Category Archives: Autologous

Thoughts on Kymriah’s ≥3L r/r FL Approval in Japan; Could Kymriah’s Price Decrease? Novartis’s APAC Market Expansion Strategy

On Friday, August 26, Japan’s Ministry of Health Labour and Welfare (MHLW) approved Kymriah (Novartis’s CD19 CAR-T) for the treatment of r/r FL (press release). Below, Celltelligence provides insights on Kymriah’s potential pricing reduction in Japan, while discussing Novartis’s cell therapy expansion in the APAC market.

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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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Gracell’s GC012F IND Submission Plans; Ph2 Portion of GC007 Trial to Start in Q3 2022; Gracell’s Q2 2022 Earnings Call Summary

On Monday, August 15, Gracell held their Q2 2022 earnings call (press release / presentation) highlighting GC012F’s (autologous BCMAxCD19 FasTCAR-T) IND filing plans both in the US and China, while updating clinical milestones for both TruUCAR and SMART CAR-T platforms. Below, Celltelligence provides insights on regulatory updates for GC012F in r/r MM and the potential delay in the GC027 trial (allogeneic CD7 TruUCAR-T) for r/r T-ALL patients.

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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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No Cell Therapy-Related Updates in August’s CHMP Agenda

On Tuesday, August 16, the CHMP agenda for August was released. As previously anticipated by the Celltelligence team, no cell therapy-related updates were observed. Recall that for the CHMP meetings from June and July 2022, the Celltelligence team prepared two full analyses providing the following EC approval timelines for Breyanzi (BMS’s CD19 CAR-T) and Yescarta (Gilead / Kite’s CD19 CAR-T):

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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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P-PSMA-101 Clinical Program Delayed; Poseida’s Global Collaboration with Roche; Poseida Q2 2022 Earnings Summary

On Thursday, August 11, 2022, Poseida released their Q2 2022 results (press release) highlighting anticipated clinical updates for H2 2022 and the recent partnership with Roche. Below, Celltelligence provides insights on a potential delay for Poseida’s P-PSMA-101 (autologous PSMA CAR-T) program, while discussing Poseida’s partnering strategy.

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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’s Ph3 KarMMa-3 Trial Meets Primary Endpoint; Potential Delays for bbT369 and SC-DARIC33; 2seventy bio Q2 2022 Earnings Call Summary

On Wednesday, August 10, 2seventy bio held their Q2 2022 earnings call (press release) highlighting positive topline results from Abecma’s (autologous BCMA CAR-T) Ph3 KarMMA-3 trial in ≥3L MM. Additionally, management provided updated data readouts for bbT369 (autologous CD20xCD79a dual CAR-T) and SC-DARIC33 (autologous CD33 CAR-T). Below, Celltelligence provides insights on Abecma’s LCM initiatives, while discussing potential clinical delays for bbT369 and SC-DARIC33.

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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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BMS Reports Positive Topline Results From Abecma’s Ph3 KarMMa-3 Trial for ≥3L MM vs SoC: Will Abecma be the First Approved CAR-T in ≥3L MM?

On Wednesday, August 10, BMS and 2seventy bio reported positive topline results from Abecma’s (BCMA CAR-T) Ph3 KarMMa-3 trial in ≥3L MM (press release). Below, Celltelligence provides insights on how Abecma’s potential approval timeline in ≥3L MM compares with key competitor Carvykti (JNJ / Legend’s BCMA CAR-T).

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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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Data Updates from Gavo-cel and TC-510 in H2 2022; TCR2 Tx Expands Its Manufacturing Capacity; TCR2 Tx Q2 2022 Earnings Call Summary

On Monday, August 8, TCR2 Tx released their Q2 2022 financial results and corporate updates (press release), highlighting anticipated data readouts from gavo-cel (autologous mesothelin TRuC-T) and TC-510 (autologous mesothelin TRuC-T with PD-1:CD28 switch) in H2 2022. Additionally, management noted the expansion of their manufacturing capacity at ElevateBio Basecamp. Below, Celltelligence provides insights on TCR2 Tx’s anticipated clinical milestones, while discussing the company’s manufacturing capacity expansion.

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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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Obe-cel’s Data Update Expected in Q4 2022; Afami-cel’s BLA Remains on Track for Q4 2022; Adaptimmune to Slow Down ADP-A2M4N7X19’s Development; Autolus and Adaptimmune Q2 2022 Earnings Summaries

On Thursday, August 4, Autolus held their Q2 2022 earnings call (press release / presentation) highlighting that initial data from obe-cel’s (CD19 CAR-T) Ph2 FELIX trial will be reported in Q4 2022. Additionally, multiple data updates from AUTO1/22 (CD19 x CD22 CAR-T) and AUTO4 (TRBC1 CAR-T) are expected at ASH 2022. On the same day, Adaptimmune reported their Q2 2022 financial results (press release) confirming afami-cel’s (MAGE-A4 SPEAR-T) anticipated BLA filing in Q4 2022, and a delayed IND submission for ADP-A2M4N7X19 (next-generation MAGE-A4 SPEAR-T). Below, Celltelligence provides insights on obe-cel’s potential approval, while discussing afami-cel’s BLA filing.

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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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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

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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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You May Have Missed: Are Cell Therapy Leaders Losing Their Innovative Edge?

During July, the Celltelligence team published a six-part series discussing the pipeline, manufacturing technology, and novel platforms from Novartis, BMS, and 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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