MOLECURE


Associated tags: University, VIB, Biology, RNA, Rutgers University, Cell biology, Yale University, Pharmaceutical industry, MOC, Sarcoidosis, Patient, Cancer, ARG1, ARG2, Research, Safety

Locations: EUROPE, UNITED KINGDOM, GERMANY, LONDON, EU, WARSAW, PL, DENMARK, GREECE, POLAND, FRANCE, US, NORWAY, UK, EUROPEAN UNION, UNITED STATES

Molecure has published its financial report for 2023 - the company has significantly accelerated the development of its clinical and pre-clinical programmes and plans to make strong progress in research in 2024 and 2025

Retrieved on: 
Wednesday, April 3, 2024
Medical device, Annual report, ARG1, Documentation, Biotechnology, Sarcoidosis, Partnership, Patient, Scientific Research Publishing, USP7, Ethics, SPO, Biomarker, Research, Health care, Conception, Cancer, Messenger, POC, PLN, Biology, Royal, MHRA, Polish, Clinical trial, Safety, MOC, Phase, ARG2, Food, FDA, SMART, CDA, Pharmaceutical industry

We initiated clinical trials of our drug candidate, which was discovered and brought into clinical trials for cancer patients by Molecure.

Key Points: 
  • We initiated clinical trials of our drug candidate, which was discovered and brought into clinical trials for cancer patients by Molecure.
  • In 2023, our focus was also on preparing for a Phase II clinical trial for OATD 01, Molecure's flagship clinical programme.
  • We are very pleased to report that the first patient has started dosing in a clinical trial at a clinical site in the UK.
  • The Company plans to obtain further grants for projects within the framework of the pipeline developed so far.

First patient in the UK is dosed in the OATD-01 Phase 2 KITE study in pulmonary sarcoidosis

Retrieved on: 
Friday, March 22, 2024
PET/CT, Contract research organization, Biotechnology, Sarcoidosis, Disease, Patient safety, Patient, Tablet, Spirometry, Messenger, Quality of life, Biology, Royal, Fibrosis, Clinical trial, European, Arrest, Safety, Pharmacokinetics, MOC, Phase, KITE, FDA, FVC, ECG, Granuloma, Pharmaceutical industry

The world's first administration of the chitotriosidase 1 (CHIT1) inhibitor (or placebo) to patient took place at the Royal Infirmary in Edinburgh.

Key Points: 
  • The world's first administration of the chitotriosidase 1 (CHIT1) inhibitor (or placebo) to patient took place at the Royal Infirmary in Edinburgh.
  • As part of the trial, patients will take a daily fixed dose of 25 mg OATD-01 or placebo tablets for 12 weeks.
  • Patient safety will be monitored regularly through laboratory tests, neurological examinations and ECG and spirometry.
  • The study will involve approximately 20-30 centres in the US, the European Union, Norway and the UK.

Molecure Announces Third Quarter 2023 Financial Results and Pipeline Highlights

Retrieved on: 
Tuesday, October 31, 2023
IND, RNA, Saskatchewan River Sturgeon Management Board, Sarcoidosis, Research, Contract research organization, MOC, Phase, Clinical trial, Financial and social rankings of sovereign states in Europe, EMA, Public, Cancer, European, Patient, Pharmaceutical industry, Cryptocurrency

This will enable the company to deliver meaningful additional data which will be important in fulfilling the longer-term potential of our pipeline.

Key Points: 
  • This will enable the company to deliver meaningful additional data which will be important in fulfilling the longer-term potential of our pipeline.
  • The planned Phase II proof-of-concept study will be the first to treat patients suffering from pulmonary sarcoidosis and is expected to start in the fourth quarter 2023.
  • Molecure signed an agreement with Simbec-Orion, a leading global Clinical Research Organization which will conduct the clinical trial on behalf of Molecure.
  • This was mainly due to higher research costs as the company’s pipeline advances, higher salaries and costs of external services.

Molecure Announces First Half 2023 Results – Significant Financial and Operating Momentum

Retrieved on: 
Friday, September 29, 2023
ARG1, Sarcoidosis, Saskatchewan River Sturgeon Management Board, POC, Partnership, CET, American Association for Cancer Research, Financial and social rankings of sovereign states in Europe, Food, Proof of concept, Acceleration, Food and Drug Administration, Clinical trial, Public, Cancer, RNA, Research, Messenger, Strategy, EMA, Trust, Patient, ARG2, European, PLN, MOC, FDA, Therapy, IND, Molecular Cancer Research, Phase, Safety, Pharmaceutical industry, Cryptocurrency, Vaccine, Fine chemical

Marcin Szumowski, CEO and President of the Management Board of Molecure said “Many events of this year were crucial for further development of Molecure.

Key Points: 
  • Marcin Szumowski, CEO and President of the Management Board of Molecure said “Many events of this year were crucial for further development of Molecure.
  • In June, we announced the updated strategy for 2023-2025, the implementation of which will enable us to continue building the company's value.
  • Bringing two of our most advanced programs to patients opened a new and exciting chapter for Molecure.
  • Molecure has signed an agreement with Simbec-Orion, a leading global Clinical Research Organisation which will conduct the clinical trial on behalf of Molecure.

The U.S. Food and Drug Administration Gives the Green Light to Molecure’s Flagship Program – Phase II Clinical Testing of OATD-01 is Ready for Launch

Retrieved on: 
Monday, July 24, 2023
Sarcoidosis, World Association of Sarcoidosis and other Granulomatous Disorders, Granuloma, European Medicines Agency, Research, RNA, EMA, Organization, Patient, European, PET/CT, MOC, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, News, Food, Disease, Pharmaceutical industry, EU

The first pulmonary sarcoidosis patients in this Phase II study are scheduled to begin receiving treatment in Q4 2O23.

Key Points: 
  • The first pulmonary sarcoidosis patients in this Phase II study are scheduled to begin receiving treatment in Q4 2O23.
  • This marks the beginning of a new chapter in the development of our flagship project, as we enter human proof-of-concept studies and begin treating pulmonary sarcoidosis patients with OATD-01.
  • In the coming weeks we are also planning to file for approval of phase II clinical trials with the European Medicines Agency (EMA).
  • That would make it possible for us to begin testing OATD-01 in the European Union – including Poland.

Molecure completes successful Secondary Public Offering (SPO) of approximately PLN 50 million (USD 12 million) with proceeds to be used to fund and build a first in class, sustainable pipeline of breakthrough therapies

Retrieved on: 
Friday, July 21, 2023
Secondary market offering, Shareholder, Partnership, Therapy, WSE, Cancer, Research, Negotiation, H share, USD, SPO, Messenger, Sale, PLN, Patient, Advertising, Machine learning, Series, Biology, Growth, MOC, Pharmaceutical industry, Security (finance)

The issue price was set at PLN 18, bringing the gross value of the offering to approximately PLN 50 million.

Key Points: 
  • The issue price was set at PLN 18, bringing the gross value of the offering to approximately PLN 50 million.
  • We would like to thank all investors for participating in the offering and for the trust they have placed in Molecure.
  • Considering the current market conditions, we view the execution of the share issue as a remarkable achievement.
  • Molecure estimates that the capital expenditure associated with the strategy from mid-2023 to the end of 2025 will amount to approximately PLN 250 million.

Molecure Files an Investigational New Drug (IND) application for lead clinical candidate OATD-01 with U.S. FDA ahead of a planned Phase 2 pulmonary sarcoidosis study

Retrieved on: 
Friday, June 23, 2023
Sarcoidosis, Saskatchewan River Sturgeon Management Board, ODD, Granuloma, Drug discovery, Quality of life, RNA, History, HIV disease progression rates, Patient, PET/CT, Steroid, MOC, FDA, IND, Idiopathic pulmonary fibrosis, Safety, Pharmaceutical industry, EU

Clearance of the IND would allow Molecure to begin an international Phase 2 proof of concept study to evaluate OATD-01 for the treatment of pulmonary sarcoidosis.

Key Points: 
  • Clearance of the IND would allow Molecure to begin an international Phase 2 proof of concept study to evaluate OATD-01 for the treatment of pulmonary sarcoidosis.
  • “Today’s IND filing is another landmark milestone for Molecure and its lead product OATD-01” said Molecure CEO Marcin Szumowski.
  • We anticipate beginning our Phase 2 trial in patients in the US and EU in the fourth quarter of this year.
  • The results of this double-blinded study will be available once the study is complete, expected in H1 2025.

Molecure Announces Full Year Financial 2022 Results – A Year of Significant Progress

Retrieved on: 
Thursday, March 30, 2023
ARG1, Sarcoidosis, Financial Oversight and Management Board for Puerto Rico v. Aurelius Investment, LLC, CET, Therapy, Medical device, American Association for Cancer Research, NASH, Switzerland, Clinical trial, European Directive on Traditional Herbal Medicinal Products, Cancer, CTA, RNA, Inflammation, Language, EMA, Fibrosis, Biocidal Products Directive, Congress, Patient, Vicki Belo, Interstitial lung disease, ARG2, Biology, Growth, Fatty liver disease, MOC, FDA, Leukemia, IPF, Molecular Cancer Research, Idiopathic pulmonary fibrosis, Safety, Disease, Pharmaceutical industry, Cryptocurrency, MD, Polish

“Molecure has made significant progress over 2022, becoming a clinical stage biotechnology company preparing our two most advanced assets to start multi-center phase I and phase II studies respectively” said Marcin Szumowski, CEO and President of the Management Board of Molecure.

Key Points: 
  • “Molecure has made significant progress over 2022, becoming a clinical stage biotechnology company preparing our two most advanced assets to start multi-center phase I and phase II studies respectively” said Marcin Szumowski, CEO and President of the Management Board of Molecure.
  • In recent weeks, we achieved an important milestone dosing the first cancer patient in a Phase I study with OATD-02, the first and only dual arginase inhibitor.
  • The Company's full year presentation to investors will be held on April 5, 2023 at 2:00 PM (CET) in an online meeting.
  • In 2022, Molecure announced a new name and brand identity.

Molecure announces first patient dosed in Phase I trial with novel, first-in-class dual arginase inhibitor OATD-02 for the treatment of cancer

Retrieved on: 
Wednesday, March 8, 2023
Pancreatic cancer, Patient, MOC, Renal cell carcinoma, Clinical trial, Ovarian cancer, Safety, Cancer, RNA, Biology, Colorectal cancer, Pharmaceutical industry

The Phase I trial is an open-label, multi-center, first in human, dose escalation study to evaluate safety, tolerability, anti-cancer activity and to establish the maximum tolerated dose of OATD-02.

Key Points: 
  • The Phase I trial is an open-label, multi-center, first in human, dose escalation study to evaluate safety, tolerability, anti-cancer activity and to establish the maximum tolerated dose of OATD-02.
  • The study is being conducted at three sites in Poland and will enroll a maximum of 40 patients with selected advanced and/or metastatic solid tumors including colorectal cancer, ovarian cancer, pancreatic cancer or renal cell carcinoma.
  • Marcin Szumowski, Chief Executive Officer of Molecure, said, “We are very excited to start this first in human clinical trial with OATD-02, the second candidate from Molecure’s proprietary pipeline to enter clinical development.
  • The important data emerging from this trial will help to guide future clinical development for OATD-02, which we hope will bring treatment benefits to patients with a broad range of tumors.”

Molecure Appoints Dr. Samson Fung, Chief Medical Officer to its Management Board as it Continues to Focus on Successfully Progressing its Expanded Clinical Portfolio

Retrieved on: 
Tuesday, January 3, 2023
Internal medicine, IPD, AstraZeneca, Wayne, RNA, Research fellow, Polish Academy of Arts and Sciences, Trinity College, University, Novartis, Biochemistry, Roche, Degenerative disease, AMGEN, Hematology, Sarcoidosis, Immunology, Senior, Publishing, Trinity College Dublin, Book, Publication, Micrometer, CMO, Organic chemistry, Cancer, Eli Lilly, Science, Doctor of Philosophy, Procter, MOC, Novo Nordisk, Research, University of Giessen, Wayne State University, Pharmaceutical industry

WARSAW, Poland, Jan. 3, 2023 /PRNewswire/ -- Molecure S.A. ("Molecure": WSE: MOC) a clinical stage biotechnology company using its world leading medicinal chemistry capabilities to discover first-in-class small molecule drug candidates that directly modulate unexplored protein and RNA targets to treat multiple incurable diseases, announces that Dr. Samson Fung, Chief Medical officer has been appointed to the Company's management board. Dr. Adam Gołębiowski has stepped down from the management board to take on the role of Senior Research Fellow at Molecure. In parallel, Dr. Zbigniew Zasłona, has been promoted to Chief Scientific Officer from his current position as VP Research Biology. Dr. Zasłona, will remain on Molecure's management board.

Key Points: 
  • Dr. Adam Gołębiowski has stepped down from the management board to take on the role of Senior Research Fellow at Molecure.
  • In parallel, Dr. Zbigniew Zasłona, has been promoted to Chief Scientific Officer from his current position as VP Research Biology.
  • I am also delighted to announce the promotion of Zbigniew to Chief Scientific Officer, which reflects the significant contribution he has made since joining Molecure.
  • Dr. Adam Gołębiowski has initiated the discovery of both of our clinical stage assets enabling Molecure to become a clinical stage company.