Kalaris Therapeutics Now Enrolling Phase 1b/2 Multiple Ascending Dose Study of TH103 in Neovascular Age-Related Macular Degeneration
Kalaris Therapeutics (NASDAQ:KLRS) has initiated enrollment for a Phase 1b/2 multiple ascending dose (MAD) study of TH103 in patients with neovascular age-related macular degeneration (nAMD). The study will evaluate up to 80 nAMD patients who will receive up to 4 monthly intravitreal injections of TH103.
The company expects to report initial data from the ongoing Phase 1a single ascending dose study in Q4 2025, with Phase 1b/2 data anticipated in 2H 2026. TH103, developed by Lasker Award recipient Dr. Napoleone Ferrara, represents a novel approach to treating exudative and neovascular retinal diseases, building on anti-VEGF therapy research.
Kalaris Therapeutics (NASDAQ:KLRS) ha avviato l'arruolamento di partecipanti in un trial di Fase 1b/2 con dosi ascendenti multiple (MAD) di TH103 per pazienti con degenerazione maculare legata all’età con neovascolarizzazione (nAMD). Lo studio prevede l’inclusione fino a 80 individui con nAMD, che riceveranno fino a quattro iniezioni intravitreali mensili di TH103.
La società prevede di pubblicare i primi dati dallo studio Fase 1a a dose singola (SAD) in Q4 2025, con i dati di Fase 1b/2 attesi nel 2H 2026. TH103, sviluppato con la partecipazione del vincitore del premio Lasker, il Dr. Napoleone Ferrara, rappresenta un nuovo approccio al trattamento delle malattie retiniche esudative e neovascolari, basato sulla ricerca nel campo della terapia anti-VEGF.
Kalaris Therapeutics (NASDAQ:KLRS) ha iniciado el reclutamiento para un ensayo Fase 1b/2 de dosis ascendentes múltiples (MAD) de TH103 en pacientes con degeneración macular asociada a la edad con neovascularización (nAMD). El estudio evaluará hasta 80 pacientes con nAMD, quienes recibirán hasta cuatro inyecciones intravítreas mensuales de TH103.
La compañía espera reportar datos iniciales del estudio Fase 1a de dosis única (SAD) en Q4 2025, con datos de Fase 1b/2 previstos para la 2H 2026. TH103, desarrollado por el ganador del premio Lasker, el Dr. Napoleone Ferrara, representa un enfoque novedoso para el tratamiento de enfermedades retinianas exudativas y neovasculares, apoyándose en la investigación de terapias anti-VEGF.
Kalaris Therapeutics (NASDAQ:KLRS)가 TH103의 다중 증량 용량(MAD) 1b/2 단계 연구에 대한 등록을 시작했습니다. 연구 대상은 당뇨성 황반변성(nAMD)으로 진단받은 환자 중 최대 80명이며 TH103을 최대 4회 월간으로 유리강내 주사합니다.
회사는 진행 중인 단일 증량 용량(SAD) 1a 단계의 초기 데이터를 2025년 4분기(Q4 2025)에 발표할 것으로 기대하며, 1b/2 단계 데이터는 2026년 하반기(2H 2026)에 공표될 예정입니다. Lasker Award 수상자 닥터 나폴로네 페라라가 개발한 TH103은 망막의 삼출성 및 신생혈관 질환 치료를 위한 새로운 접근법으로, 항 VEGF 치료 연구를 바탕으로 하고 있습니다.
Kalaris Therapeutics (NASDAQ:KLRS) a initié le recrutement pour une étude Phase 1b/2 à doses montantes multiples (MAD) de TH103 chez des patients atteints de dégénérescence maculaire liée à l’âge avec néovascularisation (nAMD). L’étude évaluera jusqu’à 80 patients nAMD, qui recevront jusqu’à quatre injections intravitréennes mensuelles de TH103.
La société prévoit de communiquer les données initiales de l’étude Phase 1a à dose unique (SAD) au Q4 2025, avec les données de Phase 1b/2 attendues au 2H 2026. TH103, développé par le lauréat du prix Lasker, le Dr Napoleone Ferrara, représente une approche nouvelle pour traiter les maladies rétiniennes exsudatives et neovasculaires, s’appuyant sur la recherche en thérapie anti-VEGF.
Kalaris Therapeutics (NASDQ:KLRS) hat die Rekrutierung für eine Phase-1b/2-Studie mit mehrfach ansteigenden Dosen (MAD) von TH103 bei Patienten mit neovaskulärer altersbedingter Makuladegeneration (nAMD) aufgenommen. Die Studie wird bis zu 80 nAMD-Patienten evaluieren, die bis zu vier monatliche Injektionsbehandlungen von TH103 erhalten.
Das Unternehmen erwartet, die ersten Daten der laufenden Phase-1a-Einzel-Dosis (SAD)-Studie im Q4 2025 zu berichten, während die Daten der Phase 1b/2 voraussichtlich im 2H 2026 vorliegen werden. TH103, entwickelt von Dr. Napoleone Ferrara, einem Lasker-Preisträger, repräsentiert einen neuartigen Ansatz zur Behandlung exsudativer und neovaskulärer retinaler Erkrankungen und baut auf der Forschung zur Anti-VEGF-Therapie auf.
Kalaris Therapeutics (NASDAQ:KLRS) قد بدأت فعليًا جمع المشاركين في تجربة المرحلة 1b/2 بجرعات متصاعدة متعددة (MAD) لـ TH103 عند مرضى التنكس البقعي المصاحب لتكوّن أوعية دموية (nAMD). ستقيّم الدراسة ما يصل إلى 80 مريضاً بـ nAMD، سيحصلون على حتى أربع حقن داخل العين شهرية لـ TH103.
تتوقع الشركة أن تُقدِم البيانات الأولية من دراسة المرحلة 1a بجرعة مفردة (SAD) في الربع الرابع من 2025، مع توقع بيانات المرحلة 1b/2 في النصف الثاني من 2026. TH103، الذي طوره د. نابولونيه فيرارا الحائز على جائزة لاسكر، يمثل نهجاً جديداً لعلاج أمراض الشبكية الانبساطية والـ neovascular، مبنياً على أبحاث العلاج المضاد-VEGF.
Kalaris Therapeutics (NASDAQ:KLRS) 已开始招募参与者，进行 TH103 针对新生血管性年龄相关性黄斑变性(nAMD)的 第一阶段1b/2 递增剂量研究。该研究计划纳入最多 80 名 nAMD 患者，患者将接受最多 4 次每月的 TH103 眼内注射。
公司预计在正在进行的 第一阶段1a 单次剂量（SAD）研究中于 2025 年第四季度（Q4 2025）公布初步数据，第一阶段1b/2的数据预计在 2026 年下半期（2H 2026）公布。 TH103 由获得拉斯克奖的 Dr. Napoleone Ferrara 开发，代表一种治疗渗出性和新生血管性视网膜疾病的新方法，建立在抗VEGF治疗研究之上。
- Expansion of clinical program with larger Phase 1b/2 study involving up to 80 patients
- Novel therapeutic approach developed by renowned scientist and Lasker Award winner Dr. Ferrara
- Potential for increased VEGF inhibition and longer retinal retention compared to existing treatments
- Initial Phase 1b/2 data not expected until second half of 2026
- Early-stage clinical development with no efficacy data yet available
Insights
Kalaris' Phase 1b/2 trial enrollment for TH103 represents meaningful progress in their clinical development pathway for nAMD treatment.
Kalaris Therapeutics has announced a significant advancement in their clinical development program for TH103, a novel treatment for neovascular age-related macular degeneration (nAMD). The company is now enrolling patients in a Phase 1b/2 multiple ascending dose (MAD) study, which represents a substantial expansion from their ongoing Phase 1a single dose trial.
The new study's design is particularly notable - it will evaluate up to 80 nAMD patients receiving up to four monthly intravitreal injections of TH103 at various dose levels. This multi-dose approach is crucial for establishing both the safety profile and preliminary efficacy signals that would be necessary before advancing to pivotal Phase 3 trials.
What makes TH103 scientifically interesting is its development by Napoleone Ferrara, whose pioneering anti-VEGF research transformed retinal disease treatment. TH103 appears to build on this foundation with a novel molecular approach designed for increased VEGF inhibition and longer retinal retention - addressing two key limitations of current therapies.
The significance of this development lies in its timing within Kalaris' overall clinical pathway: their Phase 1a data is expected in Q4 2025, with this expanded Phase 1b/2 study positioned to generate initial data in 2H 2026. This sequential approach allows for dose optimization before potential Phase 3 trials.
For nAMD patients, who currently require frequent intravitreal injections, any therapy offering enhanced efficacy or durability could represent a meaningful advance in reducing treatment burden while maintaining vision.
Recently initiated Phase 1b/2 multiple ascending dose study intended to assess safety and preliminary efficacy in nAMD patients receiving up to four initial monthly doses of TH103
Phase 1b/2 study to inform dose selection for potential Phase 3 development program, with initial data expected in 2H 2026
TH103’s ongoing Phase 1a single ascending dose study remains on track for data to be reported in Q4 2025
PALO ALTO, Calif., Sept. 15, 2025 (GLOBE NEWSWIRE) -- Kalaris Therapeutics, Inc. (Nasdaq: KLRS) (“Kalaris”), a clinical-stage biopharmaceutical company dedicated to the development and commercialization of treatments for prevalent retinal diseases, today announced that it is now enrolling a Phase 1b/2 multiple ascending dose (MAD) study of TH103 in patients with neovascular age-related macular degeneration (nAMD). The study is intended to build upon the company's ongoing Phase 1a single ascending dose (SAD) study and represents a key advance in the clinical development program for TH103 towards potential Phase 3 clinical development. The new Phase 1b/2 dose-finding study is designed to evaluate multiple dose levels of TH103 in up to 80 nAMD patients. Patients will receive up to 4 initial monthly intravitreal injections of TH103. Study assessments are expected to include safety and preliminary efficacy with a primary time point for analysis at one-month following the last injection. Patients will then be followed in an extension phase of the study.
The Phase 1b/2 study replaces the smaller Part 2 design originally planned to follow the ongoing Phase 1a study. Data from the Phase 1a study, including safety, preliminary efficacy (e.g., visual acuity and lesion morphology), and pharmacokinetics remains on track to be reported in the fourth quarter of 2025. Further details on the Phase 1b/2 design will be shared at that time.
"The Phase 1b/2 study represents an important milestone in advancing TH103 toward a potential future Phase 3 program," said Andrew Oxtoby, Chief Executive Officer of Kalaris Therapeutics. “We remain committed to developing this innovative therapy with the goal of potentially addressing major unmet needs in the treatment of retinal diseases such as nAMD."
TH103 represents a novel approach to treating exudative and neovascular retinal diseases, building on decades of research in anti-VEGF therapy. The investigational drug was developed by company co-founder and current board member Napoleone Ferrara, MD, whose pioneering work led to the creation of the anti-VEGF class of drugs that transformed the treatment of cancer and retinal diseases and for which he received the prestigious Lasker Award.
"Having dedicated my career to understanding the role of VEGF in human disease, I am encouraged by the potential of TH103 and its novel molecular approach to potentially provide both increased VEGF inhibition and longer retinal retention," said Dr. Ferrara. "This dose-finding study is a critical step in our efforts to potentially advance this novel investigational therapy toward pivotal trials that could benefit patients with exudative and neovascular retinal diseases."
About Neovascular Age-related Macular Degeneration
Neovascular AMD affects millions of people worldwide and is a leading cause of vision loss in individuals over 50. While current anti-VEGF therapies have transformed treatment outcomes, many patients continue to experience progressive vision loss despite treatment, highlighting the need for continued therapeutic innovation.
About TH103
TH103 is a dual-action investigational therapy engineered to potentially provide increased and longer-lasting anti-VEGF activity to treat exudative and neovascular retinal diseases, including neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and retinal vein occlusion (RVO). The drug represents a novel molecular approach, building on extensive research in anti-VEGF mechanisms. TH103 is currently being evaluated in an ongoing Phase 1a single ascending dose study to determine safety, preliminary efficacy, and pharmacokinetics in nAMD patients, with data on track to be reported in the fourth quarter of 2025, and a recently initiated Phase 1b/2 multiple ascending dose study in nAMD patients, with preliminary data expected in the second half of 2026. TH103 is an investigational therapy, and its safety and efficacy have not been established by regulatory authorities.
About Kalaris
Kalaris Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development and commercialization of treatments for prevalent retinal diseases with major unmet medical needs. Founded by renowned scientist Dr. Napoleone Ferrara, whose pioneering research led to the development of anti-VEGF therapy, the company is committed to advancing novel therapeutic approaches for patients with sight-threatening retinal conditions such as neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and retinal vein occlusion (RVO).
For more information, visit www.kalaristx.com.
Forward Looking Statements
This press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 that involve substantial risk and uncertainties. All statements, other than statements of historical fact, contained in this press release, including statements regarding the strategy, future operations, prospects, plans and objectives of management of Kalaris, including the therapeutic potential of TH103 for nAMD and other exudative and neovascular retinal diseases, the anticipated timelines for reporting clinical data from the Phase 1a and Phase 1b/2 clinical trials of TH103, plans to advance TH103 into Phase 3 clinical trials and to develop TH103 for additional indications and the sufficiency of Kalaris’ cash resources for the period anticipated, are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements are based on current expectations and beliefs of the management of Kalaris as well as assumptions made by, and information currently available to, the management of Kalaris and are subject to risks and uncertainties. There can be no assurance that future developments affecting Kalaris will be those that it has anticipated. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various important factors, including: risks associated with the clinical development and regulatory approval of TH103, including potential delays in the completion of clinical trials; expectations regarding the therapeutic benefits, clinical potential and clinical development of TH103; risks related to the inability of Kalaris to obtain sufficient additional capital to continue to advance its product candidate; uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; risks related to the failure to realize any value from any product candidates being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; the ability to obtain, maintain, and protect intellectual property rights related to product candidates; changes in regulatory requirements and government incentives; Kalaris’ competitive position and expectations regarding developments and projections relating to its competitors and any competing therapies that are or become available; potential adverse reactions or changes to business relationships resulting from the completion of the merger with AlloVir, Inc.; risks associated with the possible failure to realize, or that it may take longer to realize than expected, certain anticipated benefits of the merger, including with respect to future financial and operating results; the risk of involvement in current and future litigation, including securities class action litigation, that could divert the attention of the management of Kalaris, harm Kalaris’ business and for which Kalaris may not have sufficient insurance coverage to cover all costs and damages; and such other factors as are set forth in Kalaris’ public filings with the SEC, including, but not limited to, those described under the heading “Risk Factors”. Kalaris may not actually achieve the plans, intentions or expectations disclosed in its forward-looking statements, and you should not place undue reliance on its forward-looking statements. The forward-looking statements contained in this press release are made as of the date of this press release, and Kalaris does not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
Kalaris Therapeutics Investor Contact:
Corey Davis, Ph.D.
LifeSci Advisors, LLC
+1 212 915 2577
FAQ
What is the purpose of Kalaris Therapeutics' Phase 1b/2 study for TH103?
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How many patients will be enrolled in the KLRS Phase 1b/2 study of TH103?
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Who developed Kalaris Therapeutics' TH103 treatment?
