BullFrog AI and Eleison Pharmaceuticals Enter Agreement to Collaborate to Optimize Pivotal Phase 3 Trial
BullFrog AI Holdings (NASDAQ: BFRG) has entered into a collaboration agreement with Eleison Pharmaceuticals to optimize their Phase 3 clinical trial. The partnership will utilize BullFrog's Data Networks™ AI solution, powered by the bfLEAP® platform, to analyze clinical data from Eleison's ongoing Phase 3 trial of glufosfamide for pancreatic cancer.
The AI platform will focus on:
- Evaluating trial trajectory regarding safety signals
- Extracting predictive biomarkers for efficacy and safety
- Supporting future trial design
- Providing data-driven insights for Eleison's planned clinical trials
Glufosfamide, a third-generation alkylating agent, is being evaluated for second-line treatment of pancreatic cancer, which affects over 67,000 Americans and 510,000 people worldwide annually, with five-year survival rates below 5%. Eleison expects to complete the Phase 3 trial in 2027.
BullFrog AI Holdings (NASDAQ: BFRG) ha stipulato un accordo di collaborazione con Eleison Pharmaceuticals per ottimizzare il loro studio clinico di Fase 3. La partnership utilizzerà la soluzione AI Data Networks™ di BullFrog, alimentata dalla piattaforma bfLEAP®, per analizzare i dati clinici dell'attuale studio di Fase 3 di Eleison sul glufosfamide per il cancro pancreatico.
La piattaforma AI si concentrerà su:
- Valutazione della traiettoria dello studio riguardo ai segnali di sicurezza
- Estrazione di biomarcatori predittivi per efficacia e sicurezza
- Supporto alla progettazione di studi futuri
- Fornire approfondimenti basati sui dati per gli studi clinici pianificati da Eleison
Il glufosfamide, un agente alchilante di terza generazione, è in fase di valutazione come trattamento di seconda linea per il cancro pancreatico, che colpisce oltre 67.000 americani e 510.000 persone in tutto il mondo ogni anno, con tassi di sopravvivenza a cinque anni inferiori al 5%. Eleison prevede di completare lo studio di Fase 3 nel 2027.
BullFrog AI Holdings (NASDAQ: BFRG) ha firmado un acuerdo de colaboración con Eleison Pharmaceuticals para optimizar su ensayo clínico de Fase 3. La asociación utilizará la solución de IA Data Networks™ de BullFrog, impulsada por la plataforma bfLEAP®, para analizar los datos clínicos del ensayo de Fase 3 en curso de Eleison sobre glufosfamida para el cáncer de páncreas.
La plataforma de IA se centrará en:
- Evaluar la trayectoria del ensayo en relación con las señales de seguridad
- Extraer biomarcadores predictivos para eficacia y seguridad
- Apoyar el diseño de ensayos futuros
- Proporcionar información basada en datos para los ensayos clínicos planificados por Eleison
La glufosfamida, un agente alquilante de tercera generación, se está evaluando para el tratamiento de segunda línea del cáncer de páncreas, que afecta a más de 67,000 estadounidenses y 510,000 personas en todo el mundo anualmente, con tasas de supervivencia a cinco años inferiores al 5%. Eleison espera completar el ensayo de Fase 3 en 2027.
BullFrog AI Holdings (NASDAQ: BFRG)는 Eleison Pharmaceuticals와 협력 계약을 체결하여 3상 임상 시험을 최적화합니다. 이 파트너십은 BullFrog의 Data Networks™ AI 솔루션을 활용하여 bfLEAP® 플랫폼의 지원을 받아 Eleison의 진행 중인 췌장암에 대한 glufosfamide 3상 시험의 임상 데이터를 분석할 것입니다.
AI 플랫폼은 다음에 집중할 것입니다:
- 안전 신호와 관련된 시험 경로 평가
- 효능 및 안전성을 위한 예측 바이오마커 추출
- 미래 시험 설계 지원
- Eleison의 계획된 임상 시험을 위한 데이터 기반 통찰력 제공
Glufosfamide는 제3세대 알킬화제로, 췌장암의 2차 치료제로 평가되고 있으며, 매년 67,000명 이상의 미국인과 51만 명 이상의 전 세계 사람들이 영향을 받으며, 5년 생존율은 5% 미만입니다. Eleison은 2027년까지 3상 시험을 완료할 것으로 예상하고 있습니다.
BullFrog AI Holdings (NASDAQ: BFRG) a conclu un accord de collaboration avec Eleison Pharmaceuticals pour optimiser leur essai clinique de Phase 3. Le partenariat utilisera la solution AI Data Networks™ de BullFrog, alimentée par la plateforme bfLEAP®, pour analyser les données cliniques de l'essai de Phase 3 en cours d'Eleison sur le glufosfamide pour le cancer du pancréas.
La plateforme AI se concentrera sur:
- Évaluation de la trajectoire de l'essai concernant les signaux de sécurité
- Extraction de biomarqueurs prédictifs pour l'efficacité et la sécurité
- Soutien à la conception d'essais futurs
- Fourniture d'aperçus basés sur les données pour les essais cliniques prévus par Eleison
Le glufosfamide, un agent alkylant de troisième génération, est évalué pour le traitement de deuxième ligne du cancer du pancréas, qui touche plus de 67 000 Américains et 510 000 personnes dans le monde chaque année, avec des taux de survie à cinq ans inférieurs à 5 %. Eleison prévoit de terminer l'essai de Phase 3 en 2027.
BullFrog AI Holdings (NASDAQ: BFRG) hat eine Zusammenarbeit mit Eleison Pharmaceuticals vereinbart, um ihre klinische Phase-3-Studie zu optimieren. Die Partnerschaft wird die Data Networks™ AI-Lösung von BullFrog nutzen, die von der bfLEAP®-Plattform unterstützt wird, um klinische Daten aus der laufenden Phase-3-Studie von Eleison zu Glufosfamid bei Bauchspeicheldrüsenkrebs zu analysieren.
Die KI-Plattform wird sich auf Folgendes konzentrieren:
- Bewertung des Studienverlaufs hinsichtlich Sicherheitsindikatoren
- Extraktion prädiktiver Biomarker für Wirksamkeit und Sicherheit
- Unterstützung des Designs zukünftiger Studien
- Bereitstellung datengestützter Erkenntnisse für die geplanten klinischen Studien von Eleison
Glufosfamid, ein Wirkstoff der dritten Generation, wird als Zweitlinientherapie für Bauchspeicheldrüsenkrebs evaluiert, der jährlich über 67.000 Amerikaner und 510.000 Menschen weltweit betrifft, mit einer fünfjährigen Überlebensrate von unter 5 %. Eleison erwartet, die Phase-3-Studie im Jahr 2027 abzuschließen.
- Strategic partnership with Phase 3 oncology company
- AI technology application in large-scale clinical trial
- Expansion into rare cancer treatment market
- Potential for additional revenue through pharmaceutical collaboration
- Financial terms not disclosed
- Results and revenue impact uncertain until 2027
Insights
BullFrog AI's collaboration with Eleison Pharmaceuticals represents a significant commercial validation for its AI-driven drug development platform in the challenging oncology space. While financial terms remain undisclosed, this agreement is potentially material for BFRG given its micro-cap status (
The partnership focuses on applying BFRG's proprietary technology to optimize Eleison's pivotal Phase 3 trial for glufosfamide in pancreatic cancer - a disease affecting over 67,000 Americans annually with dismal survival rates below
- Near-term revenue generation through the service agreement
- Multi-year engagement potential with trial completion targeted for 2027
- Valuable real-world validation that could attract additional pharmaceutical partnerships
This deal addresses a critical industry pain point - the high failure rate and expense of late-stage clinical trials. By leveraging AI to identify predictive biomarkers and optimize patient selection, BFRG's technology could potentially increase the probability of trial success while reducing costs.
For context, the global AI in drug discovery market is projected to reach
The collaboration's success metrics will likely include whether BFRG's insights meaningfully impact trial outcomes and lead to expanded work across Eleison's pipeline of rare cancer treatments. For a company of BFRG's size, establishing a successful track record in oncology trials could significantly accelerate its growth trajectory through additional partnerships.
This collaboration between BullFrog AI and Eleison represents a potentially significant advancement in applying AI to optimize clinical trials in one of oncology's most challenging areas - pancreatic cancer. The application of BullFrog's technology to Eleison's glufosfamide Phase 3 trial addresses a critical problem in pancreatic cancer research: identifying which patients will actually benefit from treatment.
Glufosfamide's mechanism merits attention - as a glucose-conjugated alkylating agent, it exploits the Warburg effect (increased glucose uptake in cancer cells) to achieve more selective delivery to tumor cells. This approach is particularly relevant for pancreatic tumors, which are characterized by a dense stromal microenvironment that typically impedes drug delivery. Traditional alkylating agents have shown efficacy in pancreatic cancer due to systemic toxicity limiting effective dosing.
The application of AI in this context could solve several persistent challenges:
- Identifying molecular or clinical signatures that predict treatment response
- Detecting subtle safety signals earlier in the development process
- Optimizing enrollment criteria to enrich for likely responders
- Reducing trial size requirements through more precise patient selection
Pancreatic cancer's heterogeneity has contributed to the 95% failure rate of clinical trials in this indication. By analyzing data from previous glufosfamide studies, BullFrog's AI might identify patient subpopulations with better response profiles - potentially transforming a marginally effective therapy into a significantly beneficial one for the right patients.
This approach aligns with the field's shift toward precision medicine but applies it at the trial design level rather than just the treatment selection stage. If successful, this methodology could become a template for revitalizing clinical programs in other intractable cancers where traditional statistical approaches have failed to identify responder populations.
For pancreatic cancer patients, who face a median survival of just 3-6 months in the second-line setting, any advancement that improves treatment selection efficiency could translate to meaningful survival benefits and quality of life improvements.
Eleison to leverage BullFrog Data Networks™ to enhance patient clustering and safety analysis in glufosfamide clinical trials
GAITHERSBURG, Md., Feb. 27, 2025 (GLOBE NEWSWIRE) -- BullFrog AI Holdings, Inc. (NASDAQ: BFRG; BFRGW) (“BullFrog AI” or the “Company”), a technology-enabled drug development company using artificial intelligence (AI) and machine learning to enable the successful development of pharmaceuticals and biologics, today announced its entry into a collaboration agreement with Eleison Pharmaceuticals Inc. (“Eleison”), a Phase 3 oncology company focused on novel chemotherapeutic treatments for rare cancers. Under the terms of the agreement, BullFrog AI will provide access to its BullFrog Data Networks™ AI solution to enhance clinical trial efficiency and patient insights. Financial terms of the collaboration were not disclosed.
“The integration of artificial intelligence in clinical trials represents a transformative shift in how pharmaceutical companies can de-risk drug development and optimize patient outcomes,” said Vin Singh, CEO of BullFrog AI. “We are thrilled to partner with Eleison to apply our bfLEAP® AI technology, which has the potential to refine patient selection, improve trial efficiency, and ultimately accelerate the path to market for life-saving therapies.”
Through this collaboration, BullFrog AI will apply its proprietary BullFrog Data Networks™ solution, powered by the bfLEAP® platform, to analyze clinical data from Eleison’s ongoing Phase 3 trial and previous clinical studies of glufosfamide, an investigational treatment for pancreatic cancer. The platform will evaluate the current trajectory of the trial with respect to safety signals, extract predictive biomarkers for efficacy and safety performance from prior studies to support future trial design, and provide data-driven insights to optimize Eleison’s planned clinical trials for inhaled lipid-complexed cisplatin (ILC) and dibromodulcitol (DBD). These insights are expected to streamline trial efficiency and improve decision-making for Eleison’s broader oncology pipeline.
Glufosfamide is a third-generation alkylating agent designed for greater specificity and tumor uptake, with reduced systemic toxicities and side effects. It is currently being evaluated by Eleison in a pivotal Phase 3 international randomized clinical trial, for the second-line treatment of patients with pancreatic cancer. Although pancreatic cancer is among the rarer cancer types, it is the third leading cause of death by cancer in the United States. More than 67,000 Americans and 510,000 people worldwide are diagnosed with pancreatic cancer annually. Few therapeutic options exist to treat the disease and five-year survival rates are typically less than
“Our collaboration with BullFrog AI underscores our commitment to innovation in drug development,” said Edwin Thomas, CEO of Eleison. “By leveraging AI-powered analytics, we aim to generate deeper insights into patient responses and safety trends, which will not only benefit our glufosfamide program but also inform the strategic direction of our broader oncology pipeline.”
About BullFrog AI
BullFrog AI leverages Artificial Intelligence and machine learning to advance drug discovery and development. Through collaborations with leading research institutions, BullFrog AI uses causal AI in combination with its proprietary bfLEAP™ platform to analyze complex biological data, aiming to streamline therapeutics development and reduce failure rates in clinical trials.
For more information, visit BullFrog AI at: https://bullfrogai.com
About Eleison Pharmaceuticals
Eleison’s mission is to acquire and develop drug candidates with existing and significant safety and efficacy data; and ultimately to obtain regulatory approval and commercialize new therapeutics for patients with life-threatening cancers. In addition to its glufosfamide program, the Company has two other programs in late-stage clinical development; ILC in development for small cell lung cancer and pediatric osteosarcoma, and DBD for brain cancers. The Company has entered into development and marketing partnerships with leading pharmaceutical companies in China, S. Korea, and Israel. Eleison was founded in 2009 and is headquartered in Princeton, NJ. Additional information about Eleison can be found at our website www.eleison-pharma.com.
Safe Harbor Statement
This press release contains forward-looking statements. We base these forward-looking statements on our expectations and projections about future events, which we derive from the information currently available to us. Such forward-looking statements relate to future events or our future performance, including: our financial performance and projections; our growth in revenue and earnings; and our business prospects and opportunities. You can identify forward-looking statements by those that are not historical in nature, particularly those that use terminology such as "may," "should," “could,” “will,” "expects," "anticipates," "contemplates," "estimates," "believes," "plans," "projected," "predicts," "potential," or "hopes" or the negative of these or similar terms. In evaluating these forward-looking statements, you should consider various factors, including: our ability to change the direction of the Company; our ability to keep pace with new technology and changing market needs; and the competitive environment of our business. These and other factors may cause our actual results to differ materially from any forward-looking statement. Forward-looking statements are only predictions. The forward-looking events discussed in this press release and other statements made from time to time by us or our representatives, may not occur, and actual events and results may differ materially and are subject to risks, uncertainties, and assumptions about us. We are not obligated to publicly update or revise any forward-looking statement, whether as a result of uncertainties and assumptions, the forward-looking events discussed in this press release and other statements made from time to time by us or our representatives might not occur.
Contact:
Dave Gentry
RedChip Companies, Inc.
1-407-644-4256
BFRG@redchip.com
FAQ
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