Category Archives: Autologous

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Kymriah Sales Unaffected By COVID-19, but Ph3 Adult ALL Trial Withdrawn; Novartis Q2 2020 Earnings Update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

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Purchase Blast$599.00

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BMS and bluebird bio Resubmit Ide-cel to FDA; Dynamic H1 2021 BCMA Launch Environment Expected with Janssen

On Wednesday, July 29, BMS and bluebird bio announced (press release) the resubmission of their BLA application for ide-cel (bb2121) to the FDA. According to the press release, the submission provides further details on the CMC module, addressing the additional regulatory information requested by the FDA in May 2020 (see previous insight). Below, Celltelligence provides additional thoughts on ide-cel’s potential approval, and the possible benefit a delayed ide-cel launch could have for Janssen.

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 the EMA Validating BMS’s Liso-cel Marketing Authorization Application

On Friday, July 17, BMS announced (press release) that the EMA has validated BMS’s MAA for lisocabtagene maraleucel (liso-cel). Below, Celltelligence provides thoughts on Liso-cel’s MAA and the potential impact of a Liso-cel approval for Novartis and Gilead (Kite).

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.

Thoughts on Autolus’s Preclinical Pipeline Update; AACR II 2020 Investor Call Summary

On Thursday, June 25, Autolus held an investor call (press release / presentation), highlighting updated preclinical data from their AUTO5 (T cell lymphoma), AUTO6NG (neuroblastoma, osteosarcoma, small cell lung cancer, and melanoma), and AUTO7 (metastatic castration-resistant prostate cancer, mCRPC) programs. Below, Celltelligence provides thoughts on the significance of these data sets, and the potential impact that Autolus’s next-generation CAR-T products could have on treating solid tumors.

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.

Novartis Ph1b PORTIA Results Presented at Virtual AACR II

On Monday, June 23, Novartis presented (Ulrich Jaeger et al, June 2020) updated clinical data from the Kymriah + pembrolizumab (pembro, a PD-1 inhibitor) Ph1 PORTIA study in ≥3L R/R DLBCL. Below, FENIX provides thoughts on the significance of this data, and particularly how it compares to recent CAR-T + checkpoint inhibitor data from Gilead (Yescarta), BMS (Liso-cel), and Autolus (AUTO3).

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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Autolus Ph1/2 ALLCAR19 Results and EHA 2020 Investor Call Summary

On Friday, June 12, Autolus held an investor call (press release/ presentation), highlighting updated clinical data from the AUTO1 (CD19 CAR-T) Ph1/2 ALLCAR19 study in ≥2L adult ALL. The data was also presented at EHA (Claire Roddie et al, June 2020). Below, FENIX provides thoughts on the significance of this data, and particularly how it compares to competitor CD19 CAR-Ts from Novartis (Kymriah), Gilead (Yescarta), and Cellectis (UCART19).

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.

Ziopharm Appoints Carl June as Chairman of Scientific Advisory Board

On Monday, June 15, Ziopharm announced (press release) the appointment of Carl June as chairman to the company’s newly formed scientific advisory board (SAB). Below, FENIX provides thoughts on this appointment, particularly around June’s experience pioneering the initial CAR-T studies leading to the commercialization of 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.