Barzolvolimab

Celldex Therapeutics said it will discontinue a Phase II study of barzolvolimab after the anti-KIT mAb failed to improve itching symptoms in patients with prurigo nodularis (PN), sending its shares down about 7% during after-hours trade on Tuesday. While the candidate led to "profound" mast cell depletion, this did not help resolve itch or skin lesions in patients with PN compared with placebo, Celldex said, suggesting mast cells aren't the main pathogenic driver of the disease. The company is testing barzolvolimab in several immunology and inflammation (I&I) diseases that may have a link to mast cell pathology, including urticaria, atopic dermatitis (AD) and symptomatic dermographism.However, PN isn't the first disease in which barzolvolimab has struck out. About a year ago, Celldex reported Phase II data showing that the mAb depleted mast cells in patients with eosinophilic oesophagitis, but did not improve symptoms or reduce disease activity, prompting it to discontinue development in the indication. Looking beyond PNFor the placebo-controlled PN trial, Celldex recruited 140 patients with severe disease who had an inadequate response to topical medicines or could not take such treatments for a medical reason. Participants were randomised to take either 150 mg or 300 mg of barzolvolimab every four weeks for a 24-week treatment period, following a 450-mg loading dose.According to Celldex, the mAb missed its primary endpoint, with no significant difference between the treatment arms and placebo in the proportion of patients who achieve a four point or greater improvement in Worst Itch Numeric Rating Scale (WI-NRS) from baseline to week 12. In addition, the percentage of patients receiving barzolvolimab with Investigator's Global Assessment for Chronic Nodular Prurigo - Stage (IGA-CPNG-S 0/1) did not differentiate from placebo, falling short on the secondary endpoint. The company also noted that no improvements were observed with longer barzolvolimab treatment at week 24. "It is disappointing that this study did not confirm the promising signal we observed in the intravenous Phase Ib trial, and that the robust tryptase reductions seen in this study did not result in improvement of PN symptoms for patients who greatly need effective treatments," said CEO Anthony Marucci. "We remain focused on driving mast cell category creation and delivering on barzolvolimab’s promise for patients with allergic, inflammatory, and autoimmune diseases."The company plans to report topline data from a Phase II AD study in late 2026, while topline results from a Phase III trial in patients with chronic spontaneous urticaria are due in either September or October. Enrollment in a Phase III trial for cold urticaria is on track.

Today, a brief rundown of news involving Summit Therapeutics and Celldex Therapeutics, as well as updates from Gilead Sciences, Lupin and Jupiter Neuroscience that you may have missed.A new analysis from a global late-stage study of Summit Therapeutics and Akesos dual-acting cancer immunotherapy ivonescimab indicated that the drugs effect on survival may have increased with time. In April 2025, Summit said that ivonescimab succeeded in the trial in second-line, EGFR-mutated lung cancer but that treatment was only associated with a positive trend on survival that missed statistical significance. With longer follow-up, that figure, which was initially a 21% reduction in death risk, has improved to 24%, nearly mirroring what was seen in a similar, China-only study. The results among drug recipients in China and Western countries were similar as well, Summit said. Investors have been skeptical as to whether ivonescimabs results in China will be replicated in worldwide trials with broader populations. Wednesdays result is a strong counter to that pushback, wrote Stifel analyst Dara Azar. A global study in front-line lung cancer is expected to read out later this year.A closely watched autoimmune drug from Celldex Therapeutics failed a mid-stage trial in a chronic skin condition and will be discontinued in that indication, the company said Tuesday. Celldexs drug, barzolvolimab, missed all of its study objectives in patients with prurigo nodularis, a disease that causes itchy lumps to form on the skin. The ongoing trial is one of many evaluating barzolvolimab in diseases where depleting counts of mast cells is thought to be beneficial, and the most eagerly anticipated a late-stage study in chronic spontaneous urticaria should read out in September or October. Celldex stressed that no new safety issues were observed in Tuesdays readout, and that finding is the most relevant takeaway, wrote Leerink Partners analyst Thomas Smith, who added that his team remains bullish ahead of the coming Phase 3 data. Celldex shares dipped about 5%.Gilead Sciences and Merck & Co. revealed detailed study data supporting a potential once-weekly HIV tablet. In June, the partners revealed, without specifics, that a combination of Mercks islatravir and Gileads lenacapavir helped people who switched off of other treatments in two Phase 3 studies. At a medical meeting Wednesday, the companies disclosed that none of islatravir/lenacapavir recipients in those trials had detectable levels of HIV after 48 weeks of treatment, versus 0.3% of those on Gileads Biktarvy and 1.3% of people on standard antivirals. The combination's safety profile was comparable to other treatments, too, analysts at RBC Capital Markets wrote in a client note Tuesday. Still, the RBC team noted how the combination's success could backfire financially somewhat on Gilead, which splits profits to the treatment with Merck. Each patient switching off Biktarvy, which Gilead also sells, “represents a negative bottom-line impact for the company,“ they wrote. Gilead shares ticked down 3% Tuesday.India-based pharmaceutical company Lupin is spinning two cancer drug prospects into a new biotechnology startup itll majority own. That startup, Kaveri Therapeutics, will advance into global studies Lupins LNP7457 and LNP8701, both of which have produced Phase 1 data over the last year or so. Lupin will have an 82.2% stake in Kaveri and provide seed funding. Kaveri, meanwhile, will seek out additional financing for the coming studies.Jupiter Neuroscience has grabbed partial rights to an experimental psychedelic from Toronto-based drug developer PharmAla Biotech, the companies said Tuesday. The deal is centered around ALA-002, a version of MDMA specially formulated to lower the risk of abuse or cardiovascular problems. PharmAla is currently evaluating the treatment in social anxiety disorder and autism spectrum disorder. Jupiter is paying $3.33 million in cash and stock upfront for U.S. rights and could add another roughly $97 million in downstream payments should the drug hit certain milestones. '