On December 7, 2024 Amgen (NASDAQ:AMGN) reported new data demonstrating that adding BLINCYTO (blinatumomab) to chemotherapy significantly improves disease-free survival (DFS) in newly diagnosed pediatric patients with National Cancer Institute (NCI) standard risk (SR) B-cell acute lymphoblastic leukemia (B-ALL) of average or higher risk of relapse (Press release, Amgen, DEC 7, 2024, View Source [SID1234648863]). The data are from a Phase 3 study (AALL1731) conducted by the Children’s Oncology Group. The results were simultaneously published in the New England Journal of Medicine and will be presented during the plenary session on Sunday, Dec. 8, at 2 p.m. PT at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition in San Diego.

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"Over the last decade, BLINCYTO has reshaped the treatment landscape for B-ALL, offering a critical lifeline for thousands of adult and pediatric patients," said Jay Bradner, M.D., executive vice president of Research and Development and chief scientific officer at Amgen. "These powerful new data leave us little doubt about the profound impact of this medicine for a large number of children affected by this disease. We are grateful to the Children’s Oncology Group, along with the patients, families and clinical teams, for their dedication and partnership in advancing this critical study to improve the lives of children with cancer."

Based on the results of the first pre-specified interim analysis for efficacy, the study met its primary endpoint of DFS and study randomization was terminated early based on the recommendation from the data and safety monitoring committee due to the benefit observed in the BLINCYTO arm compared to the chemotherapy-only arm. Overall, the 3-year DFS was 96.0% for patients treated with chemotherapy plus BLINCYTO compared to 87.9% for those treated with only chemotherapy. The hazard ratio (HR) was 0.39 [95% confidence interval (CI) 0.24-0.64], indicating a 61% reduction in the risk of disease relapse, secondary malignant neoplasm or remission death with BLINCYTO. At 3 years, more patients remained alive and cancer free when treated with BLINCYTO plus chemotherapy compared to chemotherapy alone.

"The AALL1731 study results are truly practice-changing, further solidifying blinatumomab’s role as the standard of care for a large number of children with B-ALL," said Sumit Gupta, M.D., Ph.D., FRCPC, co-chair of the Children’s Oncology Group AALL1731 study and oncologist and clinician investigator, Division of Haematology/Oncology at The Hospital for Sick Children (SickKids) and associate professor of pediatrics at the University of Toronto. "These breakthrough data showing a significant improvement in disease-free survival are poised to bring substantial clinical value to children with newly diagnosed B-ALL."

The addition of BLINCYTO to chemotherapy in standard risk patients resulted in outcomes similar to those previously achieved in only the most favorable pediatric risk subsets. Among SR-Average patients, 3-year DFS was 97.5% for patients treated with BLINCYTO compared to 90.2% for those treated with only chemotherapy (HR 0.33, CI 0.15-0.69). For SR-High patients, 3-year DFS was 94.1% for those treated with BLINCYTO compared to 84.8% for those treated with only chemotherapy (HR 0.45, 95% CI 0.24-0.85).

"Relapsed ALL remains a major cause of pediatric cancer mortality, with nearly half of the relapses occurring in children with standard-risk B-ALL," said Rachel E. Rau, M.D., co-chair of the Children’s Oncology Group AALL1731 study, pediatric hematologist-oncologist at Seattle Children’s Hospital and associate professor of pediatrics at the University of Washington. "These findings underscore the progress made with blinatumomab in preventing relapse and support its role as a critical addition to current therapeutic strategies."

Safety results are consistent with the known safety profile of BLINCYTO. BLINCYTO has demonstrated a positive balance of benefits and risks, with only 0.3% of first courses associated with Grade 3+ cytokine release syndrome (CRS) and 0.7% with seizures. A higher risk of infections was observed in the BLINCYTO arm.

These results provide the first evidence supporting BLINCYTO for use in the consolidation phase in newly diagnosed pediatric Philadelphia chromosome-negative (Ph-) B-ALL patients. This groundbreaking first-in-class Bispecific T-cell Engager (BiTE) therapy is now backed by additional evidence reinforcing its role in redefining a standard of care for both adult and pediatric patients, starting from one month old, regardless of measurable residual disease (MRD) status. The findings further establish BLINCYTO as a versatile first-line consolidation therapy across all ages and treatment backbones.

The NCI’s Cancer Therapy Evaluation Program (CTEP), which sponsored the study will share data with the U.S. Food and Drug Administration as part of their ongoing communications relating to the trial.

On December 7, 2024 Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported interim clinical data as of a July 5, 2024 data cutoff from the ongoing phase 1/2 trial of petosemtamab, a Biclonics targeting EGFR and LGR5, in previously treated (2L+) patients (pts) with recurrent/metastatic (r/m) head and neck squamous cell carcinoma (HNSCC) (Press release, Merus, DEC 7, 2024, View Source [SID1234648857]). These data were presented by Christophe Le Tourneau MD, Ph.D., Institut Curie, Paris, France at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Asia Congress on Saturday, Dec. 7 in Singapore.

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"Petosemtamab clinical data in r/m HNSCC continues to demonstrate potentially practice changing efficacy and safety, both as monotherapy in 2L+ and in combination with pembrolizumab in 1L PD-L1 expressing HNSCC," said Fabian Zohren, M.D., Ph.D., Chief Medical Officer of Merus. "Further, the monotherapy durability of petosemtamab thus far compares favorably to current standard of care, which we believe is another positive indicator for the likelihood of success of our phase 3 investigation of petosemtamab and pembrolizumab in 1L PD-L1 expressing HNSCC."

"Head and neck squamous cell carcinoma remains a deadly disease with limited treatment options," added Dr. Le Tourneau. "With its strong clinical outcomes across a large dataset of patients, regardless of HPV status and EGFR expression, petosemtamab has the potential to become a new standard of care for patients with recurrent/metastatic head and neck cancer."

Presentation title: Petosemtamab (MCLA-158) monotherapy in previously treated (2L+) recurrent/metastatic (r/m) head and neck squamous cell carcinoma (HNSCC): Phase 2 trial
Observations in the presentation include:

As of a July 5, 2024 data cutoff date, 82 pts were treated with petosemtamab 1500 mg Q2W
The efficacy population consists of 75 pts who had the opportunity for 4 or more months follow up and ≥1 post-baseline tumor assessment; or who discontinued early due to disease progression or death
Seven pts were not efficacy evaluable: 6 pts were previously described at AACR (Free AACR Whitepaper) 2023 and one additional patient withdrew due to infusion related reaction (IRRs) on Day 1
Confirmed overall response rate (ORR): 36% (90% CI: 27–46; 27/75) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. per investigator assessment, including 4 complete responses (CRs), with one CR continuing on treatment for more than 3 years as of the data cutoff; and 13% (2/15) ORR in HPV associated cancer with another 5 patients achieving stable disease
At the time of data cutoff, 10 pts remain on treatment including 8 responders and 2 pts with stable disease
Median duration of response (DOR), progression free survival (PFS) and overall survival (OS) were 6.2, 4.9 and 11.4 months
For the most mature data set, the single arm cohort previously presented at AACR (Free AACR Whitepaper) 2023, as of a July 5, 2024 data cutoff, for all 54 patients, the median DOR, PFS and OS were 6.7, 5.1, and 12.0 months, respectively; among the 48 treatment evaluable subset, they were 6.7, 5.2, and 12.5 months, respectively
Petosemtamab 1500 mg Q2W continues to be well tolerated with a manageable safety profile with no new safety signals observed (82 pts)
Infusion related reactions (IRRs) were predominantly seen on day 1 of cycle 1; a clinically meaningful reduction in the incidence and severity of IRR was observed with an updated administration regimen
As of a July 5, 2024 data cutoff date, 28 pts were treated with petosemtamab 1100 mg Q2W
The efficacy population consists of 27 pts who had the opportunity for 4 or more months follow up and ≥1 post-baseline tumor assessment; or who discontinued early due to disease progression or death
One pt was not evaluable for efficacy due to withdrawing consent with <2 months treatment
ORR: 19% (90% CI: 8–35; 5/27), including 2 CRs, by RECIST v1.1. per investigator assessment
The full presentation is available on the Merus website.

Petosemtamab Clinical Development
r/m HNSCC: LiGeR-HN1 phase 3 trial in 1L and LiGeR-HN2 phase 3 trial in 2/3L enrolling; phase 2 trial of petosemtamab in combination with pembrolizumab in PD-L1+ 1L HNSCC ongoing with a clinical data update planned for 2025

mCRC: Phase 2 trial of petosemtamab in combination with standard chemotherapy in 2L metastatic colorectal cancer (mCRC) enrolling; phase 2 trial in 1L mCRC in combination with standard chemotherapy planned to initiate in 2025, and phase 2 trial in 3L+ monotherapy planned to initiate in 2025; mCRC initial clinical data planned for 2025

Company Conference Call and Webcast Information
Merus will hold a conference call and webcast for investors on December 7, 2024 at 9:00 a.m. ET. A replay will be available after the completion of the call in the Investors and Media section of our website for a limited time. 

Date & Time: Dec. 07, 2024 at 9:00 a.m. ET
Webcast link: Available on our website
Dial-in: Toll Free: 1 (800) 715-9871/ International: 1 (646) 307-1963
Conference ID: 1978503

About Head and Neck Cancer
Head and neck squamous cell carcinoma (HNSCC) describes a group of cancers that develop in the squamous cells that line the mucosal surfaces of the mouth, throat, and larynx. These cancers begin when healthy cells change and grow in an unchecked manner, ultimately forming tumors. HNSCC is generally associated with tobacco consumption, alcohol use and/or HPV infections, depending on where they develop geographically. HNSCC is the sixth most common cancer worldwide and it is estimated that there were more than 930,000 new cases and over 465,000 deaths from HNSCC globally in 2020.1 The incidence of HNSCC continues to rise and is anticipated to increase by 30% to more than 1 million new cases annually by 2030.2 HNSCC is a serious and life-threatening disease with poor prognosis despite currently available standard of care therapies.

1 Sung et al. CA Cancer J Clin, 71:209-49, 2021; 2 Johnson, D.E., Burtness, B., Leemans, C.R. et al. Head and neck squamous cell carcinoma. Nat Rev Dis Primers 6, 92 (2020)

About Petosemtamab
Petosemtamab, or MCLA-158, is a Biclonics low-fucose human full-length IgG1 antibody targeting the epidermal growth factor receptor (EGFR) and the leucine-rich repeat containing G-protein-coupled receptor 5 (LGR5). Petosemtamab is designed to exhibit three independent mechanisms of action including inhibition of EGFR-dependent signaling, LGR5 binding leading to EGFR internalization and degradation in cancer cells, and enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) activity.

On December 6, 2024 EpimAb Biotherapeutics, a global clinical stage biotechnology company specializing in the development of bispecific antibodies, reported the acceptance of a late-breaking abstract featuring our novel BCMA targeted T cell engager (TCE) EMB-06 (CND106) as an oral presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in San Diego, California to be held between December 7-10, 2024 (Press release, EpimAb Biotherapeutics, DEC 6, 2024, View Source [SID1234654055]).

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This presentation will highlight the full Phase I clinical results for EMB-06 (CND106), a novel BCMA targeting TCE designed with an optimized efficacy and safety profile, in relapsed or refractory multiple myeloma patients. EpimAb recently granted the exclusive rights to develop and commercialize EMB-06 (CND106) outside of Greater China to Candid Therapeutics. The oral presentation details are as follows:

Title: A Phase I Study of a Novel BCMA×CD3 Bispecific Antibody EMB-06 in Relapsed or Refractory Multiple Myeloma
Session Date: December 8
Session Time: 10:45 – 11:00AM local time
Location: Pacific Ballroom Salons 18-19 (Marriott Marquis San Diego Marina)
Presentation number: 498

"We are very pleased to share the full results of the EMB-06 FIH study as an oral presentation at the ASH (Free ASH Whitepaper) Annual Conference, and we believe the data highlights EMB-06’s differentiated efficacy and safety profile in multiple myeloma patients," said Dr. Chengbin Wu, Founder and CEO of EpimAb. "The results of this study also provide validation of our TCE technology platform and we will further leverage this expertise to advance novel therapies for diseases with significant unmet need."

About EMB-06

EMB-06 is a novel 2+2 BCMA×CD3 T-cell engaging bispecific antibody discovered using EpimAb’s proprietary CD3 panel and bispecific platforms. Importantly, this molecule has demonstrated lower levels of cytokine release in preclinical and clinical studies.

On December 6, 2024 BostonGene, a leading provider of AI-driven molecular and immune profiling solutions, reported the selection of 10 abstracts for poster presentations and two abstracts for online publication at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, which will be held December 7-10, 2024, in San Diego, California. BostonGene will exhibit in booth #1955 (Press release, BostonGene, DEC 6, 2024, View Source [SID1234648860]).

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"We are excited to present our research findings at ASH (Free ASH Whitepaper) that underscores the transformative potential of integrating molecular and immune profiling with advanced analytics. This approach is pivotal in advancing precision medicine and improving outcomes for individuals battling cancer," said Nathan Fowler, MD, Chief Medical Officer at BostonGene.

Details of the presentations are below:

Abstract: 1593
Title: Machine Learning-Based Approach to Improve Classification and Diagnostics of Peripheral T-Cell Lymphomas
Date & time: Saturday, December 7 | 5:30 PM -7:30 PM
Presenter: Anastasia Sobol, MS, BostonGene

BostonGene developed a machine learning-based classifier to aid in the diagnoses of peripheral T-cell lymphoma not otherwise specified (PTCL-NOS) cases. Using this transcriptomic classifier to examine over 400 cases, approximately 50% of PTCL-NOS cases were reclassified into specific subtypes based on the gene expression pattern of each sample. These findings may enhance the understanding of PTCL pathogenesis and lead to improved diagnostic methods.

Research conducted in collaboration with Weill Cornell Medicine

Abstract: 3610
Title: Novel Plasma Cell-Free RNA-Based Liquid Biopsy Approach for CLL
Date & time: Sunday, December 8 | 6:00 PM – 8:00 PM
Presenter: Andrey Shubin, PhD, BostonGene

To address gaps in disease monitoring for chronic lymphocytic leukemia (CLL) patients, BostonGene developed a novel liquid biopsy approach based on plasma cell-free RNA (cfRNA) sequencing. From a simple blood draw, the cfDNA assay revealed malignant B-cell fractions, B-cell receptor repertoires and clinically significant mutations from cfRNA transcriptomes, as well as associations between treatment and immune- or tissue-specific processes. This liquid biopsy platform may support longitudinal monitoring CLL dynamics and minimal residual disease with further validation.

Research conducted in collaboration with Massachusetts General Hospital and Harvard Medical School

Abstract: 2981
Title: Gene Expression-Based Classifier Reclassifies Burkitt Lymphoma, HGBL NOS, DLBCL NOS, and Double/Triple Hit Lymphomas into Subtypes with More Uniform Mutational and Microenvironment Landscapes and Treatment Response
Date & time: Sunday, December 8 | 6:00 PM – 8:00 PM
Presenter: Juan Pablo Alderuccio, MD, Sylvester Comprehensive Cancer Center at the University of Miami

A machine learning-driven, expression-based classifier was applied to high-grade B-cell lymphomas, identifying subgroups based on unique genomic and transcriptomic features. Validated using large datasets, this classifier could accurately and repeatedly divide aggressive lymphoma cases into diffuse large B-cell and Burkitt lymphoma-like groups based on gene expression. These findings illustrate the clinical applications of a gene expression-based classifier in identifying subsets of patients with aggressive lymphomas.

Research conducted in collaboration with the Sylvester Comprehensive Cancer Center at the University of Miami

Abstract: 3038
Title: Acalabrutinib with Rituximab is Highly Effective as a First Line Treatment for Older Patients with Mantle Cell Lymphoma
Date & time: Sunday, December 8 | 6:00 PM – 8:00 PM
Presenter: Preetesh Jain, MD, MBBS, PhD, DM, The University of Texas MD Anderson Cancer Center

A phase II clinical trial for mantle cell lymphoma patients receiving acalabrutinib and rituximab demonstrated a 94% overall response rate, with 90% of patients achieving complete remission. Correlative analyses with next-generation sequencing and immunoprofiling techniques revealed key features of the immune system’s dynamics and adaptive response following treatment with the combination.

Research conducted in collaboration with the MD Anderson Cancer Center

Abstract: 2982
Title: Use of Molecular Immune Signatures for Frontline Treatment Selection in Patients with Advanced Stage Follicular Lymphoma
Date & time: Sunday, December 8 | 6:00 PM – 8:00 PM
Presenter: Tony Zhuang, MD, MD Anderson Cancer Center

Transcriptomic analysis of pretreatment biopsies from advanced follicular lymphoma (FL) patients revealed that B-cell-associated gene signatures were linked with survival in FL patients receiving chemoimmunotherapy, while T-cell signatures correlated with improved outcomes in patients treated with lenalidomide and rituximab. These findings support the clinical application of transcriptomic profiling for FL patients.

Research conducted in collaboration with the MD Anderson Cancer Center

Abstract: 2958
Title: Circulating Tumor DNA Predicts Outcomes in Follicular Lymphoma: Analysis from a Prospective Study
Date & time: Sunday, December 8 | 6:00 PM – 8:00 PM
Presenter: Rahul Lakhotia, MBBS, National Institutes of Health

An ongoing prospective clinical trial examined the utility of serial circulating tumor DNA (ctDNA) for monitoring disease progression in follicular lymphoma patients. Detectable in over 90% of patients, baseline ctDNA levels correlated with FLIPI prognostic scores, total metabolic tumor volume and spontaneous regression. Serial ctDNA analysis accurately reflected tumor dynamics, demonstrating its value as a minimally invasive tool for tracking disease progression.

Research conducted in collaboration with the National Cancer Institute, University of South Florida, National Institutes of Health, Medical College of Georgia, University of Virginia, Adaptive Biotechnologies

Abstract: 4341
Title: Comprehensive Analysis of Malignant B-Cell Receptors Provides Insights into B-Cell Lymphoma Pathogenesis
Date & time: Monday, December 9 | 6:00 PM – 8:00 PM
Presenter: Evgeniia Alekseeva, PhD, BostonGene

Aimed at characterizing B-cell receptor (BCR) repertoires, BostonGene leveraged a blood-based approach to discover biomarkers capable of distinguishing B-cell lymphoma subtypes. Several features, including BCR isotype, IGVH somatic hypermutation rate and chain structure, were associated with specific subtypes, highlighting the potential for diagnostic biomarkers within BCR repertoires.

Abstract: 4377
Title: Radiation Therapy and Monocyte Activation in Large B-cell Lymphoma Patients Treated with CAR T-Cell Therapy
Date & time: Monday, December 9 | 6:00 PM – 8:00 PM
Presenter: Penny Fang, MD Anderson Cancer Center

A study evaluating CART-treated large B-cell lymphoma (LBCL) patients revealed radiation therapy reshapes the immune landscape, particularly by increasing monocyte levels, proliferation and cytotoxicity. This shift suggested radiation therapy is a viable bridging therapy for CART LBCL patients, promoting a suppressive immunotype linked with decreased toxicity and increased treatment response.

Research conducted in collaboration with the MD Anderson Cancer Center

Abstract: 4348
Title: Genomic and Spatial Proteomic Characterization of the Microenvironment of Diffuse Large B-Cell Lymphoma in African American Patients
Date & time: Monday, December 9 | 6:00 PM – 8:00 PM
Presenter: Michelle Lee, MD, PhD, Winship Cancer Institute of Emory University

A flagship multiomics study characterizing diffuse large B-cell lymphoma (DLBCL) in African American patients revealed the prevalence of immune-inflamed microenvironments, molecular alterations and distinct spatial cellular communities. These findings suggest tumor-specific factors may drive the disparity in survival outcomes and underscore the need for larger, more diverse clinical cohorts.

Research conducted in collaboration with the Winship Cancer Institute of Emory University, MD Anderson Cancer Center and Georgia Institute of Technology

Abstract: 4364
Title: Evaluating the clinical utility of comprehensive whole exome sequencing (WES) and RNA-seq for patients with lymphoma
Date & time: Monday, December 9 | 6:00 PM – 8:00 PM
Presenter: Dai Chihara, MD, PhD, MD Anderson Cancer Center

The BostonGene Tumor PortraitTM test, featuring integrated genomic and transcriptomic profiling, was used to generate clinically relevant findings, treatment recommendations and matched clinical trials for lymphoma patients. With a median turnaround time of just 8 days, the Tumor PortraitTM test’s robust findings and rapid turnaround time demonstrated the utility of integrated whole exome and transcriptome sequencing for lymphoma patients.

Research conducted in collaboration with the MD Anderson Cancer Center

Online only
Title: Tumor Genomics and Microenvironment Characterization of Diffuse Large B-Cell Lymphoma in Asian and Pacific Islander Patients

Integrated whole exome and transcriptome sequencing was performed on diffuse large B-cell lymphoma (DLBCL) tumors from the Hawaii Surveillance, Epidemiology, and End Results residual tissue repository, constituting an initial characterization of the DLBCL microenvironment in Asian and Pacific Islander patients, an under-represented population in prior studies. The findings suggest existing classification systems may not represent DLBCL heterogeneity in non-European populations, illustrating the need for studies with more diverse patient populations to reveal how ancestry, socioeconomic elements and environmental factors contribute to DLBCL pathobiology and outcomes.

Research conducted in collaboration with the Winship Cancer Institute of Emory University and MD Anderson Cancer Center

Title: Comprehensive Molecular Characterization of Monomorphic Post-Transplant Lymphoproliferative Disorder (PTLD)

Comparative analysis of Epstein-Barr virus (EBV)-positive and -negative post-transplant lymphoproliferative disorder (PTLD) patients with diffuse large B-cell lymphoma (DLBCL) uncovered distinct immune signatures and a higher prevalence of protumor elements among EBV-positive PTLD patients. When compared with immunocompetent-DLBCL, PTLD samples contained a higher fraction of plasma B-cells. While EBV-negative PTLDs largely resembled de novo DLBCLs, EBV-positive PTLDs were enriched with unique molecular features. These findings emphasize the role of EBV status in PTLD biology and associated clinical outcomes.

Research conducted in collaboration with the MD Anderson Cancer Center

In addition to the poster presentations, the abstracts have been published online in the November supplemental issue of "Blood."

On December 6, 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 a collaboration with Sanofi to explore the combination of its allogeneic g-NK cell therapy, IDP-023, with Sanofi’s CD38-targeting monoclonal antibody, Sarclisa (isatuximab) (Press release, Indapta Therapeutics, DEC 6, 2024, View Source [SID1234648859]).

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Indapta has amended its ongoing phase 1 study of IDP-023, to add a cohort of IDP-023 in combination with Sarclisa for patients with relapsed/refractory multiple myeloma. Up to three dose levels of IDP-023 will be explored in the combination.

Under the agreement, Indapta will sponsor the clinical trial, Sanofi will supply Sarclisa, and the Parties will co-fund the trial. As presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Meeting, IDP-023 administered with or without interleukin-2 achieved a mean maximum reduction in serum M-protein or light chain of 73% in eight relapsed/refractory myeloma patients. This appears to be superior to prior trials of natural killer cells in myeloma.

"With its deep experience in multiple myeloma and pipeline of products in hematologic malignancies and immunologic disorders, Sanofi is an excellent partner to help Indapta develop our differentiated natural killer cell product," said Robert Sikorski, Indapta’s Chief Medical Officer. "We look forward to a close collaborative relationship and leveraging Sanofi’s expertise in the design of potential subsequent studies."

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.