ValiRx (VAL ), a life science focused on early-stage cancer therapeutics and women’s health said three of its preclinical evaluation projects are active and “progressing according to plan.”
In September 2021, ValiRx announced that it had entered an evaluation agreement with an unnamed London university to investigate a novel technology designed to treat breast cancer.
The evaluation is investigating the action of the molecule against triple negative breast cancer and other indications. Under the deal, ValiRx is conducting a series of preclinical tests on the drug candidate to validate the technology and determine suitability for commercialisation.
This evaluation project has now completed 5 out of the 9 months scheduled for scientific evaluation. To date this has encompassed formulation development and in vitro cell assays.
In December 2021, ValiRx entered into an agreement with Japan’s Hokkaido University to investigate a drug candidate for use in oncology. Specifically, the evaluation is investigating the action of the molecule against Endometrial, Pancreatic and Bile Duct Cancers, it said.
Today, ValiRx said the evaluation project has completed 3 out of the 12 months scheduled for scientific evaluation. To date, the work has focused on both drug delivery and formulation.
In addition, in February 2022 the company entered into a further evaluation agreement with University of Barcelona (Spain) to investigate another drug candidate for use in oncology.
In this case, the evaluation is investigating the mode of action and potential utility as a treatment of KRAS (a GTPase protein made by the oncogene, Kirsten Rat Sarcoma Virus) dependent cancers including Uterine and Pancreatic Cancers, the company told investors.
This project has completed 1 out of the 12 months scheduled for scientific evaluation and to date, the work has expanded the IP protection and initiated chemical synthesis, it reported.
Meanwhile, ValiRx, which in recent years has reformulated its leading anti-cancer therapy, VAL201 to make VAL301, a treatment for endometriosis, said VAL301 is undergoing preclinical cell-based assays to confirm the breadth of biological pathways involved.
Utilising newer cell-based analytical technologies, this work programme is designed to complement historical data and to move the project towards formal preclinical studies.
ValiRx said the clinical development plan has also been updated to reflect current regulations and to identify the specific preclinical studies required to progress towards clinical trials.VAL301 remains the subject of a material transfer agreement with an undisclosed Japanese company, as announced back in 2020. The company informed investors that this agreement remains active and ValiRx continues to share and discuss data with the Japanese team.
Meanwhile, ValiRx said it is also still actively seeking either a partner ‘or external funding’ to progress the company’s novel cancer treatment drug VAL401 through to clinical development.
Another one of its drug candidates targeting sepsis - BC201 - is being developed with Black Cat Bio and OncoLytika, with the mechanism of action of BC201 being investigated with a wide range of preclinical tests. ValiRx said “encouraging initial results” will be published soon.
These preclinical investigations are being funded by BlackCat Bio from recently secured seed funding and project managed by OncoLytika. If successful, ValiRx has a beneficial interest of 40% of the project; however, the company has no financial commitment to the consortium.
Back in November 2021, ValiRx entered a Letter of Intent with TheoremRx Inc to sub-license the use of the VAL201 peptide - a candidate developed for prostate cancer - for all oncology applications. The sub-license remains conditional on TheoremRx completing a fundraiser.
In a strategy update, the company reiterated to investors that it is currently operating as a virtual Biotech Company, meaning it out-sources all testing of current evaluation and pre-clinical projects to a wide range of external contract research organisations (CROs).
The Company said it is of the view that this fragmented approach to early-stage drug development is non-optimal. As a result, it is assessing options to acquire capabilities and infrastructure to create a more efficient and effective translational drug development service
ValiRx said an integrated services entity “would be used for both in-house projects and offered to third parties, such as the increasing number of innovative biotechnology companies.”
The revenue generated from providing pre-clinical development services would enable continued investment in advanced testing and analysis technology and support the progression of ValiRx in-house pipeline projects.
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