Category Archives: CAR-T

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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bluebird & 2seventy to Split in October; Marcela Maus Appointed to 2seventy’s Board of Directors; bluebird Receives $75M in Private Equity Financing Before Separation

On Tuesday, September 7, bluebird bio announced (press release) that the separation of their oncology business (2seventy bio) is anticipated to occur in mid-October 2021. Additionally, bluebird appointed Marcela Maus to their Board of Directors. Upon the separation of the two companies, Maus will transition to 2seventy’s Board of Directors. Furthermore, on Wednesday, September 8, bluebird announced (press release) that they have secured an additional $75M in private placement equity financing. Below, Celltelligence provides insights on bluebird’s decision to split into two companies, while discussing how Maus could help 2seventy achieve their clinical development goals.

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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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JW Tx’s Relma-cel (JWCAR029; CD19 CAR-T) Approved in China as Benoda for ≥3L R/R LBCL

On Friday, September 3, the Chinese NMPA announced (press release) the approval of JW Therapeutic’s relma-cel (relmacabtagene autoleucel / JWCAR029; CD19 CAR-T) in ≥3L r/r LBCL. Of note, relma-cel will be commercialized under the brand name Benoda. Below, Celltelligence provides insights on potential reimbursement hurdles JW Tx may face in China, while discussing Kymriah’s (Novartis’s CD19 CAR-T) delayed Chinese approval.

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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 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

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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

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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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UPDATED: Indications Table for CD19 CAR-T US Approvals and Submissions

New content: The Celltelligence team has updated their CD19 CAR-T indications table for estimated US approvals and submissions following key Q2 2021 earnings presentations and recent press releases (see below for download).

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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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Novartis’s Ph3 BELINDA Trial Fails in 2L NHL; All Eyes on 2L Positive Data for Yescarta and Breyanzi

On Tuesday, August 24, Novartis announced (press release) an update on Kymriah’s (CD19 CAR-T) Ph3 BELINDA trial in 2L NHL. Of note, the BELINDA study did not meet its primary endpoint (EFS) compared to the standard of care (SoC). Below, Celltelligence provides insights on how Novartis could use this opportunity to accelerate Kymriah’s indication in r/r FL, while prioritizing their more novel next-generation CAR-T programs.

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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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Cilta-cel’s Review Progresses in the US and EU; Legend Continues Expanding their CARTITUDE Program; Legend Q2 2021 Earnings Call Summary

On Monday, August 23, Legend released their Q2 2021 results (press release) highlighting the initiation of cilta-cel’s (BCMA CAR-T) review processes for r/r MM in the US and Europe. Furthermore, management noted the expansion of the CARTITUDE program with the initiation of a Ph3 CARTITUDE-5 trial for newly diagnosed MM (NNMM) patients. Below, Celltelligence provides insights on likely US and EU approvals for cilta-cel, while commenting on Legend’s aggressive strategy to move cilta-cel into earlier lines of therapy.

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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 Accepts Gilead’s KITE-363 (CD19 x CD20 CAR-T) IND in LBCL

On Thursday, August 19, Gilead (Kite) announced (press release) that the FDA has accepted the IND for KITE-363 (CD19 x CD20 CAR-T) in LBCL. Below, Celltelligence provides details on KITE-363’s IND application while discussing potential competition KITE-363 may face upon approval.

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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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