I-Mab Presents Positive Uliledlimab Pharmacokinetics Data at 2024 World Conference on Lung Cancer
I-Mab (NASDAQ: IMAB) presented positive pharmacokinetics data for uliledlimab, a CD73-targeting antibody, at the 2024 World Conference on Lung Cancer. The data, derived from three Phase 1 studies, supports dosing strategies for upcoming clinical trials. Key findings include:
- 95% of the simulated population achieved target threshold with 30 mg/kg of uliledlimab
- Positive correlation between uliledlimab concentration and overall response rate probability in mNSCLC patients
- CD73 receptor occupancy in peripheral B cells reached and maintained at 90% or above
- 30 mg/kg dose with a single boost on C1D8 maintained target concentration of 80 μg/mL
A randomized Phase 2 study of uliledlimab combined with pembrolizumab and chemotherapy is expected to begin in 1H 2025.
I-Mab (NASDAQ: IMAB) ha presentato dati di farmacocinetica positivi per uliledlimab, un anticorpo mirato al CD73, durante la Conferenza Mondiale sul Cancro ai Polmoni del 2024. I dati, derivati da tre studi di Fase 1, supportano le strategie di dosaggio per i prossimi studi clinici. I principali risultati includono:
- Il 95% della popolazione simulata ha raggiunto la soglia target con 30 mg/kg di uliledlimab
- Correlazione positiva tra la concentrazione di uliledlimab e la probabilità di risposta globale nei pazienti con mNSCLC
- Occupazione del recettore CD73 nelle cellule B periferiche raggiunta e mantenuta al 90% o superiore
- Il dosaggio di 30 mg/kg con un singolo rinforzo il C1D8 ha mantenuto una concentrazione target di 80 μg/mL
Uno studio randomizzato di Fase 2 di uliledlimab combinato con pembrolizumab e chemioterapia dovrebbe iniziare nel 1H 2025.
I-Mab (NASDAQ: IMAB) presentó datos de farmacocinética positivos para uliledlimab, un anticuerpo dirigido a CD73, en la Conferencia Mundial sobre Cáncer de Pulmón de 2024. Los datos, derivados de tres estudios de Fase 1, respaldan las estrategias de dosificación para los próximos ensayos clínicos. Los hallazgos clave incluyen:
- El 95% de la población simulada alcanzó el umbral objetivo con 30 mg/kg de uliledlimab
- Correlación positiva entre la concentración de uliledlimab y la probabilidad de tasa de respuesta global en pacientes con mNSCLC
- Ocupación del receptor CD73 en células B periféricas alcanzada y mantenida al 90% o más
- La dosis de 30 mg/kg con un solo refuerzo en C1D8 mantuvo una concentración objetivo de 80 μg/mL
Se espera que un estudio aleatorizado de Fase 2 de uliledlimab combinado con pembrolizumab y quimioterapia comience en el 1H 2025.
I-Mab (NASDAQ: IMAB)는 2024 세계 폐암 회의에서 CD73를 겨냥한 항체인 uliledlimab의 긍정적인 약리학적 데이터 발표했습니다. 이 데이터는 세 가지 1상 연구에서 파생되었으며 향후 임상 시험을 위한 투여 전략을 지원합니다. 주요 발견 내용은 다음과 같습니다:
- 95%의 시뮬레이션된 인구가 30 mg/kg의 uliledlimab로 목표 임계값에 도달했습니다.
- mNSCLC 환자에서 uliledlimab의 농도와 전체 반응률 확률 간의 긍정적인 상관관계
- 말초 B 세포에서 CD73 수용체 점유율이 90% 이상에 도달하고 유지됨
- C1D8에서의 단일 부스터와 함께 30 mg/kg의 용량이 80 μg/mL의 목표 농도를 유지했습니다.
uliledlimab과 pembrolizumab 및 화학요법을 병용한 무작위 2상 연구는 2025년 상반기에 시작될 것으로 예상됩니다.
I-Mab (NASDAQ: IMAB) a présenté des données pharmacocinétiques positives pour uliledlimab, un anticorps ciblant le CD73, lors de la Conférence Mondiale sur le Cancer du Poumon en 2024. Les données, dérivées de trois études de Phase 1, soutiennent les stratégies de dosage pour les prochains essais cliniques. Les principales conclusions incluent :
- 95 % de la population simulée a atteint le seuil cible avec 30 mg/kg d'uliledlimab
- Corrélation positive entre la concentration d'uliledlimab et la probabilité de taux de réponse global chez les patients atteints de mNSCLC
- Occupation du récepteur CD73 dans les cellules B périphériques atteinte et maintenue à 90 % ou plus
- La dose de 30 mg/kg avec un seul renforcement le C1D8 a maintenu une concentration cible de 80 μg/mL
Une étude de Phase 2 randomisée sur uliledlimab associé à pembrolizumab et à la chimiothérapie devrait commencer au premier semestre 2025.
I-Mab (NASDAQ: IMAB) hat auf der Weltkonferenz über Lungenkrebs 2024 positive pharmakokinetische Daten zu uliledlimab, einem auf CD73 zielenden Antikörper, präsentiert. Die Daten stammen aus drei Phase-1-Studien und unterstützen Dosierungsstrategien für bevorstehende klinische Studien. Die wichtigsten Ergebnisse umfassen:
- 95 % der simulierten Bevölkerung erreichten die Zielschwelle mit 30 mg/kg uliledlimab
- Positive Korrelation zwischen der Konzentration von uliledlimab und der Gesamtansprechrate bei mNSCLC-Patienten
- CD73-Rezeptorbesetzung in peripheren B-Zellen wurde bei 90 % oder mehr erreicht und gehalten
- Die Dosis von 30 mg/kg mit einem einzigen Boost am C1D8 hielt eine Zielkonzentration von 80 μg/mL aufrecht.
Eine randomisierte Phase-2-Studie zu uliledlimab in Kombination mit Pembrolizumab und Chemotherapie wird voraussichtlich im 1. Halbjahr 2025 beginnen.
- Positive correlation between uliledlimab concentration and overall response rate probability in mNSCLC patients
- 95% of simulated population achieved target threshold with 30 mg/kg dose
- CD73 receptor occupancy in peripheral B cells reached and maintained at 90% or above
- 30 mg/kg dose with single boost maintained target concentration of 80 μg/mL
- Planned Phase 2 study combining uliledlimab with pembrolizumab and chemotherapy in 1H 2025
- None.
Insights
The PK/PD modeling data for uliledlimab presented at WCLC 2024 provides valuable insights into its potential as a CD73 inhibitor for mNSCLC treatment. Key findings include:
- 95% of the simulated population achieved target threshold with 30 mg/kg dose
- Positive correlation between uliledlimab concentration and ORR probability
- CD73 receptor occupancy in B cells maintained at >90%
- 80 μg/mL Ctrough target threshold associated with PFS benefit
These results support the dosing strategy for upcoming clinical trials and suggest uliledlimab's potential efficacy in combination with immunotherapy. However, it's important to note that Phase 2 trials are yet to begin and real-world efficacy remains to be established.
The data presented for uliledlimab is promising for mNSCLC treatment. By targeting CD73, it aims to reduce adenosine-driven immunosuppression in the tumor microenvironment. This approach could potentially enhance the efficacy of existing immunotherapies like pembrolizumab. The positive exposure-response relationship and high receptor occupancy are encouraging. However, it's important to remember that PK/PD data, while informative, doesn't guarantee clinical success. The upcoming randomized Phase 2 study combining uliledlimab with pembrolizumab and chemotherapy will be important in determining its real-world efficacy and safety profile in mNSCLC patients.
For I-Mab (NASDAQ: IMAB), this data represents a positive step in their clinical pipeline. The PK/PD results support advancing uliledlimab to Phase 2 trials, potentially accelerating the drug's development timeline. However, investors should note that the next major catalyst - the Phase 2 study initiation - is not expected until 1H 2025. This timeline suggests a long runway before potential commercialization. While the data is encouraging, it's important to consider that many promising cancer drugs fail in later-stage trials. I-Mab's financial position and ability to fund ongoing research will be important factors to monitor in the interim.
- Pharmacokinetic/pharmacodynamic (PK/PD) modeling data from three Phase 1 studies providing dosing support for upcoming clinical trials
- Exposure-Response (E-R) Analysis showed a positive correlation between uliledlimab concentration and ORR probability in mNSCLC patients
- Randomized Phase 2 study of uliledlimab in combination with pembrolizumab plus chemotherapy expected to begin in 1H 2025
Uliledlimab (TJ004309) is an antibody designed to target CD73, the rate-limiting enzyme critical for adenosine-driven immunosuppression in the tumor microenvironment. Blocking CD73 allows anti-tumor immunity to proceed without the presence of an adenosine-induced "immunological fog". The WCLC 2024 presentation includes data from uliledlimab PK/PD analyses from three Phase 1 studies including patients with treatment naïve metastatic non-small cell lung cancer (mNSCLC).
"The PK/PD analysis presented at WCLC underscores our view that uliledlimab has the potential to be a differentiated, best-in-class, CD73 inhibitor. The data support our dose selection work and upcoming combination studies, with a study of uliledlimab plus pembrolizumab plus chemotherapy expected to begin in the first half of 2025," said Phillip Dennis, MD, PhD, Chief Medical Officer of I-Mab. "We are particularly encouraged by the E-R analysis, which showed a positive relationship between uliledlimab exposure and the probability of an overall response in patients with NSCLC, as well as positive target engagement data and dose proportional PK results. These data, plus a previously presented favorable safety profile and clinical efficacy, fortify our view that uliledlimab has the potential to meaningfully improve the care of patients with mNSCLC."
Poster Title: Integrated PK/PD Modeling for Uliledlimab, an Anti-CD73 Monoclonal
Antibody, in Non-Small Cell Lung Cancer Patients (Poster #2979)
Data are based on analysis of three Phase 1 studies conducted in
Key Findings Include:
- Most of the simulated population (
95% ) could achieve the target threshold with 30 mg/kg of uliledlimab - Integrated PK/PD modeling and pharmacometrics analyses indicate there is a positive relationship between the probability of overall response and uliledlimab trough concentration in NSCLC patients
- CD73 receptor occupancy (RO) in peripheral B cells achieved
90% or above and maintained at high levels until the end of treatment - The 30 mg/kg dose with a single boost dose on C1D8 provided uliledlimab concentrations that achieved the target concentration of 80 μg/mL immediately after the first dose and maintained this threshold afterward
- A Ctrough target threshold of 80 μg/mL may be clinically meaningful, associated with PFS benefit and is achievable by a 30 mg/kg initial dose followed by a booster dose on Cycle 1, Day 8 (C1D8)
A full copy of the poster is available on the I-Mab website, on the "Innovation, Publications & Presentations" tab.
About I-Mab
I-Mab (NASDAQ: IMAB) is a
Forward Looking Statements
This announcement contains forward-looking statements. These statements are made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as "will", "expects", "believes", "designed to", "anticipates", "future", "intends", "plans", "potential", "estimates", "confident", and similar terms or the negative thereof. I-Mab may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the "SEC"), in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about I-Mab's beliefs and expectations, are forward-looking statements. Forward-looking statements in this press release include, without limitation, statements regarding: the Company's pipeline and capital strategy, including the Company's stock repurchase program; the projected advancement of the Company's portfolio and anticipated milestones and related timing; the market opportunity and I-Mab's potential next steps (including the potential expansion, differentiation, or commercialization) for uliledlimab, givastomig and ragistomig; the Company's expectations regarding the impact of data from ongoing and future clinical trials; the Company's financial condition and results of operations and anticipated changes in the Company's revenues or expenses; the Company's expectations regarding its cash runway; timing and progress of studies and trials (including with respect to patient enrollment); and the availability of data and information from ongoing studies and trials. Forward-looking statements involve inherent risks and uncertainties that may cause actual results to differ materially from those contained in these forward-looking statements, including but not limited to the following: I-Mab's ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may or may not support further development or New Drug Application/Biologics License Application (NDA/BLA) approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of I-Mab's drug candidates; I-Mab's ability to achieve commercial success for its drug candidates, if approved; I-Mab's ability to obtain and maintain protection of intellectual property for its technology and drugs; I-Mab's reliance on third parties to conduct drug development, manufacturing and other services; and I-Mab's limited operating history and I-Mab's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates, as well as those risks more fully discussed in the "Risk Factors" section in I-Mab's most recent annual report on Form 20-F, as well as discussions of potential risks, uncertainties, and other important factors in I-Mab's subsequent filings with the SEC. All forward-looking statements are based on information currently available to I-Mab. I-Mab undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law.
I-Mab Contacts
Investors & Media |
Tyler Ehler |
Senior Director, Investor Relations |
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