Tag Archives: Allogeneic

Different Strategies for Enhancing CAR-Ts to Treat Solid Tumors; Preclinical Results from Allogene’s ALLO-316; TCR2 Tx’s Allogeneic TRuC-T Platform; AACR 2022 Analysis 4

AACR 2022 Analysis 4: Several key cell therapy-related topics were discussed to overcome the challenges associated with utilizing CAR-Ts for solid tumors. Additionally, preclinical results were presented from Allogene and TCR2 Tx. Below, Celltelligence provides insights and context for each presentation. The following topics are covered below:

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How Engineered CAR-NK Cells Could Overcome Several Major Challenges Faced by CAR-Ts; Nkarta and CRISPR Tx Report Preclinical Data for Developing a CD70 CAR-NK and a NK:T Treatment; AACR 2022 Analysis 1

AACR 2022 Analysis 1: Several preclinical and clinical updates were presented describing potential strategies to overcome key hurdles associated with NK-based cell therapies. Below, Celltelligence provides insights and context for each presentation. The following topics are covered below:

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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 Chinese CAR-T Ambitions after Lilly CRL and ODAC

On March 24, Lilly announced that the FDA has issued a CRL for Sintilimab + Pemetrexed and Platinum Chemotherapy in 1L non-squamous NSCLC. The CRL stated that the review cycle is complete, but the FDA is unable to approve the application in its current form, which is consistent with the outcome from February’s ODAC meeting which voted 14-1 against approving Lilly-Innovent’s PD-1 inhibitor (Lilly press release here). Recall that Lilly submitted an application to the FDA using only one pivotal trial conducted entirely in China. Despite the widespread lead-up and adcom media coverage, very little analysis or implications came through the lens of cell therapy, specifically CAR-T products. Since China is the #2 geography for conducting CAR-T clinical trials after the US, the Celltelligence team provides some hot takes on what the CRL outcome may mean for Chinese cell therapy companies with Western ambitions.

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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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TCR2 Tx Submits Gavo-cel’s Protocol Amendment to the FDA; TC-510’s IND Filed in Q1 2022; TCR2 Tx Q4 2021 Earnings Release

On Tuesday, March 22, TCR2 Tx reported their Q4 2021 results (press release) highlighting gavo-cel’s (TC-210; autologous mesothelin TRuC-T) protocol amendment and TC-510’s (gavo-cel + PD-1 x CD28 switch; autologous mesothelin TRuC-T) IND filing to the FDA. Furthermore, management provided preclinical updates for TC-520 (CD70 TRuC-T + IL-15 enhancement) and their allogeneic program. Below, Celltelligence provides insights on how TCR2 Tx could reprioritize their mesothelin TRuC-T franchise while discussing the company’s allogeneic program.  

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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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Legend Achieves Two Major Milestone Payments for Carvykti

On Friday, February 11, Legend announced that they have achieved two milestones under their collaboration with JNJ for the development of Carvykti (cilta-cel; BCMA CAR-T), resulting in an aggregate payment of $50M to Legend. Below, Celltelligence guesses which milestones the payments could be related to.

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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 Appoints Bing Wang as Chief Financial Officer

On Thursday, February 10, Cellectis announced (press release) the appointment of Bing Wang as Chief Financial Officer. Below, Celltelligence provides insights on how Cellectis could leverage Wang’s vast financial experience.

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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 Remains Confident on TALEN Editing Safety; UCART22 Clinical Updates Anticipated at ASH 2021; UCARTMESO on Track to Enter the Clinic in 2022; 2seventy Provides Further Insights on Their Business Separation; Cellectis Q3 2021 Earnings Call Summary

On Friday, November 5, Cellectis held their Q3 2021 earnings call (press release) highlighting UCART22’s (allogeneic CD22 CAR-T) Ph1 BALLI-01 trial update at ASH 2021 and a preclinical data presentation for UCARTMESO (allogeneic mesothelin CAR-T) at SITC 2021. Furthermore, Cellectis discussed Allogene’s recent clinical hold, and provided an update on their manufacturing facilities in Paris, France, and Raleigh, NC. On the same day, bluebird bio announced their Q3 2021 earnings (press release) highlighting 2seventy’s successful business separation. Moreover, on Thursday, November 4, 2seventy bio (press release) provided additional guidance covering clinical updates and manufacturing capabilities.

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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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When Will the FDA Lift Allogene’s Clinical Hold on AlloCAR-T Programs? Allogene to Present Major Clinical Updates at ASH 2021; Could ALLO-501A’s Pivotal Trial Include Consolidation Dosing? Allogene Q3 2021 Earnings Call Summary

On Thursday, November 4, Allogene held their Q3 2021 earnings call (press release) highlighting their interactions with the FDA to resolve the clinical hold on their AlloCAR-T clinical programs and preparation for ALLO-501A’s (allogeneic CD19 CAR-T) pivotal trial. Moreover, management outlined the clinical data expected from their CD19 and BCMA CAR-T programs at ASH 2021. Below, Celltelligence will discuss Allogene’s clinical hold and the potential impact to their joint venture with Overland Pharma, while providing insights on the likelihood of ALLO-501A’s pivotal trial, including consolidation dosing.

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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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Takeda to Acquire GammaDelta Tx; Will Gilead (Kite) Pursue Gadeta?

On Wednesday, October 27, Takeda announced (press release) that they aim to fully acquire GammaDelta Therapeutics during Q1 2022 of Takeda’s fiscal year. Below, Celltelligence provides insights on why Takeda’s acquisition of GammaDelta Tx makes sense, while discussing whether Gilead (Kite) could prioritize acquiring Gadeta.

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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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Autolus Confirms Obe-cel’s Ph1b/2 FELIX Trial Readout in 2022; Could Obe-cel be Approved by Early 2023? Yescarta Gains Reimbursement Approval in Australia and Gilead (Kite) Continues Expanding to Novel Cell Platforms with Appia Bio’s Collaboration; Autolus Q2 2021 Earnings Call Summary

On Thursday, August 5, Autolus held their Q2 2021 earnings call (press release / presentation) highlighting that obe-cel’s (CD19 CAR-T) Ph1b/2 FELIX study in r/r ALL readout is on track for 2022. On the same day, Gilead (Kite) announced Yescarta’s (CD19 CAR-T) reimbursement approval in Australia (press release) and a collaboration with Appia Bio for the development of CAR invariant natural killer T (CAR-iNKT) cells for hematological malignancies (press release).

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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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