NLS Biotech News

Orexo has announced positive topline results from the clinical study OX640-002.

Hansa Biopharma has announced positive full results from the 15-HMedIdeS-09 single arm Phase 2 study of imlifidase, a first in class IgG cleaving enzyme, in Guillain-Barré Syndrome (GBS) and an indirect treatment comparison of the 15-HMedIdeS-09 study data to the International Guillain-Barré Syndrome Outcome Study (IGOS), a worldwide prospective study by the Inflammatory Neuropathy Consortium on prognosis and biomarkers of GBS.

Immunovia has announced the successful completion of the CLARITI study, (Clinical Validation of Next-Generation Test for Early-Stage Pancreatic Cancer) to detect early-stage pancreatic ductal adenocarcinoma (PDAC).

The first dose has been administered in the company’s Phase II clinical study evaluating the drug candidate sevuparin for the treatment of chronic kidney disease (CKD) with associated anemia.

The trial will be conducted in patients with pre-existing anti-AAV antibodies which limit use of gene therapy treatment.

Modus Therapeutics has received approval from the relevant authorities in Italy for its planned Phase IIa clinical trial with sevuparin.

Alligator Bioscience and Aptevo Therapeutics report favorable safety, tolerability and evidence of biological activity of ALG.APV-527, with more than half of evaluable patients achieved stable disease.

The company has presented positive Phase 2 data on its lead drug candidate mitazalimab in 1st line pancreatic cancer at the 39th Annual Meeting of the Society for Immunotherapy of Cancer, taking place November 6-10 in Houston, TX.

Medivir has announced a clinical trial collaboration and supply agreement with Eisai to evaluate fostrox in combination with lenvatinib mesylate in a randomized, phase 2b study in second-line advanced liver cancer patients.

Orexo has announced the first participants have been dosed with OX640, an intranasal rescue medication for severe allergic reactions (incl. anaphylaxis) with powder-based epinephrine, in a new study in subjects with allergic rhinitis (hay fever).