Globenewswire | August 23, 2023
Vincerx Pharma, Inc. a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, today reported that it has received clearance for its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 clinical trial for VIP943. Vincerx expects to enroll the first patient in the study early in the fourth quarter of 2023.
"The IND clearance by the FDA is a significant step forward for the VIP943 development program, our first candidate from our antibody-drug conjugate (ADC) platform to enter clinical trials," said Ahmed Hamdy, M.D., Chief Executive Officer of Vincerx. "Our next-generation platform is designed to improve efficacy and address safety challenges associated with many ADCs. It combines an internalizing antibody binding to CD123, a novel KSPi payload, a selective and stable linker, and exclusive CellTrapper™ technology. We believe VIP943 has the potential to become a much needed treatment option for patients with acute myeloid leukemia (AML). We're eager to start the clinical program and unlock the potential therapeutic benefits of this compound."
Dr. Hamdy concluded by saying, “2023 is shaping up to be a very positive year for Vincerx. Within the last eight months, we successfully filed two INDs (VIP236 and VIP943) and swiftly garnered clearance from the FDA within 30 days. We believe these accomplishments highlight the strength of our development, drug manufacturing, and regulatory expertise. Looking ahead, in addition to beginning our Phase 1 trial for VIP943, we also expect to provide preliminary results for VIP236 by late 2023 or early 2024. Collectively, these milestones support the potential for our strategy to develop small molecule and antibody-based conjugate therapies to improve the care of patients with cancer.”
VIP943 is a novel ADC developed using Vincerx’s next-generation ADC technology designed to enhance intracellular accumulation of the KSPi payload (kinesin spindle protein inhibitor), potentially leading to higher efficacy, while limiting unwanted side effects. VIP943 binds to CD123, a validated target in myeloid malignancies. Once inside of the cell, it releases its KSPi payload. Vincerx’s CellTrapper™ technology ensures that the KSPi payload accumulates in the target cells, limiting uptake into non-target, non-dividing cells.
VIP943 has demonstrated increased survival and reduced tumor burden in AML (acute myelogenous leukemia) cell lines and patient-derived tumor models. In addition, Vincerx presented preclinical data on VIP943 at ASH 2022 demonstrating superiority against Mylotarg™, an approved ADC, with significantly improved safety in monkeys and better efficacy in a mouse model of acute leukemia. Preclinical data suggest that VIP943 does not induce significant cytokine release and demonstrated favorable safety in monkeys with an optimal drug, metabolism and pharmacokinetics profile.
The Phase 1 trial of VIP943 is intended to assess safety, pharmacokinetics/phamacodynamics, and preliminary efficacy of VIP943 in patients with advanced AML and myelodysplastic syndrome (MDS).
About Vincerx Pharma, Inc.
Vincerx Pharma, Inc. (Vincerx) is a clinical-stage biopharmaceutical company committed to developing differentiated and novel therapies to address the unmet medical needs of patients with cancer. Vincerx has assembled a seasoned management team with a proven track record of successful oncology drug development, approvals, and value creation. The company’s diverse pipeline consists of the next-generation antibody conjugate, VIP943, on track to begin a Phase 1 study in early Q4 2023; small molecule drug-conjugate, VIP236, in Phase 1; preclinical antibody drug conjugate, VIP924; CDK9 inhibitor, enitociclib, currently in an NIH-sponsored Phase 1; and its next-generation modular bioconjugation platform.
PRnewswire | July 28, 2023
TriRx Pharmaceutical Services, LLC, a Contract Development and Manufacturing Organization (CDMO), welcomed the UK Government's recent announcement on England's second Investment Zone, focused on Life Sciences in the Liverpool City Region.
TriRx Speke Ltd. is the first investor and is well-positioned to further advance its capabilities by adding upstream technologies to manufacture monoclonal antibodies to an existing large-scale biotech purification facility. The current facility has significant capacity to support the high-growth large-molecule pharmaceutical market. Monoclonal antibodies (also referred to as mAbs) are a type of immunotherapy that work by blocking certain diseases from affecting healthy cells and are used to treat numerous types of diseases including cancers, arthritis and skin conditions. This additional investment to augment the TriRx facility at Speke will foster economic growth, create high-value jobs and complement the existing Speke Biopharmaceutical cluster in the region.
"We are delighted to be expanding our capability in this critical immunotherapy area, to become a worldwide center of technical excellence located in the UK in the monoclonal antibody development and manufacturing field to serve the human and animal pharmaceutical markets," said Tim Tyson, Chairman and CEO of TriRx.
About TriRx Pharmaceutical Services:
TriRx Pharmaceutical Services is a global contract development and manufacturing organization (CDMO) serving global pharmaceutical, biopharmaceutical and animal health markets. Headquartered approximately 50 miles outside of New York City in Norwalk, Connecticut, TriRx operates facilities in multiple regions providing state-of-the-art laboratory, manufacturing, packaging, warehousing, and technical service capabilities. Founded and led by a team of pharmaceutical industry executives, who have served as both contract service providers and outsourcing customers, TriRx has a profound and multifaceted understanding of client needs. It has the knowledge and commitment to deliver an exceptional experience on every project, consistently meeting or exceeding quality standards, regulatory requirements, on-time-in-full (OTIF) delivery, and all other customer requirements and expectations.
PRNewswire | July 24, 2023
PharmaKinnex (PK), an inside sales solution provider for the pharmaceutical industry, and Data360, a data and engagement solutions provider for healthcare marketers, today announced a strategic partnership to further enhance client reach and improve patient outcomes.
From rare disease to oncology and beyond, this unique partnership is designed to deliver increased profits to clients, enable more advanced and secure data analysis, and most importantly, connect patients with life-saving treatments. PharmaKinnex and Data360 are proud to be a part of this newest revolution in pharmaceuticals and medicine, deploying Fingerprint AI solutions.
"The strategic partnership aligns perfectly with our mission to bring unprecedented value to our clients," said Michael White, CEO of PharmaKinnex. "Data360's powerful solutions to identify, target, and engage individuals, while providing valuable analytics about those audiences, will extend our reach to more potential patients and prescribers, providing a sizable edge in the rare disease sector."
Integration of Data360's deep insights with PK's marketing expertise will improve PK's call plans, allowing PK to message to new audiences and reach prescribers ahead of the competition. The partnership positions PK as the only inside sales organization with access to such a high level of data, offering a unique and powerful industry advantage.
"We are eager to partner with PharmaKinnex and contribute our solutions that identify and engage relevant audiences throughout their digital life, and so improve the patient journey experience," said James Miller, president & CEO of Data360. "For this unique market offering, Data360 will identify health care professionals (HCPs) and patients searching online for rare diseases by activating our Fingerprint AI solution. By providing insights for timeliness, relevance, and intent behavior, Data360 will equip PK with valuable insights and reach to elevate its services to clients."
Data360's Fingerprint AI technology is sparking a revolution in healthcare marketing, fueling omnichannel programs with its ability to hyper-target both HCP and patient or caregiver audiences based on online behavior and in-market search criteria.
Data360's datasets, coupled with the Fingerprint AI solution, empower brand teams, healthcare marketers, clinical trial teams, and now PK to leverage audience intent. Its service achieves high-quality, segmented, and targeted leads for HCP marketing, patient engagement, and clinical trial recruitment.
PharmaKinnex is the leading multichannel marketing company in the U.S. that exclusively serves Life Sciences clients. PK is also the longest-tenured independent company in its competitive set, with over 18 years of continuous support of its industry partners. The PK Call Center successfully executes high-ROI product detailing, inside sales and customer service programs. Each solution is designed with the support of the experienced, award-winning PK leadership team and is tailored to target every important constituency identified, including but not limited to office-based prescribers (physicians, NPs, PAs) across every specialty, hospitals and health systems.
With the mission to turn data into intelligence, Data360 provides solutions and services to effectively identify, target, and engage audiences. We empower healthcare marketers seeking broader and better access to physicians, HCPs, patients, and caregivers. We deliver unequaled first-party data, proprietary technology (Fingerprint AI) for access to audience intent and behavior, and a focus on cost-effective and compliant ways to activate and engage healthcare audiences.