SOUTH SAN FRANCISCO, Calif. - CytomX Therapeutics, Inc. (NASDAQ:CTMX) announced today initial data from its ongoing Phase 1a clinical study of CX-904, showing a favorable safety profile and signs of anti-cancer activity in patients with advanced pancreatic cancer. The investigational therapy is a PROBODY T-cell engager designed to precisely target cancer cells while minimizing effects on healthy tissue.
As of April 16, 2024, the study enrolled 35 patients with various metastatic solid tumors known to express the epidermal growth factor receptor (EGFR), including pancreatic and colorectal cancers. These patients, with a median of four prior lines of therapy, were assigned to either initial non-step dosing cohorts or subsequent step-dosing cohorts.
The trial's findings to date indicate that CX-904 can be administered in an outpatient setting due to its favorable safety profile. Notably, no cytokine release syndrome of any grade was observed in step-dosing cohorts, and only Grade 1 cases occurred in the highest non-step dosing cohort.
Efficacy-wise, two out of six patients with pancreatic cancer experienced a confirmed partial response, and all six achieved disease control. One patient saw an 83% tumor reduction, while another had a 51% reduction and continued on the study treatment as of the data cutoff.
Preliminary pharmacokinetic and pharmacodynamic analyses support the PROBODY T-cell Engager platform's mechanism of action, with maintained masking in circulation and evidence of T-cell activation and tumor infiltration. The trial continues with dose escalation and optimization, aiming to establish a recommended Phase 2 dose.
The company expects to provide a further update on the Phase 1a dose escalation by the end of 2024. These data will guide discussions with global development partner Amgen (NASDAQ:AMGN) regarding potential Phase 1b expansion cohorts in specific EGFR-positive tumor types.
CytomX's CEO, Sean McCarthy, expressed optimism about the potential of CX-904 to provide meaningful tumor reductions in difficult-to-treat cancers and its overall safety. The company, known for its conditionally activated, masked biologics, anticipates that CX-904 could expand the possibilities for T-cell engagers across various cancer types.
InvestingPro Insights
As CytomX Therapeutics, Inc. (NASDAQ:CTMX) continues to make strides in the development of CX-904 for the treatment of advanced pancreatic cancer, investors and stakeholders may find the following InvestingPro Data and Tips insightful. According to the latest metrics, CytomX Therapeutics holds a market capitalization of $283.8 million, indicating a substantial presence in the biotechnology sector. Despite showing a promising clinical profile for CX-904, the company's P/E ratio stands at a negative 493.75, reflective of the high-risk nature often associated with biotech investments.
InvestingPro Tips suggest that while CytomX has more cash than debt on its balance sheet, which is a positive signal for financial stability, the company is quickly burning through cash. This could be due to the significant investment required for research and development in the biotech industry. Moreover, analysts anticipate a sales decline in the current year, which investors should consider when evaluating the company's future revenue streams.
The stock's performance presents a mixed picture, with a significant hit over the last week, yet a strong return over the last month, three months, and even the last year. This volatility highlights the dynamic nature of investing in biotech firms, where news on clinical trials and regulatory developments can lead to substantial price swings.
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