Shares of ADC Therapeutics SA (NYSE:ADCT) were trading at $1.54, down 49%, or $1.54, after the firm disclosed top-line data from the phase III Lotis-5 confirmatory trial testing Zynlonta (loncastuximab tesirine) in combination with rituximab to treat relapsed or refractory diffuse large B-cell lymphoma. The drug, which won accelerated approval from the U.S. FDA in April 2021, achieved statistical significance on the trial's primary endpoint of progression-free survival and turned up “no detrimental effect” on the key secondary efficacy endpoint of overall survival, the company said. But 27, or 13.2%, deaths were recorded in the treatment arm vs. nine, or 4.6%, in the control group.

Innovent submits NDA for CLDN18.2 ADC for gastric cancer

Innovent Biologics Co. Ltd.’s Claudin18.2-targeted antibody-drug conjugate (ADC), arcotatug tavatecan (IBI-343, TAK-921), met the primary endpoint in the international multicenter phase III G-Hope-001 trial in advanced gastric cancer, according to interim results. Based on the positive clinical results, Innovent has submitted its NDA to China’s National Medical Products Administration (NMPA) for the treatment of previously treated locally advanced unresectable or metastatic CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma patients who have received at least two prior systemic therapies. The application has been accepted with priority review.

Autobahn on the fast track with bipolar thyroid agonist

Achieving high marks in the phase II Amplify-BD trial for bipolar I and II depression, Autobahn Therapeutics Inc.’s elunetirom, an oral, once-daily, brain-penetrant central nervous system thyroid hormone receptor agonist, is moving toward a registrational path and a clinical readout in major depressive disorder (MDD). Top-line results of elunetirom showed a statistically significant improvement of 16.8 points in the Hamilton Depression Rating Scale (HAMD-17) total score from baseline at week six, which was the primary endpoint. It also demonstrated a 75% response rate and a 50% remission rate at week six, as well as a favorable safety and tolerability profile. Top-line data of the phase II MDD trial, Amplify, are expected in the third quarter. With the latest data, the company plans to engage with the FDA on a path forward.

SCOTUS breathes new life into skinny labels

The U.S. Supreme Court handed Hikma Pharmaceuticals and the entire generic industry a big victory today with its 9-0 opinion ensuring the future of skinny labels and correcting the Federal Circuit’s flawed understanding of infringed inducement. The unanimous decision in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma Inc. “will certainly be a sigh of relief for the generic drug industry and will support the continued use of skinny labeling to avoid infringement of method-of-use patents,” Chad Landmon, chair of Polsinelli’s Hatch Waxman and biologics practice, told BioWorld. He added that it “certainly affirms the practice of skinny labeling and will generally shield generic companies who have appropriately carved out the patented indication from their label from being held liable for induced infringement even if there are general statements made about the generic product being AB-rated.”

Ona raises $86.6M series B for ADCs to treat advanced cancers

Antibody-drug conjugate specialist Ona Therapeutics SL has closed an oversubscribed series B at $86.6 million, as clinical development of the lead program ONA-255 in advanced treatment-resistant breast cancer gathers steam. Ona’s aim of treating aggressive and refractory cancers builds on de novo discovery of target antigens in biopsies from patients with advanced metastatic disease who have undergone several lines of therapy. The company is not disclosing what these targets are, but says they are implicated in driving the biology of tumor cell resistance to therapy. While ONA-255 is first being tested against breast cancer, Ona said its target and others the company discovered are relevant to a range of solid tumors.

Neuro stocks outpace broader markets as psychedelics, Axsome shine

The BioWorld Neurological Diseases Index finished May up 12.29%, outpacing both the Nasdaq Biotechnology Index and the Dow Jones Industrial Average. A Trump executive order targeting serious mental illness sent shares of psychedelic drug developers like NRX Pharmaceuticals Inc. higher in April.

Innate immunity and microbiome allied against pulmonary fibrosis

The microbiome and a frontline innate antimicrobial sensor, Toll-like receptor 5 (TLR5), play an essential role in the development of idiopathic pulmonary fibrosis. A scientific collaboration led by researchers at the National Institute of Environmental Health Sciences has revealed how TLR5 protects against fibrosis through its ability to modulate the lung microbiome. Their study also shows that activating TLR5 protects against fibrosis and corrects pulmonary dysbiosis.

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