Acrivon Therapeutics Announces FDA has Granted Breakthrough Device Designation for ACR-368 OncoSignature Assay for Endometrial Cancer
Acrivon Therapeutics (ACRV) announces FDA Breakthrough Device designation for its ACR-368 OncoSignature assay in endometrial cancer. This multiplex immunofluorescence assay is designed to identify patients likely to respond to ACR-368 treatment, currently in a registrational-intent Phase 2b trial.
The company's clinical data at ESMO 2024 showed a confirmed overall response rate of 62.5% and demonstrated significant segregation between biomarker-positive and negative patient groups (p=0.009). The assay was developed using their AP3 (Acrivon Predictive Precision Proteomics) platform, which combines generative AI for drug design and indication finding.
Market research indicates strong interest in ACR-368's clinical profile, with an estimated 30,000 annual cases of high-grade, locally advanced or metastatic, recurrent endometrial cancer in the U.S.
Acrivon Therapeutics (ACRV) annuncia la designazione di Dispositivo Innovativo da parte della FDA per il suo saggio ACR-368 OncoSignature nel cancro endometriale. Questo saggio di immunofluorescenza multipla è progettato per identificare i pazienti che potrebbero rispondere al trattamento con ACR-368, attualmente in uno studio clinico di Fase 2b con intento registrativo.
I dati clinici dell'azienda presentati all'ESMO 2024 hanno mostrato un tasso di risposta globale confermato del 62,5% e hanno dimostrato una significativa separazione tra i gruppi di pazienti positivi e negativi ai biomarcatori (p=0,009). Il saggio è stato sviluppato utilizzando la loro piattaforma AP3 (Acrivon Predictive Precision Proteomics), che combina l'intelligenza artificiale generativa per la progettazione di farmaci e la scoperta di indicazioni.
La ricerca di mercato indica un forte interesse per il profilo clinico di ACR-368, con circa 30.000 casi annuali di cancro endometriale ad alto grado, localmente avanzato o metastatico, ricorrente negli Stati Uniti.
Acrivon Therapeutics (ACRV) anuncia la designación de Dispositivo Innovador por parte de la FDA para su ensayo ACR-368 OncoSignature en cáncer endometrial. Este ensayo de inmunofluorescencia multiplex está diseñado para identificar a los pacientes que probablemente responderán al tratamiento con ACR-368, actualmente en un ensayo clínico de Fase 2b con intención de registro.
Los datos clínicos de la empresa presentados en ESMO 2024 mostraron una tasa de respuesta global confirmada del 62,5% y demostraron una segregación significativa entre los grupos de pacientes positivos y negativos a los biomarcadores (p=0,009). El ensayo se desarrolló utilizando su plataforma AP3 (Acrivon Predictive Precision Proteomics), que combina inteligencia artificial generativa para el diseño de fármacos y la búsqueda de indicaciones.
La investigación de mercado indica un fuerte interés en el perfil clínico de ACR-368, con un estimado de 30.000 casos anuales de cáncer endometrial de alto grado, localmente avanzado o metastásico, recurrente en EE. UU.
Acrivon Therapeutics (ACRV)는 자궁내막 암에 대한 ACR-368 OncoSignature 검사에 대해 FDA 혁신 장치 지정을 발표했습니다. 이 다중 면역형광 검사는 ACR-368 치료에 반응할 가능성이 있는 환자를 식별하기 위해 설계되었으며, 현재는 등록 의도를 가진 2b 단계 시험 중입니다.
회사의 임상 데이터는 ESMO 2024에서 확인된 전체 반응률이 62.5%임을 보여주었으며, 바이오마커 양성 및 음성 환자 그룹 간의 유의미한 분리를 입증했습니다 (p=0.009). 이 검사는 AP3 (Acrivon Predictive Precision Proteomics) 플랫폼을 사용하여 개발되었으며, 이는 약물 설계 및 적응증 발견을 위한 생성적 AI를 결합합니다.
시장 조사에 따르면 ACR-368의 임상 프로필에 대한 강한 관심이 있으며, 미국에서 연간 30,000건의 고등급, 국소 진행성 또는 전이성 재발 자궁내막 암 사례가 추정됩니다.
Acrivon Therapeutics (ACRV) annonce la désignation de Dispositif Innovant par la FDA pour son test ACR-368 OncoSignature dans le cancer de l'endomètre. Ce test d'immunofluorescence multiplex est conçu pour identifier les patients susceptibles de répondre au traitement par ACR-368, actuellement en essai clinique de Phase 2b avec intention d'enregistrement.
Les données cliniques de l'entreprise présentées lors de l'ESMO 2024 ont montré un taux de réponse global confirmé de 62,5% et ont démontré une séparation significative entre les groupes de patients positifs et négatifs aux biomarqueurs (p=0,009). Le test a été développé en utilisant leur plateforme AP3 (Acrivon Predictive Precision Proteomics), qui combine l'IA générative pour la conception de médicaments et la recherche d'indications.
Les études de marché indiquent un fort intérêt pour le profil clinique de l'ACR-368, avec environ 30 000 cas annuels de cancer de l'endomètre de haut grade, localement avancé ou métastatique, récurrent aux États-Unis.
Acrivon Therapeutics (ACRV) gibt die Erteilung der FDA-Designierung als Durchbruchgerät für seinen ACR-368 OncoSignature-Test bei Endometriumkarzinom bekannt. Dieser Multiplex-Immunfluoreszenztest ist darauf ausgelegt, Patienten zu identifizieren, die voraussichtlich auf die Behandlung mit ACR-368 ansprechen werden, die sich derzeit in einer registrierungsbezogenen Phase-2b-Studie befindet.
Die klinischen Daten des Unternehmens, die auf der ESMO 2024 präsentiert wurden, zeigten eine bestätigte Gesamtrücklaufquote von 62,5% und demonstrierten eine signifikante Trennung zwischen biomarker-positiven und negativen Patientengruppen (p=0,009). Der Test wurde mithilfe ihrer AP3 (Acrivon Predictive Precision Proteomics)-Plattform entwickelt, die generative KI für die Arzneimittelentwicklung und Indikationsfindung kombiniert.
Marktforschung zeigt ein starkes Interesse an dem klinischen Profil von ACR-368, mit geschätzten 30.000 jährlichen Fällen von hochgradigem, lokal fortgeschrittenem oder metastasierendem, rezidivierendem Endometriumkarzinom in den USA.
- FDA Breakthrough Device designation received for ACR-368 OncoSignature assay
- High overall response rate of 62.5% in clinical trials
- Significant market opportunity with 30,000 annual cases in the U.S.
- Statistically significant patient segregation (p=0.009) demonstrating assay effectiveness
- None.
Insights
The FDA's Breakthrough Device designation for Acrivon's ACR-368 OncoSignature assay represents a significant milestone with multiple strategic implications. The designation typically accelerates the regulatory pathway, potentially reducing time-to-market by 6-12 months and enabling priority review for both the diagnostic and its companion therapeutic.
The clinical data is particularly compelling, with a 62.5% overall response rate (95% CI, 30.4-86.5) and a statistically significant p-value of 0.009 for patient selection. This level of statistical significance strongly validates the assay's predictive capabilities, potentially positioning it as a best-in-class companion diagnostic for endometrial cancer treatment.
The market opportunity is substantial and growing. With ~30,000 annual cases of high-grade, advanced endometrial cancer in the U.S. and considering typical diagnostic test pricing, this could represent a
The dual advancement of both ACR-368 in Phase 2b trials and ACR-2316 in Phase 1 demonstrates strong pipeline momentum. The successful completion of two dose-escalation cohorts for ACR-2316 suggests efficient clinical execution and potential for accelerated development timelines.
The integration of AI through the AP3 platform for both biomarker development and drug design represents a competitive advantage, potentially enabling more precise patient selection and improved clinical outcomes. This technology-driven approach could establish a new paradigm in precision oncology, particularly valuable in a market where treatment resistance and patient selection remain significant challenges.
The ACR-368-tailored OncoSignature assay is being used to predict patients most likely to respond to ACR-368 in Acrivon’s ongoing, registrational-intent, multicenter Phase 2b trial of ACR-368 in patients with endometrial cancer and other tumor types
Clinical data presented at ESMO 2024 demonstrates statistically significant segregation of patient responders in biomarker-positive versus biomarker-negative subgroups based on prospective OncoSignature patient selection (p-value = 0.009)
Drug-tailored, proprietary OncoSignature biomarker assays are developed using the generative AI-driven Acrivon Predictive Precision Proteomics (AP3) platform, which is also used for streamlined, biologically rational drug design and indication finding
WATERTOWN, Mass., Feb. 05, 2025 (GLOBE NEWSWIRE) -- Acrivon Therapeutics, Inc. (“Acrivon” or “Acrivon Therapeutics”) (Nasdaq: ACRV), a clinical stage precision medicine company utilizing its Acrivon Predictive Precision Proteomics (AP3) platform for the discovery, design, and development of drug candidates through a mechanistic match to patients whose disease is predicted sensitive to the specific treatment, announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for the ACR-368 OncoSignature assay, a multiplex immunofluorescence assay for the identification of endometrial cancer patients who may benefit from ACR-368 treatment. The designation reflects the FDA’s determination that the device is reasonably expected to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions.
“We are pleased that the FDA has designated our ACR-368 OncoSignature assay, developed specifically to prospectively predict tumor sensitivity to ACR-368 and used in our advancing registrational-intent clinical study, as a Breakthrough Device for patients with endometrial cancer,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president, and founder of Acrivon Therapeutics. “This is the second such designation for our ACR-368 OncoSignature assay and represents yet another powerful validation of our generative AI-driven AP3 platform. The enrollment and dosing continues for both ACR-368 in our ongoing Phase 2b trials, as well as for ACR-2316, our internally-developed Phase 1 asset, which is a novel, differentiated WEE1/PKMYT1 inhibitor uniquely enabled by AP3. We have now completed enrollment in the first two dose-escalation cohorts of the ACR-2316 Phase 1 trial and initiated dosing in the third cohort.”
A company-sponsored, blinded, third-party KOL market research study showed strong interest in the emerging clinical profile of ACR-368. There is an estimated ~30,000 (and growing) new cases of high-grade, locally advanced or metastatic, recurrent (progressed on anti-PD-1 and chemotherapy) endometrial cancer per year in the U.S. The company presented positive clinical data at ESMO 2024 demonstrating a confirmed overall response rate (ORR) of
The Breakthrough Devices Program is intended to provide patients and health care providers with timely access to medical devices by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and marketing authorization.
About Acrivon Therapeutics
Acrivon is a clinical stage biopharmaceutical company developing precision oncology medicines that it matches to patients whose tumors are predicted to be sensitive to each specific medicine by utilizing Acrivon’s proprietary proteomics-based patient responder identification platform, Acrivon Predictive Precision Proteomics, or AP3. The generative AI-driven AP3 platform is engineered to measure compound-specific effects on the entire tumor cell protein signaling network and drug-induced resistance mechanisms in an unbiased manner yielding terabytes of high resolution proprietary quantitative data for pathway-based drug design, indication finding, and response prediction. These distinctive capabilities enable AP3’s direct application for streamlined rational drug discovery for monotherapy activity, the identification of rational drug combinations, and the creation of drug-specific proprietary OncoSignature companion diagnostics that are used to identify the patients most likely to benefit from Acrivon’s drug candidates. Acrivon is currently advancing its lead candidate, ACR-368 (also known as prexasertib), a selective small molecule inhibitor targeting CHK1 and CHK2 in a potentially registrational Phase 2 trial across multiple tumor types. The company has received Fast Track designation from the Food and Drug Administration, or FDA, for the investigation of ACR-368 as monotherapy based on OncoSignature-predicted sensitivity in patients with platinum-resistant ovarian or endometrial cancer. Acrivon’s ACR-368 OncoSignature test, which has not yet obtained regulatory approval, has been extensively evaluated in preclinical studies, including in two separate, blinded, prospectively-designed studies on pretreatment tumor biopsies collected from past third-party Phase 2 trials in patients with ovarian cancer treated with ACR-368. The FDA has granted Breakthrough Device designations for the ACR-368 OncoSignature assay for the identification of patients with endometrial cancer or for patients with ovarian cancer, who may benefit from ACR-368 treatment. The company reported positive clinical data for ovarian and endometrial cancers in April 2024, and in September 2024 it reported additional positive clinical data for endometrial cancer, including a confirmed overall response rate of
In addition to ACR-368, Acrivon is also leveraging its proprietary AP3 precision medicine platform for developing its co-crystallography-driven, internally-discovered pipeline programs. These include ACR-2316, the company’s second clinical stage asset, a novel, potent, selective WEE1/PKMYT1 inhibitor designed for superior single-agent activity through strong activation of not only CDK1 and CDK2, but also of PLK1 to drive pro-apoptotic cell death, as demonstrated in preclinical studies against benchmark inhibitors. In addition, the company has a preclinical cell cycle program with an undisclosed target.
Acrivon has developed AP3 Interactome, a proprietary, computational analytics platform driven by machine learning for integrated comprehensive analyses across all large, in-house AP3 phosphoproteomic drug profiling data sets to advance its in-house research programs.
Forward-Looking Statements
This press release includes certain disclosures that contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 about us and our industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release, including statements regarding our future results of operations or financial condition, preclinical and clinical results, business strategy and plans and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these words or other similar terms or expressions. Forward-looking statements are based on Acrivon’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties that are described more fully in the section titled “Risk Factors” in our reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this press release are made as of this date, and Acrivon undertakes no duty to update such information except as required under applicable law.
Investor and Media Contacts:
Adam D. Levy, Ph.D., M.B.A.
alevy@acrivon.com
Alexandra Santos
asantos@wheelhouselsa.com
FAQ
What is the response rate of ACR-368 in endometrial cancer patients according to ESMO 2024 data?
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How does ACRV's OncoSignature assay select patients for ACR-368 treatment?
