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Calidi Biotherapeutics Announces Issuance of New U.S. Patent Covering Novel SuperNova Technology Platform

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Calidi Biotherapeutics (NYSE American: CLDI) has been granted U.S. Patent No. 12,036,278 for its SuperNova technology platform. This patent, titled 'Smallpox Vaccine for Cancer Treatment,' covers methods and compositions related to cancer immunotherapy, specifically combining smallpox vaccines with various stem cell types.

The patent strengthens Calidi's intellectual property portfolio and supports the advancement of its CLD-201 program into clinical trials. It broadens previously allowed claims to include 21 smallpox vaccine virus strains and 19 different stem cell types. The SuperNova platform aims to shield viral payloads from the immune system, enhancing delivery to tumor sites and improving the therapeutic efficacy of oncolytic viruses.

Calidi plans to submit an IND to initiate a first-in-human clinical trial of this off-the-shelf allogeneic therapy, focusing on patients with advanced solid tumors.

Positive
  • Issuance of new U.S. Patent No. 12,036,278 for SuperNova technology platform
  • Patent covers 21 smallpox vaccine virus strains and 19 different stem cell types
  • Strengthens intellectual property portfolio
  • Positions company to advance CLD-201 program into clinical trials
  • Potential to enhance delivery of oncolytic viruses to tumor sites
Negative
  • None.

Insights

The issuance of a new patent for Calidi Biotherapeutics' SuperNova technology is significant because it enhances the company's intellectual property portfolio and protects their novel approach to cancer treatment. This technology uses adipose-derived mesenchymal stem cells loaded with an oncolytic vaccinia virus, a method designed to shield the viral payload from the immune system and improve delivery to tumor sites. The combination of stem cells and the smallpox vaccine virus leverages the body's immune response to target and destroy cancer cells, potentially leading to more effective treatments for advanced solid tumors.

This patent also broadens claims to cover 21 smallpox vaccine virus strains, which implies that Calidi has a versatile and potentially more effective platform. For investors, this could mean an enhanced competitive edge and a stronger position in the market for oncolytic virotherapies. The company's plans to advance CLD-201 into clinical trials indicate progress and potential future revenue streams, though clinical trials are inherently risky and expensive.

Understanding the efficiency of viral shielding and delivery mechanisms could be key for Calidi's success. The success in clinical trials will be critical for validating the efficacy and safety of this treatment, which could lead to regulatory approval and commercial success. However, investors should also consider the potential costs and time associated with these trials.

The new patent strengthens Calidi Biotherapeutics' intellectual property, which is a key asset for any biotech company. Protecting their SuperNova platform from potential competition could enhance the company's market position and attractiveness to investors, partners and future acquirers. This is particularly relevant if the technology proves to be as effective as initial research suggests.

Securing patents is a important step for biotech companies because it not only protects their innovations but also aids in securing funding and partnerships. For Calidi, this could mean an influx of investment capital and strategic alliances, which are essential for progressing through costly and lengthy clinical trials. Investors should watch for developments in these areas as indicators of the company's financial health and future potential.

However, it’s important to note that while the patent is a positive development, the financial implications will largely depend on the outcomes of clinical trials and subsequent regulatory approvals. The patent grants exclusivity, which is financially beneficial, but it does not guarantee a successful product. Thus, investors need to balance this news with the understanding of the inherent risks in biopharma development.

The issuance of U.S. Patent No. 12,036,278 to Calidi Biotherapeutics is a strategically important move, as it provides legal protection for their SuperNova platform. The patent covers methods and compositions related to combining a smallpox vaccine with various stem cell types, which can be important in safeguarding the company’s proprietary technology from infringement and maintaining a competitive advantage.

This broad patent grant, which includes 21 smallpox vaccine virus strains, suggests a comprehensive strategy to cover multiple aspects of their technology, potentially deterring competitors from developing similar therapies. Moreover, the strong intellectual property portfolio can enhance Calidi's leverage in potential partnerships and licensing deals, which are common in the biotech industry.

From a legal perspective, this patent fortifies Calidi's position as it moves towards clinical trials. Investors should consider the strength and breadth of patent protection as a positive indicator of future stability and potential for exclusivity in the market. However, it's also essential to monitor any potential legal challenges or litigation that could arise, which can be costly and time-consuming.

SAN DIEGO, July 18, 2024 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics, Inc. (NYSE American: CLDI or “Calidi”), a clinical-stage biotechnology company developing a new generation of targeted antitumor virotherapies, today announced the issuance of a new patent for the company’s SuperNova technology, strengthening its intellectual property portfolio and positioning Calidi to advance its CLD-201 program into the clinic.

The United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 12,036,278 titled, “Smallpox Vaccine for Cancer Treatment,” directed to Calidi’s SuperNova platform composed of adipose-derived mesenchymal stem cells loaded with oncolytic vaccinia virus.

“This latest patent granted to Calidi covering meaningful features of our SuperNova platform represents an important milestone, as we prepare to advance CLD-201 into the clinic,” said Allan Camaisa, CEO and Chairman of the Board of Calidi Biotherapeutics. “We are pleased to continue strengthening an already robust intellectual property portfolio, and feel well-positioned to fully capture the potential of our universal off-the-shelf SuperNova platform to radically transform the landscape for patients with advanced solid tumors.”

The patent covers methods and compositions related to immunotherapy of cancer, specifically compositions combining a smallpox vaccine with stem cells, selected from among 19 different stem cell types and their combinations. Importantly, this patent broadens previously allowed claims to include 21 smallpox vaccine virus strains. Extensive Calidi research has shown the potential ability of the SuperNova platform to shield the viral payload from the immune system, supporting efficient delivery to tumor sites and effectively potentiating oncolytic viruses’ therapeutic efficacy.

“We see great potential in our SuperNova technology to address the vast unmet need for effective treatments of solid tumors,” said Dr. Boris Minev, President, Medical and Scientific Affairs at Calidi Biotherapeutics and a patent inventor. “Building on the initial clinical success of our autologous adipose-derived stem cells loaded with vaccinia oncolytic viruses, we look forward to submitting an IND to initiate our first-in-human clinical trial of this off-the-shelf allogeneic therapy, as we continue building our understanding of the safety and effectiveness of CLD-201 in patients with advanced solid tumors.”

About Calidi Biotherapeutics

Calidi Biotherapeutics (NYSE American: CLDI) is a clinical-stage immuno-oncology company with proprietary technology designed to arm the immune system to fight cancer. Calidi’s novel stem cell-based platforms are utilizing potent allogeneic stem cells capable of carrying payloads of oncolytic viruses for use in multiple oncology indications, including high-grade gliomas and solid tumors. Calidi’s clinical stage off-the-shelf, universal cell-based delivery platforms are designed to protect, amplify, and potentiate oncolytic viruses leading to enhanced efficacy and improved patient safety. Calidi’s preclinical off-the-shelf enveloped virotherapies are designed to target disseminated solid tumors. This dual approach can potentially treat, or even prevent, metastatic disease. Calidi Biotherapeutics is headquartered in San Diego, California. For more information, please visit www.calidibio.com.

Forward-Looking Statements

This press release may contain forward-looking statements for purposes of the “safe harbor” provisions under the United States Private Securities Litigation Reform Act of 1995. Terms such as “anticipates,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predicts,” “project,” “should,” “towards,” “would” as well as similar terms, are forward-looking in nature, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements include, but are not limited to, statements concerning upcoming key milestones (including the reporting of interim clinical results and the dosing of patients), planned clinical trials, and statements relating to the safety and efficacy of Calidi’s therapeutic candidates in development. Any forward-looking statements contained in this discussion are based on Calidi’s current expectations and beliefs concerning future developments and their potential effects and are subject to multiple risks and uncertainties that could cause actual results to differ materially and adversely from those set forth or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that Calidi is not able to raise sufficient capital to support its current and anticipated clinical trials, the risk that early results of clinical trials do not necessarily predict final results and that one or more of the clinical outcomes may materially change following more comprehensive review of the data, and as more patient data becomes available, the risk that Calidi may not receive FDA approval for some or all of its therapeutic candidates. Other risks and uncertainties are set forth in the section entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in the Company’s Registration Statements filed with the SEC on Form S-4 filed on August 2, 2023, on Form S-1 filed on October 6, 2023, on Form S-1 filed on January 29, 2024, as amended on February 7, 2024, on Form 10-K filed on March 15, 2024, and Final Prospectus filed on April 17, 2024.

For Investors and Media:

Stephen Thesing

IR@Calidibio.com


FAQ

What is the new patent issued to Calidi Biotherapeutics (CLDI) for?

Calidi Biotherapeutics (CLDI) has been issued U.S. Patent No. 12,036,278 titled 'Smallpox Vaccine for Cancer Treatment,' covering their SuperNova technology platform composed of adipose-derived mesenchymal stem cells loaded with oncolytic vaccinia virus.

How does the new patent strengthen Calidi Biotherapeutics' (CLDI) position?

The new patent strengthens Calidi Biotherapeutics' (CLDI) intellectual property portfolio and positions the company to advance its CLD-201 program into clinical trials. It broadens previously allowed claims to include 21 smallpox vaccine virus strains and 19 different stem cell types.

What is the potential benefit of Calidi Biotherapeutics' (CLDI) SuperNova platform?

Calidi Biotherapeutics' (CLDI) SuperNova platform has shown potential to shield viral payloads from the immune system, supporting efficient delivery to tumor sites and effectively potentiating oncolytic viruses' therapeutic efficacy in treating advanced solid tumors.

What are Calidi Biotherapeutics' (CLDI) plans for the CLD-201 program?

Calidi Biotherapeutics (CLDI) plans to submit an IND to initiate a first-in-human clinical trial of the off-the-shelf allogeneic therapy CLD-201 in patients with advanced solid tumors.

Calidi Biotherapeutics, Inc.

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Biotechnology
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