BHV-1100 News - LARVOL Sigma

|||||||||| BHV-1100 / PeptiDream, Biohaven
Journal, IO biomarker: Targeting Senescent Alveolar Epithelial Cells Using Engineered Mesenchymal Stem Cell-Derived Extracellular Vesicles To Treat Pulmonary Fibrosis. (Pubmed Central) - Feb 21, 2024
CD38-ARM-MSC-EVs effectively restored the NAD+ levels, reversed the epithelial-mesenchymal transition phenotype, and rejuvenated senescent A549 cells in vitro, thereby mitigating multiple age-associated phenotypes and alleviating PF in aged mice. Thus, this study provides a technology to engineer MSC-EVs and support our CD38-ARM-MSC-EVs to be developed as promising agents with high clinical potential against PF.

|||||||||| BHV-1100 / PeptiDream, Biohaven
Expansion, Persistence, and Characteristics of Autologous, Bhv-1100 Armored Memory-like NK Cells Infused Prior to Autologous Stem Cell Transplant in MRD+ Multiple Myeloma Patients: A First-i... (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_2540;
P1
This represents an innovative approach to boost autologous cancer immunosurveillance in the context of ASCT. Aside from anticipated infusion reactions, no severe/unexpected adverse events were noted; longer follow-up is required to assess safety and efficacy.

|||||||||| BHV-1100 / PeptiDream, Biohaven
Expansion, persistence, and characteristics of autologous, BHV-1100 ARMored memory-like NK cells infused prior to autologous stem cell transplant in MRD+, newly diagnosed multiple myeloma patients (Trianti Upper Foyer; In Person) - Sep 10, 2023 - Abstract #IMW2023IMW_278;
P1
We are herein reporting data on in vivo expansion and functional characterization of ARMored CIML NK for the first 4 patients. CIML NK cells were manufactured with a 100% success rate and infused at a target dose of 5-10x106 cells.

||||||||||  BHV-1100 / PeptiDream, Biohaven
Trial primary completion date, Minimal residual disease:  Autologous Memory-like NK Cell Therapy With BHV-1100 (Formerly KP1237), Low Dose IL-2 in Multiple Myeloma Patients (clinicaltrials.gov) -  Aug 29, 2023
P1, N=25, Recruiting,  Sponsor: Biohaven Pharmaceuticals, Inc.
CIML NK cells were manufactured with a 100% success rate and infused at a target dose of 5-10x106 cells. Trial primary completion date: Oct 2023 --> Oct 2025

||||||||||  BHV-1100 / PeptiDream, Biohaven
Trial completion date, Trial primary completion date, Minimal residual disease:  Autologous Memory-like NK Cell Therapy With BHV-1100 (Formerly KP1237), Low Dose IL-2 in Multiple Myeloma Patients (clinicaltrials.gov) -  Jun 22, 2023
P1, N=25, Recruiting,  Sponsor: Biohaven Pharmaceuticals, Inc.
Trial primary completion date: Oct 2023 --> Oct 2025 Trial completion date: Jun 2026 --> Oct 2026 | Trial primary completion date: Jun 2023 --> Oct 2023

||||||||||  BHV-1100 / PeptiDream, Biohaven
Phase classification, Minimal residual disease:  Autologous Memory-like NK Cell Therapy With BHV-1100 (Formerly KP1237), Low Dose IL-2 in Multiple Myeloma Patients (clinicaltrials.gov) -  Feb 16, 2023
P1, N=25, Recruiting,  Sponsor: Biohaven Pharmaceuticals, Inc.
Trial completion date: Jun 2026 --> Oct 2026 | Trial primary completion date: Jun 2023 --> Oct 2023 Phase classification: P1/2 --> P1

||||||||||  BHV-1100 / PeptiDream, Biohaven
Enrollment open, Combination therapy, Minimal residual disease:  Autologous Memory-like NK Cell Therapy With BHV-1100 (Formerly KP1237), Low Dose IL-2 in Multiple Myeloma Patients (clinicaltrials.gov) -  Oct 26, 2021
P1/2, N=25, Recruiting,  Sponsor: Biohaven Pharmaceuticals, Inc.
Phase classification: P1/2 --> P1 Not yet recruiting --> Recruiting

||||||||||  BHV-1100 / PeptiDream, Biohaven
Trial completion date, Trial primary completion date, Combination therapy, Minimal residual disease:  Autologous Memory-like NK Cell Therapy With BHV-1100 (Formerly KP1237), Low Dose IL-2 in Multiple Myeloma Patients (clinicaltrials.gov) -  May 6, 2021
P1/2, N=25, Not yet recruiting,  Sponsor: Biohaven Pharmaceuticals, Inc.
Not yet recruiting --> Recruiting Trial completion date: Feb 2023 --> Jun 2026 | Trial primary completion date: May 2022 --> Jun 2023

||||||||||  BHV-1100 / PeptiDream, Biohaven
Trial completion date, Trial initiation date, Trial primary completion date, Combination therapy, Minimal residual disease:  Autologous Memory-like NK Cell Therapy With BHV-1100 (Formerly KP1237), Low Dose IL-2 in Multiple Myeloma Patients (clinicaltrials.gov) -  Feb 10, 2021
P1/2, N=25, Not yet recruiting,  Sponsor: Kleo Pharmaceuticals
Trial completion date: Feb 2023 --> Jun 2026 | Trial primary completion date: May 2022 --> Jun 2023 Trial completion date: Feb 2022 --> Feb 2023 | Initiation date: Nov 2020 --> Mar 2021 | Trial primary completion date: Dec 2021 --> Mar 2022

||||||||||  BHV-1100 / PeptiDream, Biohaven
New P1/2 trial, Combination therapy, Minimal residual disease:  Autologous Memory-like NK Cell Therapy With BHV-1100 (Formerly KP1237), Low Dose IL-2 in Multiple Myeloma Patients (clinicaltrials.gov) -  Nov 17, 2020
P1/2, N=25, Not yet recruiting,  Sponsor: Kleo Pharmaceuticals

|||||||||| KP1237 / PeptiDream, Kleo Pharma
[VIRTUAL] A novel site-directed chemical conjugation technology confers antitumor activity via native Fc receptor to plasma immunoglobulin by attaching tumor binders () - Oct 14, 2020 - Abstract #SITC2020SITC_1660;
Methods Design of synthetic chemical reagents included antibody binding group capable of covalent bond formation with specific lysine, CD38 binding moiety proven to work in our clinical candidate KP1237, and tunable non-cleavable linker...KPMW101 induces IvIg to adopt Fc effector mechanisms like ADCC and ADCP. Our in vitro data and in vivo studies confirm KPMW101 ability to kill tumor cells, making IvIg into an active antitumor therapeutic agent.

|||||||||| KP1237 / PeptiDream, Kleo Pharma
[VIRTUAL] A novel site-directed chemical conjugation technology confers antitumor activity via native Fc receptor to plasma immunoglobulin by attaching tumor binders () - Oct 14, 2020 - Abstract #SITC2020SITC_925;
Methods Design of synthetic chemical reagents included antibody binding group capable of covalent bond formation with specific lysine, CD38 binding moiety proven to work in our clinical candidate KP1237, and tunable non-cleavable linker...KPMW101 induces IvIg to adopt Fc effector mechanisms like ADCC and ADCP. Our in vitro data and in vivo studies confirm KPMW101 ability to kill tumor cells, making IvIg into an active antitumor therapeutic agent.

|||||||||| KP1237 / PeptiDream, Kleo Pharma
[VIRTUAL] A first-in-class ex vivo combination between cytokine-induced memory like (CIML) NK cells and a CD38 targeting antibody recruiting molecule (ARM) as a novel approach to target NK cells without cellular engineering for the treatment of multiple myeloma. (Poster Board 423) - Apr 29, 2020 - Abstract #ASCO2020ASCO_2229;
This led to the development of the combination drug product consisting of patient autologous CIML NK cells, KP1237 and IVIG. Clinical development is under way for (MRD+) MM patients eligible for ASCT.



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