On June 6, 2022 Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, reported an update to its strategic priorities and the streamlining and realignment of resources to support its key value-generating indications and programs and extend its estimated cash runway into late 2024 (Press release, Vincerx Pharma, JUN 6, 2022, View Source [SID1234615685]).
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Strategic Update Summary:
Prioritizing VIP152 clinical studies to focus on:
Monotherapy in patients with high grade B-cell lymphoma characterized by translocations of MYC and BCL-2 or BCL-6 (aka double-hit diffuse large B-cell lymphoma [DLBCL])
Monotherapy in patients with high-risk chronic lymphocytic leukemia (CLL)
Combination with Bruton tyrosine kinase (BTK) inhibitor in patients with high-risk CLL
Continuing to prioritize advancement of first-in-class and potentially best-in-class bioconjugation assets
Streamlining and realigning resources to support prioritized VIP152 indications and advancement of the bioconjugation programs
Reducing full-time employees by 33%
Implementing additional cost reduction measures
Extending estimated cash runway into late 2024
Positioning company to continue executing on important clinical and preclinical milestones
"Given the unprecedented market conditions, we are making a strategic decision to focus our resources on our ongoing double-hit DLBCL and CLL clinical trials and our next-generation bioconjugation platform to deliver the greatest benefit in these patients as well as maximize value for our shareholders," said Ahmed Hamdy, M.D., Chief Executive Officer of Vincerx.
"The VIP152 program was designed as a signal-seeking program," added Dr. Hamdy. "Nineteen (19) patients with various MYC+ cancers have been treated. We saw stable disease in 3 patients with ovarian cancer (with one of the three patients completing cycle 6). Despite this preliminary signal in ovarian cancer, the combination of challenging market conditions and the promising VIP152 preclinical and clinical data we have seen in double-hit DLBCL and CLL patients create a compelling rationale for us to focus our efforts on these two indications."
"We continue to be excited about our preclinical bioconjugation platform—a diverse, modular platform of linkers and payloads that can be conjugated with antibodies and small molecules to create novel targeted therapeutics for a broad range of solid tumors and hematologic malignancies and remain on track to file an IND in the second half of this year for VIP236. We also remain on track to file an IND in the second half of 2023 for our initial antibody drug conjugate (ADC), VIP943. We believe our ADCs represent a paradigm-shifting technology with a proprietary and highly differentiated linker and warhead. These innovations are expected to improve efficacy and safety versus current ADCs," continued Dr. Hamdy.
To support this strategy, Vincerx also announced the streamlining and realignment of resources and the implementation of certain cost reduction measures, including a 33% reduction of full-time employees. "Reducing our staff was not an easy decision. It was the tremendous effort of our Vincerx colleagues that allowed us to execute efficiently, despite the extreme pressures of the pandemic. I want to sincerely thank every Vincerx colleague who has been impacted by this realignment. Their contributions have, without a doubt, brought us closer to achieving our goals. The realignment announced today will allow us to focus on and invest in the indications and programs we believe will generate the greatest value while reducing our operating expenses—all with the goal of achieving our anticipated key milestones for VIP152 and our bioconjugation platform," concluded Dr. Hamdy.
CLINICAL UPDATES
VIP152 (as of April 19, 2022):
VNC-152-101 study enrollment (Patients with MYC+ cancer, which included overexpression, translocation, deletion, or amplification):
High-grade lymphoma arm (n=4)
Histologies: triple-hit, double-hit, double expressor and primary mediastinal (n=1 each)
Gynecologic malignancies (n=5)
Includes 1 patient with endometrial cancer who received combination therapy of VIP152 + pembrolizumab
Triple negative breast cancer (n=2)
Tumor agnostic group (n=7)
Consists of various types of gastrointestinal cancer (n=6) and melanoma (n=1)
VNC-152-102 study enrollment:
CLL that has failed BTK inhibitor therapy, as well as venetoclax therapy (n=1)
Clinical outcomes from VNC-152-101 and VNC-152-102:
No new safety signals were identified; manageable treatment-related adverse events included neutropenia and gastrointestinal toxicity (i.e., nausea, vomiting and diarrhea); only 1 patient discontinued due to an adverse event (i.e., Grade 1 nausea)
Progressive disease was observed in 16 patients, despite evidence of tumor shrinkage in some patients including the patient with CLL who had failed BTK inhibitor and venetoclax therapy. Best response in all 19 patients has been stable disease in 3 patients with ovarian cancer as reported at the AACR (Free AACR Whitepaper) Annual Meeting in 2022.
Abstract accepted for poster presentation at the upcoming European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting, titled "VIP152 is a novel CDK9 inhibitor with improved selectivity, target modulation, and cardiac safety in patients with lymphoma."
Presenting author: Melanie Frigault, PhD
Abstract number: P1269
Session date and time: Friday, June 10, 2022; 16:30-17:45 CEST
Bioconjugation Platform:
Continue to advance next-generation modular bioconjugation platform, comprised of a first-in-class SMDC for solid tumors (VIP236) and two potentially best-in-class assets for hematologic malignancies (VIP943 and VIP924)
VIP236: IND filing in solid tumors expected in 2H 2022
VIP943 (anti-CD123) and VIP924 (anti-CXCR5): Manufacturing is underway and IND filing for VIP943 expected in 2H 2023 and VIP924 in 2024