Category Archives: Biotech Companies Canada

AmorChem’s RNA Zipcode Delivery Technology Investment Exits via New York-Based Kodikaz Therapeutic Solutions, Inc.

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MONTREAL–(BUSINESS WIRE)–AmorChem II Fund L.P. (”AmorChem”) is delighted to announce that its RNA Zipcode delivery program has been acquired by Kodikaz Therapeutic Solutions, Inc. (”Kodikaz”), a New York City biotech focused on targeted delivery of cancer therapeutics. The RNA Zipcode program was the first university-based investment of AmorChem’s second fund and was developed by Professors Eric Lécuyer (Montreal Clinical Research Institute), Mathieu Blanchette (McGill University), and Jérôme Waldispühl (McGill University).

”We invested in this technology ahead of current trends and prior to the pandemic of 2020, when the promise of RNA-based therapeutics was crystallized in an effort that saved millions of lives. Focus on RNA-based therapeutics has grown steadily since, though one of the major issues remains delivery – not only to the appropriate tissue – but also to the correct subcellular localization. The work of Kodikaz on targeted delivery of therapeutics to cancer cells using their DNA zipcode technology made them a most attractive receptor for our assets, and in fact, both groups saw synergy in combining the two approaches. It’s truly exciting to see our RNA Zipcode program now move forward in collaboration between the researchers and the Kodikaz group, which includes a seasoned management team already in place,” says Kevin McBride, General Partner & CSO at AmorChem.

”The success of our RNA Zipcode program highlights our specialized investment strategy: digging deep into Quebec academia searching for novel therapeutic approaches that will benefit patients. This often means that AmorChem bets on nascent technologies that have not yet been proven. In the RNA Zipcode case, our team spearheaded the collaboration between three teams from two major research institutions and AmorChem’s investment leveraged additional financial support from several granting agencies. Our mobilization of the appropriate human and financial resources allowed us to attract a valuable partner. This is now bringing a transformative academic technology one step closer to patients while building Kodikaz’s pipeline to a full suite of complementary delivery tools,” comments Inès Holzbaur, Managing Partner at AmorChem.

”This is a great opportunity to partner with world-renowned inventors that bring expertise in artificial intelligence and RNA delivery. We are excited to bring in the new capability that permits us to further control delivery not only to the targeted cell but also within the cell with high specificity,” says Anthony Johnson, Kodikaz President & CEO.

The transaction was made possible by the great collaboration of Axelys and McGill University’s Office of Innovation + Partnerships. The RNA Zipcode program was generously supported by grants from the Genomic Applications Partnership Program (Genome Canada and Genome Quebec), as well as the Programme de soutien aux organismes de recherche et d’innovation (Ministère de l’Économie, de l’Innovation et de l’Énergie) and Médicament Québec.

About AmorChem

AmorChem (www.amorchem.com) is a leading early-stage venture capital fund launched in 2011 in Montreal. The AmorChem team utilizes its deep understanding of fundamental science to uncover its therapeutic potential and focuses its core expertise in translational research to accelerate therapeutic drug discovery and development across a broad spectrum of disease areas. The fund capitalizes on both its venture capital expertise and its entrepreneurial experience to spark the creation of start-up companies and help shape them into the next generation of biotech companies. With over $85M under management, AmorChem has financed over 30 university projects and started up several biotechnology companies from the fruits of this innovative research.

For more information on Kodikaz, visit www.kodikaz.com.

Contacts

Media contact
Inès Holzbaur

514 513-7453

ines@amorchem.com

Neurenati Therapeutics Strengthens Its Board of Directors With the Appointment of Dr. Marielle Cohard-Radice

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MONTREAL–(BUSINESS WIRE)–Neurenati Therapeutics, a pediatric rare diseases-focused company, is delighted to announce the appointment of a highly-experienced executive in the pharma industry as an independent board member.

Dr Marielle Cohard-Radice is a gastroenterologist who held various executive positions in several therapeutic areas over three decades. She is currently Executive Vice-president, Global Head of Development Operations at Daiichi Sankyo.

“Marielle’s role will be key in refining our clinical development strategy and maximize our development success rate. Welcome on the board of directors,” added Maxime Ranger, CEO of Neurenati.

“Newborns with Hirschsprung’s disease deserve a treatment option to avoid surgery. Preclinical efficacy data showed that NEU-001 hold promise in regenerating the enteric nervous system of these children. Looking forward to supporting Neurenati in its efforts,” said Dr. Cohard-Radice

Both independent board members, Dr Alexandre Lebeaut and Dr Marielle Cohard-Radice will assist Neurenati to create its scientific and clinical advisory board in upcoming months.

NEW MANAGEMENT TEAM MEMBER

Neurenati also announces the appointment of Dr Marie-Eve Bordeleau as Senior Director, Preclinical development. Prior to joining Neurenati’s team, Dr Bordeleau was Deputy Director of the Molecular genetics of stem cells research unit, IRIC, Université de Montréal, under the direction of Dr. Guy Sauvageau. She will be responsible for the entire preclinical program in addition to overseeing the manufacturing of NEU-001.

ABOUT NEURENATI

Neurenati Therapeutics is a Québec-based biotech company dedicated to developing therapies for rare diseases. The first technology targets Hirschsprung disease (HSCR), a life-threatening gastrointestinal (GI) birth defect characterized by the lack of nerves in parts of the lower GI tract. Neurenati proposes an innovative therapy involving growth factor to treat newborns with HSCR, thereby averting the need for surgery and associated complications.

Contacts

MEDIA CONTACT
Maxime Ranger, PhD MBA

President and CEO

Neurenati Therapeutics Inc

E: maxime@neurenati.com
T: +1.514.825.9035

PANCREACTIC CANCER: SUCCESFUL TRIAL AGAINST PANCREATIC CANCER WITH DEFENCE’S ARM-002 ANTI-CANCER VACCINE

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Vancouver, BC, Canada, May 1st, 2024 – Defence Therapeutics Inc. (“Defence” or the “Company”), (CSE: DTC, OTCQB: DTCFF, FSE: DTC), a Canadian biopharmaceutical company developing novel immune-oncology therapeutics and drug delivery technologies, is pleased to announce the successful completion of a pre-clinical vaccination trial using its ARM-002TM vaccine against pancreatic cancer. The vaccine was shown to be therapeutically effective against pre-established pancreatic cancer especially when combined with the anti-PD-1 immune-checkpoint inhibitor.

In the context of an in vivo pre-clinical study, Defence tested its ARM-002TM vaccine pulsed with a pancreatic cancer lysate in combination with the anti-PD-1 immune-checkpoint in animals with pre-established Pan02 tumors. Animals’ follow-up revealed that the vaccine is indeed potent as all treated animals remained alive for over 40 days (equivalent to almost 5 years in the human scale) with tumor growth heavily impaired/blocked compared to other treatments/controls. Since Defence is interested in targeting “hard-to-treat” cancers, these results represent an important infliction point and an incentive to redirect its Phase I trial using the ARM-002TM anti-cancer vaccine to target pancreatic cancer.

Pancreatic cancer begins when uncontrolled cellular growth occurs in the pancreas. It is rarely diagnosed at early stages when the chance of curing the disease is the greatest as it often doesn’t cause symptoms until it metastasises to other organs. This classifies this type of cancer as a “hard-to-treat” cancer as patients at that point face limited treatment options.

Treatment for pancreatic cancer depends on the cancer stage as well as its location. Although the first goal of pancreatic cancer treatment is to get rid of the cancer, this unrealistic option often shifts to improving quality of life and keeping the cancer from growing or causing more harm. As such, treatments available for pancreatic cancer often involve surgery, radiation, chemotherapy or a combination, and are associated with limited clinical benefits or life-related complications. For instance, even if surgery to remove the whole pancreas is performed, patients would then rely on taking medicine their entire life to replace the hormones and enzymes made by the pancreas. Alternatively, chemotherapy (often combined with radiation therapy) can shrink the cancer, but it is often associated with resistance and/or relapse. As these standards of care fail in large set of patients, the next available option relies on immunotherapy, which uses the body’s immune system to kill cancer cells.

“Defence’s goal is to bring our proprietary and innovative immune therapies to the clinical stage for the benefit of the cancer patients. We often say that our Accum® platform is highly versatile as it can lead to the development of verticals promoting different products for multiple indications. This also applies to a single product as it can be adapted to various diseases as demonstrated with our ARM-002TM vaccine in vivo pre-clinical studies, which was shown to impair the growth of solid T-cell lymphoma, melanoma and now pancreatic cancer” says Mr. Plouffe, Chief Executive Officer of Defence Therapeutics.

Pancreatic Cancer Market size is estimated to surpass USD 36 Billion by the end of 2036, growing at a CAGR of 18% during the forecast period of 2024-2036. In 2023, the industry size of the pancreatic cancer was over USD 6 Billion. The growth of the market can be attributed to the rising prevalence of cancer cases among people across the world.

https://www.researchnester.com/reports/pancreatic-cancer-market/5299

About Defence:

Defence Therapeutics is a publicly-traded clinical-stage biotechnology company working on engineering the next generation vaccines and ADC products using its proprietary platform. The core of Defence Therapeutics platform is the ACCUM® technology, which enables precision delivery of vaccine antigens or ADCs in their intact form to target cells. As a result, increased efficacy and potency can be reached against catastrophic illness such as cancer and infectious diseases.

For further information:

Sebastien Plouffe, President, CEO and Director

P: (514) 947-2272

Splouffe@defencetherapeutics.com

www.defencetherapeutics.com

Cautionary Statement Regarding “Forward-Looking” Information

This release includes certain statements that may be deemed “forward-looking statements”. All statements in this release, other than statements of historical facts, that address events or developments that the Company expects to occur, are forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”, “believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions “will”, “would”, “may”, “could” or “should” occur. Although the Company believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in the forward-looking statements. Factors that could cause the actual results to differ materially from those in forward-looking statements include regulatory actions, market prices, and continued availability of capital and financing, and general economic, market or business conditions. Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking statements. Forward-looking statements are based on the beliefs, estimates and opinions of the Company’s management on the date the statements are made. Except as required by applicable securities laws, the Company undertakes no obligation to update these forward-looking statements in the event that management’s beliefs, estimates or opinions, or other factors, should change.

Neither the CSE nor its market regulator, as that term is defined in the policies of the CSE, accepts responsibility for the adequacy or accuracy of this release.

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Ventus Therapeutics Announces Results from Phase 1 Clinical Trial of VENT-02, a Novel, Orally Administered, Brain-Penetrant NLRP3 Inhibitor

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VENT-02 demonstrated robust pharmacodynamic modulation, a broad therapeutic index, and potential for once-daily dosing

VENT-02 provided full target coverage with a single dose

No dose-limiting toxicities or serious adverse events observed

Initiation of clinical trials in CNS diseases expected beginning in the second half of 2024

WALTHAM, Mass. & MONTREAL–(BUSINESS WIRE)–Ventus Therapeutics, a clinical-stage biopharmaceutical company utilizing its proprietary structural biology and computational chemistry platform, ReSOLVE™, to develop differentiated small molecule therapeutics, today announced results from its Phase 1 clinical trial of VENT-02, a novel, oral, brain-penetrant NLRP3 inhibitor. The Phase 1 trial evaluated the pharmacodynamics, pharmacokinetics, safety, and tolerability of VENT-02 across a broad range of single and multiple ascending doses in adult healthy volunteers.

“We are pleased with the results of this trial in which VENT-02 demonstrated a broad therapeutic index and complete target coverage, underscoring its potential to treat diseases of the CNS as well as peripheral diseases with high unmet needs,” said Xavier Valencia, M.D., Head of Clinical Development at Ventus. “Our next trial for VENT-02, a Phase 1b trial in patients with Parkinson’s disease, will evaluate multiple doses and dose regimens against a placebo control and assess a collection of markers that map multiple components of inflammation to disease activity. Based on the promising pharmacodynamic and safety data from this Phase 1 trial and our clinical development plans, we believe VENT-02 is poised to demonstrate best-in-class potential.”

In this Phase 1 clinical trial, VENT-02 was well-tolerated, with no dose-limiting toxicities or serious adverse events reported and only mild or moderate treatment-related adverse events observed. The moderate adverse events included headache and nausea and were only observed at a dose multiple times higher than the intended therapeutic doses.

VENT-02 demonstrated full target engagement through 100% inhibition of IL-1ß in the blood in an ex vivo whole blood challenge assay, significant drug levels in the CSF for 24 hours, and robust reduction of inflammatory biomarkers such as hsCRP. Based on the half-life and target coverage observed in the trial, VENT-02 has demonstrated the potential for once-daily dosing.

“The excellent properties of VENT-02 are a reflection of Ventus’ industry-leading exploration of NLRP3, including demonstrating proof-of-concept in preclinical studies in multiple disease-relevant models, validating biomarkers, and collaborating with academic institutions and the Michael J. Fox Foundation,” said Ventus President and CEO, Marcelo Bigal, M.D., Ph.D. “As a result, we are ready to bring VENT-02 into Parkinson’s disease and other pre-defined diseases where the CNS plays an important role, capitalizing on innovative trials that we are crafting to be informative in reducing risk in the future steps of clinical development. In addition, we expect that our planned trials will allow us to explore the potential impact of NLRP3 inhibition across multiple patient populations suffering from serious diseases.”

Ventus expects to initiate a Phase 1b trial of VENT-02 in patients with Parkinson’s disease in the second half of 2024 and a Phase 2 trial in patients with treatment-refractory epilepsy in 2025.

About NLRP3

NLRP3 is the best understood member of a family of proteins known as inflammasomes. Inflammasomes are multiprotein complexes that regulate the innate immune system and are involved in intracellular surveillance of danger and pathogen signals that trigger an intense inflammatory response, including the release of IL-1β and IL-18 and the induction of pyroptosis, an inflammatory form of cell death. Therapeutic inhibition of NLRP3 can prevent the formation of the NLRP3 inflammasome, which in turn inhibits the production of IL-1β and IL-18 as well as pyroptosis. Aberrant activation of the NLRP3 inflammasome has been associated with systemic conditions, including fibrotic, dermatological, and rheumatological diseases, and is a key driver of disease pathology in several neurological disorders, including Parkinson’s disease, Alzheimer’s disease, and treatment-refractory epilepsy.

About Ventus Therapeutics

Ventus Therapeutics is a clinical-stage biopharmaceutical company deploying deep protein science expertise and a proprietary computational chemistry platform to develop novel small molecule therapeutics for immunology, inflammation, and neurology disorders. Using its proprietary drug discovery platform, ReSOLVE™, the company screened its first target in 2020, selected three development candidates in 2022, and advanced its two wholly-owned product candidates into the clinic in 2023: VENT-03, a potent, selective, oral cGAS inhibitor in Phase 1, and VENT-02, a potent, brain-penetrant, oral NLRP3 inhibitor in Phase 1. In addition, Ventus has out-licensed VENT-01, a peripherally-restricted NLRP3 inhibitor, to Novo Nordisk A/S. These programs exemplify Ventus’ robust discovery capabilities and focus on differentiated programs for multi-indication immunology and neurology targets. For more information, please visit www.ventustx.com and engage with Ventus on LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements. These statements involve known and unknown risks, uncertainties, and other important factors that may cause Ventus’ actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “would,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential,” or “continue” or the negative of these terms or other similar expressions. All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements regarding the timing, progress, and results of Ventus’ clinical trials, the anticipated timing of initiation and completion of trials, the period during which the results of the trials will become available, and Ventus’ development plans. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond Ventus’ control, you should not rely on these forward-looking statements as predictions of future events. Such risks include, but are not limited to, the risk that Ventus is unable to further advance VENT-02 and VENT-03 in clinical development, obtain regulatory approval, and ultimately commercialize VENT-02 and VENT-03, or experience significant delays in doing so; that Ventus will require substantial additional funding to finance its operations; that the development and commercialization of pharmaceutical products is subject to extensive regulation, and the regulatory approval processes of the U.S. Food and Drug Administration and comparable foreign authorities are lengthy, time-consuming, and inherently unpredictable; and that Ventus’ success depends on its, its current and future licensors’, and its exclusive licensees’ ability to obtain, maintain, enforce, and protect its intellectual property and its proprietary technologies. Forward-looking statements included herein are based upon information available to Ventus as of the date of this press release, and while Ventus believes such information forms a reasonable basis for such statements, such information may be limited or incomplete, and Ventus’ statements should not be read to indicate that it has conducted an exhaustive inquiry into, or review of, all potentially available relevant information. The events and circumstances reflected in the forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, Ventus does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances, or otherwise.

Contacts

Media
Dan Budwick

1AB

dan@1abmedia.com

Flosonics Medical Secures $20 Million USD in Series C Funding Led by New Leaf Venture Partners to Accelerate Growth

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SUDBURY, Ontario–(BUSINESS WIRE)–#flopatch–Flosonics Medical, a leader in wearable medical ultrasound, today announced its Series C financing, raising $20 million USD. The round was led by New Leaf Venture Partners, with participation from previous investors Arboretum Ventures, Genesys Capital, and iGan Partners. This new funding will support Flosonics as the company continues to innovate and drive market adoption of FloPatch, a first-in-class wearable Doppler ultrasound for hemodynamic assessments.

Vijay Lathi, an experienced MedTech investor with a focus on data convergence and guiding growth-stage companies, will join Flosonics Medical’s board of directors. “We are thrilled to have New Leaf Venture Partners lead our Series C round and welcome Vijay Lathi to our board,” said Joe Eibl, CEO of Flosonics Medical. “This investment not only validates our past successes but also enables us to accelerate our plans for expansion and innovation. We are committed to leveraging this funding to further enhance the standard of care for critically ill patients with FloPatch and expand our reach into new markets.”

On behalf of New Leaf Venture Partners, Vijay Lathi expressed enthusiasm about the partnership: “Our investment into Flosonics is driven by the clear and significant impact their technology will have on patients in critical situations, and the quality of the team behind it. Flosonics Medical stands at the forefront of wearable ultrasound, and we look forward to contributing to their continued success.”

Flosonics Medical plans to use the Series C investment to accelerate commercial growth, expand indications for use, and continue evidence generation. The company aims to address the growing demand for wearable AI-assisted sensors to improve patient management inside and outside the hospital.

About: Flosonics Medical is a Canadian medical device company engaged in the research and development of innovative ultrasound technology. Founded in 2015, the company’s mission is to improve patient care and the practice of medicine through technology-enabled solutions and ground-breaking clinical research.

About New Leaf Venture Partners: New Leaf Venture Partners is a leader in healthcare technology venture investing. Our investment professionals bring a unique blend of technical, operational, and clinical experience to our investments, working closely with our entrepreneurs and management teams to help build successful companies. New Leaf Ventures invests in both healthcare-related information technology companies as well as public and private biopharmaceutical companies as well as. New Leaf currently manages over $500 million in assets through several funds. New Leaf was formed in 2005 as the healthcare spinoff from the Sprout Group, one of the oldest U.S. venture capital funds. For more information please visit www.nlvpartners.com.

Contacts

For media inquiries: rgibson@flosonicsmedical.com.

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.

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

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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

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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

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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