SPL-108 / Splash Pharma - LARVOL DELTA

Developing CD8 T cell mRNA Vaccines Targeting BK Polyomavirus Large T Antigen (WTC 2025) - "2024 Transpl108: 1834)... We successfully generated LTag-based mRNA vaccine core constructs, eliciting BKPyV-specific T cell responses in a cell culture vaccination model. This innovative approach will be taken to preclinical humanized mouse models before entering phase I/II trials. If effective and well tolerated, vaccination increasing BKPyV-specific T cell responses is predicted to improve protection from new-onset BKPyV-DNAemia/nephropathy and the efficacy of clearance following reduced immunosuppression, without inducing rejection."

Late-breaking abstract • Renal Disease • CD4 • CD8 • HLA-B • IFNG • TNFA

SPL-108 mitigates metastasis and chemoresistance in tubo-ovarian carcinoma. (PubMed, Transl Oncol) - "SPL-108 treatment has anti-metastatic properties and may play a role in chemoresistance in preclinical models of TOCs independent of CD44 expression. Ongoing in vitro and in vivo studies will help guide further clinical development of SPL-108."

Journal • Oncology • Ovarian Cancer • Solid Tumor • ABCB1 • CD44

Phase I trial of daily subcutaneous SPL-108 injections in combination with paclitaxel in patients with platinum resistant CD44+ advanced ovarian epithelial cancer. (PubMed, Int J Gynecol Cancer) - P1 | "The combination of SPL-108 with weekly paclitaxel was safe and well tolerated. Encouraging antitumor activity was observed, with 72% of patients deriving a clinical benefit."

Combination therapy • Journal • P1 data • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Pain • Solid Tumor • CD44

PARP and ABCB1 (MDR1) inhibitor treatment of ovarian cancer cell lines and PDX models demonstrate no synergistic effect (SGO 2022) - "Learning Objective: Discuss the relationship between novel therapeutic agent SPL-108 in the context of parp inhibitor resistance"

Preclinical • Oncology • Ovarian Cancer • Solid Tumor • ABCB1

An open-label phase 1 trial of the safety and efficacy of daily subcutaneous SPL-108 injections when used in combination with paclitaxel in patients with platinum-resistant, CD44+, advanced ovarian epithelial cancer. (ASCO 2018) - P1; "Safety will be assessed and subjects without dose-limited toxicity continue 6 cycles, unless disease progression or unacceptable toxicity occurs. Arm II is the Exploratory Expansion Phase: 12 subjects receive SPL-108 daily dose determined in the Arm I Safety phase with concurrent 80 mg/m2 paclitaxel."

Clinical • Combination therapy • P1 data • Ovarian Cancer

[VIRTUAL] Open label phase I trial using SPL-108 in combination with weekly paclitaxel final report with molecular correlates. (ASCO 2020) - "Daily SPL-108 300mg SQ in combination with weekly PTX is safe and feasible. The promising clinical activity on drug resistant ovarian tumors warrants further investigation. Resistance to SPL-108 are characterized by lack of function of TP53, mostly early truncations."

Clinical • Combination therapy • P1 data • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor • CD44 • TP53

An open-label phase 1 trial of the safety and efficacy of daily subcutaneous spl-108 injections in combination with paclitaxel in patients with platinum-resistant, CD44+, advanced ovarian epithelial cancer (SGO 2019) - "Paclitaxel in combination with SPL-108 is safe and well tolerated at the doses used. Four of 6 patients have shown prolonged PR and stable disease as well as clinical benefit from symptomatic ascites. Expansion cohort results are pending and will be presented."

Clinical • Combination therapy • P1 data

Normative Voice Range Profile of the Young Female Voice. (PubMed, J Voice) - "A normative dataset usable for optimization of future voice assessments has been established. It may especially benefit evaluation and treatment planning for younger females suffering from vocal fold nodules."

Journal

[VIRTUAL] SPL-108 mediates metastasis and chemoresistance in high-grade serous tubo-ovarian carcinoma (SGO 2021) - No abstract available

Oncology • Ovarian Cancer • Solid Tumor

Safety and Efficacy Study of Daily SPL-108 Injections In Conjunction With Paclitaxel in Women With Ovarian Cancer (clinicaltrials.gov) - P1; N=14; Active, not recruiting; Sponsor: Splash Pharmaceuticals, Inc.; Trial completion date: Feb 2020 ➔ Jun 2020

Clinical • Combination therapy • Trial completion date

Safety and Efficacy Study of Daily SPL-108 Injections In Conjunction With Paclitaxel in Women With Ovarian Cancer (clinicaltrials.gov) - P1; N=14; Active, not recruiting; Sponsor: Splash Pharmaceuticals, Inc.; Recruiting ➔ Active, not recruiting; Trial completion date: Dec 2018 ➔ Feb 2020; Trial primary completion date: Nov 2018 ➔ Dec 2019

Clinical • Combination therapy • Enrollment closed • Trial completion date • Trial primary completion date

An open-label phase 1 trial of the safety and efficacy of daily subcutaneous spl-108 injections in combination with paclitaxel in patients with platinum-resistant, CD44+, advanced ovarian epithelial cancer (SGO 2019) - "Paclitaxel in combination with SPL-108 is safe and well tolerated at the doses used. Four of 6 patients have shown prolonged PR and stable disease as well as clinical benefit from symptomatic ascites. Expansion cohort results are pending and will be presented."

Clinical • Combination therapy • P1 data