Category Archives: Autologous

You May Have Missed: CARsgen Partners with Moderna; AZ to Collaborate in the Development of a New CAR-T in Solid Tumors; Gilead to Evaluate Novel Dual CAR-T; Poseida and Roche Publish P-CD19CD20-ALLO1’s New Trial; Germany’s G-BA Completes Carvykti’s Reimbursement – August 2023 Recap (Blast 1/2)

In August 2023, the Celltelligence team detected several relevant news items that were not discussed in individual blasts but are also worth highlighting. Celltelligence will publish a two-part series discussing the news and providing insights about their importance in the cell therapy space. In this first summary, the following topics are covered:

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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 BMS Joining Cellares’s Technology Adoption Partnership Program to Evaluate the Automated Production of One of Its Key CAR-Ts; Could Cellares’s Cell Shutter Become a Competitive Advantage for BMS?

On Monday, August 28, Cellares announced (press release) that BMS joined its Technology Adoption Partnership (TAP) program, entering into a proof-of-concept transfer process for the manufacturing of one of its CAR-Ts using Cellares’s proprietary Cell Shuttle platform. Below, Celltelligence provides insights into the features of Cellares’s end-to-end automated process for cell therapy production while discussing the potential competitive advantage that this partnership could represent for BMS.

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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 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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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 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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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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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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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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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

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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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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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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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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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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 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.

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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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.

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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