AEMD: Authorization to Conduct Study in India Moves Oncology Initiatives Ahead

By M. Marin

NASDAQ:AEMD

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Clearance from India’s drug authority advances goal to study Hemopurifier® in patients with solid tumors

Aethlon Medical (NASDAQ:AEMD) has received clearance from India’s central drug authority to conduct a phase 1 trial of the Hemopurifier® in patients being treated with checkpoint inhibitor therapy. Despite the many benefits of checkpoint inhibitors, the majority of patients do not respond to them. AEMD’s hypothesis is that using the Hemopurifier combined with checkpoint inhibitor treatment can increase the percent of patients who can benefit.

The Drug Controller General of India (DCGI), which is India’s central drug authority, has authorized the company to conduct a phase 1 safety, feasibility and dose-finding trial of the Hemopurifier® in patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment such as Keytruda® or Opdivo®. PD-1, or Programmed Cell Death Protein 1, is a protein found on the cell surface that plays a role in inhibiting immune responses. Treatment such as Keytruda®, a type of immunotherapy, helps to block the PD-1 pathway to prevent cancer cells from hiding and, in turn, help the immune system work. While Keytruda® and other anti-PD-1 monotherapy treatments represent a substantial advance in cancer treatment, with certain tumor types it does not work on the majority of cancer patients.

… to potentially support that Hemopurifier with checkpoint inhibitors can improve overall patient outcomes

For example, according to NIH, “Pembrolizumab (Keytruda® is the brand name) has provided a new first-line option for patients with advanced NSCLC (Non-Small Cell Lung Cancer) and patients can achieve sustained remission once they respond to it, but less than 30% of patients will respond to pembrolizumab.” That means that the majority of patients do not respond to checkpoint inhibitors. The company’s hypothesis is that using the Hemopurifier in conjunction with treatment of checkpoint inhibitors can increase the percent of patients who can respond to the combined treatment.

In advance of the trial, AEMD will pursue an internal in vitro binding study of relevant targets. The company can conduct this study on its own without having to hire an outside CRO or use outside laboratory facilities, which will contain costs. Prior in vitro studies have documented that the Hemopurifier® captures exosomes underlying various types of cancer. This particular in vitro study will specifically evaluate the Hemopurifier against PD-1 proteins. As noted, the company expects the Hemopurifier in conjunction with an inhibitor can help improve overall patient outcomes and demonstrate proof of concept about the device’s benefits in treating solid tumors. The AEMD trial is expected to begin following completion of this in vitro study to confirm that relevant targets are bound by the Hemopurifier.

AEMD will then seek to obtain approval by the respective Ethics Boards of interested sites in India. The company has had a strong clinical working relationship with Medanta Medicity Hospital in Delhi, India, which is currently participating in a study of the Hemopurifier in COVID patients and it would not surprise us if Medanta Medicity Hospital had interest in participating in the study.

Checkpoint inhibitors such as Keytruda have been used to treat 25+ different types of cancer. By launching a basket oncology trial to study the impact of the Hemopurifier on a variety of cancerous tumors, AEMD believes it can generate data to support the Hemopurifier’s ability to improve outcomes, when combined with checkpoint inhibitor treatment, in multiple tumor types where cancer associated extracellular vesicles may promote immune suppression and resistance to anti-PD-1 antibodies. Given the Hemopurifier’s demonstrated ability to remove exosomes, management believes the device can be used to affect improved outcomes in a number of cancers.

Moreover, by focusing on multiple cancers, the company has also expanded the opportunities for patient enrollment, as well as building a database to support regulatory approval. By including both Keytruda and Opdivo can also facilitate patient enrollments.

… Planning a similar oncology clinical trial in Australia…

AEMD continues to work with the CRO (contract research organization) supervising its initiatives in Australia, NAMSA, to launch a similar oncology clinical trial in Australia; specifically, a safety, feasibility and dose finding trial in solid tumors in patients failing treatment with anti-PD-1 antibodies. This is consistent with the company’s strategy to focus its clinical efforts initially in Australia and India, where costs are substantially lower. The company’s goal is to maximize its R&D spending to advance the Hemopurifier. Australia offers an R&D tax incentives rebate program, which enables companies to receive a tax rebate of up to 43.5% on clinical trial related R&D costs and is expected to help reduce costs, lower risk, and accelerate time to market.

Focus on areas of oncology, organ transplantation, infectious disease

… potentially helping to increase the availability of viable organs

The oncology study is also consistent with Aethlon’s goal to focus on the areas of oncology, organ transplantation and then infectious disease. The company recently announced an initiative to determine the Hemopurifier’s ability to improve the outcomes of organ transplantation in addition to its existing cancer and COVID-19 studies. Aethlon will investigate the Hemopurifier’s ability to remove viruses and exosomes from harvested organs to increase the number of organs that can be transplanted successfully. The process potentially could reduce complications such as viral infection, delayed graft function and even rejection following transplant surgery. Because the Hemopurifier will be incorporated into the existing machine perfusion organ preservation circuit, it will not extend the organ preservation timeline, which is critical given that organs have a short window during which they remain viable for transplantation.

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