Lantern Pharma's Investigational Drug-Candidate, LP-184, Receives Second Fast Track Designation from FDA for Treatment of Triple Negative Breast Cancer (TNBC)
Lantern Pharma (NASDAQ: LTRN) announced that its drug candidate LP-184 received FDA Fast Track Designation for treating Triple Negative Breast Cancer (TNBC), marking its second such designation in 2024 following one for Glioblastoma. TNBC affects approximately 29,000 patients annually in the US, with over 50% relapsing within 3-5 years. LP-184, currently in Phase 1A clinical trials, has shown significant preclinical efficacy in TNBC models, including tumor regression of 107-141% in PDX models. The drug has demonstrated promising synergy with checkpoint inhibitors and effectiveness against PARP inhibitor-resistant cases.
Lantern Pharma (NASDAQ: LTRN) ha annunciato che il suo candidato farmaco LP-184 ha ricevuto la Designazione Fast Track dalla FDA per il trattamento del Cancro Mammario Triplo Negativo (TNBC), segnando la sua seconda designazione di questo tipo nel 2024, dopo quella per il Glioblastoma. Il TNBC colpisce circa 29.000 pazienti ogni anno negli Stati Uniti, con oltre il 50% che recidiva entro 3-5 anni. LP-184, attualmente in fase di sperimentazione clinica di Fase 1A, ha mostrato una significativa efficacia preclinica nei modelli di TNBC, inclusa una regressione tumorale del 107-141% nei modelli PDX. Il farmaco ha dimostrato una promettente sinergia con gli inibitori del checkpoint e un'efficacia contro i casi resistenti agli inibitori PARP.
Lantern Pharma (NASDAQ: LTRN) anunció que su candidato a fármaco LP-184 recibió la Designación Fast Track de la FDA para el tratamiento del Cáncer de Mama Triple Negativo (TNBC), marcando su segunda designación de este tipo en 2024, después de la de Glioblastoma. El TNBC afecta a aproximadamente 29,000 pacientes anualmente en EE. UU., con más del 50% recayendo en un período de 3 a 5 años. LP-184, actualmente en ensayos clínicos de Fase 1A, ha mostrado una eficacia preclínica significativa en modelos de TNBC, incluida una regresión tumoral del 107-141% en modelos PDX. El fármaco ha demostrado una prometedora sinergia con inhibidores de puntos de control y efectividad en casos resistentes a inhibidores de PARP.
Lantern Pharma (NASDAQ: LTRN)는 자사의 약물 후보 LP-184가 삼중음성 유방암(TNBC) 치료를 위해 FDA의 패스트 트랙 지정을 받았다고 발표했습니다. 이는 2024년 글리오블라스토마에 대한 첫 번째 지정에 이어 두 번째 지정입니다. TNBC는 미국에서 매년 약 29,000명의 환자에게 영향을 미치며, 3-5년 이내에 50% 이상이 재발합니다. 현재 임상 시험 1A 단계에 있는 LP-184는 TNBC 모델에서 107-141%의 종양 퇴축을 포함하여 상당한 전임상 효능을 보여주었습니다. 이 약물은 체크포인트 억제제와의 유망한 시너지 효과를 입증했으며 PARP 억제제 저항성 사례에 대해서도 효과적입니다.
Lantern Pharma (NASDAQ: LTRN) a annoncé que son candidat-médicament LP-184 a reçu la désignation Fast Track de la FDA pour le traitement du cancer du sein triple négatif (TNBC), marquant sa deuxième désignation de ce type en 2024, après celle pour le glioblastome. Le TNBC touche environ 29 000 patients chaque année aux États-Unis, avec plus de 50 % qui récidivent dans les 3 à 5 ans. LP-184, actuellement en essais cliniques de phase 1A, a montré une efficacité préclinique significative dans les modèles de TNBC, y compris une régression tumorale de 107 à 141 % dans les modèles PDX. Le médicament a démontré une synergie prometteuse avec les inhibiteurs de point de contrôle et une efficacité contre les cas résistants aux inhibiteurs de PARP.
Lantern Pharma (NASDAQ: LTRN) gab bekannt, dass sein Arzneikandidaten LP-184 von der FDA die Fast-Track-Designierung zur Behandlung von Triple-negativem Brustkrebs (TNBC) erhalten hat, was die zweite solche Designierung im Jahr 2024 darstellt, nach der für Glioblastom. TNBC betrifft jährlich etwa 29.000 Patienten in den USA, wobei über 50 % innerhalb von 3-5 Jahren rückfällig werden. LP-184, das sich derzeit in klinischen Phase-1A-Studien befindet, hat eine signifikante präklinische Wirksamkeit in TNBC-Modellen gezeigt, einschließlich eines Tumorrückgangs von 107-141 % in PDX-Modellen. Das Medikament hat vielversprechende Synergien mit Checkpoint-Inhibitoren und Wirksamkeit gegen PARP-Inhibitor-resistente Fälle gezeigt.
- Received FDA Fast Track Designation for TNBC treatment, potentially expediting regulatory review
- Second Fast Track Designation in 2024, showing multiple potential applications
- Demonstrated significant preclinical efficacy with 107-141% tumor regression in TNBC models
- Shows synergy with checkpoint inhibitors, potentially expanding treatment options
- Still in early Phase 1A trials, with significant development stages ahead
- Efficacy data to preclinical studies, no human trial results yet
Insights
The FDA's Fast Track Designation for LP-184 in TNBC represents a significant regulatory milestone. The designation acknowledges both the serious nature of TNBC, affecting 29,000 US patients annually and LP-184's promising preclinical data. Key highlights include demonstrated tumor regression of 107-141% in TNBC PDX models and synergistic potential with checkpoint inhibitors.
The dual Fast Track Designations (TNBC and GBM) within months signal strong regulatory confidence in LP-184's potential. The ongoing Phase 1A trial across multiple solid tumors will be important in validating the preclinical efficacy. The high relapse rate of
For a small-cap biotech with a market cap of
The integration of AI through the RADR® platform in drug development adds a competitive edge, potentially reducing development costs and improving success rates. Investors should monitor the Phase 1A trial progress closely, as positive safety data could trigger significant value inflection points and potential partnership discussions.
- This is the second Fast Track Designation granted to LP-184 in 2024, following the designation for Glioblastoma (GBM) announced in October 2024.
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Fast Track Designation for LP-184 recognizes TNBC as a serious condition impacting approximately 29,000 patients annually in the US, with over
50% of patients relapsing within 3-5 years. - LP-184 has demonstrated significant preclinical efficacy in TNBC models, including those resistant to PARP inhibitors, and recent data shows promising synergy with checkpoint inhibitors in TNBC.
- Fast Track Designation is designed to expedite FDA review of important new drugs to treat serious conditions and fill an unmet medical need.
- LP-184 is currently being evaluated in a Phase 1A clinical trial (NCT05933265) across multiple solid tumor indications, including TNBC.
LP-184 demonstrated tumor regression of 107
LP-184 is currently in a Phase 1A clinical trial designed to evaluate the safety and tolerability of this synthetically lethal investigational drug candidate in a broad range of solid tumors, including TNBC. LP-184 was optimized and advanced in part with Lantern's AI platform, RADR®, which helped validate mechanisms that could be exploited in the clinical setting to eradicate challenging cancers and uncover insights in targeted patient populations.
"Receiving a second FDA Fast Track Designation for LP-184 reinforces the significant potential of this drug candidate to address critical unmet needs in aggressive cancers, especially those like TNBC where patients have limited therapeutics options," stated Panna Sharma, President and CEO of Lantern Pharma. "Recent data presented at the Immuno-Oncology Summit demonstrated LP-184's ability to sensitize TNBC tumors that are non-responsive to checkpoint inhibitors, potentially expanding treatment options for patients with limited therapeutic choices."
About TNBC and the Need for Novel Therapies
TNBC represents approximately
Compelling Preclinical Data Demonstrates LP-184's Potential in TNBC
The graph above demonstrates LP-184's remarkable anti-tumor activity across a panel of 10 TNBC patient-derived xenograft (PDX) models. Notably, LP-184 showed consistent efficacy in both PARPi (PARP inhibitor) resistant and PARPi sensitive tumors, with treatment resulting in complete tumor regression (107
LP-184's unique mechanism of action is driven by the enzymatic activation of the drug by Prostaglandin Reductase 1 (PTGR1), which converts LP-184 into its highly potent cytotoxic form specifically within cancer cells. RADR® platform analysis and subsequent in-vivo validation studies have shown that PTGR1 is frequently elevated in TNBC tumors compared to normal tissue, making these cancers particularly susceptible to LP-184 treatment. This biomarker-driven approach allows for the potential identification of patients most likely to respond to LP-184 therapy, aligning with current and emerging precision medicine approaches in TNBC treatment.
About LP-184
LP-184 is a small molecule drug candidate and next-generation acylfulvene that preferentially damages DNA in cancer cells that overexpress specific biomarkers or harbor mutations in DNA damage repair pathways. LP-184 was developed using Lantern's proprietary RADR® AI platform to identify patient populations and cancer subtypes that have the potential to respond to treatment. The compound is being evaluated in multiple solid tumors where it has shown nanomolar potency and activity in drug-resistant cancers. LP-184 has received Orphan Drug Designations from the FDA for the treatment of pancreatic cancer, glioblastoma (GBM), and ATRT, and has also been granted a Rare Pediatric Disease Designation for ATRT.
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. Our lead development programs include a Phase 2 clinical program and multiple Phase 1 clinical trials. 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 STATEMENT:
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