On November 7, 2024 AbCellera (Nasdaq: ABCL) reported new data on its T-cell engager (TCE) platform, to be presented as a poster at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 39th Annual Meeting at the George R. Brown Convention Center in Houston, Texas (Press release, AbCellera, NOV 7, 2024, View Source [SID1234647990]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

AbCellera’s presentation, which is available for viewing here, describes:

Strategies to address key challenges in TCE development:

CD3-binding antibodies to widen the therapeutic window by generating TCEs with potent tumor-cell killing and optimal cytokine release
Molecules to enhance efficacy for solid tumor indications by increasing T-cell activation and proliferation through costimulation of CD28 and 4-1BB
Application of the platform to two of AbCellera’s TCE programs:

Preclinical characterization of TCEs against solid tumor targets B7-H4 and PSMA show tumor-cell killing and cytokine release profiles that are differentiated from clinical benchmarks

On November 7, 2024 Indapta Therapeutics, Inc., a privately held clinical stage biotechnology company developing next-generation differentiated cell therapies for the treatment of cancer and autoimmune diseases, reported the presentation of clinical and preclinical data at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) meeting in Houston, TX (Press release, Indapta Therapeutics, NOV 7, 2024, View Source [SID1234647989]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The clinical presentation (Abstract #1483), entitled "Activity of IDP-023 Allogeneic g-NK Cells Without Antibody Targeting in First-in-Human Phase 1/2 Study in Patients with Advanced Multiple Myeloma or Non-Hodgkin Lymphoma," summarized the data from the safety run-in of the Phase 1 trial. Patients received one to three doses of IDP-023, with or without interleukin-2 (IL-2). The treatment was generally well-tolerated, with no dose limiting toxicities. The most common adverse events were cytopenias related to the conditioning chemotherapy. Objective responses were observed in five of nine patients treated. Of the five patients treated with IDP-023 and IL-2, four achieved an objective response (one very good partial response, two partial responses, one minimal response). Of the eight relapsed/refractory myeloma patients, the mean maximum decrease in serum M-protein or light chain was 73%, with three patients achieving a reduction of 84% or greater.

"We are encouraged to observe this degree of clinical activity during the safety run-in, at the lowest cell dose and without the addition of a targeting antibody," said Dr. Robert Sikorski, Chief Medical Officer of Indapta. "We look forward to the enrollment in the antibody cohorts, in which multiple myeloma patients will receive IDP-023 in combination with a CD38-targeting monoclonal antibody, and non-Hodgkin’s lymphoma patients will receive IDP-023 in combination with a CD20-targeting monoclonal antibody. In our preclinical models, the addition of a targeting monoclonal antibody markedly increases efficacy."

In Abstract #365, entitled, "Artificial Intelligence-Based Dynamic Single-Cell Imaging Reveals Enhanced Migration and Immune Synapse Formation by IDP-023, an Allogeneic g-NK Cell Product," researchers demonstrated that the enhanced antibody-dependent cellular cytotoxicity (ADCC) of g-NK cells is driven in part by faster cell migration and a higher frequency of synapse formation with target cells compared to conventional NK cells. Faster migration correlates with enhanced expression of CD2 (LFA-2), a protein involved in leukocyte adhesion, as a potential factor in the increased migration and cytotoxic functions of IDP-023.

In Abstract #1285, entitled, "IDP-023 has superior single agent and antibody-dependent cytotoxicity against solid tumor cell lines compared to conventional NK cells," data presented demonstrate potent activity of g-NK cells against HER2 and EGFR positive cells lines, both without and with tumor targeting antibodies. Furthermore, the analysis of publicly available datasets of patients treated with trastuzumab, a monoclonal antibody used to treat HER2-positive breast and other cancers, show that patients with increased levels of naturally occurring g-NK cells had a higher rate of pathological complete response in a neoadjuvant study and improved distant disease-free survival in an adjuvant study.

"These data demonstrate both the differentiated mechanism of g-NK cells, as well as their potential efficacy in solid tumors," said Stefanie Mandl-Cashman, Chief Scientific Officer of Indapta Therapeutics. "In addition, analyses of clinical outcomes in patients treated with trastuzumab highlight the powerful effect of naturally occurring g-NK cells on the outcome of patients undergoing therapy with monoclonal antibodies, demonstrating the strong antibody-dependent cellular toxicity of g-NK cells."

Indapta’s Proprietary g-NK Cell Therapy

Indapta’s universal, allogeneic NK cell therapy platform consists of a potent subset of naturally occurring NK cells, known as "g minus" NK cells, or "g-NK" cells. g‑NK cells arise from epigenetic changes resulting from exposure to cytomegalovirus (CMV). To generate IDP-023, Indapta preferentially expands g-NK cells from healthy donors, with low donor to donor variability. IDP-023 has several differentiated mechanisms of killing target cells without the need for genetic engineering, including highly robust antibody-dependent cell mediated cytotoxicity (ADCC), the targeting of HLA-E expressing cells via the NKG2C receptor, and the inherent anti-viral activity of g-NK cells.

Indapta’s g-NK can release dramatically more immune activating cytokines and cell-killing compounds than conventional NK cells. In preclinical studies, IDP-023 has demonstrated more potent and durable antitumor activity when combined with cancer targeting monoclonal antibodies as compared to conventional NK cells. (Bigley et al., Blood Advances 2021, View Source). g-NK cells in combination with a B cell targeting antibody can also deplete normal B cells from healthy donors or patients with autoimmune disease.

On November 7, 2024 Brenus Pharma reported the publication of a scientific article describing its new "off-the-shelf" cancer treatment in "Frontiers in Oncology" Section Cancer Immunity and Immunotherapy (Press release, Brenus Pharma, NOV 7, 2024, View Source [SID1234647988]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Brenus’ platform mimics patients’ relapsing conditions in lab, to educate the immune system against tumors evolution with the largest panel of multi-specific targets available. Its lead candidate is a proteomic-guided immunotherapy, designed to treat patients with advanced or metastatic CRC.

Results show that the murine surrogate treatment inhibits tumor growth and improves survival of treated mice bearing tumors. It has also shown efficacy in a PD1-resistant model, with an increased infiltration of CD8+T cells in cold tumors, associated with strong safety data.

Indeed, the treatment’s in vitro exposition to standards of care induces the expression of cancer-related proteins linked to therapeutic pressure, which were then safely rendered immunogenic by haptenation (in vitro chemical tagging). The final product thus obtained reinforces the recognition of tumor antigens by the immune system, allowing its activation against patient’s tumor cells after intradermal injection.

The findings, published in collaboration with renowned academic institutions and scientific partners, emphasize the potential of Brenus Pharma’s platform to overcome challenges faced in CRC, particularly in cases where standard immunotherapies like anti-PD1 have proven ineffective.

"These studies demonstrate that we can produce an immunotherapeutic approach inducing a safe anti-tumor response to target cancer cells in a proof-of-concept syngeneic mouse model. The technology has now been adapted with the human first candidate. This is providing solid foundations for the first-in-human study, moving us closer to offering therapeutic solutions for patients. We extend our gratitude to all co-authors for their invaluable contributions," said Dr. George Alzeeb, Innovation Manager at Brenus Pharma.

On November 7, 2024 Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, reported financial results for the third quarter ended September 30, 2024, and provided recent business highlights (Press release, Arcellx, NOV 7, 2024, View Source [SID1234647987]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We believe the data from the recently published ASH (Free ASH Whitepaper) abstracts continues to differentiate anito-cel’s clinical profile as a potentially best-in-class treatment option for multiple myeloma patients," said Rami Elghandour, Arcellx’s Chairman and Chief Executive Officer. "The 30.2-month median progression-free survival demonstrated in our Phase 1 study in a challenging patient cohort coupled with the promising results from our iMMagine-1 Phase 2 registrational study highlight the potential impact we could have for patients. That impact is further enhanced by the high tolerability demonstrated through both the Phase 1 and iMMagine-1 studies to date, where notably, no delayed or non-ICANS neurotoxicities were observed in the over 140 patients treated to date. Patients and clinicians evaluate cell therapies on their safety, efficacy, delivery reliability, service, and accessibility. We believe we’re well positioned to deliver on these important factors in a differentiated way that best serves the multiple myeloma community. Our partnership with Kite allows us to leverage their established global commercial capabilities, positive brand recognition with physicians, and industry-leading manufacturing reliability and turnaround times which we believe contributes to our competitive advantage. It’s an exciting time at Arcellx! We are preparing for the commercial launch of anito-cel as there remains an unmet need for a therapy that physicians can use across a broad patient population."

Recent Business Progress

Announced presentations at the 66th American Society for Hematology Annual Meeting and Exposition:

Phase 2 Registrational Study of Anitocabtagene Autoleucel for the Treatment of Patients With Relapsed and/or Refractory Multiple Myeloma: Preliminary Results From the iMMagine-1 Trial (abstract #1031)

As detailed in the abstract (#1031) as of June 1, 2024, 58 patients had received anito-cel infusion with ≥2 months of follow-up after infusion, with a median follow-up of 10.3 months (range, 2.0-17.8). The median age was 66 years (range, 38-77). Patients had received a median of four prior lines of treatment (range, 3-8) with 26 patients (45%) having received only three prior lines of treatment. Forty patients (69%) were triple-class refractory and 20 (34%) were penta-class refractory.

Investigator-assessed overall response rate (ORR) per International Myeloma Working Group (IMWG) criteria was 95% (55/58) with a complete response/stringent complete response (CR/sCR) rate of 62% (36/58). Of those evaluable for minimal residual disease (MRD) testing (n=39), 36 (92%) achieved MRD negativity at least to the level of 10-5. The Kaplan–Meier-estimated 6-month progression-free survival (PFS) and overall survival (OS) rates (95% CI) were 90% (77-96) and 95% (85-98), respectively. Median (mPFS) and median OS have not yet been reached.

No delayed neurotoxicities, including no parkinsonism, no cranial nerve palsies, and no Guillain-Barré syndrome have been observed to date. Forty-six patients (79%) had either no cytokine release syndrome (CRS) (n=9, 16%) or Grade (Gr) 1 CRS (n=37, 64%). Thirty-one patients (53%) had no fever or CRS in the first four days of anito-cel. Any Grade CRS was observed in 49 patients (84%; Gr3/4 0%). Any Grade ICANS was observed in 5 patients (9%; Gr3 2%), with all cases resolved without sequelae. Three deaths occurred due to adverse events (AEs) (both related and unrelated; retroperitoneal hemorrhage, CRS, and fungal infection). No additional treatment or therapy-related deaths or Grade ≥3 CRS or ICANs events have occurred to date. Cytopenias were the most common Grade ≥3 treatment-emergent AEs; 36 patients (62%) had Grade ≥3 neutropenia, 15 (26%) had Grade ≥3 thrombocytopenia, and 15 (26%) had Grade ≥3 anemia.

Conclusions

Preliminary results from the first 58 patients in the Phase 2 iMMagine-1 study demonstrate deep and durable responses and manageable safety in a high-risk fourth line or higher (4L+) RRMM population including triple- and penta-class refractory disease. Notably, no delayed neurotoxicities, including no cranial nerve palsies, Guillain-Barré syndrome, or Parkinsonian-like symptoms have been observed with anito-cel to date. Updated Phase 2 data with a more recent data cut will be presented at the oral presentation during ASH (Free ASH Whitepaper).

Presentation details:

Speaker: Ciara Freeman, M.D., Ph.D., H. Lee Moffitt Cancer Center
Session Name: 655. Multiple Myeloma: Cellular Therapies: Unleashing Cell Therapies Against Myeloma
Session Date: Monday, December 9, 2024
Session Time: 4:30 p.m. – 6:00 p.m.
Presentation Time: 5:30 p.m.
Location: Marriott Marquis San Diego Marina, Pacific Ballroom Salons 24-26
Publication Number: 1031
Submission ID: 198499

Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM) (abstract #4825)

In the Phase 1 study, 40 patients were enrolled and 38 patients received anito-cel. All 38 patients demonstrated investigator-assessed clinical response per 2016 IMWG criteria, (ORR, 100%) with 30 CR/sCR (≥CR rate, 79%), 5 very good partial response (≥VGPR rate, 92%), and 3 partial response (PR). Of those evaluable for MRD testing (n=28), 25 (89%) achieved MRD negativity at 10-5. With a median follow-up of 38.1 months, median OS was not reached and median PFS was 30.2 months. The safety profile was manageable with no delayed neurotoxicities observed to date, including no parkinsonism, no cranial nerve palsies, and no Guillain-Barré syndrome. Further investigations of anito-cel are ongoing in 4L+ RRMM (iMMagine-1, NCT05396885) and in earlier lines (iMMagine-3, NCT06413498).

Presentation details:

Speaker: Michael R. Bishop, M.D., The University of Chicago
Session Name: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities
Session Date: Monday, December 9, 2024
Presentation Time: 6:00 p.m. – 8:00 p.m.
Location: San Diego Convention Center, Halls G-H
Publication Number: 4825
Submission ID: 201080

Health Related Quality of Life (HRQoL) in Relapsed/Refractory Multiple Myeloma (RRMM): A Systematic Literature Review (SLR) and Meta-Analysis (abstract #4721)

Quantifying pre-treatment HRQoL burden is important as a reference for contextualizing baseline patient burden as emerging therapies for RRMM continue to evolve. This SLR synthesized studies that reported data for key multiple myeloma HRQoL instruments. It found that patients with RRMM had clinically meaningful impairments from population norms in important domains, such as Global Health Status and cognitive, physical, and emotional functioning. The SLR also found that pre-treatment HRQoL worsened with increasing lines of therapy.

Presentation details:

Speaker: Rahul Banerjee, M.D., Fred Hutchinson Cancer Center
Session Name: 653. Multiple Myeloma: Clinical and Epidemiological: Poster III
Session Date: Monday, December 9, 2024
Presentation Time: 6:00 p.m. – 8:00 p.m.
Location: San Diego Convention Center, Halls G-H

Treatment Patterns and Outcomes in Triple-Class Exposed Patients with Relapsed and Refractory Multiple Myeloma: Findings from the Flatiron Database (abstract #6962)

In order to understand the contemporary unmet need in the rapidly evolving treatment landscape for patients with triple-class exposed RRMM – those exposed to immunomodulatory drugs, proteasome inhibitors, and anti-CD38 monoclonal antibodies – in the 4L+ setting, a retrospective cohort study using the Flatiron Health electronic health record (HER) was conducted (sample size=594). This study found no clear standard of care in the 4L+ setting, and suboptimal health outcomes under the current treatment landscape (ORR=34%, PFS=4.1 months, and OS=15.4 months), emphasizing an urgent need for more effective and durable therapies for patients in this setting. This abstract will be published in a supplemental issue of Blood in November 2024.

First patients dosed in iMMagine-3, a global randomized Phase 3 study, assessing anito-cel in patients previously treated with both an immunomodulatory (IMiD) drug and an anti-CD38 monoclonal antibody. Kite is manufacturing for this study.

Third Quarter 2024 Financial Highlights

Cash, cash equivalents, and marketable securities:

As of September 30, 2024, Arcellx had cash, cash equivalents, and marketable securities of $676.7 million. Arcellx anticipates that its cash, cash equivalents, and marketable securities will fund its operations into 2027.

Collaboration revenue:

Collaboration revenue were $26.0 million and $15.0 million for the quarters ended September 30, 2024 and 2023, respectively, an increase of $11.0 million. This increase was primarily driven by the December 2023 expansion to the license and collaboration agreement with Kite Pharma, Inc.

R&D expenses:

Research and development expenses were $39.2 million and $43.8 million for the quarters ended September 30, 2024 and 2023, respectively, a decrease of $4.6 million. This decrease was primarily driven by an expense in 2023 associated with our Lonza manufacturing services agreement. The decrease was partially offset by increased costs relating to other preclinical pipeline programs and increased personnel costs, which include non-cash stock-based compensation expense.

G&A expenses:

General and administrative expenses were $20.5 million and $16.0 million for the quarters ended September 30, 2024 and 2023, respectively, an increase of $4.5 million. This increase was primarily driven by increased personnel costs, which include non-cash stock-based compensation expense.

Net losses:

Net losses were $25.9 million and $39.3 million for the quarters ended September 30, 2024 and 2023, respectively.

Upcoming Webcast Event:

Arcellx will host a live webcast event with an expert panel of clinicians on Monday, December 9, 2024, at 8:30 p.m. PT to discuss clinical results from its Phase 1 and iMMagine-1 trials. The event will be accessible from Arcellx’s website at www.arcellx.com in the Investors section. A webcast replay will be archived and available for 30 days following the event.

On November 7, 2024 IASO Biotherapeutics ("IASO Bio"), a biopharmaceutical company dedicated to discovering, developing, manufacturing and commercializing innovative cell therapy and antibody products, reported that the results of the phase 1b/2 clinical study FUMANBA-1 of its fully human anti-BCMA CAR-T therapy, Equecabtagene Autoleucel (trade name: Fucaso), for the treatment of relapsed/refractory multiple myeloma (R/RMM), have been published in the leading medical journal JAMA Oncology (Press release, IASO Biotherapeutics, NOV 7, 2024, View Source [SID1234647986]). The study evaluated the efficacy and safety of Equecabtagene Autoleucel in patients with R/RMM who had previously received ≥3 lines of prior therapies. The results demonstrated that Equecabtagene Autoleucel achieved a high overall response rate and durable remission in patients, with a favorable safety profile.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

JAMA Oncology published clinical data on 103 patients who received infusion of Equecabtagene Autoleucel (Fucaso) as of September 9, 2022, with a median follow-up of 13.8 months (range: 0.4-27.2 months). In terms of efficacy, among the 101 evaluable patients, the overall response rate (ORR) was 96.0% (97/101), and the stringent complete response/complete response rate (sCR/CR) was 74.3% (75/101). Among the 89 patients without prior CAR-T therapy, the ORR was 98.9% (88/89), and the sCR/CR rate was 78.7% (70/89). In these 101 patients, the median time to response was 16 days (range: 11-179), while the median duration of response (DOR) and median progression-free survival (PFS) had not been reached yet. The 12-month PFS rate was 78.8% (95% CI: 68.6-86.0). Additionally, 95% (96/101) of the patients achieved minimal residual disease (MRD) negativity, with a median time to MRD negativity of 15 days (range: 14-186). All patients with sCR/CR achieved MRD negativity, and the median duration of MRD negativity had not been reached.

In terms of safety, 93.2% (96/103) of the patients experienced cytokine release syndrome (CRS), most of which were grade 1 or 2, with only one patient experiencing grade 3 or higher CRS. Only 1.9% (2/103) of the patients developed immune effector cell-associated neurotoxicity syndrome (ICANS), with one case each of grade 1 and grade 2.

Notably, updated data from this study, as of December 31, 2022, was presented during the 2023 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. The median follow-up had increased to 18.07 months, with an ORR of 96.1% among the 103 evaluable patients. The sCR/CR rate was 77.7%, and all patients who achieved CR or better exhibited 100% MRD negativity. Among the 91 patients without prior CAR-T therapy, the ORR reached 98.9%, with an sCR/CR rate of 82.4% and an MRD negativity rate of 97.8%. Notably, 81.7% of these patients remained MRD-negative at 12 months post-infusion, with a 12-month PFS rate was 85.5%. In addition, Equecabtagene Autoleucel could showed prolonged persistence in the body, at 12 months post-infusion, 50% of patients had a vector copy number (VCN) above the limit of detection, and 40% still had detectable VCN persistence at 24 months.

Professor Lu-gui Qiu, from the Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, stated: "The results of the FUMANBA-1 study demonstrate the encouraging efficacy and safety of Equecabtagene Autoleucel in treating patients with relapsed/refractory multiple myeloma. Its groundbreaking fully human scFv design overcomes the high immunogenicity issues commonly associated with animal-derived CAR-T cells while maintaining optimal affinity for BCMA-expressing tumor cells. Its excellent dissociation kinetics facilitates rapid expansion and long-term persistence of Equecabtagene Autoleucel in vivo."

Professor Huang He, from The First Affiliated Hospital, Zhejiang University School of Medicine, stated, "Equecabtagene Autoleucel (Fucaso) was approved in China in June 2023. Over the past year since its launch, it has brought significant survival benefits to patients with relapsed/refractory multiple myeloma in China and from overseas. Meanwhile, we have accumulated valuable real-world experience, and we expect this innovative therapy to benefit more patients."

Professor Chunrui Li, from Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, stated: "Equecabtagene Autoleucel is the world’s first fully human CAR-T therapy to be approved. It’s binding to BCMA, utilizing both heavy and light chains with optimal affinity, facilitates dissociation from BCMA antigen after tumor cell killing, thereby reducing CAR-T cell self-exhaustion. Along with lower immunogenicity, this leads to rapid, deep, and sustained remission in patients with multiple myeloma."

Dr. Jie Chen, Chief Medical Officer of IASO Bio, stated: "We are delighted that the phase 1b/2 clinical study data of Equecabtagene Autoleucel for the treatment of R/RMM has been published in JAMA Oncology. The results of this study, which targeted patients with R/RMM who had previously received ≥3 lines of prior therapies are very inspiring. We thank the FUMANBA-1 research team for their rigorous scientific approach and high-standard execution. Currently, IASO Bio is actively conducting and advancing the phase III clinical study (FUMANBA-3) of Equecabtagene Autoleucel for the treatment of multiple myeloma patients who have received 1-2 lines of prior therapies. We anticipate this clinical study, based on clinical data from Chinese patients, will yield positive results soon, bringing new treatment option for more patients."

About FUMANBA-1 study

FUMANBA-1 is a single-arm, open-label phase 1b/2 registrational clinical study conducted in 14 Chinese centers to assess the efficacy and safety of the Equecabtagene Autoleucel in patients with R/RMM who have received ≥3 lines of prior therapies. The trial enrolled patients with RRMM who had previously received at least three lines of therapy, including proteasome inhibitors and immunomodulatory agents-based chemotherapy regimens, and had disease progression on their last line of therapy. Patients who had previously received BCMA CAR-T therapy were also eligible for enrollment.

About Equecabtagene Autoleucel (Fucaso)

Equecabtagene Autoleucel (Fucaso) is an innovative fully-human anti- BCMA CAR-T cell therapy which uses lentivirus as a gene vector to transfect autologous T cells. The CAR contains a fully-human scFv, CD8a hinge and transmembrane, and 4-1BB-mediated co-stimulation and CD3ζ activation domains. Based on rigorous molecular structure screening and comprehensive in vitro and in vivo functional evaluations, Fucaso demonstrates rapid and potent efficacy, accompanied by exceptional long-term persistence in vivo, enabling patients to achieve higher and deeper remissions, providing continuous protection and care for those suffering from multiple myeloma.