Clinical Trials
44
27 active
Approvals
3
Total approvals
Agencies
2
Regulatory bodies
Founded
1981
Active, not recruiting
27
61.4%
Completed
14
31.8%
Terminated
2
4.5%
Withdrawn
1
2.3%
- AbbVie is initiating the pivotal phase 2/3 Revival trial testing pivekimab sunirine plus Venclexta and azacitidine in first-line AML patients unfit for intensive chemotherapy, with enrollment starting in July. - The CD123-targeting ADC previously demonstrated a 63% complete response rate in a phase 1/2 study of 49 first-line unfit patients, though two treatment-related deaths were observed. - AbbVie has also launched a phase 1b pediatric trial evaluating pivekimab sunirine in children aged 6 months to 17 years with relapsed or refractory AML across approximately 30 global sites. - Pivekimab sunirine, acquired through the $10 billion ImmunoGen buyout, is currently under FDA review for blastic plasmacytoid dendritic cell neoplasm with a decision expected in 2026.
- CytomX Therapeutics announced key 2026 milestones for varsetatug masetecan, a masked antibody-drug conjugate targeting EpCAM in colorectal cancer patients. - The company plans to release Phase 1 expansion data in Q1 2026 from approximately 100 patients and initiate a combination study with bevacizumab. - CytomX aims to align with FDA on registrational study design for the potential first-in-class ADC in advanced colorectal cancer. - The company is also advancing CX-801, a masked interferon alpha-2b, in combination with pembrolizumab for advanced melanoma treatment.
- CytomX Therapeutics has appointed Rachael Lester as Senior Vice President and Chief Business Officer to lead strategy and business development functions for the company's masked biologics platform. - Lester brings over two decades of experience in biopharmaceutical business development, including previous roles at Replicate Bioscience, Harpoon Therapeutics, and Onyx Pharmaceuticals. - The appointment comes as CytomX advances its clinical pipeline including CX-2051 for colorectal cancer and CX-801 for melanoma, both utilizing the company's PROBODY therapeutic platform. - CytomX's multi-modality platform has produced therapeutic candidates across antibody-drug conjugates, T-cell engagers, and immune modulators with strategic partnerships including Amgen, Bristol Myers Squibb, and Regeneron.
- Crescent Biopharma has appointed Jan Pinkas, Ph.D., as chief scientific officer, bringing over two decades of oncology drug development experience including expertise in antibody-drug conjugates. - The company expects to begin dosing patients in a global Phase 1 trial of CR-001, a PD-1 x VEGF bispecific antibody, in early 2026. - Crescent anticipates submitting an IND application for CR-002, a novel antibody-drug conjugate, in mid-2026. - Dr. Pinkas previously served as chief scientific officer at Pyxis Oncology and contributed to the development of ELAHERE, an approved ADC for platinum-resistant ovarian cancer.
- Oxford BioTherapeutics announced that Boehringer Ingelheim has selected a third drug candidate targeting OB33 to advance into IND-enabling studies under their ongoing collaboration. - The target was identified using OBT's proprietary OGAP-Verify discovery platform, which has demonstrated enhanced sensitivity and target selection capabilities for therapeutic antibodies. - The milestone triggers a payment to OBT and represents the latest success in a partnership that began in 2013 and has yielded multiple development-stage assets. - Two candidates from the collaboration are currently in clinical trials, with this third candidate joining one other compound already in IND-enabling studies.
- Day One Biopharmaceuticals has appointed Michael Vasconcelles, M.D., as Head of Research and Development, bringing over 25 years of oncology research and development expertise to the company. - Dr. Vasconcelles will oversee the company's research, development, and medical affairs infrastructure while supporting OJEMDA's growth and expanding the pipeline of targeted therapies. - The appointment comes at a pivotal time for Day One as it transitions from focusing primarily on pediatric cancer to developing transformative medicines for patients of all ages with life-threatening diseases. - Dr. Vasconcelles previously served as Executive Vice President at ImmunoGen, where he led the transformation into a global biotech enterprise and optimized ELAHERE's commercialization strategy.
- Pharmaceutical and biotech companies across Europe and North America have made significant board appointments, bringing industry veterans and scientific experts to strengthen their leadership teams. - Notable appointments include former CDC Director Dr. Julie Louise Gerberding joining ARTIDIS and former Roche neuroscience head Dr. Paulo Fontoura taking on dual advisory roles. - Companies ranging from clinical-stage biotechs to established pharmaceutical firms are adding expertise in areas including oncology, neuroscience, infectious diseases, and antimicrobial resistance.
- CytomX's EpCAM-targeting antibody-drug conjugate CX-2051 demonstrated a 28% confirmed response rate in late-line colorectal cancer patients, significantly outperforming current standard therapies with single-digit response rates. - The novel PROBODY® masking technology appears to successfully target EpCAM, a previously "undruggable" tumor antigen, with manageable safety profile and no dose-limiting toxicities observed in the Phase 1 study. - Median progression-free survival reached 5.8 months with 43% response rate at the highest dose level (10 mg/kg), supporting plans to advance to Phase 2 trials in first half of 2026.
- Cantargia's anti-IL1RAP antibody-drug conjugate demonstrated potent anti-tumor activity across different IL1RAP expression levels in preclinical models, with a single dose achieving 100% survival in high-expressing tumors. - The ADC targets IL1RAP, a protein overexpressed in many tumor cells and their microenvironment, providing a dual-targeting approach that could potentially improve cancer treatment outcomes. - Preclinical safety data showed the ADC was well-tolerated with no significant changes in body weight, liver and kidney enzyme levels, or histological abnormalities in assessed organs.
- The Federal Circuit has affirmed that ImmunoGen's patent application for a specific dosing regimen of mirvetuximab soravtansine (IMGN853) was obvious, despite the inventors' claim of solving an unknown ocular toxicity problem. - The court emphasized that "the obviousness inquiry is generally agnostic to the particular motivation of the inventors," establishing that a solution can be obvious even if the specific problem it addresses wasn't recognized in prior art. - The ruling creates significant implications for pharmaceutical companies developing second-generation patents on dosing regimens, potentially strengthening generic companies' ability to challenge Orange Book-listed patents.
