A Phase I Study of Repeated Neural Stem Cell Based Virotherapy in Combination With N-Acetylcysteine Amid (NACA) and Standard Radiation and Chemotherapy for Newly Diagnosed High Grade Glioma

The goal of this clinical trial is to learn about the safety and feasibility of administering repeated doses of neural stem cell (NSC)-conditionally replicative adenovirus (CRAd)-survivin (S)-protomer (p)k7, in persons with newly diagnosed high grade glioma.
The main questions it aims to answer are:
whether multiple doses of NSC-CRAd-S-pk7 are safe and feasible
how multiple doses of NSC-CRAd-S-pk7 influence tumor response, overall survival, time to tumor progression, and quality of life.
Participants will:
undergo a biopsy to confirm high grade glioma, then receive the first dose of NSC-CRAd-S-pk7 into the brain
about 2 weeks later, undergo surgery to remove the tumor and receive the second dose of NSC-CRAd-S-pk7 into the brain
start chemoradiation about 2 weeks after surgery, then about 2 weeks later, receive the 3rd dose of NSC-CRAd-S-pk7 into the brain
four weeks later, at the end of chemoradiation, receive a fourth dose of NSC-CRAd-S-pk7 into the brain.
after radiation is finished, receive standard of care chemotherapy and tumor-treating fields. Two additional doses of NSC-CRAd-S-pk7 will be given every 4 weeks.
Every other patient enrolled will receive N-acetylcysteine amide (NACA), from registration until the day prior to surgery and the second dose of NSC-CRAd-S-pk7.

开始日期2024-06-01

申办/合作机构

Northwestern University

NCT03072134 / Completed临床1期IIT

Neural Stem Cell Oncolytic Adenoviral Virotherapy of Newly Diagnosed Malignant Glioma

Malignant gliomas have a very poor prognosis with median survival measured in months rather than years. It is a disease in great need of novel therapeutic approaches. Based on the encouraging results of our preclinical studies which demonstrate improved efficacy without added toxicity, the paradigm of delivering a novel oncolytic adenovirus via a neural stem cell line in combination with radiation and chemotherapy is well-suited for evaluation in newly diagnosed malignant gliomas. The standard-of-care allows application of virotherapy as neoadjuvant therapy and assessment of the cooperative effects with radiation/chemotherapy without altering the standard treatment.

开始日期2017-04-24

申办/合作机构

Northwestern University

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项与 Neural Stem Cell Oncolytic Adenoviral Virotherapy(Northwestern University) 相关的文献（医药）

2019-03-01·Molecular Therapy - Oncolytics2区 · 医学

Enhanced Delivery of Oncolytic Adenovirus by Neural Stem Cells for Treatment of Metastatic Ovarian Cancer

2区 · 医学

ArticleOA

作者: Mooney, Rachael ; Machado, Diana ; Lesniak, Maciej S ; Batalla-Covello, Jennifer ; Tirughana, Revathiswari ; Aboody, Karen S ; Majid, Asma Abdul ; Liu, Xueli ; Curiel, David T ; Gonzaga, Joanna ; Hammad, Mohamed

Oncolytic virotherapy is a promising approach for treating recurrent and/or drug-resistant ovarian cancer. However, its successful application in the clinic has been hampered by rapid immune-mediated clearance or neutralization of the virus, which reduces viral access to tumor foci. To overcome this barrier, patient-derived mesenchymal stem cells have been used to deliver virus to tumors, but variability associated with autologous cell isolations prevents this approach from being broadly clinically applicable. Here, we demonstrate the ability of an allogeneic, clonal neural stem cell (NSC) line (HB1.F3.CD21) to protect oncolytic viral cargo from neutralizing antibodies within patient ascites fluid and to deliver it to tumors within preclinical peritoneal ovarian metastases models. The viral payload used is a conditionally replication-competent adenovirus driven by the survivin promoter (CRAd-S-pk7). Because the protein survivin is highly expressed in ovarian cancer, but not in normal differentiated cells, viral replication should occur selectively in ovarian tumor cells. We found this viral agent was effective against cisplatin-resistant ovarian tumors and could be used as an adjunct treatment with cisplatin to decrease tumor burden without increasing toxicity. Collectively, our data suggest NSC-delivered CRAd-S-pk7 virotherapy holds promise for improving clinical outcome, reducing toxicities, and improving quality of life for patients with advanced ovarian cancer.

2016-12-01·Journal of Translational Medicine2区 · 医学

Single dose GLP toxicity and biodistribution study of a conditionally replicative adenovirus vector, CRAd-S-pk7, administered by intracerebral injection to Syrian hamsters

2区 · 医学

ArticleOA

作者: Auffinger, Brenda ; Chang, Alan L ; Kanojia, Deepak ; Qiao, Jian ; Zhang, Lingjiao ; Kane, Joshua Robert ; Miska, Jason ; Ahmed, Atique U ; Spencer, Drew A ; Young, Jacob S ; Strong, Theresa V ; Wu, Meijing ; Kim, Julius Woongki ; Mann, Jill F ; Lesniak, Maciej S ; Aboody, Karen S ; Hébert, Charles D

BACKGROUNDCRAd-S-pk7 is a conditionally replicative oncolytic adenoviral vector that contains a survivin promoter and a pk7 fiber modification that confer tumor-specific transcriptional targeting and preferential replication in glioma while sparing the surrounding normal brain parenchyma.METHODSThis IND-enabling study performed under GLP conditions evaluated the toxicity and biodistribution of CRAd-S-pk7 administered as a single intracerebral dose to Syrian hamsters, a permissive model of adenoviral replication. Two hundred and forty animals were stereotactically administered either vehicle (n = 60) or CRAd-S-pk7 at 2.5 × 10(7), 2.5 × 10(8), or 2.5 × 10(9) viral particles (vp)/animal (each n = 60) on day 1. The animals were closely monitored for toxicology evaluation, assessment of viral distribution, and immunogenicity of CRAd-S-pk7.RESULTSChanges in hematology, clinical chemistry, and coagulation parameters were minor and transient, and consistent with the inflammatory changes observed microscopically. These changes were considered to be of little toxicological significance. The vector remained localized primarily in the brain and to some degree in the tissues at the incision site. Low levels of vector DNA were detected in other tissues in a few animals suggesting systemic circulation of the virus. Viral DNA was detected in brains of hamsters for up to 62 days. However, microscopic changes and virus-related toxicity to the central nervous system were considered minor and decreased in incidence and severity over time. Such changes are not uncommon in studies using adenoviral vectors.CONCLUSIONThis study provides safety and toxicology data justifying a clinical trial of CRAd-S-pk7 loaded in FDA-approved HB1.F3.CD neural stem cell carriers administered at the tumor resection bed in humans with recurrent malignant glioma.

2015-08-01·EBioMedicine1区 · 医学

Neural Stem Cell Carriers for the Treatment of Glioblastoma Multiforme

1区 · 医学

ReviewOA

作者: Lesniak, Maciej S ; Miska, Jason

Grade IV astrocytoma, termed glioblastoma multiforme (GBM) is one the most aggressive malignancies known to man. Despite intensive therapies, the median survival has remained approximately 15 months. One of the major challenges to the treatment of CNS malignancies is the blood brain barrier (BBB). The barrier is designed to be incredibly selective, which means few therapeutics given to patients will reliably arrive at the site of the malignancy. To overcome the BBB and low blood flow that tends to occur within these tumors, various biodegradable materials, polymers and nanoparticles that can slowly release therapeutics at the site of the tumor have been developed. In the past, various chemotherapies have been attempted to be delivered in this way (Kane et al., 2015). The major problem with direct treatment of tumors is the low amount of diffusion and inefficient delivery of therapeutics. There have been attempts at enhanced delivery using convection based therapies, which until this point have not generated significant survival advantage in patients. Furthermore, the diffuse nature of the tumor means it may spread far from the treatment site. It is for these reasons that a carrier with a high amount of versatility and tumor-homing capability is urgently needed. Beginning with a critical discovery in 2000, it was demonstrated that neural stem cells (NSCs) have intrinsic glioma-tropic properties, even to distant sites (Aboody et al., 2000). Since this initial finding, NSCs have been manipulated in a number of ways to elicit anti-cancer effects. First, NSCs can be engineered to produce different genes. In a pioneering preclinical study, Dr. Aboody's laboratory generated an NSC cell line carrying cytosine deaminase (CD). After systemic treatment with the pro-drug Gancyclovir (GCV), the suicide gene converts the GCV into its toxic di (and tri) phosphate form only where the NSCs have migrated. This has provided significant efficacy in a pre-clinical model of GBM while preventing off-target toxicity (Aboody et al., 2013). A phase I clinical trial utilizing this approach has recently completed accrual (Clinical Trial Identifier — NCT02015819). Other groups have generated NSC cell lines with other anti-cancer agents. NSCs expressing the anti-tumor molecule TRAIL (tumor necrosis factor-related apoptosis-inducing ligand) have recently come back into focus after groups have been able to sensitize glioblastoma cells to TRAIL using a number of novel compounds such as the cardiac glycoside lanatoside C and the histone deacetylase inhibitor MS-275 (TENG et al., 2014, Bagci-onder et al., 2013). Both therapies are thought to function by influencing alternative death receptor (DR) expression on the surface of glioblastoma cells, thus providing alternative targets for TRAIL induced cell death. Other than directly modifying the NSC, these cells can also be loaded with therapeutic cargo. Our group had previously loaded NSC with mesoporous nanoparticles containing doxorubicin, attached via a pH sensitive linker (Cheng et al., 2013). This targeted release of chemotherapeutics had significant impact on animal survival in a mouse model of glioma. Other nanoparticles have also been successfully loaded into NSC, for example another group loaded gold nanorods (AuNR) onto NSC carriers, which enhanced the distribution of the nanoparticles to the tumor tissue (Mooney et al., 2014). After treatment with near-infrared radiation, the gold nanoparticles convert light to tumor-killing heat, which therapeutic effect covers a significantly larger area than injection of particles alone. The use of NSC carriers has recently been extended into the loading of adenoviruses. By allowing either the infection or replication only within cancer cells, the use of recently developed conditionally targeted or replicative adenoviruses (CRAds) has become an attractive modality for treatment. This allows for a “1–2 punch” of both oncolysis and enhanced delivery of therapeutics, while also minimizing off-target toxicity. By loading a conditionally replicative adenovirus (CRAd-Survivin-pk7) onto NSC carriers, we have demonstrated enhanced anti-tumor efficacy compared to viral treatment alone (Ahmed et al., 2013). Previous studies have been performed to suggest this modality of CRAd delivery is efficacious and is currently planned for a phase-I clinical trial. The route of delivery of NSCs is critical for an efficacious therapy, because the amount of NSCs that can make it to the glioma tissue is highly dependent on their route of administration. In murine models of GBM, injection of NSCs contralateral to the tumor site causes their migration and efficient delivery of therapy (Ahmed et al., 2013). The problem in human patients is that intratumoral injections are invasive and troublesome for repeat injections. While intravenous administration of NSCs can still cause migration to the tumor site, the efficacy of this route remains controversial. Recently, as a way to curtail these limitations, it has been demonstrated that NSC can be delivered intra-nasally and efficiently migrate to the tumor tissues. The intranasal route allows for repeat administration and has higher amounts of NSC migration (Schmidt et al., 2014). These methods of direct treatment to the tumor have advanced significantly from simply administering drugs directly to the tumor site. Stem cells and the therapies they carry provide a powerful new platform for treating malignancies. The field of cellular carriers is still in its infancy, and there are still many obstacles to overcome for this therapy to become successful. It is important to note that the loading of adenoviruses into NSCs enhances survival in a murine model of glioma much better than virus loaded mesenchymal stem cells (MSC), both of which are tumor tropic carriers (Ahmed et al., 2011). This suggests that the trafficking efficacy of carriers might be closely linked to the similarity between the origin of the carrier and the malignancy. Substantial work needs to be done in understanding what causes different types of carriers to migrate to tissues differentially. With the results of some early clinical trials on the horizon, we will get a clearer picture of how efficacious NSCs are as carriers of therapeutics. Through the development of both increasingly specific therapeutics and better delivery systems, there is a hope that we will see dramatic enhancements in patient outcomes for this terrible disease.

项与 Neural Stem Cell Oncolytic Adenoviral Virotherapy(Northwestern University) 相关的新闻（医药）

2024-06-03

·BioSpace

Calidi Biotherapeutics Presents CLD-101 Phase 1 Trial Update and Preclinical Data Highlighting RTNova and CLD-201 at 2024 ASCO Annual Meeting

- NeuroNova (CLD-101) Phase 1 update highlights enrollment progress, safety and feasibility in delivering up to four weekly doses of CLD-101 - Showcased preclinical data on RTNova (CLD-400) platform’s ability to survive bloodstream and reach all tumors systemically - Non-clinical data supporting the upcoming SuperNova (CLD-201) clinical trial SAN DIEGO--(BUSINESS WIRE)-- Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology company developing a new generation of targeted immunotherapies, today announced the presentation of three abstracts in a poster session during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. These posters, presented on June 1, 2024, include an update from the City of Hope-led Phase 1 study of Calidi's CLD-101 program, and preclinical data surrounding Calidi’s RTNova (CLD-400) and CLD-201 platforms. “We are thrilled by the opportunity to present at ASCO and showcase the progress we have made across our various programs. Calidi’s cutting edge approach to antitumor virotherapy is evident through the entirety of our pipeline, and these data updates are reflective of the tireless work from our scientific team and collaborators” said Allan Camaisa, CEO and Chairman of the Board at Calidi Biotherapeutics. “In our CLD-101 program, NeuroNova’s safety and tolerability observed in the patients dosed thus far, reaffirms our belief in the combination of neural stem cells and antitumor viruses as a potentially transformative therapy for high-grade glioma patients. We are encouraged by the initial safety pro cohorts 2 and 3, enabling the ongoing recruitment and dosing of the fourth cohort. Along with our clinical progress, we continue to be excited by our novel preclinical programs, RTNova (CLD-400), and look forward to filing our IND application with the FDA on Supernova (CLD-201) for a future phase 1 clinical trial, with their potential ability to treat a diverse set of solid tumors.” Key highlights from the company’s three presentations at ASCO are below: Poster Title: Phase 1 study of multiple intracerebral doses of a neural stem cell-based oncolytic virotherapy for treatment of recurrent high-grade gliomas Abstract Number: TPS2102 Session Title: Central Nervous System Tumors CLD-101 is a cutting-edge therapeutic candidate in Calidi’s NeuroNova program, comprising tumor-tropic neural stem cells (NSCs) that deliver an oncolytic adenovirus – CRAd-S-pk7 – selectively to tumor sites. The study focuses on the safety and feasibility of delivering up to four weekly intracerebral doses of CRAd-S-pk7 to patients with recurrent high-grade gliomas. All participants receive a uniform dose of 1.50 x 108 NSCs and 1.875 x 1011 viral particles, the maximum feasible dose from the initial human study. Secondary objectives for the study include assessing the biological activity, biodistribution, immunogenicity, safety, and preliminary clinical efficacy of CRAd-S-pk7. The initial patient began treatment in May 2023. Currently, three patients in Treatment Schedule 2 and three in Treatment Schedule 3 have been enrolled and treated safely. Calidi is currently enrolling patients in Treatment Schedule 4. Poster Title: Transforming tumor immune microenvironments with a novel systemic enveloped oncolytic virotherapy targeting all tumor sites Abstract Number: 2559 Session Title: Developmental Therapeutics – Immunotherapy Calidi’s RTNova (CLD-400) systemic antitumor virotherapy platform is a novel tumor-selective vaccinia virus strain, a program designed to target all tumor sites and capable of producing a high amount of enveloped vaccinia viruses (envRTs) resistant to humoral immunity. The technology allows the therapy to reach every tumor systemically, killing tumor cells, and expressing any desired protein within the tumor, thus modifying the tumor microenvironment. In preclinical murine models, envRT-01 targeted multiple tumor types and led to tumor growth inhibition with a single systemic injection of 4.5e6 PFU env-RT-01 envRT-01 induced changes in tumor immune microenvironment, targeted lung cancer and metastatic sites, and induced dramatic changes in lung metastasis tumor microenvironments. Poster Title: Non-clinical evidence supporting the upcoming SuperNova (CLD-201) clinical trial: Cell-based oncolytic virotherapy for multiple solid tumors Abstract Number: 2553 Session Title: Developmental Therapeutics – Immunotherapy Animals treated with the maximum tolerated dose of 2e6 PU/animal showed no signs of adverse toxicity and exhibited a reduction in tumor volume compared to the control group. No toxicity findings were associated with CLD-201 in the disease-free model, and additionally, virus detection in the lungs was cleared within two weeks following the last CLD-201 treatment. CLD-201 induced potent cytolysis across multiple cancer types in in-vitro models. Local administration of CLD-201 induced both robust local and systemic immune cell infiltration. Calidi is expecting to initiate a Phase 1 non-randomized trial to assess the safety and initial anti-tumor effects of CLD-201 administered intratumorally. Copies of the posters are available on the Publications section of Calidi’s website. 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 . 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.

临床1期免疫疗法ASCO会议临床结果

2024-03-11

·BioSpace

Calidi Biotherapeutics and City of Hope Announce Funding from the California Institute for Regenerative Medicine (CIRM) to Advance CLD-101 (NeuroNova) in Ovarian Cancer

City of Hope was awarded $5.3 million from CIRM to develop a treatment for metastatic ovarian cancer using Calidi’s licensed lead asset, CLD-101. The grant highlights CIRM’s continued support of novel platforms targeting a variety of invasive and metastatic cancers. SAN DIEGO & LOS ANGELES--(BUSINESS WIRE)-- Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology company developing a new generation of targeted oncolytic virotherapies, and City of Hope, one of the largest cancer research and treatment organizations in the United States, today jointly announced that the California Institute for Regenerative Medicine (CIRM) has awarded Karen Aboody, M.D., City of Hope professor in the Department of Stem Cell Biology and Regenerative Medicine and Division of Neurosurgery, a $5.3 million grant to fund preclinical translational studies, product manufacturing, and clinical trial design using Calidi’s licensed oncolytic virotherapy product, CLD-101, in patients with chemo-resistant, metastatic ovarian cancer. CLD-101 is the lead therapeutic candidate in Calidi’s NeuroNova program, comprising tumor-tropic neural stem cells (NSCs) that deliver an oncolytic adenovirus (NSC-CRAd-S-pk7) selectively to tumor sites. 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 San Diego, California. For more information, please visit . 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 U.S. and one of the leading research centers for diabetes and other life-threatening illnesses. City of Hope research has been the basis for numerous breakthrough cancer medicines, as well as human synthetic insulin and monoclonal antibodies. With an independent, National Cancer Institute-designated comprehensive cancer center at its core, City of Hope brings a uniquely integrated model to patients spanning cancer care, research and development, academics and training, and innovation initiatives. City of Hope’s growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and treatment facilities in Atlanta, Chicago and Phoenix. City of Hope’s affiliated group of organizations includes Translational Genomics Research Institute and AccessHopeTM. For more information about City of Hope, follow us on Facebook, Twitter, YouTube, Instagram and LinkedIn. About the California Institute for Regenerative Medicine (CIRM) At CIRM, we never forget that we were created by the people of California to accelerate stem cell treatments to patients with unmet medical needs, and act with a sense of urgency to succeed in that mission. To meet this challenge, our team of highly trained and experienced professionals actively partners with both academia and industry in a hands-on, entrepreneurial environment to fast track the development of today’s most promising stem cell technologies. With $5.5 billion in funding and more than 150 active stem cell programs in our portfolio, CIRM is one of the world’s largest institutions dedicated to helping people by bringing the future of cellular medicine closer to reality. For more information go to . 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: Contacts 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. View this news release online at:

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100 项与 Neural Stem Cell Oncolytic Adenoviral Virotherapy(Northwestern University) 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
高级别胶质瘤	临床1期	-	Northwestern University	2024-06-01
多形性胶质母细胞瘤	药物发现	美国	National Cancer Institute	2017-04-24
少突神经胶质瘤	药物发现	美国	National Cancer Institute	2017-04-24
WHO III 级混合胶质瘤	药物发现	美国	National Cancer Institute	2017-04-24