Foxy-5 / WntResearch - LARVOL DELTA

Positive ad hoc results from neoadjuvant Foxy-5 treatment of colon cancer patients in the ongoing phase II NeoFox study (ESMO-GI 2024) - P2 | "Our ad hoc observations show that neo-adjuvant treatment with the drug candidate Foxy-5 may impair both venous and perineural invasion and may also induce TNM downstaging when administered pre-operatively in patients with stage II/III colon cancer. Based on these retrospective analyses, the NeoFox study will be amended to confirm the observations in a prospective setting."

Clinical • P2 data • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • WNT5A

WntResearch's scientific founder publishes study on WNT5A signaling in scientific journal [Google translation] (Cision) - "WntResearch announces today that a study describing WNT5A signaling and its mechanism of action has been published in the scientific journal Cells. The publication strengthens the hypothesis that Foxy-5, through its ability to mimic WNT5A signaling, can inhibit the spread of colon cancer....The research group investigated in cell lines and in a mouse model whether and how WNT5A signaling affects the LGR5 receptor and its ligand RSPO3, both of which are promoters of WNT/β-catenin signaling. The researchers found that WNT5A and Foxy-5 signaling reduced the expression of both LGR5 and RSP03 as well as β-catenin activity in colon cancer cells and tissue."

Preclinical • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

WntResearch receives greatly extended patent protection for a salt of Foxy-5 (Cision) - "WntResearch announces today that the company has been granted a new substance patent in Europe for a new, more soluble, salt of the drug candidate Foxy-5. The patent was granted by the European Patent Office (EPO) and means that the intellectual property protection for Foxy-5 is extended until the year 2041. WntResearch has a solid patent strategy aimed at strengthening and extending the protection of the drug substance Foxy-5, its manufacturing process and medical use. The current patent applies to a new salt of Foxy-5 ('Stable composition of Foxy-5 hexapeptide with high solubility') and extends patent protection for Foxy-5 until the year 2041."

Patent • Oncology

WntResearch's CEO Pernilla Sandwall presents the company at several events in September [Google translation] (Cision) - "During September, WntResearch CEO Pernilla Sandwall will participate in several events to present the company and its drug candidate Foxy-5. Pernilla Sandwall will present WntResearch and the drug candidate Foxy-5, whose purpose is to counteract the spread of cancer."

Clinical data • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

WntResearch hopes for in-depth talks about Foxy-5 [Google translation] (BioStock) - "A phase II clinical study with Foxy-5 is currently underway, where the candidate is evaluated in patients with stage II/III colon cancer....During the summer, the Spanish authorities approved the company's revised study plan for the study. It means, among other things, that the patients' participation in the study will be shortened by almost two years. Now that the change has been given the go-ahead by both the Medicines Authority and the Central Ethics Review Committee in Spain, the recruitment of the first patient is expected to begin in September....That part of the study will be carried out in Spain and is expected to take about six months....WntResearch currently expects to be able to present final results in 2025."

P2 data • Trial status • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

"BioStock: WntResearch tar Foxy-5 vidare med optionsprogram https://t.co/vD3WdUwOu9" (@CisionNews)

CEO Pernilla Sandwall invited to present Foxy-5 at scientific workshop on Wnt signaling in Heidelberg March 17 [google translation] (Cision) - "Six researchers and two pharmaceutical company representatives active in Wnt signaling will be speakers, including Pernilla Sandwall....'I will tell you about Foxy-5 and above all about our observations in the ongoing phase 2 study, which I think will arouse great interest'."

P2 data • Colon Cancer • Gastrointestinal Cancer • Oncology

WntResearch CEO Pernilla Sandwall presents the company at the Life-Science Day in Gothenburg on March 8 [Google translation] (Cision) - "Pernilla will present the company and the drug candidate Foxy-5 whose purpose is to prevent metastases from occurring. Pernilla will also talk about what the interesting observations made in connection with the ongoing phase 2 study mean for the continuation of the study. The study is conducted on patients affected by colon cancer."

P2 data • Colon Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Presentation of data on previously reported significant observations with Foxy-5 in colon cancer [Google translation] (Cision) - "CEO Pernilla Sandwall gives a video presentation on the data from the ad hoc analysis. It showed a statistically significant difference between the control group and Foxy-5 treated patients with colon cancer with regard to three prognostic parameters at the time of surgery ie after only three weeks of treatment....Pernilla Sandwall explains and clarifies data on TNM grading, respectively spread to surrounding nerves and vessels....Data are presented in graphs to more clearly show the difference between the two groups."

Clinical data • Colon Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

NeoFox: Foxy-5 as Neo-Adjuvant Therapy in Subjects With Wnt-5a Low Colon Cancer (clinicaltrials.gov) - P2 | N=100 | Active, not recruiting | Sponsor: WntResearch AB | Unknown status ➔ Active, not recruiting | Trial completion date: Mar 2022 ➔ Dec 2024 | Trial primary completion date: Mar 2022 ➔ Dec 2024

Enrollment closed • Trial completion date • Trial primary completion date • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

"WntResearch files a patent application expanding the commercial potential of Foxy-5 https://t.co/g9qwSHHyQn" (@CisionNews)

"BioStock: WntResearch’s Foxy-5 shows potential in leukemia https://t.co/iYf0UROQeb" (@CisionNews)

Hematological Malignancies • Leukemia • Oncology

A Novel WNT5A-Mimicking Peptide Affects Leukemia Cell Survival in the Bone Marrow Microenvironment (ASH 2021) - "BMMSC and BM biopsies from 5 healthy donors (HD), 6 MDS and 13 AML patients at diagnosis were submitted to analysis of WNT5a mRNA expression and methylation after Azacytidine (1μM) treatment by real-time PCR, and WNT5a protein levels by immunohistochemistry and immunofluorescence (IF). WNT5a downregulation in MDS and AML patients occurs probably by methylation and contributes to poor prognosis. Foxy-5, by restoring WNT5a levels, could represent a strategy to counterbalance several oncogenic processes present in leukemia by reducing ROS production and, consequently, inhibiting cell growth and differentiation, downregulating PI3K and MAPK pathways, disrupting actin polymerization and decreasing autophagy. Thus, Foxy-5 treatment may be an important approach to impair leukemia growth and maintenance and arises as a promising therapeutic target."

Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • AKT1 • CCND1 • CD34 • CTNNB1 • CXCL12 • GLI2 • ITGAM • WNT5A

A randomized, multicenter, open-label controlled phase 2 trial of Foxy-5 as neoadjuvant therapy in patients with WNT5A negative colon cancer (ESMO-GI 2019) - "Results The first patient is expected to be included on March 13, 2019. Conclusion This innovative approach of targeting the metastatic process might lead to further improvements in outcomes of colon cancer patients who are at high risk for relapse."

Clinical • P2 data

[VIRTUAL] WNT5A MIMETIZER TREATMENT REDUCES REACTIVE OXYGEN SPECIES, PROLIFERATION, CHEMOTAXIA, AND SELF-COFFEE IN LEUKEMIC CELLS (HEMO 2020) - "In vitro treatment with Foxy-5 was able to reduce the production of ROS, proliferation and chemotaxis of leukemic cells. AML patients have high levels of ROS, creating a hypoxic environment and activating a cascade of critical reactions for the proliferation and migration of leukemic cells, contributing to the progression of this neoplasm. Interestingly, in the co-culture of leukemic cells with stromal cells, treatment with Foxy-5 was effective in reducing the autophagy of leukemic cells, an event related to the production of ROS."

Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • CXCL12 • GLI2

NeoFox: Foxy-5 as Neo-Adjuvant Therapy in Subjects With Wnt-5a Low Colon Cancer (clinicaltrials.gov) - P2; N=100; Recruiting; Sponsor: WntResearch AB

Clinical • New P2 trial