Category Archives: BCMA

FDA Lifts Clinical Hold on CART-ddBCMA’s Ph2 iMMagine-1 Trial; How Did the Hold Impact CART-ddBCMA Development Timelines? Arcellx’s Q2 2023 Results Summary

On Monday, August 14, Arcellx released its Q2 2023 results (press release) disclosing that the FDA has lifted the partial clinical hold placed on CART-ddBCMA’s (BCMA CAR-T) Ph2 iMMagine-1 trial in ≥4L MM. Below, Celltelligence provides insights on the protocol changes done in the trial while discussing how this may affect Arcellx’s development timelines for its leading asset.

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GC012F’s US Trial Initiated; GC012F to Be Evaluated in SLE in the US; Pipeline Reprioritization; Gracell’s Q2 2023 Earnings Call Summary

On Monday, August 14, Gracell held its Q2 2023 earnings call (press release) highlighting the initiation of GC012F’s (BCMA x CD19 FasTCAR-T) Ph1b/2 trial for ≥4L MM in the US, while disclosing the company’s intention to submit an IND to the FDA for the evaluation of GC012F for SLE. Additionally, Gracell announced a reprioritization of its pipeline and confirmed the closing of the private placement financing reported on August 7. Below, Celltelligence provides insights on GC012F’s clinical milestones in MM, while analyzing GC012F options in SLE and the company’s reprioritized pipeline.

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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 to Share FDA’s Feedback on Potential CB-010 Pivotal Trial by YE 2023; Caribou’s Q2 2023 Earnings Summary

On Tuesday, August 8, Caribou released their Q2 2023 results and business updates (press release) confirming plans to meet the FDA to discuss a potential pivotal trial for CB-010 (allogeneic CD19 CAR-T) in 2L LBCL and its hopes to share the FDA’s feedback by YE 2023. Moreover, the company highlighted the recent Pfizer investment in Caribou’s CB-011 (allogeneic BCMA CAR-T) program. Below, Celltelligence provides insights on how Caribou’s plans to run a potential trial in 2L LBCL may evolve and compares them to those of its main 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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Thoughts on Astellas’s Strategic Investment in Poseida; Astellas Gains Rights over P-MUC1C-ALLO1 Program; First Patient in P-CD19CD20-ALLO1 Trial to Be Dosed in Early 2024; Gracell Announces Private Investment

On Monday, August 7, Poseida and Astellas announced (press release) a strategic investment to support the advancement of Poseida’s cell therapy assets in solid tumors with Astellas receiving the right of exclusive negotiation and first refusal to license P-MUC1C-ALLO1 (allogeneic MUC1C CAR-T). Additionally, Poseida provided (press release) a business update on its allogeneic CAR-T programs and Gracell reported (press release) up to $150M in private placement financing by a syndicate of premier healthcare investors. Below, Celltelligence provides insights on Astellas’s interest in allogeneic cell therapies, while discussing how Poseida and Gracell could benefit from these investments.

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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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Yescarta Sales Continue to Increase While Tecartus Revenue Plateaus; Gilead Considers Entry into Autoimmune Diseases; Gilead’s Q2 2023 Earnings Call Summary

On Thursday, August 3, Gilead (Kite) held its Q2 2023 earnings call (press release / presentation) highlighting the increased sales for Yescarta and the regulatory milestones of its cell therapy franchise. Additionally, the company reaffirmed its confidence in the therapeutic potential of CART-ddBCMA (KITE-772; BCMA CAR-T), developed in collaboration with Arcellx, despite the FDA’s clinical hold on its Ph2 iMMagine-1 trial in ≥4L MM. Below, Celltelligence provides insights on Gilead’s cell therapy revenue increase ex-US, while discussing the potential entrance of the company in the autoimmune disease space.

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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’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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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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