Category Archives: Autologous

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.

About The Author

The Celltelligence Team

|
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.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

Encouraging Preclinical Data from ARI-0003, a New Academic Dual CAR-T for NHL; Can ARI-0003 Repeat the Success of ARI-0001? MiNK Tx Presented Preclinical Data of MiNK-215 in NSCLC; ASCGT 2023 Analysis 3

ASGCT 2023 Analysis 3: The Hospital Clinic of Barcelona presented preclinical data supporting the development of ARI-0003 (CD19 x BCMA CAR-T), its new academic cell therapy for the treatment of NHL patients. Moreover, MiNK Tx presented preclinical data of MiNK-215, the company’s FAP-targeting iNKT cell therapy. Bellow, Celltelligence provides insights and context for key selected presentations while discussing if ARI-0003 could replicate ARI-0001’s successful clinical development and point-of-care model.

About The Author

The Celltelligence Team

|
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.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

No Cell Therapy-Related Updates in May’s CHMP Agenda; Abecma Likely to Be Included in June’s Agenda

On Monday, May 22, the CHMP Agenda for May was released. Of note, Abecma’s (BMS’s BCMA CAR-T) Type II Variation (T2V) for ≥3L MM was absent from the agenda, and no other cell therapy-related updates were observed. Therefore, based on the agenda, no updates are expected on the CHMP highlights to be published on Friday, May 26.

About The Author

The Celltelligence Team

|
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.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

SC-DARIC33 Shows Promising Preliminary Clinical Results; 2seventy Bio Reveals Next-Generation AML Program; ASGCT 2023 Analysis 2

ASGCT 2023 Analysis 2: 2seventy bio presented preliminary clinical results of SC-DARIC33’s (autologous drug-regulated CD33 CAR-T) Ph1 PLAT-08 trial and several updates on preclinical assets at ASGCT. Moreover, on Friday, May 19, the company held a virtual R&D Deep Dive event further detailing the data presented at ASGCT 2023, disclosing the main features of its new AML asset 27T32 (next-generation autologous drug-regulated CD33 x CLL1 dual CAR-T) and confirming anticipated milestones for the rest of their pipeline assets (presentation). Below, Celltelligence provides insights on the potential advantage that drug-regulated activation could confer to SC-DARIC33 over other cell therapies in the AML space while commenting on the novel asset, 27T32, disclosed by the company.

About The Author

The Celltelligence Team

|
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.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

Ph1 TSCAN-001 Trial Shows Encouraging Preliminary Results; TScan to Initiate Trial in Solid Tumors in 2023; 8 IND Submissions Expected by YE 2024; Kelonia Presents Promising In Vivo CAR-T Preclinical Results; ASCGT 2023 Analysis 1

ASGCT 2023 Analysis 1: Tscan presented preliminary clinical data of the Ph1 TSCAN-001 trial while Kelonia presented preclinical results of its innovative in vivo CAR-T platform. Moreover, on May 17, TScan held a virtual ASGCT meeting further detailing their initial clinical results. Below, Celltelligence provides insights and context for key selected presentations. The following topics are covered:

About The Author

The Celltelligence Team

|
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.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

Legend to Present Multiple Updates at ASCO and EHA 2023; Legend to Use Raised Funding for Carvykti’s Development; Legend’s Q1 2023 Earnings Summary

On Thursday, May 18, Legend reported its Q1 2023 clinical updates and financial results (press release) highlighting Carvykti’s (BCMA CAR-T) upcoming clinical presentations at ASCO and EHA 2023, and its WW revenue during this period. Below, Celltelligence provides insights on CARTITUDE-4 data to be presented in the upcoming conferences and Carvykti’s future development.

About The Author

The Celltelligence Team

|
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.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

Why Kite’s New Leader Makes Strategic Sense for Gilead; Allogene’s CMO Pursues Other Opportunities

On May 16, Gilead (Kite) announced the appointment of Cindy Perettie as EVP of Kite (press release), overseeing the cell therapy business. Moreover, on May 18, Replay Bio announced (press release) the appointment of Allogene’s former CMO, Arun Balakumaran, as the company’s new CMO. Below, Celltelligence provides insights on how Perettie’s healthcare experience and background could benefit Gilead’s pursuit of bringing cell therapy to solid tumors.

About The Author

The Celltelligence Team

|
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.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

GC012F Results in MM and NHL to Be Presented at ASCO and EHA; New GC012F Trial in SLE; GC007g Demonstrates Remarkable Ph1 IIT Results in ALL; Gracell’s Q1 2023 Earnings Call Summary

On Monday, May 15, Gracell held its Q1 2023 earnings call (press release) highlighting the presentation of results from GC012F (BCMA x CD19 FasTCAR-T) and GC007g (allogeneic CD19 CAR-T) in several hematological indications at ASCO and EHA 2023, while disclosing the initiation of a Ph1 IIT evaluating GC012F in refractory systemic lupus erythematosus (SLE). Below, Celltelligence provides insights on the interest of Gracell in establishing a collaboration for the development of the GC012F’s Ph1b/2 trial for ≥4L MM to be initiated in the US, while comparing GC012F to its main competitors in the SLE field.

About The Author

The Celltelligence Team

|
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.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

Adaptimmune and TCR2 Tx to Discuss Merger at the End of May; Completion of Afami-cel’s rolling BLA Submission Remains on Track; Adaptimmune’s and TCR2 Tx’s Q1 2023 Earnings Call Summary

On Friday, May 12, Adaptimmune held its Q1 2023 earnings call (press release) highlighting that the company will host a General Meeting on May 30 to evaluate the merger with TCR2 Tx while confirming that afami-cel’s (autologous MAGE-A4 SPEAR-T) rolling BLA submission is expected to be completed in mid-2023. Similarly, TCR2 Tx confirmed a special stockholder meeting to endorse the deal with Adaptimmune on the same day (press release). Below, Celltelligence provides insights on the importance of the approval of the merger for both companies, while discussing Adaptimmune’s anticipated plans for its MAGE-A4 assets.

About The Author

The Celltelligence Team

|
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.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.

CB-010 to Be Evaluated in 2L LBCL; CB-011’s Ph1 Trial in MM Initiated; No Updates on Poseida’s Milestones for 2023; Caribou’s and Poseida’s Q1 2023 Earnings Call Summary

On Tuesday, May 9, the following companies released their Q1 2023 results and business updates:

About The Author

The Celltelligence Team

|
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.

If you receive our email blasts, you already have an account.

Sign UpFREE

You’ll be able to access the full article from your Celltelligence Library after signing up.