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Prelude Therapeutics Announces Publication of Abstracts for Presentation at the 36th EORTC-NCI-AACR Symposium

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Prelude Therapeutics (Nasdaq: PRLD) announced the publication of three abstracts for presentation at the 36th EORTC-NCI-AACR Symposium in Barcelona, Spain from October 23-25, 2024. The abstracts focus on the company's SMARCA Degrader Programs, including:

1. First clinical results from a Phase 1 trial of PRT3789, a first-in-class SMARCA2 degrader, in patients with advanced solid tumors with SMARCA4 mutations.

2. Discovery of first-in-class precision antibody drug conjugates with a potent SMARCA 2/4 dual degrader payload.

3. The selective SMARCA2 degrader, PRT3789, enhancing the efficacy of standard chemotherapy in SMARCA4 mutant NSCLC models.

Prelude expects to conclude monotherapy dose escalation for PRT3789 by year-end 2024 and identify the biologically active dose for future trials. The company is also enrolling patients in back-fill cohorts enriched for NSCLC and SMARCA4 loss-of-function mutations at higher dose levels.

Prelude Therapeutics (Nasdaq: PRLD) ha annunciato la pubblicazione di tre astrazioni per presentazioni al 36° Simposio EORTC-NCI-AACR che si svolgerà a Barcellona, Spagna, dal 23 al 25 ottobre 2024. Le astrazioni si concentrano sui Programmi Degradatori SMARCA dell'azienda, compresi:

1. I primi risultati clinici di uno studio di Fase 1 di PRT3789, un degradatore SMARCA2 di prima classe, in pazienti con tumori solidi avanzati con mutazioni SMARCA4.

2. Scoperta di coniugati anticorpali di precisione di prima classe con un potente payload di degradatore duale SMARCA 2/4.

3. Il degradatore selettivo SMARCA2, PRT3789, che aumenta l'efficacia della chemioterapia standard nei modelli NSCLC mutanti SMARCA4.

Prelude prevede di concludere l'escalation della dose in monoterapia per PRT3789 entro la fine del 2024 e identificare la dose biologicamente attiva per futuri studi. L'azienda sta anche reclutando pazienti in coorti di back-fill arricchite per NSCLC e mutazioni a perdita di funzione SMARCA4 a livelli di dose più elevati.

Prelude Therapeutics (Nasdaq: PRLD) anunció la publicación de tres resúmenes para presentación en el 36° Simposio EORTC-NCI-AACR que se llevará a cabo en Barcelona, España, del 23 al 25 de octubre de 2024. Los resúmenes se centran en los Programas Degradadores SMARCA de la empresa, que incluyen:

1. Primeros resultados clínicos de un ensayo de Fase 1 de PRT3789, un degradador SMARCA2 de primera clase, en pacientes con tumores sólidos avanzados con mutaciones SMARCA4.

2. Descubrimiento de conjugados de fármacos anticuerpo de precisión de primera clase con un potente payload de degradador dual SMARCA 2/4.

3. El degradador selectivo SMARCA2, PRT3789, que mejora la eficacia de la quimioterapia estándar en modelos NSCLC mutantes SMARCA4.

Prelude espera concluir la escalación de dosis en monoterapia para PRT3789 a finales de 2024 e identificar la dosis biológicamente activa para futuros ensayos. La empresa también está reclutando pacientes en cohortes de back-fill enriquecidas para NSCLC y mutaciones SMARCA4 con pérdida de función en niveles de dosis más altos.

프렐류드 테라퓨틱스(나스닥: PRLD)는 2024년 10월 23일부터 25일까지 스페인 바르셀로나에서 열리는 제36회 EORTC-NCI-AACR 심포지엄에서 발표할 세 가지 초록의 발표를 알렸습니다. 초록은 회사의 SMARCA 분해 프로그램에 중점을 두고 있습니다. 내용은 다음과 같습니다:

1. SMARCA4 변이를 가진 진행성 고형암 환자에서 최초의 SMARCA2 분해제인 PRT3789의 1상 시험에서 첫 번째 임상 결과.

2. 강력한 SMARCA 2/4 이중 분해제 페이로드를 가진 최초의 정밀 항체 약물 접합체 발견.

3. SMARCA4 돌연변이 NSCLC 모델에서 표준 화학요법의 효능을 증대시키는 선택적 SMARCA2 분해제 PRT3789.

프렐류드는 2024년 연말까지 PRT3789의 단일 요법 용량 증량을 마치고 향후 임상 시험을 위한 생물학적으로 활성인 용량을 확인할 예정입니다. 회사는 또한 NSCLC 및 SMARCA4 기능 상실 변이에 대한 후속 보충 집단에 환자를 모집 중입니다.

Prelude Therapeutics (Nasdaq: PRLD) a annoncé la publication de trois résumés pour une présentation au 36e Symposium EORTC-NCI-AACR qui se tiendra à Barcelone, Espagne, du 23 au 25 octobre 2024. Les résumés mettent l'accent sur les Programmes Dégradeurs SMARCA de l'entreprise, comprenant :

1. Premiers résultats cliniques d'un essai de Phase 1 de PRT3789, un dégradeur SMARCA2 de première classe, chez des patients atteints de tumeurs solides avancées avec des mutations SMARCA4.

2. Découverte de conjugats d'anticorps de précision de première classe avec une cargaison puissante de dégradeur double SMARCA 2/4.

3. Le dégradeur sélectif SMARCA2, PRT3789, améliorant l'efficacité de la chimiothérapie standard dans des modèles NSCLC mutés SMARCA4.

Prelude prévoit de conclure l'escalade de dose en monothérapie pour PRT3789 d'ici la fin de 2024 et d'identifier la dose biologiquement active pour de futurs essais. L'entreprise recrute également des patients dans des cohortes de remplissage pour NSCLC et des mutations de perte de fonction SMARCA4 à des niveaux de dose plus élevés.

Prelude Therapeutics (Nasdaq: PRLD) gab die Veröffentlichung von drei Abstracts bekannt, die beim 36. EORTC-NCI-AACR-Symposium vom 23. bis 25. Oktober 2024 in Barcelona, Spanien, präsentiert werden. Die Abstracts konzentrieren sich auf die SMARCA-Degrader-Programme des Unternehmens, einschließlich:

1. Erste klinische Ergebnisse einer Phase-1-Studie zu PRT3789, einem erstmaligen SMARCA2-Degrader, bei Patienten mit fortgeschrittenen soliden Tumoren mit SMARCA4-Mutationen.

2. Entdeckung von erstmaligen präzisen Antikörper-Arzneimittel-Konjugaten mit einer potenten SMARCA 2/4-Dual-Degrader-Belastung.

3. Der selektive SMARCA2-Degrader PRT3789 verbessert die Wirksamkeit der Standardchemotherapie bei SMARCA4-mutierten NSCLC-Modellen.

Prelude erwartet, bis Ende 2024 die Dosissteigerung der Monotherapie für PRT3789 abzuschließen und die biologisch aktive Dosis für zukünftige Studien zu bestimmen. Das Unternehmen rekrutiert außerdem Patienten in Auffüllkohorten, die für NSCLC und SMARCA4-Funktionsverlustmutationen auf höheren Dosen angereichert sind.

Positive
  • Phase 1 trial of PRT3789 (SMARCA2 degrader) is progressing, with dose escalation expected to conclude by year-end 2024
  • Enrollment of patients in back-fill cohorts for NSCLC and SMARCA4 mutations is ongoing
  • Preclinical data shows potential for SMARCA2/4 dual degrader payload in antibody drug conjugates
  • PRT3789 demonstrates enhanced efficacy of standard chemotherapy in SMARCA4 mutant NSCLC models
Negative
  • None.

PRT3789, a novel, highly-selective SMARCA2 degrader in patients with advanced solid tumors with a SMARCA4 mutation plenary session presentation: October 24, 2024, 10:00 AM CEST (4:00 AM EST)

WILMINGTON, Del., Oct. 09, 2024 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Nasdaq: PRLD) (“Prelude” or the “Company”), a clinical-stage precision oncology company, today announced the publication of three abstracts regarding its SMARCA Degrader Programs at the 36th EORTC-NCI-AACR Symposium taking place in Barcelona, Spain October 23-25, 2024. The abstracts can be found at Conference (eortc.org).

“We are delighted to have this opportunity to share additional information from our SMARCA degrader programs to the scientific and medical communities as we continue to progress both the clinical and preclinical development of these novel first-in-class approaches for patients with high unmet needs,” stated Kris Vaddi, Ph.D., Chief Executive Officer of Prelude.

Continued Vaddi, “In addition to the updates we will be providing from our Phase 1 trial of PRT3789, we are looking forward to presenting the first preclinical data from our precision degrader antibody conjugates program. These data demonstrate that a highly potent dual SMARCA2/4 degrader payload can be conjugated to an antibody to specifically target tumor cells and safely induce tumor regressions in preclinical models. This approach has potential to replace chemotherapy payloads on ADCs and expand the therapeutic opportunities well beyond SMARCA4 mutated cancers.”

PRT3789 is a first-in-class, potent and highly selective SMARCA2 degrader, in Phase 1 clinical development in biomarker selected SMARCA4 mutant patients. Enrollment remains on track, and the Company expects to conclude monotherapy dose escalation by year end 2024 and identify the biologically active dose to advance for future trials. In addition, enrollment of patients into back-fill cohorts enriched for NSCLC and SMARCA4 loss-of-function mutations and higher dose levels is ongoing. The objective is to assess clinical activity in a more homogeneous group of patients with high unmet need, at the biologically active dose, to support planned discussions with regulatory agencies.

Abstracts and Presentation Times:

First Clinical Results from a Phase 1 Trial of PRT3789, a First-in-Class Intravenous SMARCA2 Degrader, in Patients with Advanced Solid Tumors with a SMARCA4 Mutation
Proffered Paper Plenary Session #3, Room 111 + 112, Thursday, October 24 from 10:00 AM – 10:12 AM (CEST)

The abstract published today included data as of a May 28, 2024 cutoff date with updated data to be presented at the conference. The Company previously presented initial interim data from this study at the 2024 European Society of Medical Oncology (ESMO) Congress 2024 on September 13, 2024. A copy of this presentation can be accessed at Guo_PRT3789-01_ESMO_presentaion_Sep2024.pdf (preludetx.com).

Discovery of First-in-Class Precision Antibody Drug Conjugates with a Potent SMARCA 2/4 Dual Degrader Payload that Safely Achieve Maximal and Tumor Specific Degradation and Efficacy in Mouse Models
Poster Session – Antibody Drug Conjugates, Abstract #167 Exhibition Hall Location PB155, Thursday, October 24, 9:00 AM – 5:30 PM (CEST)

The Selective SMARCA2 Degrader, PRT3789, Counteracts the Protective Cellular Stress Response to Chemotherapy and Enhances the Efficacy of Standard of Care Chemotherapeutic Agents in SMARCA4 Mutant NSCLC Models
Poster Session – Combination Therapies, Abstract #220, Exhibition Hall Location PB208, Thursday, October 24, 9:00 AM – 5:30 AM (CEST)

About Prelude Therapeutics 

Prelude Therapeutics is a leading precision oncology company developing innovative medicines in areas of high unmet need for cancer patients. Our pipeline is comprised of several novel drug candidates including first-in-class, highly selective IV and oral SMARCA2 degraders, and a potentially best-in-class CDK9 inhibitor. We are also leveraging our expertise in targeted protein degradation to discover, develop and commercialize next generation degrader antibody conjugates (Precision ADCs) with partners. We are on a mission to extend the promise of precision medicine to every cancer patient in need. For more information, visit preludetx.com.

Cautionary Note Regarding Forward-Looking Statements 

This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, anticipated discovery, preclinical and clinical development activities for Prelude’s product candidates, the potential safety, efficacy, benefits and addressable market for Prelude’s product candidates, and clinical trial results for Prelude’s product candidates. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The words “believes,” “anticipates,” “estimates,” “plans,” “expects,” “intends,” “may,” “could,” “should,” “potential,” “likely,” “projects,” “continue,” “will,” “schedule,” and “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are predictions based on the Company’s current expectations and projections about future events and various assumptions. Although Prelude believes that the expectations reflected in such forward-looking statements are reasonable, Prelude cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval is inherently uncertain. Forward-looking statements are subject to risks and uncertainties that may cause Prelude's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to Prelude's ability to advance its product candidates, the receipt and timing of potential regulatory designations, approvals and commercialization of product candidates, clinical trial sites and our ability to enroll eligible patients, supply chain and manufacturing facilities, Prelude’s ability to maintain and recognize the benefits of certain designations received by product candidates, the timing and results of preclinical and clinical trials, Prelude's ability to fund development activities and achieve development goals, Prelude's ability to protect intellectual property, and other risks and uncertainties described under the heading "Risk Factors" in Prelude’s Annual Report on Form 10-K for the year ended December 31, 2023, its Quarterly Reports on Form 10-Q and other documents that Prelude files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and Prelude undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof, except as may be required by law.  

Investor Contact: 
Robert A. Doody Jr.
Senior Vice President, Investor Relations 
484.639.7235
rdoody@preludetx.com


FAQ

What is PRT3789 and what is its current development stage?

PRT3789 is a first-in-class, potent and highly selective SMARCA2 degrader developed by Prelude Therapeutics (PRLD). It is currently in Phase 1 clinical development for patients with advanced solid tumors harboring SMARCA4 mutations.

When will Prelude Therapeutics (PRLD) complete the dose escalation for PRT3789?

Prelude Therapeutics expects to conclude the monotherapy dose escalation for PRT3789 by the end of 2024 and identify the biologically active dose for future trials.

What new preclinical data is Prelude Therapeutics (PRLD) presenting at the EORTC-NCI-AACR Symposium?

Prelude is presenting preclinical data on precision degrader antibody conjugates, showing that a potent dual SMARCA2/4 degrader payload can be conjugated to an antibody to target tumor cells and induce tumor regressions in preclinical models.

How does PRT3789 interact with chemotherapy in SMARCA4 mutant NSCLC models?

According to the abstract, PRT3789, a selective SMARCA2 degrader, counteracts the protective cellular stress response to chemotherapy and enhances the efficacy of standard chemotherapeutic agents in SMARCA4 mutant NSCLC models.

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