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DRUG CLASS:

Capillary permeability modulator

18h
CENDIFOX: CEND-1 in Combination with Neoadjuvant FOLFIRINOX with or Without Panitumumab (clinicaltrials.gov)
P1/2, N=50, Active, not recruiting, Anup Kasi | Recruiting --> Active, not recruiting | Phase classification: P1b/2a --> P1/2 | Trial completion date: Sep 2025 --> Sep 2026 | Trial primary completion date: Sep 2023 --> Sep 2025
Enrollment closed • Phase classification • Trial completion date • Trial primary completion date • Combination therapy
|
BRAF (B-raf proto-oncogene)
|
5-fluorouracil • Vectibix (panitumumab) • oxaliplatin • irinotecan • leucovorin calcium • certepetide (LSTA1)
6d
BOLSTER: A Study of LSTA1 When Added to Standard of Care Versus Standard of Care Alone in Patients With Advanced Solid Tumors (clinicaltrials.gov)
P2, N=80, Recruiting, Lisata Therapeutics, Inc. | Trial completion date: Dec 2025 --> Mar 2026 | Trial primary completion date: Dec 2025 --> Mar 2026
Trial completion date • Trial primary completion date • Metastases
|
cisplatin • Imfinzi (durvalumab) • gemcitabine • 5-fluorouracil • oxaliplatin • leucovorin calcium • certepetide (LSTA1)
6d
FORTIFIDE: LSTA1 Phase 1b/2a Continuous Infusion Trial in mPDAC (clinicaltrials.gov)
P1/2, N=30, Not yet recruiting, Lisata Therapeutics, Inc. | Trial completion date: Jun 2027 --> Sep 2027 | Initiation date: Dec 2024 --> Mar 2025 | Trial primary completion date: Jun 2027 --> Sep 2027
Trial completion date • Trial initiation date • Trial primary completion date • Metastases
|
gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • oxaliplatin • irinotecan • leucovorin calcium • certepetide (LSTA1)
15d
FORTIFIDE: LSTA1 Phase 1b/2a Continuous Infusion Trial in mPDAC (clinicaltrials.gov)
P1/2, N=30, Recruiting, Lisata Therapeutics, Inc. | Not yet recruiting --> Recruiting
Enrollment open • Metastases
|
gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • oxaliplatin • irinotecan • leucovorin calcium • certepetide (LSTA1)
3ms
FORTIFIDE: LSTA1 Phase 1b/2a Continuous Infusion Trial in MPDAC (clinicaltrials.gov)
P1/2, N=30, Not yet recruiting, Lisata Therapeutics, Inc.
New P1/2 trial • Metastases
|
gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • oxaliplatin • irinotecan • leucovorin calcium • certepetide (LSTA1)
4ms
CEND-1 Injection (QLC12102) in Patients With Advanced Metastatic Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov)
P1/2, N=50, Completed, Qilu Pharmaceutical Co., Ltd. | Recruiting --> Completed | Phase classification: P1b/2 --> P1/2 | Trial completion date: May 2023 --> Jun 2024 | Trial primary completion date: May 2023 --> Jun 2024
Trial completion • Phase classification • Trial completion date • Trial primary completion date • Metastases
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paclitaxel • certepetide (LSTA1)
4ms
Enrollment open • Combination therapy • Metastases
|
gemcitabine • albumin-bound paclitaxel • certepetide (LSTA1)
4ms
Intraperitoneal LSTA1 in CRS-HIPEC (clinicaltrials.gov)
P1, N=0, Withdrawn, University of California, San Diego | N=21 --> 0 | Trial completion date: Dec 2029 --> Jun 2024 | Recruiting --> Withdrawn | Trial primary completion date: Dec 2028 --> Jun 2024
Enrollment change • Trial completion date • Trial withdrawal • Trial primary completion date • Surgery
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certepetide (LSTA1)
5ms
Haystack Oncology and Lisata Therapeutics Initiate Research Collaboration to Use the Haystack MRD Technology to Evaluate Efficacy of Pancreatic Cancer Therapy (GlobeNewswire)
"Haystack Oncology...and Lisata Therapeutics...announced a research collaboration. Lisata will deploy the highly sensitive Haystack MRD technology for the detection of circulating tumor DNA (ctDNA) in a clinical study evaluating certepetide plus chemotherapy as an investigational treatment for metastatic pancreatic cancer. In the FORTIFIDE study, Lisata is investigating the safety, tolerability, and efficacy of its lead product candidate, certepetide...in subjects with metastatic pancreatic ductal adenocarcinoma (mPDAC) who have progressed on FOLFIRINOX, a treatment for pancreatic cancer. As part of this research, Lisata has engaged Haystack to use its MRD technology to measure serum ctDNA levels at multiple timepoints in patients throughout the study as an exploratory endpoint for analyzing the early therapeutic effect of certepetide."
Licensing / partnership
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certepetide (LSTA1)
10ms
New P2 trial • Combination therapy • Metastases
|
gemcitabine • albumin-bound paclitaxel • certepetide (LSTA1)
11ms
Enrollment closed • Metastases
|
gemcitabine • albumin-bound paclitaxel • certepetide (LSTA1)
1year
Enrollment change • Metastases
|
cisplatin • Imfinzi (durvalumab) • gemcitabine • paclitaxel • certepetide (LSTA1)
1year
Trial completion date • Trial primary completion date • Metastases
|
cisplatin • Imfinzi (durvalumab) • gemcitabine • paclitaxel • docetaxel • certepetide (LSTA1)
1year
Phase classification • Metastases
|
cisplatin • Imfinzi (durvalumab) • gemcitabine • paclitaxel • docetaxel • certepetide (LSTA1)
over1year
BOLSTER: A Study of LSTA1 When Added to Standard of Care Versus Standard of Care Alone in Patients With Advanced Solid Tumors (clinicaltrials.gov)
P2a, N=120, Recruiting, Lisata Therapeutics, Inc. | Trial completion date: May 2026 --> Dec 2025 | Trial primary completion date: May 2026 --> Dec 2025
Trial completion date • Trial primary completion date • Metastases
|
cisplatin • Imfinzi (durvalumab) • gemcitabine • paclitaxel • docetaxel • certepetide (LSTA1)
over1year
A phase Ib/II, open-label, multicenter study to evaluate the safety, efficacy, and pharmacokinetics/pharmacodynamics of αvβ3/5 integrin and neuropilin-1 targeting peptide LSTA1 in patients with metastatic pancreatic ductal adenocarcinoma. (ASCO 2023)
Here we report the safety and efficacy results from a Phase Ib/II, multicenter study of LSTA1 plus (SoC) gemcitabine and locally produced nab-paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC). LSTA1 combined with SoC showed an acceptable safety profile in patients with mPDAC. Compared with historical SoC data, LSTA1 plus SoC numerically improved ORR and PFS. Higher NRP1 expression is associated with better ORR and PFS, suggesting NRP1 may be a potential biomarker of LSTA1 plus chemotherapy for mPDAC treatment.
Clinical • P1/2 data • PK/PD data • Metastases
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NRP1 (Neuropilin 1)
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gemcitabine • albumin-bound paclitaxel • certepetide (LSTA1)
almost2years
Expression and role of deleted in malignant brain tumor protein 1 in acute respiratory distress syndrome rats induced by sepsis (PubMed, Zhonghua Wei Zhong Bing Ji Jiu Yi Xue)
DMBT1 is a novel early biomarker of ARDS by affecting alveolar epithelial cell, alveolar capillary permeability and inflammatory response.
Preclinical • Journal
|
IL6 (Interleukin 6) • IL10 (Interleukin 10)
over2years
Preclinical assessment of the pharmacokinetics, disposition, and duration of action of the dual alphav-integrin and neuropilin-1 targeting peptide CEND-1 (ESMO 2022)
The duration of the tumor-penetrating effect of CEND-1 was evaluated by assessing tumor accumulation of Evans Blue and Doxorubicin in two different models of hepatocellular carcinoma (HCC): TGFα/c-myc-double transgenic mice and HepG2 xenografted mice. Conclusions These results indicate a favourable in vivo PK profile of CEND-1 after intravenous administration and demonstrate a specific and long-lasting tumour homing and tumor penetrability. Therefore, even single injections of CEND-1 may elicit long-lasting tumor PK improvements for co-administered anti-cancer agents.
PK/PD data • Preclinical
|
MYC (V-myc avian myelocytomatosis viral oncogene homolog) • NRP1 (Neuropilin 1) • TGFA (Transforming Growth Factor Alpha)
|
doxorubicin hydrochloride • certepetide (LSTA1)
almost3years
iRGD mediated delivery of neoantigens to enable immunotherapy in integrin b5-rich tumors (AACR 2022)
Our recent data shows that KrasLSL-G12D/+ Trp53LSL-R172H/+ Pdx1-Cre (KPC) mice treated with iRGD co-administered with Gemcitabine increased survival compared to drug alone. Our preliminary data showed tumor regression in 70%, and complete response in 42% of the mice treated with iRGD plus OVA1. We are now working on adapting this strategy to pancreatic cancer.
Tumor Mutational Burden • IO biomarker
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KRAS (KRAS proto-oncogene GTPase) • TMB (Tumor Mutational Burden) • CD8 (cluster of differentiation 8) • NRP1 (Neuropilin 1) • PDX1 (Pancreatic And Duodenal Homeobox 1)
|
KRAS G12D • TMB-L • KRAS G12
|
gemcitabine • certepetide (LSTA1)
almost3years
SARS-CoV-2 membrane protein causes the mitochondrial apoptosis and pulmonary edema via targeting BOK. (PubMed, Cell Death Differ)
Overall, M protein activated the BOK-dependent apoptotic pathway and thus exacerbated SARS-CoV-2 associated lung injury in vivo. These findings proposed a proapoptotic role for M protein in SARS-CoV-2 pathogenesis, which may provide potential targets for COVID-19 treatments.
Journal
|
BCL2 (B-cell CLL/lymphoma 2)
almost3years
Salvage Therapy for Relapsed Malignant Pleural Mesothelioma: A Systematic Review and Network Meta-Analysis. (PubMed, Cancers (Basel))
Patients with malignant pleural mesothelioma (MPM) have very poor prognoses, and pemetrexed plus platinum is the standard first-line therapy...Tremelimumab, vorinostat, nivolumab alone, chemotherapy (CTX), asparagine-glycine-arginine-human tumor necrosis factor plus CTX, and nivolumab plus ipilimumab all produced noticeable PFS benefits compared with placebo. Nivolumab plus ipilimumab had the best PFS ranking (SUCRA: 92.3%). Second-line treatment with nivolumab plus ipilimumab provided the OS and PFS outcomes for patients with relapsed MPM.
Retrospective data • Review • Journal
|
TNFA (Tumor Necrosis Factor-Alpha)
|
Keytruda (pembrolizumab) • Opdivo (nivolumab) • Yervoy (ipilimumab) • Imjudo (tremelimumab) • pemetrexed • Zolinza (vorinostat) • Arenegyr (NGR-hTNF)
almost3years
Arsenic-induced lung inflammation and fibrosis in a rat model: Contribution of the HMGB1/RAGE, PI3K/AKT, and TGF-β1/SMAD pathways. (PubMed, Toxicol Appl Pharmacol)
In conclusion, the current study demonstrates that sub-chronic arsenic exposure triggers the inflammatory response and collagen fiber deposition in rat lung tissue. The potential mechanism may be closely related to activation of the pro-inflammatory-related HMGB1/RAGE pathway and initiation of the PI3K/AKT and TGF-β1/SMAD pathways.
Preclinical • Journal
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SMAD4 (SMAD family member 4) • HMGB1 (High Mobility Group Box 1) • IL18 (Interleukin 18) • TGFB1 (Transforming Growth Factor Beta 1) • MMP9 (Matrix metallopeptidase 9) • IL1B (Interleukin 1, beta) • SMAD2 (SMAD Family Member 2) • SMAD3 (SMAD Family Member 3)
3years
CENDIFOX: CEND-1 in Combination With Neoadjuvant FOLFIRINOX With or Without Panitumumab (clinicaltrials.gov)
P1b/2a, N=50, Recruiting, Anup Kasi | Not yet recruiting --> Recruiting
Clinical • Enrollment open • Combination therapy
|
BRAF (B-raf proto-oncogene)
|
5-fluorouracil • Vectibix (panitumumab) • oxaliplatin • irinotecan • leucovorin calcium • certepetide (LSTA1)
over3years
iRGD-liposomes enhance tumor delivery and therapeutic efficacy of antisense oligonucleotide drugs against primary prostate cancer and bone metastasis. (PubMed, Adv Funct Mater)
Overall, we provide here a delivery system that can significantly increase ASO accumulation and efficacy in solid tumors. These benefits are achieved without significant side effects, providing a way to increase the antitumor efficacy of ASOs.
Clinical • Journal
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AR (Androgen receptor)
|
AR expression
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certepetide (LSTA1)
4years
CEND-1 in Combination With Nabpaclitaxel and Gemcitabine in Metastatic Pancreatic Cancer (clinicaltrials.gov)
P1, N=30, Completed, DrugCendR Inc. | Active, not recruiting --> Completed | Trial completion date: Dec 2020 --> Jun 2020 | Trial primary completion date: Nov 2019 --> Jun 2020
Clinical • Trial completion • Trial completion date • Trial primary completion date • Combination therapy
|
CA 19-9 (Cancer antigen 19-9)
|
gemcitabine • albumin-bound paclitaxel • certepetide (LSTA1)
almost5years
The pleura and the endocrine system. (PubMed, Eur J Intern Med)
It can lead to a rise in the releasing factor for growth hormone (GHRH), human beta chorionic gonadotropin (Beta-hCG), and insulin-like growth factor 2 (IGF2). The consequence of such hormonal imbalance include hypertrophic pulmonary osteoarthropathy, gynecomastia, and refractory hypoglycemia, respectively.
Review • Journal
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ER (Estrogen receptor) • IGF2 (Insulin-like growth factor 2)