Tamra Sami

Japanese diagnostics company Craif Inc. has raised $33 million in a series D round to accelerate its push into the U.S., where it aims to prove that a simple urine test powered by microRNA analysis and artificial intelligence can help detect cancers earlier, beginning with pancreatic cancer.

Chimeric Therapeutics Ltd. has halted its phase I/II study of CHM-2101, a first-in-class cadherin-17-targeted autologous CAR T therapy for gastrointestinal cancers, after a second patient at the highest dose level experienced dose-limiting toxicities. The company will discontinue development of the therapy in its current form and pivot to an early-stage in vivo CAR program targeting the same antigen.

Shandong Boan Biotechnology Co. Ltd. reported early signs of antitumor activity for BA-1302, its CD228-targeted antibody-drug conjugate (ADC), in a phase Ia trial in China involving heavily pretreated patients with advanced solid tumors.

Can a gut-targeted, oral metabolite therapy deliver disease modification in type 1 diabetes without the hospital burden and immunosuppression associated with antibody approaches? Melbourne, Australia-based Immunobiota Therapeutics Pty Ltd. believes it can. The company’s IBT-100 is an oral, non-immunosuppressive therapy for type 1 diabetes moving toward phase Ib/IIa testing as developers look beyond glucose control and injectable immune therapies toward disease modification.

Researchers have identified a potential new way to prevent malaria by using an experimental compound to stop the parasite at a late liver-stage “sweet

The U.S. FDA has granted a humanitarian device exemption (HDE) approval to Oncosil Medical Ltd.'s Oncosil brachytherapy device to treat distal cholangiocarcinoma (dCCA), a rare bile duct cancer. The approval makes Oncosil “the first and only U.S. FDA-approved Class III device for the treatment of dCCA,” CEO Nigel Lange said during a conference call with analysts.

Japan's Ministry of Health, Labour and Welfare has given the green light to a raft of new drugs, including the first global approval for GSK plc's Hibsago (bepirovirsen). An antisense oligonucleotide, bepirovirsen is approved as a functional cure for chronic hepatitis B (CHB) virus infection in adults who have received at least six months of prior nucleos(t)ide analogue therapy and meet predefined viral marker criteria. The approval marks the first and only functional cure for CHB approved in Japan.

Chimeric Therapeutics Ltd. has halted its phase I/II study of CHM-2101, a first-in-class cadherin-17 (CDH17)-targeted autologous CAR T therapy for gastrointestinal cancers, after a second patient at the highest dose level experienced dose-limiting toxicities. The company will discontinue development of the therapy in its current form and pivot to an early-stage in vivo CAR program targeting the same antigen.

Arch Venture Partners and Population Health Partners have launched newco Sentivera around an undisclosed preclinical immunology asset from Haisco Pharmaceutical Group Co. Ltd. in a deal worth more than $1.5 billion, creating a potentially significant competitor in the race to develop oral therapies for type 2 inflammatory diseases.

Chinese peptide therapeutics developer Shaanxi Micot Pharmaceutical Technology Co. Ltd. said its injectable neuroprotective agent, MT-200605, met phase II endpoints in acute ischemic stroke. MT-200605 is a small-molecule TrkB agonist designed to cross the blood-brain barrier, activate the BDNF/TrkB signaling pathway and eliminate oxygen free radicals, with the aim of interrupting the post-stroke ischemic cascade and supporting neurological repair.