Ligand Announces that Janssen has Received Approval from European Commission for TECVAYLI® (teclistamab) for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma

On August 24, 2022 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported that the Janssen Biotech, Inc. (Janssen) received conditional marketing authorization (CMA) from the European Commission for TECVAYLI (teclistamab) as monotherapy for the treatment of patients with relapsed or refractory (R/R) multiple myeloma (Press release, Ligand, AUG 24, 2022, View Source [SID1234618609]). Teclistamab is a T-cell redirecting, bispecific antibody targeting both B-cell maturation antigen (BCMA) and CD3 that was discovered by Janssen scientists using OmniAb’s OmniRat antibody discovery technology.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the terms of the licensing agreement with an affiliate of Janssen, OmniAb is eligible to receive a $10 million milestone payment upon the first commercial sale of teclistamab in the United Kingdom, Italy, Germany, France, or Spain.

"Approval of Janssen’s TECVAYLI by the European Commission adds another important medicine for the treatment of relapsed or refractory multiple myeloma. This marks the first European approval of an OmniAb-derived antibody, and the first approval of an OmniAb-derived bispecific antibody," said Matt Foehr, President and COO of Ligand. "We look forward to the continued advancement of therapies our collaborators have discovered using the OmniAb platform."

Ligand’s previously announced spin-off of OmniAb and merger (Business Combination) with Avista Public Acquisition Corp. II (APAC) (NASDAQ: AHPA), a publicly traded special purpose acquisition company (SPAC), remains on track to close in the fourth quarter of 2022. Under the terms of the separation and distribution agreement between Ligand and OmniAb, the milestone payments related to the first commercial sale of TECVAYLI will remain with the OmniAb business regardless of timing and achievement of the milestone and the timing of the merger closing. The license agreement between OmniAb and CNA Development LLC does not include royalty payments, and OmniAb will not receive royalties on sales of TECVAYLI.

About OmniAb

The OmniAb discovery platform provides Ligand’s pharmaceutical industry partners access to the diverse antibody repertoires and high-throughput screening technologies to enable discovery of next-generation therapeutics. At the heart of the OmniAb platform is the Biological Intelligence (BI) of our proprietary transgenic animals, including OmniRat, OmniChicken and OmniMouse that have been genetically modified to generate antibodies with human sequences to facilitate development of human therapeutic candidates. OmniFlic (transgenic rat) and OmniClic (transgenic chicken) address industry needs for bispecific antibody applications though a common light chain approach, and OmniTaur features unique structural attributes of cow antibodies for complex targets. We believe the OmniAb animals comprise the most diverse host systems available in the industry and they are optimally leveraged through computational antigen design and immunization methods, paired with high-throughput single B cell phenotypic screening and mining of next-generation sequencing datasets with custom algorithms to identify fully human antibodies with superior performance and developability characteristics. An established core competency focused on ion channels and transporters further differentiates our technology and creates opportunities in emerging target classes. OmniAb antibodies have been leveraged across modalities, including bispecific antibodies, antibody-drug conjugates and others. The OmniAb suite of technologies span from BI-powered repertoire generation to cutting edge antibody discovery and optimization offering a highly efficient and customizable end-to-end solution for the growing discovery needs of the global pharmaceutical industry.