Tag Archives: Small player

You May Have Missed: Gilead Terminates 2 Arms in ZUMA-25 Trial; UPenn Starts Trial in Prostate Cancer with Former Tmunity Asset; A2 Bio Publishes New Study in Solid Tumors; Cartesian to Initiate Trial in SLE

In the past few weeks, the Celltelligence team detected several relevant news items that were not discussed in individual blasts but are also worth highlighting. In this blast, Celltelligence will cover the following topics: 

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GC012F Achieves 100% sCR in Chinese IIT for NDMM; First R/R MM Patient Dosed with GC012F in the US; AbbVie Terminates Agreement with Caribou

Gracell presented clinical updates of the ongoing GC012F’s (BCMA x CD19 FasTCAR-T) Ph1 IIT in high-risk (HR) transplant-eligible (TE) NDMM patients in China at the International Myeloma Society (IMS) Annual Meeting 2023 (press release). Moreover, on Tuesday, September 26, the company disclosed the dosing of the first patient in the Ph1b/2 trial evaluating GC012F in ≥4L MM in the US (press release). On the same day, Caribou reported AbbVie’s decision to terminate the collaboration agreement for the development of allogeneic cell therapy candidates (Form 8-K). Below, Celltelligence provides insights on GC012F’s clinical development while discussing the impact that the termination of the collaboration may have on Caribou and AbbVie.

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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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2seventy bio Announces Strategic Restructuring and Pipeline Reprioritization; Abecma’s US Revenue Guidance Lowered; Nick Leschly to Resign as CEO; Company to Expand Strategic Partnership with JW Tx

On September 12, 2023, 2seventy bio held a conference call (webcast / press release) announcing the strategic restructuring of the company’s business operations and R&D model. Measures include a 40% workforce reduction and a pipeline reprioritization and are driven by a projected decrease in Abecma’s (BMS / 2seventy BCMA CAR-T) revenue for 2023. Additionally, the company disclosed Nick Leschly’s decision to step down as CEO. On the same day, 2seventy announced the expansion of its collaboration with JW Tx adding 2 new assets from its pipeline: a solid tumor targeting TCR-T and a CAR-T for autoimmune diseases (press release). Below, Celltelligence provides insights on 2seventy’s new Abecma revenue projections for 2023 and the collaborative R&D model that the company aims to implement for its pipeline.

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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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Immatics to Combine its PRAME TCR-Ts with Moderna’s Investigational mRNA Vaccine; Cellares and Lyell Enter into a New Collaboration; Adaptimmune Appoints Karen Chagin as Senior VP of Early Stage Development

On Monday, September 11, a series of cell therapy-related news items were observed:

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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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Precision and Imugene Agree on Terms for the Transfer of Azer-cel; Precision to Deprioritize its Cell Therapy Franchise

On Tuesday, August 15, Precision Biosciences announced (press release) a strategic transaction with Imugene for the exclusive WW licensing of azer-cel (PBCAR0191; allogeneic CD19 CAR-T) in oncology, which also included option to develop up to 3 other cancer programs. Additionally, Imugene disclosed (press release) its intention to continue azer-cel’s Ph1/2a trial in ≥3L NHL and r/r ALL, while planning the initiation of a potentially registrational trial in 2024. Below, Celltelligence provides insights on azer-cel’s transaction agreement, while analyzing the possible therapeutic potential of the combination of the licensed CD19 CAR-T with Imugene’s proprietary onCARlytics platform.

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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’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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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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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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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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