Lantern Pharma’s Investigational Drug-Candidate, LP-184, Receives Fast-Track Designation in Glioblastoma from the FDA
Lantern Pharma's investigational drug-candidate, LP-184, has received Fast Track Designation from the FDA for the treatment of Glioblastoma (GBM). This designation is designed to expedite FDA review of important new drugs for serious conditions with unmet medical needs. GBM affects over 13,000 U.S. adults annually and approximately 300,000 globally. LP-184, to be developed as STAR-001 by Starlight Therapeutics (a Lantern Pharma subsidiary), has the potential to be the first new GBM drug in over 20 years.
LP-184 is currently in a Phase 1A clinical trial evaluating its safety and tolerability in various solid tumors, including GBM. The drug was optimized using Lantern's AI platform, RADR®, which has over 100 billion data points and aids in cancer therapy discovery and development. A Phase 1b/2a clinical trial for recurrent GBM is targeted to start in late 2024/early 2025.
Il candidato farmaco in fase di investigazione di Lantern Pharma, LP-184, ha ricevuto la Designazione Fast Track dalla FDA per il trattamento del Glioblastoma (GBM). Questa designazione è pensata per accelerare la revisione da parte della FDA di nuovi farmaci importanti per condizioni gravi con bisogni medici insoddisfatti. Il GBM colpisce oltre 13.000 adulti negli Stati Uniti ogni anno e circa 300.000 a livello globale. LP-184, che sarà sviluppato come STAR-001 da Starlight Therapeutics (una sussidiaria di Lantern Pharma), ha il potenziale per essere il primo nuovo farmaco per il GBM in oltre 20 anni.
LP-184 è attualmente in una studio clinico di Fase 1A che valuta la sua sicurezza e tollerabilità in vari tumori solidi, incluso il GBM. Il farmaco è stato ottimizzato utilizzando la piattaforma AI di Lantern, RADR®, che ha oltre 100 miliardi di punti dati e aiuta nella scoperta e nello sviluppo della terapia per il cancro. Un studio clinico di Fase 1b/2a per il GBM ricorrente è previsto per iniziare a fine 2024/inizio 2025.
El candidato a medicamento en investigación de Lantern Pharma, LP-184, ha recibido la Designación de Vía Rápida de la FDA para el tratamiento de glioblastoma (GBM). Esta designación está diseñada para acelerar la revisión por parte de la FDA de nuevos medicamentos importantes para condiciones graves con necesidades médicas no satisfechas. El GBM afecta a más de 13,000 adultos en EE. UU. anualmente y aproximadamente 300,000 a nivel mundial. LP-184, que se desarrollará como STAR-001 por Starlight Therapeutics (una subsidiaria de Lantern Pharma), tiene el potencial de ser el primer nuevo medicamento para el GBM en más de 20 años.
LP-184 está actualmente en un ensayo clínico de Fase 1A que evalúa su seguridad y tolerabilidad en varios tumores sólidos, incluyendo el GBM. El medicamento fue optimizado utilizando la plataforma de IA de Lantern, RADR®, que cuenta con más de 100 mil millones de puntos de datos y ayuda en el descubrimiento y desarrollo de terapias contra el cáncer. Se prevé que un ensayo clínico de Fase 1b/2a para GBM recurrente comience a finales de 2024/principios de 2025.
Lantern Pharma의 실험적 약물 후보인 LP-184가 Glioblastoma (GBM) 치료를 위해 FDA로부터 신속 심사 지정(Fast Track Designation)을 받았습니다. 이 지정은 중대한 의학적 필요를 충족하지 못하는 심각한 질환에 대해 중요한 새로운 약물에 대한 FDA의 심사를 신속하게 할 수 있도록 설계되었습니다. GBM은 매년 13,000명 이상의 미국 성인을 영향을 미치며, 전 세계적으로는 약 300,000명에 이릅니다. LP-184는 Lantern Pharma의 자회사인 Starlight Therapeutics (명칭: STAR-001)에 의해 개발될 것이며, 20년 이상 만에 첫 번째 새로운 GBM 약물이 될 가능성을 가지고 있습니다.
현재 LP-184는 1A상 임상 시험에 있으며, 다양한 고형 종양, GBM을 포함하여 안전성과 내약성을 평가하고 있습니다. 이 약물은 Lantern의 AI 플랫폼인 RADR®를 사용하여 최적화되었으며, 이 플랫폼은 1,000억 개 이상의 데이터 포인트를 보유하고 있으며 암 치료법 발견 및 개발에 도움을 줍니다. 재발성 GBM에 대한 1b/2a상 임상 시험이 2024년 말에서 2025년 초에 시작될 예정입니다.
Le candidat médicament investigational de Lantern Pharma, LP-184, a reçu la Dénomination Fast Track de la FDA pour le traitement du glioblastome (GBM). Cette dénomination est conçue pour accélérer l'examen par la FDA de nouveaux médicaments importants pour des conditions graves ayant des besoins médicaux non satisfaits. Le GBM affecte plus de 13 000 adultes aux États-Unis chaque année et environ 300 000 à l'échelle mondiale. LP-184, qui sera développé sous le nom de STAR-001 par Starlight Therapeutics (une filiale de Lantern Pharma), a le potentiel d'être le premier nouveau médicament pour le GBM en plus de 20 ans.
LP-184 est actuellement en essai clinique de Phase 1A évaluant sa sécurité et sa tolérance dans divers tumours solides, y compris le GBM. Le médicament a été optimisé en utilisant la plateforme d'IA de Lantern, RADR®, qui dispose de plus de 100 milliards de points de données et aide à la découverte et au développement des thérapies anticancéreuses. Un essai clinique de Phase 1b/2a pour le GBM récurrent est prévu pour débuter fin 2024/début 2025.
Der investigationalen Arzneikandidat von Lantern Pharma, LP-184, hat von der FDA die Fast Track Designation zur Behandlung von Glioblastom (GBM) erhalten. Dieses Designation dient dazu, die FDA-Prüfung wichtiger neuer Medikamente für schwere Erkrankungen mit unerfüllten medizinischen Bedürfnissen zu beschleunigen. GBM betrifft jährlich über 13.000 Erwachsene in den USA und etwa 300.000 weltweit. LP-184, das als STAR-001 von Starlight Therapeutics (einer Tochtergesellschaft von Lantern Pharma) entwickelt wird, hat das Potenzial, das erste neue GBM-Medikament seit über 20 Jahren zu werden.
LP-184 befindet sich derzeit in einer Phase 1A klinischen Studie, die seine Sicherheit und Verträglichkeit bei verschiedenen soliden Tumoren, einschließlich GBM, bewertet. Das Medikament wurde unter Verwendung der KI-Plattform von Lantern, RADR®, optimiert, die über 100 Milliarden Datenpunkte verfügt und bei der Entdeckung und Entwicklung von Krebstherapien unterstützt. Eine Phase 1b/2a klinische Studie für wiederkehrendes GBM ist für Ende 2024/Anfang 2025 geplant.
- Fast Track Designation received for LP-184 in Glioblastoma treatment
- Potential to be the first new drug for GBM in over 20 years
- Currently in Phase 1A clinical trial for solid tumors including GBM
- Utilization of AI platform RADR® with over 100 billion data points for drug development
- Phase 1b/2a clinical trial for recurrent GBM not starting until late 2024/early 2025
Insights
The FDA's Fast Track Designation for LP-184 in Glioblastoma (GBM) is a significant milestone for Lantern Pharma. This designation acknowledges the urgent need for new treatments in GBM, a devastating brain cancer with poor prognosis. LP-184's potential as the first new GBM drug in over two decades is particularly noteworthy.
The upcoming phase 1b/2a trial, slated for late 2024/early 2025, will be crucial in determining LP-184's efficacy and safety in recurrent GBM patients. The Fast Track status could accelerate the drug's path to market if clinical results are positive.
Lantern's use of AI in drug development, through their RADR® platform, is an innovative approach that could potentially reduce costs and timelines in oncology drug discovery. This AI-driven method may give Lantern a competitive edge in identifying promising drug candidates and optimal patient populations.
Lantern Pharma's Fast Track Designation for LP-184 is a positive catalyst for the company's stock. This designation often leads to increased investor interest and can potentially accelerate the drug's path to market, which is important for a company with a
The GBM market, affecting over 300,000 patients globally, represents a significant commercial opportunity. If LP-184 proves successful, it could capture a substantial market share, given the lack of new treatments in the past 20 years.
Investors should monitor the upcoming phase 1b/2a trial closely, as positive results could drive substantial stock appreciation. However, it's important to note that the trial is still over a year away and biotech investments carry high risks, especially for early-stage companies like Lantern Pharma.
- Fast Track Designation is designed to expedite FDA review of important new drugs to treat serious conditions and fill an unmet medical need.
-
Fast Track Designation for LP-184 (STAR-001) recognizes Glioblastoma (GBM) as a serious condition impacting more than 13,000
U.S. adults each year and approximately 300,000 globally. - A phase 1b/2a clinical trial for recurrent GBM is targeted to start in late 2024/early 2025.
- LP-184, which will be developed as STAR-001 for CNS and other neuro-oncology indications by Starlight Therapeutics, a wholly owned subsidiary of Lantern Pharma, has the potential to be the first new drug for treating GBM in more than 20 years.
About GBM and the need for improved and novel therapies.
Glioblastoma (GBM) affects nearly 13,000 patients annually in the US and approximately 300,000 globally, with a mortality rate of
No new drugs for GBM have been approved in over two decades. Lantern Pharma is advancing LP-184, a molecule which demonstrates synthetic lethality when combined with agents that cause DNA damage repair deficiency.2 Additionally, LP-184 has shown that it causes double-stranded breaks in the DNA of recurrent GBM (rGBM) cancer cells in multiple in-vivo models and is currently being advanced in early clinical stage studies.
“Receiving FDA Fast Track Designation for Lantern Pharma’s LP-184 in GBM reinforces our belief that this drug-candidate can help in the critical need to find effective treatment options for patients with GBM and further supports the potential of LP-184 to address the challenges in aggressive CNS cancers, where patients have a critical need for novel and life extending therapies” said Panna Sharma, President and CEO of Lantern Pharma.
Current status of LP-184 & STAR-001 in clinical trials & development
LP-184 is currently being studied in a phase 1A clinical trial to evaluate the safety, tolerability and maximum tolerated dose (MTD) of the potential therapy in a wide range of tumors, including GBM. The full study design can be viewed here (clinicaltrials.gov). Once the MTD has been established, Lantern has plans to advance the drug-candidate LP-184 as STAR-001 through its wholly owned subsidiary, Starlight Therapeutics, in GBM and other CNS and brain cancers.
Lantern also anticipates further using RADR® to determine potential additional suitability for LP-184 in combination with other approved agents for the control of cancer progression in multiple other patient subgroups. Lantern has provided information on the development of LP-184 in GBM and has also discussed its plan to advance STAR-001 (LP-184 for CNS cancers) in multiple publicly available webinars, including on:
- June 26, 2024 — STAR-001 in Multiple Brain and CNS Cancers with Dr. Marc Chamberlain, and
- July 31, 2024 — Born from AI, Lighting The Way in CNS Cancer Treatment with Mr. Panna Sharma.
The proposed goals for the development of Phase 1b/2a clinical studies are targeting a rGBM specific trial to begin in late 2024 or early 2025. This trial is being planned to assess LP-184 in a Phase 1b/2a study as mono-therapy and in combination with spironolactone in rGBM to assess safety, pharmacokinetics and preliminary efficacy. Concurrently, Lantern will conduct a retrospective correlative analysis of multiple key markers of DNA damage as exploratory endpoints. EGFR expression or mutation status, MGMT status and expression of DNA damage repair pathway are also planned to be studied as potential response predictors to help inform and guide future late-stage trials and to stratify enrollment.
About the FDA Fast Track process
The FDA’s Fast Track process is designed to facilitate development and expedite the review of therapies intended to treat serious conditions and address unmet medical needs to potentially bring important new medicines to patients sooner. Companies whose programs are granted Fast Track Designation are eligible for more frequent interactions with the FDA during clinical development. For more information on Fast Track designation, please visit the FDA’s website at www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track.
About Lantern Pharma:
Lantern Pharma (NASDAQ: LTRN) is an AI company transforming the cost, pace, and timeline of oncology drug discovery and development. Our proprietary AI and machine learning (ML) platform, RADR®, leverages over 100 billion oncology-focused data points and a library of 200+ advanced ML algorithms to help solve billion-dollar, real-world problems in oncology drug development. By harnessing the power of AI and with input from world-class scientific advisors and collaborators, we have accelerated the development of our growing pipeline of therapies that span multiple cancer indications, including both solid tumors and blood cancers and an antibody-drug conjugate (ADC) program. On average, our newly developed drug programs have been advanced from initial AI insights to first-in-human clinical trials in 2-3 years and at approximately
Our lead development programs include a Phase 2 clinical program and multiple Phase 1 clinical trials. We have also established a wholly-owned subsidiary, Starlight Therapeutics, to focus exclusively on the clinical execution of our promising therapies for CNS and brain cancers, many of which have no effective treatment options. Our AI-driven pipeline of innovative product candidates is estimated to have a combined annual market potential of over
Please find more information at:
- Website: www.lanternpharma.com
- LinkedIn: https://www.linkedin.com/company/lanternpharma/
- X: @lanternpharma
Forward-looking Statements:
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, among other things, statements relating to: future events or our future financial performance; the potential advantages of our RADR® platform in identifying drug candidates and patient populations that are likely to respond to a drug candidate; our strategic plans to advance the development of our drug candidates and antibody drug conjugate (ADC) development program; estimates regarding the development timing for our drug candidates and ADC development program; expectations and estimates regarding clinical trial timing and patient enrollment; our research and development efforts of our internal drug discovery programs and the utilization of our RADR® platform to streamline the drug development process; our intention to leverage artificial intelligence, machine learning and genomic data to streamline and transform the pace, risk and cost of oncology drug discovery and development and to identify patient populations that would likely respond to a drug candidate; estimates regarding patient populations, potential markets and potential market sizes; sales estimates for our drug candidates and our plans to discover and develop drug candidates and to maximize their commercial potential by advancing such drug candidates ourselves or in collaboration with others. Any statements that are not statements of historical fact (including, without limitation, statements that use words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," “model,” "objective," "aim," "upcoming," "should," "will," "would," or the negative of these words or other similar expressions) should be considered forward-looking statements. There are a number of important factors that could cause our actual results to differ materially from those indicated by the forward-looking statements, such as (i) the risk that our research and the research of our collaborators may not be successful, (ii) the risk that observations in preclinical studies and early or preliminary observations in clinical studies do not ensure that later observations, studies and development will be consistent or successful, (iii) the risk that we may not be successful in licensing potential candidates or in completing potential partnerships and collaborations, (iv) the risk that none of our product candidates has received FDA marketing approval, and we may not be able to successfully initiate, conduct, or conclude clinical testing for or obtain marketing approval for our product candidates, (v) the risk that no drug product based on our proprietary RADR® AI platform has received FDA marketing approval or otherwise been incorporated into a commercial product, and (vi) those other factors set forth in the Risk Factors section in our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission on March 18, 2024. You may access our Annual Report on Form 10-K for the year ended December 31, 2023 under the investor SEC filings tab of our website at www.lanternpharma.com or on the SEC's website at www.sec.gov. Given these risks and uncertainties, we can give no assurances that our forward-looking statements will prove to be accurate, or that any other results or events projected or contemplated by our forward-looking statements will in fact occur, and we caution investors not to place undue reliance on these statements. All forward-looking statements in this press release represent our judgment as of the date hereof, and, except as otherwise required by law, we disclaim any obligation to update any forward-looking statements to conform the statement to actual results or changes in our expectations.
1 In patients with glioblastoma (GBM) an aggressive and severe type of brain tumor, the cancer medicine temozolomide is more effective in those with a methylation of the gene's promoter. Overall, MGMT methylation or hyper-methylation is associated with prolonged patient survival in clinical prediction models, while under-methylation or no-methylation can be derived as a result of exposure to temozolomide and cause resistance to temozolomide therapy and therefore no benefit from the use of temozolomide in GBM.
2 Bachchu Lal, Aditya Kulkarni, Joseph McDermott, Rana Rais, Jesse Alt, Ying Wu, Hernando Lopez-Bertoni, Sophie Sall, Umesh Kathad, Jianli Zhou, Barbara S. Slusher, Kishor Bhatia, John Laterra; Preclinical Efficacy of LP-184, a Tumor Site Activated Synthetic Lethal Therapeutic, in Glioblastoma. Clin Cancer Res 15 October 2023; 29 (20): 4209 4218. https://doi.org/10.1158/1078-0432.CCR-23-0673
View source version on businesswire.com: https://www.businesswire.com/news/home/20241015926202/en/
Investor Relations
mailto: ir@lanternpharma.com
ph: (972) 277-1136
Source: Lantern Pharma Inc.
FAQ
What is the Fast Track Designation granted to Lantern Pharma's LP-184 (LTRN)?
How many people are affected by Glioblastoma according to Lantern Pharma (LTRN)?
What is the current clinical trial status of LP-184 (LTRN)?
How does Lantern Pharma (LTRN) use AI in drug development?
