Deals involving antibody-drug conjugate (ADC) therapies continue to gain momentum with Daiichi Sankyo Co. Ltd. and Merck & Co. Inc. the latest firms to team up on global development and commercialization activities, as Daiichi offers up rights to three of its potentially first-in-class ADC candidates for $22 billion, making it the largest ADC agreement to date.
The EMA is standing firm on its refusal to recommend approval of the amyotrophic lateral sclerosis (ALS) treatment Albrioza in Europe after re-examining Amylyx Pharmaceuticals Inc.’s marketing authorization application and remaining unconvinced that the main study demonstrated the drug effectively slows disease progression.
There are several pan-PIM kinase inhibitors in development for cancer indications, but startup Mysthera Therapeutics AG hopes to become the first biotech company to develop them in the autoimmune diseases space, having secured $3.5 million in seed capital from founding investor Forty51 Ventures.
In the ultra-rare disease congenital hyperinsulinism, an overproduction of insulin leads to persistent hypoglycemia and can cause neurological complications due to high glucose needs of the brain. About half of children go on to develop seizures or intellectual problems, but current therapeutic options are limited and there are no approved drugs specifically for the condition.
Immunovant Inc. is seeking a $450 million windfall on the back of the “best-in-class potential” of its early stage monoclonal antibody for IgG-mediated autoimmune diseases, IMVT-1402, which a phase I readout demonstrated could supersede the firm’s lead, batoclimab.
Aboleris Pharma has closed a €27.3 million (US$28.7 million) series A financing, funds it plans to put toward progressing into the clinic a monoclonal antibody against a novel T-cell target with “first-in-class potential” to treat rheumatoid arthritis. The Gosselies, Belgium-based company’s antibody, ABO-21009, is designed to “rebalance” the immune system by inhibiting CD45RC, a protein expressed on the surface of a subset of disease-causing T cells.
The U.K.’s Competition Appeal Tribunal has rejected appeals by drugmakers, including Actavis plc and Allergan Inc., against a ruling by regulators that they hiked the price of a life-saving adrenal insufficiency drug excessively for almost a decade, saddling the companies with fines amounting to nearly £130 million (US$159 million).
Although preclinical studies of genetically engineered interleukin-18 (IL-18) historically indicated its potential in cancer treatment, interest in the cytokine languished after GSK plc shelved its IL-18 therapeutic on lack of responses in a phase II melanoma trial. But in 2020, Yale University-based professor of immunobiology Aaron Ring set about reviving IL-18 as a cancer therapeutic. He went on to engineer a decoy-resistant form of IL-18 and then founded Simcha Therapeutics Inc. to develop the drug – named ST-067.
Five years after Gilead Sciences Inc. gave up on momelotinib in the wake of two phase III failures in myelofibrosis, the JAK1/2 and ACVR1 inhibitor has found its way to the market in the hands of GSK plc. Branded Ojjaara, the drug gained U.S. FDA approval for use in intermediate- or high-risk myelofibrosis patients with anemia regardless of prior administration with JAK inhibitors such as Jakafi (ruxolitinib, Incyte Corp.).
Acelyrin Inc.’s shares tumbled after its interleukin-17A inhibitor, izokibep, failed to reachstatistical significance in part B of a phase IIb/III trial inmoderate to severe hidradenitis suppurativa (HS), but the company remains undeterred with its plans to advance the drug for the inflammatory skin condition.