NurExone Presenting Novel Regulatory Pathways for Exosomes Therapies at Global Summit

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.

Alpha Cancer Technologies (ACT) Publishes Pre-Clinical Study Results in Cancer Cell International Demonstrating Excellent Safety and Significant Anti-Tumor Activity from the Company’s Next Generation ADC, ACT-903

Alpha Cancer Technologies (ACT) Publishes Pre-Clinical Study Results in Cancer Cell International Demonstrating Excellent Safety and Significant Anti-Tumor Activity from the Company’s Next Generation ADC, ACT-903




Alpha Cancer Technologies (ACT) Publishes Pre-Clinical Study Results in Cancer Cell International Demonstrating Excellent Safety and Significant Anti-Tumor Activity from the Company’s Next Generation ADC, ACT-903

ACT-903 conjugate demonstrated significant anti-tumor activity, with tumors becoming undetectable in 9 of 10 mice, and all 10 mice surviving through Day 60 with no obvious signs of toxicity

ACT’s technology highlights the potential to use the natural function of AFP as a carrier protein to deliver a payload uniquely targeted to cancer cells, while reducing risk of immune reactions or anti-drug antibody accumulation

Alpha fetoprotein conjugates had a very low percentage of free toxin detectable in blood after administration, and did not show any bone marrow accumulation of cytotoxic payload, suggesting limited off-target toxicity

TORONTO–(BUSINESS WIRE)–#ACT903–Alpha Cancer Technologies Inc. (ACT), a biopharmaceutical company focused on developing and commercializing targeted immuno-oncology and immunomodulation therapies based on its proprietary recombinant human Alpha Fetoprotein (AFP) platform, today announced the publication of pre-clinical study results in Cancer Cell International highlighting the company’s recombinant human AFP (ACT-101) conjugate with maytansine in mouse xenograft models of colorectal cancer. Results from the study demonstrate the exceptional safety profile and potent anti-tumor activity of multiple ACT-101 conjugates through the successful targeting of the alpha fetoprotein receptor uniquely located on cancerous cells and myeloid-derived suppressor cells (MDSCs).

The AFP receptor has been found on the surface of cancer cells and MDSCs exclusively, making it an attractive target for the delivery of toxins selectively to tumor cells and MDSCs. Human AFP acts as a shuttle protein, transporting a variety of molecules including targeted anti-cancer agents inside the cell via the AFP receptor. ACT-101 is a recombinantly produced non-glycosylated form of human AFP, which will carry and deliver maytansine and other chemotherapy payloads to tumor cells via the AFP receptor. The selection of maytansine was based on its prior efficacy in clinical studies when incorporated into ADCs.

The AFP receptor has emerged as a novel target for cancer therapeutics given the expression of AFP on most cancers and MDSCs, and lack of presence on normal tissues. Studies were performed to investigate the use of ACT-101 conjugated with maytansine for targeted toxin delivery to cancer. Four structurally different ACT-101-maytansinoid conjugates containing cleavable glutathione sensitive linkers were initially investigated in a mouse xenograft model of colorectal cancer (COLO-205). Reduction in tumor volume was seen for all four conjugates compared to control (p < 0.05). The anti-tumor effects of the conjugate selected for further development, ACT-903, persisted after treatment discontinuation, with tumors becoming undetectable in 9 of 10 mice, and all 10 mice surviving through Day 60 with no obvious signs of toxicity. A follow-up study performed in the same model compared the effects of single intravenous doses of ACT-903 (10–50 mg/kg) to control groups receiving vehicle or ACT-101. A significant reduction of tumor burden compared to control was achieved in the 40 and 50 mg/kg dose groups. Survival was also significantly prolonged in the 40 mg/kg and 50 mg/kg cohorts. Free maytansine blood levels at 4 hours were 0.008% of the dose, indicating stability in circulation as was expected based on in vitro plasma stability studies. No obvious signs of toxicity were seen in any of the treated groups. The observed efficacy and excellent tolerability of ACT-903 in these xenograft models support advancing the development of ACT-903 into clinical studies.

“Based on the evidence we continue to observe in our pre-clinical studies, we believe ACT-903 has the potential to address the limitations of current-generation antibody drug conjugates through a targeted delivery exclusively to cancer and immune suppressor cells, allowing for greater efficacy with minimal toxicity,” said Dr. Igor Sherman, CEO of ACT. “Given the broad range of cancer cells expressing the AFP receptor, we believe our technology offers a potential pan-cancer opportunity and we look forward to continuing the development of this program to bring it to cancer patients in the shortest possible time.”

The manuscript, titled “High anti-tumor activity of a novel alpha-fetoprotein-maytansinoid conjugate targeting alpha-fetoprotein receptors in colorectal cancer xenograft model,” was published in Cancer Cell International on April 5, 2023 and the full manuscript can be accessed here.

About Alpha Cancer Technologies, Inc.

Alpha Cancer Technologies Inc., (ACT) is a private clinical stage biotechnology company with immuno-oncology, theranostics and immunomodulation platforms under development. The company’s drug products use ACT’s patented recombinant human alpha fetoprotein (AFP or ACT-101). ACT’s immuno-oncology products target AFP receptors uniquely expressed on almost all solid and liquid tumors and immune suppressor cells but are absent on normal cells. This approach utilizes next-generation ADC technology and offers the benefits of much lower toxicity and greater efficacy compared to conventional chemotherapy and other targeted therapies. ACT is based in Toronto, Ontario, Canada. For more information, please visit www.alpha-cancer.com

Contacts

Richard Potts, Chair

Alpha Cancer Technologies Inc.
Tel: +1 (416) 464-2678

Email: rpotts@alpha-cancer.com

Igor Sherman, Ph. D., President & CEO

Alpha Cancer Technologies Inc.
Tel: +1 (416) 826-6626

Email: isherman@alpha-cancer.com

For investors, please contact:
Stephen Jasper

Gilmartin Group
Tel: +1 (858) 525-2047

Email: stephen@gilmartinir.com

Nanostics – micro-flow cytometry to quantify extracellular vesicle size, concentration and marker abundance, with advanced machine learning algorithms to determine disease states

Nanostics is focused on development and commercialization of novel, non-invasive diagnostic tests for cancer. Its core technology is an advanced liquid biopsy platform that can accurately diagnose cancer from a single drop of blood. Its lead product, ClarityDx Prostate, is the most accurate diagnostic test to diagnose aggressive prostate cancer, and is positioned to emerge as the world’s leading diagnostic tool for prostate cancer.

Nanostics - micro-flow cytometry to quantify extracellular vesicle size, concentration and marker abundance, with advanced machine learning algorithms to determine disease states

EVs carrying disease-specific biomarkers like nucleic acid and proteins are continuously released from cells and can be found in biological fluids including blood, urine, semen, and cerebrospinal fluid.  The levels of disease-specific EVs are closely related to disease progression making EVs promising targets for minimally invasive diagnostic assays.

Technology designed to accurately detect and measure EVs has the potential to greatly improve liquid biopsy diagnostics. At Nanostics, we use micro-flow cytometry (µFCM) to quantify EV size, concentration, and marker abundance for millions of EVs in minutes. We then use advanced machine learning to analyze the vast amount of data generated using µFCM to provide rapid and precise results that continuously improve with every test.

The EV and machine learning platform ClarityDX® is set to transform the diagnostic landscape and make easy-to-use, minimally invasive predictive tests a reality in the near future.

At Nanostics, we use micro-flow cytometry (µFCM) to quantify EV size, concentration, and marker abundance for millions of EVs in minutes. We then use advanced machine learning to analyze the vast amount of data generated using µFCM to provide rapid and precise results that continuously improve with every test.

The EV and machine learning platform ClarityDX® is set to transform the diagnostic landscape and make easy-to-use, minimally invasive predictive tests a reality in the near future.

The ability to detect and measure EVs is transforming the diagnostic landscape in immunology, neurology, cardiology, and oncology. The ClarityDX® platform technology is well-positioned for future pipeline products including tests for screening, early diagnosis, complementary diagnosis, monitoring, and management for many diseases and medically-related events. Nanostics’ R&D team continues to expand the product pipeline through in-house and partnered projects to include additional liquid biopsy diagnostic tests to improve patient care.

Nanostics – micro-flow cytometry to quantify extracellular vesicle size, concentration and marker abundance, with advanced machine learning algorithms to determine disease states

More info : http://www.nanosticsdx.com

Keywords : machine learning, exosomes, extracellular vesicles, diagnostics, oncology, cancer, prostate cancer, cardiovascular, neuroscience, biofluids , liquid biopsy , micro-flow cytometry

Alpha Cognition – developing novel treatments for neurodegenerative diseases such as Alzheimer’s Dementia and Amyotrophic Lateral Sclerosis

Alpha Cognition is a clinical stage, biopharmaceutical company dedicated to developing novel treatments for under-served neurodegenerative diseases such as Alzheimer’s Dementia and Amyotrophic Lateral Sclerosis (ALS).

Alpha Cognition - developing novel treatments for neurodegenerative diseases such as Alzheimer’s Dementia and Amyotrophic Lateral Sclerosis

ALPHA-1062, a patented new chemical entity that has demonstrated safety and improved ALPHA-1062, is a patented new chemical entity being developed as a new generation acetylcholinesterase inhibitor for the treatment of Alzheimer’s disease, with expected minimal gastrointestinal side effects. ALPHA-1062’s active metabolite is differentiated from donepezil and rivastigmine in that it binds neuronal nicotinic receptors, most notably the alpha-7 subtype, which is known to have a positive effect on cognition. ALPHA-1062 is also being developed in combination with memantine to treat moderate to severe Alzheimer’s dementia and as an intranasal formulation for traumatic brain injury.

ALPHA-0602 (Progranulin) is expressed in several cell types in the central nervous system and in peripheral tissues, promotes cell survival, regulates certain inflammatory processes, and plays a significant role in regulating lysosomal function and microglial responses to disease. Its intended use for the treatment of neurodegenerative diseases has been patented by the Company and Alpha-0602 has been granted an Orphan Drug Designation for the treatment of Amyotrophic Lateral Sclerosis by the FDA.

ALPHA-0702 and ALPHA-0802 are Granulin Epithelin Motifs, or GEMs, derived from full length progranulin which have therapeutic potential across multiple neurodegenerative diseases. Progranulin is comprised of 7½ Granulin Epithelin Motifs (GEMs). GEMs are important in regulating cell growth, survival, repair, and inflammation. Individual granulin domain peptides are approximately 60 amino acids in length (~7kDa). GEMs are metabolically stable and resistant to proteolysis (long half-life). Evidence suggests that not all GEMs are equally potent at promoting cell survival signaling or reducing proteinopathy, and may compete (e.g., binding to effectors) with active GEMs and effectively decrease their potency. Specific GEM combinations have been shown to be more effective than full length progranulin in promoting Cathepsin D maturation. GEMs have been shown to be important in regulating cell growth, survival, repair, and inflammation. Alpha-0702 and ALPHA-0802 are designed to deliver this with potentially lower toxicity, and greater therapeutic effect.

More info : http://www.alphacognition.com/

Keywords : Alpha Cognition , neurodegenerative diseases , dementia , Alzheimer’s Dementia , Alzheimer Disease , Amyotrophic Lateral Sclerosis , acetylcholinesterase inhibitor , orphan drug , CNS , neuroscience , traumatic brain injury , Granulin Epithelin Motifs , Gene Therapy

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