Arecor Therapeutics PLC (AIM: AREC) has been granted by the European Patent Office two patents protecting its novel formulations of high concentration Humira biosimilar. Humira (adalimumab) is a monoclonal antibody indicated for a number of inflammatory diseases such as rheumatoid arthritis or Chron’s disease. It is sold by AbbVie and has been a blockbuster ever since launching in 2003 (global sales in 2021 reported as $21 billion). Humira was originally approved as a 50 mg/ml product comprising citrate as key formulation ingredient, which AbbVie further improved to 100 mg/ml without citrate. High-concentration adalimumab represents now 80% of the total US market. Arecor’s patents (EP3592383B1 and EP3592385B1) allow achieving adalimumab concentration over 100 mg/ml, which have been achieved using Arestat, its proprietary formulation technology platform .
Enhertu has been approved in the US as the first HER2-directed therapy for patients with previously treated HER2-mutant (HER2m) metastatic non-small cell lung cancer (NSCLC). HER2 a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours, including lung, breast, gastric and colorectal cancers. This is the third tumour type approved by the FDA for Enhertu **in three years, following approval in breast and gastric cancers. Enhertu is an engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by AstraZeneca (LSE/STO/Nasdaq: AZN) and Daiichi Sankyo. They have announced Enhertu reported a confirmed objective response rate of 57.7% in patients with HER2m. Notably, about 60% of HER2-negative patients fall into the HER2-low category, i.e., there is some HER2 protein, but not enough to be considered HER2-positive. Enhertu was first approved in December 2019 in HER2-positive breast cancer. AstraZeneca paid $1.35 billion upfront for the collaboration rights, and upon this approval will owe Daiichi Sankyo further $200 million in milestone payments. Good timing, as Daiichi recently lost a $42 million patent infringement case.
AstraZeneca axes Phase 2 heart disease drug in partnership with Moderna. AZD8601 is an mRNA-based therapy encoding the vascular endothelial growth factor (VEGF-A), a paracrine factor involved in new blood vessel formation and the production of specialised cells that contribute to repair and regeneration of the heart. AZD8601 was being administered during the trials directly into the myocardium of patients undergoing elective coronary artery bypass surgery. AZD8601 is still listed as part of Moderna’s pipeline.
More on axing! Galapagos has dropped yet another 4 programs, including a JAK1/TYK2 inhibitor for inflammatory diseases, a JAK1 inhibitor for osteoarthritis, a chitinase inhibitor for idiopathic pulmonary fibrosis, and a compound with an undisclosed mode of action tackling fibrosis. Galapagos has also pulled out metabolic diseases and osteoarthritis R&D and handled back certain respiratory disease drug rights to Molecure. Why? Galapagos new strategy under Paul Stoffels will focus on CAR-T target of heematological cancers and, in the long term, severe long-term solid cancers.