Aggressive Cancers In Young People Are On The Rise – Can The Immune System Fight Back Better? Indaptus Therapeutics Thinks So

Cancer among people under 50 is on the rise across the world, growing nearly 80% in the last three decades. While poor diets, alcohol use, tobacco use and obesity are among the factors, even younger people in seemingly good health are being diagnosed with cancer at an alarming rate. Known as early-onset cancers, it's particularly concerning given advancing age is the top risk factor for cancer overall. 

Treating early-onset cancers holds its own unique challenges. After all, chemotherapy and radiation, which can be effective, can significantly reduce the quality of life in patients, plus there are concerns about the long-term impact these treatments will have on fertility, cognitive function and cardiovascular health. With years of life ahead for younger cancer patients, those are big concerns – concerns that biotechnology companies like Indaptus Therapeutics Inc. INDP are looking to address with novel approaches involving immunotherapy. 

Immunotherapies: Promise And Shortcomings 

Immunotherapies have been around for over 100 years, but in the past decade are attracting increasing interest due to multiple factors, including fewer side effects and the potential to treat most cancers. Administered as pills, injections or intravenously, immunotherapies help the body's immune system attack cancer cells. On its own, the immune system has difficulty finding and attacking cancer cells, but with these therapies, it can be an avid hunter. 

Immunotherapies can also help stimulate the immune system, getting it to work harder to pinpoint and fight cancer cells and make other cancer treatments more effective. Plus, it can help patients stay cancer-free for a longer period of time because the immune system is trained, via the therapies, to attack cancer cells if they ever resurface. It's why companies like Indaptus are developing novel immunotherapies. 

But that's not to say there aren't downsides to immunotherapies for cancer treatment. For starters, patients can experience a bad reaction, side effects include flu-like symptoms such as fever, chills and fatigue, as well as weight gain, swelling, heart palpitations, stuffy head and diarrhea. Some immunotherapies can cause the immune system to go after major organs such as the heart, liver and kidneys. Plus, immunotherapies take longer to work than other cancer therapies, requiring long durations of exposure ranging from weeks to months, which can lead to immune-related toxicities. It also doesn't work for everyone, with response rates often under 50%.

Indaptus' Nex-Gen Approach To Immunotherapies

But it doesn't have to be that way. At least if Indaptus has its way. Positioning itself as a next-generation immunotherapy cancer drug company, Indaptus Therapeutics, building on the observation that tumor growth can reverse in the presence of bacterial infections, has developed a proprietary platform that exploits bacteria's natural ability to activate both innate and adaptive cellular immune pathways. 

The company, leveraging its insight into the levels and ratio of activating signals necessary to elicit a broad immune response, is creating and advancing a pipeline of proprietary, attenuated and killed non-pathogenic gram-negative bacterial candidates designed to be widely accessible with broad antitumor and antiviral activity. 

Indaptus says its Decoy Therapeutics candidates are unique in their ability to work with a variety of existing therapies, including checkpoint therapy and targeted antibodies, to produce strong anti-tumor responses against established tumors. What's more, the company says its Decoy Therapeutics are designed to flush out of the body within a few hours, reducing the potential for long-term toxicity. In humans, Indaptus says Decoy Therapeutics transiently activate more than 50 cytokines/chemokines that may work together in attacking tumors.

Decoy20 Preclinical Studies Advancing 

Indaptus' lead candidate Decoy20, has demonstrated in preclinical studies the ability to elicit single-agent activity and durable anti-tumor responses in the combination setting against colorectal, hepatocellular, pancreatic carcinoma and non-Hodgkin's lymphoma in standard pre-clinical models. 

According to the company, its human studies have demonstrated that Decoy20 clears within two hours and induces activity in over 50 cytokines/chemokines involved in anti-tumor immune responses. Tolerability results were consistent with the proposed mechanism of action. Common side effects like fever, chills and hypotension were temporary and resolved within 24 to 48 hours.

Building on its phase 1 study, Indaptus received Clinical Trial Authorization from Health Canada in February to initiate its clinical trial of Decoy20 in the country – allowing it to expand the U.S. trial to sites in Canada, broaden patient recruitment and enhance trial research. "Expanding to Canada represents a significant step in our mission to evaluate Decoy20, a broad immune system activator, in patients with solid tumors," said Jeffrey Meckler, CEO of Indaptus, when the news was announced. With trials underway in the U.S. and expanding into Canada, Indaptus expects to release proof of concept data later this year or in early 2026. 

Collaborations, Funding In Focus 

In addition to advancing its clinical development activities for Decoy20, Indaptus is also exploring collaborations, strategic alliances and license agreements to enhance its capital resources and support its research and development efforts. 

On the collaboration front, last fall, the biotech inked a clinical supply agreement with biotech firm BeiGene to evaluate Decoy20 in combination with BeiGene's anti-PD-1 antibody, tislelizumab, for treating advanced solid tumors. PD-1 inhibitors are considered key agents in modern immunotherapy and have produced impressive response rates in some patients, reports Indaptus. In preclinical studies, Indaptus said Decoy20, when used in combination with a PD-1 inhibitor and an oral non-steroidal anti-inflammatory agent, demonstrated tumor eradication rates of 80-100%. Indaptus hopes to find a treatment combination that similarly improves outcomes in humans.

As for funding, the company has raised over $7 million since August via registered direct offerings and private placements with warrants. Additionally, the company entered into a Standby Equity Purchase Agreement (SEPA), allowing for the sale of up to $20 million of common stock over 36 months. Indaptus plans to continue seeking equity or debt financing this year and may also pursue collaborations or strategic partners to support its funding needs. 

Early-onset cancer is growing at an alarming rate. While immunotherapies hold a lot of promise, they come with a lot of unwanted side effects. Indaptus is trying to change that with its next-generation approach. To learn more about Decoy Therapeutics and Indaptus, click here. 

Featured photo by Angiola Harry on Unsplash.

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