Clinical Trials
7
1 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Active, not recruiting
1
14.3%
Completed
4
57.1%
Recruiting
1
14.3%
Terminated
1
14.3%
No approval data available
- Adagene announced a preclinical milestone in its collaboration and license agreement with Exelixis tied to XB404, triggering a $2.0 million payment from Exelixis. - XB404 uses Adagene's SAFEbody masking technology to deliver a cytotoxic payload to ROR1/2-expressing tumors while minimizing on-target, off-tumor side effects. - A second payment was triggered by candidate selection for another SAFEbody antibody-drug conjugate program, with Adagene also eligible for development, commercialization milestones and royalties.
- The FDA has granted Fast Track designation to muzastotug (ADG126) in combination with pembrolizumab for treating adult patients with microsatellite stable metastatic colorectal cancer without liver metastases. - Muzastotug is a next-generation masked anti-CTLA-4 SAFEbody engineered to overcome CTLA-4-mediated Treg resistance with enhanced safety and efficacy compared to existing CTLA-4 therapies. - The designation is supported by emerging clinical evidence showing encouraging efficacy, deep and durable responses, and a favorable safety profile in heavily pretreated patients. - Adagene plans to share updated Phase 1b/2 clinical data in the coming months and begin a registration trial in 2027.
- Third Arc Bio has entered a licensing agreement with Adagene to develop two masked CD3 T cell engagers using Adagene's SAFEbody precision masking technology platform. - The partnership aims to address precision challenges in solid tumor immunotherapy by combining Third Arc Bio's ARCStim Platform with Adagene's tumor-specific activation capabilities. - Adagene will receive $5 million upfront and is eligible for up to $840 million in development and commercial milestones, plus royalties on sales. - The collaboration expands Third Arc Bio's portfolio of novel CD3- and CD28-targeting T cell engagers while allowing Adagene to retain development rights in Greater China, Singapore, and South Korea.
- Over 80 CD47 inhibitor drugs are currently in clinical trials across Phase I to Phase III stages, targeting both hematologic malignancies and solid tumors. - The first CD47 inhibitor drug approval is projected by 2028, with leading companies including Gilead Sciences, ALX Oncology, and I-Mab Biopharma driving innovation. - CD47 represents a promising "don't eat me" immune checkpoint target for cancer treatment, particularly for patients who don't respond to PD-1/PD-L1 inhibitors. - Future development focuses on bispecific antibodies, combination therapies, and biomarker-guided personalized treatment strategies to minimize toxicities while maximizing efficacy.
- Adagene Inc. has entered a strategic partnership with ConjugateBio Inc. to provide a proprietary antibody for development as novel bispecific antibody-drug conjugates (ADCs). - The collaboration leverages Adagene's SAFEbody precision masking technology and ConjugateBio's third-generation linker-payload capabilities to advance ADC development in the rapidly growing market. - Under the agreement terms, Adagene will receive upfront payments plus milestone and royalty payments while retaining all non-ADC rights to the partnered antibody. - The ADC market is projected to exceed $30 billion by 2030, with ConjugateBio focusing on first-in-class bispecific ADCs targeting solid tumors across multiple cancer indications.
- Sanofi has committed up to $25 million in strategic investment to Adagene, extending the biotech's cash runway into 2027 and supporting clinical development of its lead SAFEbody candidate muzastotug. - The partnership includes Sanofi exercising its option on a third SAFEbody discovery program and sponsoring a combination clinical trial with muzastotug in over 100 patients with advanced solid tumors. - Adagene's SAFEbody technology uses precision masking to enable tumor-specific targeting while minimizing toxicity in healthy tissues, addressing key safety challenges in cancer immunotherapy. - The collaboration reinforces Sanofi's aggressive R&D expansion strategy, following recent major deals including a $5.2 billion alliance with Exscientia and acquisitions totaling over $6 billion in immuno-oncology assets.
- Adagene launches investigator-initiated Phase 2 trial of ADG126 (muzastotug) in combination with KEYTRUDA for stage II/III colorectal cancer patients, with enrollment starting April 2025. - The neoadjuvant study will evaluate major pathologic response as the primary endpoint in up to 20 patients, focusing on tumor reduction before surgery. - The trial aims to demonstrate the potential of combining CTLA-4-mediated T regulatory cell depletion with PD-1 inhibition to enhance anti-tumor immunity in early-stage treatment.
- Updated Phase 1b/2 trial data reveals ADG126 combined with pembrolizumab achieved a 33% overall response rate in microsatellite stable colorectal cancer patients, showing improvement from previous 23% response rate. - All responding patients remain on treatment with maintenance doses of either 10 mg/kg every 3 or 6 weeks, demonstrating sustained therapeutic effect. - The study implemented flexible dose modifications to optimize individual patient treatment outcomes, with final time-to-event data expected in 2025.
- CD137-targeted therapies are emerging as a promising approach in cancer immunotherapy due to their ability to stimulate and expand cytotoxic T cells, enhancing tumor cell killing. - Several pharmaceutical companies, including BioNTech and Genmab, are actively developing CD137-targeted therapies, with multiple candidates in clinical trials, primarily in Phase 2. - Combination therapies involving CD137 agonists with checkpoint inhibitors or chemotherapy show synergistic benefits, potentially improving outcomes for difficult-to-treat malignancies. - The market for CD137-targeted therapies is expected to grow significantly, driven by the demand for effective treatments and the potential to address limitations of existing immunotherapies.
