Companies also provide insights into proposed strategic merger
SAN MATEO, CA, USA I January 29, 2025 I 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) was 100%. 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.
- Evaluable patients with late-stage TNBC (n=37)
- As presented at ESMO, the confirmed ORR was 27% and DCR was 62%, with 6-month DOR and PFS rates of 39% and 25%, respectively.
- Evaluable patients with HR+/HER2- breast cancer (n=58)
- As presented at ESMO, the confirmed ORR was 39%, DCR was 78%, and 6-month DOR and PFS rates of 70% and 55%, respectively, with a median (range) PFS of 7.4 (3.7-9.2) months.
Also presented at ESMO, OQY-3258 demonstrated meaningful activity in patients with brain metastases, reporting an intracranial ORR of 41% (n=17), which included three complete and four partial transcranial responses. Additionally, in patients with brain metastases, PFS (95% confidence interval) was 4.6 (2.0-9.8) months with OQY-3258 compared with 2.8 (1.5-3.9) months for historical data with Trodelvy. OQY-3258 has demonstrated a favorable safety profile, with the most common Grade ≥3 adverse events being manageable hematologic toxicities, such as neutropenia and leukopenia, that did not lead to treatment discontinuation. Notably, no Grade ≥3 rash or interstitial lung disease/pneumonitis was observed, and there was only one case each of Grade 3 diarrhea and stomatitis. This differentiated safety profile sets OQY-3258 apart from other TROP2 ADCs.
“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 95% of the combined entity and Vincerx equity holders expected to hold approximately 5%. The proposed merger provides for a minimum fully diluted equity value of $13.66 million for existing Vincerx stockholders at closing and, as a condition to the closing of the merger, completion of a concurrent private offering of Vincerx equity securities of at least $20 million. Additionally, Oqory-designated investors will provide interim financing to Vincerx of $1.5 million in two tranches, approximately $1,000,000 of which was provided on December 27, 2024, and approximately $500,000 of which is to be provided on or prior to January 31, 2025. The entry into a definitive merger agreement is contingent on a number of conditions, including satisfactory completion of due diligence by Vincerx and Oqory, interim financing for Vincerx in the amount of at least $500,000 on or prior to January 31, 2025, commitments by investors for the concurrent financing, and negotiation of the terms of a definitive merger agreement. Once a definitive merger agreement is executed, the closing of any merger will be subject to customary closing conditions, including regulatory approvals, stockholder approval from both parties, completion of the minimum $20 million financing, and the continued listing of Vincerx’s common stock on Nasdaq.
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.
SOURCE: Vincerx Pharma
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Companies also provide insights into proposed strategic merger
SAN MATEO, CA, USA I January 29, 2025 I 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) was 100%. 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.
- Evaluable patients with late-stage TNBC (n=37)
- As presented at ESMO, the confirmed ORR was 27% and DCR was 62%, with 6-month DOR and PFS rates of 39% and 25%, respectively.
- Evaluable patients with HR+/HER2- breast cancer (n=58)
- As presented at ESMO, the confirmed ORR was 39%, DCR was 78%, and 6-month DOR and PFS rates of 70% and 55%, respectively, with a median (range) PFS of 7.4 (3.7-9.2) months.
Also presented at ESMO, OQY-3258 demonstrated meaningful activity in patients with brain metastases, reporting an intracranial ORR of 41% (n=17), which included three complete and four partial transcranial responses. Additionally, in patients with brain metastases, PFS (95% confidence interval) was 4.6 (2.0-9.8) months with OQY-3258 compared with 2.8 (1.5-3.9) months for historical data with Trodelvy. OQY-3258 has demonstrated a favorable safety profile, with the most common Grade ≥3 adverse events being manageable hematologic toxicities, such as neutropenia and leukopenia, that did not lead to treatment discontinuation. Notably, no Grade ≥3 rash or interstitial lung disease/pneumonitis was observed, and there was only one case each of Grade 3 diarrhea and stomatitis. This differentiated safety profile sets OQY-3258 apart from other TROP2 ADCs.
“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 95% of the combined entity and Vincerx equity holders expected to hold approximately 5%. The proposed merger provides for a minimum fully diluted equity value of $13.66 million for existing Vincerx stockholders at closing and, as a condition to the closing of the merger, completion of a concurrent private offering of Vincerx equity securities of at least $20 million. Additionally, Oqory-designated investors will provide interim financing to Vincerx of $1.5 million in two tranches, approximately $1,000,000 of which was provided on December 27, 2024, and approximately $500,000 of which is to be provided on or prior to January 31, 2025. The entry into a definitive merger agreement is contingent on a number of conditions, including satisfactory completion of due diligence by Vincerx and Oqory, interim financing for Vincerx in the amount of at least $500,000 on or prior to January 31, 2025, commitments by investors for the concurrent financing, and negotiation of the terms of a definitive merger agreement. Once a definitive merger agreement is executed, the closing of any merger will be subject to customary closing conditions, including regulatory approvals, stockholder approval from both parties, completion of the minimum $20 million financing, and the continued listing of Vincerx’s common stock on Nasdaq.
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.
SOURCE: Vincerx Pharma
Post Views: 208
