Ferronova – Nanoparticle Trial Begins in Patients With Gastric and Oesophageal Cancers

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ADELAIDE, Australia–(BUSINESS WIRE)–Australian biotech company Ferronova has announced the initiation of a clinical trial of the company’s FerroTrace® nanoparticle technology in patients with gastric and oesophageal cancers. It follows the completion of a first-in-human trial in 2020-2022 in oral cancer patients.

The MAGMAP trial will enrol 60 patients and commenced today with the first patient at the Royal Adelaide Hospital, to be followed by Flinders Medical Centre and Queen Elizabeth Hospital in South Australia, and then expanding to the Peter MacCallum Cancer Centre and Austin Hospital/Olivia Newton John Cancer Centre in Victoria. Trial imaging is supported by the South Australian Health and Medical Research Institute (SAHMRI) and the National Imaging Facility.

The MAGMAP trial (Clinicaltrials.gov ID: NCT05899985) is a multi-centre, partially blinded, side-by-side comparator study to assess the safety and tolerability, feasibility, and potential added diagnostic and clinical value of FerroTrace® for mapping high-risk lymph nodes in subjects.

Ferronova Chief Executive Officer Mr Stewart Bartlett said it is potentially an important study offering the promise of an innovative approach for identifying and assessing lymph nodes at high risk of containing cancer.

“Gastric, gastric-oesophageal junction, and oesophageal cancers have very poor outcomes, even where the tumour is localised to a primary location and surrounding lymph nodes where surgery is intended to be curative, and this trial is an important step to test whether our novel technology can improve outcomes in this group of patients.”

Studies show following surgery, the 5-year relative survival rates for localised gastric and oesophageal cancers are approximately 74.7% and 48.5% respectively. Where the cancer has also spread to lymph nodes, the 5-year relative survival is only 34.6% and 27.7% [1][2].

Ferronova’s FerroTrace® product is a super-paramagnetic iron oxide nanoparticle targeting CD206 receptors found in lymph nodes. It offers a unique targeting mechanism designed to enable a longer lymph node retention time allowing the use of MRI and a handheld surgical magnetic detector to identify and assess lymph nodes containing FerroTrace®.”

Principal Investigator, Dr Markus Trochsler said the trial will investigate the feasibility of mapping lymph nodes directly draining a primary tumour which theoretically have the highest risk of containing metastasis.

“Gastric and oesophageal cancers are difficult to treat due to unpredictable and extensive lymphatic drainage network in this area of the body, which means lymph nodes containing cancer could potentially be found anywhere from the neck down to the abdomen. At present, when these metastases are very small, they cannot be detected with current imaging technology” Dr Trochsler said.

“This pilot study may lead to providing us with another alternative, being a more informed treatment plan. We are testing whether nanoparticles can identify lymph nodes which are at high-risk of containing cancer cells. It will support us to progress to larger randomised trials where we will investigate tailoring our treatment approach based on the identification and position of these nodes.”

Mr Bartlett said the study enrolment is predicted to take 12-15 months, and he hoped the results will lead to new methods of treating patients facing uncertain outcomes.

“The enrolment of the first patient is an important milestone for Ferronova,” Mr Bartlett said.

“We are incredibly thankful for the investigators and their support teams, led by Dr Trochsler, as well as Associate Professor Kanhere at the RAH, Professor Watson and Dr Bright at Flinders, Dr Liu at the Austin and Peter Mac, and Dr Dwyer at SAHMRI. They have all put in an incredible amount of work and planning to design and initiate this trial. We look forward to seeing the results when the trial is complete.”

About Ferronova

Ferronova is an Australian biotechnology company headquartered in Adelaide, South Australia. Shareholders include Renew Pharmaceuticals Limited, Uniseed, the University of South Australia, Artesian Venture Partners and the South Australian Venture Capital Fund (SAVCF), Powerhouse Ventures, the University of Wellington in New Zealand, the University of Sydney, PAN Ventures, Australian Unity, and ex-Macquarie Bank executive Allan Moss. Grant assistance has been provided by the SA Government since 2016 and the Federal Government’s BioMedTech Horizons Program, operated by MTPConnect. In 2023, Ferronova was awarded an Australian Government CRC-P grant to progress a nanoparticle formulation through to a Phase 1b brain cancer clinical trial. For more information go to: www.ferronova.com.au

1 Cancer of the oesophagus – cancer stat facts, National Cancer Institute SEER. Available at: https://seer.cancer.gov/statfacts/html/esoph.html (Accessed: 5 April 2024).

2 Cancer of the stomach – cancer stat facts, National Cancer Institute SEER. Available at: https://seer.cancer.gov/statfacts/html/stomach.html (Accessed: 5 April 2024).

Contacts

For more information:

Ferronova
Stewart Bartlett, CEO

Email: marketing@ferronova.com.au

NurExone Presenting Novel Regulatory Pathways for Exosomes Therapies at Global Summit

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TORONTO and HAIFA, Israel, March 01, 2024 (GLOBE NEWSWIRE) — NurExone Biologic Inc. (TSXV: NRX) (Germany: J90) (the “Company” or “NurExone”), a pioneering biopharmaceutical company, is pleased to announce that Dr. Ina Sarel, the Head of CMC, Quality and Regulatory Affairs at NurExone, will be leading a workshop at the upcoming Exosome Characterization & Analytical Development Summit. Dr. Sarel will be sharing with her expert colleagues insight and information on the topic of “Regulatory Challenges in the Development of an Extracellular Vesicles (EVs) – Based Clinical Product.”

Dr. Sarel joins a prestigious lineup of speakers including representatives from leading exosome companies, e.g. AbbVie, RION Therapeutics, Aegle Therapeutics and universities, e.g. Harvard Medical school. With her experience in regulatory affairs and her deep understanding of the exosome field, Dr. Sarel is well-positioned to provide perspective on how to navigate the complex regulatory landscape and ensure the successful development of exosome-based therapeutics.

Dr. Sarel who led the activities that resulted in the grant of Orphan Drug Designation for ExoPTEN, an exosome-therapy being developed by the Company, stated “NurExone is developing a platform for using exosomes to create wide range of nanodrugs including our first drug – ExoPTEN, for treating patients with acute spinal cord injury. We are proud to share our development outcomes together with our regulatory expertise and are committed to advancing the field of exosome therapeutics for clinical use.”

The Exosome Characterization & Analytical Development Summit is a premier event that brings together experts from academia and industry to discuss the latest advancements in exosome characterization and analytical development. The summit will take place on April 23-25, 2024 in Boston, MA. To learn more about the summit and to register, please visit the Conference Website.

About NurExone Biologic Inc.

NurExone Biologic Inc. is a TSXV listed pharmaceutical company that is developing a platform for biologically-guided exosome-based therapies to be delivered, non-invasively, to patients who have suffered Central Nervous System injuries. The company’s first product, ExoPTEN for acute spinal cord injury, was proven to recover motor function in 75% of laboratory rats when administered intranasally. ExoPTEN has been granted Orphan Drug Designation bythe FDA. The NurExone platform technology is expected to offer novel solutions to drug companies interested in noninvasive targeted drug delivery for other indications.

For additional information, please visit www.nurexone.com or follow NurExone on LinkedIn, Twitter, Facebook, or YouTube.

For more information, please contact:

Dr. Lior Shaltiel
Chief Executive Officer and Director
Phone: +972-52-4803034
Email: info@nurexone.com

Thesis Capital Inc.
Investment Relation – Canada
Phone: +1 905-347-5569
Email: IR@nurexone.com

Dr. Eva Reuter
Investment Relation – Germany
Phone: +49-69-1532-5857
Email: e.reuter@dr-reuter.eu

FORWARD-LOOKING STATEMENTS

This press release contains certain forward-looking statements, including statements about the Company’s future plans and intellectual property, the scientific and development and commercial activities to be carried out by the company, the efficient loading of exosomes, future potential manufacturing, clinical, licensing and marketing activities and the treatment of certain conditions. Wherever possible, words such as “may”, “will”, “should”, “could”, “expect”, “plan”, “intend”, “anticipate”, “believe”, “estimate”, “predict” or “potential” or the negative or other variations of these words, or similar words or phrases, have been used to identify these forward-looking statements. These statements reflect management’s current beliefs and are based on information currently available to management as at the date hereof. Forward-looking statements involve significant risk, uncertainties and assumptions. Many factors could cause actual results, performance or achievements to differ materially from the results discussed or implied in the forward-looking statements. Certain assumptions include the ability of the Company to commercialize its intellectual property internally and through licensing and that the Company has the appropriate team in order to realize commercialization. Risks and uncertainties include, but are not limited to, risks related to the Company’s early stage of development, lack of revenues to date, government regulation, market acceptance for its products, rapid technological change, dependence on key personnel, protection of the Company’s intellectual property and dependence on the Company’s strategic partners. These factors should be considered carefully and readers should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in this press release are based upon what management believes to be reasonable assumptions, the Company cannot assure readers that actual results will be consistent with these forward-looking statements. These forward-looking statements are made as of the date of this press release, and the Company assumes no obligation to update or revise them to reflect new events or circumstances, except as required by law.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.