MedNess: bite-size biopharma and medtech news

FDA approves Scemblix® (asciminib) for the treatment of R/R CML based on Ph 3 ASCEMBL trial results
“CML can be difficult to treat when currently available treatments fail patients, when treatment side effects cannot be tolerated, or sometimes both,” expressed Dr. Michael J. Mauro**, Hematologist and Myeloproliferative Neoplasms Program Leader at Memorial Sloan Kettering Cancer Center (MSK). “The addition of Scemblix into the CML treatment landscape gives us a novel approach to combat this blood cancer, helping address clinical challenges in patients struggling after switching to a second treatment, as well as in patients who develop the T315I mutation and face significantly worse outcomes.”

FDA Fast Track Designation for Nemvaleukin Alfa in Combination With Pembrolizumab for the Treatment of Platinum-Resistant Ovarian Cancer
"This Fast Track designation in platinum-resistant ovarian cancer highlights the potential clinical utility of nemvaleukin in combination with pembrolizumab in this difficult-to-treat disease for which there is no approved immunotherapy and there remains a significant need for new treatment options," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes. "We are excited to initiate our planned ARTISTRY-7 phase 3 trial in platinum-resistant ovarian cancer, as we advance nemvaleukin toward potential registration and seek to help patients living with this disease."

A Monash University startup is developing a new therapeutic approach to treat fibrosis
Inosi Therapeutics, a spinout from Monash University recently announced a $1.5 million seed round. The investment was  led by IP group and Monash Investment Holdings, the university’s funding arm.
Inosi is developing a new therapeutic approach to treat fibrosis, a condition associated with many chronic diseases where tissue damage leads to scarring and a loss of organ function.The company aims to develop first-in-class therapeutic Insulin Regulated Aminopeptidase (IRAP) inhibitors, that have so far demonstrated significant protective effects against diabetes-induced kidney disease and cardiovascular disease.
There is a huge unmet need for therapies that can prevent or reverse fibrosis to modify the progression of disease. Monash researchers Prof Siew Chai, Dr Tracey Gaspari, Prof Rob Widdop and Prof Phil Andrews collaborated on a technology.

Gilead and Merck to Evaluate Trodelvy® (sacituzumab govitecan-hziy) in Combination With KEYTRUDA® (pembrolizumab) in Patients With 1L mTNBC
“Trodelvy has already been established as a preferred treatment option in second-line metastatic TNBC,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “Looking ahead, we are excited about the opportunity to advance Trodelvy as a potential treatment for first-line metastatic TNBC. This helps further our ambition of displacing chemotherapy with Trodelvy to improve outcomes for people living with cancer.”

Elevate Bio buys out Life Edit Therapeutics to take over the gene therapy pipeline
 David Hallal, Chairman and Chief Executive Officer of ElevateBio, said "ElevateBio’s powerful suite of enabling technologies, which now includes Life Edit’s genome editing capabilities as well as our existing iPSC, viral vector, and cell engineering platforms, is designed to disrupt the rapidly advancing fields of cell and gene therapy”. The initial pipeline will focus on in vivo gene therapies for neurological disorders though the exact pipeline is not yet known.