Category Archives: Uncategorized

Afami-cel’s BLA Filing on Track for 2022; Next-Gen MAGE-A4 SPEAR-T To Treat Ovarian Cancer; 2seventy Successfully Launched; Adaptimmune Q3 2021 Earnings Call Summary

On Thursday, November 4, Adaptimmune held their Q3 2021 earnings call (press release) highlighting that they are preparing the CMC documentation and analytical data for afami-cel’s (MAGE-A4 SPEAR-T; formerly ADP-A2M4) potential BLA filing in 2022. Furthermore, management announced a new ADP-A2M4CD8 (next-gen MAGE-A4 SPEAR-T) Ph2 SURPASS-3 trial in ovarian cancer and discussed the prioritization of ADP-A2M4CD8’s combination with pembrolizumab (PD1 inhibitor) over afami-cel. On the same day, bluebird bio announced (press release) the successful launch of 2Seventy bio.

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Autolus’s Obe-cel US Regulatory Filing Planned for Early 2023; BMS Invests in Clade Therapeutics; New Gracell CD19 UCAR-T Ph1 Trial in R/R B-ALL and B-NHL Posted; Autolus Q3 2021 Earnings Call Summary

On Wednesday, November 3, Autolus held their Q3 2021 earnings call (press release / presentation) highlighting updates from obe-cel (CD19 CAR-T; formerly AUTO1) and their next-generation candidates. On the same day, Clade Therapeutics announced (press release) that they have secured $87M in Series A financing with participation from BMS. Finally, a new Gracell early Ph1 trial evaluating an allogeneic CD19 UCAR-T in r/r B-ALL and B-NHL was observed on CT.gov.

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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’s Breyanzi and Abecma Sales Increase; Could Abecma’s Continued Viral Vector Shortage Favor Cilta-cel’s Upcoming Launch? No Updates on GSK’s Cell Therapy Assets; BMS and GSK Q3 2021 Earnings Call Summaries

On Wednesday, October 27, BMS held their Q3 2021 earnings presentation (press release / presentation) highlighting Breyanzi’s (CD19 CAR-T) and Abecma’s (BCMA CAR-T) continued revenue growth. Furthermore, management commented that Abecma’s vector supply issues may not be fully resolved before H2 2022. On the same day, GSK presented their Q3 2021 financial results (press release / presentation). However, the company did not provide any updates on their cell therapy assets in development.

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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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Takeda to Acquire GammaDelta Tx; Will Gilead (Kite) Pursue Gadeta?

On Wednesday, October 27, Takeda announced (press release) that they aim to fully acquire GammaDelta Therapeutics during Q1 2022 of Takeda’s fiscal year. Below, Celltelligence provides insights on why Takeda’s acquisition of GammaDelta Tx makes sense, while discussing whether Gilead (Kite) could prioritize acquiring Gadeta.

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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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Novartis Receives Priority Review for Kymriah in R/R FL

On Wednesday, October 27, Novartis announced (press release) that the FDA has granted Kymriah (CD19 CAR-T) Priority Review in r/r FL. Below, Celltelligence provides insights on Kymriah’s anticipated US approval in ≥3L r/r FL.

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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 Continue to Decline; Novartis Files Kymriah for R/R FL in the US and EU; Why is Novartis Prioritizing YTB323 in 2L DLBCL? Novartis Q3 2021 Earnings Call Summary

On Tuesday, October 26, Novartis held their Q3 2021 earnings presentation (press release / presentation) highlighting Kymriah’s (CD19 CAR-T) continued sales decline and the US + EU regulatory submissions for Kymriah in r/r FL. Of note, management announced that in 2022, they intend to initiate a registrational trial for YTB323 (next-gen CD19 CAR-T) in 2L r/r DLBCL. Below, Celltelligence provides insights on Kymriah’s Q3 2021 sales revenue, while discussing likely US and EU approval timelines for Kymriah in r/r FL. Finally, Celltelligence outlines why declining Kymriah revenue doesn’t matter for a committed Novartis.

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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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Thoughts on TCR2 Tx’s Collaboration With BMS

On Monday, October 25, TCR2 Therapeutics announced (press release) a clinical trial collaboration with BMS to evaluate gavo-cel (TC-210; mesothelin TRuC-T) with Opdivo (nivolumab; PD1 inhibitor) ± Yervoy (ipilimumab; CTLA-4 inhibitor) in a Ph2 trial for refractory mesothelin-expressing solid tumors. Below, Celltelligence provides insights on why TCR2 Tx may have chosen BMS’s checkpoint inhibitors and how BMS could leverage this collaboration for their own solid tumor programs.

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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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JNJ Prepares for Cilta-cel’s Upcoming Approval; Could JNJ’s / Legend’s New Patient-Focused Digital Platform and Sales Force Strategy Position Cilta-cel for a Successful Launch?

On Thursday, October 21, FiercePharma published an article (publication) discussing cilta-cel’s launch strategy with Serge Messerlian, Janssen’s US Oncology President. Messerlian commented on JNJ’s / Legend’s plan to develop a digital platform for cilta-cel (BCMA CAR-T) while confirming that cilta-cel and Darzalex (JNJ’s CD38 antibody for r/r MM; daratumumab) will have separate sales teams. Below, Celltelligence provides insights on how JNJ / Legend could leverage Darzalex’s patient-focused digital platform and sales force team to increase patient referrals for cilta-cel upon 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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TCR2 Tx Pivots Away from Liquid Tumors; Will Enhanced TRuC-Ts Improve Efficacy in Solid Tumors? TCR2 Tx Explores New Targets and Allogeneic Candidates; TCR2 Tx’s R&D Day

On Wednesday, October 20, TCR2 Therapeutics held an R&D Day (press release / presentation) highlighting the reprioritization of their pipeline to solely focus on solid tumors. Additionally, management reported updated safety data from gavo-cel’s (TC-210; mesothelin TRuC-T) Ph1/2 trial and additional details on the design of the Ph2 portion. TCR2 Tx presented their strategy for TRuC-T enhancements, new targets in development, and their allogeneic program. Finally, on Tuesday, October 19, a change in TCR2 Tx’s website and logo was observed.

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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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Cilta-cel on Track to Gain FDA Approval in Q4 2021; JNJ Q3 2021 Earnings Call Summary

On Tuesday, October 19, JNJ held their Q3 2021 earnings presentation (press release / presentation) highlighting cilta-cel’s (BCMA CAR-T) anticipated FDA approval by YE 2021. Below, Celltelligence provides insights on cilta-cel’s potential US and EU regulatory timelines.

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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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