Category Archives: Uncategorized

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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Allogene ALLO-501 Ph1 ALPHA Results and ASCO 2020 Investor Call Summary

On Friday, May 29, Allogene held an investor call (press release/presentation), highlighting updated clinical data from the ALLO-501 (CD19 allogeneic CAR-T) Ph1 ALPHA study, in ≥3L NHL (DLBCL or FL). The data was also presented at ASCO (Sattva Neelapu et al, May 2020). Below, FENIX provides thoughts on the promising positive data from the ALPHA study, and particularly how ALLO-501 compares to equivalent autologous CD19 CAR-Ts from Novartis (Kymriah), Gilead (Yescarta), and BMS (liso-cel).

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New Autolus AUTO1 Pivotal Trial in Adult ALL Posted

A new Autolus-sponsored AUTO1 Ph1b/2 AUTO1-AL1 trial in R/R adult ALL has been observed on CT.gov. Of note, the trial uses a split dosing regimen. Below, FENIX provides insights on this new pivotal trial and how a split dose could differentiate Autolus’s position compared to CAR-T leaders Novartis and Gilead in R/R adult ALL.

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Autolus Provides Update on CAR-T Program; Q1 2020 Call

On Thursday, May 7, Autolus held their Q1 2020 earnings call (press release/slides), highlighting their current clinical progress, enrollment, and potential initiation of their pivotal trial AUTO1-AL1 in adult R/R ALL. Below, FENIX provides thoughts on Autolus’s cell therapy program, particularly in the context of the ongoing health emergency.

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Thoughts on Allogene CAR-T Pipeline Update; Q1 2020 Call Summary

On Wednesday, May 6, Allogene held their Q1 2020 earnings call (webcast/press release/ slides), highlighting the off-the-shelf benefits allogeneic products have over autologous products, particularly during the COVID-19 pandemic. Below, FENIX provides thoughts on Allogene’s cell therapy program in the context of the ongoing health emergency.

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Thoughts on Yescarta vs Kymriah Q1 2020 Sales Comparison

Yescarta sales continued to grow versus the previous quarter (Q4 2019), seemingly with little initial impact from COVID-19, in contrast to Kymriah which reported a slight dip in Q1 2020 sales (see previous FENIX insight). Below, FENIX provides thoughts on published revenues and possible factors influencing HCPs’ CAR-T prescribing preferences.

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Gilead/Kite Q1 2020 Earnings Update

On Thursday, April 30, Gilead held their Q1 2020 earnings call (press release / financial report / slides). Of note, Yescarta sales continued to grow versus the previous quarter (Q4 2019), seemingly with little initial impact from COVID-19, in contrast to Kymriah which saw a slight dip in Q1 2020 sales. Below, FENIX provides thoughts on Gilead’s cell therapy program, particularly in the context of the ongoing COVID-19 pandemic.

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Novartis Oncology Q1 2020 Earnings Update

On Tuesday, April 28, Novartis held their Q1 2020 earnings call (press release / financial report / slides). Of note, Kymriah sales fell slightly versus the previous quarter (Q4 2019), possibly due to the impact of COVID-19. However, Novartis underlined its confidence in the oncology field’s “resilience” and the company’s full-year sales outlook. Below, FENIX provides thoughts on Novartis’s cell therapy program, particularly in the context of the ongoing COVID-19 pandemic.

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New Novo Insulin Savings Program

Novo Nordisk announced plans to initiate a new US insulin savings program starting on January 2, 2020. Under the new plan, Novo will offer a $99 Cash Card Program for a select volume of any of its insulin analog products as well as the launch of NovoLog and NovoLog Mix Authorized Generics (AG). Below, FENIX provides thoughts on the New Novo insulin program in the context of similar programs by Lilly and Sanofi.

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New Zafgen Data Suggests Clinical Hold Will Remain; Strategic Options to be Explored

Zafgen announced that it is planning to “strategic options to maximize shareholder value,” including a merger, acquisition, or in-licensing opportunity. Following preliminary data from a new animal study, Zafgen believes that in the short-term, there is a low probability of resolving the clinical hold placed on ZGN-1061. Below, FENIX provides brief thoughts on potential outcomes for Zafgen and ZGN-1061. 

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