On September 6, 2022 Pleco Therapeutics BV, a specialty biopharmaceutical company developing novel treatments designed to detoxify the cancer micro-environment reported the final close of its Series A financing, with total funds raised of €17.3 million (Press release, Pleco Therapeutics, SEP 6, 2022, View Source [SID1234619114]). The funds will be used to complete development and commercialise the Company’s novel lead Plecoid Product, PTX-061, to improve the effectiveness of chemotherapy in patients with Acute Myeloid Leukaemia (AML).
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The investments include €3.6 million in new equity committed by Oost NL and a select number of private investors, €5m in government funding from the Netherlands Enterprise Agency (Rijksdienst voor Ondernemend Nederland, RVO), and €8.7 million in equity and R&D project financing from Hyloris Pharmaceuticals SA (Euronext Brussels: HYL) previously announced in late 2021.
In total, at final close, the round exceeds the Company’s goal of €15 million. It provides sufficient funds to complete the development of PTX-061’s regulatory dossier in AML and to be ready for submission to the FDA and EMA as early as 2024, and to accelerate preclinical work in other indications such as Small-Cell Lung Cancer (SCLC).
Pleco’s novel Plecoid therapies are patented, innovative treatments that include chelating agents with different characteristics, that have the potential to positively change the balance of protein expression within the cancer microenvironment, removing the burden of toxic metals within the cell, thereby improving the effectiveness of existing chemotherapy.
Whilst AML is a relatively rare disease, the effectiveness of current chemotherapy may be limited because the leukaemia cells can become resistant to it over time. The majority of patients will relapse, even after an initial successful treatment. Relapses carry a poor prognosis; most patients no longer respond to treatment and die from anaemia, infection, or multiorgan failure. Worldwide the incidence of AML is estimated to be 350,000 cases per year (4.7 cases per 100,000 population)1. In the US, there was an estimated 20,050 new cases of AML in 2022 and 11,540 deaths2.
Pleco’s technology provides a platform for the development of a pipeline of therapies. In addition to PTX-061 for AML, the current pipeline includes additional candidates in preclinical testing for the treatment of other rare diseases such as SCLC.
Ivo Timmermans, Chief Executive Officer of Pleco Therapeutics, commented: "We are delighted to have secured the funds needed to progress our lead drug candidate through development, for the treatment of AML, a blood cancer that carries a very poor prognosis. We welcome our new shareholders and are grateful for the support from Oost NL and RVO."
Pleco’s funding from the RVO is the maximum granted under its Innovation Credit scheme that helps entrepreneurs with promising and challenging innovations with excellent market perspective. It provides special funding, a national and international network, and personal advice for innovative start-ups.
Pleco recently announced its expansion, with the incorporation of its subsidiary, Pleco Therapeutics USA, Inc., and the appointment of Michael Stalhamer as its President and first US-based employee. Mr Stalhamer also serves on the global leadership team as Vice President (VP) Product Development and Regulatory Affairs.
About Acute Myeloid Leukaemia (AML)
AML is a type of heterogenous haematological malignancy that originates from immature white blood cells (blasts) in the bone marrow, which may be derived from either a hematopoietic stem cell or a lineage-specific progenitor cell. AML generally spreads quickly to the bloodstream and can then spread to other parts of the body including lymph nodes, spleen, central nervous system, and testicles. AML is an orphan disease and is the most common type of acute leukaemia in adults and is primarily a disease of the adulthood; the median age of newly diagnosed AML patients is around 67 years. Worldwide the incidence of AML is estimated to be 350,000 cases per year (4.7 cases per 100,000 population, Globocan). In the US, there was an estimated 20,050 new cases of AML in 2022 and 11,540 deaths. Additionally, AML is more common in males. AML can arise de novo or secondarily either due to the progression of other diseases or due to treatment with cytotoxic agents.