The solid tumors market is experiencing significant innovation, with Aethlon Medical initiating a clinical trial for its Hemopurifier device and recent FDA approvals of new immunotherapy combinations. These developments aim to address unmet needs in cancer treatment and improve patient outcomes.
Aethlon Medical's Hemopurifier Trial
Aethlon Medical (NASDAQ: AEMD) has activated a clinical trial site at the Royal Adelaide Hospital in Australia for its Hemopurifier device. This trial focuses on patients with solid tumors who have developed resistance to anti-PD-1 therapies like Keytruda and Opdivo. The Hemopurifier is designed to remove tumor-produced extracellular vesicles (EVs) from the bloodstream, potentially enhancing the effectiveness of immunotherapies.
Steven LaRosa, MD, Chief Medical Officer of Aethlon Medical, stated, "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."
The trial aims to assess the safety, feasibility, and optimal dosing of the Hemopurifier. By removing EVs, which are implicated in cancer spread and immunotherapy resistance, the Hemopurifier could improve response rates to anti-PD-1 antibodies. Preclinical studies have demonstrated the device's ability to reduce exosomes in the plasma of cancer patient samples.
The primary endpoint of the trial is to monitor adverse events and changes in safety lab tests. Secondary endpoints include examining the number of Hemopurifier treatments needed to decrease EV concentrations and whether these changes improve the body's ability to attack tumor cells.
Immuneering's Promising Data in Pancreatic Cancer
Immuneering is developing universal-RAS/RAF medicines for cancer patients. Initial data from a Phase 2a clinical trial of IMM-1-104, in combination with modified gemcitabine/nab-paclitaxel for first-line pancreatic cancer treatment, showed a 40% objective response rate (ORR) and an 80% disease control rate in the first five patients.
Ben Zeskind, Ph.D., Co-Founder and CEO of Immuneering, noted, "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."
These early results suggest that IMM-1-104 could significantly improve outcomes for pancreatic cancer patients, who typically face a poor prognosis. The trial aims to evaluate the efficacy of IMM-1-104 across various tumor types to identify the best opportunities for future development.
Market Growth and Recent FDA Approvals
The solid tumors market is projected to reach $375.4 billion by 2034, with a CAGR of 7.45% from 2024 to 2034. This growth is fueled by advancements in targeted therapies, immunotherapies, and personalized medicine.
Recent FDA approvals for immunotherapy combinations in endometrial cancer, including AstraZeneca's durvalumab, Merck's pembrolizumab, and GlaxoSmithKline's dostarlimab, highlight the expanding treatment landscape. These approvals offer new options for patients with advanced endometrial cancer, regardless of mismatch repair deficiency (dMMR) status.
Additionally, the FDA granted accelerated approval to Roche's trastuzumab deruxtecan for HER2-positive solid tumors, marking the first tumor-agnostic approval for an antibody-drug conjugate. This approval allows the drug to be used across various cancer types if the tumors express high levels of HER2.
Implications for Investors
Investors should monitor smaller biotechs like Aethlon Medical and Immuneering, as their innovative approaches could disrupt the market if clinical trials prove successful. However, these investments carry higher risk due to the early stage of development.
