Category Archives: Topics

Cellectis Remains Confident on TALEN Editing Safety; UCART22 Clinical Updates Anticipated at ASH 2021; UCARTMESO on Track to Enter the Clinic in 2022; 2seventy Provides Further Insights on Their Business Separation; Cellectis Q3 2021 Earnings Call Summary

On Friday, November 5, Cellectis held their Q3 2021 earnings call (press release) highlighting UCART22’s (allogeneic CD22 CAR-T) Ph1 BALLI-01 trial update at ASH 2021 and a preclinical data presentation for UCARTMESO (allogeneic mesothelin CAR-T) at SITC 2021. Furthermore, Cellectis discussed Allogene’s recent clinical hold, and provided an update on their manufacturing facilities in Paris, France, and Raleigh, NC. On the same day, bluebird bio announced their Q3 2021 earnings (press release) highlighting 2seventy’s successful business separation. Moreover, on Thursday, November 4, 2seventy bio (press release) provided additional guidance covering clinical updates and manufacturing capabilities.

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New Yescarta Study in R/R DLBCL for Outpatient Administration

On Friday, November 5, a new investigator-initiated study evaluating Gilead (Kite)’s Yescarta (CD19 CAR-T) in the outpatient setting for r/r DLBCL was observed on CT.gov. Below, Celltelligence provides details for this trial, while discussing how this Yescarta outpatient study compares to key competitor Breyanzi (BMS’s CD19 CAR-T).

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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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When Will the FDA Lift Allogene’s Clinical Hold on AlloCAR-T Programs? Allogene to Present Major Clinical Updates at ASH 2021; Could ALLO-501A’s Pivotal Trial Include Consolidation Dosing? Allogene Q3 2021 Earnings Call Summary

On Thursday, November 4, Allogene held their Q3 2021 earnings call (press release) highlighting their interactions with the FDA to resolve the clinical hold on their AlloCAR-T clinical programs and preparation for ALLO-501A’s (allogeneic CD19 CAR-T) pivotal trial. Moreover, management outlined the clinical data expected from their CD19 and BCMA CAR-T programs at ASH 2021. Below, Celltelligence will discuss Allogene’s clinical hold and the potential impact to their joint venture with Overland Pharma, while providing insights on the likelihood of ALLO-501A’s pivotal trial, including consolidation dosing.

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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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Afami-cel’s BLA Filing on Track for 2022; Next-Gen MAGE-A4 SPEAR-T To Treat Ovarian Cancer; 2seventy Successfully Launched; Adaptimmune Q3 2021 Earnings Call Summary

On Thursday, November 4, Adaptimmune held their Q3 2021 earnings call (press release) highlighting that they are preparing the CMC documentation and analytical data for afami-cel’s (MAGE-A4 SPEAR-T; formerly ADP-A2M4) potential BLA filing in 2022. Furthermore, management announced a new ADP-A2M4CD8 (next-gen MAGE-A4 SPEAR-T) Ph2 SURPASS-3 trial in ovarian cancer and discussed the prioritization of ADP-A2M4CD8’s combination with pembrolizumab (PD1 inhibitor) over afami-cel. On the same day, bluebird bio announced (press release) the successful launch of 2Seventy bio.

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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’s Obe-cel US Regulatory Filing Planned for Early 2023; BMS Invests in Clade Therapeutics; New Gracell CD19 UCAR-T Ph1 Trial in R/R B-ALL and B-NHL Posted; Autolus Q3 2021 Earnings Call Summary

On Wednesday, November 3, Autolus held their Q3 2021 earnings call (press release / presentation) highlighting updates from obe-cel (CD19 CAR-T; formerly AUTO1) and their next-generation candidates. On the same day, Clade Therapeutics announced (press release) that they have secured $87M in Series A financing with participation from BMS. Finally, a new Gracell early Ph1 trial evaluating an allogeneic CD19 UCAR-T in r/r B-ALL and B-NHL was observed on CT.gov.

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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 Cilta-cel US Delay

Yesterday’s PDUFA delay for JNJ/Legend’s BCMA CAR-T product cilta-cel was unexpected (see previous insight), and it brings up some potentially relevant questions. Below, Celltelligence discusses if the benefit to BMS is as obvious as one may think.

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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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Cilta-cel US Delay to February 28, 2022

After market close today, November 1, 2021, Legend announced the PDUFA delay for cilta-cel to February 28, 2022, a delay of 3 months from the original action date of November 29, 2021. The news comes on the heels of bullish commentary from Legend’s October 18 R&D day (see previous insight) and JNJ’s Q3 2021 earnings on October 21 (see previous insight).

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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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Yescarta’s Sales Decline; Gilead’s (Kite) New Manufacturing Facility in Maryland to Be Operational By Mid-2022; Health Canada Approves Tecartus in MCL; Gilead’s Q3 2021 Earnings Call Summary

On Thursday, October 28, Gilead held their Q3 2021 earnings call (press release / presentation) highlighting Yescarta’s (CD19 CAR-T) sales decline and the anticipated opening of their new manufacturing facility in Frederick County, Maryland. On the same day, Gilead announced (press release) that Health Canada has approved Tecartus (CD19 CAR-T) in r/r mantle cell lymphoma (MCL), based on results from the Ph2 ZUMA-2 trial. Below, Celltelligence provides insights on the potential impact of increased ATC competition on Yescarta’s Q3 sales revenue, while outlining likely US and EU approval timelines for Yescarta in 2L r/r DLBCL and Tecartus in r/r adult ALL. Finally, Celltelligence discusses Tecartus’s approval and reimbursement in Canada.

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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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BMS’s Breyanzi and Abecma Sales Increase; Could Abecma’s Continued Viral Vector Shortage Favor Cilta-cel’s Upcoming Launch? No Updates on GSK’s Cell Therapy Assets; BMS and GSK Q3 2021 Earnings Call Summaries

On Wednesday, October 27, BMS held their Q3 2021 earnings presentation (press release / presentation) highlighting Breyanzi’s (CD19 CAR-T) and Abecma’s (BCMA CAR-T) continued revenue growth. Furthermore, management commented that Abecma’s vector supply issues may not be fully resolved before H2 2022. On the same day, GSK presented their Q3 2021 financial results (press release / presentation). However, the company did not provide any updates on their cell therapy assets in 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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Takeda to Acquire GammaDelta Tx; Will Gilead (Kite) Pursue Gadeta?

On Wednesday, October 27, Takeda announced (press release) that they aim to fully acquire GammaDelta Therapeutics during Q1 2022 of Takeda’s fiscal year. Below, Celltelligence provides insights on why Takeda’s acquisition of GammaDelta Tx makes sense, while discussing whether Gilead (Kite) could prioritize acquiring Gadeta.

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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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