Ajinomoto has announced a deal with Exelixis to incorporate AJICAP, its proprietary site-specific bioconjugation and linker technologies, in the development of Exelixis antibody-drug conjugate (ADC) programs. Ajinomoto is eligible to receive development, regulatory, and commercial milestone payments as well as royalties on commercial sales.
Exelixis is developing next generation ADCs for the treatment of various cancers. AJICAP is Ajinomoto Co.’s proprietary site-specific bioconjugation and stable linker technologies which are reportedly compatible with commonly used antibody isotypes.
Tatsuya Okuzumi, General Manager, Business Development Group, Bio-Pharma Services Department, Ajinomoto said “The combination of Exelixis’ antibodies and payloads with Ajinomoto Co.’s AJICAP opens up a wide range of oncology applications and may be harnessed to provide a clinical benefit to patients.”
As part of the agreement, Exelixis will have the right to use the AJICAP technology to support its aim of advancing multiple ADCs with “the potential for higher efficacy and lower toxicity than currently available options,” as Ajinomoto said in its press release. Ajinomoto introduced AJICAP in 2018.
The goal with ADCs is to focus the antineoplastic effects of cancer drugs, so they cause less systemic effects. These drugs comprise a monoclonal antibody (mAb) attached via a linker to a cytotoxic drug or prodrug—the payload. The linker must ensure the payload stays attached to the mAb in plasma. The mAb is designed to bind to a specific tumor-associated/tumor-
Early ADCs carried traditional chemotherapeutics, but newly approved ADCs carry more potent drugs. These drugs have shown impressive activity against treatment-refractory cancers, but they feature current drawbacks, including systemic toxicity, inadequate biomarkers for patient selection, acquired resistance, and unknown benefit in combination with other treatments. Advances in synthetic biochemistry have introduced a new generation of ADCs, which aim to improve these drugs’ tissue specificity and cytotoxicity.
A dozen ADCs have been granted FDA approval, with nine getting the nod since just 2017. 2020 was a landmark year for deals and partnerships in the ADC arena, indicating the high interest in this field. Clinicaltrials.gov currently lists 400 trials for ADCs in cancer.
AJICAP technology includes what the company describes as its “off-the-shelf” feature. In its press release, the company says the technology allows, “… any therapeutic antibody at any stage of development to be conjugated to drug-payloads of choice without the need for antibody engineering or cell line development, and stable/hydrophilic linkers to generate antibody-drug conjugates with an enhanced therapeutic window.”
As its pharmaceutical arm, Ajinomoto Bio-Pharma Services is a contract development and manufacturing organization (CDMO) with sites in Belgium, United States, Japan, and India. In addition, Ajinomoto Co. and Ajinomoto Bio-Pharma Services offer a range of platform technologies and capabilities for pre-clinical and pilot programs to commercial quantities, including AJIPHASE oligonucleotide manufacturing technology, CORYNEX and TALAMAX protein expression systems, AJICAP site-specific conjugation, and linker technologies for ADCs, continuous flow manufacturing, and more.
Exelixis’ discovery efforts have so far resulted in four commercially available products, CABOMETYX (cabozantinib), COMETRIQ (cabozantinib), COTELLIC (cobimetinib) and MINNEBRO (esaxerenone).