Thursday, September 19, 2024

Immunotherapy Clinical Trial News – Stocks to Watch; (Nasdaq: $AEMD), (NYSE: $BMY), (NYSE: $MRK), (Nasdaq: $IMRX), (NASDAQ: $IOVA), (NASDAQ: $KZIA)

 

Immunotherapy Clinical Trial News – Stocks to Watch; (Nasdaq: $AEMD), (NYSE: $BMY), (NYSE: $MRK), (Nasdaq: $IMRX), (NASDAQ: $IOVA), (NASDAQ: $KZIA)

 


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.

 

Stocks mentioned in this article: Aethlon Medical, Inc. (Nasdaq: AEMD), Bristol Myers Squibbs (NYSE: BMY), Merck & Co. (NYSE:MRK), Immuneering Corporation (Nasdaq: IMRX), Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) and Kazia Therapeutics Limited (NASDAQ: KZIA),.

 

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.”

Paid News Dissemination of behalf of AEMD

 

Read this article featuring AEMD in full at https://www.investorideas.com/news/2024/biotech/09191Immunotherapy-Clinical-Trials.asp

 

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 (NYSE:MRKKeytruda® (pembrolizumab) or Bristol Myers Squibb's (NYSE: BMYOpdivo® (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 (Nasdaq: IMRX), 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. (NASDAQ: IOVA), 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.

 

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 (NASDAQ: KZIA), 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

 

Research biotech and medical device/ tech stocks at Investorideas.com

https://www.investorideas.com/BIS/Stock_List.asp


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Breaking Medical Technology News: Aethlon (NASDAQ: $AEMD) Receives Ethics Committee Approval for Hemopurifier® Cancer Trial in India

 


 


 

 

 


Breaking Medical Technology News: Aethlon (NASDAQ: $AEMD) Receives Ethics Committee Approval for Hemopurifier® Cancer Trial in India

 

Aethlon Medical Granted Full Ethics Approval from the Medanta Institutional Ethics Committee for a Safety, Feasibility, and Dose Finding Study of its Hemopurifier® in Cancer Patients with Solid Tumors Not Responding to Anti-PD-1 Antibodies

 

SAN DIEGO, CA, September 19, 2024 - (Investorideas.com Newswire) Aethlon Medical, Inc. (Nasdaq: AEMD),  a medical therapeutic company focused on developing products to treat cancer and life threatening infectious diseases, 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 Keytruda® (pembrolizumab) or 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.

Paid News Dissemination of behalf of AEMD

 

Read this news featuring AEMD in full at https://www.investorideas.com/news/2024/09191AEMD-Ethics-Committee-Approval-for-Hemopurifier.asp

"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 trails.”

 

At present, only approximately 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.

 

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.

 

About Aethlon and the Hemopurifier®

Aethlon Medical is a medical therapeutic company focused on developing the Hemopurifier, a clinical stage immunotherapeutic device which is designed to combat cancer and life-threatening viral infections and for use in organ transplantation. 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.

 

Additional information can be found at www.AethlonMedical.com.

 

Forward Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve risks and uncertainties. Statements containing words such as "may," "believe," "anticipate," "expect," "intend," "plan," "project," "will," "projections," "estimate," "potentially" or similar expressions constitute forward-looking statements. Such forward-looking statements are subject to significant risks and uncertainties and actual results may differ materially from the results anticipated in the forward-looking statements. These forward-looking statements are based upon Aethlon's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Factors that may contribute to such differences include, without limitation, the Company's ability to successfully complete development of the Hemopurifier and to successfully demonstrate the utility of the Hemopurifier in patients with solid tumors in our planned oncology clinical trials; the Company’s ability to recruit patients for and manage its clinical trials and studies; the results of the safety, feasibility and dose finding study; unforeseen changes in regulatory requirements; and other potential risks. The foregoing list of risks and uncertainties is illustrative but is not exhaustive. Additional factors that could cause results to differ materially from those anticipated in forward-looking statements can be found under the caption "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended March 31, 2024, and in the Company's other filings with the Securities and Exchange Commission, including its quarterly Reports on Form 10-Q. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except as may be required by law, the Company does not intend, nor does it undertake any duty, to update this information to reflect future events or circumstances.

 

Company Contact:
Jim Frakes
Chief Financial Officer
Aethlon Medical, Inc.
Jfrakes@aethlonmedical.com   

 

Investor Contact:
Susan Noonan
S.A. Noonan Communications, LLC
susan@sanoonan.com

 

Aethlon Medical Inc. (Nasdaq:AEMD) is a featured biotech stock on Investorideas.com

 

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Tuesday, September 17, 2024

Breaking Mining Stock News: New Destiny Mining (TSXV: $NED.V) Drilling Hole 9 at the Jim Kelly Gold Zone - Treasure Mountain Silver Project, Hope BC; @NEDminingcorp

Breaking Mining Stock News: New Destiny Mining (TSXV: $NED.V) Drilling Hole 9 at the Jim Kelly Gold Zone - Treasure Mountain Silver Project, Hope BC; @NEDminingcorp

 


Vancouver, British Columbia - September 17, 2024 (Investorideas.com Newswire) New Destiny Mining Corp. (TSXV: NED), (the "Company" or "NED") provides a further update on its 2024 drilling program at the Treasure Mountain project, near Princeton, BC.

 

Drilling continues at the Jim Kelly gold zone. Hole TMN24-09 aimed to test the mineralized zone intersected in hole TMN24-08 (see press release from September 9th). It was drilled at a steeper angle to intersect the mineralized zone at depth (see cross-section below).

 

Paid news dissemination on behalf of New Destiny Mining

 

Read this news, featuring NED in full at https://www.investorideas.com/news/2024/09171NED-Hole-9-Treasure-Mountain-Silver-Project-BC.asp

 

 



 

Figure 1. Cross-section of holes TMN-08 and TMN-09 at the Jim Kelly area. The red dashed line shows the interpreted extension of Jim Kelly mineralized zone.

Hole TMN24-09 intersected an interval of a brecciated rock with carbonate alteration and silicification and disseminated pyrite and chalcopyrite from 80.29 to 80.79 meters depth (see top photo below). This zone is interpreted to be the down dip extension of the Jim Kelly mineralized zone intersected in Hole 08 (see cross-section above). This hole also intersected several intervals of quartz-carbonate veins. An interval of semi-massive sulfide was intersected (from 138.79 to 139.09 m) within a gabbro that included 10-15% pyrite, pyrrhotite, and chalcopyrite (see bottom photo below).



 

Figure 2. Photo of core from hole TMN24-09 showing a) interval of brecciated, silicified and carbonate altered rock with pyrite and chalcopyrite (top photo), and b) interval of semi-massive sulfide with pyrite, pyrrhotite, and chalcopyrite (bottom photo)

Hole TMN24-09 indicates geological continuity of the mineralized zone to depth, although the mineralized zone is narrower in hole 9. Further drilling is planned to test the strike extension and better define the geometry of the Jim Kelly mineralized zone.

 

The Treasure Mountain property covers 10,819 hectares and is located 38 km west of the Copper Mountain mine at Princeton in southern BC. Targets on the property include critical minerals in porphyry copper-moly deposits, and gold-quartz vein and polymetallic silver-rich vein deposits.

 



Map showing Treasure Mountain property and targets for 2024

Readers are cautioned that historical records referred to in this News Release have been examined but not verified by a Qualified Person. Further work is required to verify that historical records referred to in this News Release are accurate.

 

Dr. Mathew Ball, P.Geo., a Qualified Person as defined by NI 43-101 and consultant to the Company, approved the technical information contained in this News Release.

 

ON BEHALF OF THE BOARD OF DIRECTORS

"Al Beaton"

Director

604-488-3900

 

Investor Relations:
Lubica Parilakova
ir@NewDestinyMining.com

 




Forward Looking Information

This news release includes certain statements that constitute "forward-looking information" within the meaning of applicable securities law, including without limitation, the Company's information and statements regarding or inferring the future business, operations, financial performance, prospects, and other plans, intentions, expectations, estimates, and beliefs of the Company. Such statements include statements regarding the completion of the proposed transactions. Forward-looking statements address future events and conditions and are necessarily based upon a number of estimates and assumptions. These statements relate to analyses and other information that are based on forecasts of future results, estimates of amounts not yet determinable and assumptions of management. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions or future events or performance (often, but not always, using words or phrases such as "expects" or "does not expect", "is expected", "anticipates" or "does not anticipate", "plans", "estimates" or "intends", or stating that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved), and variations of such words, and similar expressions are not statements of historical fact and may be forward-looking statements. Forward-looking statement are necessarily based upon several factors that, if untrue, could cause the actual results, performances or achievements of the Company to be materially different from future results, performances or achievements express or implied by such statements. Such statements and information are based on numerous assumptions regarding present and future business strategies and the environment in which the Company will operate in the future, including the price of gold and other metals, anticipated costs and the ability to achieve goals, and the Company will be able to obtain required licenses and permits. While such estimates and assumptions are considered reasonable by the management of the Company, they are inherently subject to significant business, economic, competitive and regulatory uncertainties and risks including that resource exploration and development is a speculative business; that environmental laws and regulations may become more onerous; that the Company may not be able to raise additional funds when necessary; fluctuating prices of metals; the possibility that future exploration, development or mining results will not be consistent with the Company's expectations; operating hazards and risks; and competition. There can be no assurance that economic resources will be discovered or developed. Accordingly, actual results may differ materially from those currently anticipated in such statements. Factors that could cause actual results to differ materially from those in forward looking statements include continued availability of capital and financing and general economic, market or business conditions, the loss of key directors, employees, advisors or consultants, equipment failures, litigation, competition, fees charged by service providers and failure of counterparties to perform their contractual obligations. Investors are cautioned that forward-looking statements are not guarantees of future performance or events and, accordingly are cautioned not to put undue reliance on forward-looking statements due to the inherent uncertainty of such statements. The forward-looking statements included in this news release are made as of the date hereof and the Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as expressly required by applicable securities legislation.

 

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release

 

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