Cytokinetics, Pyxis Oncology, and CytomX Therapeutics have announced strategic milestones and pipeline priorities for 2025, signaling significant developments in their respective clinical programs. These updates highlight a focus on advancing key drug candidates and achieving critical clinical trial objectives.
Cytokinetics Gears Up for Potential Aficamten Launch
Cytokinetics is preparing for a potentially transformative year in 2025, with its primary focus on the anticipated approval and commercial launch of aficamten for obstructive hypertrophic cardiomyopathy (HCM) in the United States. The FDA has set a target action date of September 26, 2025, for aficamten. The company is also actively developing go-to-market strategies in Germany and expanding commercial readiness activities in Europe, anticipating potential approval by the European Medicines Agency (EMA) in the first half of 2026.
In addition to regulatory preparations, Cytokinetics expects to report topline results from the MAPLE-HCM Phase 3 clinical trial in the first half of 2025. This trial compares aficamten monotherapy to metoprolol monotherapy in patients with symptomatic obstructive HCM. The company also anticipates completing patient enrollment in the ACACIA-HCM Phase 3 trial of aficamten in patients with non-obstructive HCM in the second half of 2025.
Robert I. Blum, Cytokinetics’ President and Chief Executive Officer, stated, "In 2025 we are poised for a defining year with principal focus to the potential approval and commercial launch of aficamten for obstructive HCM in the United States."
Pyxis Oncology Prioritizes PYX-201 Development
Pyxis Oncology is concentrating its resources on advancing PYX-201, a first-in-concept antibody-drug conjugate (ADC) targeting Extradomain-B Fibronectin (EDB+FN) in the tumor extracellular matrix. Preliminary Phase 1 data showed a 50% objective response rate (ORR) in heavily pretreated head and neck squamous cell carcinoma (HNSCC) patients, with a 100% disease control rate (DCR) in six evaluable patients.
Across multiple solid tumor types, including HNSCC, ovarian cancer, non-small cell lung cancer (NSCLC), HR+/HER2- breast cancer, triple-negative breast cancer (TNBC), and sarcoma, PYX-201 achieved a 26% ORR in the Phase 1 trial (n=31). Dose-dependent responses were observed, including in patients who had previously progressed on taxanes. Pyxis Oncology plans to initiate monotherapy and combination therapy expansion trials, including a frontline HNSCC study in combination with pembrolizumab, with patient dosing expected to begin in early 2025. Preliminary data from these cohorts are expected in the second half of 2025 and the first half of 2026.
Lara S. Sullivan, M.D., President and Chief Executive Officer of Pyxis Oncology, commented, "We are excited about the potential of PYX-201, an innovative, first-in-concept ADC uniquely designed to target the tumor extracellular matrix."
CytomX Focuses on CX-2051 and Pipeline Prioritization
CytomX Therapeutics is prioritizing the development of CX-2051, a PROBODY antibody-drug conjugate (ADC) targeting EpCAM (Epithelial Cell Adhesion Molecule), initially in advanced metastatic colorectal cancer (CRC). EpCAM is highly expressed in CRC but has been historically difficult to target due to its expression on normal tissues. CX-2051 utilizes a next-generation topoisomerase-1 inhibitor payload (CAMP59) and a cleavable payload-antibody linker designed to enhance anti-tumor activity through a bystander effect.
The Phase 1 study of CX-2051 is ongoing, with patient enrollment focused on advanced CRC patients who have received three or more prior lines of systemic therapy. Initial Phase 1a data are expected in the first half of 2025. CytomX is also continuing Phase 1 studies of CX-904 (EGFRxCD3 PROBODY T-cell engager) and CX-801 (PROBODY Interferon-alpha 2b) with data expected in 2H 2025.
Sean McCarthy, D.Phil., chief executive officer and chairman of CytomX, stated, "Our top strategic objective for 2025 is the development of CX-2051... We are encouraged by our early clinical progress and remain on track to deliver initial Phase 1a dose escalation data in the first half of 2025."
