Category Archives: Uncategorized

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Kymriah Sales Unaffected By COVID-19, but Ph3 Adult ALL Trial Withdrawn; Novartis Q2 2020 Earnings Update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

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Thoughts on Fate Therapeutics Updates to their CAR-T Programs in DLBCL and MM; Q1 2020 Call

On Monday, May 11, Fate Therapeutics held their Q1 2020 earnings call (press release), highlighting clinical and preclinical development updates to their pipeline, operational progress, and the recently established collaboration with Janssen for iPSC-derived CAR-NK and CAR-T assets. Below, FENIX provides thoughts on Fate’s cell therapy clinical strategy, particularly in the context of the current 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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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.

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 Precision’s Allogeneic CAR-T Programs in NHL and MM; Q1 2020 Call

On Friday, May 15, Precision Biosciences held their Q1 2020 earnings call (press release/presentation), highlighting the current clinical progress for their three Ph1/2 allogeneic CAR-T candidates:

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 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.

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.

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.

Gilead Announces EMA Approval for End-to-End Yescarta CAR-T Manufacturing at Amsterdam Facility

On Friday, June 12, Gilead announced (press release) that the European Medicine Agency (EMA) has approved the company’s Amsterdam facility for end-to-end manufacturing of Yescarta. Below, FENIX highlights the potential impact on Yescarta’s EU turn-around-time (TAT), and the effect this may have on Kymriah sales.

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.