Calidi Biotherapeutics Announces FDA Clearance of IND Application for CLD-201 in Solid Tumors
Calidi Biotherapeutics (NYSE American: CLDI) has received FDA clearance for its Investigational New Drug (IND) application for CLD-201, an allogeneic stem cell-based immunotherapy targeting solid tumors in adults. The therapy will focus on treating breast cancer, head & neck cancer, and soft tissue sarcoma.
The IND application included preclinical data showing CLD-201's potential to evade viral inactivation by the patient's immune system and effectively target cancer cells. The innovative treatment combines adipose tissue-derived stem cells with oncolytic vaccinia virus, representing a unique approach in cancer therapy.
Upcoming clinical trials will evaluate the safety, tolerability, and preliminary efficacy of CLD-201 in patients with these difficult-to-treat tumors, addressing significant unmet medical needs.
Calidi Biotherapeutics (NYSE American: CLDI) ha ottenuto l'autorizzazione dalla FDA per la sua domanda di Nuovo Farmaco Sperimentale (IND) relativa a CLD-201, un'immunoterapia allogenica a base di cellule staminali rivolta ai tumori solidi negli adulti. La terapia sarà focalizzata sul trattamento di cancro al seno, tumori testa-collo e sarcoma dei tessuti molli.
La domanda IND includeva dati preclinici che dimostrano il potenziale di CLD-201 di eludere l'inattivazione virale da parte del sistema immunitario del paziente e di colpire efficacemente le cellule tumorali. Il trattamento innovativo combina cellule staminali derivate dal tessuto adiposo con un virus oncolitico vaccinia, rappresentando un approccio unico nella terapia oncologica.
I prossimi studi clinici valuteranno la sicurezza, la tollerabilità e l'efficacia preliminare di CLD-201 in pazienti affetti da questi tumori difficili da trattare, rispondendo a bisogni medici ancora insoddisfatti.
Calidi Biotherapeutics (NYSE American: CLDI) ha recibido la aprobación de la FDA para su solicitud de Nuevo Fármaco en Investigación (IND) para CLD-201, una inmunoterapia basada en células madre alogénicas dirigida a tumores sólidos en adultos. La terapia se centrará en el tratamiento de cáncer de mama, cáncer de cabeza y cuello, y sarcoma de tejidos blandos.
La solicitud IND incluyó datos preclínicos que muestran el potencial de CLD-201 para evadir la inactivación viral por parte del sistema inmunológico del paciente y atacar eficazmente las células cancerosas. El tratamiento innovador combina células madre derivadas del tejido adiposo con un virus oncolítico vaccinia, representando un enfoque único en la terapia contra el cáncer.
Los próximos ensayos clínicos evaluarán la seguridad, tolerabilidad y eficacia preliminar de CLD-201 en pacientes con estos tumores difíciles de tratar, abordando necesidades médicas significativas no cubiertas.
Calidi Biotherapeutics (NYSE American: CLDI)가 성인 고형암을 대상으로 하는 동종 줄기세포 기반 면역치료제 CLD-201에 대한 임상시험계획(IND)을 FDA로부터 승인받았습니다. 이 치료법은 유방암, 두경부암, 연조직 육종 치료에 중점을 둘 예정입니다.
IND 신청서에는 CLD-201이 환자의 면역체계에 의한 바이러스 비활성화를 회피하고 암세포를 효과적으로 표적할 수 있는 잠재력을 보여주는 전임상 데이터가 포함되어 있습니다. 이 혁신적인 치료법은 지방 조직 유래 줄기세포와 종양 용해성 백시니아 바이러스를 결합하여 암 치료에 독특한 접근법을 제시합니다.
향후 임상시험에서는 이러한 치료가 까다로운 종양 환자에서 CLD-201의 안전성, 내약성 및 초기 효능을 평가하여 중요한 미충족 의료 수요를 해결할 예정입니다.
Calidi Biotherapeutics (NYSE American : CLDI) a obtenu l'autorisation de la FDA pour sa demande de nouveau médicament expérimental (IND) concernant CLD-201, une immunothérapie allogénique à base de cellules souches ciblant les tumeurs solides chez l'adulte. Cette thérapie se concentrera sur le traitement du cancer du sein, des cancers de la tête et du cou, ainsi que des sarcomes des tissus mous.
La demande IND comprenait des données précliniques démontrant la capacité de CLD-201 à échapper à l'inactivation virale par le système immunitaire du patient et à cibler efficacement les cellules cancéreuses. Ce traitement innovant combine des cellules souches dérivées du tissu adipeux avec un virus oncolytique vaccinia, représentant une approche unique en thérapie anticancéreuse.
Les essais cliniques à venir évalueront la sécurité, la tolérance et l'efficacité préliminaire de CLD-201 chez des patients atteints de ces tumeurs difficiles à traiter, répondant ainsi à des besoins médicaux importants non satisfaits.
Calidi Biotherapeutics (NYSE American: CLDI) hat von der FDA die Genehmigung für seinen Antrag auf ein Prüfpräparat (IND) für CLD-201 erhalten, eine allogene, auf Stammzellen basierende Immuntherapie, die sich gegen solide Tumoren bei Erwachsenen richtet. Die Therapie konzentriert sich auf die Behandlung von Brustkrebs, Kopf- und Halskrebs sowie Weichteilsarkomen.
Der IND-Antrag enthielt präklinische Daten, die das Potenzial von CLD-201 zeigen, der viralen Inaktivierung durch das Immunsystem des Patienten zu entgehen und Krebszellen effektiv zu bekämpfen. Die innovative Behandlung kombiniert aus Fettgewebe gewonnene Stammzellen mit einem onkolytischen Vaccinia-Virus und stellt damit einen einzigartigen Ansatz in der Krebstherapie dar.
Kommende klinische Studien werden die Sicherheit, Verträglichkeit und vorläufige Wirksamkeit von CLD-201 bei Patienten mit diesen schwer behandelbaren Tumoren untersuchen und damit bedeutende medizinische Bedarfe adressieren.
- FDA clearance received for CLD-201 IND application
- Preclinical data demonstrates effectiveness in targeting cancer cells
- Novel therapy combining stem cells with oncolytic virus
- Potential to treat multiple types of solid tumors
- Clinical trials yet to begin - no human efficacy data available
- Safety and tolerability still to be established in patients
Insights
FDA clearance for Calidi's cancer-targeting cell therapy validates their innovative platform, enabling critical advancement toward clinical trials; significant milestone for this micro-cap biotech.
The FDA's clearance of Calidi Biotherapeutics' IND application for CLD-201 represents a critical regulatory milestone that validates their scientific approach and manufacturing capabilities. This investigational therapy utilizes a pioneering mechanism - combining adipose-derived stem cells with oncolytic vaccinia virus - designed to protect the virus from premature immune clearance while enabling targeted delivery to cancer cells.
The focus on three distinct solid tumor types (breast cancer, head & neck cancer, and soft tissue sarcoma) suggests a strategic approach to clinical development, targeting areas with significant unmet medical needs where traditional treatments often show efficacy. The allogeneic (off-the-shelf) nature of this therapy could provide significant manufacturing and logistical advantages over autologous approaches if successfully developed.
While this clearance enables the vital transition from preclinical to clinical testing, investors should understand the substantial pathway ahead. The upcoming trials will initially focus on safety and tolerability, with efficacy as a secondary endpoint. For a company with Calidi's market capitalization (
The uniqueness of their platform technology potentially creates broader applications beyond the initial indications if the delivery mechanism proves successful in humans. However, the significant gap between IND clearance and potential commercialization typically spans several years and multiple clinical trial phases.
FDA's IND clearance derisks Calidi's platform technology, creating potential inflection point for this micro-cap biotech despite significant remaining clinical and financial hurdles.
The FDA clearance of Calidi's IND application for CLD-201 represents a significant derisking event for this
For micro-cap biotechs, IND clearances often serve as critical valuation inflection points that can attract institutional investor interest and potential strategic partnerships. The uniqueness of Calidi's approach using adipose-derived stem cells as delivery vehicles for oncolytic viruses creates differentiation in the competitive immuno-oncology landscape.
The therapeutic focus on multiple solid tumor types (breast cancer, head & neck cancer, and soft tissue sarcoma) demonstrates a broad potential application rather than a niche approach, expanding the potential market opportunity if successful in clinical trials. However, investors should note that clinical development of complex biologics typically requires substantial capital, likely necessitating future financing rounds or partnerships.
While current market conditions have challenged small-cap biotech valuations, regulatory validations like this IND clearance provide concrete evidence of progress that can help companies rise above sector headwinds. The allogeneic (off-the-shelf) nature of CLD-201 also aligns with industry trends toward scalable cell therapies rather than patient-specific manufacturing approaches.
Though substantial development risks remain, this milestone establishes a foundation for potential value-creating clinical data in the coming years.
SAN DIEGO, April 17, 2025 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology company pioneering targeted antitumor virotherapies, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for CLD-201. This investigational, allogeneic stem cell-based immunotherapy is set to advance into clinical development for the treatment of solid tumors in adults, focusing on breast cancer, head & neck cancer and soft tissue sarcoma.
The IND application included preclinical data demonstrating the potential of CLD-201 to evade viral inactivation by the patient’s immune system and effectively target and kill cancer cells. The upcoming clinical trials will assess the safety, tolerability, and preliminary efficacy of CLD-201 in patients with these difficult-to-treat tumors, addressing significant unmet medical needs.
“This FDA-cleared IND is a monumental milestone for Calidi Biotherapeutics and for patients worldwide. This allogeneic virotherapy product can transform how we treat cancer. It’s a one-of-a-kind product that has never been manufactured before using adipose tissue-derived stem cells in combination with oncolytic vaccinia virus. Its versatility in being able to treat solid tumors is remarkable,” said Allan Camaisa, CEO and Chairman at Calidi. “I am proud of our executives and staff that have worked tirelessly to make this application possible.”
“This remarkable achievement underscores the innovative approach and dedication of our exceptional team. The potential of CLD-201 to revolutionize the treatment of multiple solid tumors is truly exciting. We are eager to see its clinical application in providing new hope and improved outcomes for patients battling these challenging cancers,” said Boris Minev, MD, President, Medical and Scientific Affairs at Calidi.
"This milestone is a testament to the comprehensive and robust pre-clinical, CMC, and development package supporting the clinical advancement of CLD-201. It highlights the expertise and dedication of Calidi's teams in pushing forward innovative immunotherapies," said Antonio F. Santidrian, PhD, Chief Scientific Officer & Head of Technical Operations at Calidi.
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 31, 2025. 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.
FAQ
What is CLD-201 and how does it work against solid tumors?
Which types of cancer will CLDI's CLD-201 initially target in clinical trials?
What is the significance of FDA's IND clearance for CLDI's CLD-201?
What makes CLDI's CLD-201 therapy unique in cancer treatment?
