Immunotherapy Clinical Trials - A New Approach to Treating Cancer

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 30% of cancer patients who receive pembrolizumab or nivolumab treatment for solid tumors will have lasting clinical responses to these agents. Extracellular vesicles (EVs) produced by tumors have been implicated in resistance to anti-PD-1 therapies as well as the spread of cancers. 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."

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 40% and an initial disease control rate of 80%, with all five patients continuing on treatment -

- 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 40% and Disease Control Rate of 80% are very encouraging – and both more than would be expected for gemcitabine/nab-paclitaxel alone- we are still in the early stages of this trial, with more scans for all five of these initial patients and for additional patients planned to come. Nevertheless, it was encouraging to see a complete response in the very first pancreatic cancer patient treated with IMM-1-104 in this combination, with the patient now on treatment for over six months," said Ben Zeskind, Ph.D., Co-Founder and CEO of Immuneering. "Looking at the bigger picture, our Phase 2a trial aims to evaluate the efficacy of IMM-1-104 in multiple settings across various tumor types, to identify the highest priority opportunities for future development. If the early trends with IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel continue, we will have an exciting direction for potential future development of IMM-1-104, which could greatly improve the prognosis for a drastically underserved patient population."

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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