Kelun-Biotech and Crescent Biopharma Form Strategic Partnership to Advance Novel Oncology Therapeutics
核心洞察
Kelun-Biotech (搜索) and Crescent Biopharma announced a strategic partnership to develop CR-001, a PD-1 (搜索) x VEGF (搜索) bispecific antibody, and SKB105 (搜索), an integrin beta-6 (搜索)-directed ADC with topoisomerase payload.
The collaboration grants Kelun-Biotech (搜索) exclusive rights to CR-001 in Greater China while Crescent receives exclusive rights to SKB105 (搜索) in the US, Europe and other global markets.
Both therapeutic candidates are expected to enter Phase 1/2 monotherapy clinical trials in Q1 2026, with combination studies to follow.
Kelun-Biotech (搜索) and Crescent Biopharma have announced a strategic partnership to develop and commercialize two novel oncology therapeutics, marking a significant expansion of both companies' global reach and therapeutic portfolios. The collaboration centers on CR-001, a PD-1 (搜索) x VEGF (搜索) bispecific antibody, and SKB105 (搜索) (also known as CR-003), an integrin beta-6 (搜索)-directed antibody-drug conjugate (ADC) with a topoisomerase payload.
Under the partnership terms, Crescent has granted Kelun-Biotech (搜索) exclusive rights to research, develop, manufacture and commercialize CR-001 in Greater China, including mainland China, Hong Kong, Macau and Taiwan. Conversely, Kelun-Biotech has granted Crescent exclusive rights to research, develop, manufacture and commercialize SKB105 (搜索) in the United States, Europe and all other markets outside of Greater China.
Financial Structure and Milestone Payments
The collaboration involves substantial financial commitments from both parties. Kelun-Biotech (搜索) will receive an upfront payment of $80 million from Crescent and is eligible for additional milestones of up to $1.25 billion, plus tiered middle single-digit to low double-digit royalties on net sales of SKB105 (搜索). Crescent will receive an upfront payment of $20 million from Kelun-Biotech and is eligible for additional milestones of up to $30 million, plus tiered low to middle single-digit royalties on net sales of CR-001.
CR-001: PD-1 x VEGF Bispecific Antibody
CR-001 is a tetravalent bispecific antibody designed to combine two complementary, validated mechanisms in oncology through blockade of PD-1 (搜索) and VEGF (搜索). The PD-1 checkpoint inhibition aims to restore T cells' ability to recognize and destroy tumor cells, while blocking VEGF is intended to reduce blood supply to tumor cells and inhibit tumor growth.
In preclinical studies, CR-001 demonstrated cooperative pharmacology with increased binding to PD-1 (搜索) and signal blockade in the presence of VEGF (搜索), as well as robust anti-tumor activity. The molecule was intentionally designed to replicate the cooperative pharmacology of ivonescimab, which demonstrated superior efficacy results compared to pembrolizumab in a large, third-party Phase 3 trial in non-small cell lung cancer (搜索).
Crescent plans to initiate a global Phase 1/2 clinical trial of CR-001 in patients with solid tumors (搜索) in the first quarter of 2026. The trial is designed to enroll both treatment-naïve and previously-treated patients with multiple solid tumor types, including non-small cell lung cancer (搜索) and various gastrointestinal and gynecological tumors (搜索). The company anticipates reporting proof-of-concept clinical data from the Phase 1/2 trial in the first quarter of 2027.
SKB105: Integrin Beta-6 Targeted ADC
SKB105 (搜索) represents a differentiated ADC targeting integrin beta-6 (搜索) (ITGB6 (搜索)) with a topoisomerase 1 (搜索) inhibitor payload. ITGB6 is overexpressed in many solid tumors (搜索) but shows minimal to no expression in most normal tissues, potentially reducing the risk of systemic toxicity and off-target effects.
The molecule consists of an anti-ITGB6 (搜索) fully human IgG1 monoclonal antibody conjugated via a stable, clinically validated cleavable linker. SKB105 (搜索) incorporates proprietary Kthiol® irreversible conjugation technology, designed to enhance stability and tumor-specific payload delivery while reducing adverse effects. In preclinical models, SKB105 demonstrated a favorable efficacy, safety, and pharmacokinetic profile.
Kelun-Biotech (搜索) plans to initiate a Phase 1/2 trial of SKB105 (搜索) in Greater China in the first quarter of 2026, with proof-of-concept data expected in the first quarter of 2027.
Combination Strategy and Pipeline Expansion
The partnership enables both companies to explore novel combination strategies. CR-001's anti-VEGF (搜索) activity may normalize the vasculature at the tumor site, potentially improving the localization and effectiveness of combination therapies, such as administration with ADCs. Both Crescent and Kelun-Biotech (搜索) retain rights to independently develop CR-001 in additional combinations, including with proprietary ADC pipeline assets.
Crescent also announced details of its expanded pipeline, including CR-002, a topoisomerase inhibitor ADC directed to PD-L1 (搜索). The company is on track to submit an Investigational New Drug Application for CR-002 in mid-2026 to support initiation of a Phase 1/2 trial in the second half of 2026.
Financial Backing and Development Timeline
Concurrent with the partnership announcement, Crescent secured $185 million in private placement financing from institutional and accredited investors, including Forbion, Fairmount, Vestal Point Capital, BVF Partners, ADAR1, Balyasny Asset Management and Venrock Healthcare Capital Partners. The financing is expected to provide cash runway into 2028 and support multiple key clinical data readouts beginning in Q1 2027.
The companies have outlined an aggressive development timeline with multiple milestones planned through 2027, including initiation of the first CR-001 x ADC combination trial expected by year-end 2026 and initial combination data anticipated by year-end 2027.
"This collaboration complements and strengthens our differentiated oncology pipeline by the addition of CR-001 and also enables us to advance the development of SKB105 (搜索) in the global market," said Dr. Michael Ge, chief executive officer of Kelun-Biotech (搜索). Joshua Brumm, chief executive officer of Crescent, noted that the partnership "expands our pipeline with the addition of SKB105, furthers our strategy of advancing multiple modalities across our portfolio, and accelerates our efforts to deliver synergistic combinations with CR-001."