Gosuranemab

ILT4 is an immunosuppressive receptor commonly expressed on myeloid cells. Antagonism of ILT4 may induce a proinflammatory state and stimulate antitumor T-cell response, especially with PD-(L)1 blockade. On April 7, 2024,  the latest clinical data of the anti-ILT4 IgG4 monoclonal antibody, MK-4830, in combination with pembrolizumab (pembro) in patients with previously untreated advanced head and neck squamous cell carcinoma (HNSCC) or non-small cell lung cancer (NSCLC) were reported in 2024 AACR. MK-4830's R&D ProgressThe drug MK-4830 is a monoclonal antibody that targets LILRB2. Monoclonal antibodies are a type of drug that are designed to bind to specific proteins in the body and can be used for various therapeutic purposes. LILRB2 is the specific target of MK-4830, and it is involved in various diseases and conditions. In terms of therapeutic areas, MK-4830 is being developed for the treatment of neoplasms, endocrinology and metabolic diseases, urogenital diseases, and digestive system disorders.  According to the Patsnap Synapse, MK-4830 has reached the highest phase of Phase 2 globally. And the clinical trial distributions for MK-4830 are primarily in the United States, China and United Kingdom. The key indication is Esophageal Squamous Cell Carcinoma.  Detailed Clinical Result of MK-4830This non-randomized, parallel assignment, open-labeled study (NCT03564691) was aimed to evacuate the safety, efficacy, and biomarker analyses for MK-4830 + pembro from the multi-cohort expansion phase of patients (pts) with previously untreated advanced HNSCC or NSCLC.   In this study, pts aged ≥18 y with previously untreated advanced HNSCC and PD-L1 combined positive score (CPS) ≥1 (cohort D) or NSCLC regardless of PD-L1 status (cohorts E and F) were enrolled. Pts in all cohorts received either MK-4830 800 mg (cohorts D and E) or 1600 mg (cohort F) + pembro 200 mg Q3W for ≤35 cycles. Primary end points were safety and ORR per RECIST v1.1 by investigator assessment. Exploratory end points included DOR and PFS per RECIST v1.1 by investigator assessment and evaluating possible biomarkers of response to MK-4830 + pembro. The result showed that at data cut-off (September 27, 2023), 35, 47, and 11 pts were enrolled and received treatment in cohorts D, E, and F, respectively. Median study follow-up was 34.4 mo (range, 26.5-42.4) in cohort D, 35.9 mo (22.4-39.8) in cohort E, and 38.7 mo (37.6-39.6) in cohort F. Adverse events (AEs) occurred in 33 pts (94%) in cohort D, 43 pts (91%) in cohort E, and 10 pts (91%) in cohort F. Treatment-related AEs (TRAEs) occurred in 20 pts (57%) in cohort D, 26 pts (55%) in cohort E, and 6 pts (55%) in cohort F; grade 3-5 TRAEs occurred in 5 pts (14%), 4 pts (9%), and 1 pt (9%), respectively. One pt in cohort E and 1 pt in cohort F died due to a TRAE (pneumonitis and pneumonia, respectively). ORR was 24% (95% CI, 11-41) in cohort D, 30% (17-45) in cohort E, and 27% (6-61) in cohort F. Median DOR was 16.4 mo (range, 2.2+ to 24.4+) in cohort D, 14.8 mo (4.2+ to 32.9+) in cohort E, and 8.4 mo (3.0-21.5) in cohort F. Median PFS was 5.2 mo (95% CI, 2.0-8.0) in cohort D, 4.3 mo (1.8-8.1) in cohort E, and 3.3 (1.2-7.6) in cohort F. In cohort D, T-cell-inflamed gene expression profile (TcellinfGEP) and tumor mutational burden (TMB) did not enrich for response to MK-4830 + pembro. In cohorts E and F, PD-L1 tumor proportion score (TPS) and TcellinfGEP trended higher in pts with response to MK-4830 + pembro than pts with no response; TMB did not trend with response. It can be concluded that in pts with advanced HNSCC or NSCLC, first-line MK-4830 + pembro had a manageable AE profile with modest antitumor activity. Consistent with what was previously observed for pembro alone, a trend was observed between PD-L1 TPS and response to MK-4830 + pembro in pts with NSCLC. How to Easily View the Clinical Results Using Synapse Database?If you want to know the other clinical results of popular conferences, please lick on the “Clinical Results” on the homepage of Patsnap Synapse, which provides multi-dimensional screening and filtering of drugs, indications, targets, companies, result evaluation, release date, popular conferences, etc. to help you quickly locate the data you need.  Select the clinical meeting you are interested in, such as ESMO. In the results, you can quickly locate the data you want to view by indication, phase and drug name.  A single result clearly shows important information such as registration number, phase, indication, Sponsor/Collaborator, biomarker, Trial number, dosing regimen and more.  If you would like to view more information about this result, you can go to the result detail page by clicking on the title.  Above the headings, we provide the original source of the outcome data. The basic information is supplemented with more information beyond the list, such as company, study. design, etc.  In the important Outcome Measures section, we provide both list and flowchart forms, which are convenient for you to overview the comparison group information and core indicator data.  Finally, if you need to download these results, you can conveniently check the check boxes on the left side of the list, or directly click the "Export" button to download the data for personalized analysis and file sharing. 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SINGAPORE, Aug. 17, 2022 (GLOBE NEWSWIRE) -- Tessa Therapeutics Ltd. (Tessa), a clinical-stage cell therapy company developing next-generation cancer treatments for hematological malignancies and solid tumors, today announced the dosing of the first patient in a Phase 1b clinical trial investigating TT11, the company’s autologous CD30 chimeric antigen receptor T-cell (CAR-T) therapy, in combination with Bristol Myers Squibb’s nivolumab as a potential second-line treatment for patients with relapsed or refractory CD30-positive classical Hodgkin lymphoma (cHL). The Phase 1b open-label trial (ACTION; NCT05352828) will enroll up to 14 patients with CD30+ cHL with relapsed or refractory disease after front-line therapy combining PD-1 antibody and CAR-T therapy in a “sandwich” study design. Patients will initially receive two cycles of nivolumab dosed at four-week intervals followed by lymphocyte depleting treatment with fludarabine/bendamustine chemotherapy. Patients will then receive a single infusion of TT11, followed by two additional cycles of nivolumab. The primary endpoint of the trial is safety and tolerability of the combination regimen. Secondary endpoints will evaluate key efficacy indicators including overall response rate, duration of response, and progression-free survival. “Initiation of this Phase 1b clinical trial marks an important milestone for our autologous CD30.CAR-T program as we now have the opportunity to evaluate TT11 in combination with nivolumab as a potential second-line treatment for relapsed or refractory classical Hodgkin lymphoma,” stated John Ng, CTO and Acting CEO of Tessa Therapeutics. “Data from our ongoing clinical program investigating TT11 as a monotherapy treatment for later lines of classical Hodgkin lymphoma has demonstrated the CAR-T therapy to be safe with promising measures of efficacy. We now welcome the opportunity to capitalize on this clinical progress by investigating TT11 as a second-line combination therapy, which offers the opportunity to greatly increase the patient population who could potentially benefit from this course of care.” TT11 is an autologous CD30 chimeric antigen receptor T-cell (CAR-T) therapy that harvests the patient’s own T-cells and modifies them to target cancer cells expressing the CD30 protein, a well-validated lymphoma target. Clinical data from the pilot part of the ongoing Phase 2 CHARIOT trial of TT11 presented at ASH demonstrated a favorable safety profile and promising efficacy in 14 evaluable patients with relapsed or refractory classical Hodgkin lymphoma (cHL), with a complete response (CR) rate of 57.1 percent and an overall response rate (ORR) of 71.4 percent. Tessa expects to advance to the pivotal Phase 2 CHARIOT trial later this year. Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It has been approved by the U.S. Food and Drug Administration (FDA) as a treatment for numerous cancer indications, including classical Hodgkin lymphoma. “The current standard of care for relapsed or refractory classical Hodgkin Lymphoma is associated with short-term toxicities and long-term morbidity, with particularly poor tolerability noted among elderly patients,” said Dr. Ivan Horak, Chief Medical Officer and Chief Scientific Officer of Tessa Therapeutics. “TT11, Tessa’s CD30 CAR-T therapy, has demonstrated encouraging clinical results as monotherapy, and we believe the combination with nivolumab has the potential to further enhance efficacy and provide patients with a chemotherapy-sparing, second-line treatment option.” About Tessa Therapeutics Tessa Therapeutics is a clinical-stage biotechnology company developing next-generation cell therapies for the treatment of hematological cancers and solid tumors. Tessa’s lead clinical asset, TT11, is an autologous CD30-CAR-T therapy currently being investigated as a potential treatment for relapsed or refractory classical Hodgkin lymphoma as both a monotherapy (Phase 2) and combination therapy (Phase 1b). TT11 has been granted RMAT designation by the FDA and access to the PRIME scheme by European Medicine Agency. Tessa is also advancing an allogeneic “off-the- shelf” cell therapy platform targeting a broad range of cancers in which Epstein Barr Virus Specific T Cells (EBVSTs) are augmented with CD30-CAR. A therapy using this platform is currently the subject of a Phase 1 clinical trial in CD30-positive lymphomas. Tessa has its global headquarters in Singapore, where the company has built a state of the art, commercial cell therapy manufacturing facility. For more information on Tessa, visit www.tessacell.com.