CLINICAL TRIALS PROFILE FOR VINCREX

505(b)(2) Clinical Trials for Vincrex

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT03742258 ↗	Combination Chemotherapy and TAK-659 as Front-Line Treatment in Treating Patients With High-Risk Diffuse Large B Cell Lymphoma	Active, not recruiting	National Cancer Institute (NCI)	Phase 1	2019-03-13	The purpose of this research study is to evaluate a new investigational drug, TAK-659, given in combination with standard chemotherapy, for the treatment of Diffuse Large B-cell Lymphoma (DLBCL). ?Investigational? means that TAK-659 has not been approved by the United States Food and Drug Administration (FDA) for use as a prescription or over-the-counter medication to treat a certain condition. The primary purpose of this study is to find the appropriate and safe dose of the study drug to be used in combination with standard chemotherapy for the treatment of your disease and to determine how well the drug works in treating the disease. Other objectives include measuring the amount of the study drug in the body at different times after taking the study drug. Participation in the study is expected to last for up to 3 years after receiving the last dose of the study drug. Patients will receive the study treatment for up to 18 weeks, as long as they are benefitting.
OTC	NCT03742258 ↗	Combination Chemotherapy and TAK-659 as Front-Line Treatment in Treating Patients With High-Risk Diffuse Large B Cell Lymphoma	Active, not recruiting	Northwestern University	Phase 1	2019-03-13	The purpose of this research study is to evaluate a new investigational drug, TAK-659, given in combination with standard chemotherapy, for the treatment of Diffuse Large B-cell Lymphoma (DLBCL). ?Investigational? means that TAK-659 has not been approved by the United States Food and Drug Administration (FDA) for use as a prescription or over-the-counter medication to treat a certain condition. The primary purpose of this study is to find the appropriate and safe dose of the study drug to be used in combination with standard chemotherapy for the treatment of your disease and to determine how well the drug works in treating the disease. Other objectives include measuring the amount of the study drug in the body at different times after taking the study drug. Participation in the study is expected to last for up to 3 years after receiving the last dose of the study drug. Patients will receive the study treatment for up to 18 weeks, as long as they are benefitting.

All Clinical Trials for Vincrex

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00075725 ↗	Dexamethasone Compared With Prednisone During Induction Therapy and Methotrexate With or Without Leucovorin During Maintenance Therapy in Treating Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia	Completed	National Cancer Institute (NCI)	Phase 3	2003-12-29	This randomized phase III trial is studying dexamethasone to see how well it works compared to prednisone during induction therapy. This trial is also studying methotrexate and leucovorin calcium to see how well they work compared to methotrexate alone during maintenance therapy in treating patients with newly diagnosed acute lymphoblastic leukemia (ALL). Drugs used in chemotherapy, such as dexamethasone, prednisone, methotrexate, and leucovorin calcium, work in different ways to stop cancer cells from dividing so they stop growing or die. Giving more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.
NCT00075725 ↗	Dexamethasone Compared With Prednisone During Induction Therapy and Methotrexate With or Without Leucovorin During Maintenance Therapy in Treating Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia	Completed	Children's Oncology Group	Phase 3	2003-12-29	This randomized phase III trial is studying dexamethasone to see how well it works compared to prednisone during induction therapy. This trial is also studying methotrexate and leucovorin calcium to see how well they work compared to methotrexate alone during maintenance therapy in treating patients with newly diagnosed acute lymphoblastic leukemia (ALL). Drugs used in chemotherapy, such as dexamethasone, prednisone, methotrexate, and leucovorin calcium, work in different ways to stop cancer cells from dividing so they stop growing or die. Giving more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.
NCT00085735 ↗	Comparison of Radiation Therapy Regimens in Combination With Chemotherapy in Treating Young Patients With Newly Diagnosed Standard-Risk Medulloblastoma	Active, not recruiting	National Cancer Institute (NCI)	Phase 3	2004-04-01	This randomized phase III trial is studying how well standard-dose radiation therapy works compared to reduced-dose radiation therapy in children 3-7 years of age AND how well standard volume boost radiation therapy works compared to smaller volume boost radiation therapy when given together with chemotherapy in treating young patients who have undergone surgery for newly diagnosed standard-risk medulloblastoma. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as vincristine, cisplatin, lomustine, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving radiation therapy with chemotherapy after surgery may kill any remaining tumor cells. It is not yet known whether standard-dose radiation therapy is more effective than reduced-dose radiation therapy when given together with chemotherapy after surgery in treating young patients with medulloblastoma.

Clinical Trial Conditions for Vincrex

Condition Name

Condition Name for Vincrex
Intervention	Trials
Acute Lymphoblastic Leukemia	21
Untreated Adult Acute Lymphoblastic Leukemia	13
Untreated Childhood Acute Lymphoblastic Leukemia	11

Condition MeSH

Condition MeSH for Vincrex
Intervention	Trials
Leukemia	41
Lymphoma	39
Precursor Cell Lymphoblastic Leukemia-Lymphoma	39

Clinical Trial Locations for Vincrex

Trials by Country

Trials by Country for Vincrex
Location	Trials
Canada	213
Australia	87
New Zealand	33
Puerto Rico	23
Switzerland	7

Trials by US State

Trials by US State for Vincrex
Location	Trials
Texas	60
Ohio	56
California	55
New York	55
Illinois	53

Clinical Trial Progress for Vincrex

Clinical Trial Phase

Clinical Trial Phase for Vincrex
Clinical Trial Phase	Trials
Phase 3	30
Phase 2/Phase 3	4
Phase 2	30

Clinical Trial Status

Clinical Trial Status for Vincrex
Clinical Trial Phase	Trials
Active, not recruiting	34
Recruiting	28
Completed	13

Clinical Trial Sponsors for Vincrex

Sponsor Name

Sponsor Name for Vincrex
Sponsor	Trials
National Cancer Institute (NCI)	79
Children's Oncology Group	22
M.D. Anderson Cancer Center	12

Sponsor Type

Sponsor Type for Vincrex
Sponsor	Trials
NIH	79
Other	74
Industry	23

Vincerx Pharma: Clinical Trials Update, Market Analysis, and Projections

Introduction to Vincerx Pharma

Vincerx Pharma, Inc. is a clinical-stage biopharmaceutical company dedicated to developing innovative therapies to address the unmet medical needs of patients with cancer. The company is known for its paradigm-shifting therapeutics and a robust pipeline of next-generation treatments.

Clinical Trials Update

VIP943: Next-Generation Antibody-Drug Conjugate (ADC)

VIP943 is Vincerx's next-generation ADC being evaluated in a Phase 1 dose-escalation study for relapsed/refractory acute myeloid leukemia (AML), higher-risk myelodysplastic syndrome (HR-MDS), and B-cell acute lymphoblastic leukemia (B-ALL).

• Positive Initial Data: As of August 2024, VIP943 has demonstrated favorable safety and tolerability with no dose-limiting toxicities reported in 22 patients. The study has shown two complete responses, highlighting the potential of VIP943 as a best-in-class therapy for CD123+ hematologic malignancies[1].
• Adverse Events: Serious adverse events (SAEs) have been consistent with expectations for this patient population, with the most common SAEs including pneumonia, cellulitis, and febrile neutropenia. Only one patient experienced a drug-related SAE (Grade 3 diarrhea)[1].

VIP236: Small Molecule Drug Conjugate (SMDC)

VIP236 is Vincerx’s SMDC being evaluated in an ongoing Phase 1 dose-escalation study as a monotherapy in patients with advanced solid tumors.

• Clinical Activity: VIP236 has demonstrated positive signs of clinical activity, including tumor reduction, and an improved safety profile in heavily pretreated patients. As of September 2024, nine out of 20 evaluable patients achieved stable disease, with one patient on treatment for over 300 days and four additional patients on study for more than 120 days[4].
• Safety Profile: The Q3W schedule is well tolerated with no dose-limiting toxicity (DLT) and no severe or life-threatening diarrhea observed, validating the optimized camptothecin payload of VIP236[4].

Other Pipeline Updates

• VIP152: Vincerx is prioritizing Phase 1b studies of VIP152, focusing on double-hit DLBCL and CLL. The company continues to advance its next-generation modular bioconjugation platform, with IND filings for VIP236 and VIP943 on track[3].
• Enitociclib: The CDK9 inhibitor has completed a Phase 1 monotherapy study and continues in a Phase 1 study in collaboration with the NIH[5].

Market Analysis

Financial Performance

• Third Quarter 2024: Vincerx reported a net loss of approximately $7.8 million, or $0.17 per share, for the third quarter ended September 30, 2024. This compares to a net loss of $9.0 million, or $0.42 per share, for the same period in 2023[5].
• Cash Runway: The company expects its cash runway to extend into early 2025, providing sufficient resources to continue the development of its pipeline[1][5].

Stock Performance

• Market Cap and Enterprise Value: As of the latest data, Vincerx Pharma has a market cap of $6.51 million and an enterprise value of -$2.28 million. The stock price has decreased by -79.27% in the last 52 weeks, reflecting higher volatility compared to the market average[2].
• Analyst Consensus: Despite the current stock price, the average price target for Vincerx Pharma is $2.00, which is 930.93% higher than the current price, with a consensus rating of "Buy"[2].

Projections and Future Outlook

Clinical Milestones

• VIP943: Additional data from the Phase 1 study is expected by early 2025, which could further validate the potential of VIP943 as a best-in-class therapy[5].
• VIP236: Vincerx anticipates presenting additional Phase 1 data for VIP236 later in the year, which may provide more insights into its efficacy and safety profile[4].

Strategic Focus

• Resource Allocation: Vincerx is streamlining and realigning its resources to support key indications and programs, ensuring that the most promising therapies receive adequate funding and attention[3].
• VersAptx Platform: The company continues to advance its VersAptx platform, which has shown potential in preclinical studies to improve the efficacy of approved ADCs by overcoming historical challenges[4].

Market Potential

• Unmet Medical Needs: Vincerx is targeting significant unmet medical needs in cancer treatment, particularly in hematologic malignancies and advanced solid tumors. Successful clinical trials and regulatory approvals could position the company for substantial market growth.
• Competitive Landscape: The biopharmaceutical sector is highly competitive, but Vincerx's focus on next-generation bioconjugation and its promising clinical data could differentiate it from competitors and attract investor and market attention.

Key Takeaways

• VIP943 and VIP236: Both therapies have shown promising clinical activity and favorable safety profiles in early-stage trials.
• Financial Stability: Vincerx has a cash runway extending into early 2025, supporting continued development of its pipeline.
• Market Potential: The company's focus on addressing unmet medical needs in cancer treatment positions it for potential market growth if clinical trials are successful.
• VersAptx Platform: The platform's ability to improve ADC efficacy and safety could be a game-changer in cancer therapy.

FAQs

What are the key clinical trials currently underway at Vincerx Pharma?

Vincerx Pharma is currently conducting Phase 1 dose-escalation studies for VIP943 (an ADC for hematologic malignancies) and VIP236 (an SMDC for advanced solid tumors).

What is the VersAptx platform, and how does it contribute to Vincerx's pipeline?

The VersAptx platform is a next-generation bioconjugation technology that aims to create safer and more effective bioconjugates. It has shown potential in preclinical studies to improve the efficacy of approved ADCs.

What is the current financial status of Vincerx Pharma?

Vincerx Pharma reported a net loss of $7.8 million for the third quarter of 2024 and has a cash runway expected to last into early 2025.

How has Vincerx Pharma's stock performed recently?

Vincerx Pharma's stock price has decreased by -79.27% in the last 52 weeks, but analysts have a consensus rating of "Buy" with a significantly higher price target.

What are the potential market implications if Vincerx's clinical trials are successful?

Successful clinical trials could position Vincerx Pharma for substantial market growth, particularly in the treatment of hematologic malignancies and advanced solid tumors.

Sources

1. Vincerx Reports Positive Initial Clinical Data from Ongoing VIP943 Phase 1 Dose-Escalation Study and Provides Pipeline and Corporate Updates. Vincerx Pharma, Inc., October 7, 2024.
2. Vincerx Pharma, Inc. (VINC) Statistics & Valuation Metrics. StockAnalysis.com.
3. Vincerx Pharma Provides Key Strategic Update. Vincerx Pharma, Inc., June 6, 2022.
4. Vincerx Pharma Presents Positive Preliminary Phase 1 Data for VIP236 and Updates on Pipeline Progress at the American Association for Cancer Research (AACR) Annual Meeting 2024. Vincerx Pharma, Inc., April 8, 2024.
5. Vincerx Pharma Reports Third Quarter 2024 Financial Results. Vincerx Pharma, Inc., November 13, 2024.

Last updated: 2025-01-07