Agilex Biolabs, Australia’s largest and most technologically advanced specialist bioanalytical laboratory for clinical trials, today announced it will showcase its world-class immunoassay and immunobiology services for regulated bioanalysis at Bio-Europe 2021.
Dr Kurt J. Sales Agilex Biolabs’ Director Immunoassay said:
“Our experienced team can develop or transfer a method for any biologic to support pre-clinical GLP or clinical studies. Our world-class laboratories feature state-of-the-art equipment including Gyrolab Xplore, MSD Quickplex 120, Luminex Magpix, BD FACSymphony A3 flow cytometer and soon to be released, digital droplet quantitative real-time RT-PCR. Our scientists have expertise and experience to solve the most complex immunogenicity and drug tolerance issues, often encountered in immuno-oncology studies in both an early phase and later phase setting.”
Agilex Biolabs also features a rebate of up to 43.5% on clinical trial bioanalytical services spend as part of the Australian Government clinical trial attraction program.
Agilex Biolabs also has the leading certifications including OECD GLP Recognition with NATA (Australian Government OECD GLP Compliance monitoring authority) and ISO 17025 Accreditation for global recognition.
Australian clinical trials have remained open for business and Agilex Biolabs is a designated essential service so clients can be assured of study continuity.
Australia has led the world in keeping COVID-19 numbers down to almost zero across the country by acting swiftly to minor outbreaks.
The company has recently expanded its labs by more than 30% to accommodate biotech demand from APAC, EU and the USA. Watch the New Labs Walkthrough Video Here https://www.agilexbiolabs.com/new-labs-video
Agilex Biolabs has more than 100 staff which includes 75 dedicated laboratory staff.
Agilex Biolabs, Australia’s leading bioanalytical laboratory, has more than 24 years’ experience in performing regulated bioanalysis, including quality method development, method validation and sample analysis services. We have successfully supported hundreds of preclinical and clinical trials around the world where customers choose Australia for the streamlined regulatory process and access to the world’s most attractive R&D rebate of more than 40% on clinical trial work conducted in Australia.
We offer services for both small molecules and biologics for PK, immunogenicity (PD) and biomarker bioanalysis utilising the two platforms of LC-MS/MS and Immunoassay.
The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award winner Avance Clinical congratulated Atossa Therapeutics on the announcement of their Phase 1 final results for the AT-301 nasal spray being developed for COVID-19.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) is a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need with a current focus on breast cancer and COVID-19.
Yvonne Lungershausen, CEO, Avance Clinical said:
“As the CRO for this important study, we congratulate Atossa Therapeutics on these impressive safety and tolerability clinical results. Atossa Therapeutics have tapped the full scope of our CRO services including ClinicReady, our scientific and medical affairs specialist team. Australian clinical trials are recognized globally for their speed and accuracy and the fact that the clinical data is accepted by all major regulatory authorities including the FDA. Increasingly our clients are also tapping the generous 43.5% Australian Government rebate to support their clinical research.”
According to Atossa Therapeutics:
Atossa Therapeutics today announced final results from its Phase 1 double-blinded, randomized, placebo-controlled clinical study using Atossa’s proprietary drug candidate AT-301 administered by nasal spray. AT-301 was considered to be safe and well tolerated in healthy male and female participants in this study at two different dose levels over 14 days. AT-301 is being developed for at home use for patients recently diagnosed with COVID-19. There are currently no FDA-approved therapies to treat COVID-19 at home.
Final analysis of the data from the study indicates that there were no serious adverse events, no discontinuations, no bronchospasms, and only one subject of the 32 subjects in the study experienced adverse events that were considered moderate in severity and all other adverse events were considered mild.
Atossa’s assessment is that AT-301 nasal spray was safe and well tolerated in this study. The most common treatment-related adverse events observed with AT-301 treatment with either single or multiple doses were nasal discomfort and sneezing.
“The results from this study are very encouraging and we look forward to quickly commencing the next study of AT-301,” commented Steven Quay, M.D., Ph.D., Atossa’s President and CEO.
Atossa believes that AT-301 nasal spray will play an important role alongside the traditional vaccines now being deployed, particularly as it becomes clear that it will take months or years for vaccines to be administered around the world.
The Phase 1 study was a double-blinded, randomized, and placebo-controlled safety study of AT-301 nasal spray in 32 healthy adult subjects who were divided into two study groups.
Part A consists of two single-dose cohorts receiving either active therapy, AT-301B, or the placebo comparator AT-301A at two different doses. Part B was a multiple dose arm with cohorts receiving either AT-301A or AT-301B for 14 days at two different doses.
The primary objectives of the study were to evaluate the safety and tolerability of single and multiple doses of AT-301 administered via nasal instillation to healthy volunteers. Secondary objectives were to assess the incidence and severity of local irritation and bronchospasm following administration of AT-301 via nasal instillation.
Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need with a current focus on breast cancer and COVID-19. For more information, please visit www.atossatherapeutics.com.
About Avance Clinical
Australia’s Avance Clinical has more than 20-years of experience and is now one of Australia’s leading Contract Research Organizations. Avance Clinical facilitates quality drug development by aligning people, skills, and expertise in the pursuit of drug development for a healthier world. Avance Clinical is committed to providing high-quality clinical research services with its highly-experienced team. The collective pool of knowledge and experience at Avance Clinical continually grows through the careful selection of experts who also demonstrate passion in their chosen field. Avance Clinical offers high-quality services in an established clinical trial ecosystem, that includes world-class Investigators and Sites able to access specialized patient groups. Visit http://www.avancecro.com for more information. Other benefits include: 1. The Government R&D grant means up to 43.5% rebate on clinical trial spend 2. Telehealth pivot during COVID-19 pandemic – speed and continuity 3. Site Initiation Visit (SIV) and Study Start achieved in 5-6 weeks 4. No IND required for clinical trials 5. Full GMP material is not mandated for Phase I clinical trials 6. Established clinical trial environment with world-class Investigators and sites 7. Established healthy subject databases and specialized patient populations 8. Five independent Phase 1 facilities across Australia including hospital-based units for critical care 9. Major hospitals with world-class infrastructures and dedicated Clinical Trial Units with a long track-record in FDA compliant research 10. Seasonal studies: Northern hemisphere Sponsors can conduct their studies year-round by taking advantage of Australia’s counter-flu and allergy seasons
The leading Australian CRO for biotechs, and Frost & Sullivan Asia-Pacific CRO Market Leadership Award winner, Avance Clinical continues to celebrate their strategic partnership with Medidata, and the accreditation of seven Medidata inhouse experts.
The two organizations have been working together to deliver world-class clinical research services to Avance Clinical’s biotech customers via the Medidata Rave Clinical Cloud™.
Avance Clinical, Chief Strategy Officer, Ben Edwards said “We look forward to many more years working with Medidata as we continue to grow the business and support the development needs of our clients.”
Mr Edwin Ng, Senior Vice President, General Manager for Medidata APAC, said, “We are pleased to be supporting Avance Clinical’s exceptional growth in Australia. Avance Clinical accreditation signifies the importance of Medidata’s portfolio of products in ensuring the success of our partners’ programs, and our continued commitment to helping our partners streamline and enhance the clinical research process.”
Avance Clinical, Director Business Development Operations, Sandrien Louwaars said, “The Medidata Rave Clinical Cloud™ is a quality- and efficiency-focused unified platform that helps our biotech clients, and ensures data integrity, speed, and compliance across multisite and global studies.
“Our seven Avance Clinical accredited Medidata experts lead our efforts, and it makes a real difference for our clients having them inhouse rather than as external consultants.”
Australia’s Avance Clinical has more than 20-years of experience and is now one of Australia’s leading Contract Research Organizations. Avance Clinical is committed to providing high-quality clinical research services with its highly-experienced team. The collective pool of knowledge and experience at Avance Clinical continually grows through the careful selection of experts who also demonstrate passion in their chosen field. Avance Clinical offers high-quality services in an established clinical trial ecosystem, that includes world-class Investigators and Sites able to access specialized patient groups.
Other benefits include: 1. The Government R&D grant means up to 43.5% rebate on clinical trial spend 2. eClinical solutions – speed and continuity 3. Site Initiation Visit (SIV) and Study Start achieved in 5 – 6 weeks 4. No IND required for clinical trials 5. Full GMP material is not mandated for Phase I clinical trials 6. Established clinical trial environment with world-class Investigators and sites 7. Established healthy subject databases and specialized patient populations 8. Five independent Phase 1 facilities across Australia including hospital-based units for critical care 9. Major hospitals with world-class infrastructures and dedicated Clinical Trial Units with a long track-record in FDA compliant research 10. Seasonal studies: Northern hemisphere Sponsors can conduct their studies year-round by taking advantage of Australia’s counter-flu and allergy seasons
Medidata is leading the digital transformation of life sciences, creating hope for millions of patients. Medidata helps generate the evidence and insights to help pharmaceutical, biotech, medical device and diagnostics companies, and academic researchers accelerate value, minimize risk, and optimize outcomes. More than one million registered users across 1,600+ customers and partners access the world’s most-used platform for clinical development, commercial, and real-world data. Medidata, a Dassault Systemes company (Euronext Paris: #13065, DSY.PA), is headquartered in New York City and has offices around the world to meet the needs of its customers. Discover more at www.medidata.com and follow us @Medidata, The Operating System for Life Sciences™.
Medidata is a registered trademark of Medidata Solutions, Inc., a wholly-owned subsidiary of Dassault Systemes.
Dassault Systemes, the 3DEXPERIENCE Company, is a catalyst for human progress. We provide business and people with collaborative 3D virtual environments to imagine sustainable innovations. By creating virtual experience twins of the real world with our 3DEXPERIENCE platform and applications, our customers push the boundaries of innovation, learning and production. Dassault Systemes brings value to more than 290,000 customers of all sizes, in all industries, in more than 140 countries. For more information, visit www.3ds.com.
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Maculus Therapeutix, a preclinical-stage biopharmaceutical company which has developed a SINGLE injection delivery platform for diseases such as wet AMD (Age-related Macular Degeneration) and DME (Diabetic Macular Edema) instead of the standard 8-12 monthly injections, is pleased to welcome Privity FZ LLE as a partner and advisor for upcoming fundraising activities. Maculus plans to raise USD3 million with a USD8 million valuation for a 12-18 month period, including initial in-vivo animal studies and completion of in-vitro / in-vivo drug elution studies.
Maculus achieved the breakthrough using a patented novel tunable biodegradable proprietary product, MacuBloc, capable of delivering any FDA approved drugs for Wet AMD / DME to the site of the disease, with unique suitability for targeted and extended delivery of drugs to the back of the human eyes, MacuBloc offers significant benefits to Wet AMD patients: a single intravitreal injection that lasts a year rather than the current monthly injections, and a potential reduction in inflammation, infection, doctor visits and total cost of care, compared to current practice.
Syed H Askari, PhD, Founder, Chief Executive Officer and CTO of Maculus Therapeutix, said, “We are very excited to welcome Privity in developing this unique product, which can bring such transformative treatment to those suffering from wet AMD and DME. Our product is designed to solve each of the challenges while significantly reducing the total cost of care. More importantly, our product makes it possible to replace the 10 injections with ONE injection for any FDA approved drug, a leap ahead of the current standard of care.”
The approach will change the lives of 200 million patients worldwide who suffer from debilitating eye diseases. Current standards of care (8-12 monthly injections to the eyes for AMD and for DME) have numerous challenges: pain, inflammation, infection, loss of vision. Our product is designed to solve each of these challenges while significantly reducing the total cost of care. More importantly, our product makes it possible to replace the 10 injections by ONE injection for any FDA approved drug, a significant leap ahead of the current standard of care.
Sleem Hasan, Privity Founder and CEO, said, “Privity was founded to identify entrepreneurs with unique ideas and compelling value propositions, and Maculus fell right into this sweet spot, speaking straight at me as I had experienced diabetic retinopathy personally and amongst family members. Syed is a serial entrepreneur, his education and training in India, UK, Canada and the US, and professional career speak for themselves.”
About Maculus Therapeutix, Inc. The Maculus Therapeutix team has been together in Silicon Valley for 15 years, building Medicus Biosciences Inc., a polymer-based medical device company with current operations in San Diego, CA., and developing the polymer drug delivery platform for various diseases. Our target markets include treatments for AMD and DME. Globally, the AMD market size is $10B, growing at 7% CAGR, and the DME market size is $4B, with 10% CAGR. For more information, please visit www.maculustherapeutix.com.
About Privity FZ LLE Privity FZ LLE was founded in Dubai in 2004, an independent venture-focused advisory firm which seeks entrepreneurs with interesting and unique ideas and helps them to develop and grow. Privity is agnostic to geography and industry vertical; It focuses on the quality of the entrepreneur and the compelling value proposition of the idea. Privity draws upon its unique 4i methodology – ideas, intelligence, innovation, invention – to deliver insightful advisory and consulting services. For more information, please visit www.privitylle.com.
Per the CDC, NIOSH, and National Personal Protective Technology Laboratory Certified Equipment List, ALG Health is one of only three companies who manufacture their own mask that hold this rating.
ALG Health announced today that it received National Institute of Occupational Safety and Health (NIOSH) Surgical N95 approval for three of its Made in the U.S.A. Patriot Masks. The approvals are for the ALG Health Foldable N95 Respirator and both sizes of their Molded N95 Respirators. The surgical ratings state these products are approved and cleared for use in Healthcare settings under Food & Drug Administration (FDA)/NIOSH MOU 225-18-006 regulations. ALG Health first received NIOSH N95 ratings on all their Filtering Facepiece Respirators (FFR) in November 2020, meeting the OSHA and CDC product and manufacturing standards.
“Acquiring this next level approval for the N95 surgical rating is extremely exciting for us,” said Adam Harmon, President and CEO of ALG Health. “The largest segment we work with are those in the Healthcare industry, these credentials will give them the comfort level they deserve to know they are wearing a quality mask, that will help protect them while saving lives.”
The process to become (NIOSH) approved includes both a documentation and facility review to ensure that the product and the manufacturing process meet the given requirements. Not only must the product filter particulates at or above 95%, but the manufacturing and quality assurance procedures must also qualify. “The entire (NIOSH) organization has been great to work with during this time,” Harmon noted, “even during this pandemic, they prioritized getting American manufacturers through the process as efficiently as possible.”
Not only is ALG Health providing protection to those that wear their masks, but they are also improving those lives of the American workforce. ALG is now employing approximately 150 local workers at their two manufacturing facilities in Northwest Ohio. The company operates a 100,000 sq ft facility in Bryan, Ohio, and a smaller 10,000 sq ft facility in Defiance, Ohio.
ALG Health is also in the process of expanding its distribution network. “We are looking for reputable distributors in the Healthcare, Government, and industrial/commercial segments,” said Brian Feeney, VP of Sales and Marketing. “The demand for our high-quality American made products has been outstanding and we expect with the new surgical rating it will increase greatly. Finding the right distributor partners is paramount, as it is the ALG Health brand they will be representing.”
About NIOSH The Occupational Safety and Health Act of 1970 external icon established (NIOSH) as a research agency focused on the study of worker safety and health, and empowering employers and workers to create safe and healthy workplaces. (NIOSH) is part of the U.S. Centers for Disease Control and Prevention, in the U.S. Department of Health and Human Services. It has the mandate to assure “every man and woman in the Nation safe and healthful working conditions and to preserve our human resources.” (NIOSH) has more than 1,300 employees from a diverse set of fields including epidemiology, medicine, nursing, industrial hygiene, safety, psychology, chemistry, statistics, economics, and many branches of engineering. Visit https://www.osha.gov.
About ALG Health ALG Health is a 2020 division of the parent company, Axis LED Group, a manufacturer of commercial and governmental LED lighting. Using its manufacturing expertise, ALG Health produces personal protective equipment, including disposable surgical masks and medical-grade respirators. Having previously received (NIOSH) approval and now the (NIOSH) Surgical rating, the company is concentrating on servicing the medical community, first responders, military, manufacturing and humanitarian efforts. Visit https://www.alg-health.com.
Cofttek Holding Limited, a Chinese pharmaceutical manufacturer, has recently drawn the attention of investors, following the U.S. introduction of the FDA drug ultramicronized Palmitoylethanolamide (PEA) for COVID-19 patients. Cofttek is China’s largest manufacturer of ultramicronized Palmitoylethanolamide (PEA) raw materials. Following the U.S. news, orders at Cofttek have surged, and production capacity has been saturated.
Cofttek founder Dr. Zeng explained, “Following this FDA news, the share price of FSD Pharma (NASDAQ: HUGE), our main competitor in the USA, roared from $3 to $14 in a few days. As the largest PEA manufacturer in China, Cofttek has attracted similar attention from many investors in the industry.”
Palmitoylethanolamide (PEA), an endogenous (manufactured by the body) fatty acid amide, is emerging as a new agent in the treatment of pain and inflammation. As an endogenous agent, one that is also found in foods such as eggs and milk, no serious side effects or drug-drug interactions have been identified.
PEA is a naturally occurring fatty acid. It is similar to an endocannabinoid, which is one of a suite of molecules found in cannabis targeting CB2 receptors. CB2 receptors can modulate both inflammation and pain throughout the human body. COVID-19 is characterized by an over-exuberant inflammatory response that may lead to a cytokine storm, which is not a virus killer. But Cofttek believes it can mitigate that immune response, which can be fatal.
About Cofttek
Cofttek Holding Limited, founded in 2008, is a high-tech pharmaceutical biochemical enterprise, integrating production, R&D and sales. It is located in Luohe Chemical Industry Park, in Luohe City, Henan Province, and is committed to the research and development of advanced pharmaceuticals, providing innovative products and high-quality services for the pharmaceutical industry.
AI-assisted computing has greatly improved the efficiency of new drug research and development. Suntrap Life Technologies Co., Ltd has taken the lead to establish the Suntrap IDDNU(R) platform to serve as an international drug discovery network alliance.
In 2019, Suntrap Life Technologies established a drug research team, carried out comprehensive drug research and development projects, and built the Suntrap IDDNU (Suntrap International Drug Discovery Network Alliance) technology platform. Suntrap IDDNU is based upon the EK-DRD database, published by one of the researchers, Mr. Jason Zhao. (J Chem Inf Model. 2019 Sep 23;59(9):3619-3624. EK-DRD: A Comprehensive Database for Drug Repositioning Inspired by Experimental Knowledge). This database includes detailed information on the US FDA approved 1963 drugs (including those withdrawn from the market), and the activity information in the target, cell, animal, and clinical experiments. In addition, the Suntrap research team also included the structure and activity data of 400,838 natural compounds.
Through the collection of these data and the construction of a database, the Suntrap research team has developed a series of natural compounds for drug redirection. Based on AI drug discovery algorithms and mathematical models, it can quickly calculate the affinity between these compounds and the target, and predict the compound-protein interaction, the ability to discover multi-pharmacological (multi-target) compounds, and the discovery of the correspondence among the drug-target-disease interactions, provide a very efficient platform for systematic pre-screening of drugs. For a variety of diseases, the Suntrap research team has initiated a variety of biological drug research and development pipelines (ie. tumors, viral infections, tissue fibrosis, respiratory infectious diseases, aging-related chronic diseases, and others).
Given that the new coronavirus is still pandemic throughout the world, the Suntrap research team responded and launched the ‘Research on Anti-Coronavirus Products’ project in early 2020. Drugs claimed to be targeting the coronavirus have been clinically proven to be ineffective and have side-effects. In terms of target selection for the new drug development, the Suntrap research team aims to the development of small molecules with multi-targets, broad-spectrum, and collaborative therapeutic effectiveness, which acts not only to the original coronaviruses but also on the mutants or related strains. The Suntrap IDDNU quickly screened the antiviral activity of natural small molecular compounds from a database of drugs, herbals as well as food components, and discovered the multi-target synergistic anti-coronavirus compound “LeSoleil(R)”. The Suntrap research team, together with the Guangdong Provincial Center for Disease Control and Prevention, and the Guangdong Provincial Institute of Public Health, completed the sensitivity study and safety evaluation of ‘LeSoleil’. The experimental conclusions show that ‘LeSoleil’ has significant effectiveness in the in vitro inhibition of the coronavirus (SARS-CoV-2). Further studies confirmed the effectiveness, which laid the foundation for ‘LeSoleil’ to be further developed into a candidate for the anti-coronavirus drug. The Suntrap’s team studies have indicated that ‘LeSoleil’ has the advantages of low toxicity, good tolerability, and high accessibility, The Suntrap IDDNU guarantees the rapid development of broadspectrum COVID-19 prevention and therapeutic drugs.
‘LeSoleil’ series of specific drugs for the treatment of new coronavirus pneumonia have completed preclinical trials
In the face of the increasing spread of the new mutant coronavirus strains that are more infectious and elusive, existing drugs and vaccines are not enough to combat and completely eliminate the mutant virus. The world has an urgent need for new coronavirus therapeutic drugs. Based on this understanding, Suntrap’s research team took ‘LeSoleil’ as the main drug component and carried out further development of the ‘LeSoleil’ series. According to the characteristics of infection, different formulas were tested in drug development.
First of all, an emergency anti-coronavirus protective spray was released, which can effectively block the infection and the spread, while reducing the probability and risk of the mutation of the coronavirus. The protective spray can directly act on the nasal cavity and oral cavity, which are the initial sites where the virus infection manifested in the human body. The studies showed that the ‘LeSoleil’ spray effectively and stably prevent virus infection, inhibit virus replication, inactivate the virus, and prevent the virus from further infecting the human body. These observations also applied to the asymptomatic infected person who carries the virus, the spray could effectively eliminate the virus from being discharged droplets through breathing, sneezing, coughing, etc. After applying the ‘LeSoleil’, the exhaled air still retains the active ingredients that can effectively inhibit the virus, making the virus lose its infectivity. At present, the development of the ‘LeSoleil’ series of nasal and mouth spray formulations has been completed, including formulation design, formulation screening, mechanisms research, process optimization, and the quality evaluations of the QA and QC. The design, the quality control are strictly in accordance with domestic and international FDA regulations, which are complying with the general requirements of the current edition of the ‘People’s Republic of China Pharmacopoeia’. In addition, these nasal and mouth sprays could also effectively inhibit the inflammatory responses in the lungs, as experimented with the rat animal model of pneumonia. The experimental results show that ‘LeSoleil’ can prevent the inflammatory storm caused by the coronavirus infection, reduce the damage of the inflammation to the body, and have a good anti-inflammatory effect. At present, Suntrap’s research team has also completed the development of ‘LeSoleil’ series injections, which can treat patients with severe and critical pneumonia caused by coronavirus infection.
Furthermore, pulmonary fibrosis can also be prevented. Pulmonary fibrosis is a common sequela of patients discharged from the hospital with COVID-19, which seriously affects the quality of life and prognosis of patients. Pulmonary fibrosis is also commonly happening in other lung diseases, and currently, there are no effective therapeutics to cure pulmonary fibrosis patients.
Studies have shown that the new coronavirus can directly invade the brain’s nervous system, causing loss of sensory such as smell and taste, and affecting the functionality of human neurotransmitters, leading to the onset of anxiety, depression, and other mental illnesses. Suntrap’s research team has fully studied the targets related to pulmonary fibrosis and constructed in vivo and in vitro testing models. In the in vitro studies, the TGF-Beta1 induced HFL-1 cells fibrosis can be effectively inhibited, and in the in vivo bleomycin-induced rat pulmonary fibrosis, ‘LeSoleil’ showed reliable effectiveness in stopping the pulmonary fibrosis processes. The experiment shows that ‘LeSoleil’ can reduce oxidative stress, inflammation, and fibrosis, which reduce the tendency of post-infection pulmonary fibrosis. In the ‘LeSoleil’ neuron protection experiment, it was found that it can effectively inhibit the apoptosis of nerve cells, protect neurons and repair the damaged nervous system.
Pulmonary diseases have become more common in recent years. Although the formula and the inhaler are more complex than other forms of administrations, the ‘LeSoleil’ can directly reach the lungs and be absorbed more effectively. Such routes of absorption also bypass the liver metabolism, which usually happens with oral administration. The advantages are also prominent when compared with muscle injection, as the inhaler delivery reaches the loci more quickly and directly. The Suntrap research team has developed the ‘LeSoleil’ series administered with inhalation devices, which can treat and prevent pulmonary fibrosis, repair the damaged sensory perception of taste and smell, and are expected to completely improve the prognosis of the new coronavirus pneumonia.
In Conclusion
The weakening trend of the COVID-19 pandemics does not mean that the virus disappears completely or that the next wave of pandemics will not come. The threats of future pandemics are still looming large. The WHO warned that a virus more deadly than the current coronavirus may also be inflicting humans in the future. The Suntrap research team through modeling global pandemics data, in combination with the environmental factors and the effects of social distancing and other quarantine measures, also predicted that some influenza epidemics may also occur from March to May 2021. These epidemics are also expected to be accompanied by an explosive number of cases of pulmonary infection. The symptoms of such pulmonary infections are easily confused with that of coronavirus pneumonia, and there is also a risk of superimposed infection, which makes the coronavirus pandemics even more difficult to be prevented, treated, or managed.
The coronavirus is so small that it is invisible to the naked eye, but it is enough to distress the world. Today, with globalization prevail, no single country or nation can be standing alone unaffected. Under various situations of cultural, commercial, or political situations, the pandemic’s impact has become far more complicated than ever. Faced with the COVID-19 pandemics, human beings cannot rely on a sheer stroke of luck. Large-scale testing, mandatory isolation, and restrictions on the movement of people are not the optimal long-term measure. The prevention and control of infectious diseases require a high degree of professionalism. It is essential to adapt and follow the scientific principles in solving such a problem.
Therefore, it is the best strategy that we fight the disease actively, with efficiency as well as rationality so as to keep as much the normal operation of the society, minimize the economic impact, and develop safe and effective medicines for the pandemics.
Experimental researches have proved that the ‘LeSoleil’ series of drugs can not only block the broad-spectrum coronavirus infection, resist further development of respiratory infection, but also kill the viruses. ‘LeSoleil’ can also contain and eliminate the inflammatory storm caused by the infection, and prevent pulmonary fibrosis. It is expected that ‘LeSoleil’ will become an effective drug against this and the coming pandemics. At present, the Suntrap research team has completed the pharmacodynamic, pharmacokinetic, and safety evaluation studies of the ‘LeSoleil’ series of products. Patents have been filed and authorized in China. Clinical trials are also under planning and are expected to be completed in a short time. The Suntrap team is striving to make ‘LeSoleil’ available as soon as possible.
Cedar Clinical Research to be Evaluated to Support Phase IIb Trial of Novel PTSD Treatment
Novamind Inc. (CSE:NM) (“Novamind”), a leading mental health company specialized in psychedelic medicine, is pleased to announce that it has made a strategic investment of AU$827,486 (approximately CAN$810,000, the “Strategic Investment”), in Bionomics Limited (“Bionomics”) (ASX:BNO)(OTCQB:BNOEF) (Germany:AU000000BNO5), a biopharmaceutical company dedicated to developing better treatments for central nervous system disorders.
In addition, Cedar Clinical Research (“CCR”), a wholly owned subsidiary of Novamind based in Springville, Utah, will be evaluated by Bionomics as a clinical research site to conduct Bionomics’ Phase IIb trial examining BNC210. BNC210 has received Fast Track Designation from the U.S. Food and Drug Administration for the treatment of post-traumatic stress disorder (PTSD).
With its investment in Bionomics, Novamind joins a group of well-known investors that specialize in psychedelics and biotech: Apeiron Investments, Biotech Value Fund, Merck & Co., Mike Novogratz, and Peter Thiel, an early investor in ATAI Life Sciences.
Novamind’s Strategic Investment is included in Bionomics’ latest round of financing, which was underwritten by Apeiron Investments and received commitments for AU$16,000,000 (approximately CAN$15,680,000, the “Bionomics Financing”). Novamind will purchase a total of 5,706,800 common shares in the Bionomics Financing, at AU$0.145 per share, a 20% discount to the 30-day volume weighted average price as of February 5th, 2021. Proceeds from the Bionomics Financing will support the initiation of a Phase IIb trial for BNC210, planned for mid-2021.
Bionomics intends to evaluate Cedar Clinical Research’s deep expertise in facilitating Phase I to Phase IV clinical trials for leading pharmaceutical companies, and how it may potentially serve as a research site for Bionomics’ Phase IIb clinical trial examining BNC210 in PTSD patients.
Cedar Clinical Research, led by Novamind’s Chief Medical Officer, Dr. Reid Robison, is currently contracted for seven clinical trials with various sponsors, including leading pharmaceutical companies. Dr. Robison has led over 100 clinical trials in neuropsychiatry, researching a spectrum of psychiatric conditions, including PTSD.
“I’m happy to welcome Novamind as a strategic investor in Bionomics,” said Dr. Errol De Souza, Executive Chairman of Bionomics. “Dr. Robison and the team at Cedar Clinical Research have unique experience related to clinical trials for mental health therapeutics.”
Yaron Conforti, CEO and Director of Novamind, added, “We are pleased to participate in Bionomics’ financing to support the development of its novel drug candidate for the treatment of PTSD. Cedar Clinical Research has unique expertise in PTSD research, and we look forward to the opportunity to contribute to the development of BNC210.”
To learn more about Cedar Clinical Research, please visit cedarclinicalresearch.com.
About Bionomics Bionomics is a global, clinical stage biopharmaceutical company leveraging its proprietary platform technologies to discover and develop a deep pipeline of best in class, novel drug candidates. Bionomics’ lead drug candidate BNC210, currently in development for initiation of a second Phase II trial for the treatment of PTSD, is a novel, proprietary negative allosteric modulator of the alpha-7 nicotinic acetylcholine receptor. Beyond BNC210, Bionomics has a strategic partnership with Merck & Co., Inc (known as MSD outside the United States and Canada). To learn more, please visit bionomics.com.au.
About Novamind Novamind is a leading mental health company enabling safe access to psychedelic medicine through a network of clinics, retreats, and clinical research sites. Novamind provides ketamine-assisted psychotherapy and other novel treatments through its network of Cedar Psychiatry clinics and operates Cedar Clinical Research, a contract research organization specialized in clinical trials and evidence-based research for psychedelic medicine. Both Cedar Psychiatry and Cedar Clinical Research are wholly owned subsidiaries of Novamind. For more information on how Novamind is enhancing mental wellness and guiding people through their entire healing journey, visit novamind.ca.
Contact Information Novamind Yaron Conforti, CEO and Director Telephone: +1 (647) 953 9512 Bill Mitoulas, Investor Relations Email: bill@novamind.ca
Forward-Looking Statements This news release contains forward-looking statements. All statements other than statements of historical fact included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations including the risks detailed from time to time in the Company’s public disclosure. The reader is cautioned not to place undue reliance on any forward-looking information. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable laws.
Apollomics, Inc., an innovative biopharmaceutical company committed to the discovery and development of mono- and combination- oncology therapies, and Iterion Therapeutics, Inc., a venture-backed, clinical stage biotechnology company developing novel cancer therapeutics, today announced an exclusive collaboration and license agreement for the development and commercialization of tegavivint in Mainland China, Hong Kong, Macau and Taiwan, also known as Greater China.
Tegavivint is a potent and selective inhibitor of nuclear Beta-catenin that works through binding to TBL1 (Transducin Beta-like Protein One), a downstream target in the Wnt-signaling pathway. Iterion is pursuing the development of Tegavivint for the treatment of cancers where nuclear Beta-catenin signaling is known to play a role. Tegavivint is currently the subject of a Phase 1/2a clinical trial in patients with progressive desmoid tumors.
“As a potent and selective small molecule targeting the Wnt-signaling pathway, Tegavivint is an ideal addition to our clinical development pipeline,” said Guo-Liang Yu, Ph.D., Chief Executive Officer of Apollomics. “The preclinical work has demonstrated that the differentiated mechanism of action may be applicable in several indications as both a monotherapy and a combination treatment. We look forward to working with the Iterion team to expand development in Greater China.”
Under the terms of the agreement, Apollomics will be responsible for clinical development and commercialization in Greater China. Apollomics and Iterion will form a joint development committee to ensure ongoing collaboration of Tegavivint across indications and geographies. Iterion has received an initial cash payment for ongoing research and development costs in connection with the company’s global development of Tegavivint. Iterion is also eligible to receive potential development and sales milestone payments, as well as tiered royalties on net sales. Apollomics will be responsible for all costs related to development and commercialization activities for Tegavivint in Greater China.
Rahul Aras, Ph.D., President and Chief Executive Officer, Iterion Therapeutics, added, “As we explore multiple indications for Tegavivint in the U.S., including desmoid tumors, acute myeloid leukemia, non-small cell lung cancer, and pediatric cancers, we are excited to partner with Apollomics to expand its development and potential commercialization in Greater China. With Apollomics’ oncology focus and growing footprint in China, they are the partner of choice to successfully advance Tegavivint for cancer patients in this region.”
About Tegavivint
Tegavivint is a potent and selective inhibitor of nuclear Beta-catenin that binds to TBL1 (Transducin Beta-like Protein One), a downstream target in the Wnt-signaling pathway. Targeting TBL1 may enable specific silencing of Wnt-pathway oncogenic gene expression without affecting other necessary cellular functions that are disrupted when targeting higher up the Wnt-pathway. This avoids toxicity issues common to other drugs in this pathway.
Tegavivint has the potential for clinical utility in multiple cancer types. Tegavivint is currently the subject of a Phase 1/2a clinical trial in progressive desmoid tumors. Desmoid tumors, a rare type of sarcoma for which there is no currently approved therapy, are driven primarily by nuclear Beta-catenin signaling and, thus, present an optimal indication for demonstrating the drug’s mechanism of action as the company pursues additional clinical programs. Tegavivint has also demonstrated anti-tumor activity in multiple pre-clinical models, including acute myeloid leukemia (AML) and non-small cell lung cancer (NSCLC).
About Iterion Therapeutics
Iterion Therapeutics is a venture-backed, clinical stage biotechnology company developing novel cancer therapeutics. The company’s lead product, Tegavivint, is a potent and selective inhibitor of nuclear Beta-catenin, an oncology target implicated in cell proliferation, differentiation, immune evasion and stem cell renewal. Research demonstrating anti-tumor activity in multiple pre-clinical models indicate that Tegavivint has the potential for clinical utility in multiple cancer types. Tegavivint is currently the subject of a Phase 1/2a clinical trial in patients with progressive desmoid tumors. Iterion is also pursuing development in additional cancers where nuclear Beta-catenin signaling has been shown to play a role, including acute myeloid leukemia (AML), non-small cell lung cancer (NSCLC), and pediatric cancers, including sarcomas, lymphoma and other solid tumors. This research/clinical trial was supported with a $15.9 million grant from the Cancer Prevention & Research Institute of Texas. For more information on Iterion, please visit https://iteriontherapeutics.com.
About Apollomics, Inc.
Apollomics, Inc. is an innovative biopharmaceutical company committed to the discovery and development of mono- and combination- oncology therapies to harness the immune system and target specific molecular pathways to eradicate cancer. The company’s existing pipeline consists of several development-stage assets, including novel, humanized monoclonal antibodies that restore the body’s immune system to recognize and kill cancer cells, and targeted therapies against uncontrolled growth signaling pathways. For more information, please visit www.apollomicsinc.com.
Iterion Therapeutics Contact:
Tiberend Strategic Advisors, Inc. Ingrid Mezo (Media) 646-604-5150 imezo@tiberend.com
Olympus Corporation (Director, Representative Executive Officer, President and CEO: Yasuo Takeuchi) announced today that it has been selected(1) by Japan’s Ministry of Health, Labour and Welfare (MHLW) to implement the Japan-Russia Medical Cooperation Promotion Project in the field of endoscopy for the fiscal year ending March, 2021. Under the project, Olympus will promulgate gastrointestinal endoscopic/laparoscopic techniques in support of a five-year oncology plan launched by the Russian government in 2019.(2)
As part of the project, Olympus will facilitate online training programs for gastrointestinal endoscopic/laparoscopic techniques taught by Japanese oncology specialists for Russian endoscopists and oncologists. The bilateral project is being carried out in cooperation with Russia’s two premier cancer centers, the N. N. Blokhin Cancer Research Center and the P. Hertsen Moscow Oncology Research Institute branch of the Russian National Medical Research Radiological Centre (NMRRC) as well as Asian Medical Education and Training Support (AMETS).(3) As part of the project’s initiatives, Olympus commits to disseminate Japan’s world-leading technologies for early diagnosis and treatment in Russia, contributing to the improvement of oncology treatment and research in the region.
Objectives of the MHLW’s Japan-Russia Medical Cooperation Promotion Project in the Field of Endoscopy (April 2020 – March 2021):
1. To help advance the Russian government’s oncology plan by implementing cancer educational activities for facilities and doctors specializing in that branch of medicine. These activities will take place primarily at Russia’s two premier cancer centers, the N. N. Blokhin Cancer Research Center and the P. Hertsen Moscow Oncology Research Institute within the NMRRC.
2. To provide opportunities for training and knowledge sharing on the latest medical technologies by Japanese physicians, contributing to the improvement of gastrointestinal cancer measures, from diagnosis to treatment, particularly for colorectal cancer.
Program activities were unveiled at the Japan-Russia Symposium on Colorectal Cancer Management and at the Signing Ceremony of the Memorandum of Cooperation among AMETS and the two Russian cancer centers, which were held on January 19. The signing ceremony was attended by Japanese and Russian government officials, including Mr. Sergey Muraviev, Director-General, International Cooperation and Public Relations Bureau, Ministry of Health of the Russian Federation, Dr. Teiji Takei, MHLW Assistant Minister for Global Health and Welfare, and Mr. Takeshi Matsunaga, Embassy of Japan in Russia. In addition, 1167 healthcare professionals from all over Russia attended the symposium virtually.
Supported by the MHLW since 2017, Olympus has provided its endoscopic systems for the Endoscopic Training Center at Pirogov Russian National Research Medical University, in addition to supporting training activities with Japanese physicians serving as instructors. The Japan-Russia Medical Cooperation Promotion Project is one of such initiatives by Olympus that MHLW has supported. Moving forward, Olympus will continue to assist with the training of Russian endoscopists, aiming to spread the application of endoscopic diagnosis, treatment and surgery.
(1) Selection was made in June, 2020 (2) Preventive program centered around cancers in the Russian government’s national “Healthcare project” that aims to reform its healthcare system. The program, which is promoted by the directors from the two major cancer centers mentioned above, targets an early cancer detection rate of 63% or greater, 5-year survival rate of 60% or greater, and a mortality rate of 17.3% or less. Colorectal cancer is currently the second most prevalent type of cancer in Russia. (3) A general incorporated institution whose mission is to help spread access to Japan’s world-class endoscopy and other medical technologies throughout Asia by providing human resource training support and medical-related education, and by contributing to the development of academic research. (Chairman: Seigo Kitano, President of Oita University)
For questions or additional information, please contact: Europe, Middle East and Africa (EMEA) Matthias Gengenbach +49 4023773 5867 matthias.gengenbach@olympus-europa.com
