Category Archives: CD19

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.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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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).

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

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Thoughts on Cellectis Q1 2020 Call

On Wednesday, May 6, Cellectis held their Q1 2020 earnings call (press release). The company stated that they have experienced limited disruption from COVID-19 and continue to progress with their CAR-T clinical trials and manufacturing expansion activities. Below, FENIX provides highlights and insights from the call, including how Cellectis’s ability to avoid delays to key strategic programs could help maintain its position as a leading cell therapy company developing allogeneic CAR-Ts for AML, ALL, and MM.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

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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.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

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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.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

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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.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

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.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

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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.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

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Liso-Cel PDUFA 3-Month Delay; BMS Q1 2020 Call Summary

On Thursday, May 6, BMS held their Q1 2020 earnings call (press release / slides), providing an update on their CAR-T program. As announced on May 5 (press release), the company explained that the liso-cel PDUFA date has been pushed back three months to November 16, 2020 to allow the FDA time to review additional data considered to be a major amendment. Meanwhile, BMS provided brief commentary on their BCMA CAR-Ts ide-cel and orva-cel. Below, FENIX provides highlights and analysis from the call, particularly in the context of the liso-cel PDUFA setback in a field being led by Yescarta and Kymriah.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

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.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.