Tag: MMAE

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.

Antibody drug conjugates (ADCs) offer a way to deliver a cytotoxic or an immuno-stimulatory payload directly to tumors to maximize the anti-tumor efficacy of the payload with reduced systemic toxicities. The development of ADCs has occurred over several decades. ADCs have been through several highs and lows where there was substantial excitement for the promise ADCs hold only to be followed by disinterest when there were disappointing results in the clinic. This resulted in several companies abandoning their internal ADC development efforts. Twelve ADCs globally have been approved to treat hematologic or solid tumors. The renewed interest in ADCs, is due, in part, to the recent clinical success of ADCs, the development of improved ADC technologies, and the identification of new ADC targets.

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.

Enfortumab vedotin + Pembrolizumab Approved by US FDA as the First and Only ADC + PD-1 Combination to Treat Advanced Bladder 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]

AstraZeneca has signed an exclusive global license agreement with KYM Biosciences, a joint venture of Keymed Biosciences and Lepu Biopharma, for CMG901.