Vancouver, Kelowna, and Delta, British Columbia--(Newsfile Corp. - November 14, 2024) - Investorideas.com, a go-to investing platform covering biotech and medical technology stocks releases a snapshot looking at the advancement of treatments for solid tumors as global cancer incidence rates rise, featuring Aethlon Medical, Inc. (NASDAQ: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases.
According to a recent article in Biospace,"The solid tumors market size reached a value of US$ 170.3 Billion in 2023. Looking forward, the market is expected to reach US$ 375.4 Billion by 2034, exhibiting a growth rate (CAGR) of 7.45% during 2024-2034."
Looking at the harsh reality of the rise of cancer globally, the BBC reported earlier this year, "One study found that the global incidence of early-onset cancer had increased by 79% between 1990 and 2019, with the number of cancer-related deaths in younger people rising by 29%. Another report in The Lancet Public Health described how cancer incidence rates in the US have steadily risen between the generations across 17 different cancers, particularly in Generation Xers and Millennials."
Yesterday, Aethlon Medical, Inc. (NASDAQ: AEMD) reported financial results for its fiscal second quarter ended September 30, 2024 and provided an update on recent developments, including the enrollment of a second patient in its Australian safety, feasibility and dose-finding clinical trial of the Hemopurifier®.
This news follows up on news from Monday, November 11th that the company had achieved a key milestone with enrollment of the first patient in its Australian 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 Keytruda® (pembrolizumab) or Opdivo® (nivolumab) (AEMD-2022-06 Hemopurifier Study). The patient was enrolled on October 29, 2024, by Prof. Michael Brown and his staff at the Cancer Clinical Trials Unit, CALHN, Royal Adelaide Hospital in Australia.
From the November 13th news:
During the second quarter, and subsequently, the company advanced its oncology trial efforts in Australia, while implementing cost-cutting measures to streamline operations. Management is pleased to report positive progress on these initiatives, specifically:
Clinical Trials: The first two patients have now been enrolled at the Royal Adelaide Hospital in Adelaide, Australia. Additionally, Pindara Private Hospital, in the Gold Coast section of Australia, received ethics committee approval, was trained on Aethlon's Hemopurifier®, and is now open for patient enrollment. The company has also trained a third hospital in Australia, but has not yet received ethics committee approval for that institution and it has not yet begun patient enrollment.
In September, Aethlon received ethics committee approval from Medanta Medicity Hospital in Gurugram, India, for a similar nine to 18-patient, safety, feasibility and dose-finding trial of the Hemopurifier. The company is completing the necessary logistical steps before the site can open for patient enrollment.
Management Change: In October, Aethlon's board of directors appointed James Frakes to serve as the company's permanent Chief Executive Officer, after having served as Interim Chief Executive Officer since November 2023.
Operational Efficiency: Strategic cost-cutting initiatives have allowed for optimized resource allocation, enabling continued focus on high-impact areas of the oncology trial.
"During the second fiscal quarter and subsequent period, we continued advancing our oncology trials, earlier this week announcing enrollment of the first patient at Royal Adelaide Hospital, and now updating this news to report enrollment of a second patient. This represents a critical milestone for the safety, feasibility and dose-finding trials of the Hemopurifier in patients with solid tumors who have failed treatment with anti-PD-1 antibodies," stated James Frakes, Chief Executive Officer and Chief Financial Officer of Aethlon Medical. "We now have two sites open for patient enrollment in Australia, have received ethics committee approval from a site in India, and we expect to continue to enroll subjects in our Hemopurifier cancer trial. As previously announced, we believe these studies will help inform future oncology efficacy trials. Additionally, we have made strategic cost-cutting measures to optimize company resources, in order to focus on the high-impact oncology trials in both Australia and India."
As a reminder, the primary endpoint of the approximate nine to 18-patient, safety, feasibility and dose-finding trials, is safety. The trials 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 antibody 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 subsequent efficacy and safety trials, including a Premarket Approval (PMA) study required by the FDA and other regulatory agencies.
Currently, only approximately 30% of patients who receive pembrolizumab or nivolumab will have lasting clinical responses to these agents. Extracellular vesicles (EVs) produced by tumors have been implicated in the spread of cancers as well as the resistance to anti-PD-1 therapies. The Aethlon Hemopurifier has been designed to bind and remove these EVs from the bloodstream, which may improve therapeutic response rates to anti-PD-1 antibodies. In preclinical studies, the Hemopurifier has been shown to reduce the number of EVs in cancer patient plasma samples.
The company also continues to explore opportunities to expand the use of the Hemopurifier as a treatment for life-threatening viral infections. In vitro, it has shown effectiveness in capturing viruses such as Ebola, Marburg virus, Zika, Lassa, MERS-CoV, Cytomegalovirus, Epstein-Barr, Herpes simplex, Chikungunya, Dengue, West Nile, H1N1 swine flu, H5N1 bird flu, and the reconstructed 1918 Spanish flu virus. The company's COVID-19 trial in India remains open to accommodate any potential COVID-19 admissions to the intensive care units at the two participating sites, Medanta Medicity Hospital and Maulana Azad Medical College. So far, one patient has been treated. The company is actively evaluating COVID-19 admissions and potential enrollment against the ongoing costs of maintaining the trial.
Tango Therapeutics, Inc., a clinical-stage biotechnology company committed to discovering and delivering the next generation of precision cancer medicines, also recently reported its financial results for the third quarter ended September 30, 2024, and provided business highlights.
From the news "We have made great progress with our PRMT5 development program, including positive data from the TNG462 phase 1/2 clinical trial that showcase the best-in-class potential of TNG462 in multiple tumor types, including pancreatic and non-small cell lung cancers (NSCLC). Based on these early data, we are advancing TNG462 into trials with multiple targeted and standard of care combinations, including two RAS (ON) tri-complex inhibitors from Revolution Medicines. Given that nearly all MTAP-deleted pancreatic cancer has a co-occurring RAS mutation, we believe this could be a powerful approach to changing the treatment landscape for this challenging cancer," said Barbara Weber, M.D., President and Chief Executive Officer of Tango Therapeutics. "As part of the expanded capabilities needed to rapidly move TNG462 development forward, Dr. Maeve Waldron-Lynch, M.D. is joining Tango as Senior Vice President, Head of Clinical Development. Dr. Waldron-Lynch has extensive late-stage oncology clinical development and regulatory experience and will be invaluable as we prepare to advance TNG462 to registration."
Yesterday, Adaptimmune Therapeutics plc, a company working to redefine the treatment of solid tumor cancers with cell therapy, announced data from the primary analysis of its pivotal Phase 2 IGNYTE-ESO trial of lete-cel in people with synovial sarcoma or myxoid/round cell liposarcoma (MRCLS) who received previous anthracycline-based therapy. The primary analysis data are being presented at the Connective Tissue Oncology Society (CTOS) 2024 Annual Meeting which takes place from November 13-16, 2024 in San Diego.
From the news: Based on these positive data, Adaptimmune plans to initiate a rolling Biologics License Application (BLA) submission for lete-cel for the treatment of advanced or metastatic synovial sarcoma and MRCLS by the end of 2025. Lete-cel builds on the potential of Adaptimmune's sarcoma franchise to change the way solid tumors are treated using cell therapies, more than doubling the addressable patient population eligible for Adaptimmune cell therapies to also include NY-ESO-1 positive synovial sarcoma and MRCLS solid tumors.
On November 9th, Fate Therapeutics, Inc., a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune disorders, presented initial clinical and new preclinical data for FT825 / ONO-8250, a multiplexed-engineered, chimeric antigen receptor (CAR) T-cell product candidate targeting human epidermal growth factor receptor 2 (HER2), at the 2024 Society of Immunotherapy of Cancer (SITC) 39th Annual Meeting being held in Houston, TX on November 6-10, 2024. FT825 / ONO-8250 incorporates a novel H2CasMab-2 binding domain targeting HER2 that is designed to overcome on-target, off-tumor toxicity and to recognize variants associated with poor clinical outcomes and tumor escape. In an ongoing Phase 1 study in advanced solid tumors, three patients were treated with FT825 / ONO-8250 in the first low-dose cohort as monotherapy, and no dose-limiting toxicities (DLTs) and no events of any grade of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), or graft-versus-host disease (GvHD) were observed. The multi-center, Phase 1 study is currently being conducted under a strategic collaboration with Ono Pharmaceutical Co., Ltd. (Ono).
From the news: "FT825 / ONO-8250 integrates seven novel synthetic controls of CAR T-cell function designed to overcome multiple mechanisms that impede the safe and effective treatment of solid tumors. We are very pleased with initial Phase 1 clinical observations from the first low-dose cohort, which showed a favorable safety profile, product expansion, and maintenance of an activated CAR T-cell state," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "In addition, new preclinical data for FT825 / ONO-8250 presented today at SITC highlighted the cancer-selective recognition profile of its novel HER2 antigen binding domain, including its potential to target variants uniquely expressed on tumor cells. Under our collaboration with Ono, we are excited to further assess the potential of FT825 / ONO-8250 to benefit patients with hard-to-treat advanced solid tumors who currently have limited treatment options."
While there are a lot of unanswered questions regarding the global rise in cancer rates, companies like Aethlon Medical, Inc. (NASDAQ: AEMD) are moving forward in the race for solutions with their Hemopurifier clinical trials.
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