Prestige Biopharma Receives FDA Fast Track Designation for PBP1510 in the Treatment of Pancreatic Cancer

Prestige Biopharma Receives FDA Fast Track Designation for PBP1510 in the Treatment of Pancreatic Cancer




Prestige Biopharma Receives FDA Fast Track Designation for PBP1510 in the Treatment of Pancreatic Cancer

SINGAPORE–(BUSINESS WIRE)–Prestige Biopharma has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for PBP1510 (International Non-proprietary name: Ulenistamab), in the treatment of unresectable or metastatic pancreatic adenocarcinoma (PDAC) that has relapsed following and/or is refractory to at least one line of prior therapy.

PBP1510 targets Pancreatic Adenocarcinoma Upregulated Factor (PAUF), a tumour-specific protein, found to be overexpressed in majority of pancreatic cancer cases. PAUF overexpression promotes key cellular functions, including proliferation, migration, invasion, and growth of pancreatic cancer cells, and contributes to the development of acquired resistance to chemotherapeutic agents. PBP1510 is designed to target these key biological mechanisms that results in limited effectiveness of current treatment options and rapid progression of pancreatic cancer.

By effectively inhibiting the tumorigenic effects of PAUF overexpression in preclinical models, PBP1510 represents a promising therapeutic strategy for addressing the unmet medical needs of pancreatic cancer patients. A global Phase 1/2a clinical trial is currently underway in the United States, Europe, and Asia, with the aim of bringing this innovative therapy to the clinic.

The first-in-human Phase 1/2a study is an open-label, multicentre, two-part study in patients with advanced/metastatic pancreatic cancer. Phase 1 is a dose-escalation phase, wherein PBP1510 will be administered, either as monotherapy or in combination with gemcitabine, in two separate dose-escalation cohorts. From Phase 1 part of the study a recommended Phase 2a dose (RP2D) will be determined based on the analysis of pharmacokinetics, safety, and efficacy data. Phase 2 is a dose-expansion phase, wherein PBP1510 at the RP2D in combination with gemcitabine will be administered to evaluate efficacy and safety of PBP1510.

Overall, the Phase 1/2a study aims to collect important safety data on the use of PBP1510 as a monotherapy or in combination with gemcitabine and explore the efficacy of a combined PBP1510 and gemcitabine regimen. The study will substantiate the preclinical findings of PBP1510’s synergistic antitumour activity in combination therapy with gemcitabine without increased toxicity, as anticipated from their distinct mechanisms of action.

With Fast Track designation from the FDA, PBP1510 represents a promising advancement in the treatment of pancreatic cancer. Prestige Biopharma intends to take full advantage of the benefits offered by the designation to provide faster access for patients in need.

Contacts

info@prestigebio.com

Genoscience Pharma – new approaches disrupting cancer cell lysosomal functions

Autophagy is a catabolic process which degrades a cellular own component through the lysosomal machinery. The lysosome, at the heart of the autophagy sytem is important in various processes (cancer, infection…).

Genoscience Pharma - new approaches disrupting cancer cell lysosomal functions

In Cancer, they are required in tumor cells for cellular adhesion, motility and signaling, exocytosis, angiogenesis and overall survival, growth, aggressiveness, metastatic potential and drug resistance. Because of their high metabolic rates, rapidly dividing and invasive cancer cells require increased new biomass production to survive. The lysosome is also important for adaptation to nutrient stress as it contains hydrolytic enzymes that play a major role in the degradation of intracellular macromolecules and catabolic (such as autophagy) and anabolic growth. This busy lysosomal behavior leads to alterations in lysosomal structure and function, which, paradoxically, renders cancer cells more sensitive to lysosomal destabilization. In addition, lysosomal enzyme activity is elevated in many tumors compared to adjacent normal tissue, and several reports suggest that lysosomes in tumor cells are more fragile than normal lysosomes. Therefore, lysosome seems to be a target of interest in the fight against cancers. Targeting lysosomes triggers apoptotic and lysosomal cell death pathways.

Genoscience Pharma – new approaches disrupting cancer cell lysosomal functions

In virology, It has been shown that autophagy is activated during virus and bacterial infection and that some viruses can use the autophagy system to facilitate their own replication . Some viruses, such as Coronaviruses are single stranded, positive sense RNA viruses, which induce the rearrangement of cellular membranes upon infection of a host cell. This provides the virus with a platform for the assembly of viral replication complexes, improving efficiency of RNA synthesis. Genoscience Pharma focuses on new approaches disrupting cancer cell lysosomal functions.

Genoscience Pharma was founded in 2001 by Pr Philippe Halfon, a world renowned medical expert on viral diseases, especially on Human Immunodeficient Virus (HIV) and Hepatitis C Virus (HCV). The company was initially focused on the development of anti-HCV agents. Two protease inhibitors were thus developed and out-licensed to BioLineRX. A new scientific direction was taken in 2012 after the discovery of a new chemical family: autophagy inhibitors. Following promising preliminary in vitro and in vivo results from these small molecules, including against cancer stem cells, Genoscience Pharma has decided to take the opportunity to make the difference in Oncology, especially in cancers where medical needs are still unmet. Now, Genoscience Pharma is a clinical stage biopharmaceutical company focused on translating novel scientific insights into medicines for patients with cancer.

Genoscience Pharma – new approaches disrupting cancer cell lysosomal functions

More info: https://www.genosciencepharma.com/

Keywords : lysosomal functions , cancer, oncology , Genoscience Pharma , lysosomes , infectious diseases  , virus , Covid19, leukemia , pancreatic cancer , hepatocarcinoma , small molecules

Sycai Medical – Early stage diagnosis of pancreatic cancer through Medical Imaging and Artificial Intelligence

Sycai Medical is a technological startup founded in Barcelona in 2020, born from the motivation of empowering radiologists to improve healthcare through artificial vision and big data. They develop AI-based algorithms, which helps medical professionals in the diagnosisof abdominal injuries and in the prediction of their evolution to increase early-stage cancer detection and improving the quality of life of patients with chronic diseases.

Their product Sycai Medical is an assistant, which helps radiologists to detect pancreatic cystic lesions, predicting their malignant potential and presenting similar cases to verify the diagnosis.

This kind of lesions can evolve into pancreatic cancer, the 4th cause of death by cancer in Europe with an average survival time from diagnosis of less than 5 months and currently without an efficient method or early diagnosis.

The follow-up treatment of the pancreatic cysts leads to repetitive image tests for life, due to the difficulty of predicting which ones are going to be malignant and which are staying benign. The ability of predicting their evolution is the key to increase early detection of pancreatic cancer and to optimize the follow-up treatments.

Their Artificial Intelligence and Big Data based software assists radiologists in the detection and classification of abdominal lesions on CT scans and MRIs. It also provides a prediction of the probability of each lesion to become cancer in the future, which is crucial to diagnose early-stage pancreatic cancer and to improve the life quality of patients.

More info : www.sycaimedical.com  

Artificial Intelligence – Big Data – Software – Digital Health – Medical Imaging – Oncology – Pancreatic Cancer – Abdomen – Radiology – Diagnostics – Detection  

Aduro Biotech – engineered Immunotherapy for Cancer

Aduro Biotech is a clinical-stage cancer immunotherapy company with multiple therapeutic approaches in development that have the potential to yield powerful immunotherapy combinations.

Aduro Biotech – engineered Immunotherapy for Cancer

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Scancell – innovative ImmunoBody

Scancell – innovative ImmunoBody

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