LAVA Doses First Patient in Phase 1 LAVA-1266 Study in Hematological Cancers
LAVA Therapeutics (NASDAQ: LVTX) has announced the dosing of the first patient in its Phase 1 clinical trial of LAVA-1266, a CD123-targeted Gammabody® bispecific gamma delta T cell engager. The study focuses on treating hematologic cancers, specifically acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).
The first-in-human study is being conducted in Australia, evaluating LAVA-1266's safety, pharmacokinetics, pharmacodynamic properties, and potential activity. The company expects to release initial Phase 1 data by year-end 2025. Preclinical models demonstrated tumor cell lysis with off-target effects, suggesting potential advantages over earlier CD123-targeted therapies that were by on-target, off-tumor toxicity, cytokine release syndrome, and capillary leak syndrome.
LAVA Therapeutics (NASDAQ: LVTX) ha annunciato la somministrazione della prima dose a un paziente nel suo studio clinico di fase 1 riguardante LAVA-1266, un bispecific gamma delta T cell engager mirato al CD123. Lo studio si concentra sul trattamento dei tumori ematologici, in particolare leucemia mieloide acuta (AML) e sindrome mielodisplastica (MDS).
Lo studio, primo nella storia umana, viene condotto in Australia e valuta la sicurezza, la farmacocinetica, le proprietà farmacodinamiche e l'attività potenziale di LAVA-1266. L'azienda prevede di rilasciare i dati iniziali di fase 1 entro la fine del 2025. I modelli preclinici hanno dimostrato una lisi delle cellule tumorali con effetti fuori bersaglio, suggerendo vantaggi potenziali rispetto a terapie mirate al CD123 precedenti, caratterizzate da tossicità on-target e off-tumor, sindrome da rilascio di citochine e sindrome da perdita capillare.
LAVA Therapeutics (NASDAQ: LVTX) ha anunciado la dosificación del primer paciente en su ensayo clínico de fase 1 de LAVA-1266, un gamabody® bispecífico dirigidos a CD123 para activar células T gamma delta. El estudio se centra en el tratamiento de cánceres hematológicos, específicamente leucemia mieloide aguda (AML) y sindrome mielodisplásica (MDS).
El estudio en humanos se está llevando a cabo en Australia, evaluando la seguridad, farmacocinética, propiedades farmacodinámicas y actividad potencial de LAVA-1266. La compañía espera publicar datos iniciales de la fase 1 para finales de 2025. Los modelos preclínicos demostraron lisis de células tumorales con efectos fuera de objetivo, sugiriendo ventajas potenciales sobre terapias previas dirigidas a CD123 que presentaron toxicidad on-target, off-tumor, síndrome de liberación de citoquinas y síndrome de fuga capilar.
LAVA Therapeutics (NASDAQ: LVTX)는 LAVA-1266에 대한 1상 임상 시험에서 첫 번째 환자에게 투약을 발표했습니다. 이는 CD123를 표적으로 하는 Gammabody® 이중 특정 감마델타 T 세포 결합제입니다. 이 연구는 급성 골수성 백혈병 (AML)과 골수 이형성 증후군 (MDS)이라는 혈액암 치료에 초점을 맞추고 있습니다.
인간에서 처음으로 시행되는 이 연구는 호주에서 진행되며 LAVA-1266의 안전성, 약리학적 작용, 약리역학적 특성 및 잠재적 활동을 평가하고 있습니다. 이 회사는 2025년 연말까지 1상 초기 데이터를 발표할 계획입니다. 전임상 모델에서는 목표 외 효과와 함께 종양 세포의 용해가 확인되었으며, 이는 이전의 CD123 표적 치료법보다 잠재적인 이점을 제시합니다. 이전 치료법들은 목표에서의 독성과 비종양, 사이토카인 방출 증후군 및 모세혈관 누수 증후군의 문제를 겪었습니다.
LAVA Therapeutics (NASDAQ: LVTX) a annoncé le dosage du premier patient dans son essai clinique de phase 1 pour LAVA-1266, un engageur de cellules T gamma delta bispécifique ciblant le CD123. L'étude se concentre sur le traitement des cancers hématologiques, en particulier leucémie myéloïde aiguë (AML) et syndrome myélodysplasique (MDS).
L'étude de première intention chez l'homme est menée en Australie, évaluant la sécurité, la pharmacocinétique, les propriétés pharmacodynamiques et l'activité potentielle de LAVA-1266. La société prévoit de publier les premières données de phase 1 d'ici la fin de l'année 2025. Les modèles précliniques ont montré une lyse cellulaire tumorale avec des effets hors cible, suggérant des avantages potentiels par rapport aux thérapies précédemment ciblées sur le CD123, qui étaient affectées par la toxicité on-target, off-tumor, le syndrome de libération de cytokines et le syndrome de fuite capillaire.
LAVA Therapeutics (NASDAQ: LVTX) hat die Dosierung des ersten Patienten in seiner klinischen Phase-1-Studie zu LAVA-1266 bekannt gegeben, einem CD123-zielgerichteten Gammabody® bispezifischen Gamma-Delta-T-Zell-Engager. Die Studie konzentriert sich auf die Behandlung von hämatologischen Krebserkrankungen, insbesondere akuter myeloischer Leukämie (AML) und myelodysplastischem Syndrom (MDS).
Die erste Studie am Menschen wird in Australien durchgeführt und bewertet die Sicherheit, Pharmakokinetik, pharmakodynamische Eigenschaften und mögliche Aktivitäten von LAVA-1266. Das Unternehmen erwartet, die ersten Daten der Phase 1 bis Ende 2025 zu veröffentlichen. Vorklinische Modelle zeigten eine Tumorzelllyse mit Off-Target-Effekten und deuteten auf potenzielle Vorteile im Vergleich zu früheren CD123-zielgerichteten Therapien hin, die von On-Target-, Off-Tumor-Toxizität, Zytokinfreisetzungssyndrom und kapillaren Lecksyndrom betroffen waren.
- Successful initiation of Phase 1 clinical trial with first patient dosed
- Preclinical data showed tumor cell lysis with off-target effects
- Potential advantages over previous CD123-targeted therapies
- Initial Phase 1 data not expected until end of 2025
- Early-stage clinical development with uncertain outcomes
Insights
This Phase 1 clinical trial initiation for LAVA-1266 represents a pivotal milestone in addressing significant unmet needs in hematological malignancies. The compound's unique Gammabody® platform targeting CD123 could potentially overcome historical challenges faced with previous CD123-targeted therapies.
The trial's strategic focus on AML and MDS is noteworthy - these are aggressive blood cancers with poor prognosis and treatment options. Previous CD123-targeted approaches have been hampered by serious safety concerns, including cytokine release syndrome and capillary leak syndrome. LAVA-1266's preclinical data suggesting improved safety profile through selective targeting could be a game-changing differentiator.
The Australian trial location is strategically advantageous, potentially accelerating the development timeline due to the region's streamlined regulatory pathways. The promised year-end 2025 data readout timeline appears realistic for initial safety and pharmacokinetic results from the dose escalation phase.
For a micro-cap biotech with a market cap of just
Investors should note that LAVA maintains full rights to LAVA-1266, preserving significant value potential. The Australian trial strategy typically reduces clinical development costs by
While early-stage biotechs carry inherent risks, LAVA's focused approach on addressing known safety limitations of existing CD123 therapies could position them favorably for potential partnerships or acquisition interest from larger pharmaceutical companies seeking to expand their hematological cancer portfolios.
- LAVA-1266 is a potent and selective bispecific anti-CD123 Gammabody®
- First-in-human study enrolling adult patients with CD123-expressing AML or MDS
- Initial Phase 1 data read-out expected by year-end 2025
UTRECHT, The Netherlands and PHILADELPHIA, Jan. 10, 2025 (GLOBE NEWSWIRE) -- LAVA Therapeutics N.V. (NASDAQ: LVTX, “LAVA,” “the Company”), a clinical-stage immuno-oncology company focused on developing its proprietary Gammabody® platform of bispecific gamma delta T cell engagers, announced dosing of the first patient in the Phase 1, first-in-human study of the CD123-targeted Gammabody®, LAVA-1266, an investigational agent in development for the treatment of hematologic cancers including acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).
“We are pleased to announce the dosing of the first patient with LAVA-1266, a potent and selective CD123-targeted Gammabody®. Based on the positive results of preclinical models showing tumor cell lysis with limited off-target effects, we believe that LAVA-1266’s preclinical safety and efficacy profile supports its potential as a treatment for AML and MDS,” said Stephen Hurly, President and Chief Executive Officer of LAVA Therapeutics. “We are eager to evaluate the safety, pharmacokinetics and pharmacodynamic properties and potential activity of LAVA-1266 and provide initial results from the dose escalation study by the end of the year.”
“CD123 is well-recognized as a potential therapeutic target for AML. However, the opportunity for earlier generations of CD123-targeted therapies has been limited by on-target, off-tumor toxicity, cytokine release syndrome and capillary leak syndrome,” said Charles Morris, MD, Chief Medical Officer of LAVA Therapeutics. “We are enthusiastic about LAVA-1266 based on its strong preclinical profile, and we look forward to working with our clinical study sites in Australia.”
About LAVA-1266
LAVA-1266 is a potent bi-specific, T cell engager (bsTCE) that targets CD123+ tumor cells with Vγ9Vδ2-T cells using LAVA’s Gammabody® platform. The bsTCE was designed to lyse CD123+ tumor cells with high potency and a wide therapeutic window.
Preclinical studies confirmed target cell expression by showing CD123+ expression and the presence of Vγ9Vδ2-T cells in AML patient samples. In preclinical studies, LAVA showed that LAVA-1266 preferentially targets and kills CD123 cells and induces Vγ9Vδ2-T cell activation. Furthermore, in preclinical studies, LAVA demonstrated that treatment with LAVA-1266 produces high levels of specific tumor cell lysis, with substantially less cytokine release, compared to CD3-based T cell engagers, and increased survival in an AML xenograft model, without the co-activation of immunosuppressive regulatory T cells.
About the Phase 1 First-in-human Study of LAVA-1266 (ACTRN12624001214527)
The open-label, multi-center Phase 1, first-in-human study of LAVA-1266 is currently being conducted in Australia. The study will include a dose escalation and dose expansion segment to evaluate LAVA-1266 in approximately 50 adults with CD123+ relapsed/refractory acute myeloid leukemia (AML) and certain grades of myelodysplastic syndrome (intermediate risk, high risk or extremely high risk). Patients will be dosed every two weeks (Q2W), with an initial target dose of 100 µg for the first cohort.
The study will evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity and preliminary anti-tumor activity.
About LAVA Therapeutics
LAVA Therapeutics N.V. is a clinical-stage immuno-oncology company focused on advancing its proprietary Gammabody® platform to develop a portfolio of bispecific gamma-delta T cell engagers for the potential treatment of solid tumors and hematologic malignancies. The Company utilizes bispecific antibodies engineered to selectively kill cancer cells by triggering Vγ9Vδ2 (Vgamma9 Vdelta2) T cell anti-tumor effector functions upon cross-linking to tumor-associated antigens.
LAVA’s pipeline includes three internal and partnered clinical-stage bispecific gamma-delta T cell engagers for the treatment of solid tumor and hematological cancers including LAVA 1266, targeting CD123+ cancers (ACTRN12624001214527); PF-08046052, targeting EGFR (NCT05983133); and JNJ-89853413, targeting hematological cancers (NCT06618001). The pipeline also includes preclinical programs. For more information on LAVA, please visit our website at www.lavatherapeutics.com, or follow us on LinkedIn, X, and YouTube.
Gammabody® is a registered trademark of LAVA Therapeutics N.V.
LAVA’s Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipate”, “believe”, “could”, “will”, “may”, “expect”, “should”, “plan”, “intend”, “estimate”, “potential”, “suggests”, and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on LAVA’s expectations and assumptions as of the date of this press release and are subject to various risks and uncertainties that may cause actual results to differ materially from these forward-looking statements. Forward-looking statements contained in this press release include but are not limited to statements relating to the therapeutic potential, development strategy and potential uses of LAVA’s product candidates, including LAVA-1266, the timing of initiation of clinical trials and achievement of clinical milestones, LAVA’s cash runway and the sufficiency of resources to pursue development activities, progress and data from clinical trials, and the ability of LAVA’s product candidates to treat various tumor targets and improve patient outcomes. Many factors, risks and uncertainties may cause differences between current expectations and actual results, including, among other things, the Company’s ability to leverage its initial programs to develop additional product candidates using its Gammabody® platform, the failure of LAVA’s collaborators to support or advance collaborations or LAVA’s product candidates, the timing and results of LAVA’s research and development programs and preclinical and clinical trials, the possibility that clinical trials may fail to establish sufficient efficacy, the risk that adverse events or safety signals may occur in clinical trials, the risk that results obtained in preclinical studies or clinical trials to date may not be indicative of results obtained in ongoing or future trials, the risk that adverse regulatory actions or other setbacks could occur in clinical trials even after promising results in earlier clinical trials or preclinical studies, the Company’s ability to obtain regulatory approval for and commercialize its product candidates, and the risk that setbacks in development could occur as a result of the difficulty and uncertainty of pharmaceutical product development and other factors. There may be adverse effects on the Company’s business condition and results from general economic and market conditions and overall fluctuations in the United States and international equity markets, including as a result of inflation, heightened interest rates, recent and potential future pandemics and other health crises, and hostilities, including between Russia and escalating tension in the Middle East. These and other risks are described in greater detail under the caption “Risk Factors” in LAVA’s most recent Annual Report on Form 20-F and other filings the Company makes with the Securities and Exchange Commission. LAVA assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
CONTACTS
Investor Relations
ir@lavatherapeutics.com
LifeSci Advisors (IR/Media)
Joyce Allaire
Jallaire@lifesciadvisors.com
FAQ
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