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Antibody Drug Conjugates – Acquisitions and Partnering

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AbbVie dominated the news in the last weeks of April after announcing the acquisition of Stemcentrx including the company’s late-stage rovalpituzumab tesirine (Rova-T) for $5.8bn. Furthermore, AbbVie partnered up with CytomX to jointly develop and commercialize a probody-drug conjugate (PDC) against CD71.

Stemcentrx’ Rova-T, also known as SC16LD6.5, is addressing small cell lung cancer (SCLC) and other neuroendocrine cancers such as large cell neuroendocrine carcinoma. Rova-T has received orphan drug designation from the FDA for treatment of small cell lung cancer. Rova-T targets delta-like protein 3 (DLL3), which is expressed in >80% SCLC patient tumors and is not present on healthy tissue. Rova-T comprises a D6.5 pyrrolobenzodiazepine (PBD) payload conjugated to cysteine residues on the SC16 antibody, a maleimide-containing linker with an eight-carbon polyethylene glycol spacer, cathepsin B–cleavable valine-alanine dipeptide, and self-immolating group, with an average drug-to-antibody ratio (DAR) of 2. Rova-T represents a multi-billion dollar peak revenue opportunity with expected commercialization in 2018. The acquisition expands AbbVie’s oncology pipeline with four additional early-stage clinical compounds in solid tumor indications and Stemcentrx’ portfolio of preclinical assets.

 

Together with CytomX, AbbVie will co-develop a PDC against CD71. PDCs contain a masking peptide designed to decreasing target binding to healthy tissue and remain inactive until the molecules are activated proteolytically in the tumor microenvironment, thereby minimizing toxicities. The target, transferrin receptor 1 (TfR1), also known as CD71, is ubiquitously expressed on dividing, normal or healthy cells plus a number of hematologic and solid malignant cancer cells. CD71 mediates transferrin-iron complex uptake, an essential process for cell division and therefore also for tumors. CD71 is homogeneously and highly expressed (3+ expression assessed by IHC) in almost all tumor types, including metastatic tumors. The current PDC approach should avoid targeting the many healthy cell types that also express CD71.

 

Additionally, Regeneron Pharmaceuticals and MedImmune (wholly owned subsidiary of  AstraZeneca) entered into a licensing agreement under which Regeneron will use MedImmune’s PBD-based payload and linker technology to develop ADCs against a number of cancer targets. MedImmune will have the option to develop and commercialize certain products created with this technology in territories outside of the United States.

Reslizumab: Third mAb approved in 2016

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On March 23, reslizumab (Cinqair®) became the third new monoclonal antibody product to be approved in 2016. Reslizumab targets IL-5, and it was approved by the Food and Drug Administration for use with other asthma medicines for the maintenance treatment of severe asthma in patients aged 18 years and older who have a history of severe asthma attacks (exacerbations) despite receiving their current asthma medicines. A marketing application for reslizumab is undergoing review by the European Medicines Agency.

WHO’s Open Session on INN to be held on April 12, 2016

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The World Health Organization (WHO) recently introduced new definitions for the assignment of antibody international nonproprietary names (INN). Linear protein sequence is now used to define humanness, which is a substantial change in the method by which therapeutic antibodies were previously classified as chimeric, humanized or human. The new definitions are scientifically flawed, provide results that are inconsistent with names of many existing antibody therapeutics, and do not consider advances in antibody technology and antibody development experience.

The Antibody Society will represent the Antibody Community at large at the WHO’s Open Session at the 62nd consultation on INN for pharmaceutical substances in Geneva on April 12, 2016, and we will request modifications that address the problems with the new system.
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The Antibody Society’s presentation at the WHO’s Open Session on April 12, 2016 is available to Society members. Please log in to access the presentation, located on the Presentations page in the Members Only section.

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Ixekizumab: Second mAb approved in 2016

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On March 22, ixekizumab (Taltz®) became the second monoclonal antibody product to be granted a first approval in 2016. Ixekizumab targets interleukin-17A, and it was approved by the Food and Drug Administration for treatment of adults with moderate-to-severe plaque psoriasis. A decision by the European Commission on marketing in the European Union is pending; in February 2016, the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion for ixekizumab for the treatment of moderate-to-severe plaque psoriasis in adults in the European Union who are candidates for systemic therapy.

Obiltoxaximab: First mAb approved in 2016

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Antibody impressionOn March 18, obiltoxaximab (ANTHIM®) became the first monoclonal antibody to be approved in 2016. Obiltoxaximab targets the protective antigen of Bacillus anthracis, and it was approved by the Food and Drug Administration for the treatment of inhalational anthrax due to B. anthracis in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. Administered intravenously, the product is indicated in both adult and pediatric patients. Efficacy studies in animal models of inhalational anthrax served as the basis for the effectiveness of obiltoxaximab in humans.

A total of 8 additional antibody therapeutics are now undergoing their first regulatory review in the European Union and the Unites States, suggesting that the number of approvals for new antibody products in 2016 may meet or exceed the record set in 2015. The Antibody Society maintains a comprehensive table of approved antibody therapeutics and those in regulatory review in these regions. Information about the antibody target, format and year of first approval are included in the table. Please log in to access the table, located in the Members Only section.

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