On Monday, June 15, Ziopharm announced (press release) the appointment of Carl June as chairman to the company’s newly formed scientific advisory board (SAB). Below, FENIX provides thoughts on this appointment, particularly around June’s experience pioneering the initial CAR-T studies leading to the commercialization of Kymriah.
On May 7, 2020, Ziopharm held their Q1 2020 earnings call (press release/slides), highlighting their clinical and regulatory milestones for both TCR-T and CAR-T programs. Below, FENIX provides thoughts on Ziopharm’s CD19 CAR-T and TCR-T pipeline, particularly within the context of COVID-19.
According to court documents (view here), Roche has filed a lawsuit vs. Insulet in the US District Court of Delaware, seeking royalties due to claimed infringement on a Roche patent (7,931,613). The ‘613 patent, titled “Module For A Computer Interface” was issued on April 26, 2011 and relates to the Accu-Chek Combo system. Of note, Roche’s complaint does not request Insulet to remove its products from the market. Below, FENIX provides brief thoughts on the suit.
Novo Nordisk announced positive topline results for its Ph2 AM833 and Ph1 AM833+semaglutide trials, both for the treatment of obesity. Novo previously disclosed AM833 has been given the INN of “cagrilintide.” Recall, on June 12, 2020, Novo reported topline results from the final two trials in its Ph3 semaglutide obesity program (previous FENIX insight). Below, FENIX provides an overview of the topline data as well as brief thoughts on AM833 in the context of Novo’s injectable semaglutide Ph3 obesity program.
Xeris Pharmaceuticals announced positive topline results from a Ph2 trial evaluating its pramlintide-insulin co-formulation (XP-3924). Xeris said it is planning for an end-of-Ph2 meeting with FDA later in 2020 to discuss the XP-3924 development path. Below, FENIX provides an overview of the topline results as well as thoughts on the market potential of XP-3924 in the context of other similar products, notably Adocia’s ADO09 (M1pram).
Tandem Diabetes Care announced the t:slim X2 insulin pump with Control-IQ has been approved by FDA for use in pediatric patients down to six years of age. Previously, the product was indicated for 14 years of age and older. Tandem senior management also presented at the 2020 Raymond James Healthcare Innovation Conference, providing brief commentary on the pediatric indication and market opportunity. Below, FENIX provides thoughts on the expanded indication from Medtronic, Insulet, Bigfoot, and Beta Bionics.
Following the Libre 2 FDA approval (see previous FENIX insight), Abbott authored a blog post on its website (view here), which includes a patient DTC video (view on Youtube) as well as static images that directly counter-message Dexcom’s G6 CGM. Additionally, the Libre 2 website is now live with a “coming soon” message and webform to be notified when Libre 2 becomes available. Below, FENIX provides an analysis of Abbott’s early Libre 2 messaging/counter-messaging and potential insight into a Dexcom response.
On Monday, June 15, Novartis held an investor call (presentation), highlighting advances to their activated rapid manufacturing (ARM) platform for cell therapy, and their assessment of the community setting for CD19 CAR-T therapies. Below, FENIX provides thoughts on the significance of the ARM platform compared to other rapid manufacturing methods, and the potential impact Kymriah could have outside Centers of Excellence (COE).
On the final day of ADA 2020, four diabetes-related news items were observed: full results from the ertugliflozin VERTIS-CV study, Dexcom partnered with KORE for COVID-19 remote monitoring, additional Libre RWE, Nemaura continues on its ADA PR blitz. Below, FENIX provides context and analysis for the announcements.
Today, twelve diabetes-related news items were observed: DAPA-HF delays T2DM onset, teplizumab follow-up results, Arecor uRAI Ph1 data, new Afrezza practical data, Diasome HDV Ph2 results, Hua Medicine Ph3 GKA data, ORMD-0801 in NASH, Glytec CGM POC data, Biolinq’s first-in-human CGM data, and more. Below, FENIX provides context and analysis for the announcements.