Category Archives: Topics

Obe-cel’s BLA Submission on Track for YE 2023; New Obe-cel Ph1 Trial to Start for SLE; Two Assets Added to the Pipeline; Autolus’s Q2 2023 Earnings Call Summary

On Thursday, August 3, Autolus held its Q2 2023 earnings call (press release / presentation) highlighting that obe-cel’s (CD19 CAR-T) BLA submission in r/r ALL is still expected by YE 2023. Of note, the company plans to start a new obe-cel trial in SLE in 2024 and added two new assets to its pipeline, including an allogeneic version of obe-cel. Below, Celltelligence provides insights on obe-cel’s pathway towards commercialization, while discussing its entry into the autoimmune space.

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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’s ALPHA2 Trial to Start Enrollment Ex-US; EXPAND Continues Recruiting Slowly; ALPHA3 Trial Redefined; Allogene’s Q2 2023 Earnings Call Summary

On Wednesday, August 2, Allogene held its Q2 2023 earnings call (press release) highlighting the progress of ALLO-501A’s (allogeneic CD19 CAR-T) Ph1/2 ALPHA2 trial in ≥3L LBCL and the EMA Clinical Trial Application approval to expand the study to Europe. Below, Celltelligence provides insights on ALPHA2 and Ph2 EXPAND trial timelines, while discussing the company’s potential strategy for the Ph3 ALPHA3 trial in LBCL.

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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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Updated Results of BRL-201 in R/R B-NHL; MeiraGTx and CERo Present Innovative Cell Therapy Technologies; ASGCT Spotlight on Immuno-Oncology 2023 Analysis

ASGCT Spotlight on Immuno-Oncology 2023 Analysis: BRL Medicine reported clinical updates from BRL-201’s (CD19 Quikin CAR-T) Ph1 trial in r/r B-NHL patients, while MeiraGTx and CERo Tx introduced their innovative technologies.

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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 Receives Feedback from the FDA on Azer-cel’s Registrational Pathway

On Thursday, July 27, Precision Biosciences announced (press release) the receipt of final Type B meeting minutes from the FDA providing clarity on the potential registrational pathway of its lead asset azer-cel (PBCAR0191; allogeneic CD19 CAR-T). Moreover, the company disclosed discussions with multiple potential strategic partners for the development of its cell therapy assets. Below, Celltelligence provides insights on azer-cel’s potential in LBCL, while comparing the asset with its main allogeneic competitors.

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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 Sales Decrease While Breyanzi Revenue Keeps Growing; Plans to Start a BMS-986393 Registrational Trial; BMS Invests in Immatics; BMS’s Q2 2023 Earnings Call Summary

On Thursday, July 27, BMS held its Q2 2023 earnings call (press release / presentation) highlighting Breyanzi’s (CD19 CAR-T) sales increase while reporting a revenue decrease for Abecma (BCMA CAR-T). Furthermore, the company underscored clinical and regulatory milestones of its cell therapy assets, disclosing a new potentially registrational trial for BMS-986393 (CC-95266; GPRC5D CAR-T). Finally, on Monday, July 24, Immatics announced a $35M equity investment from BMS (press release). Below, Celltelligence provides insights on how Abecma and Breyanzi sales compare to key competitors while discussing the main clinical milestones achieved by BMS’s marketed cell therapy assets in Q2 2023 and the company’s regulatory plans for its CAR-T 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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Carvykti’s Revenue Increases Over +60% QoQ; JNJ Q2 2023 Earnings Call Summary

On Thursday, July 20, JNJ held its Q2 and H1 2023 earnings call (press release / presentation) highlighting Carvykti’s (BCMA CAR-T) remarkable revenue growth. Below, Celltelligence provides insights on the increase in Carvykti sales, while discussing JNJ / Legend’s ongoing strategies to improve CAR-T manufacturing capacity and analyzing Carvykti’s supply limitations ex-US.

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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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Kymriah Sales Continue to Slowly Decrease; No Updates of T-Charge Programs; Novartis’s Q2 2023 Earnings Call Summary

On Tuesday, July 18, Novartis held its Q2 and H1 2023 earnings call (press release / presentation) reporting $129M in Kymriah’s (CD19 CAR-T) WW sales while the company did not provide any clinical or regulatory updates on its cell therapy programs. Below, Celltelligence provides insights on Kymriah’s Q2 2023 revenue while discussing if Kymriah’s approvals in ≥3L FL in several markets would be enough to offset the declining sales in the future.

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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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Caribou Shares Positive Data from ANTLER Trial in B-NHL; Pfizer Invests in Caribou’s BCMA-targeting Cell Therapies

On Thursday, July 13, Caribou held a virtual event to report follow-up data from CB-010’s (allogeneic CD19 CAR-T) Ph1 ANTLER trial for patients with ≥2L B-NHL (press release / presentation). Notably, the news came a week after Pfizer made a $25M equity investment in Caribou to advance CB-011 (allogeneic BCMA CAR-T) program (press release, Jul 6, 2023). Below, Celltelligence provides insights on CB-010’s clinical results and Caribou’s plans to discuss with the FDA the initiation of a pivotal trial in 2L LBCL, while discussing Pfizer’s investment in Caribou’s allogeneic asset for MM.

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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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No Cell Therapy-Related Updates in July’s CHMP Agenda

On Monday, July 17, the CHMP Agenda for July was released. Of note, no cell therapy-related updates were observed and both Type II Variations applications (T2V) for Abecma (BMS’s BCMA CAR-T) and Carvykti (JNJ / Legend’s BCMA CAR-T) in r/r MM were absent from the agenda.

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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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The FDA Clears Poseida’s P-CD19CD20-ALLO1 IND in B-Cell Malignancies

On Wednesday, July 5, Poseida announced (press release) that the FDA has approved the IND for P-CD19CD20-ALLO1 (allogeneic CD19 x CD20 dual CAR-T) in B-cell malignancies. Below, Celltelligence provides insights on P-CD19CD20-ALLO1’s IND clearance while discussing the potential competition that P-CD19CD20-ALLO1 could face.

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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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