Announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for VLX-1005 for the treatment of heparin induced thrombocytopenia (HIT).
27 January 2021
Quercis Pharma AG , a private clinical-stage biopharmaceutical company that leverages its new antithrombotic platform, announced that it has entered into an exclusive, global licensing agreement for two patents with the Beth Israel Deaconess Medical Center (BIDMC), an affiliate of Harvard Medical School, focusing on modulation, risk reduction of thrombotic pathologies and thrombotic events in cancer patients. These patents relate to the main pathways of thrombotic inhibitors, including P-selectin. Terms of the deal were not disclosed.
The patents relate to the inhibition of soluble P-selectin which helps prevent and / or reduce thrombotic events. Importantly, these patents also relate to the transport of cancer cells in the blood and may play an important role in preventing and reducing tumor metastases, the process by which cancer cells migrate throughout the body. The majority of cancer-associated deaths (approximately 90%) are due to metastasis of original tumor cells migrating to sites distant from the original or primary tumor 1 .
“Obtaining the exclusive license of these patents is important for Quercis, not only because it expands the set of patents for our main drug candidate from 2031 to 2039 in venous thromboembolism (VTE), but also because it concerns the role that P-selectin plays in the cascade of events that leads to acute respiratory disease syndrome (ARDS) in COVID-19 patients, ”said Stefan Wohlfeil , MD, medical director of Quercis Pharma. “We are delighted to collaborate with the world-renowned researchers at BIDMC, as their excellent research and development work is essential in delivering potentially life-saving drugs to patients who need new treatment options. "
The release of protein disulfide isomerase (PDI) from endothelial cells and platelets is a hallmark of the thrombo-inflammatory cascade. This was confirmed by a phase 2 clinical trial, which demonstrated that prophylactic administration of the investigational drug Quercis reduced the levels of the main markers of coagulation, without any VTE or major bleeding events being observed 2 . Obtaining exclusive access to these BIDMC patents will significantly strengthen the mechanistic claims of Quercis' drug candidate in many clinical indications of unmet need, such as VTE, COVID-19, sickle cell anemia and Ebola virus, between other.
The main drug candidate of Quercis acts as an antithrombotic agent with a significantly lower risk of side effects than existing therapies. Quercis plans to launch two Phase 3 clinical trials for the prevention of venous thromboembolism (VTE) in patients with pancreatic cancer and glioblastoma in the first half of 2021. It will also seek approval from the Food and Drug Administration (FDA) for the prevention of VTE concerning all types of cancer relating to these two phase 3 studies.
Quercis' new class of antithrombotic drugs is also a promising candidate for preventing and treating clinical manifestations of ARDS associated with COVID-19. Quercis is working with a number of healthcare providers around the world to expedite phase 2/3 clinical studies to confirm these hypotheses. These studies aim to provide patients with effective prophylactic and therapeutic options to combat this global pandemic, which has resulted in numerous deaths over the past year.
About Quercis Pharma AG
Quercis Pharma AG is a privately held biopharmaceutical company based in Zug, Switzerland. Quercis Pharma is developing a set of advanced-phase clinical studies focused on the prevention of venous thromboembolism (VTE) in cancer patients. In addition, Quercis targets other diseases associated with thrombotic events, such as sickle cell anemia (SCD), Ebola virus and COVID-19. The company's main drug candidate acts as an antithrombotic agent with a significantly lower risk of side effects than existing treatments. Quercis plans to launch two phase 3 studies for the prevention of VTE in patients with pancreatic cancer and glioblastoma, and will seek to obtain the Food and Drug Administration approval for the prevention of VTE for all types of cancer related to these studies. In addition, the company is preparing to conduct a number of studies looking at the treatment of SCD (phase 2) and COVID-19 (phase 2/3).
Contact
Ilias Läber, Ph.D.
President and CEO
Quercis Pharma
ilaeber@quercis.com
Anne Marie Fields
Managing Director
Groupe Rx Communications
afields@rxir.com
1 https://www.cancerquest.org/cancer-biology/metastasi
2 Zwicker et al. JCI Insight 2019
Source: prnewswire.com