Attention has turned to Cytomx Therapeutics Inc.’s CX-2029 candidate after the company held up its program with the CD166-directed antibody-drug conjugate CX-2009, based on phase II data in patients with hormone receptor-positive/HER2-non-amplified breast cancer.
Three serious adverse events have led the U.S. FDA to place a clinical hold on Diamedica Therapeutics Inc.’s phase II/III study of DM-199, a synthetic form of human tissue kallikrein-1 for treating acute ischemic stroke. The blood pressure in three participants dropped to a significantly low level shortly after receiving an I.V. dose of the therapy. All three bounced back to normal within minutes of stopping the I.V.
More than two years after the U.S. FDA shocked Intercept Pharmaceuticals Inc. with its rejection of obeticholic acid to treat fibrosis due to nonalcoholic steatohepatitis (NASH), the company has announced data it said will form the basis of a NDA refile in the disease for which there is no approved therapy.
Treating sooner in the disease course – “hit them hard, hit them early,” as CEO Tahir Mahmood put it – may change outcomes for the better with AMT-101, the candidate from Applied Molecular Transport Inc. (AMT) tested in a combo trial against ulcerative colitis (UC), officials said during a conference call with investors.
So near and yet so far for Nordic Nanovector ASA, which has ditched the phase IIb trial of its lead product, Betalutin, just short of completing recruitment, after an independent review cast doubts on the level of efficacy previously reported for the targeted radiopharmaceutical.
As an ever-increasing share of companies seek signs of efficacy for investigational drugs in early stage studies, single-arm trials to confirm those effects and support marketing applications are also becoming more common. Now, China’s Center for Drug Evaluation has released draft guidelines on how single-arm trials can be regulated, used to support the new drug application for cancer drugs, and accelerate oncology drug development.
Recently published real-world data with Firazyr (icatibant), the selective B2 bradykinin receptor antagonist from Takeda Pharmaceutical Co. Ltd. to treat acute hereditary angioedema (HAE) attacks, trained a spotlight on the space, where a handful of players compete. Among the prospects is the early stage but intriguing Star-0215 from Astria Therapeutics Inc., which could be the next advance in the kallikrein-inhibitor class.
Despite mostly positive data from the ongoing phase III study of Talaris Therapeutics Inc.’s lead asset, FCR-001, an allogeneic cell therapy for treating living donor kidney transplant patients, investors are stepping away. The Boston and Louisville, Ky.-based company’s stock took a hit June 20 as shares (NASDAQ:TALS) fell 36.7% to $4.51 each.
Immuno-oncology company Imugene Ltd. reported median overall survival for patients receiving HER-Vaxx plus chemotherapy was 13.9 months compared to 8.3 months in patients treated with chemotherapy alone in its phase II study in HER2/neu overexpressing advanced gastric cancer.
Trevi Therapeutics Inc. took its place among several late-stage contenders by scoring a win in prurigo nodularis in the form of positive data from the 360-participant, phase IIb/III Pruritus Relief through Itch-Scratch Modulation, or PRISM, trial with oral Haduvio (nalbuphine extended release).
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