Lantern Pharma Announces First Patient Dosed in Japan for The Expansion Cohort in The Phase 2 HARMONIC™ Clinical Trial of LP-300 in Never-Smoker NSCLC Patients
Lantern Pharma (NASDAQ: LTRN) has announced the first patient dosing in Japan for its Phase 2 HARMONIC™ clinical trial of LP-300 in never-smoker NSCLC patients. The trial, now expanded to ten sites across Japan and Taiwan, focuses on patients who have progressed after TKI treatment. Initial results from the U.S. trial showed an 86% clinical benefit rate and 43% objective response rate among the first seven patients. The expansion is significant as NSCLC in never-smokers occurs 2-3 times more frequently in East Asian countries, with Japan reporting 33-40% of new lung cancer cases in never-smokers.
Lantern Pharma (NASDAQ: LTRN) ha annunciato la somministrazione del primo paziente in Giappone per il suo studio clinico di Fase 2 HARMONIC™ su LP-300 in pazienti con NSCLC mai fumatori. Lo studio, ora ampliato a dieci siti in Giappone e Taiwan, si concentra su pazienti che hanno mostrato progressione dopo il trattamento con TKI. I risultati iniziali dallo studio negli Stati Uniti hanno mostrato un tasso di beneficio clinico dell'86% e un tasso di risposta obiettiva del 43% tra i primi sette pazienti. L'espansione è significativa poiché il NSCLC nei mai fumatori si verifica con una frequenza 2-3 volte maggiore nei paesi dell'Asia orientale, con il Giappone che riporta il 33-40% dei nuovi casi di cancro ai polmoni in mai fumatori.
Lantern Pharma (NASDAQ: LTRN) ha anunciado la dosificación del primer paciente en Japón para su ensayo clínico de Fase 2 HARMONIC™ de LP-300 en pacientes con NSCLC que nunca han fumado. El ensayo, ahora expandido a diez sitios en Japón y Taiwán, se centra en pacientes que han progresado después del tratamiento con TKI. Los resultados iniciales del ensayo en EE. UU. mostraron una tasa de beneficio clínico del 86% y una tasa de respuesta objetiva del 43% entre los primeros siete pacientes. La expansión es significativa, ya que el NSCLC en nunca fumadores ocurre 2-3 veces más frecuentemente en los países del este asiático, siendo Japón responsable del 33-40% de los nuevos casos de cáncer de pulmón en nunca fumadores.
Lantern Pharma (NASDAQ: LTRN)는 일본에서 비흡연 NSCLC 환자를 위한 LP-300의 2상 HARMONIC™ 임상 시험에서 첫 환자의 투약을 발표했습니다. 이 시험은 현재 일본과 대만의 10개 사이트로 확대되었으며, TKI 치료 후 진행된 환자에게 초점을 맞추고 있습니다. 미국 임상 시험의 초기 결과는 첫 7명의 환자에서 86%의 임상 이익률과 43%의 객관적 반응률을 보여주었습니다. 이 확대는 비흡연자 NSCLC가 동아시아 국가에서 2-3배 더 빈번하게 발생하며, 일본에서는 비흡연자의 새로운 폐암 사례가 33-40%를 차지한다는 점에서 중요합니다.
Lantern Pharma (NASDAQ: LTRN) a annoncé le premier dosage de patient au Japon pour son essai clinique de Phase 2 HARMONIC™ sur LP-300 chez des patients atteints de NSCLC n'ayant jamais fumé. L'essai, désormais étendu à dix sites au Japon et à Taïwan, se concentre sur des patients ayant progressé après un traitement par TKI. Les résultats initiaux de l'essai aux États-Unis ont montré un taux de bénéfice clinique de 86 % et un taux de réponse objective de 43 % parmi les sept premiers patients. Cette expansion est significative puisque le NSCLC chez les non-fumeurs se produit 2-3 fois plus fréquemment dans les pays d'Asie de l'Est, le Japon rapportant 33-40 % des nouveaux cas de cancer du poumon chez les non-fumeurs.
Lantern Pharma (NASDAQ: LTRN) hat die Verabreichung des ersten Patienten in Japan für seine Phase 2 HARMONIC™-Studie zu LP-300 bei nie rauchenden NSCLC-Patienten bekannt gegeben. Die Studie wurde inzwischen auf zehn Standorte in Japan und Taiwan ausgeweitet und konzentriert sich auf Patienten, die nach einer TKI-Behandlung Fortschritte gemacht haben. Die ersten Ergebnisse der US-Studie zeigten eine klinische Nutzenrate von 86 % und eine objektive Ansprechrate von 43 % unter den ersten sieben Patienten. Diese Erweiterung ist bedeutend, da NSCLC bei nie Rauchenden in ostasiatischen Ländern 2-3 Mal häufiger vorkommt, wobei Japan 33-40 % der neuen Lungenkrebsfälle bei nie Rauchenden meldet.
- Preliminary U.S. trial results showed 86% clinical benefit rate and 43% objective response rate
- Expansion into high-prevalence Asian markets (2-3x higher rates than US/Europe)
- Strategic entry into Japan where 33-40% of new lung cancer cases are never-smokers
- None.
Insights
The expansion of the HARMONIC trial into Japan represents a strategic advancement in LP-300's clinical development. The 86% clinical benefit rate and 43% objective response rate from the initial safety cohort are particularly noteworthy, suggesting promising efficacy. The expansion into Asian markets is especially significant given the 2-3x higher prevalence of never-smoker NSCLC in East Asian populations.
The trial's focus on patients who have progressed after TKI treatment addresses a critical market gap. Japan's higher proportion of never-smoker NSCLC patients (33-40% of new cases) provides an excellent opportunity for accelerated enrollment and potential market penetration. The involvement of the National Cancer Center Japan and Dr. Yasushi Goto adds considerable credibility to the trial.
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Ten clinical trial sites across
Japan andTaiwan are actively screening patients, with additional sites expected to also begin patient enrollment in the coming months
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U.S. clinical sites continue to actively screen and dose patients in both the LP-300 combination arm and the standard-of-care control arm of the Harmonic trial
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Non-small cell lung cancer (NSCLC) in never smokers occurs at rates 2 to 3 times higher in East Asian countries versus the US and
Europe .
The dosing of the first patient in
"The initiation of patient dosing in
Dr. Reggie Ewesuedo, VP of Clinical Development at Lantern Pharma commented, "This marks the achievement of a significant milestone for the Harmonic Trial. It is the beginning of an anticipated acceleration in enrollment following activation of sites in
The expansion into
ABOUT THE HARMONIC™ TRIAL
The HARMONIC™ trial is a multicenter, open-label, randomized Phase 2 trial designed to evaluate the efficacy and safety of LP-300 in combination with standard-of-care chemotherapy (pemetrexed/carboplatin) versus chemotherapy alone. The trial is expected to enroll approximately 90 patients across sites in
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 billions of 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
- Harmonic Trial: www.harmonictrial.com
- LinkedIn: https://www.linkedin.com/company/lanternpharma/
- X: @lanternpharma
FORWARD LOOKING STATEMENT:
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 able to secure sufficient future funding when needed and as required to advance and support our existing and planned clinical trials and operations, (iv) the risk that we may not be successful in licensing potential candidates or in completing potential partnerships and collaborations, (v) 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, (vi) 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 (vii) 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.
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