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Investorideas Featured Company: Aethlon Medical (NasdaqCM:AEMD)

Aethlon Medical, Inc.

Aethlon Medical (NASDAQ: AEMD) is a medical therapeutic company focused on developing the Hemopurifier, a clinical stage immunotherapeutic device which is designed to combat cancer and life-threatening viral infections and for use in organ transplantation. In human studies, the Hemopurifier has demonstrated the removal of life-threatening viruses and harmful exosomes from blood utilizing its proprietary lectin-based technology. This action has potential applications in cancer, where exosomes may promote immune suppression and metastasis, and in life-threatening infectious diseases. The Hemopurifier is a U.S. Food and Drug Administration (FDA) designated Breakthrough Device indicated for the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy, and with cancer types in which exosomes have been shown to participate in the development or severity of the disease. The Hemopurifier also holds an FDA Breakthrough Device designation and an open Investigational Device Exemption (IDE) application related to the treatment of life-threatening viruses that are not addressed with approved therapies.

Contact

NXT-ID, Inc. (NASDAQ:NXTD)

United States
Aethlon Medical, Inc.
11555 Sorrento Valley Road, Suite 203
San Diego, CA 92121
Phone: 619-941-0360

Australia
Aethlon Medical Australia Pty Ltd.
Level 7
330 Collins Street
Melbourne, Victoria 3000

The Aethlon Hemopurifier®

The Aethlon Hemopurifier® is a first-in-class technology designed for the rapid depletion of cancer-promoting exosomes and circulating viruses. The United States Food and Drug Administration (FDA) has designated the Hemopurifier® as a "Breakthrough Device" for the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy, and with cancer types in which exosomes have been shown to participate in the development or severity of the disease; and life-threatening viruses that are not addressed with approved therapies.

The Hemopurifier® in Cancer

Capture Tumor-Derived Exosomes Underlying Several Forms of Cancer

Upwards of ninety percent of all cancer-related deaths are attributed to metastasis; the spread of cancer from a primary site of origin to other organs or areas of the body. The mechanism of how tumors metastasize to distant sites in the body has long been one of cancer's greatest mysteries. That mystery was recently solved when circulating particles known as tumor-derived exosomes were discovered to be the seeds that promote the spread and growth of cancer metastasis.

Aethlon initiated its tumor-derived exosome research at a time when the medical community believed exosomes were merely cellular debris with no biological function. Today, a therapeutic to address tumor-derived exosomes represents a significant unmet need in cancer care. Aethlon has demonstrated that the affinity mechanism of the Hemopurifier® can capture tumor-derived exosomes underlying several forms of cancer, including breast, ovarian and metastatic melanoma.

Our extended tumor-derived exosome research

Beyond their role in metastasis, researchers have also published mounting evidence that tumor-derived exosomes contribute to tumorigenesis (the formation of cancer), cancer progression, angiogenesis (creation of blood vessels to fuel tumor growth), immune evasion, and resistance to radiation and chemotherapeutic drugs. Recent discoveries also reveal that exosomes may contribute to bacterial and viral pathogenesis, the progression of Alzheimer and Parkinson's diseases, the spread of prion proteins, and numerous inflammatory conditions.

Status of clinical studies

Due to lack of patient enrollment by the University of Pittsburgh Medical Center (UPMC) in our head and neck cancer safety trial, we and UPMC have terminated this study. We are planning a new clinical trial in oncology that will potentially include more tumor types, enabling us to build our safety database in oncology and provide data to help direct the development of our Hemopurifier as a treatment option in oncology. We are currently working with our new contract research organization, or CRO, on preparations to conduct a clinical trial in Australia in patients with solid tumors, including head and neck cancer, gastrointestinal cancers and other cancers.

The Hemopurifier® in Infectious Disease

We are Developing Medical Countermeasures with Broad-Spectrum Capabilities

The Hemopurifier is an investigational device that has not yet received FDA approval for any indication. Aethlon continues to investigate the potential for the use of the Hemopurifier in viral diseases under an open Investigational Device Exemption (IDE) and our FDA Breakthrough Designation for "…the treatment of life-threatening glycosylated viruses that are not addressed with an approved therapy." The Company currently has an open FDA approved Expanded Access Protocol for the treatment of Ebola infected patients in the U.S. and a corresponding HealthCanada approval in Canada.

Based on our studies to date, the Hemopurifier can potentially clear many viruses that are pathogenic in humans, including HCV, HIV, Sars-CoV-2, and Ebola.

We will continue to disclose material progress in our investigation of the potential for the Hemopurifier in this and other indications.

Supporting an initiative set by the U.S. Department of Health and Human Services

Emerging pathogens pose a significant threat to mankind. Of the hundreds of viral pathogens known to be infectious to man, only a few are addressed with proven antiviral drug or vaccine therapies. Beyond the looming threat of bioterrorism, a proliferation of international travel, urban crowding and global warming is expected to accelerate the emergence of future pandemics. In response, the U.S. Department of Health and Human Services (HHS) has established an initiative to support platform technology medical countermeasures with broad-spectrum capabilities. Based on preclinical studies and human treatment experiences, the Aethlon Hemopurifier® defines this initiative.

Administered to individuals infected with Ebola, Sars-CoV-2/Covid, Hepatitis C and HIV

To date, Hemopurifier therapy has been administered to individuals infected with Ebola virus, Sars-CoV-2/Covid virus, Hepatitis C virus (HCV) and the Human Immunodeficiency virus (HIV). In the case of Ebola, a remarkable response to a single administration of Hemopurifier therapy (comatose physician with multiple organ failure at the time), led to Time Magazine in November 2014 naming the Hemopurifier to be one of the "Top 25 Inventions" as well as one of the "Eleven Most Remarkable Advances in Healthcare."

Status of clinical studies

Beyond human treatment experiences, pre-clinical Hemopurifier studies have validated the broad-spectrum capture of numerous viral threats. These include: Chikungunya, Dengue and West Nile virus, as well as Vaccinia and Monkey pox, which serve as models for human Smallpox infection. Specific to pandemic influenza threats, Aethlon has validated the capture of H5N1 avian flu, H1N1 swine flu, and the reconstructed 1918 influenza virus, which represents a model for the strain of influenza that killed an estimated 50 million victims in 1918 and 1919.

Due to a scarcity of COVID patients in intensive care units eligible for enrollment into our U.S. COVID trial, we recently decided to terminate the agreement with our contract research organization (CRO). As a result, while our Investigational Device Exemption (IDE) related to severe viral infections remains open, we are discontinuing U.S. COVID clinical trial activity. We expect this decision to save the company up to $5 million over the next twelve months, which we intend to allocate towards advancing the study of our Hemopurifier in oncology.

Executive Team

James B. Frakes

Interim Chief Executive Officer and Chief Financial Officer

Mr. Frakes joined Aethlon Medical in January 2008. He has 27 years of CFO level financial responsibility for publicly traded companies, as well as, specific knowledge and experience in equity (IPO, follow-on public offerings and private placements) and debt transactions, acquisitions, public reporting and Sarbanes-Oxley section 404 internal control requirements.

Mr. Frakes received an MBA from the University of Southern California, and completed his BA with Honors at Stanford University.


Guy Cipriani

Chief Operating Officer

Mr. Cipriani had served on Aethlon's Board of Directors since June 2018. Prior to joining Aethlon as an executive, he served as the Chief Business Officer at Microbion Corporation, a company focused on the development of a new class of antibiotic therapies for difficult to treat and resistant infections. His business and corporate development responsibilities at Microbion included securing partnerships and raising dilutive and non-dilutive capital for the company's promising clinical-stage pipeline. Prior to Microbion, he served as VP of Business Development at Cascadian Therapeutics where he was responsible for licensing-in several promising pipeline candidates and generating external interest in the company's clinical-stage pipeline to set the stage for future strategic transactions. Prior to that role, Mr. Cipriani served as VP of Business Development at Cardiome Pharma Corp. where he led the negotiation of a global development and co-commercialization licensing deal with Merck & Company in 2009 around the company's lead Phase 3 cardiovascular program. Prior to Cardiome, Mr. Cipriani served as Sr. Director of Business Development for TransForm Pharmaceuticals, Inc., where his efforts helped facilitate the company's acquisition by Johnson and Johnson for $230 million in 2005. Mr. Cipriani began his pharmaceutical industry career at Eli Lilly & Company as a member of their Corporate Business Development team where he completed multiple in-licensing and out-licensing transactions for commercial, clinical and preclinical state assets. Mr. Cipriani holds a B.S.E.E., High Honors from Rochester Institute of Technology and an MBA from the Kellogg Graduate School of Management at Northwestern University.


Lee D. Arnold, PhD

Chief Scientific Officer

Lee is a creative scientific leader with 36 years of accomplishments in molecularly-targeted drug discovery. After an initial 8 publications in biophysics and biochemistry as an undergraduate at University of Waterloo, he earned a PhD in Organic Chemistry from University of Alberta. Lee began his career in pharma research at Syntex (Canada), and then joined Pfizer, where he was the inventor of Tarceva® (erlotinib) for NSCLC. During his tenure at BASF/Abbott Bioresearch Center, he established medicinal & combinatorial chemistry operations, and initiated and led two multinational multidisciplinary projects in angiogenesis leading to linifanib (ABT-869). As Vice President of Research at OSI Pharmaceuticals, Lee and his teams efficiently discovered four oncology development candidates, including the "first-in-class" agents linsitinib (IGF-1R), and ASP7486 (TORC1/2).

His acquired proficiency in synthetic & medicinal chemistry and structure-based drug design (SBDD), coupled with his broad research experience in target validation, assay development, HTS, and drug metabolism, facilitated his leadership of multidisciplinary discovery efforts as Chief Scientific Officer (CSO) in a number of innovative start-up biotechs. These included Kinagen, Coferon (self-assembling drug molecules), and Assembly Biosciences (co-invention of vebicorvir and ABI-H2158 for hepatitis B). As Senior VP of Research at Kinnate Biopharma, he was a coinventor of KIN-2787 (RAF), KIN-3248 (FGFR2/3), which are currently in clinical trials. Just prior to joining Aethlon Medical, Lee was the CSO and cofounder of Pardes Biosciences, which was founded at the start of the COVID pandemic as a virtual company that discovered and advanced the oral protease inhibitor, pomotrelvir, into clinical trials for SARS-CoV2 in only 17 months. Overall, Lee’s inventive and leadership contributions in drug discovery and development to date have resulted in an approved drug, and 16 additional development candidates, currently fueling 8 clinical trials in oncology, immunology and virology. These achievements are documented in over 94 published patents and applications, and more than 39 peer-reviewed publications.


Steven LaRosa, M.D.

Chief Medical Officer

Prior to joining Aethlon, Dr. LaRosa served as the Vice President of Clinical Development of Entasis Therapeutics, a spin-out of AstraZeneca focused on pathogen-targeted small molecules to treat serious multidrug-resistant Gram-negative infections. In this role, he acted as medical lead and was responsible for the clinical development of multiple programs, two of which were in Phase III clinical trials. Prior to joining Entasis, Dr. LaRosa was an Attending Physician and Antimicrobial Stewardship Director in the Division of Infectious Disease at Beverly Hospital, a member of Beth Israel Lahey Health (BILH) in Massachusetts. Prior to BILH, he was an Assistant Professor of Medicine at Brown Medical School and Attending Physician in the Division of Infectious Diseases at Rhode Island Hospital. He was also the Director and a Co-founder of the Ocean State Clinical Coordinating Center (OSCCC), an academic CRO that partnered with industry sponsors on clinical trials in Infectious Disease and Sepsis. Prior to that, Dr. LaRosa was a Staff Physician in the Department of Infectious Disease at the Cleveland Clinic Foundation and a Principle Investigator on numerous sepsis clinical trials. He also served as a Clinical Research Physician for Eli Lilly and Company where he led the Phase III clinical trial of recombinant human activated Protein C (Xigris); the only agent ever FDA approved for sepsis. Dr. LaRosa received his M.D. from Boston University School of Medicine (Alpha Omega Alpha). He completed an Internal Medicine residency and was Chief Resident at the Cleveland Clinic. This was followed by a clinical and research fellowship in Infectious Disease at the Massachusetts General Hospital. He holds active Board Certifications in Internal Medicine and Infectious Disease.


John Nguyen

Vice President of Manufacturing

John is an operations and technical leader with 25 years in biotech and life sciences, developing and manufacturing medical devices, building scalable team structures, and managing product lines and high-profile projects with oversight of implementations for process improvements and cost savings. John started his career at Biosite, Inc. (later became Alere, Inc.) and spent 20 years with the company in various roles in product development, technical product transfers, and operations. Prior to joining Aethlon Medical, John was at Nexus Dx as Director of Technical Operations, then promoted to Vice President of Operations and responsible for the development and transfer of new products into manufacturing with responsibility for design transfer, operational readiness, manufacturability, and process and equipment development. John has an extensive chemistry background and has worked on a multitude of diverse assay development, particle chemistry, antibody conjugations, solid phase, biotinylation and others. John holds a Bachelor of Arts in Biology from the University of San Diego.


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