Vancouver, Kelowna, and Delta, British Columbia--(Newsfile Corp. - June 20, 2024) - Investorideas.com, a go-to investing platform, releases an industry snapshot looking at the future 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.
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https://www.investorideas.com/News/2024/biotech/06200Treatments-for-Cancer-Patients-with-Solid-Tumors.asp
Research released this year predicts, "The solid tumor therapeutics market size will grow from USD 222.71 Billion in 2023 to USD 885.44 Billion in 10 years. Increasing investments of pharmaceutical companies in Research & Development will drive the solid tumor therapeutics market's growth. North America emerged as the largest market for the global Solid Tumor Therapeutics market, accounting for 44% of the total market share globally."
Current drugs available including Merck & Co., Inc.'s Keytruda® (pembrolizumab) and Bristol Myers Squibb's Opdivo® (nivolumab), solve part of the problem but the success rates call for additional solutions.
Aethlon Medical, Inc. (NASDAQ: AEMD) announced this week that, on June, 13, 2024, the Human Research Ethics Committee (HREC) of the Central Adelaide Local Health Network (CALHN) 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 Keytruda® (pembrolizumab) or Opdivo® (nivolumab) (AEMD-2022-06 Hemopurifier® Study). The approval is valid for three years, until June 13, 2027. The trial will be conducted by Prof. Michael Brown and his staff at the Cancer Clinical Trials Unit, CALHN, Royal Adelaide Hospital, located in Adelaide, Australia.
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 exosomes from the plasma of cancer patient samples.
"The approval from the Human Research Ethics Committee at Central Adelaide Local Health Network marks a significant milestone for Aethlon, as they deemed that our clinical study meets the requirements of the Australia's National Statement on Ethical Conduct in Human Research," stated Steven LaRosa, MD, Chief Medical Officer of Aethlon Medical. "We look forward to working closely with Prof. Brown and his staff, and with our Contract Research Organizations, NAMSA and ReSQClinical Research. The next steps include submission to the Therapeutic Goods Administration, the national health regulatory agency of Australia, obtaining approval from the CALHN Research Governance Committee, and conducting a site initiation visit to facilitate patient enrollment. Following this Ethics Board approval, we plan to submit to the Ethics Committees at two additional sites in Australia and one in India."
The primary endpoint of the approximate 18-patient, safety, feasibility and dose-finding trial is safety. The trial will monitorany 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 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.
In May, Bristol Myers Squibb announced that the US Food and Drug Administration (USFDA) has reassigned the previously announced Prescription Drug User Fee Act (PDUFA) goal date of the Biologics License Application (BLA) for the subcutaneous formulation of Opdivo® (nivolumab) co-formulated with Halozyme's proprietary recombinant human hyaluronidase (rHuPH20) (herein referred to as "subcutaneous nivolumab") across all previously approved adult, solid tumor Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo® plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib. The updated goal date is December 29, 2024.
From news: The application is based on results from CheckMate-67T, the first Phase 3 trial of the subcutaneous formulation of nivolumab to evaluate and demonstrate non-inferior pharmacokinetics, efficacy and consistent safety vs. its intravenous formulation. If approved, subcutaneous nivolumab has the potential to be the first and only subcutaneously administered PD-1 inhibitor.
From news: CheckMate-67T is a Phase 3 randomized, open-label trial evaluating subcutaneous administration of Opdivo® co-formulated with Halozyme's proprietary recombinant human hyaluronidase, rHuPH20, or subcutaneous nivolumab (nivolumab and hyaluronidase) compared to intravenous Opdivo, in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received prior systemic therapy. This trial presents an opportunity to potentially bring a subcutaneous formulation of Opdivo® to patients. A total of 495 patients were randomized to either subcutaneous nivolumab or intravenous Opdivo®. The co-primary endpoints of the trial are time-averaged serum concentration over 28 days (Cavgd28) and trough serum concentration at steady-state (Cminss) of subcutaneous nivolumab vs. intravenous Opdivo®. Objective response rate (ORR) is a key secondary endpoint.
According to Merck & Co., Inc., "KEYTRUDA is not chemotherapy or radiation therapy-it is an immunotherapy and it works with your immune system to help fight cancer. KEYTRUDA can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended."
Looking at key developments in the solid tumor market, BrainyInsights reported that in November 2023, AbbVie acquired ImmunoGen. The main objective behind this acquisition was to build and expand a strong portfolio base for the Solid Tumor Therapeutics Market. This acquisition will further boost AbbVie's entry into the commercial market for ovarian cancer.
In May, AbbVie showcased its "Robust Solid Tumor Pipeline at ASCO 2024 with New Data from Its Innovative Antibody-Drug Conjugate (ADC) Platform."
From the news: "Building upon our strong commitment to patients and existing leadership in hematological malignancies, we are rapidly advancing a differentiated pipeline in solid tumors," said Daejin Abidoye, M.D., Vice President, Head of Solid Tumors, Oncology Development, AbbVie. "Our ADC platform allows us to utilize selected biomarkers such as c-Met and SEZ6 to induce targeted cancer cell death by delivering potent anti-cancer agents. The data we are presenting at ASCO demonstrate the clinical potential of this approach across a wide range of difficult-to-treat tumors."
From the news: Data from the dose-escalation and colorectal cancer (CRC) dose-expansion cohort of an ongoing first-in-human Phase 1 study (NCT05029882) of ABBV-400, a potential best-in-class c-Met directed ADC, will be presented in an oral presentation. The preliminary data show that among 122 heavily pre-treated advanced CRC patients, promising antitumor activity was observed at 2.4 and 3.0 mg/kg doses administered once every 3 weeks, with confirmed objective response rate (ORR) of 18% (n=40) and 24% (n=41) respectively in those groups. In patients with higher c-Met expression, ORR was enriched to >35% at doses ≥2.4 mg/kg. The most common Gr≥3 treatment-emergent adverse events (TEAEs) were anemia (35%), neutropenia (7%) and febrile neutropenia (6%). TEAEs leading to discontinuation occurred in 25 (20.5%) patients. Additional data will be presented at the meeting.
From the news: ABBV-400 is also being evaluated in a Phase 1b basket study (NCT06084481) in advanced solid tumors as a monotherapy and a Phase 2 study (NCT06107413) in second line metastatic CRC in combination with fluorouracil, folinic acid, and bevacizumab.
From their Solid Tumor market report, BrainyInsights also says, A huge chunk of pharmaceutical companies continue to make significant contributions to the development of experimental drugs and technologies. The pharmaceutical sector, for instance, is significantly invested in research and development. Pharmaceutical firms invest in future research to bring high-quality, pharmaceuticals to the marketplace. Major pharma firms are boosting their R&D efficiency by investing heavily in R&D, to ensure long returns on investments, as well as by collaborating with R&D centres worldwide. for instance: According to Statista, Roche is expected to be the world's largest company which is investing heavily in R&D, that is, USD 14 Billion followed by Johnson & Johnson (USD 12.2 Billion), Merck & Co (USD 11.4 Billion), Pfizer (USD 10.5 Billion) and Novartis (USD 10 Billion), by the year 2026.
Aethlon Medical, Inc (NASDAQ: AEMD) says it 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 and exosomal particles underlying several forms of cancer, including breast, ovarian and metastatic melanoma.
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