Category Archives: CAR-T

Five New Autolus CAR-T Products to Enter the Clinic in 2021; AUTO1’s ALL Market Opportunity; Autolus Q4 2020 Earnings Call Summary

On Thursday, March 4, Autolus held their Q4 2020 earnings presentation (press release / slides). Management presented AUTO1’s possible market strategy in adult ALL and updated several clinical milestones. Of note, Autolus’s cash runway has been extended from 2022 to H1 2023. Below, Celltelligence provides insights into Autolus’s pipeline diversification and AUTO1’s commercial opportunity.

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 Academic CD19 CAR-T ARI-0001 Ph2 Trial in R/R ALL Posted

On Wednesday, March 3, a new ARI-0001 (autologous CD19 CAR-T) Ph2 trial (CART19-BE-02) was observed on CT.gov for the treatment of adult r/r ALL. Below, Celltelligence provides details for this trial and how ARI-0001’s point-of-care (PoC) model could potentially be replicated in other countries if proven successful.

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 Heidi Hagen’s Appointment as Interim Ziopharm CEO; Allogene Anticipates Two New Clinical Trials in 2021; Ziopharm and Allogene Q4 2020 Earnings Call Summaries

On Thursday, February 25, Ziopharm (press release / slides) and Allogene (press release) held their Q4 2020 earnings presentations. Ziopharm announced that Heidi Hagen will act as Interim CEO replacing Laurence Cooper, while Allogene presented several clinical and regulatory updates. Below, Celltelligence provides insights into Allogene’s pipeline strategy and their efforts to target the solid tumor setting in the mid- to long-term, while providing thoughts on the appointment of Heidi Hagen as Ziopharm’s Interim CEO.

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.

Ide-cel Reverts to Standard Assessment; Liso-cel’s Potential Scenarios for Approval; CHMP February Agenda and Highlights

On Friday, February 26, CHMP meeting highlights were released following Monday’s CHMP agenda. Of note, regulatory updates for BMS’s liso-cel (CD19) and ide-cel (BCMA) CAR-T products were observed, including ide-cel’s start of standard review following its loss of accelerated assessment (AA) in December 2020. No updates for cilta-cel were provided. Below, Celltelligence provides insights on possible EC approval dates for liso-cel and ide-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.

Thoughts on Poseida’s Strategies to Improve Allogeneic CAR-T Manufacturing and Efficacy; Clinical Development Updates and New Cell Therapy Platforms; Poseida’s First R&D Day Summary

On Wednesday, February 24, Poseida Therapeutics held their first R&D day (presentation). Management presented a novel booster molecule to improve allogeneic manufacturing and discussed their approach to developing next-generation technologies. Below, Celltelligence provides insights on how Poseida’s allogeneic improvements could significantly decrease manufacturing costs, while discussing Poseida’s development of CAR-T therapies from different cell sources.

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.

BMS’s New US Cell Therapy Manufacturing Site; bluebird bio Quiet on Earnings; Former Kite Head of Development Joins Daiichi Sankyo

On Tuesday, February 23, BMS announced (press release) the construction of a new cell therapy manufacturing facility in Devens, Massachusetts. On the same day, bluebird bio released their Q4 and FY 2020 results (press release) without an investor call. Finally, Daiichi Sankyo announced (press release) Ken Takeshita, former Kite global head of development, will join the company as global head of R&D. Below, Celltelligence provides insights on BMS’s possible manufacturing footprint strategy, as well as thoughts on how Takeshita’s cell therapy experience could influence Daiichi Sankyo’s R&D strategy.

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.

CAR-TCR European Summit Round-Up: Cellectis-Cytovia Partnership; JNJ’s (Janssen) Thoughts on EU CAR-T Reimbursement; Strategies to Improve CAR-T Fitness

During the CAR-TCR European Summit 2021, eight key CAR-T related topics were observed. Six updates covering Cellectis, JNJ (Janssen), Dorian Therapeutics, Antion Biosciences, Prescient Therapeutics, and Avectas are summarized below. Of note, no major clinical updates were presented by Precision BioSciences or Gilead (Kite). Below, Celltelligence provides insights and context for each presentation.

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.

Yescarta’s Median Time to CRS Improved by Prophylactic Corticosteroid Use; Thoughts on Frank Neumann Joining Kite as Worldwide Head of Clinical Development

On Wednesday, February 10, Gilead (Kite) announced (press release / abstract) updated results from cohort 6 of the Ph1/2 ZUMA-1 trial. The analysis showed that prophylactic use of corticosteroids has the potential to delay Yescarta’s CRS onset. Additionally, Gilead announced (press release) that Frank Neumann has joined Kite as Senior Vice President and Global Head of Clinical Development. Below, Celltelligence provides insights on how Yescarta’s improved safety profile could bring CRS onset parity with Breyanzi and if Kite’s recent senior management appointments could suggest a reprioritization towards 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.

Kymriah’s First Commercial Manufacturing Facility Approved in Australia; Novartis Increases Manufacturing Footprint to Six Global Centers

On Friday, February 12, Novartis announced (press release) that the Peter MacCallum Cancer Center in Melbourne has been approved by the Therapeutic Goods Administration (TGA) to commercially manufacture Kymriah. Below, Celltelligence provides thoughts on the impact of Novartis’s manufacturing footprint strategy and anticipated manufacturing approval in China.

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.

Spain Approves the First Potentially Low-Cost Academically Manufactured CD19 CAR-T for Adult ALL Patients; Could EMA Approval be Next?

On Wednesday, February 10, the Spanish Agency of Medicines and Medical Devices (AEMPS) announced (press release) the approval of ARI-0001 (autologous CD19 CAR-T) for the treatment of ≥3L adult r/r ALL. ARI-0001 has become the first academically manufactured CD19 CAR-T approved by a regulatory agency. The approval was based on data from the Ph1 CART19-BE-01 trial. Below, Celltelligence provides insights on how ARI-0001’s point-of-care manufacturing model and competitive price could impact commercially available CAR-Ts.

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.