Objective
Scope
Summary
Antibody Drug Conjugates Companies:
In the competitive landscape of the antibody drug conjugates companies are driving innovation and shaping the industry. GlaxoSmithKline (GSK), headquartered in Brentford, United Kingdom, is a major player with a focus on developing advanced ADCs and leveraging its extensive research capabilities to enhance therapeutic options. Astellas Pharma, based in Tokyo, Japan, is known for its strategic approach to ADC development, with significant advancements in treatments for various cancers. Merck & Co., located in Kenilworth, New Jersey, USA, is a key competitor with its own ADC pipeline and a strong emphasis on combining ADCs with other therapeutic modalities to improve patient outcomes. ImmunoGen, Inc., based in Waltham, Massachusetts, USA, specializes in ADC technology with its proprietary platforms, aiming to deliver targeted treatments for difficult-to-treat cancers. ADC Therapeutics, headquartered in Lausanne, Switzerland, is notable for its development of novel ADCs and innovative approaches to targeting cancer cells. Together, these companies represent a diverse and dynamic competitive landscape, characterized by their commitment to advancing ADC technology and improving cancer treatment options. AbbVie AbbVie’s Contract Manufacturing Organization (CMO) is a leader in advanced Antibody Drug Conjugate development and manufacturing. With extensive expertise in late-stage scale-up, AbbVie coordinates all elements of the ADC supply chain, including antibody intermediate production, conjugation, and final drug product fill-finish. Their facilities and expertise support clients in advancing ADC drug candidates from development to market. Partnering with AbbVie means working with a proven innovator known for its robust linker-payload conjugation processes and comprehensive supply chain planning. The company utilizes a global science and technology team and state-of-the-art facilities to streamline production and ensure successful scale-up. AbbVie’s proven global quality and operational network help mitigate risks and assure successful Biologics License Application (BLA) approval and supply chain integrity. FDA granted accelerated approval for the treatment of adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Continued approval is contingent upon verification and description of clinical benefit in a confirmatory trial.• On November 30, 2023, AbbVie declared its acquisition of ImmunoGen, Inc. (NASDAQ: IMGN) for $31.26 per share, approximately $10.1 billion. This strategic move accelerates AbbVie's entry into the solid tumour market with ImmunoGen's flagship ADC, ELAHERE, a first-in-class therapy approved for platinum-resistant ovarian cancer. ELAHERE represents a significant advancement in treating ovarian cancer, offering a potential multi-billion-dollar market opportunity. The acquisition includes ImmunoGen's promising pipeline of next-generation ADCs, which complements AbbVie's oncology portfolio. ImmunoGen's assets include IMGN-151, a next-generation anti-FRα ADC, and pivekimab sunirine, an anti-CD123 ADC for rare blood cancer. AbbVie's capacity to drive innovation and expand its oncology treatments, with a focus on advancing both solid tumours and hematologic malignancies.
AstraZeneca AstraZeneca is a global, science-driven biopharmaceutical company headquartered in Cambridge, UK. The company specialises in discovering, developing, and commercializing prescription medicines across key areas such as Oncology, Rare Diseases, and bio-pharmaceuticals covering Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Operating in more than 100 countries, AstraZeneca's innovative treatments are utilized by millions of patients globally. The technological advancements in developing ADCs are building their confidence in their potential to become the backbone of cancer care. They have limitless possibilities in exploring ADCs as a monotherapy and in combination with other cancer medicines with the potential to bring benefit to a broad population of cancer patients.• On May 20, 2024, AstraZeneca declared plans to build a USD 1.5 billion manufacturing facility in Singapore dedicated to antibody-drug conjugates (ADCs). Slated to be operational by 2029, this facility will be AstraZeneca’s first end-to-end ADC production site, integrating all stages of the ADC manufacturing process such as antibody production, drug-linker synthesis, conjugation, and final filling. Supported by the Singapore Economic Development Board (EDB), this greenfield project underscores AstraZeneca’s commitment to enhancing the global supply of its ADC portfolio and advancing precision cancer therapies. The facility focuses on sustainability, aiming for zero carbon emissions from the start of operations.
Recent Development• On April 29, 2024, the FDA granted full approval for TIVDAK (tisotumab vedotin-tftv) to treat recurrent or metastatic cervical cancer, based on positive results from the Phase 3 innovaTV 301 trial. TIVDAK is the first ADC to show significant overall survival benefits for this patient group, with a 30% reduction in the risk of death compared to chemotherapy. This approval follows its initial accelerated approval in 2021. The drug, developed by Pfizer and Genmab, offers a new treatment option for patients with advanced cervical cancer and addresses a significant unmet medical need.
• In Sep 2024, Merck launched the Mobius ADC Reactor, the first single-use reactor designed for manufacturing antibody-drug conjugates (ADCs). This innovative reactor enhances production speed and safety by eliminating labour-intensive cleaning procedures associated with traditional stainless steel or glass reactors. It offers faster turnaround times, reduced cross-contamination risks, and improved efficiency—70% higher than conventional methods. The reactor's Ultimus Film technology provides enhanced strength and leak resistance. Merck's solution includes single-use systems for chromatography and tangential flow filtration, alongside CDMO and testing services for ADCs and high-potent active pharmaceutical ingredients (HPAPIs). ADCs target specific cells, like cancer cells, minimizing damage to healthy cells.
• On December 15, 2023, the FDA approved PADCEV (enfortumab vedotin-ejfv) combined with KEYTRUDA (pembrolizumab) for treating advanced bladder cancer. This approval, based on the Phase 3 EV-302 trial, marks the first time an ADC plus PD-1 inhibitor regimen has been authorized as an alternative to platinum-based chemotherapy. The combination nearly doubled median overall survival and progression-free survival compared to standard chemotherapy. Results from the trial showed a 53% reduction in the risk of death and a 55% reduction in the risk of cancer progression. This approval expands treatment options and offers significant hope for patients.
