Category Archives: Topics

Cellectis’s First Solid Tumor CAR-T Advancing to the Clinic; Raleigh GMP Facility on Track to Start Production by YE 2021; Cellectis Q2 2021 Earnings Call Summary

On Friday, August 6, Cellectis held their Q2 2021 earnings call (press release) highlighting that their novel UCART programs, UCART20x22 (CD20 x CD22 CAR-T) and UCARTMESO (mesothelin CAR-T), are anticipated to enter the clinic in 2022. Furthermore, Cellectis confirmed that their GMP manufacturing facility in Raleigh is expected to begin production by YE 2021. Below, Celltelligence provides insights on Cellectis’s clinical program progress while discussing how their fully in-house production approach may minimize potential manufacturing backlogs due to viral vector shortage.

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The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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Autolus Confirms Obe-cel’s Ph1b/2 FELIX Trial Readout in 2022; Could Obe-cel be Approved by Early 2023? Yescarta Gains Reimbursement Approval in Australia and Gilead (Kite) Continues Expanding to Novel Cell Platforms with Appia Bio’s Collaboration; Autolus Q2 2021 Earnings Call Summary

On Thursday, August 5, Autolus held their Q2 2021 earnings call (press release / presentation) highlighting that obe-cel’s (CD19 CAR-T) Ph1b/2 FELIX study in r/r ALL readout is on track for 2022. On the same day, Gilead (Kite) announced Yescarta’s (CD19 CAR-T) reimbursement approval in Australia (press release) and a collaboration with Appia Bio for the development of CAR invariant natural killer T (CAR-iNKT) cells for hematological malignancies (press release).

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The Celltelligence Team

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The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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ALLO-501A Pivotal Trial on Track to Start by YE 2021; Allogene Prepares for Clinical Manufacturing; Allogene Q2 2021 Earnings Call Summary

On Wednesday, August 4, Allogene held their Q2 2021 earnings call (press release) highlighting clinical updates for their CD19 and BCMA CAR-T programs, and confirmed their plans to initiate cGMP manufacturing in their new Cell Forge 1 facility by YE 2021. Below, Celltelligence will discuss Allogene’s pipeline updates while providing thoughts on how the company may be preparing for ALLO-501A’s potential regulatory approval.

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The Celltelligence Team

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Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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New Gilead KITE-363 (CD19 x CD20 CAR-T) Ph1 Trial in R/R BCL Posted

On Wednesday, August 4, a new Gilead (Kite) Ph1 trial evaluating KITE-363 (autologous CD19 x CD20 CAR-T) in r/r B cell lymphoma (BCL) was observed on CT.gov. Below, Celltelligence provides details for this trial while discussing the significance of Gilead (Kite) developing a dual-targeting CAR-T.

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The Celltelligence Team

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The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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Gilead Consolidates Their Position as Market Leader; Could Tecartus in R/R Adult ALL Receive A Positive CHMP Opinion By YE 2021? Gilead’s Q2 2021 Earnings Call Summary

On Thursday, July 29, Gilead held their Q2 2021 earnings call (press release / presentation) highlighting an increase in overall revenue for their cell therapy franchise, while discussing the benefits of a potential FDA approval for Yescarta (CD19 CAR-T) in 2L r/r DLBCL. Furthermore, management highlighted the submission of a Type II variation to the EMA for Tecartus (CD19 CAR-T) in r/r adult ALL. Below, Celltelligence provides insights on how Gilead may leverage Yescarta’s and Tecartus’s expansion into new indications to consolidate their position as a cell therapy market leader, while discussing likely EU approval timelines for Tecartus.

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The Celltelligence Team

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The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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Abecma’s Viral Vector Shortage; Could JNJ Take Advantage? BMS Q2 2021 Earnings Call Summary

On Wednesday, July 28, BMS held their Q2 2021 earnings call (press release / presentation), highlighting Breyanzi’s (CD19 CAR-T) and Abecma’s (BCMA CAR-T) strong demand following their recent US approval, while discussing Abecma’s manufacturing bottleneck due to a shortage of viral vector. On the same day, bluebird bio announced (press release) a strategic alliance with Resilience for the sale of bluebird’s lentiviral manufacturing facility in North Carolina. Below, Celltelligence provides insights on how Abecma’s upcoming approval in the EU could impact BMS’s viral vector shortage and if JNJ could take advantage for cilta-cel’s launch.

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The Celltelligence Team

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Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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New Legend Ph1 Trial for LCAR-T2C (CD4 CAR-T) in R/R T Cell Lymphoma Posted

On Thursday, July 22, a new Legend-sponsored Ph1 trial in China evaluating LCAR-T2C (CD4 CAR-T) for r/r T cell lymphoma (TCL) was observed on CT.gov. Below, Celltelligence provides details for this trial while discussing Legend’s CD4 CAR-T global clinical development, and how LCAR-T2C compares to Autolus’s AUTO4 program.

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The Celltelligence Team

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Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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Is Competition from Breyanzi Responsible for a Decline in Kymriah’s Sales? Cilta-cel Remains on Track to Gain FDA Approval by EOY; Novartis and JNJ Q2 2021 Earnings Call Summaries

On Wednesday, July 21, Novartis held their Q2 2021 earnings presentation (press release / presentation) highlighting Kymriah’s sales decline. Of note, no major clinical or regulatory updates were reported. On the same day, JNJ presented their Q2 2021 financial results (press release  / presentation) highlighting the submission of cilta-cel’s (BCMA CAR-T) MAA to the EMA. Below, Celltelligence provides insights on how Breyanzi’s approval in the US could have negatively impacted Kymriah’s Q2 2021 sales while discussing cilta-cel’s potential US and EU regulatory timelines.

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The Celltelligence Team

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Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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TCR2 Tx Appoints Peter Olagunju as Chief Technical Officer

On Tuesday, July 20, TCR2 Therapeutics announced (press release) the appointment of Peter Olagunju as their first Chief Technical Officer (CTO). Below, Celltelligence provides insights on how Peter Olagunju’s extensive cell therapy development and manufacturing experience could accelerate the development and commercialization of TCR2 Tx’s lead asset, gavo-cel (mesothelin targeted TRuC-T) in solid tumors. 

About The Author

The Celltelligence Team

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Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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BioNTech Acquires Kite’s TCR-T Platform and Manufacturing Facility; Is Kite Pivoting Away from TCR-Ts?

On Monday, July 19, Gilead (Kite) announced (press release) that BioNTech will acquire Kite’s individualized TCR platform and manufacturing facility in Gaithersburg, MD. Below, Celltelligence provides insights on Gilead’s (Kite) potential approach to treat solid tumors while discussing how BioNTech’s acquisition may quickly advance their pipeline by expanding their US manufacturing footprint.

About The Author

The Celltelligence Team

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Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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