Category Archives: CAR-T

Precision Biosciences Highlights First Patient Dosed with BCMA CAR-T PBCAR269A; PBCAR0191 Clinical Updates Delayed to YE; Q2 2020 Earnings Summary

On Thursday, August 13, Precision Biosciences released their Q2 2020 financial results (press release). While no new data was presented, Precision highlighted that the first patient was dosed with PBCAR269A (an allogeneic BCMA CAR-T) for the Ph1/2 trial in r/r MM. Moreover, management confirmed that interim data from the PBCAR0191 (an allogeneic CD19 CAR-T) Ph1 study in ≥3L r/r NHL and r/r ALL will be delayed due to the COVID-19 pandemic. Below, Celltelligence provides thoughts on key competitors Precision and Allogene’s position within the allogeneic BCMA CAR-T setting and the possibility for a PBCAR0191 presentation at ASH 2020.

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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Legend Biotech Highlights FDA Filing of Cilta-Cel by YE 2020; Q2 2020 Earnings Summary

On Friday, August 28, Legend Biotech published their Q2 2020 results (press release). Management confirmed that their BCMA CAR-T, cilta-cel (JNJ-4528), co-developed with Janssen, is expected to be filed with the FDA by YE 2020, the EMA in early 2021, and with China’s NMPA in 2021. Furthermore, by YE 2020, Legend anticipates filing an IND application for LB1901 (a CD4 CAR-T) in r/r T cell lymphoma (TCL). Below, Celltelligence provides thoughts on cilta-cel’s commercial opportunity following the anticipated approval of ide-cel (BMS) around March 2021, and Legend’s market opportunity for LB1901 in the TCL setting.

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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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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Gilead Highlights No Impact of COVID-19 on Yescarta Sales; Two New LCM Initiatives for Yescarta; Q2 2020 Earnings Call Summary

On Thursday, July 30, Gilead held their Q2 2020 earnings call (press release / financial report / presentation). The company highlighted resilient Yescarta sales despite the COVID-19 pandemic, growing 11% QoQ and 37% YoY WW. Of note, Gilead highlighted the recent approval of Tecartus and ongoing LCM efforts for both approved CAR-T’s. Below Celltelligence highlights key LCM initiatives for 2021 and the significance of a synergistic authorized treatment center (ATC) onboarding protocol for Gilead.

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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bluebird bio Highlights Ide-cel Resubmission; Q2 2020 Earnings Call

On Wednesday, August 5, bluebird bio released their Q2 2020 financial results (press release). No new data was reported; however, the company highlighted the successful resubmission of their ide-cel BLA application. Below, Celltelligence provides insights on ide-cel’s potential approval date in the EU and a possible alternative messaging strategy for the CAR-T in earlier lines of therapy.

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 Allogene’s AlloCAR Program; Q2 2020 Earnings Call Summary

On Wednesday, August 5, Allogene held their Q2 2020 conference call (press release / company presentation). The company highlighted presented ASCO data from the ALLO-501 (CD19 allogeneic CAR-T) Ph1 ALPHA study in ≥3L NHL (DLBCL or FL) (Sattva Neelapu et al, May 2020). Management confirmed that the pivotal Ph1/2 ALPHA-2 study of ALLO-501A is underway, with no reported DLTs in the dose level 1 (DL1) cohort. Below, Celltelligence provides key takeaways about Allogene’s CAR-T clinical program, and thoughts on potential hurdles the company may face re-treating patients that have already received Gilead and Novartis’s CAR-Ts in earlier lines of therapy.

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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BMS Highlights Ide-cel FDA Re-submission; Q2 2020 Earnings Call

On Thursday, August 6, BMS held their Q2 2020 results (press release / presentation). The company briefly discussed their CAR-T program, highlighting that the BLA for ide-cel in ≥4L RRMM has been re-submitted. In addition, management stated that they look forward to the November PDUFA date for liso-cel in ≥3L DLBCL. Below, Celltelligence provides thoughts on BMS’s two leading CAR-Ts, both of which have experienced delays to their FDA reviews.

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 Gilead’s Recent FDA Approval for Tecartus (KTE-X19) in R/R Mantle Cell Lymphoma

On Friday, July 24, Gilead announced (press release) FDA approval of Tecartus (brexucabtagene autoleucel, formerly KTE-X19), the first and only CAR-T treatment for r/r mantle cell lymphoma (MCL). Priority review for Tecartus was based on results from the Ph2 ZUMA-2 trial; a single-arm, open-label study in which 87% of patients responded, with a 62% CR rate. Below, Celltelligence provides manufacturing insights between Yescarta/Tecartus, and how Gilead’s onboarding policy may influence competitors’ future roll-out of additional CAR-T products.

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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Kymriah Sales Unaffected By COVID-19, but Ph3 Adult ALL Trial Withdrawn; Novartis Q2 2020 Earnings Update

On Tuesday, July 21, Novartis held their Q2 2020 earnings call (press release / financial report / presentation). Of note, Kymriah sales were resilient despite COVID-19, growing +103% WW QoQ and +27% WW versus Q1 2020. Interestingly, the Ph3 OBERON trial investigating Kymriah in adult ALL has been omitted from Novartis’s pipeline. Below, Celltelligence provides thoughts on Novartis’s cell therapy program, particularly surrounding the withdrawal of the Ph3 OBERON study and the ongoing risks posed by competitors, Gilead and Autolus, on Kymriah’s continued sales growth.

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.