Crescent Biopharma Advances PD-1 x VEGF Bispecific Antibody CR-001 Toward Phase 1 Trial
核心洞察
Crescent Biopharma remains on track to submit an IND application for CR-001, a PD-1 (搜索) x VEGF (搜索) bispecific antibody, in Q4 2025 to support a global Phase 1 trial in solid tumor patients.
Preclinical data presented at SITC demonstrates CR-001's cooperative pharmacology with increased PD-1 (搜索) binding in VEGF (搜索) presence and potent anti-tumor activity in xenograft models.
The company expects to report proof-of-concept clinical data from the Phase 1 trial in the second half of 2026, with $133.3 million cash runway through 2027.
Crescent Biopharma announced significant progress in advancing its lead oncology program CR-001, a tetravalent PD-1 (搜索) x VEGF (搜索) bispecific antibody, toward clinical trials. The company remains on track to submit an Investigational New Drug (IND) application to the FDA in the fourth quarter of 2025, with plans to initiate a global Phase 1 trial in patients with solid tumors (搜索) in the first quarter of 2026.
"We have made exciting progress during 2025 advancing our pipeline of next generation therapeutics for solid tumors (搜索) toward the clinic," said Joshua Brumm, chief executive officer of Crescent. "For CR-001, our PD-1 (搜索) x VEGF (搜索) bispecific antibody, we are presenting preclinical data at SITC demonstrating cooperative pharmacology and in vivo anti-tumor activity."
Promising Preclinical Data Presented at SITC
Preclinical data from CR-001 was featured in a poster presentation on November 7, 2025, at the Society for Immunotherapy of Cancer (搜索)'s 40th Annual Meeting. The data demonstrated that CR-001 exhibits cooperative pharmacology with increased binding to PD-1 (搜索) in the presence of VEGF (搜索), augmenting the PD-1/PD-L1 (搜索) signaling blockade and enhancing T-cell activation in vitro. This cooperativity was consistent with preclinical evaluation of ivonescimab.
In efficacy studies, CR-001 showed potent anti-tumor activity in a xenograft mouse model and was well-tolerated in non-human primates after a single intravenous dose with robust PD-1 (搜索) receptor occupancy. The company expects to report proof-of-concept clinical data from the global Phase 1 trial in patients with solid tumors (搜索) in the second half of 2026.
Strategic Design Based on Validated Approach
CR-001 was designed to replicate the cooperative pharmacology of ivonescimab, which demonstrated superior efficacy compared to pembrolizumab, the current market leader, in a large, third-party Phase 3 trial in non-small cell lung cancer (搜索). The bispecific antibody combines two complementary, validated mechanisms in oncology via blockade of PD-1 (搜索) and VEGF (搜索) pathways.
Expanding Pipeline with ADC Programs
Beyond CR-001, Crescent is advancing its antibody-drug conjugate (ADC) programs. CR-002 and CR-003 are novel ADCs with topoisomerase (搜索) inhibitor payloads being developed as single agents and in combination with CR-001. The company expects to submit an IND application for CR-002 in mid-2026, while CR-003 remains in the discovery stage.
Strong Financial Position
Crescent reported a cash position of $133.3 million as of September 30, 2025, which is anticipated to fund operations through 2027. For the third quarter of 2025, the company reported research and development expenses of $20.3 million and general and administrative expenses of $5.5 million, with a net loss of $24.6 million, or $1.27 per basic and diluted share.
The company had approximately 19.6 million shares of ordinary shares and ordinary share equivalents issued and outstanding as of September 30, 2025, including ordinary shares underlying pre-funded warrants and non-voting convertible preferred stock.
Brumm emphasized the company's focus on execution: "We remain focused on executing across the business with the goal of delivering the next wave of transformative therapies for people living with cancer (搜索)."