SKL27969 / SK Bio - LARVOL DELTA

Safety, Tolerability, PK/PD & Preliminary Efficacy of SKL27969 in Advanced Solid Tumors Patients (clinicaltrials.gov) - P1/2 | N=17 | Terminated | Sponsor: SK Life Science, Inc. | N=96 ➔ 17 | Trial completion date: Sep 2024 ➔ Mar 2024 | Active, not recruiting ➔ Terminated | Trial primary completion date: Sep 2024 ➔ Mar 2024; The study has been terminated based on portfolio prioritization. No safety trends or issues were identified at any dose level.

Enrollment change • Metastases • Trial completion date • Trial primary completion date • Trial termination • Breast Cancer • Ependymoma • Glioblastoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA • PD-L1

Safety, Tolerability, PK/PD & Preliminary Efficacy of SKL27969 in Advanced Solid Tumors Patients (clinicaltrials.gov) - P1/2 | N=96 | Active, not recruiting | Sponsor: SK Life Science, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Breast Cancer • Ependymoma • Glioblastoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA • PD-L1

Tumor pharmacokinetics and pharmacodynamics in patient-derived xenograft models of glioblastoma treated with the PRMT5 inhibitor SKL27969 (SNO 2023) - "SKL27969 is well tolerated, achieves pharmacologically relevant unbound concentrations in GBM PDX models, and is associated with significant target modulation. Ongoing studies are evaluating in vivo survival benefit from combining PRMT5 inhibition with radiation therapy."

PK/PD data • Preclinical • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • CASP3

Tumor pharmacokinetics and pharmacodynamics in patient-derived xenograft models of glioblastoma treated with the PRMT5 inhibitor SKL27969 (SNO 2023) - "SKL27969 is well tolerated, achieves pharmacologically relevant unbound concentrations in GBM PDX models, and is associated with significant target modulation. Ongoing studies are evaluating in vivo survival benefit from combining PRMT5 inhibition with radiation therapy."

PK/PD data • Preclinical • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • CASP3

SKL27969, an oral selective PRMT5 inhibitor, sensitizes the effect of DNA-damaging agents in preclinical models of multiple solid tumors (AACR 2023) - "Robust antitumor effects were observed after treatment with SKL27969 in combination with paclitaxel or gemcitabine in NSCLC PDX or pancreatic cancer CDX models. This is the first preclinical study that suggests the therapeutic potential of SKL27969 in combination with currently approved DNA-damaging agents, and supports further clinical investigation of SKL27969’s role in improving the therapeutic benefit of standard therapies."

Preclinical • Breast Cancer • CNS Tumor • Gastrointestinal Cancer • Glioblastoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Triple Negative Breast Cancer • PRMT5

Discovery and pharmacological characterization of SKL27969, a novel brain-penetrating PRMT5 inhibitor with strong antitumor activity, in glioblastoma and brain metastasis preclinical models (SNO 2022) - P1/2 | "Furthermore, SKL27969 showed potentiation of DNA damage when used in combination with DNA-damaging agents, which may suggest possible benefit as a combination therapy. Given the therapeutic target potential of PRMT5 in glioblastoma and other brain metastatic cancers, and the preclinical efficacy of SKL27969, these results have enabled the initiation of Phase 1/2 open-label, multicenter dose-finding study in patients with advanced solid tumors (NCT05388435)."

Preclinical • Brain Cancer • Breast Cancer • Glioblastoma • Hematological Disorders • Hematological Malignancies • Immunology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer • PRMT5

SK Biopharmaceuticals Receives Korea Drug Development Fund Investment Grant to Develop Novel Oncology Candidate, SKL27969 (PRNewswire) - "SK Biopharmaceuticals...announced that the state-run Korea Drug Development Fund (KDDF) has decided to support and finance the company's development of SKL27969, which is being evaluated as potential treatment for patients with advanced solid tumors, widening SK Biopharmaceuticals' area into oncology....SK Biopharmaceuticals will present its preclinical data of SKL27969 at the annual Society for Neuro-Oncology (SNO) conference in Tampa Bay, Florida, November 16 - 20, 2022."

Financing • Preclinical • Oncology • Solid Tumor

"Select projects targeting synthetic lethality TNG908 MRTX1719 SKL27969 AMG 193 AG-270 IDE397 JNJ-64619178 PRT543 PRT811 RP-6306 GSK3326595 GSK3368715 PF-06939999 JBI-778 TNG462 ISM020 AGX323 AT101/ AT201 @JacobPlieth @evaluatepharma https://t.co/74gBPzNLcn https://t.co/5Um0uV9GAB" (@BRAINCURES)

Synthetic lethality

Safety, Tolerability, PK/PD & Preliminary Efficacy of SKL27969 in Advanced Solid Tumors Patients (clinicaltrials.gov) - P1/2 | N=96 | Recruiting | Sponsor: SK Life Science, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oligodendroglioma • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA • PD-L1

Safety, Tolerability, PK/PD & Preliminary Efficacy of SKL27969 in Advanced Solid Tumors Patients (clinicaltrials.gov) - P1/2 | N=96 | Not yet recruiting | Sponsor: SK Life Science, Inc.

New P1/2 trial • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oligodendroglioma • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA • PD-L1

SK life science Announces FDA Clearance of IND Application for its Oncology Candidate, SKL27969, a PRMT5 Inhibitor for the Potential Treatment of Advanced Solid Tumors (PRNewswire) - "SK Life Science...announced that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application to study SKL27969 as a potential treatment of advanced solid tumors. SK life science will conduct a Phase 1/2 open-label, non-randomized, multicenter, dose escalation and expansion study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of SKL27969 in adult patients with solid tumors."

IND • New P1/2 trial • Oncology • Solid Tumor