Calidi Biotherapeutics Announces Commencement of Recruitment for Multiple Dose CLD-101 Trial in Patients with Newly Diagnosed High Grade Glioma at Northwestern University Hospital
Calidi Biotherapeutics (NYSE American: CLDI) has announced the start of recruitment for a new CLD-101 clinical trial at Northwestern University Hospital. The trial will focus on patients with newly diagnosed high-grade glioma, an aggressive form of brain cancer. The company has completed shipping the first batch of CLD-101, which combines allogeneic neural stem cells with oncolytic adenovirus CRAd-S-pk7.
This Phase 1B/2 trial, led by Dr. Maciej Lesniak and Dr. Roger Stupp, will implement a multiple-dose regime, building upon a previous Phase 1 trial that showed promising results with single doses in 12 patients. The study has received NIH/NCI SPORE funding and aims to enhance therapeutic efficacy in newly diagnosed patients. The trial is particularly significant as it involves Dr. Stupp, known for developing the FDA-approved Stupp Protocol for Glioblastoma treatment.
Calidi Biotherapeutics (NYSE American: CLDI) ha annunciato l'inizio della reclutamento per un nuovo trial clinico CLD-101 presso l'Ospedale dell'Università Northwestern. Il trial si concentrerà su pazienti con diagnosi recente di glioma ad alto grado, una forma aggressiva di cancro al cervello. L'azienda ha completato la spedizione del primo lotto di CLD-101, che combina cellule staminali neurali allogeniche con l'adenovirus oncolitico CRAd-S-pk7.
Questo trial di Fase 1B/2, guidato dal Dr. Maciej Lesniak e dal Dr. Roger Stupp, implementerà un regime a dosi multiple, basandosi su un precedente trial di Fase 1 che ha mostrato risultati promettenti con dosi singole in 12 pazienti. Lo studio ha ricevuto finanziamenti NIH/NCI SPORE e mira a migliorare l'efficacia terapeutica nei pazienti recentemente diagnosticati. Il trial è particolarmente significativo in quanto coinvolge il Dr. Stupp, noto per aver sviluppato il Protocollo Stupp approvato dalla FDA per il trattamento del Glioblastoma.
Calidi Biotherapeutics (NYSE American: CLDI) ha anunciado el inicio del reclutamiento para un nuevo ensayo clínico CLD-101 en el Hospital de la Universidad Northwestern. El ensayo se centrará en pacientes con glioma de alto grado recién diagnosticado, una forma agresiva de cáncer cerebral. La empresa ha completado el envío del primer lote de CLD-101, que combina células madre neurales alogénicas con el adenovirus oncolítico CRAd-S-pk7.
Este ensayo de Fase 1B/2, dirigido por el Dr. Maciej Lesniak y el Dr. Roger Stupp, implementará un régimen de dosis múltiples, basándose en un ensayo previo de Fase 1 que mostró resultados prometedores con dosis únicas en 12 pacientes. El estudio ha recibido financiación de NIH/NCI SPORE y tiene como objetivo mejorar la eficacia terapéutica en pacientes recién diagnosticados. El ensayo es particularmente significativo ya que involucra al Dr. Stupp, conocido por desarrollar el Protocolo Stupp aprobado por la FDA para el tratamiento del Glioblastoma.
칼리디 생명과학(Calidi Biotherapeutics, NYSE American: CLDI)가 노스웨스턴 대학교 병원에서 새로운 CLD-101 임상 시험의 모집 시작을 발표했습니다. 이 시험은 공격적인 형태의 뇌암인 고등급 교모세포종으로 최근 진단받은 환자들에 초점을 맞출 것입니다. 회사는 동종 신경 줄기 세포와 온콜리틱 아데노바이러스 CRAd-S-pk7을 결합한 CLD-101의 첫 번째 배치 배송을 완료했습니다.
맥시엣 레스니악 박사와 로저 스투프 박사가 이끄는 이 1B/2상 시험은 다중 용량 요법을 시행하며, 12명의 환자에게 단일 용량으로 유망한 결과를 보여준 이전의 1상 시험을 기반으로 합니다. 이 연구는 NIH/NCI SPORE 자금을 받았으며, 최근 진단받은 환자에서 치료 효과를 향상시키는 것을 목표로 하고 있습니다. 이 시험은 스투프 박사가 참여하고 있어 특히 중요하며, 그는 교모세포종 치료를 위한 FDA 승인 스투프 프로토콜을 개발한 것으로 알려져 있습니다.
Calidi Biotherapeutics (NYSE American: CLDI) a annoncé le début du recrutement pour un nouvel essai clinique CLD-101 à l'Hôpital de l'Université Northwestern. L'essai se concentrera sur des patients récemment diagnostiqués avec un gliome de haut grade, une forme agressive de cancer du cerveau. L'entreprise a terminé l'expédition du premier lot de CLD-101, qui combine des cellules souches neurales allogéniques avec le virus oncolytique CRAd-S-pk7.
Ce essai de Phase 1B/2, dirigé par le Dr. Maciej Lesniak et le Dr. Roger Stupp, mettra en œuvre un régime de doses multiples, s'appuyant sur un essai de Phase 1 précédent qui a montré des résultats prometteurs avec des doses uniques chez 12 patients. L'étude a reçu un financement NIH/NCI SPORE et vise à améliorer l'efficacité thérapeutique chez les patients récemment diagnostiqués. L'essai est particulièrement significatif car il implique le Dr. Stupp, connu pour avoir développé le Protocole Stupp, approuvé par la FDA, pour le traitement du Glioblastome.
Calidi Biotherapeutics (NYSE American: CLDI) hat den Start der Rekrutierung für eine neue CLD-101 klinische Studie am Northwestern University Hospital bekannt gegeben. Die Studie wird sich auf Patienten mit neu diagnostiziertem hochgradigem Gliom konzentrieren, einer aggressiven Form von Hirnkrebs. Das Unternehmen hat den Versand der ersten Charge von CLD-101 abgeschlossen, das allogene neuronale Stammzellen mit dem onkolytischen Adenovirus CRAd-S-pk7 kombiniert.
Diese Phase 1B/2-Studie, die von Dr. Maciej Lesniak und Dr. Roger Stupp geleitet wird, wird ein Mehrdosenregime implementieren, das auf einer vorherigen Phase 1-Studie basiert, die vielversprechende Ergebnisse mit Einzeldosen bei 12 Patienten zeigte. Die Studie hat NIH/NCI SPORE-Finanzierung erhalten und zielt darauf ab, die therapeutische Wirksamkeit bei neu diagnostizierten Patienten zu verbessern. Die Studie ist besonders bedeutend, da Dr. Stupp beteiligt ist, der für die Entwicklung des von der FDA genehmigten Stupp-Protokolls zur Behandlung von Glioblastom bekannt ist.
- Previous Phase 1 trial results were significant enough to be published in The Lancet Oncology
- Trial received funding support from NIH/NCI SPORE
- Study led by prominent experts, including developer of FDA-approved Stupp Protocol
- Multiple-dose regime could potentially improve efficacy compared to single-dose treatment
- None.
Insights
The commencement of CLD-101's multiple-dose trial represents a pivotal advancement in Calidi's clinical program, with several key strategic elements that enhance its potential for success. The shift from single to multiple doses in newly diagnosed high-grade glioma patients is particularly significant - early intervention with repeated treatments could substantially improve efficacy compared to the previous single-dose approach in recurrent patients.
The trial's leadership adds considerable credibility to the program. Dr. Stupp's involvement is particularly noteworthy as the developer of the current standard-of-care treatment for glioblastoma (the 'Stupp Protocol'). His participation suggests confidence in CLD-101's potential to improve upon existing treatments. The NIH/NCI SPORE grant funding further validates the scientific merit of the approach, as these grants are highly competitive and undergo rigorous peer review.
The trial builds upon encouraging Phase 1 results that warranted publication in The Lancet Oncology, one of the most prestigious journals in oncology. The expansion to multiple doses in newly diagnosed patients addresses two critical aspects: optimal timing of intervention and potential for enhanced therapeutic effect through repeated treatments. This approach could significantly improve the probability of clinical success.
From a portfolio perspective, Calidi is strategically positioning itself in the high-value glioblastoma market while developing a broader platform for solid tumors and metastatic cancer. The company's dual focus on both direct tumor delivery (CLD-101) and systemic administration platforms demonstrates a comprehensive approach to cancer treatment, potentially expanding their market opportunity beyond brain tumors.
SAN DIEGO, Feb. 24, 2025 (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 Northwestern University/Northwestern Memorial Hospital is starting recruitment for the CLD-101 clinical trial of its immunotherapy product.
Calidi Biotherapeutics has completed the shipment of the first batch of CLD-101, which comprises allogeneic neural stem cells loaded with the oncolytic adenovirus CRAd-S-pk7. This batch will support a new clinical trial in patients with newly diagnosed high-grade glioma, an aggressive and often fatal form of brain cancer.
This physician-led and NCI sponsored clinical trial, led by prominent experts Dr. Maciej Lesniak and Dr. Roger Stupp, represents a major step forward in cancer therapy. Building on the promising results from a prior Phase 1 trial involving 12 patients treated with a single dose of CLD-101 published in the prestigious journal The Lancet Oncology, the upcoming Phase 1B/2 trial introduces multiple doses of CLD-101 regime in newly diagnosed patients, aiming to enhance therapeutic efficacy and improve patient outcomes.
“I am extremely excited about the commencement of recruitment for the multiple dose CLD-101 trial in newly diagnosed HGG patients. This increases the probability of success due to the improved treatment regimen initiated as early as possible in this devastating disease,” said Dr. Lesniak, chairman of the Department of Neurological Surgery at Northwestern University’s Feinberg School of Medicine. The trial has been granted funding by the NIH/NCI SPORE to support this pioneering study.
Both Dr. Lesniak and Dr. Stupp bring a wealth of experience in treating brain tumors. Dr. Stupp is globally recognized for developing the FDA-approved Stupp Protocol, a treatment that transformed Glioblastoma care.
“We are proud to have assembled a world-class team of surgeons and neuro-oncologists to lead this trial,” said Allan Camaisa, Chief Executive Officer and Chairman at Calidi Biotherapeutics. “Should the results of this trial demonstrate treatment outcomes consistent with the previous study, now in a larger patient group and with multiple doses of CLD-101, the implications could be transformative for the treatment of brain tumors. Together with our systemic, enveloped virus platform, I believe we are developing a portfolio of products to address glioblastoma, solid tumors and metastatic cancer.”
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, (iii) Form 10-Q filed on August 13, 2024, and (iv) Form 10-Q filed on November 12, 2024. These reports may be amended or supplemented by other reports we file with the SEC from time to time.
Corporate Communications:
Dave Gentry, CEO
RedChip Companies, Inc.
1-407-644-4256
CLDI@redchip.com
Source: Calidi Biotherapeutics, Inc.
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