This section highlights FDA-related milestones and regulatory updates for drugs developed by Vincerx Pharma (VINC).
Over the past two years, Vincerx Pharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
OQY-3258, TROP2, and VIP943. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
OQY-3258 - FDA Regulatory Timeline and Events
OQY-3258 is a drug developed by Vincerx Pharma for the following indication: For patients with solid tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- OQY-3258
- Announced Date:
- January 29, 2025
- Indication:
- For patients with solid tumors.
Announcement
Vincerx Pharma, Inc. 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.
AI Summary
Vincerx Pharma, Inc. has shared details about their planned strategic merger with Oqory, Inc. The goal of this merger is to move OQY-3258, an anti-TROP2 antibody drug conjugate (ADC), into global Phase 3 clinical trials for cancer treatment. By combining the strengths of both companies, they aim to build a differentiated ADC pipeline that could better address unmet medical needs. This merger leverages Vincerx’s expertise in clinical development alongside Oqory's innovative ADC technology. The partnership intends to accelerate the advancement of OQY-3258, which has already shown promising early results and a favorable safety profile in Phase 1a/1b trials. The combined entity plans to become a leader in next-generation ADC therapies, addressing tumor types like metastatic breast cancer and solid tumors through innovative treatment solutions.
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TROP2 ADC - FDA Regulatory Timeline and Events
TROP2 ADC is a drug developed by Vincerx Pharma for the following indication: For patients with solid tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TROP2 ADC
- Announced Date:
- January 29, 2025
- Indication:
- For patients with solid tumors.
Announcement
Vincerx Pharma, Inc. today highlighted Phase 1a/1b data for Oqory's anti-TROP2 ADC, OQY-3258, for patients with solid tumors.
AI Summary
Vincerx Pharma, Inc. recently highlighted promising Phase 1a/1b data for Oqory’s anti-TROP2 ADC, OQY-3258, which is being evaluated in patients with solid tumors. The early study, which enrolled about 150 patients, showed encouraging clinical activity across several cancer subtypes, including various forms of breast cancer. Initial results suggest strong overall response rates and disease control, with many patients experiencing significant benefits. Moreover, the data indicate that OQY-3258 has a favorable safety profile, with manageable side effects such as neutropenia and leukopenia, and a lower incidence of severe off-target toxicities compared to other TROP2 ADC options.
These positive findings support the potential of OQY-3258 as an innovative treatment for TROP2-expressing tumors and justify further clinical development to address unmet needs in cancer therapy.
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VIP943 - FDA Regulatory Timeline and Events
VIP943 is a drug developed by Vincerx Pharma for the following indication: To enhance intracellular accumulation of the KSPi payload.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- VIP943
- Announced Date:
- December 4, 2024
- Indication:
- To enhance intracellular accumulation of the KSPi payload
Announcement
Vincerx Pharma, Inc. announced plans to implement cost-controls and explore strategic alternatives to support advancing the Phase 1 study of VIP943, the Company's novel CD123-targeted antibody-drug conjugate (ADC) developed with the Company's next-generation VersAptx™ platform.
AI Summary
Vincerx Pharma, Inc. announced plans to implement strict cost-controls and explore strategic alternatives to support the continued advancement of its Phase 1 study for VIP943, a novel CD123-targeted antibody-drug conjugate (ADC) developed on the VersAptx™ platform. The company believes VIP943 is a highly differentiated asset that has shown promising safety, efficacy, and tolerability in early trials, with encouraging responses noted in patients with acute myeloid leukemia (AML) and higher-risk myelodysplastic syndrome (HR-MDS). Results from additional patient cohorts are expected by early Q1 2025.
To focus resources on further developing VIP943, Vincerx is not only cost-cutting but also exploring strategic alternatives such as out-licensing, mergers, acquisitions, and other transactions. These efforts aim to maximize the value of VIP943 and the VersAptx platform while supporting further clinical development in challenging patient populations.
Read Announcement- Drug:
- VIP943
- Announced Date:
- October 7, 2024
- Indication:
- To enhance intracellular accumulation of the KSPi payload
Announcement
Vincerx Pharma, Inc. announced two complete responses in the ongoing first-in-human, Phase 1 dose-escalation study of VIP943, the Company's next-generation antibody-drug conjugate (ADC) being evaluated in relapsed/refractory acute myeloid leukemia (AML), higher-risk myelodysplastic syndrome (HR-MDS), and B-cell acute lymphoblastic leukemia (B-ALL).
AI Summary
Vincerx Pharma announced two complete responses in its ongoing first-in-human, Phase 1 dose-escalation study of VIP943, a next-generation antibody-drug conjugate (ADC). The study is focused on patients with relapsed/refractory acute myeloid leukemia (AML), higher-risk myelodysplastic syndrome (HR-MDS), and B-cell acute lymphoblastic leukemia (B-ALL). Out of 22 enrolled patients, nine received at least three doses (≥1.0 mg/kg) of VIP943. Among these, one patient with relapsed AML achieved complete remission with incomplete hematologic improvement (CRi), and one patient with HR-MDS reached complete remission with limited count recovery (CRL).
The encouraging clinical responses highlight the favorable safety and tolerability profile of VIP943, with no dose-limiting toxicities reported. The results also support the VersAptx Platform technology, which aims to create safer and more effective ADCs. Additional updates on VIP943’s progress are expected later this year.
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