CCM Biosciences has announced the upcoming presentation of data on its novel 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), scheduled for May 30 to June 3 in Chicago.
The presentation, titled "Novel, potent and selective fourth-generation inhibitors targeting EGFR for NSCLC therapy," will be featured in the Lung Cancer – Non-small cell – Metastatic session (Abstract #8622). The company will showcase its orally bioavailable EGFR inhibitors—CCM-205, CCM-245, and CCM-308—which have demonstrated the ability to overcome both on-target and off-target resistance mechanisms in lung cancer models.
Addressing a Critical Unmet Need in NSCLC Treatment
NSCLC represents approximately 80% of all lung cancer cases and remains the leading cause of cancer-related deaths globally. Epidermal growth factor receptor (EGFR)-activating mutations, particularly Del19 and L858R, are major oncogenic drivers in NSCLC, with EGFR-positive NSCLC accounting for roughly 30% of all diagnosed cases.
The current standard of care for EGFR-positive NSCLC relies on 3rd-generation EGFR inhibitors, most notably Osimertinib (Tagrisso®), which generates annual sales exceeding $6 billion. While Osimertinib effectively targets the T790M gatekeeper mutation that emerges in patients treated with earlier-generation tyrosine kinase inhibitors (TKIs), treatment inevitably leads to additional resistance mechanisms.
"To date, there are no approved therapies capable of overcoming mutational or non-mutational resistance to 3rd-generation TKIs," explained a spokesperson from CCM Biosciences. "This represents an urgent unmet medical need in the treatment landscape for NSCLC patients."
Superior Performance Against Resistance Mechanisms
According to the company, previous attempts to develop 4th-generation EGFR inhibitors have faced significant challenges due to the diversity of resistance mechanisms, with many candidates failing to progress beyond early-stage clinical trials despite substantial investment.
CCM Biosciences claims its compounds demonstrate superior efficacy compared to other investigational 4th-generation inhibitors when tested against resistance to 3rd-generation inhibitors. The company's data shows that CCM-205, CCM-245, and CCM-308 can overcome both the C797S mutation—a common resistance mechanism to Osimertinib—and various off-target resistance pathways.
Particularly noteworthy is the compounds' versatility in treatment approaches. Beyond their potent activity as monotherapies, CCM-205 and CCM-245 have shown high efficacy when combined with existing 3rd-generation EGFR inhibitors and anti-EGFR antibodies. These combination approaches appear capable of maintaining or even regressing tumor volume in models where resistance has developed—an effect not achieved by current therapies when used alone.
Advancing Toward Clinical Trials
CCM Biosciences has announced plans to file an Investigational New Drug (IND) application this year to advance clinical candidates from its EGFR inhibitor program into clinical trials. The company is actively seeking partnerships with biotechnology and pharmaceutical companies for co-development rights in selected markets.
"We're at a critical juncture in the development of these compounds," said Anisha Ghosh, a representative of CCM Biosciences. "The data we'll present at ASCO 2025 demonstrates the significant potential of our approach to addressing one of the most challenging aspects of NSCLC treatment."
Company Background and Capabilities
CCM Biosciences describes itself as a diversified biotechnology company focused on discovering and developing novel therapeutics, including small molecules, gene therapies, biologics, and nanomedicines. The company's drug discovery platforms were developed at Chakrabarti Advanced Technology, a privately funded R&D institute established in 2010 with scientists working across the US, France, and India.
As a sister company to PMC Group, a global chemical and pharmaceutical company with approximately $1 billion in annual revenue, CCM Biosciences leverages complementary contract research, development, and manufacturing capabilities to enable fully integrated drug discovery and development.
In addition to presenting research findings, CCM Biosciences will serve as a Featured Exhibitor at ASCO 2025, where it plans to showcase both its drug programs and the technological platforms used in their discovery and development.
Market Context and Potential Impact
The market for EGFR-targeted therapies in NSCLC is substantial, with CCM Biosciences noting that EGFR-positive NSCLC represents a similar market size to PD-L1-positive NSCLC—the indication addressed by pembrolizumab (Keytruda®), currently the world's top-selling drug.
If successful in clinical development, CCM Biosciences' 4th-generation EGFR inhibitors could potentially address a significant treatment gap for patients who develop resistance to current therapies, potentially extending survival and improving outcomes in this difficult-to-treat population.
