Category Archives: Autologous

No Significant Cell Therapy Updates in November’s CHMP Highlights; Celltelligence Reducing Ziopharm’s Coverage; UPDATED: Indications Table for CD19 CAR-T US Approvals and Submissions

On Friday, November 12, the CHMP meeting highlights were released following Monday’s CHMP agenda, with no cell therapy-related updates observed. Recall that on Monday, November 8, 2021, the Celltelligence team prepared a full analysis on November’s CHMP agenda, discussing the potential timelines for Yescarta’s Type II variation in r/r FL and Tecartus’s Type II variation in r/r adult ALL, while providing an updated projected approval date for cilta-cel (see previous insight).

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.

Thoughts on Afami-cel’s Promising Clinical and Translational Data for SS and MRCLS; Adaptimmune’s Ph2 SPEARHEAD-1 Trial on Track to Meet Its Primary Endpoint by YE 2021

On Thursday, November 11, Adaptimmune reported (press release) updated clinical and translational data from afami-cel’s (MAGE-A4 SPEAR-T; formerly ADP-A2M4) Ph2 SPEARHEAD-1 trial for advanced synovial sarcoma (SS) and myxoid / round cell liposarcoma (MRCLS) at CTOS 2021. Below, Celltelligence provides insights on Adaptimmune’s CMC preparations ahead of afami-cel’s BLA filing, while discussing how afami-cel compares to GSK’s lete-cel (NY-ESO-1 TCR-T) in MRCLS.

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.

Poseida to Prioritize P-BCMA-ALLO1 Over P-BCMA-101; Program Updates for P-PSMA-101 and P-MUC1C-ALLO1; Poseida Q3 2021 Earnings Summary

On Tuesday, November 9, Poseida Therapeutics released their Q3 2021 financial results (press release) highlighting their strategic shift towards allogeneic CAR-Ts for their BCMA program. Additionally, management provided further updates on their PSMA and MUC1 candidates. Below, Celltelligence provides insights on Poseida’s overarching strategy to prioritize their allogeneic BCMA and PSMA therapies while discussing their MUC1-targeting approach.

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.

NICE Suspends Breyanzi’s Appraisal for R/R NHL

On Tuesday, November 9, NICE reported that Breyanzi’s (BMS’s CD19 CAR-T) clinical and cost-effectiveness appraisal was ‘suspended’ (website). Below, Celltelligence provides insights on the importance and potential causes for Breyanzi’s suspended appraisal in the UK.

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.

Will Ziopharm Ever be Able to Commercialize Their Cell Therapy Products? Continuing Delays for Ziopharm’s TCR-T Programs; TriArm’s Joint Venture Eden BioCell Dissolved; Ziopharm Q3 2021 Earnings Call Summary

On Monday, November 8, Ziopharm held their Q3 2021 earnings call (press release) highlighting that during H1 2022 they anticipate manufacturing therapies at their Houston, TX, clinical production unit (CPU), as well as dosing the first patient in their TCR-T Library program. Moreover, management announced that they have developed four additional TCRs and plan submitting an amended IND protocol within the next few months. Below, Celltelligence provides insights on Ziopharm’s continued program delays and collaboration failures, while discussing the company’s likelihood of successfully bringing a cell therapy product to market.

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.

Will Yescarta Receive a Positive CHMP Opinion for R/R FL This Week? No Mention of Tecartus or Cilta-cel in November’s CHMP Agenda

On Monday, November 8, the CHMP agenda for November was released. Of note, Yescarta’s (Gilead’s CD19 CAR-T) Type II variation for ≥4L r/r FL is listed as ‘For Adoption’, while no updates were observed for Tecartus (Gilead’s CD19 CAR-T) in r/r adult ALL and cilta-cel (JNJ / Legend’s BCMA CAR-T) in r/r MM. Below, Celltelligence provides likely EU approval timelines for Yescarta, Tecartus, and cilta-cel.

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 Blackstone’s $250M Investment in Autolus Is Necessary for Obe-cel’s Clinical Development

On Monday, November 8, Autolus announced (press release) that they have entered into a collaboration and financing agreement with Blackstone Life Sciences for the development of obe-cel (CD19 CAR-T, formerly AUTO1) and obe-cel’s next-generation therapies in B cell malignancies. Below, Celltelligence provides insights on how Autolus’s collaboration with Blackstone could secure obe-cel’s clinical development while giving the company flexibility to develop other assets within their pipeline.

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.

Cellectis Remains Confident on TALEN Editing Safety; UCART22 Clinical Updates Anticipated at ASH 2021; UCARTMESO on Track to Enter the Clinic in 2022; 2seventy Provides Further Insights on Their Business Separation; Cellectis Q3 2021 Earnings Call Summary

On Friday, November 5, Cellectis held their Q3 2021 earnings call (press release) highlighting UCART22’s (allogeneic CD22 CAR-T) Ph1 BALLI-01 trial update at ASH 2021 and a preclinical data presentation for UCARTMESO (allogeneic mesothelin CAR-T) at SITC 2021. Furthermore, Cellectis discussed Allogene’s recent clinical hold, and provided an update on their manufacturing facilities in Paris, France, and Raleigh, NC. On the same day, bluebird bio announced their Q3 2021 earnings (press release) highlighting 2seventy’s successful business separation. Moreover, on Thursday, November 4, 2seventy bio (press release) provided additional guidance covering clinical updates and manufacturing capabilities.

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.

New Yescarta Study in R/R DLBCL for Outpatient Administration

On Friday, November 5, a new investigator-initiated study evaluating Gilead (Kite)’s Yescarta (CD19 CAR-T) in the outpatient setting for r/r DLBCL was observed on CT.gov. Below, Celltelligence provides details for this trial, while discussing how this Yescarta outpatient study compares to key competitor Breyanzi (BMS’s CD19 CAR-T).

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.

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.

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.