Celltelligence’s Post

On Monday, April 22, the CHMP Agenda (https://bit.ly/44ec9XP) for April was released. Of note, obe-cel (Autolus Therapeutics' #CD19 CAR-T) was included in the “Start of Procedure for New Application” section for the treatment of adult patients with r/r B-ALL. On Friday, April 26, when the CHMP highlights are released, Celltelligence will provide a full analysis of obe-cel in adult r/r B-ALL: https://bit.ly/CT-869482

On Tuesday, April 16, Johnson & Johnson held its Q1 2024 earnings call (press release: https://bit.ly/3JomcA2 / presentation: https://bit.ly/49A6jBa) mentioning Carvykti’s (#BCMA CAR-T) revenue remained approximately flat. Additionally, management remarked on #Carvykti approval by the FDA and the CHMP positive opinion for the treatment of 2L MM patients. Celltelligence provides insights on Carvykti’s underperforming revenue during this quarter while discussing its upcoming launch in 2L MM: https://bit.ly/CT-868307

#AACR24 Analysis 3: Kelonia Therapeutics and Carisma Therapeutics presented preclinical updates from their programs using innovative #celltherapy platforms. Celltelligence provides insights and key context for selected presentations. The following topics are covered: • Kelonia reported preclinical data from its KLN-1010, an in vivo iGPS-induced CAR-T for MM treatment • Carisma shared its new myeloid cell-based platform, referred to as Engineered Microenvironment Converters (EM-C), for solid tumors Celltelligence provides insights: https://bit.ly/CT-867710

#AACR24 Analysis 2: Poseida Therapeutics, Inc., Caribou Biosciences, and Takeda presented clinical and preclinical updates from their programs in hematological malignancies. Celltelligence provides insights and key context for selected presentations. The following topics are covered: • Poseida presented a subanalysis from the Ph1 trial (https://bit.ly/4ac3Ux8) evaluating P-BCMA-#ALLO1 (allogeneic #BCMA CAR-T) including only patients previously treated with BCMA-targeting therapies • Caribou showed CB-012’s (allogeneic CLL-1 CAR-T) preclinical data in #AML supporting IND clearance by the FDA • Takeda presented a new CD123-targeting cell therapy based on vδ1-enriched γδT cells for AML treatment Celltelligence provides insights: https://bit.ly/CT-867124

#AACR24 Analysis 1: CRISPR Therapeutics, AstraZeneca and MiNK Therapeutics presented clinical and preclinical updates from their programs in solid tumors. Celltelligence provides insights and key context for selected presentations. The following topics are covered: • CRISPR Tx provided a long-term follow-up update from its Ph1 COBALT-RCC trial evaluating #CTX130 (allogeneic #CD70 CAR-T) in patients with advanced clear cell renal cell carcinoma (#RCC)  • AZ presented a preclinical analysis on the effectiveness of CLDN18.2-targeting murine CAR-Ts in a syngeneic mouse model  • MiNK Tx reported preclinical data from MiNK-215 (allogeneic IL-15 FAP-CAR-iNKT) in patient-derived organoid models of treatment-refractory colorectal cancer (#CRC) liver metastases Celltelligence provides insights: https://bit.ly/CT-866516

On Friday, April 5, Johnson & Johnson (press release: https://bit.ly/3PVXMl4) and Legend Biotech (press release: https://bit.ly/3vBlook) announced that the FDA approved #Carvykti (#BCMA CAR-T) for the treatment of adult patients with r/r MM who have received at least one prior LoT, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), and are refractory to lenalidomide. On the same day, Bristol Myers Squibb (press release: https://bit.ly/3Ud0pS0) and 2seventy bio (press release: https://bit.ly/3Ucuxgm) announced that #Abecma (BCMA CAR-T) received approval from the FDA for the treatment of adult patients with r/r MM who have received at least 2 prior LoT, including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and an anti #CD38 antibody. Celltelligence provides insights on the BCMA CAR-Ts approval in earlier MM lines, while discussing the potential implications: https://bit.ly/CT-865930

In the past week, the Celltelligence team detected relevant news that was not discussed in individual blasts but worth highlighting. In this blast, Celltelligence will cover the following topics: • On Friday, March 15, a new Ph3 TRANSFORM FL (https://bit.ly/43qZAYZ) trial evaluating #Breyanzi (#CD19 CAR-T) compared to standard of care (SoC) therapies in r/r FL patients was observed on CT.gov • On Wednesday, March 20, Bristol Myers Squibb announced (press release: https://bit.ly/3VulPek) that the European Commission (EC) has granted approval to #Abecma (Bristol Myers Squibb / 2seventy bio’s #BCMA CAR-T) for the treatment of adult patients with r/r MM who have relapsed after at least two LoTs, including an immunomodulatory agent (#IMiD), a proteasome inhibitor (PI), and an anti-CD38 antibody Celltelligence provides insights: https://bit.ly/CT-865286

On Friday, March 15, Johnson & Johnson (press release: https://bit.ly/4a3GR86) and Legend Biotech (press release: https://bit.ly/43qvAfK) announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) recommended #Carvykti (#BCMA CAR-T) for the treatment of adult patients with r/r #MM who have received at least one prior LoT including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) and are refractory to lenalidomide. On the same day, Bristol Myers Squibb (press release: https://bit.ly/3TrG61B) and 2seventy bio (press release: https://bit.ly/4a2aLd0) reported that the FDA’s ODAC also recommended #Abecma (BCMA CAR-T) for the treatment of patients with triple-class exposed (#TCE) r/r MM. Celltelligence provides insights on the FDA efficacy and safety concerns on the two BCMA CAR-Ts, while discussing the outcomes of the #ODAC meeting: https://bit.ly/CT-864684

On Thursday, March 14, Allogene Therapeutics held its Q4 and FY 2023 earnings call (press release: https://bit.ly/3TGJuaj), noting that the start-up activities for the pivotal Ph2 #ALPHA3 trial evaluating cema-cel (formerly ALLO-501A; allogeneic #CD19 CAR-T) as consolidation therapy in 1L #LBCL are ongoing, while the company expects to initiate ALLO-329’s (allogeneic CD19 x #CD70 Dagger CAR-T) Ph1 trial in SLE in early 2025. Moreover, on Tuesday, March 12, the company entered into a collaboration agreement with Arbor Biotechnologies (press release: https://bit.ly/43lDzux), for the use of Arbor proprietary #CRISPR gene-editing technology in the design of next-generation allogeneic cell therapies for #autoimmune diseases (AIDs). Celltelligence provides insights on Allogene’s plans for its #oncology pipeline, while discussing the significance of the partnership agreement with Arbor for enhancing its AlloCAR-Ts for autoimmune diseases: https://bit.ly/CT-864097

On Monday, March 18, the CHMP Agenda (https://bit.ly/3Tl2aLd) for March was released. Of note, no #celltherapy-related updates were observed. Therefore, based on the agenda, no updates are expected to be published on the CHMP highlights on Friday, March 22: https://bit.ly/CT-863525