Calidi Biotherapeutics Receives FDA Fast Track Designation for CLD-201 (SuperNova), a First-In-Class Stem-Cell Loaded Viral Therapy for the Treatment of Patients with Soft Tissue Sarcoma
Calidi Biotherapeutics (NYSE American: CLDI) has received Fast Track designation from the FDA for CLD-201 (SuperNova), its allogeneic adipose stem-cell loaded oncolytic virus therapy for soft tissue sarcoma treatment.
The Fast Track status enables more frequent FDA interactions and potential eligibility for priority review and accelerated approval. This designation is granted to products addressing serious conditions with unmet medical needs.
Following the April 2025 FDA IND clearance, Calidi plans to conduct a Phase 1 first-in-human trial evaluating CLD-201's safety, tolerability, and efficacy in treating sarcoma, triple-negative breast cancer, and head and neck squamous cell carcinoma.
Calidi Biotherapeutics (NYSE American: CLDI) ha ottenuto la designazione Fast Track dalla FDA per CLD-201 (SuperNova), la sua terapia oncolitica a base di cellule staminali adipose allogeniche per il trattamento del sarcoma dei tessuti molli.
Lo status Fast Track consente interazioni pi霉 frequenti con la FDA e la possibilit脿 di accedere a una revisione prioritaria e a un'approvazione accelerata. Questa designazione viene concessa a prodotti che affrontano condizioni gravi con bisogni medici insoddisfatti.
Dopo l'autorizzazione IND della FDA prevista per aprile 2025, Calidi intende condurre uno studio di Fase 1 first-in-human per valutare la sicurezza, la tollerabilit脿 e l'efficacia di CLD-201 nel trattamento di sarcoma, carcinoma mammario triplo negativo e carcinoma squamoso della testa e del collo.
Calidi Biotherapeutics (NYSE American: CLDI) ha recibido la designaci贸n Fast Track por parte de la FDA para CLD-201 (SuperNova), su terapia oncol铆tica con c茅lulas madre adiposas alog茅nicas para el tratamiento del sarcoma de tejidos blandos.
El estatus Fast Track permite interacciones m谩s frecuentes con la FDA y la posible elegibilidad para revisi贸n prioritaria y aprobaci贸n acelerada. Esta designaci贸n se otorga a productos que abordan condiciones graves con necesidades m茅dicas no cubiertas.
Tras la aprobaci贸n IND de la FDA en abril de 2025, Calidi planea realizar un ensayo de Fase 1 en humanos para evaluar la seguridad, tolerabilidad y eficacia de CLD-201 en el tratamiento de sarcoma, c谩ncer de mama triple negativo y carcinoma escamoso de cabeza y cuello.
Calidi Biotherapeutics (NYSE American: CLDI)電� 鞐半秬 臁办 鞙§ 旃橂毳� 鞙勴暅 霃欖 歆�氚� 欷勱赴靹疙彫 韮戩灛 鞓綔毽嫳 氚旍澊霟姢 旃橂鞝滌澑 CLD-201 (SuperNova)鞐� 雽�頃� FDA搿滊秬韯� 鞁犾啀 鞁偓(Fast Track) 歆�鞝曥潉 氚涭晿鞀惦媹雼�.
鞁犾啀 鞁偓 歆�鞙勲姅 FDA鞕�鞚� 牍堧矆頃� 靻岉喌瓿� 鞖办劆 鞁偓 氚� 臧�靻� 鞀轨澑 臧�電レ劚鞚� 鞝滉车頃╇媹雼�. 鞚� 歆�鞝曥潃 鞚橂鞝� 氙胳订臁� 靾橃殧臧� 鞛堧姅 欷戨寑頃� 歆堩櫂鞚� 雽�靸侅溂搿� 頃橂姅 鞝滍拡鞐� 攵�鞐惄雼堧嫟.
2025雲� 4鞗� FDA鞚� IND 鞀轨澑 鞚错泟, Calidi電� CLD-201鞚� 鞎堨爠靹�, 雮挫暯靹� 氚� 須姤鞚� 韽夑皜頃橁赴 鞙勴暅 1靸� 斓滌磮 鞚胳泊 鞁滍棙鞚� 鞐半秬 臁办 鞙§, 靷检鞚岇劚 鞙犽癌鞎�, 霊愱步攵� 韼疙弶靹疙彫鞎旍棎 雽�頃� 歆勴枆頃� 瓿勴殟鞛呺媹雼�.
Calidi Biotherapeutics (NYSE American : CLDI) a obtenu la d茅signation Fast Track de la FDA pour CLD-201 (SuperNova), sa th茅rapie virale oncolytique charg茅e en cellules souches adipeuses allog茅niques destin茅e au traitement du sarcome des tissus mous.
Le statut Fast Track permet des interactions plus fr茅quentes avec la FDA ainsi qu'une 茅ventuelle 茅ligibilit茅 脿 une r茅vision prioritaire et 脿 une approbation acc茅l茅r茅e. Cette d茅signation est accord茅e aux produits traitant des affections graves pour lesquelles il existe des besoins m茅dicaux non satisfaits.
Suite 脿 l'autorisation IND de la FDA pr茅vue pour avril 2025, Calidi pr茅voit de mener un essai de phase 1 en premi猫re administration 脿 l'homme 茅valuant la s茅curit茅, la tol茅rabilit茅 et l'efficacit茅 de CLD-201 dans le traitement du sarcome, du cancer du sein triple n茅gatif et du carcinome 茅pidermo茂de de la t锚te et du cou.
Calidi Biotherapeutics (NYSE American: CLDI) hat von der FDA die Fast Track-Zulassung f眉r CLD-201 (SuperNova) erhalten, eine allogene adip枚se Stammzell-beladene onkolytische Virustherapie zur Behandlung von Weichteilsarkomen.
Der Fast Track-Status erm枚glicht h盲ufigere Interaktionen mit der FDA sowie die potenzielle Berechtigung f眉r eine vorrangige Pr眉fung und beschleunigte Zulassung. Diese Bezeichnung wird Produkten verliehen, die schwerwiegende Erkrankungen mit ungedecktem medizinischem Bedarf behandeln.
Nach der IND-Freigabe durch die FDA im April 2025 plant Calidi eine Phase-1-Erst-in-Mensch-Studie zur Bewertung der Sicherheit, Vertr盲glichkeit und Wirksamkeit von CLD-201 bei der Behandlung von Sarkomen, triple-negativem Brustkrebs und Plattenepithelkarzinomen des Kopf- und Halsbereichs.
- Received FDA Fast Track designation for CLD-201, enabling expedited development and review process
- Previously obtained FDA IND clearance in April 2025
- Potential to address multiple cancer types including sarcoma, triple-negative breast cancer, and head/neck cancer
- Product still in early development stage with no clinical data yet
- Phase 1 trial yet to commence, indicating long pathway to potential commercialization
Insights
FDA Fast Track status for Calidi's CLD-201 accelerates development timeline and validates therapeutic potential for serious unmet needs in sarcoma treatment.
The FDA's decision to grant Fast Track designation for Calidi's CLD-201 (SuperNova) represents a significant regulatory milestone that could materially accelerate the development timeline for this first-in-class therapy. This designation is particularly valuable as it's reserved exclusively for treatments addressing serious conditions with substantial unmet needs 鈥� validating both the severity of soft tissue sarcoma and the therapeutic potential of Calidi's approach.
CLD-201's technology platform is scientifically distinctive, combining allogeneic adipose stem-cells with an oncolytic virus 鈥� essentially creating a protected viral delivery system that may overcome key limitations of traditional oncolytic virotherapies. The mechanism potentially enables more effective delivery of genetic medicine to tumor sites while evading immune clearance.
The regulatory advantages conferred by Fast Track status are substantial: enhanced FDA communication, potential eligibility for priority review (shortening review from 10 to 6 months), and possible accelerated approval pathways. These benefits can significantly reduce time-to-market and development costs.
Notably, the company has already secured IND clearance (announced April 17, 2025) and is advancing toward a Phase 1 trial with an expanded scope beyond soft tissue sarcoma to include triple-negative breast cancer and head and neck squamous cell carcinoma 鈥� suggesting confidence in CLD-201's broader applications and expanding the potential market opportunity if successful.
While this early-stage therapy still faces significant clinical hurdles, this regulatory advancement represents meaningful validation for Calidi's therapeutic approach and substantially improves the development pathway for their lead candidate.
SAN DIEGO, July 29, 2025 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics, Inc. (鈥淐alidi鈥� or the 鈥淐ompany鈥�) (NYSE American: CLDI), a clinical-stage biotechnology company pioneering the development of targeted therapies with the potential to deliver genetic medicines to distal sites of disease,聽today announced that it received Fast Track designation from the聽U.S. Food and Drug Administration聽(FDA) for聽CLD-201 (SuperNova), the company鈥檚 allogeneic adipose stem-cell loaded oncolytic virus for the treatment of soft tissue sarcoma.
Fast Track designation is granted to products that are developed to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs. This designation is intended to facilitate development and expedite review of qualifying drugs. CLD-201 will benefit from this designation through more frequent interactions with the FDA along with potential eligibility for priority review and accelerated approval.
Guy Travis Clifton, M.D., Chief Medical Officer of Calidi commented, 鈥淔DA IND clearance and Fast Track designation represents an important milestone in the development of CLD-201. This designation underscores the unmet medical need in sarcoma and provides scientific and regulatory validation of CLD-201. We believe CLD-201 has the potential to provide durable and transformational treatment to patients with sarcoma as well as patients with other advanced tumor types. We want to thank the FDA for its support and partnership and look forward to continued collaboration with the agency.鈥�
FDA Investigational New Drug (IND) clearance for CLD-201 was announced on April 17, 2025. The planned Phase 1 trial will be a first-in-human, open-label, multicenter study to evaluate the safety, tolerability and efficacy of CLD-201 in sarcoma, triple-negative breast cancer, and head and neck squamous cell carcinoma.
About CLD-201
CLD-201 is comprised of adipose-derived mesenchymal stem cells (AD-MSC) loaded with oncolytic vaccinia virus, for the treatment of patients with advanced solid tumors including sarcoma, triple-negative breast cancer, and head and neck squamous cell carcinoma. Stem-cell loading of an oncolytic virus helps protect the virus from clearance by the body鈥檚 immune system and allows virus to amplify within the stem cell, leading to an increase in potency and immune activation and enhanced efficacy in pre-clinical animal models.
About Calidi Biotherapeutics
Calidi Biotherapeutics (NYSE American: CLDI) is a clinical-stage biotechnology company pioneering the development of targeted therapies that can deliver genetic medicines to sites of disease. The company's proprietary Redtail platform represents a decade of development and expertise in designing viral vectors that can evade immune detection allowing for systemic delivery and distal sites of disease in oncology and, potentially, other indications. This advanced enveloped technology is intended to shield the virus from immune clearance, allowing virotherapy to effectively reach tumor sites, induce tumor lysis, and deliver potent gene therapies to metastatic locations.
The lead candidate from the Redtail platform, currently in IND-enabling studies, targets non-small cell lung cancer, ovarian cancer, and other tumor types with high unmet medical need. Additionally, Calidi is developing clinical-stage protected virotherapies for intratumoral and localized administration, focusing on a subset of injectable cancer indications.
Calidi Biotherapeutics is headquartered in San Diego, California. For more information, please visit聽.
Forward-Looking Statements
This press release may contain forward-looking statements for purposes of the 鈥渟afe harbor鈥� provisions under the United States Private Securities Litigation Reform Act of 1995. Terms such as 鈥渁nticipates,鈥� 鈥渂elieve,鈥� 鈥渃ontinue,鈥� 鈥渃ould,鈥� 鈥渆stimate,鈥� 鈥渆xpect,鈥� 鈥渋ntends,鈥� 鈥渕ay,鈥� 鈥渕ight,鈥� 鈥減lan,鈥� 鈥減ossible,鈥� 鈥減otential,鈥� 鈥減redicts,鈥� 鈥減roject,鈥� 鈥渟hould,鈥� 鈥渢owards,鈥� 鈥渨ould鈥� 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 use of proceeds from the offering, that the closing of offering will occur or will occur on the anticipated closing date, upcoming key milestones, planned clinical trials, and statements relating to the safety and efficacy of Calidi鈥檚 therapeutic candidates in development. Any forward-looking statements contained in this discussion are based on Calidi鈥檚 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 鈥淩isk Factors鈥� and 鈥淐autionary Note Regarding Forward-Looking Statements鈥� in the Company鈥檚 Form 10-K filed on March 31, 2025 and Form 10-Q filed on May 14, 2025. These reports may be amended or supplemented by other reports we file with the SEC from time to time.
Contact:
Dave Gentry
RedChip Companies, Inc.
1-407-644-4256
FAQ
What is the significance of FDA Fast Track designation for Calidi Biotherapeutics (CLDI)?
What types of cancer will Calidi Biotherapeutics' CLD-201 trial target?
When did Calidi Biotherapeutics (CLDI) receive FDA IND clearance for CLD-201?
What is CLD-201 (SuperNova) by Calidi Biotherapeutics?
What is the current development stage of Calidi's CLD-201 therapy?
