SIRPant-M (RB-1355) / Bobcatbio - LARVOL DELTA

Intratumoral cellular immunotherapy with autologous hyperactivated M1 SIRPα-low macrophages in non-Hodgkin lymphoma: Clinical results from a first-in-human Phase 1 study (ASH 2025) - P1 | "In this phase 1 first-in-human study RB-1355 has shown to be a safe and easily administeredcellular therapy, not requiring lymphodepleting chemotherapy or specific antigen expression, withpromising anti-tumoral activity and favorable immunological effects in patients with heavily pre-treatedNHL. Higher doses and retreatment, with the goal of promoting secondary immune responses andfurther restructuring of the TME, may be needed to induce more frequent and durable responses.Forthcoming analysis of ctDNA, peripheral blood cytokines, and circulating T cells will further inform ourunderstanding of RB-1355 mechanism of action and dose optimization."

Clinical • First-in-human • IO biomarker • P1 data • B Cell Lymphoma • Cutaneous T-cell Lymphoma • Cytomegalovirus Infection • Dermatology • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • CD20 • CXCL9 • SIRPA • SPP1

SMART101 Donor T-Lymphoid Progenitors to Accelerate Immune Reconstitution Post-Haploidentical Peripheral Blood Stem Cell Transplantation with Post-Transplant Cyclophosphamide: SI101-02 First-in-Human Phase I/II (ASH 2023) - P1/2 | "Conclusion SMART101 is the first-generation of allogeneic TLP cell therapy obtained from Smart Immune's proprietary GMP manufacturing platform. The duration and the depth of T cell immunodeficiency post haplo PTCy HSCT is expected to be significantly reduced by the infusion of SMART101 thereby decreasing the non-relapse mortality and morbidity rates and thus improving the overall clinical outcome of this therapy."

First-in-human • P1/2 data • Post-transplantation • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Malignancies • Immunology • Infectious Disease • Myelodysplastic Syndrome • Oncology • Transplantation • CD34 • CD7

Phase 1 Study of Autologous Sirpα-Low Macrophages (SIRPant-M) Administered By Intratumoral Injection Alone or in Combination with External-Beam Radiotherapy in Patients with Relapsed or Refractory Non-Hodgkin Lymphoma (NCT05967416) (ASH 2023) - P1 | "Tumor response, including abscopal response, is evaluated by Lugano criteria or other Workgroup criteria as appropriate for the tumor type at the end of the DLT-period (Day 30), Week 12 and per SOC thereafter. Serial blood samples and a tumor biopsy before and 16 days after treatment are collected for multi-parameter analyte detection including pro-inflammatory cytokines, multiplex flow cytometry, scRNA sequencing, and ctDNA analysis to investigate pharmacodynamics and mechanism of action."

Clinical • Combination therapy • P1 data • Cutaneous T-cell Lymphoma • Graft versus Host Disease • Hematological Malignancies • Immunology • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • SIRPA

SI101. Opening Ceremony, State of the ACS, and Martin Memorial Lecture | Looking Forward Together in an Uncertain Time (ACS-CLINCON 2025) - "The ACS Executive Director and CEO will deliver a "State of the ACS" Address followed by the 79th presentation of the prestigious Martin Memorial Lecture. If you would like to claim credit for the Martin Memorial Lecture, please select the NL01 session."

A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants With Macular Edema Secondary to Inflammation (MESI) - PINNACLE (clinicaltrials.gov) - P3 | N=150 | Recruiting | Sponsor: Kodiak Sciences Inc | Not yet recruiting ➔ Recruiting

Enrollment open • Inflammation • Macular Edema • Ophthalmology

A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants With Macular Edema Secondary to Inflammation (MESI) - PEAK (clinicaltrials.gov) - P3 | N=150 | Recruiting | Sponsor: Kodiak Sciences Inc | Not yet recruiting ➔ Recruiting | Trial primary completion date: Dec 2026 ➔ Feb 2026

Enrollment open • Trial primary completion date • Inflammation • Macular Edema • Ophthalmology

Optimization of friction stir welding parameters for enhanced mechanical properties of AISI 1018 carbon steel. (PubMed, Sci Rep) - "Confirmation tests aligned with the predicted outcomes, which demonstrates the effectiveness of the optimized parameters. The findings provide a structured framework to optimize FSW parameters and offer valuable insights for industrial applications in the automotive and structural manufacturing sectors."

Journal

Mechanical properties and residual stresses in multi pass AISI 304 to AISI 1018 steel welds by SMAW and GTAW. (PubMed, Sci Rep) - "Additionally, PWHT enhanced impact toughness, with increases of 17.3% for SMAW weldments and 21.4% for GTAW weldments. The weld area exhibited the highest hardness values across all weldments; however, a slight reduction in tensile strength was observed after PWHT due to material softening effects."

Journal

Ultrasound-Assisted Synthesis of 2‑Benzylidene-1-Indanone Derivatives and Evaluation as a Corrosion Inhibitor for Mild Steel in 1 M HCl Solution. (PubMed, ACS Omega) - "This study explores the ultrasound-assisted synthesis of three 2-benzylidene-1-indanone derivatives and assesses their effectiveness as corrosion inhibitors for mild steel AISI 1018 in 1 M HCl through electrochemical techniques and density functional theory (DFT) quantum chemical calculations...These inhibitors achieve efficiencies greater than 98%, and their inhibitory effect does not increase with higher concentrations. A comparison of computational predictions and experimental analyses indicates that the pyridine ring and the diethylamino group reduce the inhibitory capacity of carbon steel in acidic environments."

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Effect of boriding time on the effective thermal diffusivity of the borided AISI 1018 steel. (PubMed, Sci Rep) - "The crystalline structure of the layers was analyzed by X-ray diffraction and optical microscopy. The mechanical properties and the thermal diffusivity of the steel-boride layered materials were evaluated by Vickers micro indentation and Photothermal Spectroscopy, respectively."

Journal

A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants With Macular Edema Secondary to Inflammation (MESI) - PINNACLE (clinicaltrials.gov) - P3 | N=150 | Not yet recruiting | Sponsor: Kodiak Sciences Inc

New P3 trial • Inflammation • Macular Edema • Ophthalmology

A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants With Macular Edema Secondary to Inflammation (MESI) - PEAK (clinicaltrials.gov) - P3 | N=150 | Not yet recruiting | Sponsor: Kodiak Sciences Inc

New P3 trial • Inflammation • Macular Edema • Ophthalmology

Global linear accelerator requirements and personalised country recommendations: a cross-sectional, population-based study. (PubMed, Lancet Oncol) - "The LSI and LINAC shortage grade systems are effective for evaluating, monitoring, and forecasting global LINAC needs. The LSI and LINAC shortage grade highlight the substantial disparities in radiotherapy availability and underscore the urgent need for investment in radiotherapy capacity building, particularly in many low-income and middle-income countries."

Journal • Oncology

Study of SIRPant-M in Participants With Relapsed or Refractory Non-Hodgkin's Lymphoma (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: SIRPant Immunotherapeutics, Inc. | Trial completion date: Mar 2025 ➔ Dec 2025 | Trial primary completion date: Mar 2025 ➔ Jun 2025

Trial completion date • Trial primary completion date • B Cell Lymphoma • Chronic Lymphocytic Leukemia • Cutaneous T-cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Sezary Syndrome • SIRPA

Synthesis and Electrochemical Properties of Oleylamine as a Sour Saline Corrosion Inhibitor Under Laminar Flow at 40 °C. (PubMed, Materials (Basel)) - "The dynamic anticorrosive behavior of oleylamine on carbon mild steel (AISI 1018) surfaces was evaluated using a laminar flow of 100 rpm and tested with potentiodynamic polarization (PDP) and electrochemical impedance spectroscopy (EIS) measurements...However, at 100 ppm of the inhibitor, an efficiency of over 95% was achieved. After the electrochemical tests, the surface of the steel samples with the inhibitor revealed the formation of an inhibitor layer that prevented the corrosion of the steel."

Journal

SI101. Opening Ceremony, State of the ACS, and Martin Memorial Lecture | Combat Trauma: Lessons Learned and Future Challenges for Surgery (ACS-CLINCON 2024) - "The Martin Memorial Lecture was established in 1946 to honor ACS founder Franklin H. Martin, MD, FACS, and his wife, Isabelle Hollister Martin. The Martin Memorial Lecture was combined with the American Urological Association (AUA) Lecture, established in 1967, and has addressed critical topics in surgery each year."

Surgery • Urology

Discovery, characterization and mechanism of a Microbacterium esterase for key d-biotin chiral intermediate synthesis. (PubMed, Bioresour Bioprocess) - "Herein, a novel esterase EstSIT01 belonging to family V was identified from Microbacterium chocolatum SIT101 through genome mining and phylogenetic analysis...Molecular docking and MD simulations suggest that the high stereoselectivity for meso-diester may attribute to the narrow entrance tunnel and unique binding pocket structure. Collectively, EstSIT01 holds great potential for preparing chiral carboxylic acids and esters."

Journal

SIRPant Immunotherapeutics Announces First Patient Dosed in Phase 1 Clinical Trial Evaluating SIRPant-M in Patients with Relapsed/Refractory Non-Hodgkin Lymphoma (GlobeNewswire) - "SIRPant Immunotherapeutics, Inc...today announced the first patient has been dosed in the Company’s Phase 1, first-in-human, multi-center study evaluating SIRPant-M alone or in combination with focal external-beam radiotherapy (XRT) in patients with relapsed/refractory Non-Hodgkin lymphoma (R/R-NHL)....we look forward to providing updates as early outcomes emerge in in 2024."

Trial status • Cutaneous T-cell Lymphoma • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma

SIRPant Immunotherapeutics Announces FDA Clearance of IND Application for SIRPant-M for the Treatment of Solid Tumors (GlobeNewswire) - "SIRPant Immunotherapeutics, Inc...today announced that the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application for the Company’s lead product candidate, SIRPant-M™, an autologous SIRPαlow activated macrophage therapy, to treat solid tumors. Eligible tumor types include, among others, head and neck cancer, non-melanoma skin cancers, bladder and kidney cancers, low-grade prostate cancer, triple-negative breast cancer and certain sarcomas...'We look forward to progressing SIRPant-M^TM through clinical development and dosing the first patients in both the NHL and solid tumor trial in 2024.'....The Phase 1, multi-center clinical study is designed to evaluate the safety, determine the recommended dose for Phase 2, and assess preliminary anti-tumor activity in subjects with solid tumors that have progressed following available standard treatment, or for whom no standard treatment exists."

IND • New P1 trial • Bladder Cancer • Breast Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Non-melanoma Skin Cancer • Oncology • Prostate Cancer • Sarcoma • Skin Cancer • Solid Tumor • Triple Negative Breast Cancer

Study of SIRPant-M in Participants With Relapsed or Refractory Non-Hodgkin's Lymphoma (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: SIRPant Immunotherapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Lymphocytic Leukemia • Cutaneous T-cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Sezary Syndrome • SIRPA

Performance assessment of vegetable-based additive enriched cutting fluid for eco-friendly machining environment. (PubMed, Environ Sci Pollut Res Int) - "The investigation focuses on determining the effects of canola oil-based cutting fluid with three different volume percentages of boric acid additives over the machining forces and surface roughness while turning hardened AISI 1018 mild steel...The implementation of hybrid modeling is considered to be a novel attempt to minimize the machining objectives. It has been recorded a negligible error percentage of 0.66% between GRA and ANN prediction."

Journal

SIRPant Immunotherapeutics Receives FDA Orphan Drug Designation for SIRPant-M for the Treatment of T-Cell Lymphoma (GlobeNewswire) - "SIRPant Immunotherapeutics Inc...announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for the Company’s lead product candidate, SIRPant-M, an autologous SIRPαlow activated macrophage therapy, for the treatment of T-cell lymphoma."

Orphan drug • Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

Orphan Designation: Treatment of T-cell lymphoma (FDA) - Date Designated: 11/06/2023

Orphan drug • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

A first-in-human Phase 1/2 clinical trial of SIRPαlow activated macrophages (SIRPant-M) for the treatment of R/R-NHL (SITC 2023) - "An SRC will review any adverse events and DLTs. Blood samples and biopsies will be collected for multi-parameter analyte detection, multiplex flow cytometry, scRNA sequencing, and ctDNA analysis to investigate safety, pharmacodynamics, and mechanism of action."

Clinical • P1/2 data • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CALR • SIRPA

SI101. Opening Ceremony (ACS-CLINCON 2023) - "An annual overview of the College will be reported by the Executive Director. The Martin Memorial Lecture, sponsored by the American Urological Association, follows immediately.."

Urology