Moleculin Announces Positive In Vivo Efficacy Data of Annamycin in Orthotopic and Experimental Lung Metastatic Models of Sarcoma
Moleculin Biotech (Nasdaq: MBRX) presented positive in vivo efficacy data of Annamycin in orthotopic and experimental lung metastatic models of sarcoma at the IASLC 2024 World Conference on Lung Cancer. Key findings include:
1. Annamycin demonstrated high uptake and retention in lung parenchyma of mice and rats, exceeding doxorubicin levels by 10- to 30-fold.
2. Treatment with Annamycin resulted in statistically significant inhibition of tumor growth and extension of survival in orthotopic lung cancer models.
3. Annamycin exhibited consistent efficacy in vivo in orthotopic and experimental lung metastatic models of sarcoma, breast, and colon cancer.
4. Preclinical tests and ongoing clinical studies show Annamycin has a better cardiac safety profile compared to doxorubicin, with no cardiotoxicity observed.
Annamycin is currently in clinical trials for relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases, with Fast Track Status and Orphan Drug Designations from FDA and EMA.
Moleculin Biotech (Nasdaq: MBRX) ha presentato dati positivi di efficacia in vivo di Annamycin in modelli ortotopici e sperimentali di metastasi polmonari da sarcoma durante la Conferenza Mondiale IASLC 2024 sul Cancro del Polmone. I principali risultati includono:
1. Annamycin ha dimostrato un elevato assorbimento e mantenimento nel parenchima polmonare di topi e ratti, superando i livelli di doxorubicina di 10-30 volte.
2. Il trattamento con Annamycin ha portato a un inibizione statisticamente significativa della crescita tumorale e a un'estensione della sopravvivenza nei modelli di cancro polmonare ortotopico.
3. Annamycin ha mostrato un efficacia consistente in vivo in modelli ortotopici e sperimentali di metastasi polmonari da sarcoma, cancro al seno e cancro al colon.
4. I test preclinici e gli studi clinici in corso mostrano che Annamycin ha un profilo di sicurezza cardiaca migliore rispetto alla doxorubicina, senza osservare cardiotossicità.
Annamycin è attualmente in fase di sperimentazione clinica per leucemia mieloide acuta (AML) in recidiva o refrattaria e metastasi polmonari da sarcoma dei tessuti molli (STS), con lo stato di Fast Track e le designazioni di Farmaco Orfano da parte della FDA e dell'EMA.
Moleculin Biotech (Nasdaq: MBRX) presentó datos positivos de eficacia in vivo de Annamycin en modelos ortotópicos y experimentales de metástasis pulmonares de sarcoma en la Conferencia Mundial IASLC 2024 sobre el Cáncer de Pulmón. Los hallazgos clave incluyen:
1. Annamycin demostró alta absorción y retención en el parénquima pulmonar de ratones y ratas, superando los niveles de doxorubicina entre 10 y 30 veces.
2. El tratamiento con Annamycin resultó en una inhibición estadísticamente significativa del crecimiento tumoral y extensión de la supervivencia en modelos de cáncer de pulmón ortotópicos.
3. Annamycin presentó eficacia consistente in vivo en modelos ortotópicos y experimentales de metástasis pulmonares de sarcoma, cáncer de mama y cáncer de colon.
4. Las pruebas preclínicas y los estudios clínicos en curso muestran que Annamycin tiene un mejor perfil de seguridad cardiaca en comparación con doxorubicina, sin observarse cardiotoxicidad.
Annamycin se encuentra actualmente en ensayos clínicos para leucemia mieloide aguda (AML) en recaída o refractaria y metástasis pulmonares de sarcoma de tejidos blandos (STS), con Estado de Vía Rápida y Designaciones de Medicamento Huérfano de la FDA y la EMA.
Moleculin Biotech (Nasdaq: MBRX)는 IASLC 2024 세계 폐암 회의에서 사르코마의 정위치 및 실험적 폐 전이 모델에서 Annamycin의 in vivo 효능 데이터를 긍정적으로 발표했습니다. 주요 발견 사항은 다음과 같습니다:
1. Annamycin은 쥐와 쥐의 폐 실질에서 높은 흡수 및 유지를 보여주었으며, 이는 독소루비신 수준을 10배에서 30배 초과했습니다.
2. Annamycin 치료는 정위치 폐암 모델에서 종양 성장의 통계적으로 유의미한 억제와 생존 연장을 가져왔습니다.
3. Annamycin은 사르코마, 유방암 및 대장암의 정위치 및 실험적 폐 전이 모델에서 일관된 in vivo 효과를 보였습니다.
4. 전임상 시험 및 진행 중인 임상 연구는 Annamycin이 독소루비신에 비해 더 나은 심장 안전성 프로파일을 가지고 있으며 심장 독성이 관찰되지 않았다는 것을 보여줍니다.
Annamycin은 현재 재발 또는 난치성 급성 골수성 백혈병 (AML) 및 연조직 사르코마 (STS) 폐 전이를 위한 임상 시험 중에 있으며, FDA 및 EMA로부터 신속 심사 상태 및 희귀 의약품 지정이 있습니다.
Moleculin Biotech (Nasdaq: MBRX) a présenté des données d'efficacité in vivo d'Annamycin dans des modèles de métastases pulmonaires sarcomateuses orthotopiques et expérimentaux lors de la Conférence mondiale IASLC 2024 sur le cancer du poumon. Les principales conclusions incluent :
1. Annamycin a démontré une forte absorption et rétention dans le parenchyme pulmonaire de souris et de rats, dépassant les niveaux de doxorubicine de 10 à 30 fois.
2. Le traitement par Annamycin a entraîné une inhibition statistiquement significative de la croissance tumorale et une prolongation de la survie dans des modèles de cancer du poumon orthotopiques.
3. Annamycin a montré une efficacité cohérente in vivo dans des modèles de métastases pulmonaires sarcomateuses, mammaires et colorectal orthotopiques et expérimentaux.
4. Les tests précliniques et les études cliniques en cours montrent qu'Annamycin a un meilleur profil de sécurité cardiaque par rapport à la doxorubicine, sans cardiotoxicité observée.
Annamycin est actuellement en essais cliniques pour des leucémies aiguës myéloïdes (LAM) en rechute ou réfractaires et des métastases pulmonaires de sarcome des tissus mous (STS), bénéficiant d'un statut de Fast Track et d'une désignation de médicament orphelin de la FDA et de l'EMA.
Moleculin Biotech (Nasdaq: MBRX) präsentierte positive in vivo Wirksamkeitsdaten zu Annamycin in orthotopischen und experimentellen Lungenmetastasenmodellen des Sarkoms auf der IASLC 2024 Weltkonferenz zum Lungenkrebs. Zentrale Ergebnisse sind:
1. Annamycin zeigte hohe Aufnahme und Retention im Lungenparenchym von Mäusen und Ratten, die die Doxorubicinwerte um das 10- bis 30-Fache übertrafen.
2. Die Behandlung mit Annamycin führte zu einer statistisch signifikanten Hemmung des Tumorwachstums und zu einer Verlängerung der Überlebenszeit in orthotopischen Lungenkrebsmodellen.
3. Annamycin zeigte eine konstante Wirksamkeit in vivo in orthotopischen und experimentellen Lungenmetastasenmodellen des Sarkoms, Brust- und Dickdarmkrebs.
4. Präklinische Tests und laufende klinische Studien zeigen, dass Annamycin ein besseres kardiologisches Sicherheitsprofil im Vergleich zu Doxorubicin aufweist, ohne Herztoxizität zu beobachten.
Annamycin befindet sich derzeit in klinischen Studien für rezidivierende oder refraktäre akute myeloische Leukämie (AML) und Lungenmetastasen des Weichgewebesarkoms (STS), mit Fast-Track-Status und Orphan-Drug-Designationen von der FDA und der EMA.
- Annamycin demonstrated high uptake and retention in lung parenchyma, exceeding doxorubicin levels by 10- to 30-fold
- Treatment with Annamycin resulted in statistically significant inhibition of tumor growth and extension of survival in orthotopic lung cancer models
- Annamycin exhibited consistent efficacy in vivo in various cancer models
- Annamycin showed no cardiotoxicity in preclinical and ongoing clinical studies
- Annamycin has Fast Track Status and Orphan Drug Designations from FDA and EMA for various indications
- None.
Data recently presented at the International Association for the Study of Lung Cancer (IASLC) 2024 World Conference on Lung Cancer
Treatment with Annamycin results in statistically significant inhibition of tumor growth and extension of survival in orthotopic lung cancer models
Annamycin continues to be
The poster titled "Annamycin: Opening New Doors for Organotropic Targeting of Primary and Metastatic Lung Cancer," authored by Waldemar Priebe, PhD (Founder, Founding Scientist, and Chair of Scientific Advisory Board for Moleculin) and coworkers was recently presented at the IASLC 2024 World Conference on Lung Cancer. The presented poster outlined results from the efficacy assessment studies of Annamycin, Moleculin's next-generation anthracycline in orthotopic models of lung cancer and sarcoma lung metastasis models in comparison with doxorubicin (a commonly prescribed anthracycline).
"Annamycin continues to exhibit consistent activity against different type of cancers including therapy resistant cancers such as soft tissue sarcoma lung metastases while also avoiding cardiotoxicity, which continues to be a significant side effect limiting the clinical use of anthracyclines. Importantly, the presented data demonstrates that treatment with Annamycin results in statistically significant inhibition of tumor growth and extension of survival in orthotopic lung cancer models, which is consistent with the preliminary results we are seeing in our sarcoma clinical trials. This further underscores Annamycin's potential to provide a much-needed treatment option for patients with primary or metastatic lung cancers, as a single agent and in combination with currently used therapeutics. Combined with the encouraging growing body of clinical data from our ongoing studies, we remain confident in Annamycin's potential to address significant unmet needs in a wide range of cancers," commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin.
Key Highlights
- Annamycin demonstrated high uptake and retention in lung parenchyma of mice and rats.
- The therapeutic effects of doxorubicin (DOX) are diminished due to low lung DOX uptake as demonstrated in the tested in vivo models. In contrast, Annamycin exhibits consistent efficacy in vivo in orthotopic and experimental lung metastatic models of sarcoma, breast, and colon cancer. This correlated with high Annamycin concentration in lungs, which exceeded DOX levels by 10- to 30-fold.
- Preclinical tests clearly demonstrate a better cardiac safety profile of Annamycin when compared to DOX and no cardiotoxicity of Annamycin in the in vivo models. No cardiotoxicity of Annamycin has been noted in ongoing clinical studies.
- The observed organotropic properties of Annamycin, its efficacy in vivo, and its promising safety profile warrant further translational studies to evaluate Annamycin in patients with primary or metastatic lung cancers, as a single agent and in combination with currently used therapeutics.
Annamycin is currently being evaluated in ongoing clinical trials for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases. Annamycin currently has Fast Track Status and Orphan Drug Designation from the FDA for the treatment of relapsed or refractory acute myeloid leukemia, in addition to Orphan Drug Designation for the treatment of soft tissue sarcoma. Furthermore, Annamycin has Orphan Drug Designation for the treatment of relapsed or refractory acute myeloid leukemia from the European Medicines Agency (EMA).
About Moleculin Biotech, Inc.
Moleculin Biotech, Inc. is a Phase 3 clinical stage pharmaceutical company advancing a pipeline of therapeutic candidates addressing hard-to-treat tumors and viruses. The Company's lead program, Annamycin, is a next-generation anthracycline designed to avoid multidrug resistance mechanisms and to eliminate the cardiotoxicity common with currently prescribed anthracyclines. Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases.
The Company is initiating the MIRACLE (Moleculin R/R AML AnnAraC Clinical Evaluation) Trial (MB-108), a pivotal, adaptive design Phase 3 trial evaluating Annamycin in combination with cytarabine, together referred to as AnnAraC, for the treatment of relapsed or refractory acute myeloid leukemia. Following a successful Phase 1B/2 study (MB-106), with input from the FDA, the Company believes it has substantially de-risked the development pathway towards a potential approval for Annamycin for the treatment of AML. This study is subject to appropriate future filings with potential additional feedback from the FDA and their foreign equivalents.
Additionally, the Company is developing WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic and other cancers. Moleculin is also engaged in the development of a portfolio of antimetabolites, including WP1122 for the potential treatment of pathogenic viruses, as well as certain cancer indications.
For more information about the Company, please visit www.moleculin.com and connect on X, LinkedIn and Facebook.
Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, whether the results shown in the animal models can be replicated in clinical trials. Although Moleculin believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin has attempted to identify forward-looking statements by terminology including 'believes,' 'estimates,' 'anticipates,' 'expects,' 'plans,' 'projects,' 'intends,' 'potential,' 'may,' 'could,' 'might,' 'will,' 'should,' 'approximately' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
Investor Contact:
JTC Team, LLC
Jenene Thomas
(908) 824-0775
MBRX@jtcir.com
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SOURCE Moleculin Biotech, Inc.
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