There is one oncolytic virus on the market, Amgen’s Imlygic, a herpes-derived treatment, which can be useful when injected squarely into melanoma lesions. However, it mostly does not work in patients with metastatic disease.
Urovant’s vibegron fails Irritable bowel syndrome phase 2 trial
A phase 2a clinical trial of vibegron of Urovant in Irritable bowel syndrome (IBS) patients has flunked primary endpoint. The problem depresses the prospects of Urovant in one indication but still leaves it set up to secure approval in overactive bladder and be taken over by Sumitovant Biopharma.
Urovant has commenced a multifront R&D campaign since buying small molecule beta-3 agonist vibegron from Merck in 2017. The drug did not do any better than a generic control in a phase 3 trial in overactive bladder patients. However, Urovant progressed quickly for filing for FDA approval earlier this year in a bid to set vibegron as a rival to beta-3 agonist Myrbetriq of Astellas.
The prospects of Urovant finally adding IBS to the list of conditions treated by vibegron experienced a hit when the company disclosed a phase 2a trial fails its primary endpoint.
Genmab discards antibody-drug conjugate after the early-phase fiasco
Genmab is ditching an antibody-drug conjugate after it flunked the mark in early-phase trials.
The candidate, enapotamab vedotin, aims AXL, which is overexpressed in multiple blood cancers and solid tumors. It did present some evidence of clinical activity, but its promise did not support in different dosing regimens or biomarkers. Hence it got exited from Genmab’s pipeline.
The move comes after Genmab pulled off a USD 506 million Nasdaq IPO, part of which was for a fund to enapotamab vedotin. The rest of the funds would bankroll the development of tisotumab vedotin and take it to the market, and drive other programs through the clinic.
Terminating enapotamab vedotin will allow the resources for Genmab’s other prospects, as said by CEO Jan van de Winkel, PhD, in the statement. That covers Seagen-partnered tisotumab vedotin, which is in phase 2 for cervical and ovarian cancers and other solid tumors.
Polyphor picks up USD 3.3 Million from Cystic Fibrosis Foundation for inhaled antibiotic
Polyphor snagged a USD 3.3 million from the Cystic Fibrosis Foundation in order to develop an inhaled antibiotic for lung infections, which are often fatal in people with cystic fibrosis.
The funds will bankroll a phase 1b/2a study of an inhaled version of murepavadin, an antibiotic, which aims multidrug-resistant Pseudomonas aeruginosa infections. The drug is presently delivered intravenously, so an inhaled version could make it possible for treating patients outside of a hospital or clinic.
J.P. Clancy, M.D., vice president of clinical research at the Cystic Fibrosis Foundation said in a statement that a remarkable number of Cystic Fibrosis people have multi-drug resistant strains of Pseudomonas each year that require IV antibiotics and hospitalization. They hope to determine whether the inhaled version of this new medicine could confer an alternative treatment option for Cystic Fibrosis people that could potentially decrease their treatment burden.
Murepavadin aims Pseudomonas, targeting its outer membrane that could give it an advantage to other inhaled antibiotics. The latter can usually resist Pseudomonas infections, but as they target a broad spectrum of bacteria, can also contribute to the increase of antibiotic-resistant bugs.
