Tag: monomethyl auristatin E

Philadelphia-based Medicus Oncology gains global development and commercialization rights to PF-08046031 (CD228V), a melanotransferrin-targeted antibody-drug conjugate (ADC) originating from Pfizer's Seagen acquisition, as Pfizer retains a co-development role, milestone eligibility, and tiered royalties.

Data from a Phase 1/2 dose-escalation and expansion study of JK06, a 5T4-targeted antibody-drug conjugate (ADC) being developed by SalubrisBio, have shown promising results...

The Phase 3 EV-303 is an ongoing clinical trial evaluating enfortumab vedotin (Padcev™; Pfizer and Astellas Pharma), a Nectin-4 directed antibody-drug conjugate (ADC), in combination with pembrolizumab (Keytruda™; Merck & Co), a PD-1 inhibitor, as neoadjuvant and adjuvant treatment (before and after surgery) versus surgery alone, the current standard of care, in patients with muscle-invasive bladder cancer (MIBC) who are not eligible for or declined cisplatin-based chemotherapy.

Updated results from the first-in-human phase 1 TORL123-001 (TRIO-049) trial (NCT05103683) investigating TOTL-1-23 (see: ADC Drugmap) in patients diagnosed with advanced or metastatic cancer, showed good tolerability and antitumor activity in heavily pretreated patients with ovarian and endometrial cancers that expressed claudin-6 (CLDN6).

Danish Adcendo and Shanghai-based Multitude Therapeutics have signed a licensing agreement for the development of ADCE-T02, a novel, highly differentiated antibody-drug conjugate (ADC) targeting Tissue Factor (TF), a transmembrane glycoprotein expressed by subendothelial cells and fibroblasts, that plays an important role in hemostasis regulation.

Preclinical data of a novel ADC being developed by Elevation Oncology, demonstrated proof-of-concept for its differentiated HER3-ADC program. 

The United States Food and Drug Administration has granted Fast Track Designation for China-based RemeGen's RC88, a mesothelin (MSLN)-targeting antibody-drug conjugate (ADC). The investigational drug is intended for the treatment of patients diagnosed with platinum-resistant recurrent epithelial ovarian, fallopian tube, and primary peritoneal cancers.

The U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for tisotumab vedotin (Tivdak®; Genmab and Pfizer) for the treatment of patients with recurrent or metastatic cervical cancer.

The U.S. Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for priority review for enfortumab vedotin-ejfv (Padcev® ; Astellas/Seagen with pembrolizumab (Keytryuda® ( Merck & Co; Merck Sharp & Dohme/MSD) as a combination therapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC), a form of bladder cancer that has spread to surrounding organs or muscles, or other parts of the body.

Results today from the Phase 3 innovaTV 301 randomized global trial, which showed treatment with tisotumab vedotin (Tivdak®; Seagen/Genmab)* demonstrated a statistically significant and clinically meaningful 30% reduction in the risk of death in recurrent or metastatic cervical cancer patients with disease progression on or after front-line therapy, compared with chemotherapy (HR: 0.70, 95% CI: 0.54-0.89, p=0.0038).[1]