The Cancer Battle - How Smaller Companies Are Making Big Advancements in Treatments for Solid Tumors

Rhea-AI Summary

Aethlon Medical, Inc. (NASDAQ: AEMD) has received ethics approval for a clinical trial of its Hemopurifier® device in patients with solid tumors. The trial, to be conducted at Pindara Private Hospital in Australia, will evaluate the safety and feasibility of the Hemopurifier® in patients with stable or progressive disease during anti-PD-1 monotherapy treatment.

The Hemopurifier® is designed to remove harmful exosomes from biological fluids, which may improve therapeutic response rates to anti-PD-1 antibodies. The device has shown promise in preclinical studies for reducing exosomes in cancer patient plasma samples.

This development comes as the solid tumor therapeutics market is projected to reach $885.44 Billion by 2033, with smaller companies making significant advancements in treatments alongside big pharma.

Positive

• Aethlon Medical received ethics approval for a clinical trial of Hemopurifier® in solid tumor patients
• The Hemopurifier® has shown potential to remove harmful exosomes in preclinical studies
• The solid tumor therapeutics market is projected to reach $885.44 Billion by 2033

Negative

• Only about 30% of cancer patients have lasting clinical responses to current anti-PD-1 therapies
• The Hemopurifier® trial is still in early stages, focusing on safety and feasibility

Medical Research Analyst

The approval of Aethlon Medical's Hemopurifier® trial for solid tumors is a significant development. This device's unique approach of removing harmful exosomes could potentially enhance the efficacy of existing immunotherapies like Keytruda® and Opdivo®. With only 30% of patients responding to these therapies, the Hemopurifier® could address a critical unmet need. The trial's focus on safety and dose-finding is prudent, laying groundwork for future efficacy studies. However, investors should note that this is still an early-stage trial and success in larger studies will be important for market potential.

Oncology Expert

The approval of TECELRA® by Adaptimmune Therapeutics marks a milestone as the first engineered cell therapy for solid tumors in the U.S. Its 43% overall response rate in synovial sarcoma is promising, especially given the lack of new treatments in over a decade. However, the 4.5% complete response rate and median 6-month duration of response indicate room for improvement. The accelerated approval pathway means continued approval hinges on confirmatory trials, which investors should monitor closely. This breakthrough could pave the way for cell therapies in other solid tumors, potentially expanding the market significantly.

Financial Analyst

The solid tumor therapeutics market's projected growth from $222.71 billion to $885.44 billion by 2033 presents significant opportunities for both established pharma and innovative smaller companies. Aethlon Medical and Adaptimmune Therapeutics are well-positioned to capture market share with their novel approaches. However, investors should consider the long development timelines and high costs associated with bringing these therapies to market. The potential for acquisitions, as seen with Bristol Myers Squibb's $4.1 billion purchase of Turning Point Therapeutics, could provide substantial returns for early investors in successful smaller companies.

Vancouver, Kelowna, and Delta, British Columbia--(Newsfile Corp. - August 12, 2024) - Investorideas.com, a go-to investing platform covering biotech and medical technology issues a snapshot on recent news and developments for the 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.

Read the full article at Investorideas.com
https://www.investorideas.com/News/2024/biotech/08120Cancer-Battle.asp

The Brainy Insights estimates that the USD 222.71 Billion solid tumor therapeutics market will reach USD 885.44 Billion by 2033.

Looking at the current list of FDA approved drugs to treat solid tumors anywhere in the body as reported by Cancer.Gov, the market is currently dominated by big Pharma. Some of the currently approved drugs include Bristol Myers Squibb's Augtyro (Repotrectinib), Dabrafenib Mesylate from Novartis AG, Dostarlimab-gxly by GlaxoSmithKline and Keytruda (Pembrolizumab) by Merck & Co., Inc.

Even with FDA approval these drugs are not the Holy Grail and don't offer 100% effectiveness for all patients, or lasting results.

But there are other alternatives on the horizon coming from smaller innovative companies, and not all of the solutions are drugs.

Aethlon Medical, Inc's. (NASDAQ: AEMD) answer is the Hemopurifier®. 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.

Aethlon Medical, Inc. just announced that, on August 6, 2024, the Bellberry Human Research Ethics Committee (BHREC) granted full ethics approval to the Pindara Private Hospital for a 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 Merck's Keytruda® (pembrolizumab) or Bristol Myers Squibb's Opdivo® (nivolumab) (AEMD-2022-06 Hemopurifier Study). The approval is valid for one year, until August 6, 2025. The trial will be conducted by Dr. Marco Matos and his staff at the Pindara Private Hospital, located in Queensland, Australia.

"We are quite pleased that the BHREC accepted our responses to their thoughtful questions during their review and determined that our study meets the requirements of the National Statement application. Dr. Matos and his research team have a proven track record of enrollment in device trials in oncology patients that provides momentum to these trials," stated Dr. Steven LaRosa, MD, Chief Medical Officer of Aethlon Medical. "This is the second ethics committee approval we have received for our oncology trial in Australia after receiving approval from the ethics committee for Royal Adelaide Hospital in June."

Dr. LaRosa continued, "The next step is to receive approval from the Research Governance Office at each hospital which reviews indemnities and insurance. Once these approvals are obtained, Aethlon, in concert with our Australian Contract Research Organization, ReSQ, will conduct Site Initiation Visits (SIVs), after which patient enrollment may proceed."

More from the news: Currently, 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 exosomes in cancer patient plasma samples.

The primary endpoint of the approximate 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.

Elevation Oncology, Inc., an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, last week announced promising initial data from the dose escalation portion of the ongoing Phase 1 clinical trial of EO-3021 in patients with advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2, including gastric, gastroesophageal junction (GEJ), pancreatic or esophageal cancers.

"Gastric and GEJ cancers are devastating diseases, which occur frequently in the U.S. and globally and which, despite recent advancements, still have high levels of mortality," said Kohei Shitara, M.D., Chief, Department of Gastrointestinal Oncology, National Cancer Center Hospital East in Kashiwa, Japan and principal investigator on the Phase 1 clinical trial. "There is a particular need for highly selective therapies that benefit patients with Claudin 18.2-expressing tumors. To that end, I am excited by the initial data with EO-3021, which suggest it could change the treatment paradigm for a significant portion of patients with gastric or GEJ cancer. I am excited to evaluate EO-3021 in the expansion portion of this Phase 1 clinical trial."

"We are pleased to share initial data from our Phase 1 clinical trial of EO-3021," said Dr. Valerie Malyvanh Jansen, MD, Ph.D, Chief Medical Officer of Elevation Oncology. "EO-3021 was designed to maximize efficacy while minimizing the potential for free MMAE, with the goal of offering patients an improved safety profile and physicians a more readily combinable agent. We are encouraged to see the benefits of EO-3021's site-specific conjugation translate clinically, with minimal MMAE-associated toxicities observed in our Phase 1 trial. Coupled with the promising anti-tumor activity reported in patients with gastric or GEJ cancer, the data suggest that EO-3021 is a potential best-in-class Claudin 18.2 antibody drug conjugate. We look forward to advancing into monotherapy dose expansion and initiating our combination cohorts in the months ahead, as well as reporting additional data from our ongoing trial in the first half of 2025."

Adaptimmune Therapeutics plc, a company working to redefine the treatment of solid tumor cancers with cell therapy, on August 2^nd announced US Food and Drug Administration (FDA) accelerated approval of TECELRA® (afamitresgene autoleucel) for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. TECELRA is the first engineered cell therapy for a solid tumor cancer approved in the U.S., and the first new therapy option in more than a decade for synovial sarcoma, a rare, soft tissue cancer that most commonly impacts young adults.

Adrian Rawcliffe, Adaptimmune's Chief Executive Officer said, "The approval of TECELRA is a momentous step in Adaptimmune's journey to redefine the way cancer is treated and the culmination of a decade of groundbreaking R&D. I want to thank the patients, caregivers, investigators, and clinical teams as well as everyone at Adaptimmune and our partners who made possible this watershed moment for cell therapy and for people with synovial sarcoma. We are committed to advancing our robust clinical pipeline to serve more patients in need and plan to progress lete-cel, the next late-stage investigational treatment in our sarcoma franchise, with a rolling BLA submission to the FDA next year."

More from the news: The approval of TECELRA was based on results of the SPEARHEAD-1 (Cohort 1) trial, which included 44 patients. The major efficacy outcome was overall response rate (ORR) determined by independent review and supported by duration of response. TECELRA treatment resulted in an ORR of 43% with a complete response rate of 4.5%. The median duration of response was 6 months (95% CI: 4.6, not reached). Among patients who were responsive to the treatment, 39% had a duration of response of 12 months or longer.

OS Therapies, Inc., a clinical-stage oncology-focused immunotherapy company developing cancer vaccines and antibody drug conjugate (ADC) therapeutic candidates, announced in late July, positive data from a Phase 1 clinical trial of OST-HER2 in patients with HER2-expressing solid tumors in breast cancer and other cancers. Additionally, the Company announced positive preclinical efficacy data for OST-HER2 in multiple models of breast cancer.

More from the news: The FDA has granted Rare Pediatric Disease Designation (RPDD), Orphan Drug Designation (ODD), and Fast Track Designation (FTD) for OST-HER2 in Osteosarcoma. OST-HER2, a biologic therapeutic candidate, is a Lm (Listeria monocytogenes) vector-based off-the-shelf immunotherapeutic vaccine designed to prevent metastasis, delay recurrence, and increase overall survival in patients with osteosarcoma and other solid tumors. The proposed OST-HER2 mechanism of action is based on innate and adaptive immune stimulating responses activated by the Lm vector. This treatment generates T cells that can eliminate or slow potential micrometastases that can grow into recurrent osteosarcoma and other solid tumors, including breast cancer. T cell responses home in on HER2 expressed by the tumor and then kill the cell, releasing additional tumor targets. There are currently no approved adjuvant treatments for recurrent osteosarcoma in the United States.

The anticipated $885.44 Billion market by 2033 is a big pie and investors following the treatment of solid tumors have alternatives to big Pharma as the smaller players bring new solutions to market. If successful, we may see acquisitions like the Bristol Myers Squibb's $4.1 billion acquisition of Turning Point Therapeutics for Augtyro.

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FAQ

What is the Hemopurifier® device developed by Aethlon Medical (NASDAQ: AEMD)?

The Hemopurifier® is a medical device designed to remove harmful exosomes from biological fluids. It has potential applications in cancer treatment, particularly in improving response rates to anti-PD-1 therapies for solid tumors.

What is the current status of Aethlon Medical's (NASDAQ: AEMD) Hemopurifier® clinical trial?

Aethlon Medical has received ethics approval for a safety, feasibility, and dose-finding clinical trial of the Hemopurifier® in patients with solid tumors at Pindara Private Hospital in Australia. The trial will evaluate patients with stable or progressive disease during anti-PD-1 monotherapy treatment.

What is the projected market size for solid tumor therapeutics by 2033?

According to The Brainy Insights, the solid tumor therapeutics market is projected to reach USD 885.44 Billion by 2033, growing from USD 222.71 Billion.

How does Aethlon Medical's (NASDAQ: AEMD) Hemopurifier® potentially improve cancer treatment?

The Hemopurifier® is designed to remove extracellular vesicles (EVs) produced by tumors, which have been implicated in resistance to anti-PD-1 therapies. By removing these EVs, the device may improve therapeutic response rates to anti-PD-1 antibodies in cancer treatment.