Tag Archives: Manufacturing

Gilead Reports Outstanding Cell Therapy Revenue Growth; Yescarta’s Manufacturing Capacity Scaled to Address Demand; Updated Regulatory Milestones for Yescarta and Tecartus in the EU; Gilead’s Q2 2022 Earnings Call Summary

On Tuesday, August 2, Gilead (Kite) held their Q2 2022 earnings call (press release / presentation) highlighting an increase in revenue for their cell therapy franchise, while discussing EU regulatory milestones for Yescarta and Tecartus (CD19 CAR-Ts). Below, Celltelligence provides insights on Gilead’s cell therapy revenue increase, while discussing how Gilead’s manufacturing strategy could accommodate Yescarta’s expected increase in demand.

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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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Are Cell Therapy Leaders Losing Their Innovative Edge? Spotlight on Gilead (Blast 6/6)

As the cell therapy field continues to grow and evolve, companies are developing innovative strategies to overcome the current challenges that the field is facing. In our Spotlight blasts 1-2 and 3-4, the Celltelligence team discussed Novartis’s and BMS’s pipeline, manufacturing technology, novel platforms, and potential strategy for maintaining an innovative clinical 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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Kymriah’s Sales Decline; PHE885 Pivotal Study Initiated; YTB323’s Anticipated Submission Delayed to 2025; Novartis’s Q1 2022 Earnings Call Summary

On Tuesday, April 26, 2022, Novartis held their Q1 2022 earnings call (press release / presentation) highlighting a decline in Kymriah’s (CD19 CAR-T) sales. Additionally, management noted Kymriah’s positive CHMP opinion in ≥3L FL, PHE885’s (T-Charge BCMA CAR-T) Ph2 trial initiation in 4L MM, and YTB323’s (T-Charge CD19 CAR-T) delayed regulatory filing in 2L DLBCL. Below, Celltelligence provides insights on Kymriah’s Q1 2022 revenue, while discussing YTB323’s delayed submission.

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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’s Obe-cel Receives FDA RMAT Designation; JNJ / Legend Update Carvykti’s HCP Website

On Monday, April 25, 2022, Autolus announced (press release) that the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to obe-cel (AUTO1; autologous CD19 CAR-T) for adult r/r B-ALL. On the same day, Carvykti’s (JNJ / Legend’s autologous BCMA CAR-T) HCP website was updated to include onboarded treatment centers and additional product messaging (Carvykti HCP website). Below, Celltelligence provides insights on how RMAT designation may accelerate obe-cel’s regulatory pathway, while analyzing Carvykti’s updated HCP website.

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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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ALLO-501A Pivotal Trial on Track to Initiate in Mid-2022; Which BCMA Program Will Be Prioritized? New Registrational ALLO-647 Trial Anticipated for Mid-2022; Allogene Q4 2021 Earnings Call Summary

On Wednesday, February 23, Allogene held their Q4 2021 earnings call (press release) highlighting that their AlloCAR-T studies have resumed enrollment following the removal of the clinical hold in January 2022. Furthermore, Allogene confirmed that ALLO-501A’s pivotal trial is anticipated to start by mid-2022, and the company is preparing CMC data for the BLA submission. Below, Celltelligence provides insights on Allogene’s upcoming clinical updates while discussing how Allogene’s preparation of CMC data could position the company for a successful regulatory review.

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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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Will 2seventy’s Novel Pipeline Assets be Innovative Enough? 2seventy’s Research Deep Dive Investor Event Summary

On September 21 – 22, 2seventy bio (bluebird bio’s oncology business) held two Research Deep Dive sessions (Day 1 presentation / Day 2 presentation) detailing their novel pipeline assets across liquid and solid tumors. Below, Celltelligence provides insights on how 2seventy’s novel assets compare with key competitors, while discussing innovative manufacturing options for 2seventy.

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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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JNJ / Legend Announce a New EU Manufacturing Site in Belgium

On Tuesday, June 22, JNJ (press release) and Legend (press release / presentation) announced the establishment of a state-of-the-art manufacturing facility in Ghent, Belgium. Of note, the new manufacturing site could become a key pillar for JNJ / Legend’s global collaboration to develop and commercialize cilta-cel (BCMA CAR-T). Below, Celltelligence provides insights into JNJ / Legend’s potential manufacturing strategy in Europe and how this compares to key competitor BMS.

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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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Autolus Pivots Manufacturing Away from the US; TCR2 Takes Over Autolus’s Rockville Facility; Is Confidence in AUTO1 Wavering?

On Monday, March 29, Autolus announced (press release) an update to their manufacturing strategy for the commercial supply of AUTO1 (CD19 CAR-T). Autolus aims to expand existing operations in the UK while terminating the lease for their US manufacturing facilities in Rockville, MD. Moreover, on the same day, TCR2 Therapeutics announced (press release) that they are seeking to accelerate commercial-scale manufacturing timelines by leasing a new manufacturing facility in Rockville, MD. Below, Celltelligence provides thoughts on Autolus’s manufacturing strategy, while contrasting Autolus’s possible headwinds with TCR2’s potential opportunities.

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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