The Cancer Battle - How Smaller Companies Are Making Big Advancements in Treatments for Solid Tumors
Aethlon Medical, Inc. (NASDAQ: AEMD) has received ethics approval for a clinical trial of its Hemopurifier® device in patients with solid tumors. The trial, to be conducted at Pindara Private Hospital in Australia, will evaluate the safety and feasibility of the Hemopurifier® in patients with stable or progressive disease during anti-PD-1 monotherapy treatment.
The Hemopurifier® is designed to remove harmful exosomes from biological fluids, which may improve therapeutic response rates to anti-PD-1 antibodies. The device has shown promise in preclinical studies for reducing exosomes in cancer patient plasma samples.
This development comes as the solid tumor therapeutics market is projected to reach $885.44 Billion by 2033, with smaller companies making significant advancements in treatments alongside big pharma.
Aethlon Medical, Inc. (NASDAQ: AEMD) ha ricevuto l'approvazione etica per un trial clinico del suo dispositivo Hemopurifier® in pazienti con tumori solidi. Il trial, che si svolgerà presso il Pindara Private Hospital in Australia, valuterà la sicurezza e la fattibilità dell'Hemopurifier® in pazienti con malattia stabile o progressiva durante il trattamento con monoterapia anti-PD-1.
L'Hemopurifier® è progettato per rimuovere esosomi dannosi dai fluidi biologici, il che potrebbe migliorare i tassi di risposta terapeutica agli anticorpi anti-PD-1. Il dispositivo ha mostrato promesse negli studi preclinici per ridurre gli esosomi nei campioni di plasma di pazienti oncologici.
Questo sviluppo avviene mentre il mercato delle terapie per tumori solidi è previsto raggiungere i 885,44 miliardi di dollari entro il 2033, con le aziende più piccole che stanno facendo progressi significativi nei trattamenti accanto alle grandi case farmaceutiche.
Aethlon Medical, Inc. (NASDAQ: AEMD) ha recibido la aprobación ética para un ensayo clínico de su dispositivo Hemopurifier® en pacientes con tumores sólidos. El ensayo, que se llevará a cabo en el Pindara Private Hospital en Australia, evaluará la seguridad y la viabilidad del Hemopurifier® en pacientes con enfermedad estable o progresiva durante el tratamiento con monoterapia anti-PD-1.
El Hemopurifier® está diseñado para eliminar exosomas dañinos de fluidos biológicos, lo que podría mejorar las tasas de respuesta terapéutica a los anticuerpos anti-PD-1. El dispositivo ha mostrado promesas en estudios preclínicos para reducir exosomas en muestras de plasma de pacientes con cáncer.
Este desarrollo se produce mientras se proyecta que el mercado de terapias para tumores sólidos alcance los 885,44 mil millones de dólares para 2033, con empresas más pequeñas logrando avances significativos en tratamientos junto a las grandes farmacéuticas.
Aethlon Medical, Inc. (NASDAQ: AEMD)는 고형 종양 환자에 대한 Hemopurifier® 장치의 임상 시험에 대한 윤리적 승인을 받았습니다. 이번 시험은 호주 Pindara Private Hospital에서 수행되며, Anti-PD-1 단일 요법 치료 중 안정성 및 Hemopurifier®의 적용 가능성을 평가할 것입니다.
Hemopurifier®는 생물학적 액체에서 해로운 외소포를 제거하도록 설계되어 있으며, 이는 Anti-PD-1 항체에 대한 치료 반응률을 향상시킬 수 있습니다. 이 장치는 암 환자의 혈장 샘플에서 외소포를 줄이는 데 있어 전임상 연구에서 유망한 결과를 보였습니다.
이 개발은 고형 종양 치료 시장이 2033년까지 8,854억 4천만 달러에 이를 것으로 예상되는 가운데 이루어졌습니다. 작은 기업들이 대형 제약회사와 함께 치료의 중요한 진전을 이루고 있습니다.
Aethlon Medical, Inc. (NASDAQ: AEMD) a reçu l'approbation éthique pour un essai clinique de son dispositif Hemopurifier® chez des patients atteints de tumeurs solides. L'essai, qui sera réalisé à l'hôpital privé de Pindara en Australie, évaluera la sécurité et la faisabilité de l'Hemopurifier® chez des patients présentant une maladie stable ou progressive pendant le traitement par monothérapie anti-PD-1.
Le Hemopurifier® est conçu pour éliminer les exosomes nocifs des fluides biologiques, ce qui pourrait améliorer les taux de réponse thérapeutique aux anticorps anti-PD-1. L'appareil a montré des résultats prometteurs dans des études précliniques pour réduire les exosomes dans des échantillons de plasma de patients atteints de cancer.
Ce développement intervient alors que le marché des thérapies contre les tumeurs solides devrait atteindre 885,44 milliards de dollars d'ici 2033, avec de petites entreprises réalisant des avancées significatives dans les traitements aux côtés des grandes sociétés pharmaceutiques.
Aethlon Medical, Inc. (NASDAQ: AEMD) hat die ethische Genehmigung für eine klinische Studie mit seinem Hemopurifier® Gerät bei Patienten mit soliden Tumoren erhalten. Die Studie wird im Pindara Private Hospital in Australien durchgeführt und bewertet die Sicherheit und Durchführbarkeit des Hemopurifier® bei Patienten mit stabiler oder fortschreitender Erkrankung während der Anti-PD-1-Monotherapie.
Der Hemopurifier® wurde entwickelt, um schädliche Exosome aus biologischen Flüssigkeiten zu entfernen, was die therapeutischen Ansprechraten auf Anti-PD-1-Antikörper verbessern könnte. Das Gerät hat in präklinischen Studien vielversprechende Ergebnisse bei der Reduzierung von Exosomen in Plasma-Proben von Krebspatienten gezeigt.
Diese Entwicklung erfolgt, während der Markt für Therapien bei soliden Tumoren bis 2033 voraussichtlich 885,44 Milliarden Dollar erreichen wird, wobei kleinere Unternehmen signifikante Fortschritte in der Behandlung neben großen Pharmaunternehmen erzielen.
- Aethlon Medical received ethics approval for a clinical trial of Hemopurifier® in solid tumor patients
- The Hemopurifier® has shown potential to remove harmful exosomes in preclinical studies
- The solid tumor therapeutics market is projected to reach $885.44 Billion by 2033
- Only about 30% of cancer patients have lasting clinical responses to current anti-PD-1 therapies
- The Hemopurifier® trial is still in early stages, focusing on safety and feasibility
Insights
The approval of Aethlon Medical's Hemopurifier® trial for solid tumors is a significant development. This device's unique approach of removing harmful exosomes could potentially enhance the efficacy of existing immunotherapies like Keytruda® and Opdivo®. With only
The approval of TECELRA® by Adaptimmune Therapeutics marks a milestone as the first engineered cell therapy for solid tumors in the U.S. Its
The solid tumor therapeutics market's projected growth from
Vancouver, Kelowna, and Delta, British Columbia--(Newsfile Corp. - August 12, 2024) - Investorideas.com, a go-to investing platform covering biotech and medical technology issues a snapshot on recent news and developments for the treatment of solid cancer tumors, featuring Aethlon Medical, Inc. (NASDAQ: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases.
Read the full article at Investorideas.com
https://www.investorideas.com/News/2024/biotech/08120Cancer-Battle.asp
The Brainy Insights estimates that the USD 222.71 Billion solid tumor therapeutics market will reach USD 885.44 Billion by 2033.
Looking at the current list of FDA approved drugs to treat solid tumors anywhere in the body as reported by Cancer.Gov, the market is currently dominated by big Pharma. Some of the currently approved drugs include Bristol Myers Squibb's Augtyro (Repotrectinib), Dabrafenib Mesylate from Novartis AG, Dostarlimab-gxly by GlaxoSmithKline and Keytruda (Pembrolizumab) by Merck & Co., Inc.
Even with FDA approval these drugs are not the Holy Grail and don't offer
But there are other alternatives on the horizon coming from smaller innovative companies, and not all of the solutions are drugs.
Aethlon Medical, Inc's. (NASDAQ: AEMD) answer is the Hemopurifier®. In human studies, the Hemopurifier® has demonstrated the removal of life-threatening viruses and in pre-clinical studies, the Hemopurifier® has demonstrated the removal of harmful exosomes from biological fluids, 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.
Aethlon Medical, Inc. just announced that, on August 6, 2024, the Bellberry Human Research Ethics Committee (BHREC) granted full ethics approval to the Pindara Private Hospital for a safety, feasibility and dose-finding clinical trial of the Hemopurifier® in patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Merck's Keytruda® (pembrolizumab) or Bristol Myers Squibb's Opdivo® (nivolumab) (AEMD-2022-06 Hemopurifier Study). The approval is valid for one year, until August 6, 2025. The trial will be conducted by Dr. Marco Matos and his staff at the Pindara Private Hospital, located in Queensland, Australia.
"We are quite pleased that the BHREC accepted our responses to their thoughtful questions during their review and determined that our study meets the requirements of the National Statement application. Dr. Matos and his research team have a proven track record of enrollment in device trials in oncology patients that provides momentum to these trials," stated Dr. Steven LaRosa, MD, Chief Medical Officer of Aethlon Medical. "This is the second ethics committee approval we have received for our oncology trial in Australia after receiving approval from the ethics committee for Royal Adelaide Hospital in June."
Dr. LaRosa continued, "The next step is to receive approval from the Research Governance Office at each hospital which reviews indemnities and insurance. Once these approvals are obtained, Aethlon, in concert with our Australian Contract Research Organization, ReSQ, will conduct Site Initiation Visits (SIVs), after which patient enrollment may proceed."
More from the news: Currently, only approximately
The primary endpoint of the approximate nine to 18-patient, safety, feasibility and dose-finding trial is safety. The trial will monitor any adverse events and clinically significant changes in lab tests of Hemopurifier treated patients with solid tumors with stable or progressive disease at different treatment intervals, after a two-month run in period of PD-1 antibody, Keytruda® or Opdivo® monotherapy. Patients who do not respond to the PD-1 therapy will be eligible to enter the Hemopurifier period of the study, where sequential cohorts will receive 1, 2 or 3 Hemopurifier treatments during a one-week period. In addition to monitoring safety, the study is designed to examine the number of Hemopurifier treatments needed to decrease the concentration of EVs and if these changes in EV concentrations improve the body's own natural ability to attack tumor cells. These exploratory central laboratory analyses are expected to inform the design of a subsequent efficacy and safety, Premarket Approval (PMA), study required by regulatory agencies.
Elevation Oncology, Inc., an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, last week announced promising initial data from the dose escalation portion of the ongoing Phase 1 clinical trial of EO-3021 in patients with advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2, including gastric, gastroesophageal junction (GEJ), pancreatic or esophageal cancers.
"Gastric and GEJ cancers are devastating diseases, which occur frequently in the U.S. and globally and which, despite recent advancements, still have high levels of mortality," said Kohei Shitara, M.D., Chief, Department of Gastrointestinal Oncology, National Cancer Center Hospital East in Kashiwa, Japan and principal investigator on the Phase 1 clinical trial. "There is a particular need for highly selective therapies that benefit patients with Claudin 18.2-expressing tumors. To that end, I am excited by the initial data with EO-3021, which suggest it could change the treatment paradigm for a significant portion of patients with gastric or GEJ cancer. I am excited to evaluate EO-3021 in the expansion portion of this Phase 1 clinical trial."
"We are pleased to share initial data from our Phase 1 clinical trial of EO-3021," said Dr. Valerie Malyvanh Jansen, MD, Ph.D, Chief Medical Officer of Elevation Oncology. "EO-3021 was designed to maximize efficacy while minimizing the potential for free MMAE, with the goal of offering patients an improved safety profile and physicians a more readily combinable agent. We are encouraged to see the benefits of EO-3021's site-specific conjugation translate clinically, with minimal MMAE-associated toxicities observed in our Phase 1 trial. Coupled with the promising anti-tumor activity reported in patients with gastric or GEJ cancer, the data suggest that EO-3021 is a potential best-in-class Claudin 18.2 antibody drug conjugate. We look forward to advancing into monotherapy dose expansion and initiating our combination cohorts in the months ahead, as well as reporting additional data from our ongoing trial in the first half of 2025."
Adaptimmune Therapeutics plc, a company working to redefine the treatment of solid tumor cancers with cell therapy, on August 2nd announced US Food and Drug Administration (FDA) accelerated approval of TECELRA® (afamitresgene autoleucel) for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. TECELRA is the first engineered cell therapy for a solid tumor cancer approved in the U.S., and the first new therapy option in more than a decade for synovial sarcoma, a rare, soft tissue cancer that most commonly impacts young adults.
Adrian Rawcliffe, Adaptimmune's Chief Executive Officer said, "The approval of TECELRA is a momentous step in Adaptimmune's journey to redefine the way cancer is treated and the culmination of a decade of groundbreaking R&D. I want to thank the patients, caregivers, investigators, and clinical teams as well as everyone at Adaptimmune and our partners who made possible this watershed moment for cell therapy and for people with synovial sarcoma. We are committed to advancing our robust clinical pipeline to serve more patients in need and plan to progress lete-cel, the next late-stage investigational treatment in our sarcoma franchise, with a rolling BLA submission to the FDA next year."
More from the news: The approval of TECELRA was based on results of the SPEARHEAD-1 (Cohort 1) trial, which included 44 patients. The major efficacy outcome was overall response rate (ORR) determined by independent review and supported by duration of response. TECELRA treatment resulted in an ORR of
OS Therapies, Inc., a clinical-stage oncology-focused immunotherapy company developing cancer vaccines and antibody drug conjugate (ADC) therapeutic candidates, announced in late July, positive data from a Phase 1 clinical trial of OST-HER2 in patients with HER2-expressing solid tumors in breast cancer and other cancers. Additionally, the Company announced positive preclinical efficacy data for OST-HER2 in multiple models of breast cancer.
More from the news: The FDA has granted Rare Pediatric Disease Designation (RPDD), Orphan Drug Designation (ODD), and Fast Track Designation (FTD) for OST-HER2 in Osteosarcoma. OST-HER2, a biologic therapeutic candidate, is a Lm (Listeria monocytogenes) vector-based off-the-shelf immunotherapeutic vaccine designed to prevent metastasis, delay recurrence, and increase overall survival in patients with osteosarcoma and other solid tumors. The proposed OST-HER2 mechanism of action is based on innate and adaptive immune stimulating responses activated by the Lm vector. This treatment generates T cells that can eliminate or slow potential micrometastases that can grow into recurrent osteosarcoma and other solid tumors, including breast cancer. T cell responses home in on HER2 expressed by the tumor and then kill the cell, releasing additional tumor targets. There are currently no approved adjuvant treatments for recurrent osteosarcoma in the United States.
The anticipated
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FAQ
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