Category Archives: Topics

FDA to Potentially Clear ALLO-501A’s Pivotal Study in Q3 2022; Nirogacestat Combo Deprioritized; Data from ALLO-316 Delayed to 2023; Allogene Q2 2022 Earnings Call Summary

On Tuesday, August 9, Allogene held their Q2 2022 earnings call (press release) highlighting an anticipated FDA clearance of ALLO-501A’s (allogeneic CD19 CAR-T) pivotal trial in ≥3L DLBCL, while announcing the deprioritization of ALLO-715’s (allogeneic BCMA CAR-T) combination with nirogacestat. Of note, no major updates were presented from ALLO-316’s (allogeneic CD70 CAR-T) clinical development. Below, Celltelligence provides insights on how Allogene could accelerate ALLO-501A’s regulatory pathway, while discussing Allogene’s upcoming clinical updates.

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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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Data Updates from Gavo-cel and TC-510 in H2 2022; TCR2 Tx Expands Its Manufacturing Capacity; TCR2 Tx Q2 2022 Earnings Call Summary

On Monday, August 8, TCR2 Tx released their Q2 2022 financial results and corporate updates (press release), highlighting anticipated data readouts from gavo-cel (autologous mesothelin TRuC-T) and TC-510 (autologous mesothelin TRuC-T with PD-1:CD28 switch) in H2 2022. Additionally, management noted the expansion of their manufacturing capacity at ElevateBio Basecamp. Below, Celltelligence provides insights on TCR2 Tx’s anticipated clinical milestones, while discussing the company’s manufacturing capacity expansion.

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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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Precision’s Cash Runway Extended to YE 2024; No Major Clinical Updates; Precision BioSciences Q2 2022 Earnings Call Summary

On Monday, August 8, Precision BioSciences released their Q2 2022 earnings results (press release) highlighting PBCAR0191’s (allogeneic CD19 CAR-T) data readout in June 2022. Of note, no major updates were reported for PBCAR19B (allogeneic stealth CD19 CAR-T) or PBCAR269A (allogeneic BCMA CAR-T). Below, Celltelligence provides insights on PBCAR0191’s potential approval pathway, while discussing potential clinical delays for Precision’s MM programs.

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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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Thoughts on Poseida’s Strategic Global Collaboration with Roche

On Wednesday, August 3, Poseida announced (press release / presentation) a strategic global collaboration with Roche to develop and commercialize existing and novel allogeneic cell therapies for hematologic indications. Of note, Poseida will receive $110M upfront and further milestone payments potentially exceeding $6B in aggregate value. Below, Celltelligence provides insights on Roche’s shift in interest regarding cell therapies, while discussing Poseida’s partnering strategy.

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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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UCART20x22 Receives FDA IND Clearance; Novel Universal CAR-T Program; No Clinical Milestone Updates for UCART22, UCART123, or UCARTCS1; Cellectis’s Q2 2022 Earnings Call Summary

On Friday, August 5, Cellectis held their Q2 2022 earnings call (press release) highlighting UCART20x22’s (allogeneic CD20xCD22 dual CAR-T) FDA IND clearance for r/r NHL. Of note, no major clinical updates were provided for allogeneic therapies UCART22 (CD22 CAR-T), UCART123 (CD123 CAR-T) or UCARTCS1 (CS1 CAR-T). Below, Celltelligence provides insights on Cellectis’s FDA IND clearance and pipeline development.

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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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Obe-cel’s Data Update Expected in Q4 2022; Afami-cel’s BLA Remains on Track for Q4 2022; Adaptimmune to Slow Down ADP-A2M4N7X19’s Development; Autolus and Adaptimmune Q2 2022 Earnings Summaries

On Thursday, August 4, Autolus held their Q2 2022 earnings call (press release / presentation) highlighting that initial data from obe-cel’s (CD19 CAR-T) Ph2 FELIX trial will be reported in Q4 2022. Additionally, multiple data updates from AUTO1/22 (CD19 x CD22 CAR-T) and AUTO4 (TRBC1 CAR-T) are expected at ASH 2022. On the same day, Adaptimmune reported their Q2 2022 financial results (press release) confirming afami-cel’s (MAGE-A4 SPEAR-T) anticipated BLA filing in Q4 2022, and a delayed IND submission for ADP-A2M4N7X19 (next-generation MAGE-A4 SPEAR-T). Below, Celltelligence provides insights on obe-cel’s potential approval, while discussing afami-cel’s BLA filing.

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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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Gilead Reports Outstanding Cell Therapy Revenue Growth; Yescarta’s Manufacturing Capacity Scaled to Address Demand; Updated Regulatory Milestones for Yescarta and Tecartus in the EU; Gilead’s Q2 2022 Earnings Call Summary

On Tuesday, August 2, Gilead (Kite) held their Q2 2022 earnings call (press release / presentation) highlighting an increase in revenue for their cell therapy franchise, while discussing EU regulatory milestones for Yescarta and Tecartus (CD19 CAR-Ts). Below, Celltelligence provides insights on Gilead’s cell therapy revenue increase, while discussing how Gilead’s manufacturing strategy could accommodate Yescarta’s expected increase in demand.

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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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You May Have Missed: Are Cell Therapy Leaders Losing Their Innovative Edge?

During July, the Celltelligence team published a six-part series discussing the pipeline, manufacturing technology, and novel platforms from Novartis, BMS, and Gilead (Kite):

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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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Gracell Appoints Wendy Li as Chief Medical Officer

On Monday, August 1, Gracell announced (press release) the appointment of Wendy Li as Chief Medical Officer (CMO). Below, Celltelligence provides insights on how Gracell could leverage Li’s vast experience in the CAR-T field.

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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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Abecma’s Sales Increase While Breyanzi’s Revenue is Affected by Manufacturing Issues; No Clinical Milestone Updates for Breyanzi or Abecma; Oxford Biomedica’s Expanded LSA Agreement; BMS’s Q2 2022 Earnings Call Summary

On Wednesday, July 27, BMS held their Q2 2022 earnings call (press release / presentation) highlighting Breyanzi’s (CD19 CAR-T) sales decrease and US approval in 2L LBCL. Moreover, management reported a revenue increase for Abecma (BCMA CAR-T). Of note, no updated clinical milestones for Breyanzi and Abecma were observed. Below, Celltelligence provides insights on how Breyanzi and Abecma revenue compares with key competitors Kymriah (CD19 CAR-T; Novartis), Yescarta (CD19 CAR-T; Gilead / Kite), and Carvykti (BCMA CAR-T; JnJ / Legend). Additionally, Celltelligence discusses BMS’s LSA expansion agreement with Oxford Biomedica.

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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