Category Archives: Uncategorized

Will Tecartus Receive a Positive CHMP Opinion for R/R Adult ALL This Week? Cilta-cel Remains on Track for a November 2021 Opinion; No Mention of Breyanzi or Yescarta in September’s CHMP Agenda

On Monday, September 13, the CHMP agenda for September was released. Of note, Tecartus’s (Gilead’s CD19 CAR-T) Type II Variation for r/r adult ALL is listed as ‘For Adoption’, while cilta-cel (JNJ / Legend’s BCMA CAR-T) appears under the ‘List of Questions (LoQ)’ section. No updates were observed for Breyanzi (BMS’s CD19 CAR-T) in DLBCL or Yescarta (Gilead’s CD19 CAR-T) in FL. Below, Celltelligence provides likely EU approval timelines for Tecartus and cilta-cel.

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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

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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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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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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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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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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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Cellectis’s First Solid Tumor CAR-T Advancing to the Clinic; Raleigh GMP Facility on Track to Start Production by YE 2021; Cellectis Q2 2021 Earnings Call Summary

On Friday, August 6, Cellectis held their Q2 2021 earnings call (press release) highlighting that their novel UCART programs, UCART20x22 (CD20 x CD22 CAR-T) and UCARTMESO (mesothelin CAR-T), are anticipated to enter the clinic in 2022. Furthermore, Cellectis confirmed that their GMP manufacturing facility in Raleigh is expected to begin production by YE 2021. Below, Celltelligence provides insights on Cellectis’s clinical program progress while discussing how their fully in-house production approach may minimize potential manufacturing backlogs due to viral vector shortage.

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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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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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ALLO-501A Pivotal Trial on Track to Start by YE 2021; Allogene Prepares for Clinical Manufacturing; Allogene Q2 2021 Earnings Call Summary

On Wednesday, August 4, Allogene held their Q2 2021 earnings call (press release) highlighting clinical updates for their CD19 and BCMA CAR-T programs, and confirmed their plans to initiate cGMP manufacturing in their new Cell Forge 1 facility by YE 2021. Below, Celltelligence will discuss Allogene’s pipeline updates while providing thoughts on how the company may be preparing for ALLO-501A’s potential regulatory 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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New Legend Ph1 Trial for LCAR-T2C (CD4 CAR-T) in R/R T Cell Lymphoma Posted

On Thursday, July 22, a new Legend-sponsored Ph1 trial in China evaluating LCAR-T2C (CD4 CAR-T) for r/r T cell lymphoma (TCL) was observed on CT.gov. Below, Celltelligence provides details for this trial while discussing Legend’s CD4 CAR-T global clinical development, and how LCAR-T2C compares to Autolus’s AUTO4 program.

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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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