This section highlights FDA-related milestones and regulatory updates for drugs developed by Lantern Pharma (LTRN).
Over the past two years, Lantern Pharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
LP-300, STAR-001, LP-284, LP-184, and RADR. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
LP-300 + Chemotherapy (Harmonic) FDA Regulatory Timeline and Events
LP-300 + Chemotherapy (Harmonic) is a drug developed by Lantern Pharma for the following indication: Never Smokers with Non-Small Cell Lung Cancer (NSCLC).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- LP-300 + Chemotherapy (Harmonic)
- Announced Date:
- April 20, 2026
- Indication:
- Never Smokers with Non-Small Cell Lung Cancer (NSCLC)
Announcement
Lantern Pharma Inc announced it has scheduled a Type C meeting with the U.S. Food and Drug Administration (FDA) for mid-May 2026 to seek feedback on proposed protocol amendments to its ongoing Phase 2 HARMONIC™ clinical trial evaluating LP-300.
AI Summary
Lantern Pharma announced it has scheduled a Type C meeting with the U.S. Food and Drug Administration for mid‑May 2026 to seek feedback on proposed protocol amendments to its ongoing Phase 2 HARMONIC™ trial of LP‑300. The company will ask the FDA for input and concurrence on changes designed to refine the trial design and align it with emerging clinical data and the evolving treatment landscape for TKI‑refractory EGFR‑mutant non‑small cell lung cancer.
The proposed amendments, Lantern says, are supported by exploratory trial findings and aim to better define the target population and trial conduct. Key themes include focusing development on the EGFR L858R subgroup and the never‑smoker biology, emphasizing a differentiated tolerability profile, and addressing a large unmet need in this patient population. Lantern frames the meeting as a collaborative step to determine whether LP‑300 can meaningfully help patients with limited options and to advance an efficient development path.
Read Announcement- Drug:
- LP-300 + Chemotherapy (Harmonic)
- Announced Date:
- March 27, 2025
- Indication:
- Never Smokers with Non-Small Cell Lung Cancer (NSCLC)
Announcement
Lantern Pharma Provides Business Updates
AI Summary
Lantern Pharma provided key business updates alongside its Q4 and full year 2024 financial results. The company highlighted continued progress in its precision oncology programs, with its Phase 2 HARMONIC trial for LP‑300 showing an 86% clinical benefit rate and a 43% objective response rate in never‑smoker NSCLC patients. Lantern is expanding patient enrollment in Japan and Taiwan, regions with a significant percentage of NSCLC cases in never‑smokers, and expects multiple clinical readouts in 2025.
Additionally, Lantern is advancing its clinical pipeline with Phase 1 trials for LP‑184 and LP‑284 in various solid tumors, supported by their RADR® AI platform. This platform helps optimize drug candidates and improve patient targeting by processing extensive oncology data. The company also announced strategic collaborations and plans for further clinical studies, setting the stage for meaningful advancements in oncology treatment options in the near future.
Read Announcement- Drug:
- LP-300 + Chemotherapy (Harmonic)
- Announced Date:
- December 9, 2024
- Indication:
- Never Smokers with Non-Small Cell Lung Cancer (NSCLC)
Announcement
Lantern Pharma Inc announced that the first patient has been enrolled and dosed in Taiwan for its Phase 2 HARMONIC™ clinical trial evaluating LP-300 in never-smoker patients with non-small cell lung cancer (NSCLC) who have progressed after receiving treatment with tyrosine kinase inhibitors (TKIs).
AI Summary
Lantern Pharma Inc. announced that the first patient has been enrolled and dosed in Taiwan as part of its Phase 2 HARMONIC™ clinical trial. The trial is evaluating LP-300 in never-smoker patients with non-small cell lung cancer (NSCLC) who have experienced disease progression after treatment with tyrosine kinase inhibitors (TKIs). This milestone is especially important because over 50% of lung cancer cases in Taiwan occur in never-smokers—a group that shows unique clinical and genetic characteristics compared to smokers. The expansion into Taiwan is part of a broader strategy to advance the trial in Asia, where never-smoker NSCLC cases are more common than in Western populations. Multiple sites across Taiwan are now screening patients, highlighting the region’s potential to accelerate enrollment and address a critical unmet need for targeted cancer therapies. The trial aims to enroll up to 90 patients across two treatment arms.
Read Announcement- Drug:
- LP-300 + Chemotherapy (Harmonic)
- Announced Date:
- November 19, 2024
- Indication:
- Never Smokers with Non-Small Cell Lung Cancer (NSCLC)
Announcement
Lantern Pharma Inc announced that the first patient has been dosed – as part of the expansion cohort – in Japan for its Phase 2 HARMONIC™ clinical trial evaluating LP-300 in never-smoker patients with non-small cell lung cancer (NSCLC) who have progressed after receiving treatment with tyrosine kinase inhibitors (TKIs).
AI Summary
Lantern Pharma Inc. has reached an important milestone by dosing the first patient in Japan as part of the expansion cohort of its Phase 2 HARMONIC™ clinical trial. This trial is evaluating LP-300, a potential new treatment option for never-smoker patients with non-small cell lung cancer (NSCLC) who have progressed after receiving tyrosine kinase inhibitors (TKIs). The study is significant for Asia, where never-smoker NSCLC cases occur at much higher rates—up to 33-40% in Japan—compared to Western regions.
Conducted at five sites across Japan, including the prestigious National Cancer Center Japan, the HARMONIC™ trial aims to address the unmet need in these patients by offering an alternative treatment strategy. With active patient screening already underway at multiple sites in Japan and Taiwan, Lantern Pharma’s expansion into the region is expected to accelerate patient enrollment and potentially improve survival outcomes for this specific patient population.
Read Announcement- Drug:
- LP-300 + Chemotherapy (Harmonic)
- Announced Date:
- August 5, 2024
- Indication:
- Never Smokers with Non-Small Cell Lung Cancer (NSCLC)
Announcement
Lantern Pharma announced positive, preliminary results from the initial patient group in the ongoing HARMONIC™ phase 2 clinical trial.
AI Summary
Lantern Pharma announced positive, preliminary results from the first group of patients enrolled in its ongoing HARMONIC™ Phase 2 clinical trial. This study focuses on never-smokers with lung adenocarcinoma whose tumors have developed resistance to tyrosine kinase inhibitors (TKIs). In this early lead-in group of seven patients, six experienced clinical benefit from the combination of LP-300 with standard chemotherapy. Among these, three patients had a partial response with an average tumor size reduction of 51%, while the other three maintained stable disease with an average reduction of 13%. The overall clinical benefit rate was 86% and the objective response rate was 43%. Importantly, the safety profile was predictable, with no dose limiting toxicities or treatment-related serious adverse events observed. These encouraging initial findings suggest that LP-300 may help overcome treatment resistance and improve outcomes for this challenging patient subgroup.
Read Announcement
STAR-001 FDA Regulatory Events
STAR-001 is a drug developed by Lantern Pharma for the following indication: Pediatric CNS Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- STAR-001
- Announced Date:
- March 27, 2026
- Indication:
- Pediatric CNS Cancer
Announcement
Lantern Pharma Inc announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for STAR-001 in a planned Phase 1 pediatric clinical trial (IND No. 179145).
AI Summary
Lantern Pharma announced that the U.S. Food and Drug Administration has cleared the Investigational New Drug (IND No. 179145) application for STAR-001, allowing a planned Phase 1 pediatric clinical trial to proceed. The multicenter study will test STAR-001 as a single agent and in combination with spironolactone in children with relapsed or refractory central nervous system cancers, including ATRT, DIPG, GBM, medulloblastoma, and ependymoma. The trial will be conducted with POETIC, a network of 14 pediatric cancer centers in the United States, Canada, and Israel.
The open-label, dose-escalation study aims to evaluate safety and dosing as well as the potential benefit of combining STAR-001 with spironolactone. STAR-001 was identified using Lantern’s RADR® AI platform; it is designed to activate inside tumor cells and cause DNA damage, while spironolactone may block tumor DNA repair. The IND clearance is a key step toward testing this targeted strategy in pediatric neuro-oncology. (IND No. 179145)
Read Announcement
LP-284 FDA Regulatory Timeline and Events
LP-284 is a drug developed by Lantern Pharma for the following indication: Hematologic Cancers.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- LP-284
- Announced Date:
- January 20, 2026
- Indication:
- Hematologic Cancers
Announcement
Lantern Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to LP-284 for the treatment of soft tissue sarcomas.
AI Summary
Lantern Pharma announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation to LP-284 for the treatment of soft tissue sarcomas. The designation recognizes LP-284 as a candidate for a rare disease and can help speed development through incentives such as seven years of market exclusivity upon approval, tax credits for clinical trials, FDA fee exemptions, and regulatory support.
LP-284 is a small molecule that works by a synthetic lethal mechanism targeting DNA repair defects through transcription-coupled nucleotide excision repair (TC‑NER). Adult soft tissue sarcomas often show complex genomic alterations, chromosomal instability, and DNA repair deficiencies—features that make them a logical target for LP-284. Lantern’s RADR® AI platform helped identify these DNA repair vulnerabilities as potential biomarkers for response.
The designation covers a patient population of roughly 96,000 new global cases annually and aligns with a market estimated at $2.4 billion in 2025 and projected to reach $4.7 billion by 2035, highlighting a significant unmet medical need.
Read Announcement- Drug:
- LP-284
- Announced Date:
- October 28, 2025
- Indication:
- Hematologic Cancers
Announcement
Lantern Pharma Inc. announced the presentation of clinical data from its ongoing Phase 1 trial of LP-284 at the 25th Annual Lymphoma, Leukemia & Myeloma (LL&M) Congress, held October 14-17, 2025, in New York City.
AI Summary
Lantern Pharma Inc. announced it presented new clinical data for its investigational drug LP-284 at the 25th Annual Lymphoma, Leukemia & Myeloma Congress in New York City, held October 14-17, 2025.
LP-284 uses a differentiated synthetic lethal mechanism to target DNA repair flaws via transcription-coupled nucleotide excision repair, working independently of TP53 mutation status or surface antigen expression. Preclinical studies also show it can overcome resistance to BTK and proteasome inhibitors.
In the Phase 1 trial, a 41-year-old patient with aggressive Grade 3 non-germinal center B-cell DLBCL, who had failed CAR-T therapy and bispecific antibody treatment, achieved a complete metabolic response after two 28-day cycles of LP-284, with non-avid lesions observed on PET scans.
The LL&M Congress poster drew interest from biopharma companies and clinical investigators, highlighting LP-284’s potential both as a monotherapy in the post-immunotherapy setting and in combination with approved antibody therapies.
Read Announcement- Drug:
- LP-284
- Announced Date:
- July 23, 2025
- Indication:
- Hematologic Cancers
Announcement
Lantern Pharma Inc announces that a heavily pretreated patient with aggressive Grade 3 non-germinal center B-cell diffuse large B-cell lymphoma (DLBCL) achieved a complete metabolic response in the ongoing Phase 1 clinical trial of LP-284.
AI Summary
Lantern Pharma Inc. announced that the European Patent Office has issued a notice of allowance for a composition‐of‐matter patent covering its cancer drug candidate LP-284. This allowance follows earlier patent grants in the U.S., Japan, India and Mexico, extending exclusivity through early 2039 and strengthening Lantern’s global intellectual property portfolio.
LP-284 is a next‐generation acylfulvene compound optimized with Lantern’s RADR® artificial intelligence platform. It targets blood cancers driven by DNA damage repair deficiencies and is in an active Phase 1 trial in the U.S. focused on B-cell lymphomas and related malignancies.
In the ongoing Phase 1 study, a heavily pretreated patient with aggressive Grade 3 non-germinal center B-cell diffuse large B-cell lymphoma achieved a complete metabolic response after LP-284 treatment. This marked the first complete metabolic response observed in the trial to date, highlighting LP-284’s early potential in difficult-to-treat cases.
The trial is expected to finish enrolling by late 2025. If continued results confirm safety and efficacy, LP-284 could offer a new option for relapsed or refractory B-cell lymphomas in a market estimated at over $4 billion annually.
Read Announcement- Drug:
- LP-284
- Announced Date:
- July 21, 2025
- Indication:
- Hematologic Cancers
Announcement
Lantern Pharma Inc. announced that the European Patent Office (EPO) has issued a notice of allowance for a composition of matter patent covering its drug candidate LP-284.
AI Summary
Lantern Pharma Inc. announced that the European Patent Office has issued a notice of allowance for a composition of matter patent covering its drug candidate LP-284. The patent is set to grant soon and will secure exclusive rights through early 2039, bolstering Lantern’s global IP portfolio.
This EU allowance builds on similar patent approvals in the U.S., Japan, India, and Mexico. It strengthens the company’s position for future development and commercialization of LP-284, a novel agent designed to target B-cell lymphomas and other malignancies driven by B-cells.
LP-284 is currently in a Phase 1 clinical trial in the United States, aiming for completion in late 2025. The drug candidate addresses a market need worth over $4 billion annually for blood cancers, highlighting its potential to offer new treatment options for patients with aggressive B-cell cancers.
Read Announcement
LP-184 FDA Regulatory Timeline and Events
LP-184 is a drug developed by Lantern Pharma for the following indication: Prostate cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- LP-184
- Announced Date:
- December 3, 2025
- Indication:
- Prostate cancer
Announcement
Lantern Pharma Inc announced additional details and clinical insights from its completed Phase 1a dose-escalation study of LP-184 as well as highlights from its recent webinar.
AI Summary
Lantern Pharma shared additional details and clinical insights from its completed Phase 1a dose‑escalation study of LP‑184 and highlights from a recent webinar. The trial enrolled 63 heavily pretreated patients with advanced solid tumors, many with DNA damage repair (DDR) deficiencies. The study met its primary endpoints for safety and tolerability and established a recommended Phase 2 dose of 0.39 mg/kg IV on Days 1 and 8 of a 21‑day cycle. At or above therapeutic dose levels, LP‑184 showed a 54% disease control rate. Treatment‑related side effects were clinically manageable and included reversible liver enzyme elevations, nausea/vomiting, and low platelets. Several patients with BRCA1, CHEK2, or ATM alterations remain on therapy with 12–23+ months of ongoing benefit and measurable tumor shrinkage.
Lantern’s RADR® AI platform identified PTGR1 as a predictive biomarker; more than 87% of patients exceeded the bioactivation threshold and a diagnostic‑ready RT‑qPCR assay is available for patient selection. The company is planning biomarker‑guided Phase 1b/2 trials in triple‑negative breast cancer, glioblastoma, non‑small cell lung cancer, and urothelial carcinoma. The “Inside The Data” webinar with management and a Fox Chase Cancer Center KOL reviews the mechanism, case studies, and next steps and is available on YouTube.
Read Announcement- Drug:
- LP-184
- Announced Date:
- September 16, 2025
- Indication:
- Prostate cancer
Announcement
Lantern Pharma Inc. announced the successful completion of its Phase 1a clinical trial (NCT05933265) for LP-184.
AI Summary
Lantern Pharma Inc. announced the successful completion of its Phase 1a trial (NCT05933265) for LP-184 in 63 patients with advanced relapsed or refractory solid tumors. The open-label study met all primary endpoints, showing a favorable safety and pharmacokinetic profile with no dose-limiting toxicities and mostly Grade 1–2 adverse events. LP-184 achieved therapeutic concentrations at dose levels ≥0.25 mg/kg and established a recommended Phase 2 dose (RP2D) of 0.39 mg/kg on Days 1 and 8 of a 21-day cycle.
Early antitumor activity was promising: 48 percent of evaluable patients at or above therapeutic doses experienced clinical benefit, including durable responses in glioblastoma multiforme, gastrointestinal stromal tumor, and thymic carcinoma. Biomarker analyses highlighted pronounced tumor reductions in DDR-mutated cancers with CHK2, ATM, and STK11/KEAP1 alterations.
These results position LP-184 for Phase 1b/2 trials as monotherapy or in combination with PARP inhibitors and immunotherapies, initially focusing on triple-negative breast cancer, non-small cell lung cancer, and bladder cancer.
Read Announcement- Drug:
- LP-184
- Announced Date:
- August 6, 2025
- Indication:
- Prostate cancer
Announcement
Starlight Therapeutics, a wholly owned subsidiary of Lantern Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a Phase Ib/2a clinical trial to evaluate STAR-001 (LP-184) in combination with spironolactone for patients with glioblastoma multiforme (GBM) at first progression.
AI Summary
Starlight Therapeutics, a subsidiary of Lantern Pharma Inc., announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug application for a Phase Ib/2a clinical trial. This study will evaluate STAR-001 (LP-184) in combination with spironolactone for patients with glioblastoma multiforme at first progression.
The trial (IND 178511) will assess the safety, tolerability and early signs of effectiveness of the combination in recurrent GBM, one of the most aggressive brain cancers. GBM makes up about 15% of all brain tumors and has a median survival of roughly 12 months, with fewer than 5% of patients living beyond five years.
STAR-001 is a brain-penetrant, synthetically lethal DNA-damaging agent, while spironolactone helps block DNA repair by degrading ERCC3. Together, they aim to exploit repair defects in GBM cells, potentially overcoming treatment resistance.
Starlight plans to start the Phase Ib/2a trial in late 2025 or early 2026, subject to funding. The company will share updates on trial setup, patient enrollment and initial results as they become available.
Read Announcement- Drug:
- LP-184
- Announced Date:
- May 29, 2025
- Indication:
- Prostate cancer
Announcement
Lantern Pharma Inc. announced promising preclinical data for LP-184 in atypical teratoid rhabdoid tumors (ATRT), a rare and aggressive pediatric brain cancer.
AI Summary
Lantern Pharma Inc. announced promising preclinical results for its drug candidate LP-184 in treating atypical teratoid rhabdoid tumors (ATRT), a rare and aggressive pediatric brain cancer. Independent research from Johns Hopkins University presented at a recent neuro-oncology conference demonstrated that LP-184 significantly improved survival rates in mouse models. In one model, the median survival increased from 20 days to 89 days, and in another model, from 68 days to 98 days, highlighting LP-184’s potent anti-tumor activity. The data also showed that LP-184 effectively reduced cancer cell growth, increased cell death, and successfully penetrated the blood-brain barrier, all without apparent toxicity.
This compelling preclinical evidence supports Lantern Pharma’s plans to move forward with pediatric clinical trials beginning in late 2025 or early 2026, offering hope for improved treatment options for children suffering from this devastating disease.
Read Announcement- Drug:
- LP-184
- Announced Date:
- May 15, 2025
- Indication:
- Prostate cancer
Announcement
Lantern Pharma Inc. announced operational highlights
AI Summary
Lantern Pharma Inc. announced key operational highlights for the first quarter of 2025. The company is nearing the completion of its LP-184 Phase 1a clinical trial enrollment, expecting to include 62–65 patients with various solid tumors by the end of June 2025. Additionally, Lantern anticipates a new patient data readout from its LP-300 HARMONIC trial for non-small cell lung cancer in Q3 2025, which will include results from an Asian expansion cohort.
Lantern also highlighted significant advances in its RADR® AI platform. An innovative ADC development module was added, and the company filed a patent application for a blood–brain barrier penetration prediction tool, receiving a favorable report with no significant prior art. Lantern plans to release select RADR® modules to the scientific community, supporting collaborative innovation in cancer drug development while maintaining a strong financial position for future operations.
Read Announcement- Drug:
- LP-184
- Announced Date:
- May 12, 2025
- Indication:
- Prostate cancer
Announcement
Lantern Pharma Tell Benzinga Co. Secures FDA Clerance For Planned Phase 1b/2 Trial Of LP-184 In Biomarker-Defined, Treatment-Resistant NSCLC Patients With High Unmet Clinical Need
AI Summary
The FDA has granted clearance to Lantern Pharma Inc. for an amended Investigational New Drug application, allowing the company to launch a Phase 1b/2 trial of LP-184 in a specific group of advanced non-small cell lung cancer (NSCLC) patients. This unique trial targets individuals with high-risk NSCLC characterized by genetic mutations such as KEAP1 and/or STK11 along with low levels of PD-L1 expression.
In this study, LP-184 will be used in combination with Bristol-Myers Squibb’s immune checkpoint inhibitors Opdivo (nivolumab) and Yervoy (ipilimumab). The trial is set to evaluate the safety of this treatment approach, gather early evidence of its effectiveness, and study relevant biomarkers. Lantern Pharma aims to leverage the trial results to pursue fast track or accelerated approval, addressing a serious unmet need for treatment-resistant NSCLC patients.
Read Announcement- Drug:
- LP-184
- Announced Date:
- May 5, 2025
- Indication:
- Prostate cancer
Announcement
Lantern Pharma Tells Benzinga Co. Advances Drug Candidate LP-184 With IND Clearance For Phase 1b/2 Trial In Triple Negative Breast Cancer
AI Summary
Lantern Pharma recently received IND clearance from the FDA to begin a Phase 1b/2 trial for its LP-184 treatment in triple-negative breast cancer (TNBC). The trial will have two parts. The first part is an open-label study where approximately 30 patients with advanced TNBC will receive LP-184 alone to help find the best dose while assessing safety and early signs of effectiveness. The second part tests LP-184 in combination with olaparib for patients with BRCA1 or BRCA2 alterations who have already received other treatments. Early studies in animal models showed that LP-184 could help overcome resistance to PARP inhibitors. This trial aims to provide important data on safety and optimal dosing, and the results may lead to a faster regulatory approval path for LP-184 as a promising option for TNBC patients.
Read Announcement- Drug:
- LP-184
- Announced Date:
- December 3, 2024
- Indication:
- Prostate cancer
Announcement
Lantern Pharma Inc announced that the FDA has granted Fast Track Designation for investigational drug candidate, LP-184, for treatment of Triple Negative Breast Cancer (TNBC).
AI Summary
Lantern Pharma Inc announced that the U.S. FDA has granted Fast Track Designation to its investigational drug candidate LP-184 for the treatment of Triple Negative Breast Cancer (TNBC). This designation aims to speed up the review process for therapies that address urgent medical needs in serious conditions. TNBC affects nearly 29,000 patients in the U.S. each year, with over 50% of patients relapsing within 3–5 years. Early studies have shown that LP-184 can significantly slow tumor growth, including in cases resistant to other treatments like PARP inhibitors, and it may work well with checkpoint inhibitors. The drug is now being evaluated in a Phase 1A clinical trial across multiple solid tumors, including TNBC. The Fast Track Designation will allow Lantern Pharma to work closely with the FDA during development, potentially speeding access to this promising treatment for patients in need.
Read Announcement- Drug:
- LP-184
- Announced Date:
- November 26, 2024
- Indication:
- Prostate cancer
Announcement
Lantern Pharma Inc announced the presentation of new preclinical data and Phase 1b trial design for LP-184 (to be developed as STAR-001 for CNS indications) in glioblastoma at the Society for Neuro-Oncology (SNO) 2024 Annual Meeting in Houston, Texas.
AI Summary
Lantern Pharma Inc. recently announced new preclinical data and a detailed Phase 1b trial design for LP-184, to be developed as STAR-001 for central nervous system (CNS) indications in glioblastoma. The Phase 1b trial, to be presented at the SNO 2024 Annual Meeting in Houston, Texas, will evaluate LP-184 both as a stand-alone treatment and in combination with spironolactone. Preclinical studies have shown that adding spironolactone can increase glioblastoma cell sensitivity to LP-184 by up to six-fold. This enhanced response is believed to be due to the degradation of ERCC3, which makes the cancer cells less able to repair damage. The advanced brain penetrance properties of LP-184 together with its promising mechanism of action highlight its potential as a new treatment option for patients with recurrent glioblastoma, a disease with very limited effective therapies.
Read Announcement- Drug:
- LP-184
- Announced Date:
- September 23, 2024
- Indication:
- Prostate cancer
Announcement
Lantern Pharma Inc. announced that the company has been granted three rare pediatric disease designations (RPDD) by the FDA.
AI Summary
Lantern Pharma Inc., an artificial intelligence company focused on developing cancer therapies, announced that the FDA has granted three rare pediatric disease designations for its drug candidate LP-184. The designations address malignant rhabdoid tumors, rhabdomyosarcoma, and hepatoblastoma, which are serious cancers affecting a small number of children in the United States. These awards recognize LP-184’s potential to treat life-threatening pediatric conditions with few available treatment options.
The FDA’s Rare Pediatric Disease designation could help speed up the drug development process. It may also make Lantern Pharma eligible for a Priority Review Voucher if LP-184 gains marketing approval, potentially shortening review times for future applications. Early evidence from studies has shown promise in tumor regression and improved patient outcomes, offering new hope for children with these devastating cancers.
Read Announcement- Drug:
- LP-184
- Announced Date:
- August 7, 2024
- Indication:
- Prostate cancer
Announcement
Lantern Pharma announced a significant advancement demonstrating the preclinical synergy of LP-184 with checkpoint inhibitors and the ability of LP-184 to resensitize tumors that have become non-responsive to Anti-PD1 therapies.
AI Summary
Lantern Pharma announced a significant breakthrough in its preclinical studies, demonstrating that its experimental drug LP-184 can work in synergy with checkpoint inhibitors. The drug was shown to re‑sensitize tumors that stopped responding to anti‑PD1 therapies in animal models of triple negative breast cancer. By combining LP‑184 with an anti‑PD1 agent, researchers observed a stronger anti‑tumor response, offering hope for patients with cancers that no longer respond to standard immunotherapy.
The results suggest that LP‑184 can change "cold" tumors, which are usually resistant to immunotherapy, into "hot" tumors that respond better by affecting the tumor microenvironment. This includes modifying T cell activity and reducing immunosuppressive M2 macrophages. Lantern Pharma will present these findings at The Immuno‑Oncology Summit 2024 in Philadelphia, potentially paving the way for new combination treatment strategies in oncology.
Read Announcement
RADR FDA Regulatory Timeline and Events
RADR is a drug developed by Lantern Pharma for the following indication: AI platform to accelerate and optimize the development of antibody-drug conjugates (ADCs).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- RADR
- Announced Date:
- July 31, 2025
- Indication:
- AI platform to accelerate and optimize the development of antibody-drug conjugates (ADCs).
Announcement
Lantern Pharma Inc. ( announced the successful completion of targeted enrollment for its Phase 2 HARMONIC™ clinical trial in Japan.
AI Summary
Lantern Pharma Inc. announced the successful completion of targeted enrollment for its Phase 2 HARMONIC™ clinical trial in Japan. The company enrolled 10 never-smoker non-small cell lung cancer (NSCLC) patients ahead of schedule at five sites, including the National Cancer Center Japan.
The trial is testing LP-300 in combination with carboplatin and pemetrexed in patients whose cancer progressed after tyrosine kinase inhibitors. Japan was chosen because 35–40% of new NSCLC cases occur in never-smokers, compared to about 15% in Western populations.
There are no therapies approved specifically for never-smoker NSCLC, a market worth over $4 billion annually. Lantern will keep enrolling patients in Taiwan and the United States and expects to share data from all cohorts by the end of the third quarter of 2025.
Read Announcement- Drug:
- RADR
- Announced Date:
- July 15, 2025
- Indication:
- AI platform to accelerate and optimize the development of antibody-drug conjugates (ADCs).
Announcement
Lantern Pharma Inc announced the launch of an innovative AI-powered module within its proprietary RADR® platform, designed to predict the activity and efficacy of combination regimens involving DNA-damaging agents (DDAs) and DNA damage response inhibitors (DDRis) in clinical cancer treatment.
AI Summary
Lantern Pharma Inc. has launched an innovative AI-powered module within its RADR® platform. This new tool is designed to predict the activity and effectiveness of combination treatments that pair DNA-damaging agents (DDAs) with DNA damage response inhibitors (DDRis). The AI module was trained using data from 221 clinical trials and uses advanced machine learning techniques to analyze genomic, transcriptomic, and clinical data. It aims to identify the most promising drug combinations while assessing safety and key biomarker signatures, which may help pinpoint patients who could benefit the most from these tailored therapies.
The development is a significant step in precision oncology. By focusing on combinations that target the DNA damage response, this approach could streamline the development process and lower costs, addressing a rapidly growing combination cancer therapy market projected to exceed $50 billion in the coming years.
Read Announcement- Drug:
- RADR
- Announced Date:
- January 27, 2025
- Indication:
- AI platform to accelerate and optimize the development of antibody-drug conjugates (ADCs).
Announcement
Lantern Pharma Inc. announced advancements in the application of its RADR® AI platform to accelerate and optimize the development of antibody-drug conjugates (ADCs).
AI Summary
Lantern Pharma Inc. has announced significant developments with its RADR® AI platform aimed at speeding up the creation of antibody-drug conjugates (ADCs), which are innovative cancer treatments combining antibodies with potent drugs. This new advancement leverages AI to sift through large amounts of complex biological data, helping to quickly and accurately identify promising ADC targets and payload molecules. By integrating diverse data types and mutation profiles, the platform can pinpoint more effective therapeutic combinations, potentially reducing the time and cost involved in ADC development by up to 50% and 60% respectively. These improvements could pave the way for more targeted, safer treatments for cancer patients while opening up new opportunities for pharmaceutical partnerships and drug innovation in the growing ADC market.
Read Announcement
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