UPDATE – Kalaris Therapeutics Now Enrolling Phase 1b/2 Multiple Ascending Dose Study of TH103 in Neovascular Age-Related Macular Degeneration
Kalaris Therapeutics (NASDAQ:KLRS) has begun enrolling patients in a Phase 1b/2 multiple ascending dose (MAD) study for TH103, targeting neovascular age-related macular degeneration (nAMD). The study will evaluate multiple dose levels in up to 80 nAMD patients, who will receive 4 monthly intravitreal injections.
The Phase 1b/2 study replaces a smaller Part 2 design and will inform dose selection for potential Phase 3 development. Initial data is expected in 2H 2026. Meanwhile, the ongoing Phase 1a single ascending dose study remains on schedule to report data in Q4 2025.
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 iniziato l'arruolamento di pazienti in uno studio di Fase 1b/2 a dosi multiple crescenti (MAD) per TH103, mirato alla degenerazione maculare legata all'età con neovascolarizzazione (nAMD). Lo studio valuterà più livelli di dosaggio in fino a 80 pazienti con nAMD, che riceveranno 4 iniezioni intravitreali mensili.
Lo studio di Fase 1b/2 sostituisce uno schema Part 2 più piccolo e fornirà indicazioni sulla scelta della dose per un eventuale sviluppo in Fase 3. I dati iniziali sono previsti nella 2H 2026. Nel frattempo, lo studio di Fase 1a a dose singola ascendente continua secondo i tempi previsti e riferirà i dati nel Q4 2025.
TH103, sviluppato dal vincitore del Lasker Award, il Dr. Napoleone Ferrara, rappresenta un approccio innovativo al trattamento delle malattie retiniche exudative e neovascolari, basato sulla ricerca sull'anti-VEGF.
Kalaris Therapeutics (NASDAQ:KLRS) ha comenzado a inscribir pacientes en un estudio de Fase 1b/2 de dosis múltiples crecientes (MAD) para TH103, dirigido a la degeneración macular relacionada con la edad con neovascularización (nAMD). El estudio evaluará varios niveles de dosis en hasta 80 pacientes con nAMD, quienes recibirán 4 inyecciones intravítreas mensuales.
El estudio de Fase 1b/2 sustituye a un diseño más pequeño de la Parte 2 y proporcionará información para la selección de dosis para un posible desarrollo en Fase 3. Se esperan datos iniciales en 2T 2026. Mientras tanto, el estudio de Fase 1a de dosis única ascendente continúa con el calendario para reportar datos en Q4 2025.
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, basándose en la investigación de terapias anti-VEGF.
Kalaris Therapeutics(나스닥:KLRS)가 TH103를 대상으로 네발생(네오혈관화) 망막질환(nAMD)을 겨냥한 다회 증가 용량(MAD) 1b/2 상용 시험에 환자 등록을 시작했습니다. 연구는 80명의 nAMD 환자까지 다양한 용량 수준을 평가하며, 참가자들은 매월 4회 눈 안 주사를 받게 됩니다.
이 Phase 1b/2 연구는 더 작은 Part 2 설계를 대체하고 3상 개발 가능성에 대한 용량 선택 정보를 제공할 것입니다. 초기 데이터는 2H 2026에 예상됩니다. 한편 진행 중인 Phase 1a 단일 증가 용량 연구는 일정에 따라 2025년 4분기에 데이터를 보고할 예정입니다.
TH103은 Lasker Award 수상자인 Dr. Napoleone Ferrara가 개발했으며, 삼출성 및 네오혈관성 망막 질환 치료에 대한 새로운 접근을 제시하며 anti-VEGF 연구를 바탕으로 합니다.
Kalaris Therapeutics (NASDAQ:KLRS) a commencé à recruter des patients pour une étude de Phase 1b/2 à doses multiples progressives (MAD) pour TH103, ciblant la dégénération maculaire liée à l'âge avec néovascularisation (nAMD). L'étude évaluera plusieurs niveaux de dose chez jusqu'à 80 patients nAMD, qui recevront 4 injections intravitréennes mensuelles.
L'étude de Phase 1b/2 remplace un design Part 2 plus petit et fournira des informations sur la sélection de la dose pour un éventuel développement en Phase 3. Des données initiales sont prévues au 2H 2026. Entre-temps, l'étude Phase 1a à dose unique ascendante reste sur le calendrier et fournira des données au Q4 2025.
TH103, développé par le lauréat du prix Lasker, le Dr Napoleone Ferrara, représente une approche novatrice pour traiter les maladies rétiniennes exsudatives et néovasculaires, s'appuyant sur la recherche anti-VEGF.
Kalaris Therapeutics (NASDAQ:KLRS) hat mit der Rekrutierung von Patienten in eine Phase-1b/2-Studie mit zunehmender Gesamt-Dosis (MAD) für TH103 begonnen, die auf die neovaskuläre altersbedingte Makuladegeneration (nAMD) abzielt. Die Studie wird mehrere Dosierungsstufen bei bis zu 80 nAMD-Patienten bewerten, die 4 monatliche intravitreale Injektionen erhalten.
Die Phase-1b/2-Studie ersetzt ein kleineres Part-2-Design und wird Informationen zur Dosisauswahl für eine mögliche Phase-3-Entwicklung liefern. Erste Daten werden voraussichtlich in 2H 2026 erwartet. Unterdessen bleibt die laufende Phase-1a-Studie mit einer einzigen aufsteigenden Dosis planmäßig und wird Daten im Q4 2025 melden.
TH103, entwickelt von Dr. Napoleone Ferrara, einem Lasker-Preisträger, stellt einen neuartigen Ansatz zur Behandlung exsudativer und neovaskulärer retinaler Erkrankungen dar und baut auf der Forschung zu Anti-VEGF-Therapien auf.
Kalaris Therapeutics (NASDAQ:KLRS) بدأت تسجيل المرضى في دراسة من المرحلة 1b/2 بجرعات متعددة ترتفع تدريجياً (MAD) لـ TH103 تستهدف التنكس البقعي المرتبط بالعمر بنمو الأوعية الدموية (nAMD). ستقيم الدراسة عدة مستويات جرعات حتى 80 مريضاً بـ nAMD، الذين سيحصلون على 4 حقن داخل العين شهرياً.
ستبدل دراسة المرحلة 1b/2 تصميم Part 2 الأصغر وستوفر معلومات لاختيار الجرعة لتطوير محتمل في المرحلة 3. من المتوقع البيانات الأولية في النصف الثاني من 2026. في هذه الأثناء، تظل دراسة المرحلة 1a أحادية الجرعة المتصاعدة على الجدول الزمني للإبلاغ عن البيانات في الربع الرابع 2025.
TH103، الذي طوره الدكتور نابولوني فِرّارا الحاصل على جائزة لاسكر، يمثل نهجاً جديداً لعلاج أمراض الشبكية الخارجة والناشئة بالأوعية الدموية، ويستند إلى أبحاث العلاج المضاد-VEGF.
Kalaris Therapeutics (NASDAQ:KLRS) 已开始招募患者参与 TH103 的 Ib/2 期多次递增剂量 (MAD) 研究，目标是新生血管性年龄相关性黄斑变性（nAMD）。研究将< b>在多达80名 nAMD 患者中评估多种剂量水平，患者将接受4次每月的眼内注射。
这项 Ib/2 期研究将取代较小的 Part 2 设计，并为潜在的Ⅲ期开发的剂量选择提供信息。初步数据预计在 2026 年下半年。与此同时，正在进行的 I a 期单次递增剂量研究仍按计划在 2025 年第四季度发布数据。
TH103 由获得拉斯克奖的 Napoleone Ferrara 博士开发，代表了一种治疗渗出性和新生血管性视网膜疾病的新方法，基于 anti-VEGF 研究。
- Novel therapeutic approach building on proven anti-VEGF therapy research
- Developed by renowned scientist Dr. Napoleone Ferrara, pioneer of anti-VEGF drugs
- Expanded study size to 80 patients from originally planned smaller trial
- Potential for increased VEGF inhibition and longer retinal retention
- Extended timeline with initial data not expected until second half of 2026
- Multiple monthly intravitreal injections required
- Early-stage clinical development with no efficacy data yet available
Insights
Kalaris advances TH103 for macular degeneration into Phase 1b/2 trial with potential to improve upon current anti-VEGF treatments.
Kalaris Therapeutics has begun enrolling patients in a Phase 1b/2 multiple ascending dose (MAD) study for TH103, their candidate for neovascular age-related macular degeneration (nAMD). This represents a significant advancement in their clinical development program, replacing a smaller study originally planned to follow their ongoing Phase 1a trial.
The new study will evaluate multiple dose levels in up to 80 nAMD patients, who will receive four monthly intravitreal injections. The trial's design appears robust, focusing on both safety and preliminary efficacy markers including visual acuity and lesion morphology. This approach will provide more comprehensive data than the originally planned smaller follow-up to their Phase 1a study.
What makes TH103 particularly noteworthy is its pedigree - it was developed by company co-founder Napoleone Ferrara, whose pioneering work led to the anti-VEGF class of drugs that revolutionized treatment for both cancer and retinal diseases. The molecule appears designed for potentially increased VEGF inhibition and longer retinal retention compared to current standards of care.
The timeline indicates initial data from this study expected in the second half of 2026, while their Phase 1a single ascending dose study remains on track for data in Q4 2025. This methodical approach suggests Kalaris is positioning TH103 for a potential Phase 3 program, with this dose-finding study providing critical information for future trial design.
In the competitive landscape of nAMD treatments, where patient burden from frequent injections remains a challenge, TH103's potential for enhanced efficacy and duration could address significant unmet needs in retinal disease management.
Recently initiated Phase 1b/2 multiple ascending dose study intended to assess safety and efficacy in nAMD patients receiving 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 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 a 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 trial for TH103?
When will Kalaris (KLRS) report initial data from the TH103 Phase 1b/2 trial?
How many patients will be enrolled in the KLRS Phase 1b/2 study of TH103?
Who developed TH103 for Kalaris Therapeutics?
What is the dosing schedule for TH103 in the Phase 1b/2 trial?
