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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.
Yahoo
20-05-2025
- Business
- Yahoo
CCM Biosciences Announces Presentation of Data on its First-In-Class NSCLC Drug Program at ASCO 2025
Company's NSCLC drug program is focused on overcoming both mutational and non-mutational resistance to 3rd-generation EGFR inhibitors and outperforms other investigational 4th-generation inhibitors in a wide range of drug resistance models. MOUNT LAUREL, N.J., May 20, 2025--(BUSINESS WIRE)--CCM Biosciences, a diversified pharmaceutical discovery and development company, today announced the upcoming presentation of its 4th-generation EGFR inhibitor drug program for non-small cell lung cancer (NSCLC) at the 2025 Annual Conference of the American Society of Clinical Oncology (ASCO), taking place May 30 to June 3 in Chicago. NSCLC, which accounts for 80% of lung cancer, is the most common cause of cancer death worldwide. Epidermal growth factor receptor (EGFR)-activating mutations (Del19 or L858R) are major oncogenic drivers of NSCLC. EGFR-positive NSCLC accounts for approximately 30% of all diagnosed cases of NSCLC (a similar market size to PD-L1-positive NSCLC, which is addressed by the world's top-selling drug, Keytruda®). The current standard of care for EGFR-positive NSCLC is comprised of 3rd-generation inhibitors, most notably Osimertinib (Tagrisso®), whose annual sales exceed $6 billion. Most patients treated by tyrosine kinase inhibitors (TKIs) will eventually develop resistance mutations including the T790M gatekeeper mutation. Osimertinib, a 3rd-generation covalent TKI, is efficacious against the T790M resistance mutation and prevents its onset if administered as first line therapy. However, treatment with Osimertinib inevitably induces additional mutations, especially the C797S mutation, as well as various off-target resistance mechanisms. To date, there are no approved therapies capable of overcoming mutational or non-mutational resistance to 3rd-generation TKIs. As such, there is an urgent unmet medical need to develop next-generation EGFR inhibitors that overcome these forms of resistance. While billions of dollars have been invested over the last several years on the development of 4th-generation EGFR inhibitors that overcome tumor resistance to 3rd-generation inhibitors, due to the diversity of resistance mechanisms, these inhibitors have failed to progress beyond early-stage clinical trials. At ASCO 2025, CCM Biosciences' presentation "Novel, potent and selective fourth-generation inhibitors targeting EGFR for NSCLC therapy" in the Lung Cancer – Non-small cell – Metastatic session (Abstract #: 8622, will report novel 4th-generation, orally bioavailable EGFR inhibitors (CCM-205, CCM-245 and CCM-308) that can overcome both on-target and off-target resistance in lung cancer models, significantly outperforming the aforementioned 4th-generation inhibitors in the face of resistance to 3rd-generation inhibitors, and have significant potential clinical applications. In addition to their potent activity as monotherapies, CCM-205 and CCM-245 are highly efficacious in combination with 3rd-generation EGFR inhibitors as well as anti-EGFR antibodies, neither of which can maintain or regress tumor volume in the presence of resistance as monotherapies. CCM Biosciences is advancing clinical candidates from its EGFR inhibitor program to investigational new drug (IND) filing this year for entry to clinical trials. 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, enabling fully integrated drug discovery and development. View source version on Contacts Anisha Ghosh anisha@ 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

National Post
20-05-2025
- Business
- National Post
CCM Biosciences Announces Presentation of Data on its First-In-Class AML Drug Program at ASCO 2025
Article content Company's AML drug program is focused on both newly diagnosed and relapsed/refractory FLT3-positive AML, overcoming major forms of resistance to FDA-approved FLT3 inhibitors, and outperforms other investigational inhibitors in a wide range of drug resistance models. Article content Article content MOUNT LAUREL, N.J. — 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. Article content 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. Article content 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. Article content 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. Article content 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. Article content 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. Article content Article content Article content Article content Article content Article content


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.

National Post
20-05-2025
- Business
- National Post
CCM Biosciences Announces Presentation of Data on its First-In-Class NSCLC Drug Program at ASCO 2025
Article content Company's NSCLC drug program is focused on overcoming both mutational and non-mutational resistance to 3 rd -generation EGFR inhibitors and outperforms other investigational 4 th -generation inhibitors in a wide range of drug resistance models. Article content Article content MOUNT LAUREL, N.J. — CCM Biosciences, a diversified pharmaceutical discovery and development company, today announced the upcoming presentation of its 4th-generation EGFR inhibitor drug program for non-small cell lung cancer (NSCLC) at the 2025 Annual Conference of the American Society of Clinical Oncology (ASCO), taking place May 30 to June 3 in Chicago. Article content NSCLC, which accounts for 80% of lung cancer, is the most common cause of cancer death worldwide. Epidermal growth factor receptor (EGFR)-activating mutations (Del19 or L858R) are major oncogenic drivers of NSCLC. EGFR-positive NSCLC accounts for approximately 30% of all diagnosed cases of NSCLC (a similar market size to PD-L1-positive NSCLC, which is addressed by the world's top-selling drug, Keytruda®). The current standard of care for EGFR-positive NSCLC is comprised of 3 rd -generation inhibitors, most notably Osimertinib (Tagrisso®), whose annual sales exceed $6 billion. Most patients treated by tyrosine kinase inhibitors (TKIs) will eventually develop resistance mutations including the T790M gatekeeper mutation. Osimertinib, a 3rd-generation covalent TKI, is efficacious against the T790M resistance mutation and prevents its onset if administered as first line therapy. However, treatment with Osimertinib inevitably induces additional mutations, especially the C797S mutation, as well as various off-target resistance mechanisms. To date, there are no approved therapies capable of overcoming mutational or non-mutational resistance to 3rd-generation TKIs. As such, there is an urgent unmet medical need to develop next-generation EGFR inhibitors that overcome these forms of resistance. While billions of dollars have been invested over the last several years on the development of 4 th -generation EGFR inhibitors that overcome tumor resistance to 3 rd -generation inhibitors, due to the diversity of resistance mechanisms, these inhibitors have failed to progress beyond early-stage clinical trials. Article content At ASCO 2025, CCM Biosciences' presentation 'Novel, potent and selective fourth-generation inhibitors targeting EGFR for NSCLC therapy' in the Lung Cancer – Non-small cell – Metastatic session (Abstract #: 8622, will report novel 4 th -generation, orally bioavailable EGFR inhibitors (CCM-205, CCM-245 and CCM-308) that can overcome both on-target and off-target resistance in lung cancer models, significantly outperforming the aforementioned 4 th -generation inhibitors in the face of resistance to 3 rd -generation inhibitors, and have significant potential clinical applications. In addition to their potent activity as monotherapies, CCM-205 and CCM-245 are highly efficacious in combination with 3 rd -generation EGFR inhibitors as well as anti-EGFR antibodies, neither of which can maintain or regress tumor volume in the presence of resistance as monotherapies. Article content CCM Biosciences is advancing clinical candidates from its EGFR inhibitor program to investigational new drug (IND) filing this year for entry to clinical trials. 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. Article content 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, enabling fully integrated drug discovery and development. Article content Article content Article content Article content Article content Article content