Category Archives: Topics

Carvykti’s sBLA in 2L MM Did Not Receive Priority Review; JNJ / Legend Continue To Improve Manufacturing Capacity; Updates on Solid Tumor Programs; Legend’s Q2 2023 Earnings Call Summary

On Tuesday, August 15, Legend held its Q2 2023 earnings call (press release) highlighting that the FDA set a PDUFA date for Carvykti’s (BCMA CAR-T) sBLA in ≥2L MM on April 5, 2024. Moreover, management listed measures that the company is taking to improve its manufacturing capacity and reported updates on its solid tumor programs. Below, Celltelligence provides insights on the FDA’s standard review of Carvykti’s sBLA while discussing future development for Carvykti and the company’s solid tumor programs.

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Abecma’s US Revenue Decreased; FDA Formally Puts DARIC33’s Trial on Hold; Manufacturing Capacity Ramping Up; 2seventy bio Q2 2023 Earnings Call Summary

On Monday, August 14, 2seventy bio held its Q2 2023 earnings call (press release) acknowledging Abecma’s (BMS / 2seventy’s BCMA CAR-T) decline in US sales while disclosing updates on the SC-DARIC33’s (drug-regulated CD33 CAR-T) Ph1 PLAT-08 clinical hold. Below, Celltelligence provides insights on the causes behind Abecma’s revenue decrease while discussing the potential delay that the clinical hold might cause on DARIC33’s clinical 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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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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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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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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Completion of Afami-cel’s BLA Submission Delayed; FDA Agrees to Cohort 2 of the SPEARHEAD-1 Trial Acting as Confirmatory Evidence for Full Approval; ADP-A2M4CD8’s SURPASS-3 Trial Initiated; Adaptimmune’s Q2 2023 Earnings Call Summary

On Wednesday, August 9, Adaptimmune held its Q2 2023 earnings call (press release) disclosing that the completion of afami-cel’s (MAGE-A4 SPEAR-T) BLA submission to the FDA has been postponed to Q4 2023 while reporting the initiation of ADP-A2M4CD8’s (next-generation MAGE-A4 SPEAR-T) Ph2 SURPASS-3 trial. Additionally, management highlighted anticipated milestones for assets included in the combined pipeline resulting from the merger with TCR2 Tx. Below, Celltelligence provides insights on the consequences of the delay in afami-cel’s BLA submission while discussing Adaptimmune’s potential pipeline prioritization strategy in ovarian cancer.

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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 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

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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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ARCE Tx to Advance ARD103 into the Clinic after Promising Preclinical Results in AML; NKGen Biotech and Affimed not Proceeding to Ph2 Trial Combining AFM24 and SNK01 in Solid Tumors; ASCO Breakthrough 2023 Analysis

ASCO Breakthrough 2023 Analysis: ARCE Tx reported preclinical updates from ARD103, a CLL-1 CAR-T manufactured with its DashCAR technology, while NKGen biotech and Affimed presented initial results of their collaboration to evaluate SNK01 (autologous NK cells) in combination with AFM24 (EGFR x CD16 bispecific NK cell engager) in advanced or metastatic EGFR+ solid tumors.

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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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Cellectis to Provide Updates of All Clinical Programs in 2023; Company to Advance FAP-Targeting UCART Program in Solid Tumors into the Clinic; Precision Actively Seeking Partners to Advance Azer-cel and PBCAR19B; Cellectis’s and Precision’s Q2 2023 Earnings Call Summary

On Friday, August 4, Cellectis held its Q2 2023 earnings call (press release) highlighting anticipated updates for the clinical programs of UCART22 (allogeneic CD22 CAR-T), UCART20x22 (allogeneic CD20xCD22 CAR-T) and UCART123 (allogeneic CD123 CAR-T) later in 2023. On the same day, Precision reported its Q2 2023 earnings call (press release) reiterating 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), and the active discussions with potential partners for the development of its cell therapy assets. Below, Celltelligence provides insights on Cellectis’s updates of its UCAR-T assets, while discussing Precision’s active search for partnerships and azer-cel’s potential 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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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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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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