It’s been a rough year at Macrogenics Inc., but times may be changing. Having terminated a phase II study due to fatalities, dropped 15% of its workforce and closed research and manufacturing sites in the past year, the company has taken the helping hand of Gilead Sciences Inc. The pair have agreed to develop the bispecific MGD-024, which has a CD3 component for minimizing cytokine release syndrome, as an oncology candidate along with two additional bispecific research programs, a potential treatment for certain blood cancers, including acute myeloid leukemia and myelodysplastic syndromes.
Incyte Corp. has agreed to acquire Villaris Therapeutics Inc., the developer of a monoclonal antibody for vitiligo that aims to treat a larger proportion of the skin than an available topical cream, for $70 million up front, plus up to $310 million in potential development and regulatory milestone payments. The deal includes up to $1.05 billion in commercial milestones on net sales of auremolimab, a preclinical MAb that works against IL-15Rβ and is expected to reach the clinic in 2023.
Last week, Incyte Corp. said it was pulling its NDA seeking accelerated approval for the PI3K-delta inhibitor parsaclisib in three non-Hodgkin lymphoma subtypes, a move that followed recent decisions by Gilead Sciences Inc. and Secura Bio Inc. to withdraw from U.S. commercialization their respective PI3K-delta inhibitors in indications for which they’d received accelerated approval. But the recent spate of headlines is hardly “a condemnation” on the entire class of drugs, said Dan Gold, CEO of MEI Pharma Inc., which is aiming for a potential accelerated approval filing of its own PI3K-delta drug, zandelisib, this year.
In a deal that could total about $602 million, Syndax Pharmaceuticals Inc. will collaborate with Incyte Corp. to develop and develop axatilimab, Syndax’s anti-CSF-1R monoclonal antibody. Syndax is to receive $117 million up front, a $35 million equity investment and could bring in another $350 million in regulatory, development and commercial milestone payments.
Following late-stage studies in which Incyte Corp.'s topical ruxolitinib candidate significantly reduced skin inflammation and itch associated with atopic dermatitis (AD), the FDA has approved the medicine, making it the first and only topical JAK inhibitor approved in the U.S.
In another cautionary tale for JAK inhibitors, the U.S. FDA is requiring updated boxed warnings for three drugs in the class that are approved to treat inflammatory conditions – Pfizer Inc.’s Xeljanz/Xeljanz XR (tofacitinib), Eli Lilly and Co.’s Olumiant (baricitinib) and Abbvie Inc.’s Rinvoq (upadacitinib).
Pfizer Inc. reported on Aug. 30, 2021, that its JAK inhibitor, abrocitinib, beat Dupixent (dupilumab, Regeneron Pharmaceuticals Inc./Sanofi SA) in a head-to-head study of patients with moderate to severe atopic dermatitis. In the JADE DARE study, a higher percentage of patients taking abrocitinib had a 4-point improvement in the severity of Peak Pruritus Numerical Rating Scale (PP-NRS4) from baseline to week two compared to Dupixent.
Innocare Pharma Ltd. has signed a licensing agreement with Incyte Corp. for the exclusive rights to the monoclonal antibody Monjuvi (tafasitamab) for hematology and oncology indications in mainland China, Hong Kong, Macau and Taiwan. Under the terms of the deal, Innocare will pay Incyte an up-front fee of $35 million, as well as up to $82.5 million in potential development, regulatory and commercial milestones and tiered royalties.
Shares of Iterum Therapeutics plc fell 40% July 26 after disclosing that the FDA issued a complete response letter (CRL) for its NDA for sulopenem etzadroxil/probenecid (oral sulopenem), an anti-infective compound, for urinary tract infections (UTIs). The agency determined the NDA cannot be approved in its present form.
