Category Archives: Allogeneic

Allogene’s AlloCAR-T Programs Placed on Clinical Hold by the FDA

On Thursday, October 7, Allogene announced (press release) that the FDA has placed a clinical hold on all of Allogene’s AlloCAR-T trials, with the company providing additional insights via a webcast. Of note, the FDA ordered the clinical hold following a reported chromosomal abnormality event from a patient treated with ALLO-501A (allogeneic CD19 CAR-T) in the Ph1/2 ALPHA-2 study for r/r LBCL. Additionally, on Friday, October 8, Precision BioSciences released a statement (press release) highlighting the safety of their allogeneic CAR-T approach. Below, Celltelligence provides insights on the potential impact of the clinical hold, while discussing how other companies developing gene-edited allogeneic therapies could be affected.

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Thoughts On the Evolution of the Cell Therapy Landscape; Will Traditional αβ CAR-T Cells be Replaced by Novel Cell Types?

Although cell therapy companies have traditionally used alpha beta (αβ) T cells to manufacture CAR-T therapies, the cell therapy field is rapidly evolving with an increasing number of companies developing novel and highly differentiated platforms. Below, Celltelligence discusses how CAR-derived therapies from natural killer (NK) cells, gamma delta (γδ) T cells, macrophages, and iPSCs could treat liquid or solid tumors and whether these novel cell types may overcome the challenges and limitations faced by conventional CAR-Ts.

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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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Precision Appoints Michael Amoroso as Their New CEO

On Monday, September 27, Precision BioSciences announced (press release) the appointment of Michael Amoroso as the company’s President, Chief Executive Officer (CEO), and member of the Board of Directors, all effective October 15, 2021. Below, Celltelligence provides insights on how Amoroso could lead Precision through their next phase of growth.

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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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Adaptimmune’s Novel Gene Editing Approach; Do iPSC-derived αβT Cells Have an Advantage Over NK Cells? Thoughts on Adaptimmune’s Allogeneic Platform Virtual Event 2021

On Thursday, September 9, Adaptimmune held a virtual event (presentation) discussing the scope of their recent Genentech (Roche) collaboration. Additionally, management highlighted Adaptimmune’s strategy to knockout recombination-activating gene (RAG) in order to eliminate native TCR expression, while announcing the completion of a new allogeneic manufacturing facility by YE 2022 in Milton Park, UK. Below, Celltelligence provides insights on how Adaptimmune’s collaboration with Genentech (Roche) could potentially impact GSK’s TCR-T strategy, Adaptimmune’s decision to develop iPSC-derived αβT cells, and which alternative lymphodepletion regimens could be used for their allogeneic products.

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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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Adaptimmune Discusses Novel Engineering and Lymphodepleting Regimens During Their Allogeneic Platform Virtual Event 2021

On Thursday, September 9, Adaptimmune held a virtual event discussing their allogeneic platform (presentation). Although no significant updates were provided relating to the Genentech partnership, management discussed the overall scope and financial terms of the deal over two slides (see below).

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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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Adaptimmune Partners With Genentech to Develop iPSC-derived Allogeneic TCR-Ts

On Tuesday, September 7, Adaptimmune announced (press release) a strategic collaboration and license agreement with Genentech (Roche) to develop and commercialize allogeneic T cell therapies for multiple oncology indications. Of note, Adaptimmune will receive $150M upfront and further milestone payments potentially exceeding $3B in aggregate value. Below, Celltelligence provides insights on how Genentech (Roche) could leverage their extensive capabilities to quickly advance allogeneic TCR-Ts into the clinic, while discussing Adaptimmune’s strategy to become a leader in the allogeneic TCR-T space.

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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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Precision Partners With Tiziana for the Use of Foralumab as a Novel Lymphodepletion Agent; How Could an Anti-CD3 Antibody Improve CAR-T Efficacy? TCR2 Tx’s Gavo-cel Receives Orphan Drug Designation

On Thursday, September 2, Precision BioSciences announced (press release) an exclusive license agreement with Tiziana to evaluate foralumab (anti-CD3 monoclonal antibody) as a lymphodepletion (LD) agent for their allogeneic CAR-T therapies. On the same day, TCR2 Tx reported (press release) that the FDA has granted gavo-cel (mesothelin-targeted TRuC-T) Orphan Drug Designation (ODD) for the treatment of cholangiocarcinoma. Below, Celltelligence provides insights on how a foralumab LD regimen could enhance allogeneic CAR-T efficacy, while discussing gavo-cel’s ODD in cholangiocarcinoma.  

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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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Preliminary Results from Poseida’s P-PSMA-101 (PSMA CAR-T) Ph1 Trial in mCRPC; FDA Accepts Poseida’s P-BCMA-ALLO1 (Allogeneic BCMA CAR-T) IND in R/R MM

On Tuesday, August 31, Poseida presented (press release / webcast) preliminary results from P-PSMA-101’s (PSMA CAR-T) Ph1 trial in metastatic castration-resistant prostate cancer (mCRPC). Additionally, on Monday, August 30, Poseida announced (press release) that the FDA has accepted an IND application for P-BCMA-ALLO1 (allogeneic BCMA CAR-T) in r/r MM. Below, Celltelligence provides insights on how Poseida’s novel technology may be a key differentiating factor for the successful development of P-PSMA-101, while discussing Poseida’s position in the race to develop an allogeneic BCMA CAR-T for r/r MM.

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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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New JNJ KLK2 CAR-T (JNJ-75229414) Ph1 Trial in mCRPC Posted; Priti Hegde Joins TCR2 Tx’s Board of Directors

On Thursday, August 26, a new Janssen-sponsored Ph1 trial evaluating JNJ-75229414 (KLK2 CAR-T) in metastatic castration-resistant prostate cancer (mCRPC) was observed on CT.gov. On the same day, TCR2 Tx announced (press release) the appointment of Priti Hegde to its Board of Directors. Below, Celltelligence provides further details on JNJ-75229414’s clinical trial, the potential challenges JNJ (Janssen) may encounter targeting a solid tumor indication, how a CAR-T product could fit into JNJ’s prostate portfolio, and how Priti Hegde’s appointment could accelerate TCR2 Tx’s development of TRuC-T cells.

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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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Precision BioSciences Provides No Major Clinical Updates; Precision Q2 2021 Earnings Call Summary

On Thursday, August 12, Precision BioSciences reported their Q2 2021 results (press release) highlighting data presented at ASCO 2021 from PBCAR0191’s Ph1/2a trial in r/r NHL and ALL. Furthermore, management confirmed the dosing of the first patient in both PBCAR19B (stealth CD19 CAR-T) and PBCAR269A (BCMA CAR-T) programs. Below, Celltelligence provides details on Precision’s upcoming milestones.

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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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