The CHMP agenda for this month (June 22-25) has been released, and it includes one notable item, a potential DAPA-HF CHMP opinion, as well as several other agenda items. Below, FENIX provides diabetes-related highlights and insights from the June 2020 CHMP agenda.
On Friday, June 12, Autolus held an investor call (press release/ presentation), highlighting updated clinical data from the AUTO1 (CD19 CAR-T) Ph1/2 ALLCAR19 study in ≥2L adult ALL. The data was also presented at EHA (Claire Roddie et al, June 2020). Below, FENIX provides thoughts on the significance of this data, and particularly how it compares to competitor CD19 CAR-Ts from Novartis (Kymriah), Gilead (Yescarta), and Cellectis (UCART19).
The Libre 2 FDA approval documents have been released, and the answer is now known as to why Libre 2 was not approved to be compatible with automated insulin delivery (AID) systems. Below, FENIX provides thoughts and insight into the issue and Abbott’s potential next steps.
Late last week, BI/Lilly announced full results from the EMPERIAL-Reduced and EMPERIAL-Preserved trials, evaluating Jardiance on exercise ability in patients with heart failure. Recall, in December 2019, BI/Lilly disclosed that both EMPERIAL trials failed to show a statistically significant improvement in the 6-minute walk test (previous FENIX insight). Full results of the studies were presented during the ESC HFA Discoveries program. Below, FENIX provides thoughts on the EMPERIAL trial results in the context of Novartis’s Entresto 6MWT study as well as potential readthrough to AstraZeneca’s DETERMINE studies.
Earlier this week, Abbott announced FDA approval of Libre 2, its successor to the highly successful Libre 14 day CGM system (previous FENIX insight). Despite all of the indicated improvements that Libre 2 received, it was clearly worded that Libre 2 is not approved for use with automated insulin delivery (AID) systems. Below, FENIX hypothesizes as to the reason.
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).