Group, the sister company of CCM Biosciences and a global chemical and pharmaceutical company with ~$1 billion in annual revenue.
