J&J Completes $2 Billion Ambrx Acquisition, Boosts Pipeline for Next-Gen ADCs

On March 7, 2024, Johnson & Johnson (J&J) announced the completion of its acquisition of Ambrx Biopharma, a clinical-stage biopharmaceutical company, in a deal valued at approximately $2 billion. Ambrx specializes in a proprietary synthetic biology technology platform to design and develop next-generation antibody drug conjugates (ADCs).

The acquisition provides J&J the opportunity to design, develop, and commercialize targeted oncology therapeutics using Ambrx’s proprietary ADC technology, which incorporates highly specific-targeting monoclonal antibodies (mAbs) securely linked to a potent chemotherapeutic payload. The goal of the platform is to achieve targeted and efficient elimination of cancer cells without the prevalent side effects that are typically associated with chemotherapy, according to a company press release.

“We’re pleased to welcome Ambrx’s talented scientific team and proprietary ADC platform to Johnson & Johnson. We look forward to continuing the development of ARX517, which represents a potential first- and best-in-class PSMA [prostate-specific membrane antigen]-targeting ADC for the treatment of metastatic castration-resistant prostate cancer,” said Yusri Elsayed, global therapeutic area head, Oncology, Johnson & Johnson Innovative Medicine, in the press release. “This significant opportunity sets the stage for advancing next-generation ADCs with the aim of delivering differentiated solid tumor therapies that improve patients’ lives.”

“The Ambrx team has developed a promising pipeline and ADC platform that will be a strong complement and strategic fit to our oncology innovation strategy,” said Biljana Naumovic, worldwide vice-president, Oncology, Johnson & Johnson Innovative Medicine, in the release. “ADCs are transforming the solid tumor treatment paradigm by leveraging antibody–antigen interactions to release cytotoxic payload directly to tumor cells. This acquisition underscores our ambition to deliver enhanced, precision biologics to transform the treatment of cancers, including prostate cancer.”

In earlier news, the company announced on March 6, 2024 (1) that it has submitted a Type II variation application to the European Medicines Agency seeking approval for an indication extension of DARZALEX (daratumumab) subcutaneous (SC) formulation. Specifically, the application is seeking approval of the mAb in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) to treat adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT).

This submission is supported by data from a Phase III study (PERSEUS) evaluating D-VRd induction and consolidation therapy, ASCT, and daratumumab with lenalidomide (D-R) maintenance therapy in comparison to VRd, ASCT, and R maintenance. Results demonstrated that the study met its primary endpoint of progression-free survival.

“The impressive results from the PERSEUS study highlight the potential of this daratumumab subcutaneous-based regimen to transform patient outcomes and provide an effective therapy option in newly diagnosed, transplant-eligible multiple myeloma,” said Craig Tendler, vice-president, Clinical Development, Diagnostics, and Global Medical Affairs, Johnson & Johnson Innovative Medicine, in a company press release. “We are committed to advancing innovative regimens, such as D-VRd, as we strive towards the elimination of this complex disease. We now look forward to working with the EMA on the review of this submission.”

Reference

1. Johnson & Johnson. Johnson & Johnson Submits Application to the European Medicines Agency for DARZALEX (daratumumab)-based Quadruplet Therapy for the Treatment of Patients with Transplant-Eligible, Newly Diagnosed Multiple Myeloma. Press Release. March 6, 2024.

Source: Johnson & Johnson