Cancer’s Solid Tumors Market – the Stocks to Watch

Stocks mentioned-Aethlon Medical, Inc. (Nasdaq: $AEMD), Immuneering (Nasdaq: $IMRX), Merck (NYSE: $MRK), AstraZeneca (Nasdaq: $AZN) Roche (OTCQX: $RHHBY)

September 17, 2024 - Investorideas.com, a go-to investing platform, releases the first of a two-part series looking at news and developments for the treatment of cancer and solid tumors featuring Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening viral infections.

According to Biospace.com “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. The market is driven by advancements in targeted therapies, immunotherapies, as well as personalized medicine.”

Taking a unique approach to cancer treatment, Aethlon Medical, Inc. (Nasdaq: AEMD) just announced that the Cancer Clinical Trial Unit at Royal Adelaide Hospital was activated on September 10, 2024 to begin screening and enrolling patients in its 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 trial will be conducted by Prof. Michael Brown and his staff at the Cancer Clinical Trials Unit, CALHN, Royal Adelaide Hospital in Australia.

The Hemopurifier® is a clinical stage immunotherapeutic device which is designed to combat cancer and life-threatening viral infections and for use in organ transplantation.

The activation follows the previously announced approval by the Human Research Ethics Committee at Central Adelaide Local Health Network on June 13, 2024, and the Research Governance office at Royal Adelaide Hospital, on September, 3 2024, as well as the notification of the Therapeutic Good Administration (TGA) and completion of a Site Initiation Visit on September 9, 2024.

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"The activation of the investigative site at the Royal Adelaide Hospital marks a significant milestone for Aethlon, allowing the site to screen and enroll patients in this important clinical trial,” 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 (CROs), NAMSA and ReSQ Clinical Research, to begin enrollment and data collection. Going forward, we plan to activate a second site in Australia and also expect to receive an Ethics Committee approval for a clinical site in India.”

Currently, only approximately 30% of patients who receive Merck & Co., Inc.'s (NYSE:MRK) Keytruda® (pembrolizumab) or Bristol Myers Squibb's (NYSE: BMY) Opdivo® (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 primary endpoint of the approximately 18-patient, safety, feasibility and dose-finding trial is the incidence of adverse events and clinically significant changes in safety 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 whether 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 (Nasdaq: IMRX) is a clinical-stage oncology company seeking to develop and commercialize universal-RAS/RAF medicines for broad populations of cancer patients with an initial aim to develop a universal-RAS therapy. The Company aims to achieve universal activity through Deep Cyclic Inhibition of the MAPK pathway, impacting cancer cells while sparing healthy cells. Immuneering’s lead product candidate, IMM-1-104, is an oral, once-daily Deep Cyclic Inhibitor currently in a Phase 1/2a trial in patients with advanced solid tumors harboring RAS mutations. IMM-6-415 is an oral, twice-daily Deep Cyclic Inhibitor currently in a Phase 1/2a trial in patients with advanced solid tumors harboring RAS or RAF mutations.

The stock made big moves following news September 12^th. Immuneering 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.

“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.”

Looking at what is currently out there for patients with solid tumors, according to cancer.gov, “The Food and Drug Administration (FDA) has approved three new immunotherapy options for people with advanced endometrial cancer. The approvals are for drugs called immune checkpoint inhibitors.”

The first approval, announced on June 14, is for AstraZeneca’s (Nasdaq: AZN; (LSE:AZN) durvalumab (Imfinzi) given in combination with chemotherapy to treat people with advanced endometrial cancer whose tumors have certain genetic changes that cause them to have a characteristic known as mismatch repair deficiency (dMMR). Tumors that are dMMR are particularly susceptible to immunotherapy.

The second approval, announced on June 17, is for Merck & Co., Inc.'s (NYSE:MRK) pembrolizumab (Keytruda) given along with chemotherapy, regardless of whether tumors are dMMR. And on August 1, FDA approved dostarlimab (Jemperli) plus chemotherapy for people with advanced endometrial cancers regardless of dMMR status. Dostarlimab had previously been approved, in 2023, for advanced endometrial cancers that are dMMR.

Under the approvals, the combinations can be used as an initial therapy or as treatment for cancer that has come back after certain previous treatments.

In large clinical trials, the addition of these immunotherapy drugs to chemotherapy led to improvements in progression-free survival, which is how long people live without their cancer growing.

Cancer.gov also reported, On August 5, the agency gave an accelerated approval for Roche Holding’s (OTCQX:RHHBY) trastuzumab deruxtecan-often called T-DXd-to treat anyone with any advanced solid cancer if their tumors produce high levels of the protein HER2, or HER2-positive. To receive the drug, a patient must already have received at least one prior treatment. The approval makes T-DXd the first cancer therapy of its type, an antibody─drug conjugate, that can be used in such a “tumor agnostic” manner. T-DXd is already approved to treat people with several specific cancers, including breast and stomach.

Based on the current options and availability for patients with solid tumors, innovation is key to advancements and alternatives to traditional big pharma.

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.

Also in the future, AI may play a key role according to Biospace. “The integration of artificial intelligence (AI) and digital health is revolutionizing the solid tumors market by enhancing diagnostics, treatment planning, and patient management. AI algorithms can analyze vast amounts of medical data, including imaging, pathology slides, and genomic information, to identify patterns and provide insights that might be missed by human clinicians. For instance, AI-powered imaging tools can detect early signs of tumors with high accuracy, improving early diagnosis and treatment outcomes.”

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