Two Korean pharmaceutical and biotech companies have joined forces to gain an early foothold in the EGFR-mutant non-small cell lung cancer (NSCLC) market, which is projected to grow to 21 trillion won ($14 billion) by 2036.
Pharos iBio and Kolon Pharmaceutical aim to address unmet global demand by developing a fourth-generation EGFR inhibitor based on a “dual mechanism” strategy that not only overcomes the "C797S" resistance mutation emerging after treatment with third-generation therapies, but also blocks cancer cells’ alternative survival pathways.
Pharos iBio said Thursday that it signed a strategic memorandum of understanding with Kolon Pharmaceutical’s new drug division to jointly develop the next-generation lung cancer treatment candidate, PHI-701.
The partnership is intended to expand Pharos iBio’s accumulated AI-driven drug discovery capabilities and internal R&D achievements into external collaborative research.
Pharos iBio CEO Yoon Jeong-hyeok (left) and Kim Sun-jib, the head of Kolon Pharmaceutical's new drug division, held up their business agreement on Wednesday. (Courtesy of Pharos iBio)
The two companies plan to combine Pharos iBio’s AI-based drug design technology with Kolon Pharmaceutical’s translational research expertise for clinical development to create a next-generation inhibitor that can overcome resistance limitations associated with existing EGFR-targeted therapies.
PHI-701 is a novel candidate targeting EGFR protein mutations, a major driver of NSCLC. The companies plan to conduct joint research to advance the program into preclinical studies.
Pharos iBio will use its proprietary AI-based drug discovery platform, "Chemiverse," to design small-molecule compounds and identify optimized candidates. Kolon Pharmaceutical’s new drug division will conduct mechanistic studies on PHI-701 and oversee translational research activities, including nonclinical efficacy evaluations reflecting clinical trial design considerations.
A key focus of the PHI-701 program is acquired resistance that develops after treatment with current EGFR-targeted therapies.
Third-generation EGFR-targeted therapies have become standard treatment options for NSCLC, but the emergence of additional acquired resistance mutations such as C797S following treatment has remained a major limitation. As a result, demand is growing for next-generation EGFR inhibitors that can be used after current therapies fail.
Pharos iBio and Kolon Pharmaceutical plan to develop PHI-701 as a fourth-generation EGFR-targeted therapy with a "dual mechanism" that selectively inhibits mutant EGFR proteins while also blocking cell adhesion and migration signaling pathways, which serve as cancer cell survival bypass mechanisms.
The approach is designed not only to suppress new EGFR resistance mutations but also to block pathways that enable cancer cells to survive after resistance develops, potentially overcoming therapeutic resistance.
Combining AI design with translational research
The collaboration is also notable for integrating AI-based candidate design with translational clinical research from the earliest stages of development.
Kim Sun-jin, head of Kolon Pharmaceutical’s new drug division, said the company has built differentiated competitiveness by advancing orthotopic transplantation models for both primary and metastatic NSCLC and developing clinically translatable research strategies.
“We expect this partnership with Pharos iBio, which possesses innovative AI-based drug discovery capabilities, to maximize synergy in the development of NSCLC treatments,” he said.
Kim added that the convergence of AI and translational clinical research could dramatically shorten drug development timelines by generating highly reliable data and enabling clinical trial design from the initial stages of development.
Pharos iBio CEO Yoon Jeong-hyeok also described the partnership as a strategic collaborative research model combining AI drug design expertise with translational research know-how.
“This collaboration represents a strategic joint research model that combines AI-based drug design capabilities with translational clinical research expertise,” Yoon said. “We plan to accelerate the creation of tangible outcomes by expanding our AI-driven drug discovery capabilities, which we have steadily strengthened, into external partnerships and joint R&D.”
He added that the company aims to demonstrate the scalability and competitiveness of its AI drug discovery platform not only in rare diseases but also in high-value markets such as NSCLC.
Fourth-generation EGFR competition draws attention
The EGFR-mutant NSCLC treatment market is entering a new phase following the establishment of third-generation therapies as first-line standard treatments. As the number of patients receiving third-generation EGFR inhibitors increases, the number of patients developing subsequent resistance mutations such as C797S is also rising.
According to global market research firm DelveInsight, the global EGFR-mutant targeted NSCLC treatment market is projected to grow at a compound annual growth rate of 7.3 percent through 2036, reaching about $14.6 billion, or about 21.5 trillion won.
The collaboration between Pharos iBio and Kolon Pharmaceutical represents an early-stage joint research effort targeting this market. Since the project has not yet entered preclinical development, key determinants of success will include establishing candidate selectivity, resistance-mutation-inhibition capability, and nonclinical efficacy and safety data.
The fourth-generation EGFR inhibitor field presents a clear unmet need among patients who develop resistance after existing therapies. However, proving meaningful clinical differentiation will require not only strong inhibition of key resistance mutations such as C797S, but also selectivity against normal EGFR, effectiveness against brain metastases, and potential combination treatment strategies.
With the new agreement, Pharos iBio plans to expand the application of its AI drug discovery platform through external collaborative research, while Kolon Pharmaceutical aims to accelerate next-generation targeted cancer drug development based on its translational research expertise in NSCLC.
Hong Sook
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