AUTX-703 Granted Fast Track Designation by the FDA for R/R AML

“We are gratified by the FDA’s recognition of AUTX-703’s potential as an important, novel treatment option for relapsed or refractory AML patients, a community that remains in desperate need of new therapies,” said Kate Yen, Ph.D., Founder and Chief Executive Officer of Auron. “The FDA Fast Track Designation underscores the urgent need for innovative treatments for these patients and this milestone comes at a pivotal moment as we prepare to advance AUTX-703 into the clinic. Our team is energized by the potential to bring a first-in-class therapy to patients who have limited effective options today, while simultaneously exploring the broader applications of KAT2A/B modulation.”

Share:

More News

“The initial efficacy data from the Part C studies are consistent with the encouraging efficacy signals we previously reported for Parts A and B of THIO-101, including an 88% disease control rate in third-line NSCLC patients. This measure of efficacy is close to triple the reported outcome for standard-of-care chemotherapy

“Patients with non-muscle invasive bladder cancer continue to face a significant risk of disease recurrence despite available treatment options,” said Mark Schoenberg, M.D., Chief Medical Officer of UroGen. “UGN-501 is an investigational next-generation oncolytic virus designed to selectively destroy tumor cells while generating an anti-tumor immune response. FDA clearance of

“Whitehawk has established strong expertise in ADC technology and oncology drug development,” said Dr. Yuelei Shen, President and CEO of Biocytogen. “This collaboration further expands the application of Biocytogen’s fully human bispecific antibodies in ADC development. We look forward to supporting the efficient advancement of multiple programs by contributing high-quality

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: “The AZUR-1 results support the potential for dostarlimab to transform treatment for dMMR/MSI-H locally advanced rectal cancer. For many patients today, rectal cancer treatment comes with the tolerability burden and lasting impacts from chemotherapy, radiation and surgery. These data