Pleco Therapeutics Announces €8.7m Strategic Partnership with Hyloris to Progress its Novel Plecoid™ Agent in Acute Myeloid Leukaemia and Small Cell Lung Cancer

NIJMEGEN, Netherlands, Nov. 10, 2021 /PRNewswire/ -- Pleco Therapeutics BV, a specialty biopharmaceutical company developing novel combination chelating agents to detoxify the cancer micro-environment today announces that it has entered into a strategic partnership with Hyloris Pharmaceuticals SA (Euronext Brussels: HYL), a specialty biopharma company committed to addressing unmet medical needs through reinventing existing medications, to develop and commercialise a novel Plecoid™ Agent to improve the effectiveness of chemotherapy in patients with Acute Myeloid Leukaemia (AML) and Small Cell Lung Cancer (SCLC).

Under the terms of the agreement, worth up to €8.7 million, Hyloris will provide €1 million in several tranches over time, automatically convertible into Pleco equity under certain conditions, together with potential funding of up to an additional €7.7 million in pre-defined R&D activities against an agreed development plan.  Hyloris has been granted global exclusive co-development rights and future joint commercialisation to Pleco's fixed-dose combination (FDC) PTX-061 for the treatment of AML, with the potential to expand into SCLC with its PTX-062 programme. The companies will share worldwide gross product margins in AML and SCLC, dependent on sales volumes.

The Plecoid FDC product is a patented, innovative, clinical-stage candidate drug that combines chelating agents with different characteristics. Previous studies demonstrate that elevated levels of toxic metals are associated with inferior survival in patients with AML. Exploratory clinical studies are currently ongoing in AML patients to evaluate the metal rebalancing effect of chelating agents administered concomitantly with chemotherapy. Interim results from these exploratory studies indicate high complete remission rates and improved rates of survival.

The R&D funding from Hyloris is subject to feedback from the US FDA on the feasibility of the future clinical development requirements, to cover pre-defined R&D activities through to submission for approval in AML, plus exploratory development work in SCLC.

Ivo Timmermans, Chief Executive Officer of Pleco Therapeutics, commented: "We have developed Plecoid Agents based on breakthrough research performed at the MD Anderson Cancer Center[1], which evidenced that many AML patients have significantly elevated levels of toxic metals in their bone marrow and blood, resulting in poor overall survival.[2] We are very encouraged by the interim results from an exploratory clinical study, which demonstrated that the administration of chelating agents with standard of care chemotherapy resulted in complete remission in 85% of high-risk AML patients in this study. We are very excited to partner with Hyloris and look forward to our discussions with the FDA and mapping-out the clinical development strategy that is required for approval in AML."

Stijn Van Rompay, Chief Executive Officer of Hyloris, added: "This partnership is a great endorsement of our focused strategy and demonstrates that we are delivering on our promise to enlarge the R&D pipeline with 4 candidate products this year. We are on track to expand the portfolio with another candidate medicine before year-end and remain fully funded to advance the current product portfolio, in line with our business plan. We will also explore various financing options to accelerate our ambitious growth plans and support our shift towards higher value repurposed products to address unmet medical needs and create shareholder value."

Jean-Luc Vandebroek, Chief Financial Officer of Hyloris, concluded: "By committing to an investment of €1 million in Pleco, we gain global exclusive co-development rights and future joint commercialisation to this Plecoid, while limiting upfront financial exposure and risk until we have had feedback from the FDA and embark on the development plan. Together with the medical team at Pleco, we are now looking forward to the consultations with the regulatory bodies in the U.S., which are planned over the next coming months."

Pleco retains all rights in its other R&D activities outside of the AML and SCLC programmes, with the potential to scale its Plecoid fixed-dose combination platform into treatments for other cancers, including PTX-081, as well as neurodegenerative disorders where aberrant metal patterns have been shown to play a role.

About Acute Myeloid Leukaemia (AML)^[3]

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. 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. Datamonitor Healthcare estimates that in 2018, there were 158,400 incident cases of AML worldwide and expects that the number will increase to 169,000 by 2027.

[1] The University of Texas MD Anderson Cancer Center is devoted exclusively to cancer patient care, research, education and prevention and ranks No. 1 in cancer care in the U.S. News & World Report's 2020-21 "Best Hospitals" survey

[2] Ohanian et al, Journal of Hematology, January 2020

[3] Datamonitor Healthcare April 2021; Leukaemia & Lymphoma Society, 2019; WHO classification of AML, 2016

About Pleco Therapeutics

Pleco Therapeutics is a specialty biopharmaceutical company which aims to extend the life span and enhance the quality of life of patients through its novel Plecoid™ therapies that have been designed to dramatically increase the effectiveness of current cancer treatments. Our novel Plecoid™ therapies 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. Pleco is based in Nijmegen, the Netherlands. For more information visit www.plecotherapeutics.com. Follow us on LinkedIn and Twitter

About Hyloris Pharmaceuticals

Hyloris is a specialty biopharma company focused on innovating, reinventing, and optimising existing medications to address important healthcare needs and deliver relevant improvements for patients, healthcare professionals and payors. Hyloris has built a broad, patented portfolio of 14 reformulated and repurposed value-added medicines that have the potential to offer significant advantages over available alternatives. Outside of its core strategic focus, the Company also has 3 high barrier generic products in development and registration phase. Two products are currently in initial phases of commercialisation with partners: Sotalol IV for the treatment of atrial fibrillation, and Maxigesic® IV, a non-opioid post-operative pain treatment. The Company's development strategy primarily focuses on the FDA's 505(b)2 regulatory pathway, which is specifically designed for pharmaceuticals for which safety and efficacy of the molecule have already been established. This pathway can reduce the clinical burden required to bring a product to market, and significantly shorten the development timelines and reduce costs and risks. Hyloris is based in Liège, Belgium., visit www.hyloris.com and follow-us on LinkedIn.   

For more information, please contact:

For Pleco Therapeutics
Sue Charles, Charles Consultants – sue@charles-consultants.com +44 (0)7968 726585

For Hyloris Pharmaceuticals
Investor Relations and Media - investorrelations@hyloris.com