Breaking Through: Systemic Genetic Medicines for Hard-to-Treat Cancers

NetworkNewsWire Editorial Coverage

NEW YORK, July 9, 2025 /PRNewswire/ -- Each year, approximately 20 million people are diagnosed with cancer, and nearly 10 million lives are lost to the disease worldwide, a toll that is projected to rise in the coming decades (https://ibn.fm/dyQrw). By 2050, the American Cancer Society estimates that annual cancer diagnoses will reach 35 million. While advances in treatment have improved outcomes for some patients, the demand for more effective therapies remains urgent — and the opportunity for innovation and market impact is significant. Calidi Biotherapeutics Inc. (NYSE American: CLDI) (Profile) is taking a bold approach to this challenge with a next-generation platform designed to deliver genetic medicines directly to both primary and metastatic tumors. Using engineered viruses to transport therapeutic payloads with precision, Calidi's technology aims to transform the landscape of cancer treatment. Though oncology is its initial focus, the company is also exploring broader applications in high-need areas such as autoimmune disorders. In doing so, Calidi is positioning itself among a select group of biotech innovators, including Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX), ImmunityBio Inc. (NASDAQ: IBRX), Crispr Therapeutics AG (NASDAQ: CRSP) and CytomX Therapeutics Inc. (NASDAQ: CTMX).

• Cancer continues to be one of the leading global health crises, accounting for roughly one in every six deaths worldwide 
• Calidi Biotherapeutics Inc. has spent over 10 years developing a groundbreaking platform for the systemic delivery of genetic medicines that can precisely target tumors. 
• One of the company's core innovations is the RedTail systemic antitumor virotherapy platform.
• Calidi recently showcased promising preclinical data at two of the most prestigious oncology gatherings: AACR and ASCO.

Click here to view the custom infographic of the Calidi Biotherapeutics editorial.

Immense Human Toll, Critical Need for Research

Cancer continues to be one of the leading global health crises, accounting for roughly one in every six deaths worldwide (https://ibn.fm/ZzZHC). Among the most prevalent forms are lung cancer, with 2.2 million new cases and 1.8 million deaths in 2020, followed by breast (2.26 million cases), colorectal (1.93 million cases) and prostate cancer (1.41 million cases). In the United States alone, cancer causes some 600,000 deaths each year, and projections estimate more than two million new diagnoses in 2025. These numbers reflect not only the immense human toll but also the strain cancer places on healthcare systems globally.

The numbers also emphasize the critical need for ongoing investment in research and innovation. The global oncology drug market, valued at approximately $190.1 billion in 2023, is expected to surge to $564.5 billion by 2033, an 11.5% compound annual growth rate (https://ibn.fm/EMpur). This growth is being fueled by continued advancements in early detection, targeted treatments, immunotherapy and personalized medicine — essential tools in the effort to reduce cancer's devastating impact.

Redefining the Treatment Paradigm

Calidi Biotherapeutics Inc. (NYSE American: CLDI) has spent over 10 years developing a groundbreaking platform for the systemic delivery of genetic medicines that can precisely target tumors, including hard-to-treat metastatic sites. Central to this innovation is Calidi's proprietary enveloped viral system, which encases therapeutic payloads in a human cell membrane. This "envelope" allows the therapy to evade immune detection and travel through the bloodstream to reach distant cancer sites, where the genetic payload is activated to help eliminate tumors.

The company's long-term R&D efforts, which began with stem cell-based delivery systems and evolved into advanced enveloped virotherapies, have produced a suite of novel platforms with strong therapeutic potential. Calidi's preclinical data, presented at leading scientific conferences and in investor updates, support its progress toward Investigational New Drug (IND) filings and possible strategic partnerships. With its focus on precise delivery, localized immune activation and systemic reach, Calidi is poised to help redefine the treatment paradigm for metastatic cancer — offering a safer, more effective way to deploy genetic medicines directly to the disease.

Addressing Unmet Needs in Oncology

Calidi Biotherapeutics is a clinical-stage biotech company focused on developing genetic medicines and proprietary, genetically engineered oncolytic viruses. One of its core innovations is the RedTail systemic antitumor virotherapy platform, which utilizes a specially engineered strain of vaccinia virus designed to selectively target tumors throughout the body (https://ibn.fm/lTNMW). This platform is capable of generating high levels of enveloped vaccinia viruses that are resistant to humoral immune responses, enabling the therapy to circulate systemically, reach tumor sites and deliver genetic payloads directly into the tumor microenvironment to drive tumor cell destruction.

The lead therapeutic candidate from the RedTail platform — CLD-401 — is designed to address significant unmet needs in oncology. According to the company, CLD-401 is being developed to treat non-small cell lung cancer and other aggressive tumor types that currently have limited effective treatment options.

Converting 'Cold' Tumors into 'Hot' Targets

Calidi Biotherapeutics has made a major advance in addressing advanced and treatment-resistant cancers with CLD-401, its first drug candidate designed for systemic delivery. This investigational therapy reflects more than 10 years of Calidi's work in enveloped viral technology, leveraging a dual-action approach: destroying cancer cells while delivering genetic medicine intended to prevent recurrence at metastatic sites. Unlike traditional therapies that require localized injection, CLD-401 is administered intravenously, opening the door to a new generation of precision oncology treatments that can reach tumors anywhere in the body.

At the heart of CLD-401's therapeutic effect is Calidi's proprietary RedTail platform. This platform uses an engineered oncolytic vaccinia virus encased in a protective envelope and enhanced with a chimeric CD55 receptor, making it highly resistant to immune system clearance and allowing it to circulate effectively to metastatic tumors. The virus carries an IL-15 superagonist payload, a potent genetic medicine that not only lyses cancer cells but also activates a strong immune response. By stimulating CD8+ T cells and natural killer (NK) cells, the therapy converts immunologically "cold" tumors — those typically unresponsive to immune attack — into "hot" targets, potentially improving outcomes in difficult-to-treat cancers. Preclinical studies have validated the platform's ability to deliver this effect.

"Of particular excitement is the rapid progress we have made with RedTail, the company's approach to systemically delivering genetic medicines to metastatic sites in patients with advanced cancer using our proprietarily engineered enveloped virus," said Calidi CEO Dr. Eric Poma in a recent shareholder update (https://ibn.fm/JxyAG). "RedTail represents the culmination of over a decade of meticulous research and innovation at Calidi to create what we believe is the most advanced systemic virotherapy platform. Advancing this novel platform is the company's main focus and priority."

Showcasing Promising Preclinical Data

Calidi Biotherapeutics recently showcased promising preclinical data at two of the most prestigious oncology gatherings — the American Association for Cancer Research (AACR) and the American Society of Clinical Oncology (ASCO) — demonstrating the tumor-destroying and relapse-preventing potential of its lead candidate, CLD-401.

During the AACR Annual Meeting in April, Calidi presented findings titled "Development of a Systemic Enveloped Virotherapy for Targeting All Metastatic Sites" (https://ibn.fm/9N79P). The study highlighted how the RedTail platform's enveloped vaccinia virus, coated in a human-like extracellular membrane, can evade immune defenses, survive in circulation and reach multiple metastatic tumor sites following intravenous injection. The virus successfully delivered its genetic payload, including IL-15 superagonist, into challenging tumor models such as metastatic lung cancer. The data emphasized the platform's ability to bypass complement activation, significantly improving both circulation time and therapeutic effectiveness.

Momentum continued at the ASCO Annual Meeting in June, where Calidi shared additional results underscoring the enhanced properties of CLD-401, which features a chimeric CD55 receptor to further resist immune system clearance. Once delivered to tumors, the virus released its IL-15 superagonist payload, which stimulated a strong immune response, particularly activating CD8+ T cells and natural killer (NK) cells, within the tumor microenvironment. These immune components are essential for generating long-term, durable antitumor activity (https://ibn.fm/njnqa).

Together, the AACR and ASCO presentations underline the dual strength of CLD-401: its ability to directly lyse tumor cells and its capacity to "educate" the immune system to help prevent future recurrence. With systemic reach and targeted immune activation, RedTail positions Calidi's platform as a breakthrough in immuno-oncology, particularly for patients facing metastatic cancers with limited therapeutic options.

"Looking ahead, our roadmap for the next 18 months includes multiple critical milestones," said Poma. "We are working to complete IND-enabling studies ahead of an IND filing by the end of 2026 for our lead RedTail candidate that delivers IL-15 superagonist to tumor sites, CLD-401. Our clinical strategy includes an optimized dose-escalation study designed to swiftly demonstrate efficacy and validate the systemic administration of RedTail in patients with metastatic disease."

With strong preclinical validation and a clearly defined development path, Calidi is now preparing for clinical trials that could transform the way genetic medicines are delivered and used to combat cancer across the body.

Making Strides with Breakthrough Therapies

The biotech sector continues to push the boundaries of medical innovation, with several leading companies announcing major regulatory milestones and promising clinical advancements in an array of spaces.

Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) recently received approval from the European Commission for its proprietary ALYFTREK(R), a new once-daily CFTR modulator for the treatment of cystic fibrosis (https://ibn.fm/HCgSh). A global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions, Vertex reported that ALYFTREK is approved in the European Union for people with CF aged six years of age and older with at least one non-class I mutation in the CFTR gene, making it the broadest label for this medicine in the world.

ImmunityBio Inc. (NASDAQ: IBRX), a leading immunotherapy company, announced that the U.S. Food and Drug Administration (FDA) has granted Expanded Access authorization for the use of IBRX's Cancer BioShield(TM) platform (https://ibn.fm/diXMY). Anchored by ANKTIVA(R) (nogapendekin alfa inbakicept-pmln), the platform is designed to treat lymphopenia in adult patients with refractory or relapsed solid tumors independent of tumor type who have progressed after first-line standard-of-care treatment, chemotherapy, radiation or immunotherapy. To date no treatment exists for lymphopenia, a depletion of critical lymphocytes responsible for immunogenic cell death, specifically natural killer (NK) cells, killer CD8+ T cells and CD4+ with memory T cells.

Crispr Therapeutics AG (NASDAQ: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, is reporting updates across its in vivo cardiovascular disease programs. These updated include new data for CTX310(TM), targeting ANGPTL3, as well as continued progress on CTX320(TM), targeting the LPA gene, and CTX340(TM), targeting the AGT gene (https://ibn.fm/A8q5j). Company officials noted that the additional data from its ongoing phase 1 clinical trial for CTX310 reinforces the potential of Crispr Therapeutics' platform to transform the treatment of serious cardiovascular diseases.

CytomX Therapeutics Inc. (NASDAQ: CTMX), a leader in the field of masked, conditionally activated biologics, has updated its pipeline priorities and anticipated milestones for 2025 (https://ibn.fm/tshxj). "Our top strategic objective for 2025 is the development of CX-2051, a wholly-owned, first-in-class PROBODY ADC being developed initially in advanced metastatic colorectal cancer (CRC)," said CytomX CEO and chair Sean McCarthy. "CX-2051 targets the previously undruggable highly expressed CRC antigen, EpCAM, and carries a topoisomerase-1 inhibitor payload. This novel ADC has the potential to make a meaningful difference in the treatment of heavily pretreated CRC patients, for whom the current standard of care remains inadequate and new treatment options are urgently needed."

As these companies press forward with bold science and regulatory success, they are setting the pace for a new era in disease treatment. With each breakthrough, hope grows for patients and families impacted by complex, underserved conditions.

For more information, visit Calidi Biotherapeutics Inc. (NYSE American: CLDI).

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