On March 29, 2021 Herantis Pharma Plc ("Herantis or the Company"), an innovative clinical stage biotech company pioneering new disease modifying and regenerative therapies, reported that the Board of Directors has decided to focus all company resources on Herantis’ CDNF and xCDNF assets and to commence seeking out-licensing partners for the Lymfactin program in the treatment of Breast Cancer Related Lymphedema (BCRL) (Press release, Herantis Pharma, MAR 29, 2021, View Source,c3316583 [SID1234577488]).
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As previously announced in a press release on March 2, 2021 that while a favourable safety profile for Lymfactin has been established, and important observations on the potential activity of Lymfactin were made, the efficacy data from the Phase II Lymfactin program was inconclusive.
This prompted a full evaluation of the overall program and the company resources required to move the program forward. The review focused on learnings from this pioneering study and how best to address them to accurately capture treatment effect, implications for the overall program, resourcing requirements for the Lymfactin program moving forward, and strategic considerations together with Herantis’ central nervous system (CNS) assets. As a result of this comprehensive evaluation, Herantis’ Board of Directors have concluded that the best course of action for the Company is firstly to focus all activities, strategy and resources solely on the exciting CNS portfolio, and secondly to seek a suitable partner to take over further development of the innovative Lymfactin program.
Craig Cook CEO commented "We are at an inflection point and this is an important strategic decision. It is the right time to separate the Company assets and move forward as a pure play Neuroscience company focusing on our CDNF and xCDNF portfolios. We are very grateful to the patients, investigators and medical professionals involved in the Lymfactin program, without their contributions, we would not have been able to advance this ground-breaking research into the treatment of BCRL with Lymfactin."
In-line with this decision, Herantis will structure all its research and operations on neurodegenerative diseases, accelerating its programs in Parkinson’s Disease and other neurodegenerative diseases.
Herantis will host a live session 30th March at 10am CET/11am EET with Craig Cook, CEO and Antti Vuolanto, COO, to further discuss the company’s new strategic focus.
About Cerebral Dopamine Neurotrophic Factor – CNDF and xCDNF
Herantis focuses on disease modifying therapies for debilitating neurodegenerative diseases by restoring the neuronal protective mechanism of proteostasis, a key system in neurodegenerative disease. Proteostasis regulates proteins within the body and influences the fate of every protein from synthesis to degradation. Its failure results in a vicious cycle of pathological accumulation of protein aggregates, neuroinflammation and various forms of cellular stress that is widely implicated with the development of many neurodegenerative diseases including Parkinsons Disease, Alzheimers and other diseases. CDNF is a natural protein that occurs naturally in the body whose natural role is to protect neurons by balancing and supporting proteostasis, thereby preventing and counteracting disease generating mechanisms. Herantis is taking this natural ability and harnessing it as a treatment for neurodegenerative disease. CDNF – a biological protein – is Herantis’ lead program and a clinical stage asset; and xCDNF – a synthetic peptide version of CDNF – is Herantis’ follow-on program. Both CDNF and xCDNF have, via their multimodal mechanism of action, the potential improves neuronal survival and to stop the progression of Parkinson’s and other neurodegenerative disease and have a significant therapeutic impact on the lives of patients.
About Lymfactin
Lymfactin is the world’s first and only clinical stage gene therapy that repairs damages of the lymphatic system. It expresses the human growth factor VEGF-C, which is naturally associated with the development of lymphatic vessels. Based on preclinical studies, Lymfactin triggers the growth of new functional lymphatic vasculature in the injured area and thus repairs the underlying cause of secondary lymphedema. The first target indication for Lymfactin is Breast Cancer Associated Lymphedema; Herantis believes that Lymfactin may also be suitable for the treatment of other forms of secondary lymphedema if its safety and efficacy are established in the first indication.
Lymfactin, patented by Herantis, is based on the internationally renowned scientific research of academy professor Kari Alitalo and his research group, a national center of excellence at the University of Helsinki.