Calidi Biotherapeutics and City of Hope Announce Funding from the California Institute for Regenerative Medicine (CIRM) to Advance CLD-101 (NeuroNova) in Ovarian Cancer
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The $5.3 million grant from the California Institute for Regenerative Medicine (CIRM) to fund preclinical translational studies and clinical trial design for Calidi Biotherapeutics' CLD-101 represents a significant investment in the advancement of oncolytic virotherapy for metastatic ovarian cancer. The funding is not only indicative of the potential of CLD-101 as a therapeutic option but also underscores the importance of developing treatments for chemo-resistant cancers, which remain a major challenge in oncology.
Oncolytic virotherapy is a promising field where viruses are genetically engineered to kill cancer cells while sparing healthy cells, potentially offering a more targeted approach than traditional chemotherapy. CLD-101's use of neural stem cells to deliver the oncolytic adenovirus directly to tumor sites is particularly innovative, as it leverages the tumor-tropic properties of these cells. This could lead to more effective localization of the therapy and potentially enhance the immune response against the cancer.
From a research perspective, the outcomes of the upcoming clinical trials will be crucial in determining the efficacy and safety of CLD-101. Positive results could lead to a new treatment paradigm for patients with stage III ovarian cancer. However, it is important to note that the path from preclinical studies to FDA approval is fraught with challenges and many therapeutic candidates fail to demonstrate sufficient clinical benefits or present unforeseen adverse effects.
The financial support from CIRM for Calidi Biotherapeutics indicates a strong vote of confidence in the company's technology and its potential market impact. The focus on a next-generation manufacturing process and potency optimization for CLD-101 could result in higher yields and improved therapeutic activity, which are critical factors in the commercial viability of biopharmaceutical products.
For investors, the progress of CLD-101 through preclinical studies and into clinical trials is a key milestone to monitor. Successful trials could significantly enhance Calidi's market position and potentially lead to partnerships or acquisitions. However, investors should also be aware of the risks inherent in biotech investing, particularly in the clinical-stage development phase. Regulatory hurdles, competition from other treatments and the complex nature of cancer biology all pose potential challenges to the realization of returns on investment.
Calidi's track record of securing multiple grants from CIRM suggests a sustained level of institutional support, which can be favorable for long-term investors. Nevertheless, market reactions to these developments will depend on continuous updates and results from the clinical trials, with particular attention to be paid to the clinical update expected in the first half of 2024.
Metastatic ovarian cancer remains one of the most challenging malignancies to treat, with limited options available for patients who develop resistance to chemotherapy. The development of CLD-101 by Calidi Biotherapeutics, in collaboration with City of Hope, represents a significant stride in addressing this unmet medical need. The mechanism of action, which involves using neural stem cells to deliver an oncolytic virus to the tumor site, is a novel approach that could potentially overcome the limitations of current treatments.
The clinical implications of such a treatment are profound, especially if it demonstrates an ability to stimulate a systemic immune response against the tumor. The potential to improve clinical outcomes for women with stage III ovarian cancer is considerable, given the poor prognosis associated with this stage of the disease. However, it is imperative to approach these developments with cautious optimism until the clinical data confirms the safety and efficacy of the treatment.
The CIRM grant not only aids in the advancement of the CLD-101 program but also highlights the importance of funding innovative cancer treatments. As a medical professional, the prospect of introducing a new oncolytic virotherapy into the treatment landscape for ovarian cancer is encouraging, but it is equally important to ensure that such treatments are accessible and cost-effective for patients upon approval.
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City of Hope was awarded
$5.3 million - The grant highlights CIRM’s continued support of novel platforms targeting a variety of invasive and metastatic cancers.
Aboody and her team have been key collaborators with Calidi over the past four years, and Calidi’s knowledge and expertise has enhanced key attributes of the CLD-101 program, in particular Calidi’s next generation manufacturing process and potency optimization, leading to higher yields and improved oncolytic activity of the CLD-101 product for use in high-grade glioma, and now ovarian cancer. This proposed CLD-101 treatment utilizes a neural stem cell line to deliver an oncolytic adenovirus directly to abdominal ovarian tumor sites. The virus infects and kills the tumor cells, even if they are chemo-resistant, which then stimulates the patient’s immune system to infiltrate, recognize, and fight the tumor. In collaboration with Calidi, Aboody will lead the groundbreaking work.
“We are delighted to receive this financial support from CIRM, which enables us to complete the preclinical translational studies, product manufacturing, and clinical trial design needed for FDA approval to move this novel treatment to ovarian cancer patients within two to three years. This CIRM grant will allow us to further utilize Calidi’s manufacturing processes, which we believe will optimize the potency of the CLD-101 oncolytic virotherapy treatment product, and improve clinical outcomes for women with stage III ovarian cancer,” said Aboody.
“This is the third grant from CIRM supporting the development of Calidi’s assets, further validating our novel cell therapy platforms and their versatility for multiple cancer indications,” said Allan Camaisa, CEO and Chairman of the Board of Calidi Biotherapeutics. “We have been focused on enhanced cell manufacturing processes and providing novel options to patients with a variety of serious cancers, and we are grateful for the continued support from CIRM, as we advance our clinical programs.”
In July 2023, Calidi announced the dosing of the first patient in a City of Hope Phase 1 clinical trial evaluating CLD-101 in recurrent high-grade glioma patients. The company expects to provide a clinical update in the first half of 2024. Additionally, a previously completed Phase 1 dose escalation trial assessed the safety of a single dose of CLD-101 administered into the walls of the surgical resection cavity, in newly diagnosed high-grade glioma patients. In this trial, CLD-101 demonstrated safety and the stimulation of an anti-tumor response, with results published in Lancet Oncology.
For more information about this trial, click here or contact fbidmeshki@coh.org or (626) 218-4062.
Aboody has financial interest in and is a paid advisory board member for Calidi Biotherapeutics.
About CLD-101
The CLD-101 platform, which includes NSC-CRAd-S-pk7, is an allogeneic, “off-the-shelf” therapy comprised of an immortalized NSC line loaded with an engineered oncolytic adenovirus. In High Grade Glioma brain cancer patients, upon surgical resection of tumor, NSC-CRAd-S-pk7 is injected into the walls of the resection cavity. The anti-cancer virus it releases is expected to infect and kill any remaining tumor cells, which is also postulated to stimulate a tumor-specific immune response from the patient. Calidi holds an exclusive worldwide licensing agreement covering the NSC-CRAd-S-pk7 technology.
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
About City of Hope
City of Hope's mission is to deliver the cures of tomorrow to the people who need them today. Founded in 1913, City of Hope has grown into one of the largest cancer research and treatment organizations in the
About the California Institute for Regenerative Medicine (CIRM)
At CIRM, we never forget that we were created by the people of
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, 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 10-Q filed on November 14, 2023, and on Form S-1 filed on January 29, 2024, as amended on February 7, 2024.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240311590774/en/
For Investors:
Stephen Jasper
Gilmartin Group
stephen@gilmartinir.com
For Media:
Calidi Biotherapeutics
Stephen Thesing
ir@calidibio.com
City of Hope:
Letisia Marquez
lemarquez@coh.org
Source: Calidi Biotherapeutics, Inc.
FAQ
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