Category Archives: Topics

Insulet Expands DASH Availability in Europe; Nemaura In-Licenses Healthimation Diabetes App; Dario Enters Distribution Agreement with HMC; Arecor uRAI to be Presented Tomorrow; Adocia to Host Business Review; EASD 2020 Key Press Releases (Sept 21)

On the first day of EASD, five key press releases were observed from Insulet, Nemaura Medical, DarioHealth, Arecor, and Adocia. Below FENIX provides insights and context from each respective announcement.

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Updated AUTO3 Ph1/2 ALEXANDER Results; ESMO 2020 Investor Call Summary

On Friday, September 18, Autolus held an investor call (press release / presentation), highlighting updated clinical data from the AUTO3 (CD19/22 dual CAR-T) Ph1/2 ALEXANDER study in ≥3L DLBCL. The data was also presented at ESMO (E.Tholouli et al, Sep 2020). Below, Celltelligence provides thoughts on the significance of this data, and particularly how it compares to competitor autologous CD19 CAR-Ts from Novartis (Kymriah), Gilead (Yescarta), and BMS (liso-cel).

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Medtronic Recalls Guardian Connect App After Data Upload Disruptions

FDA’s medical device recalls website has been updated with a new recall alert regarding the Medtronic Guardian Connect CGM app. According to the FDA website, the recall is based on a Medtronic CareLink Personal website software update which resulted in the iOS app not automatically uploading its data to the website. Of note, the Guardian Connect app is compatible with both iOS and Android, though the recall only mentioned iOS issues. Below, FENIX provides thoughts on the Guardian Connect app recall and what it could mean for Medtronic and CGM-competitors Dexcom and Abbott.

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Diamyd to Move Forward with Ph3 Trial in HLA-Present T1DM Subpopulation; Additional Results from DIAGNODE-2

Yesterday, Diamyd Medical hosted a webcast to present additional details and context from the DIAGNODE-2 trial evaluating the effectiveness of Diamyd (treatment) in preserving endogenous insulin production. Recall, topline results for DIAGNODE-2 were announced earlier this week. Of note, DIAGNODE-2 showed no significant effect in HLA DR3-DQ2-absent T1DM patients as HLA-present patients were the only ones to respond to the treatment. Below, FENIX provides an overview of the results, thoughts on the Ph3 program, and insight into Diamyd’s potential to move forward without a partner.

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Thoughts on Cellectis’s CAR-T Program; Potential UCARTCS1 Protocol Changes; Q2 2020 Earnings Call

On Wednesday, August 5, Cellectis held their Q2 2020 conference call (press release). As expected, the company discussed the recent FDA hold on the UCARTCS1 Ph1 MELANI-01 trial in r/r MM. Management also stated that interim data will be presented for either UCART22 or UCART123 in Q4 2020, and that the Paris and Raleigh manufacturing sites remain on track to open later in 2020 and in 2021, respectively. Below, Celltelligence provides key takeaways from the call, and thoughts on Cellectis’s CAR-T program, particularly around the anticipated next steps for UCARTCS1.

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Abbott to Launch the First “Glucose Sport Biosensor”

Abbott announced plans to launch the novel “Libre Sense Glucose Sport Biosensor” (view website), which is intended to provide glucose readings and actionable insights to athletes with and without diabetes. Libre Sense has already received CE Mark, and Abbott said the product will be launched “in the coming weeks” to eight European countries via Abbott’s non-exclusive partnership with Phil Southerland’s Supersapiens (view Supersapiens website). Below, FENIX provides a brief overview of the Libre Sense Glucose Sport Biosensor and implications to the overall glucose-sensing market.

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Dexcom Announces New CGM Registry and Global Business Service Site in Lithuania; Dario Appoints Former LifeScan Exec to Scientific Advisory Board

Yesterday, a series of diabetes-related news items were observed: Dexcom announced its first registry committed to tracking in-hospital real-time CGM use outcomes; Dexcom announced plans to build a global business service center in Lithuania; and DarioHealth appointed Eric Milledge as chairman of its Scientific Advisory Board. Below, FENIX provides highlights and insights on the respective news items.

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Japanese NDA Submitted for Imeglimin; Poxel H1 ’20 Earnings Update

Yesterday, Poxel hosted its H1 ’20 earnings call and provided updates to its Japanese and US Imeglimin development. Of note, Poxel has submitted the Japanese NDA for Imeglimin and its US partner, Metavant, is actively preparing to initiate a Ph3 program in the US. Below, FENIX provides an overview of the Poxel earnings call and thoughts on Imeglimin development, including its market potential.

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Apple Cites T1DM Omnipod Patient Story at Tuesday Event; Jardiance Post-MI Trial (EMPACT-MI) Receives FDA FTD; Adocia Topline Results from M1Pram Ph1b Trial Extension; Welldoc/UMD Employs AI to Identify Digital Health Habits; Oramed’s Positive Diabetes Market Survey Results; Diamyd Receives $13.9M Towards Companion Medical Shares

A series of diabetes-related news items have been observed: Apple featured a T1DM patient story during the Apple Watch portion of its event; BI/Lilly announced Jardiance has received Fast Track designation for its EMPACT-MI study; Adocia announced positive topline results from its Ph1b M1Pram extension study in PWT1D; Welldoc and the University of Maryland’s Center for Health Information and Decision System (CHIDS) announced findings from a user engagement analysis; Oramed announced results from a diabetes market survey; and Diamyd received $13.9M from its divestment in Companion Medical. Below, FENIX provides highlights and insights from the respective news items.

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Senseonics Hosts Investor Event with Special Guest Ascensia

Today, Senseonics hosted a virtual investor event that also included a guest spot by Ascensia President, Robert Schumm. The goal of the event was to provide further detail to help inform financial analyst valuation models for SENS following the August 2020 partnership with Ascensia. Below, FENIX provides a summary and context from the information-rich event.

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