Calidi Biotherapeutics and City of Hope Provide Update on a Phase 1 Clinical Trial with CLD-101 Virotherapy in Patients with Recurrent High-Grade Glioma
Calidi Biotherapeutics (NYSE: CLDI) and City of Hope have reported progress on their Phase 1 clinical trial evaluating CLD-101, a neural stem cell-based oncolytic virotherapy for recurrent high-grade glioma. The trial, which is the first to assess a multiple-dose regimen of this novel treatment, has successfully treated 14 participants with up to four weekly intracerebral doses.
The study, supported by a $12 million award from the California Institute for Regenerative Medicine (CIRM), is currently enrolling participants for the highest treatment schedule. Dr. Jana Portnow, co-director of City of Hope's Brain Tumor Program and principal investigator, reported that all treatments have been well-tolerated.
The trial has expanded to include Northwestern University Feinberg School of Medicine and Stanford University Hospitals. The technology, licensed from the University of Chicago on behalf of City of Hope and University of Alabama, aims to improve clinical outcomes using stem cell technology to deliver oncolytic virus payloads to cancer sites.
Calidi Biotherapeutics (NYSE: CLDI) e City of Hope hanno riportato progressi nel loro studio clinico di Fase 1 che valuta CLD-101, una viroterapia oncolitica basata su cellule staminali neurali per il glioma ricorrente di alto grado. Lo studio, che è il primo a valutare un regime di dosaggio multiplo di questo nuovo trattamento, ha trattato con successo 14 partecipanti con fino a quattro dosi intracerebrali settimanali.
La ricerca, supportata da un finanziamento di 12 milioni di dollari dal California Institute for Regenerative Medicine (CIRM), sta attualmente reclutando partecipanti per il regime di trattamento più elevato. La Dott.ssa Jana Portnow, co-direttore del Programma Tumori Cerebrali di City of Hope e ricercatrice principale, ha riportato che tutti i trattamenti sono stati ben tollerati.
Lo studio si è ampliato per includere Northwestern University Feinberg School of Medicine e Stanford University Hospitals. La tecnologia, concessa in licenza dall'Università di Chicago per conto di City of Hope e dell'Università dell'Alabama, mira a migliorare i risultati clinici utilizzando la tecnologia delle cellule staminali per consegnare carichi virali oncolitici ai siti tumorali.
Calidi Biotherapeutics (NYSE: CLDI) y City of Hope han informado sobre el progreso de su ensayo clínico de Fase 1 que evalúa CLD-101, una viroterapia oncolítica basada en células madre neuronales para glioma de alto grado recurrente. El ensayo, que es el primero en evaluar un régimen de dosis múltiples de este nuevo tratamiento, ha tratado con éxito a 14 participantes con hasta cuatro dosis intracerebrales semanales.
El estudio, apoyado por un premio de 12 millones de dólares del California Institute for Regenerative Medicine (CIRM), está actualmente reclutando participantes para el régimen de tratamiento más alto. La Dra. Jana Portnow, co-directora del Programa de Tumores Cerebrales de City of Hope y principal investigadora, informó que todos los tratamientos han sido bien tolerados.
El ensayo se ha expandido para incluir a Northwestern University Feinberg School of Medicine y Stanford University Hospitals. La tecnología, licenciada de la Universidad de Chicago en nombre de City of Hope y la Universidad de Alabama, tiene como objetivo mejorar los resultados clínicos utilizando la tecnología de células madre para entregar cargas virales oncolíticas a los sitios de cáncer.
Calidi Biotherapeutics (NYSE: CLDI)와 City of Hope는 재발성 고등급 신경교종을 위한 신경 줄기 세포 기반의 온콜리틱 바이로테라피인 CLD-101을 평가하는 1상 임상 시험의 진행 상황을 보고했습니다. 이 시험은 이 새로운 치료법의 다중 용량 요법을 평가하는 첫 번째 시험으로, 최대 4회의 주간 뇌내 투여로 14명의 참가자를 성공적으로 치료했습니다.
이 연구는 캘리포니아 재생 의학 연구소(CIRM)로부터 1,200만 달러의 지원을 받아 현재 가장 높은 치료 일정에 참여할 참가자를 모집하고 있습니다. City of Hope의 뇌종양 프로그램 공동 책임자이자 주요 연구자인 자나 포트나우 박사는 모든 치료가 잘 견뎌냈다고 보고했습니다.
이 시험은 Northwestern University Feinberg School of Medicine과 Stanford University Hospitals를 포함하도록 확대되었습니다. 이 기술은 City of Hope와 앨라배마 대학교를 대신하여 시카고 대학교에서 라이센스를 받아, 줄기 세포 기술을 사용하여 암 부위에 온콜리틱 바이러스 화물을 전달하여 임상 결과를 개선하는 것을 목표로 하고 있습니다.
Calidi Biotherapeutics (NYSE: CLDI) et City of Hope ont rapporté des progrès dans leur essai clinique de Phase 1 évaluant CLD-101, une virothérapie oncolytique basée sur des cellules souches neurales pour le gliome à haut grade récurrent. L'essai, qui est le premier à évaluer un schéma de dosage multiple de ce nouveau traitement, a traité avec succès 14 participants avec jusqu'à quatre doses intracérébrales hebdomadaires.
L'étude, soutenue par une subvention de 12 millions de dollars du California Institute for Regenerative Medicine (CIRM), recrute actuellement des participants pour le schéma de traitement le plus élevé. Dr. Jana Portnow, co-directrice du programme de tumeurs cérébrales de City of Hope et investigatrice principale, a rapporté que tous les traitements ont été bien tolérés.
L'essai a été élargi pour inclure Northwestern University Feinberg School of Medicine et Stanford University Hospitals. La technologie, licenciée de l'Université de Chicago au nom de City of Hope et de l'Université de l'Alabama, vise à améliorer les résultats cliniques en utilisant la technologie des cellules souches pour délivrer des charges virales oncolytiques aux sites tumoraux.
Calidi Biotherapeutics (NYSE: CLDI) und City of Hope haben Fortschritte in ihrer Phase-1-Studie berichtet, die CLD-101, eine auf neuralen Stammzellen basierende onkolytische Virotherapie für wiederkehrendes hochgradiges Gliom, bewertet. Die Studie, die die erste ist, die ein Mehrdosisregime dieser neuartigen Behandlung bewertet, hat erfolgreich 14 Teilnehmer mit bis zu vier wöchentlichen intrazerebralen Dosen behandelt.
Die Studie wird durch einen 12 Millionen Dollar Zuschuss des California Institute for Regenerative Medicine (CIRM) unterstützt und rekrutiert derzeit Teilnehmer für den höchsten Behandlungsplan. Dr. Jana Portnow, Co-Direktorin des Gehirntumorprogramms von City of Hope und Hauptforscherin, berichtete, dass alle Behandlungen gut vertragen wurden.
Die Studie wurde erweitert, um Northwestern University Feinberg School of Medicine und Stanford University Hospitals einzubeziehen. Die Technologie, die im Namen von City of Hope und der University of Alabama von der University of Chicago lizenziert wurde, zielt darauf ab, klinische Ergebnisse zu verbessern, indem sie Stammzelltechnologie nutzt, um onkolytische Viruslasten an Krebsstellen zu liefern.
- All treatments well-tolerated in 14 patients
- Successfully progressing to highest treatment schedule
- Trial expanded to additional prestigious institutions
- Secured $12M CIRM funding support
- Early Phase 1 stage with no efficacy data reported yet
Insights
Calidi Biotherapeutics' Phase 1 clinical trial update for CLD-101 demonstrates encouraging progress in their neural stem cell-based oncolytic virotherapy program for recurrent high-grade glioma. The key positive signal is that the treatment has been well tolerated across all 14 patients treated to date - vital for a Phase 1 trial where safety is the primary endpoint.
The trial's advancement to the highest treatment schedule (cohort 4) without reported safety issues suggests a favorable tolerability profile, which is particularly significant for an intracerebral therapy. This progression through dose escalation without dose-limiting toxicities represents an important milestone for an experimental brain cancer treatment.
The expansion of the trial to additional prestigious institutions (Northwestern and Stanford) strengthens the study's credibility and broadens patient recruitment capabilities. The $12 million CIRM funding further validates the scientific approach.
For context, high-grade gliomas represent one of oncology's most difficult treatment challenges with extremely poor prognosis and therapeutic options. The ability to safely deliver multiple doses of an oncolytic virus directly to brain tumors could potentially address a critical unmet need.
While it's important to note that efficacy data hasn't been presented (expected in later-phase trials), Dr. Portnow's expressed optimism suggests potential preliminary signals worth pursuing. For Calidi, a company with only a
SAN DIEGO and LOS ANGELES, March 26, 2025 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics, Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology company developing a new generation of targeted antitumor virotherapies, and City of Hope, one of the largest and most advanced cancer research and treatment organizations in the United States, are pleased to jointly announce progress from a phase 1 clinical trial utilizing Calidi’s CLD-101 investigational agent (neural stem cell-based oncolytic virotherapy) that is administered intracerebrally. This trial is the first to evaluate the safety and therapeutic potential of a multiple-dose regimen of this novel virotherapy for recurrent high-grade glioma - among the most aggressive and deadly forms of brain cancer.
Conducted by City of Hope, which has a National Cancer Institute-designated Comprehensive Cancer Center known for its pioneering research, this physician-sponsored phase 1 trial is assessing the safety and feasibility of delivering up to four weekly intracerebral doses of CLD-101. To date, 14 participants have been treated and all treatment has been well tolerated. The study is currently enrolling participants to the highest treatment schedule.
“We are optimistic about the initial results in these first 14 patients. I am especially encouraged by cohort 4 as we keep enrolling participants in this highest treatment schedule,” said Dr. Jana Portnow, co-director of City of Hope’s Brain Tumor Program and the trial’s principal investigator. This clinical trial is now also open at Northwestern University Feinberg School of Medicine and Stanford University Hospitals, both globally recognized institutions in cancer research and treatment.
Dr. Karen Aboody, City of Hope professor in the Department of Stem Cell Biology and Regenerative Medicine, Division of Neurosurgery, has played a critical role in developing this approach alongside Dr. Portnow. Their collaboration secured a
“We are dedicated to improving clinical outcomes of cancer patients with the use of stem cell technology to deliver oncolytic virus payloads to cancer sites,” said Allan Camaisa, CEO and Chairman of Calidi. “Together with our systemic, enveloped virus platform, I believe we are developing a portfolio of products to address glioblastoma, solid tumors and metastatic cancer.”
Calidi licensed the technology from the University of Chicago, on behalf of City of Hope and University of Alabama. City of Hope has a financial interest in the technology.
Dr. Aboody, an inventor of the technology, has a financial interest in Calidi and is a paid advisory board member.
For more information about this trial, contact fbidmeshki@coh.org or 626-218-4062.
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.
About City of Hope
City of Hope's mission is to make hope a reality for all touched by cancer and diabetes. Founded in 1913, City of Hope has grown into one of the largest and most advanced 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 that is ranked top 5 in the nation for cancer care by U.S. News & World Report at its core, City of Hope brings a uniquely integrated model that spans cancer care, research and development, academics and training, and a broad philanthropy program that powers its work. 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 cancer treatment centers and outpatient facilities in the Atlanta, Chicago and Phoenix areas. 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, X, YouTube, Instagram and LinkedIn.
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
Letisia Marquez
City of Hope
1-626-476-7593
lemarquez@coh.org
Source: Calidi Biotherapeutics, Inc.
FAQ
What are the initial results of CLDI's Phase 1 trial for CLD-101 in brain cancer patients?
How is CLDI's CLD-101 treatment administered to high-grade glioma patients?
Which institutions are participating in CLDI's CLD-101 clinical trial?
What is the funding source for CLDI's brain cancer clinical trial?
