MOUNT LAUREL, N.J. -- CCM Biosciences, a diversified pharmaceutical discovery and development company, 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, https://www.asco.org/abstracts-presentations/ABSTRACT495872) 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 -- https://asco25.myexpoonline.com/co/ccm-biosciences -- and will be showcasing both its drug programs and the state-of-the-art platforms used to discover and develop them.