Clinical Stage CAR-T for AL Amyloidosis and immune-mediated diseases

PIPELINE & PUBLICATIONS

Pipeline

Only CAR-T in AL Amyloidosis; Tailor-Made for immune-mediated disease  Indications. Lead Program: NXC-201, a next-generation BCMA-targeting CAR-T for AL Amyloidosis and immune-mediated diseases. 

Indication

Relapsed/Refractory AL Amyloidosis​

Therapy

A sterically-optimized chimeric antigen receptor T (CAR-T) cell therapy in development for the treatment of Relapsed/Refractory AL Amyloidosis and autoimmune diseases.

An autologous CAR-T therapy (using a patients own cells) targeting BCMA which seeks out and destroys dysfunctional plasma cells that drive these diseases.

PRE-CLINICAL

PHASE 1

PHASE 2

US FDA and EU EC Orphan Drug Designation ODD

US FDA and EU EC Orphan Drug Designation ODD

Indication

Immune-Mediated Diseases

Therapy

A sterically-optimized chimeric antigen receptor T (CAR-T) cell therapy in development for the treatment of Relapsed/Refractory AL Amyloidosis and autoimmune diseases.

An autologous CAR-T therapy (using a patients own cells) targeting BCMA which seeks out and destroys dysfunctional plasma cells that drive these diseases.

PRE-CLINICAL

PHASE 1

PHASE 2

IND Enabled

Indication

UNDISCLOSED

Therapy

Cell Therapy

PRE-CLINICAL

PHASE 1

PHASE 2

PUBLICATIONS

RELAPSED/REFRACTORY LIGHT CHAIN (AL) AMYLOIDOSIS

ORAL PRESENTATION (LATE-BREAKING)
ASGCT – American Society of Gene & Cell Therapy — 27th Annual Meeting – May 10, 2024

M. Assayag, N. Asherie, S. Kfir-Erenfeld, Eyal Lebel, S. Grisariu, B. Avni, T. Dubnikov-Sharon1, S. Elias, M. Gatt, P. Stepensky. Academic BCMA-CART Cells HBI0101 (NXC-201), a Promising Approach for the Treatment of LC Amyloidosis. American Society of Gene & Cell Therapy 27th Annual Meeting. May 10, 2024.

ISA – XIX International Symposium on Amyloidosis (International Society of Amyloidosis) Presentation

E. Lebel, S. Kfir Erenfeld, N. Asherie, S. Grisariu, B. Avni, S. Elias, M. Assayag, T. Dubnikov, N. Zalcman, M. Pick, E. Zimran, C. Cohen, P. Stepensky, M.E. Gatt. Efficacy and Safety of Anti-BCMA Chimeric Antigen Receptor T-Cell (CART) (NXC-201) for the Treatment of Relapsed and Refractory AL amyloidosis. International Society of Amyloidosis. May, 2024.

ORAL PRESENTATION
ASH – 65th Annual American Society of Hematology Annual Meeting and Exposition (AL Amyloidosis) – Dec 10, 2023

Lebel, S. Kfir Erenfeld, N. Asherie, S. Grisariu, B. Avni, S. Elias, M. Assayag, T. Dubnikov, N. Zalcman, M. Pick, E. Zimran, Y. Cohen, I. Avivi, C. Cohen, P. Stepensky, M.E. Gatt. Feasibility of a Novel Academic Anti-BCMA Chimeric Antigen Receptor T-Cell (CART) (HBI0101) for the Treatment of Relapsed and Refractory AL Amyloidosis, 65th ASH Annual Meeting and Exposition, San Diego, CA. Dec 10 2023

ABSTRACT

ASH – 65th Annual American Society of Hematology Annual Meeting and Exposition – (AL Amyloidosis) – October 2023

Lebel, S. Kfir Erenfeld, N. Asherie, S. Grisariu, B. Avni, S. Elias, M. Assayag, T. Dubnikov, N. Zalcman, M. Pick, E. Zimran, Y. Cohen, I. Avivi, C. Cohen, P. Stepensky, M.E. Gatt. Feasibility of a Novel Academic Anti-BCMA Chimeric Antigen Receptor T-Cell (CART) (HBI0101) for the Treatment of Relapsed and Refractory AL Amyloidosis, 65th ASH Annual Meeting and Exposition, San Diego, CA. October 2023

ORAL PRESENTATION
IMS – International Myeloma Society – 20th Annual Meeting -Oral Presentation (AL Amyloidosis) – Sep 27-30, 2023

Lebel, S. Kfir Erenfeld, N. Asherie, S. Grisariu, B. Avni, S. Elias, M. Assayag, T. Dubnikov, N. Zalcman, M. Pick, E. Zimran, Y. Cohen, I. Avivi, C. Cohen, P. Stepensky, M.E. Gatt. Feasibility of a Novel Academic Anti-BCMA Chimeric Antigen Receptor T-Cell (CART) (HBI0101) for the Treatment of Relapsed and Refractory AL Amyloidosis, International Myeloma Society 20th Annual Meeting. 2023 Sep 27-30.

ORAL PRESENTATION (LATE-BREAKING)
ASGCT – American Society of Gene & Cell Therapy — 29th Annual Meeting – May 19, 2023

Asherie N. et al, BCMA-Targeted CART (HBI0101), a Safe and Efficacious Novel Modality of Treatment for Light Chain Amyloidosis (AL) Patients. Oral Presentation. ASGCT – American Society of Gene & Cell Therapy 29 th Annual Meeting. May 19, 2023.

LATE-BREAKING ABSTRACT
ASGCT – American Society of Gene & Cell Therapy — 29th Annual Meeting – May 19, 2023

Asherie N., Kfir-Erenfeld S., Lebel E., Assayag M., Grisariu S., Avni B., Gatt ME, Stepensky, P. BCMA-Targeted CART (HBI0101), a Safe and Efficacious Novel Modality of Treatment for Light Chain Amyloidosis (AL) Patients. Late Breaking Abstract. ASGCT – American Society of Gene & Cell Therapy 29 th Annual Meeting. May 19, 2023.

PUBLICATION
Phase 1 – AL Amyloidosis

Kfir-Erenfeld S, Asherie N, Grisariu S, Avni B, Zimran E, Assayag M, Sharon TD, Pick M, Lebel E, Shaulov A, Cohen YC, Avivi I, Cohen CJ, Stepensky P, Gatt ME. Feasibility of a Novel Academic BCMA-CART (HBI0101) for the Treatment of Relapsed and Refractory AL Amyloidosis. Clin Cancer Res. 2022 Dec 1;28(23):5156-5166. doi: 10.1158/1078-0432.CCR-22-0637. PMID: 36107221.

RELAPSED/REFRACTORY MULTIPLE MYELOMA

PUBLICATION
Phase 1/2 – Multiple Myeloma 50 patients at 800M cells

S. Kfir-Erenfeld, N. Asherie, E. Lebel, V. Vainstein, M. Assayag, S.T. Dubnikov, S. Grisariu, B. Avni, S. Elias, R. Alexander-Shani, N. Bessig, A. Shehadeh, A. Ishtay, V. Zelmanovich, E. Zimran, M. Pick, I. Roziner, R.S. Kenett, Y.C. Cohen, I. Avivi, C.J. Cohen, M.E.E. Gatt, P. Stepensky. Clinical evaluation and determinants of response to HBI0101 (BCMA CART) therapy in relapsed/refractory multiple myeloma. Blood Adv. 2024 May 20:bloodadvances.2024012967. doi: 10.1182/bloodadvances.2024012967. Epub ahead of print. PMID: 38768428.

POSTER PRESENTATION
ASH – 65th Annual American Society of Hematology Annual Meeting and Exposition – (Multiple Myeloma) – Dec 11, 2023

Lebel, N. Asherie, S. Kfir Erenfeld, S. Grisariu, B. Avni, S. Elias, M. Assayag, T. Dubnikov, N. Zalcman, M. Pick, E. Zimran, A. Shaulov, Y. Cohen, I. Avivi, C. Cohen, P. Stepensky, M.E. Safety and efficacy of a locally produced novel anti-BCMA Chimeric antigen receptor T-cell (CART) (HBI0101) for the treatment of relapsed and refractory multiple myeloma. 65th ASH Annual Meeting and Exposition, San Diego, CA. Dec 11, 2023

ABSTRACT
ASH – 65th Annual American Society of Hematology Annual Meeting and Exposition – (Multiple Myeloma) – October 2023

Lebel, N. Asherie, S. Kfir Erenfeld, S. Grisariu, B. Avni, S. Elias, M. Assayag, T. Dubnikov, N. Zalcman, M. Pick, E. Zimran, A. Shaulov, Y. Cohen, I. Avivi, C. Cohen, P. Stepensky, M.E. Safety and efficacy of a locally produced novel anti-BCMA Chimeric antigen receptor T-cell (CART) (HBI0101) for the treatment of relapsed and refractory multiple myeloma. 65th ASH Annual Meeting and Exposition, San Diego, CA. October 2023

POSTER PRESENTATION
IMS – International Myeloma Society – 20th Annual Meeting – (Multiple Myeloma) – Sep 27-30, 2023

Lebel, N. Asherie, S. Kfir Erenfeld, S. Grisariu, B. Avni, S. Elias, M. Assayag, T. Dubnikov, N. Zalcman, M. Pick, E. Zimran, A. Shaulov, Y. Cohen, I. Avivi, C. Cohen, P. Stepensky, M.E. Gatt. Efficacy and Safety of a Locally Produced Novel Anti-BCMA Chimeric Antigen Receptor T-Cell (CART) (HBI0101) for the Treatment of Relapsed and Refractory Multiple Myeloma, International Myeloma Society 20th Annual Meeting. Sep 27-30 2023.

POSTER PRESENTATION
European Society for Blood and Marrow Transplantation 49th Annual Meeting – Apr 23-26, 2023

Assayag , N. Asherie, S. Kfir Erenfeld, B. Avni, T. Dubnikov, N. Zalcman, E. Lebel, E. Zimran, A. Shaulov, M. Pick, Y. Cohen, I. Avivi, C. Cohen, M. Gatt, S. Grisariu, P. Stepensky. Point-of-care CART manufacture and delivery for the treatment of multiple myeloma and AL amyloidosis: the experience of Hadassah Medical Center. Poster Presentation, European Society for Blood and Marrow Transplantation 49th Annual Meeting. 2023 Apr 23-26.

POSTER PRESENTATION
5th European CAR T-cell Meeting – 47 Patient Clinical Data Poster Presentation – Feb 9-11, 2023

Assayag M, Asherie N, Kfir-Erenfeld S, Avni B, Dubnikov T, Zalcman N, Lebel E, Zimran E, Shaulov A, Pick M, Cohen Y, Avivi I, Cohen C, Gatt ME, Grisariu S, Stepensky P. Point-of-care CART manufacture and delivery: Expanding access to CART therapy via local institutions, Hadassah Medical Center experience. Poster Presentation, European Society for Blood and Marrow Transplantation and European Hematology Association 5th European CAR T-cell Meeting. 2023 Feb 9-11.

PUBLICATION
Phase 1 – Multiple Myeloma

Asherie N, Kfir-Erenfeld S, Avni B, Assayag M, Dubnikov T, Zalcman N, Lebel E, Zimran E, Shaulov A, Pick M, Cohen Y, Avivi I, Cohen C, Gatt ME, Grisariu S, Stepensky P. Development and manufacturing of novel locally produced anti-BCMA CART cells for the treatment of relapsed/refractory multiple myeloma: phase I clinical results. Haematologica. 2022 Oct 6. doi: 10.3324/haematol.2022.281628. Epub ahead of print. PMID: 36200421.

EDITORIAL PUBLICATION

Editorial – Sjöstrand M, Sadelain M. Driving CARs to new places: locally produced BCMA CAR T cells to treat multiple myeloma. Haematologica. 2023. doi: 10.3324/haematol.2022.282053. Epub ahead of print. PMID: 36794501. (PDF link)

PUBLICATION
Preclinical

Harush O, Asherie N, Kfir-Erenfeld S, Adler G, Barliya T, Assayag M, Gatt ME, Stepensky P, Cohen CJ. Preclinical evaluation and structural optimization of anti-BCMA CAR to target multiple myeloma. Haematologica. 2022 Oct 1;107(10):2395-2407. doi: 10.3324/haematol.2021.280169. PMID: 35354252; PMCID: PMC9521250.

TSTX PUBLICATIONS

CLINICAL TRIALS

  1. IMX-110 Phase 1b/2a Trial: IMX-110 in Patients With Advanced Solid Tumors
  2. Select IMX-110 Development Safety Update Report (DSUR) Summary
  3. IMX-110 + Tizleilizumab anti-PD-1 Phase 1b/2a Trial: Study of IMX-110 in Combination With Tislelizumab in Patients With Advanced Solid Tumors (IMMINENT-01)

SCIENTIFIC POSTERS, PUBLICATIONS & REVIEWS

  1. Nanomedicine based curcumin and doxorubicin combination treatment of glioblastoma with scFv-targeted micelles In vitro evaluation on 2D and 3D tumor models
  2.  A nanomedicine-based curcumin and doxorubicin combination treatment of glioblastoma with scFv-targeted micelles: In vitro evaluation in 2D and 3D tumor models
  3. Anti-cancer activity of anti-GLUT1 antibody-targeted polymeric micelles co-loaded with curcumin and doxorubicin
  4. Nanotechnology-based treatment for chemotherapy-resistant breast cancer
  5. Metastatic Soft Tissue Sarcomas: A Review of Treatments and New Pharmacotherapies
  6. Constitutive Activation of NF-kB during Progression of Breast Cancer to Hormone-Independent Growth
  7. Development of Curcumin as an Epigenetic Agent
  8. Micellar Nanocarriers: Pharmaceutical Perspectives
  9. Cycling cancer persister cells arise from lineages with distinct programs
  10. Leveraging and coping with uncertainty in the response of individual cells to therapy
  11. IMX-110 Preclinical Data Pack (Oct 2021)
  12. IMX-111 Preclinical Data Pack (Oct 2021)
  13. IMX-120 Preclinical Data Pack (Oct 2021) (Undisclosed)

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