Immunotherapy Clinical Trials - A New Approach to Treating Cancer
Investorideas.com releases the second part of a series on immunotherapy for cancer treatment, featuring Aethlon Medical, Inc. (NASDAQ: AEMD). Key points include:
1. Immunotherapy shows promise in improving long-term survival for advanced melanoma patients.
2. Aethlon's Hemopurifier® aims to enhance anti-PD-1 therapy responses by removing tumor-produced extracellular vesicles.
3. Aethlon received ethics approval for a clinical trial in India, following approvals in Australia.
4. The trial will evaluate Hemopurifier® in solid tumor patients with stable or progressive disease during anti-PD-1 monotherapy.
5. Other companies like Immuneering and Iovance Biotherapeutics are also advancing immunotherapy treatments with promising results.
Investorideas.com rilascia la seconda parte di una serie su immunoterapia per il trattamento del cancro, con Aethlon Medical, Inc. (NASDAQ: AEMD). I punti chiave includono:
1. L'immunoterapia mostra promesse nel migliorare la sopravvivenza a lungo termine per i pazienti con melanoma avanzato.
2. Il Hemopurifier® di Aethlon mira a migliorare le risposte alla terapia anti-PD-1 rimuovendo le vescicole extracellulari prodotte dai tumori.
3. Aethlon ha ricevuto l'approvazione etica per un trial clinico in India, dopo le approvazioni in Australia.
4. Il trial valuterà il Hemopurifier® in pazienti con tumori solidi con malattia stabile o progressiva durante la monoterapia anti-PD-1.
5. Altre aziende come Immuneering e Iovance Biotherapeutics stanno avanzando anche con trattamenti di immunoterapia con risultati promettenti.
Investorideas.com lanza la segunda parte de una serie sobre inmunoterapia para el tratamiento del cáncer, con Aethlon Medical, Inc. (NASDAQ: AEMD). Los puntos clave incluyen:
1. La inmunoterapia muestra promesas en la mejora de la supervivencia a largo plazo para pacientes con melanoma avanzado.
2. El Hemopurifier® de Aethlon tiene como objetivo mejorar las respuestas a la terapia anti-PD-1 al eliminar las vesículas extracelulares producidas por los tumores.
3. Aethlon recibió la aprobación ética para un ensayo clínico en India, tras recibir aprobaciones en Australia.
4. El ensayo evaluará el Hemopurifier® en pacientes con tumores sólidos que tengan enfermedad estable o progresiva durante la monoterapia anti-PD-1.
5. Otras empresas como Immuneering e Iovance Biotherapeutics también están avanzando en tratamientos de inmunoterapia con resultados prometedores.
Investorideas.com은 암 치료를 위한 면역 요법에 대한 시리즈의 두 번째 부분을 발표하며, Aethlon Medical, Inc. (NASDAQ: AEMD)를 소개합니다. 주요 사항은 다음과 같습니다:
1. 면역 요법은 진행성 흑색종 환자의 장기 생존률 개선에 대한 희망을 보여줍니다.
2. Aethlon의 Hemopurifier®는 종양에서 생성된 세포외 소포를 제거하여 anti-PD-1 치료 반응을 향상시키는 것을 목표로 합니다.
3. Aethlon은 호주에서의 승인을 따른 후 인도에서 임상 시험에 대한 윤리적 승인을 받았습니다.
4. 이 시험은 anti-PD-1 단독 요법 중에 안정적인 또는 진행성 질환을 가진 고형 종양 환자에서 Hemopurifier®를 평가할 것입니다.
5. Immuneering 및 Iovance Biotherapeutics와 같은 다른 회사들도 유망한 결과로 면역 요법 치료를 발전시키고 있습니다.
Investorideas.com publie la deuxième partie d'une série sur l'immunothérapie pour le traitement du cancer, mettant en avant Aethlon Medical, Inc. (NASDAQ: AEMD). Les points clés incluent :
1. L'immunothérapie montre des promesses pour améliorer la survie à long terme des patients atteints de mélanome avancé.
2. L'Hémopurificateur® d'Aethlon vise à améliorer les réponses à la thérapie anti-PD-1 en éliminant les vésicules extracellulaires produites par les tumeurs.
3. Aethlon a reçu l'approbation éthique pour un essai clinique en Inde, suite aux approbations en Australie.
4. L'essai évaluera l'Hémopurificateur® chez des patients atteints de tumeurs solides ayant une maladie stable ou progressive pendant la monothérapie anti-PD-1.
5. D'autres entreprises comme Immuneering et Iovance Biotherapeutics avancent également dans les traitements d'immunothérapie avec des résultats prometteurs.
Investorideas.com veröffentlicht den zweiten Teil einer Serie über Immuntherapie zur Krebsbehandlung, mit Aethlon Medical, Inc. (NASDAQ: AEMD). Die wichtigsten Punkte sind:
1. Immuntherapie zeigt vielversprechende Ansätze zur Verbesserung der Langzeitüberlebensrate bei fortgeschrittenen Melanom-Patienten.
2. Aethlons Hemopurifier® zielt darauf ab, die Reaktionen auf die anti-PD-1-Therapie zu verbessern, indem tumorproduzierte extrazelluläre Vesikel entfernt werden.
3. Aethlon erhielt die ethische Genehmigung für eine klinische Studie in Indien, nachdem die Genehmigungen in Australien erteilt wurden.
4. Die Studie wird den Hemopurifier® bei Patienten mit soliden Tumoren mit stabiler oder progressiver Erkrankung während der anti-PD-1-Monotherapie evaluieren.
5. Auch andere Unternehmen wie Immuneering und Iovance Biotherapeutics bringen vielversprechende Fortschritte in der Immuntherapie voran.
- Aethlon Medical received ethics approval for a clinical trial of Hemopurifier® in India
- The Hemopurifier® trial aims to improve response rates to anti-PD-1 therapies
- Aethlon plans to recruit patients for the trial in Q4 2024
- The trial will inform future oncology efficacy studies for Hemopurifier®
- Immunotherapy shows potential for long-term survival in various cancer types
- Only 30% of cancer patients currently respond to pembrolizumab or nivolumab for solid tumors
- The Hemopurifier® trial is still in early stages, focusing on safety and feasibility
Insights
The recent advancements in immunotherapy clinical trials present a significant leap forward in cancer treatment. The improved long-term overall survival rates in advanced melanoma patients and the potential for cure in responsive patients are particularly noteworthy. The extension of immunotherapy's benefits to early-stage breast cancer and muscle-invasive bladder cancer further broadens its impact.
Aethlon's Hemopurifier® technology, designed to remove tumor-produced extracellular vesicles (EVs), could potentially enhance the efficacy of existing immunotherapies like pembrolizumab and nivolumab. This approach might address the 70% non-response rate to these treatments, potentially improving outcomes for a significant portion of patients.
The multi-center clinical trials in India and Australia for the Hemopurifier® mark a important step in evaluating its safety and efficacy. If successful, this could lead to a new combination therapy approach in oncology, potentially improving response rates to immunotherapy across various solid tumors.
The immunotherapy market is experiencing robust growth, with several companies making significant strides. Aethlon Medical's (NASDAQ: AEMD) progress with the Hemopurifier® trials could position them well in this expanding sector. The potential to improve response rates to existing immunotherapies could create substantial market opportunities.
Immuneering 's positive initial response data for IMM-1-104 in pancreatic cancer is particularly promising, given the 40% initial response rate and 80% disease control rate. If these results hold in larger trials, it could lead to a significant market opportunity in a notoriously difficult-to-treat cancer type.
Iovance Biotherapeutics' lifileucel approval marks a historic milestone as the first TIL therapy and cellular therapy for solid tumors. This opens up new avenues for cellular therapies beyond blood cancers, potentially expanding the market significantly.
Investors should closely monitor these developments, as successful outcomes could lead to substantial revenue growth and market share gains for these companies in the rapidly evolving immunotherapy landscape.
The evolving landscape of immunotherapy in oncology is truly exciting. The long-term survival benefits observed across various cancer types, including melanoma, breast and bladder cancers, are reshaping our approach to treatment. The potential for cure in some patients is particularly encouraging.
Aethlon's Hemopurifier® technology presents an intriguing approach to overcoming resistance to anti-PD-1 therapies. By targeting tumor-produced extracellular vesicles, it could potentially enhance the efficacy of existing immunotherapies, addressing a significant unmet need.
The approval of lifileucel as the first TIL therapy for solid tumors is a landmark achievement. This opens up new possibilities for cellular therapies beyond hematological malignancies, potentially revolutionizing treatment paradigms for solid tumors.
As we await further results from these trials, it's important to remember that while these advancements are promising, careful evaluation of long-term outcomes and potential side effects is necessary to fully understand their place in our treatment arsenal.
Vancouver, Kelowna, and Delta, British Columbia--(Newsfile Corp. - September 19, 2024) - Investorideas.com, a go-to investing platform, releases the second of a two-part series looking at news and developments for the treatment of cancer and solid tumors focusing on immunotherapy, featuring Aethlon Medical, Inc. (NASDAQ: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening viral infections. Aethlon's Hemopurifier® is a clinical stage immunotherapeutic device designed to combat cancer.
Read the full article at Investorideas.com
https://www.investorideas.com/News/2024/biotech/09190Immunotherapy-Clinical-Trials.asp
According to News-Medical.net, "Immunotherapy, which works by enabling the body's immune system to recognize and destroy cancer cells improves long-term overall survival in patients with advanced melanoma in results from large international studies reported at ESMO 2024. Researchers leading the longest follow-up study to date suggest that immunotherapy offers the potential for cure in patients who respond to this treatment. Further clinical trials reported at ESMO 2024 show improved long-term survival with immunotherapy given before and after surgery in women with early-stage, hard-to-treat breast cancer (triple negative breast cancer) and in patients with muscle-invasive bladder cancer."
"The main message from all of these studies is that immunotherapy continues to keep its promise and hope of long-term survival for many patients with different types of cancer," said Dr. Alessandra Curioni-Fontecedro, Professor of Oncology at the University of Fribourg and Director of Oncology at the Hospital of Fribourg, Switzerland, (not involved in the study). "At ESMO 2024 we are seeing many studies in many different cancers showing that immunotherapy can work for a long time."
According to recent news from Aethlon Medical, Inc., "At present, approximately only
Following the news of cancer trials activated in Australia earlier this week, Aethlon Medical, Inc. (NASDAQ: AEMD) today announced that, on September 9, 2024, the Medanta Institutional Ethics Committee (MIEC) granted full ethics approval for Aethlon's safety, feasibility and dose-finding clinical trial of the Hemopurifier® in cancer patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Merck & Co., Inc.'s Keytruda® (pembrolizumab) or Bristol Myers Squibb's Opdivo® (nivolumab) (AEMD-2022-06 Hemopurifier® Study). The approval is valid for one year, followed by annual reviews. This trial has previously been reviewed by the Institutional Review Board at Medanta. Additionally, the company previously received a No Objection Certificate (NOC) from DCGI (the Indian Regulatory Authority) for the proposed oncology trial. The trial will be conducted by Dr. Ashok K. Vaid and his staff at the Department of Medical Oncology and Hematology at Medanta Medicity Hospital in Gurugram, India. The Hemopurifier® treatments will be performed by Dr. Puneet Sodhi from the Department of Nephrology, who has conducted more Hemopurifier® treatments than anyone else in the world.
"The approval from the MIEC, coming closely on the heels of our two ethics committee approvals in Australia, to conduct this early feasibility study, is another important step in our plan to evaluate use of the Hemopurifier as a treatment option in multiple tumor types, where cancer associated exosomes may promote immune suppression and metastasis," stated Steven LaRosa, MD, Chief Medical Officer of Aethlon Medical. "We are very pleased that the MIEC accepted our study protocol and look forward to working, again, with Medanta Hospital with the expectation of recruiting patients in the fourth calendar quarter of this year. We believe that the planned safety, feasibility and dose finding trial, taking place in both India and Australia, in solid tumors in patients failing treatment with anti-PD-1 antibodies, will help inform future oncology efficacy trials."
The primary endpoint of the approximately 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.
Immuneering Corporation, a clinical-stage oncology company seeking to develop and commercialize universal-RAS/RAF medicines for broad populations of cancer patients, recently announced positive initial response data from the first five patients treated with IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel in first line pancreatic cancer as part of its ongoing Phase 2a clinical trial.
Highlights:
- In Phase 2a arm investigating IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel, complete or partial responses have been observed in the first two patients (2/5) to date, for an initial response rate of
- Initial data are at 240 mg QD (safety lead-in dose) of IMM-1-104; additional patients have now been dosed at 320 mg QD in this arm; IMM-1-104 has been well-tolerated to date in combination with gemcitabine/nab-paclitaxel -
- Initial data are consistent with preclinical data presented at AACR, which demonstrated that IMM-1-104 combined with chemotherapy induced deeper responses than either agent alone -
- Clear path forward expected for clinical development of IMM-1-104 in combination with gemcitabine/nab-paclitaxel for pancreatic cancer, assuming initial data is representative; FDA previously granted IMM-1-104 Fast Track designation for the treatment of first- and second-line pancreatic ductal adenocarcinoma -
- Enrollment progressing in all Phase 2a arms with further data expected by year end -
Continued from the news: "We are delighted to share today's initial data on IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel. While the initial ORR of
Earlier this year, Iovance Biotherapeutics, Inc., a commercial biotechnology company focused on innovating, developing and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, announced updated clinical data for lifileucel in combination with pembrolizumab in frontline advanced melanoma, as well as translational data, from the recent 2024 ASCO Annual Meeting held earlier this year in Chicago, IL and online.
From the news: Clinical Data in Frontline Advanced Melanoma (Cohort 1A in IOV-COM-202 Trial)
Positive results from Cohort 1A in the IOV-COM-202 trial were published in an abstract1 and will be highlighted in an upcoming oral presentation at ASCO. Unprecedented response rates, as well as deep and durable responses, were observed in patients with frontline advanced melanoma who were naïve to immune checkpoint inhibitor (ICI) therapy. These results strongly support the ongoing Phase 3 TILVANCE-301 clinical trial.
National Cancer Institute reported "In an event more than three decades in the making, the Food and Drug Administration (FDA) has approved lifileucel (Amtagvi), the first treatment for cancer that uses immune cells called tumor-infiltrating lymphocytes, or TILs. Announced on February 16, the agency's decision also makes lifileucel the first cellular therapy to be approved for a solid tumor, the skin cancer melanoma."
Continued: "The agency's accelerated approval covers the use of lifileucel for people with advanced melanoma that has gotten worse after treatment with certain immunotherapy drugs or targeted therapies.
Continued: "As is the case with CAR T-cell therapy, another type of cellular therapy, lifileucel is made using a patient's own T cells. And with both therapies, the cells are collected at the hospital where the patient is being treated but are sent away to be manufactured into the final treatment."
Also seeing the potential of immunotherapy, Kazia Therapeutics Limited, an oncology-focused drug development company announced last week that an agreement has been executed with QIMR Berghofer Medical Research Institute, one of Australia's foremost cancer research centres, to obtain an exclusive license to certain intellectual property rights in relation to combination therapies consisting of PI3K inhibitor drugs, and one or more immunotherapy or PARP inhibitor drugs (PI3K combination).
From the news: Under the license agreement, Kazia receives an exclusive, worldwide, sub-licensable and royalty-bearing licence to certain intellectual property for the development of any drugs or product candidates within the PI3K inhibitor class in combination with immunotherapy or PARP inhibitors. Paxalisib, Kazia's lead product candidate, is a member of the PI3K inhibitor class.
Continued: The exclusive license agreement follows a collaboration between Kazia and QIMR Berghofer which began in December 2022 and has already led to the filing of supportive patents which include the use of paxalisib as an immune modulator in the treatment of diseases such as breast cancer.
The idea of using a patient's immune system to battle cancer makes sense and dollars for the companies that are pioneering this approach. Let the clinical trials begin!
Read part one of the series of articles at Investorideas.com
https://www.investorideas.com/News/2024/biotech/09170Solid-Tumors-Market.asp
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