Edwards’ Sapien 3 with Alterra Prestent; Koios Medical’s breast, thyroid cancer-spotting AI; Lineage Collaborates with Genentech; Novartis, BeiGene ink deal

Edwards secures FDA approval for Sapien 3 with Alterra Prestent for Transcatheter Pulmonic Valve Replacement

Edwards Lifesciences declared to receive approval from the U.S. Food and Drug Administration (FDA) to use the Edwards SAPIEN 3 transcatheter valve with the Alterra adaptive prestent (SAPIEN 3 with Alterra) for severe pulmonary regurgitation patients.

The Edwards SAPIEN 3 Transcatheter Pulmonary Valve (TPV) system combines the proven SAPIEN 3 transcatheter heart valve and the Alterra adaptive prestent to extend transcatheter therapy options for congenital heart valves disease patients. The Alterra prestent makes up for variations in size and morphology of the right ventricular outflow tract to offer a stable landing zone for the SAPIEN 3 valve.

Dr. Evan Zahn, M.D., Director of Guerin Family Congenital Heart Program at the Smidt Heart Institute, Cedars-Sinai Medical Center, and principal investigator for the ALTERRA clinical trial said that the FDA approval of the SAPIEN 3 with Alterra is excellent news for patients worldwide, many of whom have endured various surgical procedures to treat their congenital heart disease. The outstanding results achieved by SAPIEN 3 with Alterra will expand the range of patients who need pulmonary valve replacement that they can now treat with minimally invasive therapy. This will result in tremendous improvements in quality of life and reduce the number of surgeries and procedures, which congenital heart patients need throughout their lifetime.

While pulmonic heart valve replacements show a small fraction of the heart valve replacements done each year, it is usually needed to replace valves in adolescent and adult patients suffering from Tetralogy of Fallot or other congenital heart valve defects.

FDA clears Koios Medical’s ultrasound-reading AI for spotting breast, thyroid cancer in two seconds

Koios Medical, a fast-growing developer of medical device software, declared it secured the FDA clearance for Koios DS, an artificial intelligence (AI) based software platform utilized to diagnose thyroid cancer and breast cancer. The new system, built using ultrasound data from a network of 48 sites worldwide, helps physicians accurately diagnose disease and enhances speed to treatment while decreasing avoidable surgical procedures.

Breast and thyroid cancers combine for over 375,000 diagnosed cases annually in the US alone. Over 2.2 million breast and thyroid tissue biopsy procedures are performed, yet tens of thousands of cancers still go undetected.

Dr. Shah Islam, National Hospital for Neurology & Neurosurgery, London, said that Thyroid DS is a game-changer for thyroid ultrasound imaging. It will aid the diagnosis of thyroid cancer and allow for more standardized and reproductive reporting of thyroid nodules, inhibiting potentially unwarranted biopsies on benign lesions.

Thyroid disease is one of the most intricate and complicated radiological interpretations. Diagnostic uncertainty leads to a high level of variability across physicians and results in surgical procedures, downstream cost, risk of complication, and physician burn-out. The company performed studies, which proved physicians utilising Koios DS software dramatically enhanced accuracy, consistency, and efficiency.

Physicians’ thyroid cancer detection rates jumped by 14% while reducing false-positive biopsy orders by over 35%. Interpretation variability was decreased by over 50% and time spent per case dropped by 24%.

Lineage establishes an exclusive worldwide collaboration with Genentech for the development and commercialization of OpRegen® RPE Cell Therapy 

Lineage Cell Therapeutics, Inc. declared that Lineage and its subsidiary, Cell Cure Neurosciences Ltd., have entered into an exclusive worldwide collaboration and license agreement with Roche and Genentech, a member of the Roche Group, for the development and commercialization of a retinal pigment epithelium (RPE) cell therapy for the ocular disorders treatment, including advanced dry age-related macular degeneration (dry AMD) with geographic atrophy (GA).

Genentech will presume responsibility for further clinical development and commercialization of Lineage’s OpRegen program, which currently is being assessed in a Phase 1/2a open-label, dose-escalation clinical safety and efficacy study in patients with advanced dryness AMD with geographic atrophy. Under the terms of the collaboration deal, Lineage will finish the ongoing clinical study activities, complete enrollment, and perform particular manufacturing activities. Genentech will reimburse Lineage a USD 50 million upfront payment. Lineage is eligible to receive up to USD 620 million in additional development, approval, and sales milestone fees and tiered double-digit royalties.

Brian M. Culley, CEO of Lineage, said that Genentech is a clear global leader in ophthalmology and has shown a longstanding commitment to patients, innovative research, and successful product development. The desire to combine their cell therapy technology with their ophthalmology expertise and capabilities will aid in progressing the OpRegen program quickly, and they believe successfully to patients with serious ocular disorders, such as dry age-related macular degeneration. Lineage aims to pioneer a new branch of regenerative medicine based on transplanting whole cells into the body to restore activity lost to aging, injury, or disease. They believe the outcomes they have shown to date with OpRegen represent a paradigm change many did not think possible with cell therapy by restoring retinal tissue and potentially halting or reversing the expansion of geographic atrophy. He is incredibly proud of what the Lineage team has accomplished with the OpRegen program and looks forward to joining forces with the Genentech team as they work to take this program to the next level and potentially to patients in need of treatment.

Novartis, BeiGene ink licensing deal for TIGIT Inhibitor Ociperlimab

Novartis apprised of inking an option, collaboration, and licensing deal with BeiGene for the TIGIT inhibitor ociperlimab.

Under the agreement terms, Novartis will give BeiGene USD 300 million upfront. BeiGene is eligible to get another USD 700 million if the option is exercised before late 2023. The option would give Novartis the rights to develop and commercialize ociperlimab in the US, Canada, Mexico, the EU, the UK, and several other countries. BeiGene will retain rights to ociperlimab in China and all other regions. In the US specifically, BeiGene and Novartis would evenly co-commercialize the drug.

During the option period, Novartis and BeiGene will collaborate on clinical trials to explore the activity of ociperlimab with tislelizumab, the PD-1 inhibitor that Novartis licensed from BeiGene in early 2021 and now owns rights to develop in North America, Europe, and Japan. Novartis will sponsor, fund, design, and conduct these combination therapy trials. Previous research has shown that the TIGIT pathway is associated with resistance to PD-1 checkpoint inhibitors, making TIGIT a target with the potential to enhance the benefit of anti-PD-1 therapy when given concurrently.

BeiGene is currently assessing ociperlimab, also called BGB-A1217, in two Phase III clinical trials for advanced non-small cell lung cancer and other trials for various solid tumors. Specifically, in AdvanTIG-301, the firm randomizes roughly 900 patients with stage III, treatment-naïve NSCLC to one of three treatment arms. In one arm, patients will get ociperlimab, tislelizumab, and concurrent chemoradiotherapy; in another, they will get tislelizumab and chemoradiotherapy; and in the third, patients will receive just chemo.

In the AdvanTIG-301 trial, BeiGene will track patients’ progression-free survival outcomes and complete response rates on the various regimens and evaluate if patients’ PD-L1 and TIGIT expression levels can predict treatment benefit.