Category Archives: Topics

Tirzepatide CVOT Underway; Dexcom G6 CE Mark for Wear on Upper Arm; Nemaura Medical to Join Russell Indices

A series of diabetes-related news has been observed: Lilly announced it has dosed the first patient in the tirzepatide SURPASS-CVOT study, Dexcom received CE Mark for the G6 CGM to be worn on the back of the upper arm, and Nemaura Medical is set to join the Russell 2000 Index and Russell 3000 Index. Below, FENIX provides highlights and insights from the respective news items.

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New Pivotal ALLO-501A (ALPHA-2) Trial in DLBCL Posted

A new Allogene-sponsored ALLO-501A Ph1/2 ALPHA-2 trial has been observed on CT.gov. Below, FENIX provides insights on this new trial and how ALLO-501A could disrupt the autologous CD19 CAR-T market, currently being led by Novartis, Gilead, and BMS.

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Insulet Resumes Omnipod Horizon Pivotal Trial

Insulet announced it has resumed the Omnipod Horizon pivotal trial. Recall, the trial was paused in early March 2020 following a software anomaly that could lead to “using an incorrect glucose value which has the potential to impact insulin delivery.” According to the press release, Insulet expects a US launch of Omnipod Horizon in H1 ’21, which is consistent with the timeline stated during the company’s Q1 ’20 earnings call. Below, FENIX provides insight on the potential impact of the delayed launch.

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BCMA CAR-T Updates at ASCO 2020 – Ide-cel, Orva-cel, JNJ-4528

Three key oral presentations for BCMA CAR-Ts were presented at ASCO 2020: ide-cel (Ph2 KarMMa) and orva-cel (Ph1/2 EVOLVE) from BMS, and JNJ-4528 (Ph1b/2 CARTITUDE-1) from Janssen. All three studies evaluated CAR-T cells in ≥4L RRMM patients. Below, FENIX provides key data highlights and analysis on the competitiveness of each CAR-T.

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Autolus Ph1 Alexander Results and ASCO 2020 Investor Call Summary

On Monday, June 1, 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 ASCO (Wendy Osborne et al, May 2020). Below, FENIX 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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Semaglutide Ph3 Obesity Positive Topline Results (STEP 1)

Novo Nordisk announced positive topline results from the Ph3a STEP 1 trial evaluating the safety and efficacy of QW sc semaglutide 2.4mg on body weight (press release). Recall, STEP 1 is the second of the STEP trials to read out following STEP 4 in May (previous FENIX insight). Below, FENIX provides an overview of the STEP 1 results and the consistency with STEP 4.

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Update on CBMG’s CAR-T Program; Q1 Investor Call

On Wednesday, May 6, Cellular Biomedicine Group (CBMG) held their Q1 2020 earnings call (press release). The company announced the successful IND application for their BCMA CAR-T (C-CAR088) in China as well as positive data from the ongoing investigator-initiated trial. Management also expressed optimism about the early data from their bi-specific CD19/CD20 CAR-T in DLBCL. Below, FENIX provides further highlights from the call and thoughts around how CBMG’s CAR-Ts could potentially differentiate themselves, despite their early stage of development, in the CAR-T space currently led by much larger players such as Novartis, Gilead, and BMS.

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Welldoc Insulin Adjustment Program Approved by FDA; Fractyl to Initiate Study for Insulin-dependent T2DM Patients

Two diabetes-related news items have been observed: Welldoc announced FDA approval of an additional feature for the BlueStar platform called the Insulin Adjustment Program (IAP) and Fractyl Laboratories announced FDA approval of an Investigational Device Exemption (IDE) to initiate a study examining the effects of Revita DMR in T2DM patients treated with insulin. Below FENIX provides highlights and insights for the respective news items.

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Thoughts on Bigfoot’s $55M Series C and if Abbott Libre 2 FDA Approval is Imminent

Bigfoot Biomedical announced the closing of its Series C financing round for a total of $55M. With the closing of Series C, the company says it is moving closer to FDA submission of Bigfoot Unity in 2020. Recall, Bigfoot Unity is a decision support system that leverages a connected insulin pen cap and the Abbott Libre CGM. Additionally, Bigfoot’s co-founder Bryan Mazlish (view LinkedIn profile) is transitioning from president of the company to the Executive Board Director. Below, FENIX provides insights into Bigfoot’s financing, management changes, and valuation and thoughts on how the Series C closing could potentially indicate Libre 2 FDA approval is imminent.

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Josh Riff Leaves Onduo; Thoughts on AgaMatrix+Bayer for China, and Confusion on Cascade CGM Wear Time in Europe

Two diabetes-related news items have been observed: Onduo announced the departure of CEO Josh Riff and AgaMatrix Holdings announced a corporate name change to “WaveForm Diabetes,” the appointment of a new Executive Chairman and CEO, Rick Valencia, and a partnership in China with Bayer for its CGM distribution. Below, FENIX provides thoughts on the leadership appointments in Onduo and WaveForm, as well as insight into the somewhat ironic partnership between WaveForm and Bayer, and some observed confusion on 15-day vs. 14-day wear time from Menarini’s product materials.

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