Category Archives: CD22

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).

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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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.

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 Autolus’s CAR-T Program; Q2 2020 Earnings Call

On Thursday, August 6, Autolus held their Q2 2020 earnings call (press release/ presentation). The company announced that updated data from the AUTO3 Ph1/2 ALEXANDER study in ≥3L DLBCL will be presented at ESMO on September 18, 2020. In addition, management stated that they have experienced minimal interruption to their clinical program from COVID-19, except for the Ph1 AUTO4 trial (≥2L r/r TRBC1+ TCL) where data readout has been delayed from Q4 2020 to H1 2021. Below, Celltelligence provides key takeaways from the call, and thoughts on how Autolus’s CAR-T program, particularly in ALL (AUTO1) and DLBCL (AUTO3), may be able to compete with CAR-T leaders 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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Purchase Blast$599.00

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

Two New Gracell Early Ph1 Trials in MM and NHL Posted

Two new early Ph1 trials from Gracell have been observed on CT.gov: a BCMA/CD19 dual CAR-T in ≥4L R/R MM and another trial evaluating GC022F, a CD22 CAR-T rapidly manufactured <24 hours in ≥2L R/R NHL. Interestingly, both trials are being conducted at the same hospital. Below, FENIX provides insights on these new trials, particularly around how a BCMA/CD19 dual CAR-T could differentiate Gracell within the crowded BCMA MM space.

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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Novartis Discusses Their Activated Rapid Manufacturing Program and Kymriah in the Community Setting

On Monday, June 15, Novartis held an investor call (presentation), highlighting advances to their activated rapid manufacturing (ARM) platform for cell therapy, and their assessment of the community setting for CD19 CAR-T therapies. Below, FENIX provides thoughts on the significance of the ARM platform compared to other rapid manufacturing methods, and the potential impact Kymriah could have outside Centers of Excellence (COE).

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.

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).

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 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.

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.

Cellectis Q4 ’19 Earnings Update

On Thursday, March 5, Cellectis held their Q4 ‘19 earnings call, providing updates on their CAR-T clinical development program as well as their expanding manufacturing capabilities. In addition, the company provided further color around their recently-updated deal with Servier. Below, FENIX provides highlights and insights from the call, including their significance in the context of an increasingly-competitive CAR-T landscape.

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.