Vincerx Pharma, Inc. and Oqory, Inc. Highlight Promising Data for Oqory’s TROP2 Antibody Drug Conjugate, OQY-3258
Vincerx Pharma (VINC) and Oqory announced promising Phase 1a/1b data for OQY-3258, an anti-TROP2 antibody drug conjugate (ADC), and provided insights into their proposed strategic merger. The drug is currently being evaluated in three clinical trials, including two Phase 3 studies.
Key clinical results from the Phase 1a/1b study of approximately 150 patients showed: 80% confirmed overall response rate in previously untreated TNBC patients (n=35); 27% confirmed ORR in late-stage TNBC patients (n=37); and 39% confirmed ORR in HR+/HER2- breast cancer patients (n=58). Notably, the drug demonstrated a 41% intracranial ORR in patients with brain metastases.
OQY-3258 showed a favorable safety profile with manageable hematologic toxicities and no Grade ≥3 rash or interstitial lung disease/pneumonitis. The merger aims to advance OQY-3258 into global Phase 3 trials and develop next-generation ADCs.
Vincerx Pharma (VINC) e Oqory hanno annunciato dati promettenti della fase 1a/1b per OQY-3258, un coniugato di farmaco anticorpale anti-TROP2 (ADC), e hanno fornito informazioni sulla loro proposta di fusione strategica. Il farmaco è attualmente in fase di valutazione in tre studi clinici, compresi due studi di fase 3.
I risultati clinici chiave dello studio di fase 1a/1b su circa 150 pazienti hanno mostrato: 80% di tasso di risposta complessivo confermato nei pazienti con TNBC precedentemente non trattati (n=35); 27% di ORR confermato nei pazienti con TNBC in fase avanzata (n=37); e 39% di ORR confermato nei pazienti con cancro mammario HR+/HER2- (n=58). Notevolmente, il farmaco ha dimostrato un 41% di ORR intracranica nei pazienti con metastasi cerebrali.
OQY-3258 ha mostrato un profilo di sicurezza favorevole con tossicità ematologiche gestibili e nessuna eruzione cutanea di Grado ≥3 o malattia polmonare interstiziale/pneumonite. La fusione mira a portare OQY-3258 in studi globali di fase 3 e a sviluppare ADC di nuova generazione.
Vincerx Pharma (VINC) y Oqory anunciaron datos prometedores de la fase 1a/1b para OQY-3258, un conjugado de fármaco anticuerpos anti-TROP2 (ADC), y proporcionaron información sobre su propuesta de fusión estratégica. El fármaco se está evaluando actualmente en tres ensayos clínicos, incluidos dos estudios de fase 3.
Los resultados clínicos clave del estudio de fase 1a/1b con aproximadamente 150 pacientes mostraron: 80% de tasa de respuesta global confirmada en pacientes con TNBC previamente no tratados (n=35); 27% de ORR confirmada en pacientes con TNBC en etapa avanzada (n=37); y 39% de ORR confirmada en pacientes con cáncer de mama HR+/HER2- (n=58). Notablemente, el fármaco demostró un 41% de ORR intracraneal en pacientes con metastasis cerebrales.
OQY-3258 mostró un perfil de seguridad favorable con toxicidades hematológicas manejables y sin erupción cutánea de Grado ≥3 o enfermedad pulmonar intersticial/neumonitis. La fusión tiene como objetivo avanzar OQY-3258 a ensayos globales de fase 3 y desarrollar ADC de próxima generación.
Vincerx Pharma (VINC)와 Oqory가 OQY-3258, 항 TROP2 항체 약물 접합체(ADC)의 1a/1b 단계에서 유망한 데이터를 발표하고 전략적 합병 제안에 대한 통찰력을 제공했습니다. 이 약물은 현재 3개의 임상 시험, 즉 2개의 3상 연구에서 평가되고 있습니다.
약 150명의 환자를 대상으로 한 1a/1b 연구_key의 주요 임상 결과는 다음과 같습니다: 80%의 확인된 전체 반응률은 이전에 치료받지 않은 TNBC 환자(n=35); 27%의 확인된 ORR은 말기 TNBC 환자(n=37); 그리고 39%의 확인된 ORR은 HR+/HER2- 유방암 환자(n=58). 특히, 이 약물은 뇌 전이가 있는 환자에서 41%의 두개내 ORR을 나타냈습니다.
OQY-3258은 관리 가능한 혈액학적 독성과 3도 이상의 발진이나 간질성 폐질환/폐렴이 없는 우호적인 안전성 프로필을 나타냈습니다. 합병의 목표는 OQY-3258을 글로벌 3상 시험으로 진행하고 차세대 ADC를 개발하는 것입니다.
Vincerx Pharma (VINC) et Oqory ont annoncé des données prometteuses de la phase 1a/1b pour OQY-3258, un conjugé d'anticorps anti-TROP2 (ADC), et ont fourni des informations sur leur proposition de fusion stratégique. Le médicament est actuellement évalué dans trois essais cliniques, dont deux études de phase 3.
Les résultats cliniques clés de l'étude de phase 1a/1b portant sur environ 150 patients ont montré : 80% de taux de réponse global confirmé chez les patients atteints de TNBC précédemment non traités (n=35); 27% de ORR confirmée chez les patients atteints de TNBC avancé (n=37); et 39% de ORR confirmée chez les patientes atteintes de cancer du sein HR+/HER2- (n=58). Notamment, le médicament a démontré un 41% de ORR intracrânien chez les patients souffrant de métastases cérébrales.
OQY-3258 a montré un profil de sécurité favorable avec des toxicités hématologiques gérables et aucune éruption cutanée de grade ≥3 ou maladie pulmonaire interstitielle/pneumonite. La fusion vise à faire avancer OQY-3258 vers des essais mondiaux de phase 3 et à développer des ADC de nouvelle génération.
Vincerx Pharma (VINC) und Oqory haben vielversprechende Phase-1a/1b-Daten zu OQY-3258, einem Antikörper-Wirkstoff-Konjugat (ADC) gegen TROP2, bekannt gegeben und Einblicke in ihre geplante strategische Fusion gegeben. Das Medikament wird derzeit in drei klinischen Studien evaluiert, darunter zwei Phase-3-Studien.
Die wichtigsten klinischen Ergebnisse der Phase-1a/1b-Studie mit etwa 150 Patienten zeigten: 80% bestätigte Gesamtansprechrate bei zuvor unbehandelten TNBC-Patienten (n=35); 27% bestätigte ORR bei Patienten mit fortgeschrittenem TNBC (n=37); und 39% bestätigte ORR bei HR+/HER2- Brustkrebspatienten (n=58). Bemerkenswert ist, dass das Medikament eine 41% intrakranielle ORR bei Patienten mit Hirnmetastasen zeigte.
OQY-3258 wies ein günstiges Sicherheitsprofil mit handhabbaren hämatologischen Toxizitäten und ohne Grad ≥3 Hautausschläge oder interstitielle Lungenerkrankung/Pneumonitis auf. Das Ziel der Fusion ist es, OQY-3258 in globale Phase-3-Studien voranzutreiben und ADCs der nächsten Generation zu entwickeln.
- Strong efficacy data with 80% ORR in previously untreated TNBC patients
- Favorable safety profile compared to other TROP2 ADCs
- 41% intracranial ORR in patients with brain metastases
- Strategic merger to accelerate development and expand ADC pipeline
- Breakthrough Designation from China's NMPA for first-line TNBC treatment
- Lower ORR (27%) in late-stage TNBC patients
- Presence of Grade ≥3 adverse events including neutropenia and leukopenia
Insights
The clinical data for OQY-3258 represents a potentially significant breakthrough in the competitive TROP2 ADC landscape. The standout 80% confirmed overall response rate in first-line TNBC treatment surpasses current market standards, while the 100% disease control rate suggests exceptional efficacy. Particularly noteworthy is the drug's performance in brain metastases, with an intracranial ORR of 41% and superior PFS compared to Trodelvy's historical data.
The differentiated safety profile, marked by the absence of Grade ≥3 rash or interstitial lung disease, positions OQY-3258 favorably against existing TROP2 ADCs like Trodelvy and Dato-DXd. The optimized serum-stable linker design appears to be delivering on its promise of reduced off-target toxicity, a critical factor for both patient quality of life and potential market adoption.
Two pivotal Phase 3 trials are already underway, targeting both HR+/HER2- and triple-negative breast cancer. The Breakthrough Designation from China's NMPA for first-line TNBC treatment accelerates the path to a major market. The merger between Vincerx and Oqory strategically combines development expertise with ADC technology, potentially creating a formidable player in the rapidly growing ADC market, estimated to reach $30 billion by 2028.
The clinical profile of OQY-3258 addresses several critical unmet needs in breast cancer treatment. The 76-80% ORR in first-line TNBC represents a potential paradigm shift in treating this aggressive cancer subtype. Most notably, the drug's ability to effectively treat brain metastases, with a 41% intracranial ORR, tackles one of the most challenging aspects of breast cancer management.
The safety data reveals a important advantage: manageable hematologic toxicities without treatment discontinuation and minimal incidence of severe adverse events typically associated with TROP2 ADCs. This favorable toxicity profile could enable longer treatment durations and better compliance, potentially leading to improved real-world outcomes.
The comprehensive efficacy across multiple breast cancer subtypes - including 39% ORR in HR+/HER2- patients - suggests broad therapeutic potential. The durability of response, with 6-month DOR rates of 70% in HR+/HER2- patients, indicates sustained clinical benefit that could translate to meaningful survival advantages in the ongoing Phase 3 trials.
Companies also provide insights into proposed strategic merger
SAN MATEO, Calif., Jan. 29, 2025 (GLOBE NEWSWIRE) -- Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, and Oqory, Inc., a private biopharmaceutical company dedicated to developing next-generation antibody drug conjugates (ADCs) for the treatment of cancer, today highlighted Phase 1a/1b data for Oqory’s anti-TROP2 ADC, OQY-3258, for patients with solid tumors. The companies also provided insights into their proposed strategic merger, which aims to advance OQY-3258 into global Phase 3 trials and build a differentiated ADC pipeline by leveraging their combined expertise.
OQY-3258, also known as ESG401, is an anti-TROP2 ADC currently under evaluation in three clinical trials:
- A Phase 1a/1b clinical trial for patients with solid tumors (NCT04892342).
- A Phase 3 study in patients with locally advanced or metastatic HR+/HER2- breast cancer (NCT06383767).
- A Phase 3 study as a first-line treatment in patients with unresectable recurrent or metastatic triple-negative breast cancer (NCT06732323), which garnered Breakthrough Designation from China’s National Medical Products Administration (NMPA) on November 6, 2024.
As of August 2024, the Phase 1a/1b study had enrolled approximately 150 patients, with promising preliminary results in multiple breast cancer subtypes. Recent data highlights, including those presented at the 2024 European Society for Medical Oncology (ESMO), include:
- Evaluable patients with previously untreated TNBC (n=25)
- As presented at ESMO, the confirmed overall response rate (ORR) was
76% and disease control rate (DCR) was100% . Median duration of response (DOR) and progression-free survival (PFS) had not yet been reached. - A recent data cut from January 2025, with ten additional patients (n=35) evaluable for efficacy, showed an improved confirmed ORR of
80% , with median DOR and PFS still not reached.
- As presented at ESMO, the confirmed overall response rate (ORR) was
- Evaluable patients with late-stage TNBC (n=37)
- As presented at ESMO, the confirmed ORR was
27% and DCR was62% , with 6-month DOR and PFS rates of39% and25% , respectively.
- As presented at ESMO, the confirmed ORR was
- Evaluable patients with HR+/HER2- breast cancer (n=58)
- As presented at ESMO, the confirmed ORR was
39% , DCR was78% , and 6-month DOR and PFS rates of70% and55% , respectively, with a median (range) PFS of 7.4 (3.7-9.2) months.
- As presented at ESMO, the confirmed ORR was
Also presented at ESMO, OQY-3258 demonstrated meaningful activity in patients with brain metastases, reporting an intracranial ORR of
“The compelling clinical activity demonstrated in our Phase 1a/1b trial highlights the potential of OQY-3258 to address significant unmet needs in TROP2-expressing tumors,” said Michael King, CEO of Oqory, Inc. “With its optimized serum-stable linker design, OQY-3258 has shown a markedly lower incidence of severe off-target toxicity compared with other marketed TROP2 therapies, positioning it as a differentiated late-stage ADC for metastatic breast cancer and other TROP2-expressing cancers. Our proposed merger with Vincerx represents a pivotal step toward advancing this asset into global Phase 3 trials and driving innovation in next-generation ADCs.”
Raquel Izumi, Ph.D., Acting CEO of Vincerx, added, “The proposed merger with Oqory reflects our commitment to develop transformative therapies for patients with cancer. The promising efficacy and favorable safety profile demonstrated by OQY-3258 highlights its potential as a best-in-class anti-TROP2 ADC. By bringing together Vincerx’s development expertise and Oqory’s ADC technologies, we aim to accelerate the development of OQY-3258, while building a pipeline of next-generation ADCs that address significant unmet patient needs.”
About Proposed Merger
Vincerx and Oqory are parties to a binding term sheet, as amended, pursuant to which Oqory would merge into Vincerx, with Oqory equity holders expected to own approximately
The description of the binding term sheet and proposed merger contained herein is only a summary and is qualified in its entirety by reference to the binding term sheet, as amended, a copy of which has been filed by Vincerx with the Securities and Exchange Commission.
About OQY-3258 (also known as ESG401)
OQY-3258 is Oqory’s anti-TROP2 ADC with an optimized enzyme-dependent linker technology and an SN-38 payload with established efficacy and manageable side effect profile. As of August 2024, OQY-3258 has completed Phase 1a/1b development in about 150 patients with solid tumors, including metastatic HR+/HER2- and triple-negative breast cancer. OQY-3258 has shown efficacy in these patients, including reduction of brain metastasis and responses in heavily pretreated patients. To date, OQY-3258 has exhibited a differentiated safety profile versus other marketed TROP2 ADCs. Notably, no Grade ≥3 interstitial lung disease/pneumonitis or rash have been observed. Gastrointestinal effects have been mild and mainly Grade 1/2. Neutropenia and leukopenia have been the major adverse events, which were manageable and did not result in discontinuation of study drug. OQY-3258 is being evaluated in a Phase 3 study as first-line treatment in patients with unresectable recurrent or metastatic triple-negative breast cancer (NCT06732323) and in a Phase 3 study in patients with unresectable locally advanced or metastatic HR+/HER2- breast cancer (NCT06383767); both currently conducted by Shanghai Escugen Biotechnology Co., Ltd., Oqory’s development partner.
About Oqory, Inc.
Oqory, Inc. is an innovator in the field of ADCs with expertise in advancing targeted cancer therapies. The Company’s pipeline includes multiple ADC programs, with two currently in clinical development and several next-generation ADCs in preclinical stages. These programs are designed to address critical unmet needs in indications such as breast cancer, non-small cell lung cancer, small cell lung cancer, multiple myeloma, and other metastatic solid tumors. Powered by a proprietary ADC platform, Oqory is focused on delivering therapies that improve outcomes for patients with cancer.
Oqory is based in San Diego, California.
About Vincerx Pharma, Inc.
Vincerx Pharma, Inc. is a clinical-stage biopharmaceutical company committed to developing differentiated and novel therapies to address the unmet medical needs of patients with cancer. Vincerx’s pipeline consists of a next-generation ADC, VIP943, currently in Phase 1; a small molecule drug conjugate, VIP236, which has completed its Phase 1 study; a CDK9 inhibitor, enitociclib, which has completed a Phase 1 monotherapy study; a preclinical ADC, VIP924; and VersAptx™, a versatile, next-generation bioconjugation platform.
Vincerx is based in San Mateo, California, and has a research subsidiary in Monheim, Germany.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of U.S. federal securities laws. Forward-looking statements, which are based on certain assumptions and describe future plans, strategies, expectations and events, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “would,” “could,” “suggest,” “seek,” “intend,” “plan,” “goal,” “potential,” “on-target,” “on track,” “project,” “estimate,” “anticipate,” or other comparable terms. All statements other than statements of historical facts included in this press release are forward-looking statements. Forward-looking statements include, but are not limited to, the entry into a definitive merger agreement; the anticipated terms and conditions of the merger, including the
Actual results, conditions, and events may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause actual results, conditions, and events to differ materially from those indicated in the forward-looking statements include, but are not limited to: the satisfactory completion of the parties’ respective due diligence; the completion of the interim financing; the parties’ capital requirements, availability, and sufficiency of capital, and cash runway; the results of Vincerx's due diligence review of Oqory, which has not been completed as of the date hereof; the ability of the parties to successfully negotiate and enter into a definitive merger agreement and the actual terms thereof; the parties’ ability to satisfy the conditions precedent to the merger to be contained in a definitive merger agreement, including completion of the concurrent offering of Vincerx equity securities of at least
Vincerx® and VersAptx™ are trademarks of Vincerx. Oqory and the Oqory logo are trademarks of Oqory.
Additional Information
In connection with the proposed merger transaction, Vincerx will file relevant materials with the SEC, including a proxy statement on Schedule 14A. A definitive proxy statement will be sent to holders of Vincerx’s common stock when it becomes available. Investors and securityholders and other interested parties are urged to carefully read the proxy statement (including any amendments or supplements thereto) and any other documents filed with the SEC when they become available, because they will contain important information about Vincerx, Oqory, and the proposed merger. Investors and securityholders may obtain free copies of these documents and other documents filed with the SEC by Vincerx (when they become available) through the website maintained by the SEC at http://www.sec.gov, or by directing a request to: Vincerx Pharma, Inc., 1825 S. Grant Street, San Mateo, CA 94402. Copies of the documents filed by Vincerx are also available free of charge in the “Investors—SEC Filings & Financials—SEC Filings” section of Vincerx’s website at: https://investors.vincerx.com/financial-information/sec-filings.
Participants in the Solicitation
Vincerx, Oqory, and their respective directors and officers are or may be considered “participants” (as defined in Section 14(a) of the Securities Exchange Act of 1934) in the solicitation of proxies from the holders of Vincerx’s common stock with respect to the proposed transactions described herein. Information about Vincerx’s directors and executive officers, including compensation, is set forth in the sections entitled “Election of Directors—Directors and Nominees” and “Executive Officers” of Vincerx’s definitive proxy statement for its 2024 Annual Meeting of Stockholders, filed with the SEC on April 10, 2024, the section entitled “Compensation of Directors and Executive Officers” of Vincerx’s definitive proxy statement for its special meeting of stockholders, filed with the SEC on December 10, 2024 (the “2025 Special Meeting Proxy Statement”), as well as the Vincerx’s Current Report on Form 8-K filed on December 27, 2024.
Information about the ownership of Vincerx’s common stock by Vincerx’s executive officers and directors is set forth in the section entitled “Security Ownership of Certain Beneficial Owners and Management” in the 2025 Special Meeting Proxy Statement, as well as the Form 3 filed on January 6, 2025 for Kevin Haas. Updated information regarding the identity of potential participants, and their direct or indirect interests (by security holdings or otherwise), will be reflected in Forms 3, 4, or 5 to be filed with the SEC, as well as the section entitled “Security Ownership of Certain Beneficial Owners and Management” of Vincerx’s definitive proxy statement on Schedule 14A and other materials to be filed with the SEC regarding the proposed transactions. All of these documents are or will be available free of charge at the SEC’s website at www.sec.gov and in the “Investors—SEC Filings & Financials—SEC Filings” section of Vincerx’s website at https://investors.vincerx.com/financial-information/sec-filings.
Stockholders, potential investors, and other readers should read the definitive proxy statement carefully when it becomes available before making any voting or investment decisions. These documents can be obtained free of charge from the sources indicated above.
No Offer or Solicitation
This communication shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities, in any jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.
Contacts:
Gabriela Jairala
Vincerx Pharma, Inc.
gabriela.jairala@vincerx.com
Michael King
Oqory, Inc.
MKing@oqory.com
FAQ
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