Calidi Biotherapeutics Announces FDA Clearance of the Northwestern University IND Application for CLD-101 Clinical Trial in High-Grade Glioma
Calidi Biotherapeutics (NYSE American: CLDI) announced FDA clearance of Northwestern University's IND application for CLD-101, a novel stem-cell based platform delivering oncolytic viruses to tumors. A Phase 1b/2 clinical trial for newly diagnosed high-grade glioma is expected to start in late 2024 at Northwestern University. The trial will evaluate safety and feasibility of multiple CLD-101 doses in addition to standard treatments.
A previous Phase 1 study at Northwestern showed promising results, with median progression-free survival of 9.05 months and overall survival of 18.4 months. CLD-101 is also being evaluated in a Phase 1 trial for recurrent high-grade glioma at City of Hope, with interim data expected in the first half of 2025. City of Hope received a $5.3 million grant from CIRM to support CLD-101 studies in ovarian cancer.
Calidi Biotherapeutics (NYSE American: CLDI) ha annunciato l'approvazione della FDA per la richiesta IND della Northwestern University per CLD-101, una piattaforma innovativa basata su cellule staminali che somministra virus oncolitici ai tumori. Un trial clinico di fase 1b/2 per gli gliomi ad alto grado diagnosticati recentemente è previsto per iniziare alla fine del 2024 presso la Northwestern University. Lo studio valuterà la sicurezza e la fattibilità di più dosi di CLD-101 oltre ai trattamenti standard.
Un precedente studio di fase 1 presso la Northwestern ha mostrato risultati promettenti, con una sopravvivenza libera da progressione mediana di 9,05 mesi e una sopravvivenza complessiva di 18,4 mesi. CLD-101 è anche in fase di valutazione in uno studio di fase 1 per gli gliomi ad alto grado recidivanti presso il City of Hope, con dati provvisori attesi nella prima metà del 2025. Il City of Hope ha ricevuto un finanziamento di 5,3 milioni di dollari da CIRM per supportare gli studi su CLD-101 nel cancro ovarico.
Calidi Biotherapeutics (NYSE American: CLDI) anunció la autorización de la FDA para la solicitud IND de la Universidad Northwestern para CLD-101, una plataforma innovadora basada en células madre que entrega virus oncolíticos a los tumores. Se espera que un ensayo clínico de fase 1b/2 para gliomas de alto grado diagnosticados recientemente comience a finales de 2024 en la Universidad Northwestern. El ensayo evaluará la seguridad y la viabilidad de múltiples dosis de CLD-101 además de los tratamientos estándar.
Un estudio previo de fase 1 en Northwestern mostró resultados prometedores, con una supervivencia libre de progresión mediana de 9.05 meses y una supervivencia global de 18.4 meses. CLD-101 también se está evaluando en un ensayo de fase 1 para gliomas de alto grado recurrentes en City of Hope, con datos interinos esperados en la primera mitad de 2025. City of Hope recibió una de CIRM para apoyar los estudios de CLD-101 en cáncer de ovario.
Calidi Biotherapeutics (NYSE American: CLDI)는 노스웨스턴 대학교의 IND 신청서에 대해 FDA의 승인을 발표했습니다. 이는 종양에 온콜리틱 바이러스를 전달하는 CLD-101라는 혁신적인 줄기세포 기반 플랫폼입니다. 신생 고등급 신경교종을 위한 1b/2상 임상 시험이 2024년 말 노스웨스턴 대학교에서 시작될 예정입니다. 이 시험은 표준 치료와 함께 CLD-101의 여러 용량의 안전성 및 실행 가능성을 평가할 것입니다.
노스웨스턴에서 진행된 이전의 1상 연구는 9.05개월의 중위 무진행 생존 기간과 18.4개월의 전체 생존 기간을 기록하며 유망한 결과를 보였습니다. CLD-101은 또한 City of Hope에서 재발한 고등급 신경교종에 대한 1상 임상 시험에서 평가되고 있으며, 2025년 상반기에 중간 데이터를 기대하고 있습니다. City of Hope는 CLD-101의 난소암 연구를 지원하기 위해 CIRM으로부터 $5.3백만의 보조금을 받았습니다.
Calidi Biotherapeutics (NYSE American: CLDI) a annoncé l'approbation de la FDA pour la demande IND de l'Université Northwestern concernant CLD-101, une plateforme innovante basée sur des cellules souches qui délivre des virus oncolytiques aux tumeurs. Un essai clinique de phase 1b/2 pour des gliomes de haut grade nouvellement diagnostiqués devrait commencer fin 2024 à l'Université Northwestern. L'essai évaluera la sécurité et la faisabilité de plusieurs doses de CLD-101 en plus des traitements standard.
Un précédent essai de phase 1 à Northwestern a montré des résultats prometteurs, avec une survie médiane sans progression de 9,05 mois et une survie globale de 18,4 mois. CLD-101 est également évalué dans un essai de phase 1 pour des gliomes de haut grade récidivants au City of Hope, avec des données intermédiaires attendues au premier semestre de 2025. Le City of Hope a reçu une subvention de 5,3 millions de dollars de la part de CIRM pour soutenir les études sur CLD-101 dans le cancer de l'ovaire.
Calidi Biotherapeutics (NYSE American: CLDI) hat die FDA-Genehmigung für den IND-Antrag der Northwestern University für CLD-101 bekannt gegeben, eine neuartige, auf Stammzellen basierende Plattform zur gezielten Abgabe von onkolytischen Viren an Tumoren. Eine Phase 1b/2 klinische Studie für neu diagnostizierte Hochgradgliome soll Ende 2024 an der Northwestern University beginnen. Die Studie wird die Sicherheit und Durchführbarkeit mehrerer Dosen von CLD-101 zusätzlich zu den Standardbehandlungen bewerten.
Eine frühere Phase-1-Studie an der Northwestern zeigte vielversprechende Ergebnisse, mit einer medianen progressionsfreien Überlebenszeit von 9,05 Monaten und einer Gesamtüberlebenszeit von 18,4 Monaten. CLD-101 wird auch in einer Phase-1-Studie für rezidivierende Hochgradgliome am City of Hope evaluiert, wobei interimistische Daten in der ersten Hälfte von 2025 erwartet werden. City of Hope erhielt einen Zuschuss in Höhe von 5,3 Millionen USD von CIRM zur Unterstützung der CLD-101-Studien bei Eierstockkrebs.
- FDA clearance for IND application of CLD-101 for high-grade glioma treatment
- Phase 1b/2 clinical trial expected to start in late 2024
- Previous Phase 1 study showed median progression-free survival of 9.05 months and overall survival of 18.4 months
- $5.3 million grant received from CIRM for CLD-101 studies in ovarian cancer
- None.
Insights
The FDA clearance of Northwestern University's IND application for Calidi's CLD-101 is a significant milestone in the development of novel treatments for high-grade glioma. This allogeneic immunotherapy utilizes neural stem cells to deliver engineered oncolytic adenoviruses, representing an innovative approach to targeting brain tumors.
Key points to consider:
- The upcoming Phase 1b/2 trial will evaluate multiple doses of CLD-101 in newly diagnosed high-grade glioma patients, potentially addressing a critical unmet need in neuro-oncology.
- Previous Phase 1 results showed promising safety and potential efficacy, with median progression-free survival of
9.05 months and overall survival of18.4 months. - The involvement of prominent researchers and institutions (Northwestern University, City of Hope) adds credibility to the project.
- Additional ongoing trials and funding support (e.g.,
$5.3 million CIRM grant for ovarian cancer studies) suggest broader potential applications for CLD-101.
While this news is encouraging, investors should note that the Phase 1b/2 trial is not expected to start until late 2024, with interim data from another ongoing trial expected in H1 2025. This timeline indicates a long-term investment horizon for potential returns.
The clearance of the IND application for CLD-101 in high-grade glioma treatment is a noteworthy development in neuro-oncology. High-grade gliomas, particularly glioblastoma, have dismal prognoses with current standard-of-care therapies, making new approaches crucial.
CLD-101's mechanism of action is particularly intriguing:
- Neural stem cells act as "Trojan horses" to deliver oncolytic viruses, potentially enhancing tumor penetration and reducing systemic toxicity.
- The combination with standard treatments (surgery, radiation, chemotherapy) suggests a multi-modal approach that could improve outcomes.
- The observed anti-tumor immune responses in the Phase 1 trial hint at potential immunomodulatory effects, which could be significant for long-term tumor control.
The
Trial will evaluate multiple doses of CLD-101 for the treatment of newly diagnosed high-grade glioma
CLD-101 is Calidi’s novel allogeneic immunotherapy utilizing neural stem cells to deliver engineered oncolytic adenoviruses
Phase 1b/2 trial expected to initiate in the first quarter of 2025
SAN DIEGO, Sept. 30, 2024 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics, Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology company developing a new generation of targeted antitumor virotherapies, today announced that the U.S. Food and Drug Administration (FDA) has cleared Northwestern University’s Investigational New Drug (IND) application for Calidi’s CLD-101. CLD-101 is a novel stem-cell based platform designed to deliver oncolytic viruses to tumors, enhancing their antitumor effects. The Phase 1b/2 clinical trial is expected to commence in late 2024 at Northwestern University.
The Phase 1b/2 open label study of CLD-101 will evaluate the safety and feasibility of administering multiple doses of CLD-101 in patients with newly diagnosed high-grade glioma. Eligible patients, with a confirmed biopsy diagnosis, will receive repeated doses of CLD-101 in addition to surgery, standard-of-care radiation therapy, and chemotherapy.
“This IND clearance marks an important achievement in the fight against high-grade glioma, one of the most challenging cancers to treat,” said Maciej S. Lesniak, MD, Chairman of the Department of Neurological Surgery at Northwestern University Feinberg School of Medicine and Member of Calidi’s Scientific and Medical Advisory Board. “Our research on the ability of stem cells to protect oncolytic viruses and deliver them to tumors suggests the potential of CLD-101 in the treatment of brain cancer. We are pleased to undergo this trial with Calidi, the licensee and manufacturer of CLD-101, and we look forward to advancing the clinical development of this novel treatment option for patients.”
Dr. Alfred Yung, Calidi Medical Advisory Board member and a Blue Ribbon Panel advisor to the White House Cancer Moonshot initiative, added, “I have been very impressed by Dr. Lesniak’s promising work in high-grade glioma patients using CLD-101 (NeuroNova), and I am very pleased by this FDA clearance, which enables this groundbreaking research to continue in further clinical trials.” Dr. Yung is also professor of Neuro-oncology at The University of Texas MD Anderson Cancer Center, where he held the Margaret and Ben Love Chair of Clinical Cancer Care and dual appointment as professor of Cancer Biology.
In 2021, a Phase 1 dose-escalation study of CLD-101 (NSC/CRAd-S-pk7) was completed at Northwestern University with newly diagnosed high-grade glioma patients. Following neurosurgical resection, CLD-101 was administered directly into the resection cavity walls. The trial results indicated that treatment was feasible and safe, with no formal dose-limiting toxicity observed. Moreover, anti-tumor immune responses were also observed. Results showed median progression-free survival of 9.05 months and overall survival was 18.4 months, with findings published in Lancet Oncology in 2021.
“The promising results from our previously completed trial with Northwestern University demonstrated the safety and potential efficacy of CLD-101 in patients with newly diagnosed high-grade glioma, a notoriously difficult to treat cancer with a five-year survival rate in adults of just 5 to 10 percent,” said Allan Camaisa, CEO and Chairman of the Board of Calidi. “Encouraged by these results, we continue to believe that CLD-101 offers a novel therapeutic option for patients with high-grade glioma. Calidi remains committed to fighting all cancers and developing our novel immunotherapies to target some of the most difficult-to-treat tumor types.”
CLD-101 is also being evaluated in a Phase 1 trial in collaboration with City of Hope, a non-profit clinical research center, for recurrent high-grade glioma patients. Calidi expects to report interim clinical data from the trial in the first half of 2025. City of Hope was awarded
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 (i) Form S-4 filed on August 2, 2023 and the corresponding prospectus filed on August 4, 2023, and (ii) on Form S-1 filed on April 15, 2024, and the Company’s periodic reports filed with the SEC on (i) Form 10-K filed on March 15, 2024, (ii) Form 10-Q filed on May 14, 2024, and (iii) Form 10-Q filed on August 13, 2024. These reports may be amended or supplemented by other reports we file with the SEC from time to time.
For Investors and Media:
Stephen Thesing
ir@calidibio.com
Source: Calidi Biotherapeutics, Inc.
FAQ
What is CLD-101 and how does it work in treating high-grade glioma?
When is the Phase 1b/2 clinical trial for CLD-101 (CLDI) expected to begin?
What were the results of the previous Phase 1 study of CLD-101 (CLDI) in high-grade glioma patients?
Is Calidi Biotherapeutics (CLDI) conducting any other trials with CLD-101?
