Clinical Trials
11
0 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Completed
8
72.7%
Terminated
3
27.3%
No approval data available
- Prelude Therapeutics has received FDA clearance of an Investigational New Drug application for PRT13722, a first-in-class oral KAT6A inhibitor, according to MarketBeat. - The clearance allows the company to begin a Phase 1 trial in hormone receptor-positive, HER2-negative breast cancer, the program's initial clinical stage. - PRT13722 targets KAT6A, an epigenetic regulator implicated in cancer cell growth, a mechanism not yet validated in the clinic. - Prelude Therapeutics is also developing a broader pipeline of small-molecule targeted cancer therapies in the biotechnology segment.
- Prelude Therapeutics received FDA clearance of its IND application for PRT13722, a first-in-class oral KAT6A selective degrader for HR+/HER2- breast cancer. - The company expects to begin enrolling patients in a first-in-human Phase 1 trial in the fourth quarter of 2026. - Selective KAT6A degradation aims to improve efficacy and hematological safety versus dual KAT6A/B inhibitors, which show overlapping toxicities with backbone therapies. - The Phase 1 study will assess safety, tolerability, pharmacokinetics, pharmacodynamics and antitumor activity as monotherapy and in combination with endocrine and targeted therapies.
- Sana Biotechnology has appointed Brian Piper as Executive Vice President and Chief Financial Officer, bringing over 25 years of biopharmaceutical financial expertise to the engineered cell therapy company. - The company expects to generate initial clinical data for SC451 in type 1 diabetes treatment and SG293 in B-cell related diseases within the next 12-18 months. - Piper previously served as CFO at Scorpion Therapeutics until its acquisition by Eli Lilly in 2025, and brings experience in capital formation and operational excellence. - The appointment comes at a pivotal time as Sana advances its hypoimmune-modified pancreatic islet cell therapy and in vivo CAR-T platform programs.
- Prelude Therapeutics presented first preclinical data for PRT12396, a JAK2V617F-selective JH2 inhibitor that demonstrates disease-modifying potential in myeloproliferative neoplasms while preserving normal JAK2 function. - The company also disclosed a novel mutant calreticulin (mCALR) targeted degrader antibody conjugate with a CDK9 degrader payload that selectively kills malignant clones while sparing healthy cells. - PRT12396 has completed GLP toxicology studies and is on track for IND filing in the first quarter of 2026, with the program subject to an exclusive option agreement with Incyte. - Both therapeutic approaches target the two primary driver mutations responsible for disease progression in the majority of MPN patients, potentially offering transformative treatment options.
- Prelude Therapeutics' PRT3789 demonstrated anti-tumor activity in SMARCA4-mutated NSCLC and esophageal cancer patients during Phase 1 dose escalation. - The Phase 1 trial of PRT3789 showed the drug was generally well-tolerated, with no dose-limiting toxicities or study drug-related serious adverse events. - The company aims to confirm the biologically active dose of PRT3789 by year-end and advance monotherapy and docetaxel combination studies. - Preclinical data suggests that dual SMARCA2/4 degraders attached to antibodies could expand treatment possibilities beyond SMARCA4 mutations.
