GemVax & KAEL Co., Ltd.

- Topline supports moving to Phase 3 trial and shows potential to develop GV1001 as the world's first PSP treatment SEOUL, South Korea, Oct. 29, 2024 /PRNewswire/ -- GemVax & KAEL Co., Ltd. ("GemVax"; KOSDAQ ticker: 082270) announced that topline results of a Phase 2a clinical trial (the "Phase 2a PSP Clinical Trial") of GV1001, an investigational peptide drug for the treatment of progressive supranuclear palsy ("PSP"), were presented at "Neuro2024: The PSP and CBD International Research Symposium" in Toronto, Canada, at 4:45 p.m. local time on 24th October. Continue Reading Figure 1. PSP-Rating Scale Total Score (PSP-RS Type + PSP-P Type_ LS mean using MMRM) (PRNewsfoto/GemVax & KAEL) Figure 2. PSP-Rating Scale Total Score (PSP-RS Type_ simple average) (PRNewsfoto/GemVax & KAEL) Figure 3. Responder Rate (PSP-RS Type) (PRNewsfoto/GemVax & KAEL) View PDF

Shares of Fate Therapeutics climbed nearly 4% in premarket trading after the company announced positive interim data from a Phase I study of FT516 for patients with relapsed / refractory B-cell lymphoma. San Diego-based Fate presented the interim data over the weekend at the virtually-held 2021 American Society of Clinical Oncology (ASCO) Annual Meeting. FT516 is the company’s universal, off-the-shelf natural killer (NK) cell product candidate developed from an engineered clonal master-induced pluripotent stem cell (iPSC) line. FT516 is designed to maximize antibody-dependent cellular cytotoxicity to destroy antibody-coated cancer cells. Data showed that eight of 11 patients evaluated for assessment of safety and efficacy achieved an objective response, including six patients who achieved a complete response, as assessed by PET-CT scan per Lugano 2014 criteria. Eight of those 11 patients had aggressive B-cell lymphoma. Of those, five were refractory to their most recent prior therapy, and four patients were previously treated with autologous CD19 CAR-T cell therapy, Fate said in its announcement. In particular, Fate highlighted a 36-year-old male who was diagnosed with “triple-hit, high-grade B-cell lymphoma with rearrangements of MYC, BCL2, and BCL6 genes.” The trial patient was refractory to all prior lines of therapy with the exception of autologous CD19 CAR T-cell therapy. After his first treatment cycle with FR516, the patient saw a complete response with resolution of all metabolically active diseases and an 85% reduction in the size of target lesions. At the time of the March 11 data cutoff date, the patient completed a second FT516 treatment cycle, after which the response assessment continued to show complete response. Wayne Chu, Senior Vice President of Clinical Development at Fate Therapeutics, said the data from the Phase I study continues to reinforce its safety profile while underscoring its potential clinical benefit. "Based on the favorable therapeutic profile of FT516 that continues to emerge and the potential to treat patients on-demand without delay, we plan to initiate multiple indication-specific, dose-expansion cohorts for patients with B-cell lymphomas to broadly assess FT516 in combination with CD20-targeted monoclonal antibody regimens, including those used as standard-of-care in earlier-line settings,” Chu said in a statement. The FT516 treatment regimen was well tolerated. Elsewhere at ASCO: Samsung Pharm Co. – Korea-based Samsung presented results from a Phase III study of Riavax (GV1001), which showed that the immunotherapeutic provided nearly one year of overall survival in pancreatic cancer patients compared to placebo. Data showed Riavax proved 11.3 months of OS compared to 7.5 months, a statistically significant improvement. Another key endpoint, time to tumor progression (TTP), also saw a statistical significance with 7.3 months in the treatment group compared with 4.5 months in the control group. No specific safety issues were reported. “These results indicate that Riavax should be considered as one of the treatment options for patients with locally advanced and metastatic pancreatic cancer with high serum eotaxin levels,” Samsung said in a statement. Riavax is a peptide drug designed to activate immune cells to attack cancer cells. It is known to extend survival in pancreatic cancer patients with high serum eotaxin levels when administered in combination with the current chemotherapy, Gemcitabine/Capecitabine, the company said. Samsung Pharm in-licensed domestic rights to Riavax from its affiliate, GemVax & KAEL Co., Ltd., in 2014. Merck – Merck and Japan’s Eisai Inc. announced data from the Phase III CLEAR study supporting potential approval of a combination of Keytruda and Lenvima, an orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai. A new analysis evaluating health-related quality of life (HRQoL) based on patient-reported outcomes shows the combination therapy improved quality of life measures for patients compared to the chemotherapy treatment sunitinib. The companies believe this data supports other clinical findings that suggest the combination of Keytruda and Lenvima could be a first-line treatment for patients with advanced renal cell carcinoma. “This new analysis builds on earlier findings from the CLEAR/KEYNOTE-581 trial and further supports the potential use of Keytruda plus Lenvima for the treatment of patients in the first-line setting,” Gregory Lubiniecki, Vice President of Oncology Clinical Research at Merck Research Laboratories, said in a statement. Caris Life Sciences – Texas-based Caris will present findings from a study that offers a deeper understanding of how immunotherapies impact leiomyosarcoma (LMS), rare cancer that affects smooth muscle tissue, through the use of whole exome and whole transcriptome sequencing. The findings show that traditional predictive biomarkers of response to immunotherapies (IO) are unlikely to be helpful in LMS and recommend that future trials focus on combination therapies instead. In its announcement, Caris noted that historically, LMS had been reported to have immunohistochemical and gene expression signatures that suggest an immune-responsive tumor microenvironment. Despite this, immune checkpoint inhibitors have demonstrated minimal activity in LMS. The study found that only a small proportion of LMS specimens were identified as high tumor mutational burden (TMB-H) or high microsatellite instability (MSI-H). This suggests that the neoantigen burden in LMS may not be sufficient to promote a robust anti-tumor response, even in the presence of PD-L1 positive tumor cells, the company said. Featured Jobs on BioSpace