Category Archives: Topics

Allogene Doses First Patients With ALLO-316 (CD70 CAR-T) and Presents Novel TurboCARs for Solid Tumors; bluebird’s Oncology Newco Renamed as 2seventy bio; Allogene and bluebird bio Q1 2021 Earnings Call Summaries

On Wednesday, May 5, Allogene held their Q1 2021 earnings call (press release) highlighting the initiation of ALLO-316’s Ph1 TRAVERSE trial in renal cell carcinoma (RCC) and provided several updates across their CAR-T programs. On the same day, bluebird bio reported their Q1 2021 results (press release) and confirmed that the oncology Newco will be called 2seventy while highlighting Abecma’s FDA approval in ≥5L MM. Below, Celltelligence provides insights on how Allogene may strategically advance their CAR-T programs while discussing Allogene’s growing potential in the solid tumor setting with their TurboCAR platform. Furthermore, Celltelligence will discuss 2seventy bio’s corporate structure while commenting on Abecma’s potential EU approval timeline.

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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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ACGT Summit Round-Up: Strategies to Overcome the Challenges of Solid Tumor Targeting

During the Alliance for Cancer Gene Therapy (ACGT) Summit 2021 on April 29, three key cell therapy related topics were discussed to overcome the challenges associated with the solid tumor microenvironment (TME):

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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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GILD: Q1 2021 Earnings Call Summary; JNJ: Cilta-cel MAA Submitted

On Thursday, April 29, Gilead held their Q1 2021 earnings call (press release / presentation), highlighting the rapid recovery of their cell therapy sales revenue, while discontinuing several Yescarta and Tecartus programs. Furthermore, on Friday, April 30, JNJ announced (press release) cilta-cel’s (BCMA CAR-T) MAA submission to the EMA for r/r multiple myeloma (MM). Below, Celltelligence provides insights on how Gilead may leverage Yescarta’s European expansion to recover and grow market share, while discussing cilta-cel’s potential EU approval timelines.

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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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BMY: Q1 2021 Earnings Call Summary

On Thursday, April 29, BMS held their Q1 2021 earnings call (press release / presentation), highlighting the rapid onboarding of ATCs for Breyanzi (CD19 CAR-T) and Abecma (BCMA CAR-T) in the US. Below, Celltelligence provides insights on how BMS may leverage Breyanzi and Abecma onboarding as a package for centers hesitant to offer a third CD19 CAR-T.

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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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Kymriah’s Sales Continue to Grow; Novartis Q1 2021 Earnings Call Summary

On Tuesday, April 27, Novartis held their Q1 2021 earnings presentation (press release / presentation) highlighting Kymriah’s continued growth. Of note, no major clinical or regulatory updates were reported. Below, Celltelligence provides its latest US ATC count and insights on how Novartis’s expanding ATC footprint could have facilitated Kymriah’s continued sales growth compared to key competitor Gilead (Kite).

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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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Thoughts on BMS’s New Abecma Ph1/2 KarMMa-7 Basket Combination Trial

On Thursday, April 22, a new Abecma (BCMA CAR-T) Ph1/2 combinational trial (KarMMa-7) for the treatment of r/r MM was observed on CT.gov. Below, Celltelligence provides insights on how BMS could strategically leverage the Ph1/2 KarMMa-7 trial to improve Abecma’s efficacy while investigating several fully owned compounds to disrupt the current SOC regimens for r/r MM.

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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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BMS Announces New EU Manufacturing Site in the Netherlands; AUTO4 (TRBC1 CAR-T) Receives Innovation Passport and ILAP Designation; Allogene’s ALLO-715 Receives RMAT Designation by the FDA; No Major Updates in April’s CHMP Agenda

On Thursday, April 22, BMS announced (press release) that they plan to build a new cell therapy manufacturing site in Europe. Furthermore, Autolus confirmed (press release) that the UK Medicines and Healthcare products Regulatory Agency (MHRA) granted AUTO4 an Innovation Passport and entry into the Innovative Licensing and Access Pathway (ILAP) evaluating the TRBC1-targeting CAR-T in a Ph1/2 trial for peripheral T cell lymphoma (PTCL). Allogene announced (press release) that the FDA granted a Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-715 (BCMA CAR-T) for the Ph1 UNIVERSAL trial in r/r MM. Finally, no major regulatory updates were observed for Abecma, Breyanzi, or cilta-cel from this week’s April CHMP Agenda (publication). Below, Celltelligence provides insights into BMS’s potential manufacturing strategy in Europe. Moreover, Celltelligence will provide thoughts on AUTO4’s ILAP designation and how this may accelerate approvals compared to the EMA’s PRIME designation, while discussing ALLO-715’s RMAT designation.

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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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Yescarta Reimbursement in Japan Matched to Kymriah’s Latest Price Adjustment; Will Breyanzi be Priced Similarly?

On Wednesday, April 21, Japan’s Ministry of Health, Labor, and Welfare (MHLW) listed Yescarta (Gilead) in the NHI’s reimbursement price list (press release, PharmaJapan, Apr 2021). Below, Celltelligence provides thoughts on Japan’s pricing for Yescarta and Kymriah and how this could impact Breyanzi’s (BMS) reimbursement discussions.

About The Author

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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Humanigen Cancels Collaboration with Gilead (Kite) to Test Lenzilumab with Other Commercial CD19 CAR-Ts; FDA Accepts Allogene’s TurboCAR ALLO-605 (BCMA CAR-T) IND; First Patient Dosed with Ziopharm’s RPM CD19 CAR-T in Taiwan; No Regulatory Updates for Cilta-cel in JNJ’s Q1 2021 Earnings Call

A series of cell therapy-related news items have been 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 Regains Control of Their Allogeneic CAR-T Pipeline and Shifts Focus to their Stealth Cell Program; Alan List Joins Precision as CMO

On Thursday, April 15, Precision BioSciences announced (press release / presentation) that they have entered into a Program Purchase Agreement to reacquire all global rights for their allogeneic CAR-T program. Furthermore, Alan List was appointed (press release) as the company’s new Chief Medical Officer (CMO) and a member of the senior leadership team. Below, Celltelligence provides insights on Precision’s decision to fully control their allogeneic pipeline and how Precision’s new senior leadership could potentially accelerate stealth cell clinical development.

About The Author

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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