Tag Archives: Autologous

Could Abecma and Carvykti Be Approved in January 2024? Obe-cel MAA Could Happen in Q1 2024; December CHMP Highlights

On Friday, December 15, the CHMP meeting highlights were released. Of note, Carvykti (JNJ / Legend’s BCMA CAR-T) was absent from the CHMP highlights, implying that the Type II Variation (T2V) for its approval in ≥2L MM has received a second Request for Supplementary Information (RSI). Moreover, recall that the Abecma (BMS / 2seventy’s BCMA CAR-T) T2V in ≥3L MM was not included on Monday’s CHMP agenda. Below, Celltelligence provides insights on the December CHMP meeting with updated EU timelines for both cell therapies, while discussing the possible timeline for obe-cel accelerated assessment. 

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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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Anito-cel Elicits Improved Responses Across HR Subgroups; Gracell’s GC012F Shows Best-In-Class Safety and Efficacy Profiles; Increased Lymphodepleting Dose Enhances P-BCMA-ALLO1’s Responses Significantly; ASH 2023 Analysis 6

ASH 2023 Analysis 6: Arcellx, Gracell, and Poseida presented updated clinical data about their cell therapies in multiple myeloma. Below, Celltelligence provides insights and context for key selected presentations. The following topics are covered below: 

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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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Abecma T2V Receives a Second RSI; When Could Abecma and Carvykti Receive a Positive CHMP Opinion? November CHMP Highlights

On Friday, November 10, the CHMP meeting highlights were released. Of note, Abecma (BMS’s BCMA CAR-T) was absent from the CHMP highlights, implying that it has received a second Request for Supplementary Information (RSI) for its approval in ≥3L MM. Moreover, recall that the Carvykti (JNJ’s / Legend’s BCMA CAR-T) T2V in ≥2L MM was not included on Monday’s CHMP Agenda. Below, Celltelligence provides insights on the November CHMP meeting with updated EU timelines for both cell therapies.

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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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GC012F Achieves 100% sCR in Chinese IIT for NDMM; First R/R MM Patient Dosed with GC012F in the US; AbbVie Terminates Agreement with Caribou

Gracell presented clinical updates of the ongoing GC012F’s (BCMA x CD19 FasTCAR-T) Ph1 IIT in high-risk (HR) transplant-eligible (TE) NDMM patients in China at the International Myeloma Society (IMS) Annual Meeting 2023 (press release). Moreover, on Tuesday, September 26, the company disclosed the dosing of the first patient in the Ph1b/2 trial evaluating GC012F in ≥4L MM in the US (press release). On the same day, Caribou reported AbbVie’s decision to terminate the collaboration agreement for the development of allogeneic cell therapy candidates (Form 8-K). Below, Celltelligence provides insights on GC012F’s clinical development while discussing the impact that the termination of the collaboration may have on Caribou and AbbVie.

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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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AMT Designation Program and CDRP Pilot to Facilitate CMC Development of Products; ASGCT 2023 Policy Summit Analysis (Blast 2/2)

ASGCT 2023 Policy Summit Analysis 2: CMC information plays a fundamental role in the development and regulation of cell and gene therapies (CGTs), which has motivated the generation of new policies to facilitate and expedite its evaluation. Celltelligence is publishing a two-part series discussing the strategies the FDA is following to keep up with innovation in the CGT field and providing insights about their relevance in the cell therapy space. In this second blast, 2 new non-CGT-specific FDA policy initiatives focused on addressing CMC challenges are covered:

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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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Carvykti’s Type II Variation Application Submitted to the EMA; Carvykti’s Submission to the FDA Planned; Could Carvykti be First Approved for ≥2L MM in Europe Ahead of the US?

On Thursday, May 25, Legend announced (press release) that a Type II Variation (T2V) application was submitted to the EMA for Carvykti’s (BCMA CAR-T) use in ≥2L MM patients. Below, Celltelligence provides insights on Carvykti’s regulatory timelines to gain a label extension for this setting in Europe, while discussing its to-date absent filing with the FDA.

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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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Abecma and Breyanzi Sales Accelerate; Initiation of CAR-T Program in Immunology; Vector Manufacturing Facility Acquisition; Leadership Transition Plan; BMS’s Q1 2023 Earnings Call Summary

On Thursday, April 27, BMS held its Q1 2023 earnings call (press release / presentation) highlighting significant revenue increase from both Abecma (BCMA CAR-T) and Breyanzi (CD19 CAR-T). Importantly, BMS disclosed its intention to initiate a Ph1 trial evaluating CD19 NEX-T CAR-T in severe refractory systemic lupus erythematosus (SLE). Additionally, on Wednesday, April 26, BMS announced that Giovanni Caforio, CEO and Chairman of the Board will retire on November 1, 2023 (press release). Finally, on the same day, BMS reported the acquisition of Novartis’s in-house viral vector production facility at Libertyville, Illinois, US (press release). Below, Celltelligence provides insights on how Abecma and Breyanzi sales compare to key competitors while discussing the main clinical milestones achieved by BMS’s marketed assets and its intention to enter the autoimmune field.

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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 Carvykti’s CARTITUDE-4 Meeting Its Primary Endpoint in 2 – 4L MM

On Friday, January 27, JNJ and Legend reported (JNJ’s press release; Legend’s press release) positive topline results from Carvykti’s (BCMA CAR-T) Ph3 CARTITUDE-4 trial in 2 – 4L MM. Below, Celltelligence provides insights on how Carvykti’s potential approval timeline in r/r MM compares with key competitor Abecma (BMS / 2seventy’s BCMA CAR-T), while discussing JNJ / Legend’s difficulties in delivering Carvykti to patients.

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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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Breyanzi Meets Primary Endpoint in Pivotal Trial for R/R CLL

On Thursday, January 26, BMS announced (press release) that Breyanzi (CD19 CAR-T) has met its primary endpoint (CR) in the Ph1/2 TRANSCEND CLL 004 trial for patients with ≥3L CLL / SLL. Below, Celltelligence provides insights on Breyanzi’s market opportunity for CLL, while discussing potential approval timelines in the US.

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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 Gilead’s Acquisition of Tmunity

On Tuesday, December 20, 2022, Gilead (Kite) announced (press release) the acquisition of Tmunity Therapeutics. As part of the transaction, Gilead will continue Tmunity’s strategic research and licensing agreement with UPenn. Below, Celltelligence provides insights on the acquisition, while discussing Gilead’s potential strategy when it comes to solid tumors.

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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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