CXCR5

Partnerships will employ Vaccinex’s ActivMAb® platform for viral display of complex antigens to enable antibody discoveryROCHESTER, N.Y., Nov. 07, 2024 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating cancer and neurodegenerative disease through the inhibition of SEMA4D, today announced the signing of several proprietary project agreements with Amgen, Merck, Chugai, Absci, Gigagen (Grifols), Merus, Soleil, ThirdArc and Incyte, employing Vaccinex’s ActivMAb® technology to generate antibodies to complex antigen targets. In addition, Vaccinex has signed agreements to provide Charles River Labs, OmniAb, Adimab and other undisclosed strategic partners with materials to facilitate their antibody discovery programs using transgenic animal species for immunization or very large synthetic antibody libraries. The financial terms of the agreements are undisclosed. Vaccinex’s proprietary ActivMAb® Technology enables expression of functional, properly folded complex proteins such as GPCRs and Ion Channels on the relatively simple membrane of poxvirus providing a source of antigen for various antibody discovery strategies. These strategies may involve development of antibody and antibody-based immunotherapies including bi-specifics, antibody drug conjugates (ADC), CAR-T cells, T cell engagers, etc. “Our technology is a powerful component of antibody discovery strategies targeting complex membrane proteins and enables both our own R&D efforts and those of our partners,” said Ernest Smith, Chief Scientific Officer of Vaccinex. “These agreements and partnerships with established companies underscore ActivMAb’s unique ability to address previously hard to drug targets in a format ideally suited for antibody discovery.” Vaccinex will present data and examples of successful antibody discovery campaigns against potential oncology targets using the ActivMab Technology at the Society for Immunotherapy of Cancer’s 29th Annual Meeting held November 8-10, 2024, in Houston, TX. MeetingSITC 39th Annual MeetingDate:Saturday, Nov. 9, 2024Location:Exhibit Halls A B George R. Brown Convention CenterPoster Title:Discovery of high affinity functional antibodies specific for CXCR5, P2X7 and other multi-pass membrane receptorsPoster Number1100PresenterElizabeth Evans, PhD, Chief Operating Officer, Vaccinex, Inc. About ActivMAb®ActivMAb is a proprietary antibody discovery platform developed by Vaccinex with unique capabilities for important multi-pass membrane targets such as G-protein-coupled receptors (GPCRs) and ion channels. The ActivMAb technology has multiple applications including discovery of antibodies specific for complex membrane antigens, discovery of antibodies with optimized developability, and protein optimization for expression and activity. Its novel capabilities enable selection of unique antibody drugs against difficult high-value targets, including multi-pass membrane proteins against which small molecule drugs have demonstrated low efficacy or high toxicity. The first clinical candidate selected through use of this technology (CHS-114, a fully human monoclonal antibody targeting CCR8), is in clinical development for cancer immunotherapy by Coherus Biosciences, Inc. About Vaccinex Inc. Vaccinex, Inc. is pioneering a differentiated approach to treating slowly progressive neurodegenerative diseases and cancer through the inhibition of semaphorin 4D (SEMA4D). The Company’s lead drug candidate, pepinemab, blocks SEMA4D, a potent biological effector that it believes triggers damaging inflammation in chronic diseases of the brain and prevents infiltration and activation of immune cells in tumors. Pepinemab is being studied as a monotherapy in the Phase 1b/2 SIGNAL-AD study in Alzheimer’s Disease, and the Company has previously published promising Phase 2 data in Huntington’s disease. Because it is well-tolerated, pepinemab could be an important contributor to combination therapy in AD. In oncology, pepinemab is being evaluated in combination with KEYTRUDA® in the Phase 1b/2 KEYNOTE-B84 study in recurrent or metastatic head and neck cancer (HNSCC) and in combination with BAVENCIO® in a Phase 1b/2 study in patients with metastatic pancreatic adenocarcinoma (PDAC). The oncology clinical program also includes several investigator-sponsored studies in solid tumors including breast cancer and melanoma. Vaccinex has global commercial and development rights to pepinemab and is the sponsor of the KEYNOTE-B84 study which is being performed in collaboration with Merck Sharp & Dohme Corp, a subsidiary of Merck and Co, Inc. Kenilworth, NJ, USA. Additional information about the study is available at: clinicaltrials.gov. KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc., Kenilworth, NJ, USA. BAVENCIO®/avelumab is provided by Merck KGaA, Darmstadt, Germany, previously as part of an alliance between the healthcare business of Merck KGaA, Darmstadt, Germany and Pfizer. Forward Looking StatementsTo the extent that statements contained in this presentation are not descriptions of historical facts regarding Vaccinex, Inc. (“Vaccinex,” “we,” “us,” or “our”), they are forward-looking statements reflecting management’s current beliefs and expectations. Such statements include, but are not limited to, statements about our plans, ability to capitalize on, expectations and objectives with respect to the “Antigen Virus” applications of the ActivMab® platform, and other statements identified by words such as “believe,” “being,” “could,” “will,” “potential,” and similar expressions or their negatives (as well as other words and expressions referencing future events, conditions, or circumstances). Forward-looking statements involve substantial risks and uncertainties that could cause the outcome of our research and pre-clinical development programs, clinical development programs, future results, performance, or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, uncertainties inherent in the execution, cost and completion of preclinical studies and clinical trials, that interim and preliminary data may not be predictive of final results and does not ensure success in later preclinical studies and clinical trials, uncertainties related to regulatory approval, risks related to our dependence on our lead product candidate pepinemab, the possible delisting of our common stock from Nasdaq if we are unable to regain compliance with the Nasdaq listing standards, and other matters that could affect our development plans or the commercial potential of our product candidates. Except as required by law, we assume no obligation to update these forward-looking statements. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, see the section titled “Risk Factors” in our periodic reports filed with the Securities and Exchange Commission (“SEC”) and the other risks and uncertainties described in the Company’s annual year-end Form 10-K and subsequent filings with the SEC. Investor Contact Elizabeth Evans, PhD Chief Operating Officer, Vaccinex, Inc. (585) 271-2700 eevans@vaccinex.com

On February 28th, Viatris, a pharmaceutical company based in the United States, and Idorsia, a Swiss pharmaceutical company, announced the establishment of a significant global research and development collaboration. Under the terms of the agreement, Viatris will gain global exclusive rights to develop and commercialize two Phase 3 clinical-stage drugs (Selatogrel and Cenerimod) from Idorsia and may potentially expand cooperation to include additional innovative assets in the future. Selatogrel is reported to be a potential life-saving medication for patients with a history of acute myocardial infarction (AMI), designed to be administered by the patients themselves. This drug is a fast-acting, reversible, and highly selective P2Y12 inhibitor, intended for early treatment during the onset of AMI to protect cardiac muscle tissue. It is aimed at preventing worsening of heart conditions and reducing mortality risk during the critical timeframe from the emergence of symptoms to the first medical intervention. According to Idorsia, a large-scale international multicenter, double-blind, randomized controlled Phase 3 study named "Study of Selatogrel in Suspected Acute Myocardial Infarction" (SOS-AMI) is being conducted to evaluate the clinical efficacy and safety of self-administered Selatogrel at 16mg on top of standard care at the time of suspected AMI symptoms. This study has been granted a Special Protocol Assessment agreement by the U.S. FDA and has received "Fast Track" designation, indicating its role in fostering communication and collaboration for the development of drugs for serious conditions with unmet medical needs. Cenerimod, as a result of two decades of research in Idorsia's laboratories, has emerged as a highly selective S1P1 receptor modulator, available in a once-daily oral tablet form. This drug could offer a new therapeutic approach for systemic lupus erythematosus (SLE), a serious disease that significantly impacts patients' lives and for which current treatment options are limited. In December 2022, Idorsia launched a project named OPUS (Oral S1P1 Receptor Modulation for SLE), which included two multicenter, randomized, double-blind, placebo-controlled phase III studies. The aim of the study is to evaluate the efficacy, safety, and tolerability of cenerimod 4mg in adults with moderate to severe SLE on top of standard therapy. The primary endpoint is to demonstrate the improvement in disease activity and control of the condition with cenerimod compared to placebo at 12 months, with the primary endpoint being the achievement of an SRI-4 response from baseline. Similarly, cenerimod's use in the treatment of SLE has also been granted "Fast Track" designation by the FDA. Through this collaboration, Viatris leverages its strong financial position and global operational infrastructure, combined with Idorsia's mature and efficient drug development team and their innovative capabilities, to jointly advance the development and commercialization of these two potential blockbuster drugs as well as other future innovative assets. Under the terms of the agreement, Idorsia will transfer the development projects of Selatogrel and Cenerimod, along with some related personnel, to Viatris. In exchange, Viatris will make an upfront payment of $350 million to Idorsia, with potential additional milestone payments dependent on development and regulatory approval progress. In addition, once these two drugs achieve annual net sales, Viatris will pay Idorsia tiered sales milestone payments as well as royalties at a percentage ranging from high single-digits to low double-digits. Both Viatris and Idorsia will jointly bear the costs of developing these two drugs. To oversee the further development of these two phase III clinical stage projects until regulatory approval, the parties will establish a joint development committee to provide guidance. Furthermore, the agreement also grants Viatris the right of first refusal and first negotiation for other specific assets in Idorsia's pipeline, allowing Viatris the right to firstly decline or accept proposals for collaboration on these assets under certain conditions. Acute Myocardial InfarctionAcute Myocardial Infarction (AMI) refers to the pathological process in which myocardial cells undergo necrosis due to sudden obstruction of the coronary arteries leading to an interruption of blood flow. This condition is primarily caused by the rupture of atherosclerotic plaques in the coronary arteries, secondary thrombosis formation, or other reasons leading to acute occlusion of the coronary vessels. Clinically, the main symptoms of acute myocardial infarction include, but are not limited to, chest pain (often described as crushing, constrictive or heaviness), dyspnea (which may or may not be present), nausea, and diaphoresis. Chest pain is typically persistent and may radiate to the left shoulder, left arm, neck, lower jaw, or even the back. Acute myocardial infarction is divided into ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction (NSTEMI). In the case of STEMI, due to the more urgent condition and involvement of a complete occlusive coronary thrombus, urgent reperfusion therapy is required to restore myocardial blood flow. For NSTEMI, medication therapy is needed to stabilize the condition, and reperfusion treatment options are selected based on the patient's specific circumstances. When diagnosing acute myocardial infarction, doctors primarily rely on electrocardiograms and biomarkers. The treatment for acute myocardial infarction primarily includes antiplatelet therapy, anticoagulation, nitrate medications, beta-blockers, statins, and reperfusion strategies, among others. According to statistics from the Synapse database, the number of drugs currently available or in clinical phases 1/2/3 for the treatment of acute myocardial infarction is relatively limited on a global scale. The main therapeutic targets under investigation include plasminogen (PLG), angiotensin-converting enzyme (ACE), adrenergic beta-1 receptor, sodium-glucose cotransporter 2 (SGLT2), purinergic P2Y12 receptor (P2Y12R), IL-6, and others. SelatogrelPlatelet adhesion, activation, and aggregation play a critical role in the formation of thrombosis during atherosclerosis. In this process, the interaction between adenosine diphosphate (ADP) and the P2Y12 receptor on platelets is a crucial step. Antagonizing platelet P2Y12 receptors can inhibit the processes of platelet activation and aggregation. This means that the binding of ADP to the receptor is prevented, thereby reducing platelet aggregation responses and the consequent stimulation of thrombus formation. Selatogrel is a selective P2Y12 receptor antagonist developed by Idorsia for original research and is currently undergoing Phase 3 clinical studies aimed at patients with acute myocardial infarction. Selatogrel was initially developed by Actelion, the predecessor of Idorsia. On January 26, 2017, Johnson & Johnson announced a full cash tender offer to acquire all outstanding shares of the Swiss pharmaceutical company Actelion at a price of $280 per share (totaling $30 billion in cash). As part of the transaction, Actelion spun off its drug research and early clinical development assets into a newly established Swiss biopharmaceutical company, Idorsia. According to the results of a Phase 1 clinical study published in 2014, the potent, highly selective, and reversible P2Y12 receptor antagonist Selatogrel (ACT-246475) showed exposure-related platelet inhibitory effects. An exploratory formulation improved the bioavailability and antiplatelet activity of ACT-246475. According to the results of a phase 2 clinical study published in the "J Am Coll Cardiol" journal in 2020, a total of 47 patients received treatment with Selatogrel, with 24 individuals receiving a dose of 8 mg and 23 receiving a dose of 16 mg. This was followed by 43 patients being treated with ticagrelor (another P2Y12 receptor antagonist under investigation), and one patient with clopidogrel (a P2Y12 receptor antagonist). Among patients receiving 8 mg and 16 mg doses, the proportion achieving an effective response within 30 minutes post-administration was 91% and 96%, respectively, both meeting the pre-specified efficacy target of over 85%. The response rate was not affected by the type of AMI, age, or gender. Notably, a similar response rate was observed at 15 minutes post-administration (8 mg: 75%; 16 mg: 91%), and this inhibitory effect was maintained at 60 minutes after administration (8 mg: 75%; 16 mg: 96%). The findings indicate that a single subcutaneous injection of Selatogrel is safe and feasible in AMI patients, producing significant, rapid, and dose-related antiplatelet effects. Systemic Lupus ErythematosusSystemic Lupus Erythematosus (SLE) is the most common type of lupus, which is an autoimmune disease. This means that the immune system becomes dysfunctional and mistakenly attacks the body's own tissues. Unlike certain autoimmune diseases that only affect a single organ, SLE has the potential to affect multiple parts of the body. Statistics show that there are at least 5 million people worldwide living with some form of lupus, with 90% of those affected being female, most commonly developing the disease between the ages of 15 and 44. Additionally, the prevalence of lupus is higher among Asian and Afro-Caribbean populations compared to Caucasians. In SLE, the abnormal immune response can target the body's own tissues, potentially affecting the skin, joints, kidneys, heart, as well as other organs. Given the capacity of SLE to cause damage to any part of the body, the manifestations of the disease are incredibly diverse. Therefore, the symptoms of Systemic Lupus Erythematosus (SLE) are diverse and often resemble those of many other conditions, requiring the exclusion of these similar symptoms before a definitive diagnosis can be made. This leads to SLE being frequently overlooked or misdiagnosed. However, early diagnosis is crucial for controlling lupus symptoms, initiating treatment to reduce the risk of long-term complications, and accessing a broader range of patient support services, such as local patient groups. According to the Synapse database, there are currently approximately 400 therapeutic drugs and candidates in the pipeline worldwide for the treatment of SLE, whether on the market or in the research and development stage. Key therapeutic targets include glucocorticoid receptor (GR), calcineurin (CaN), inosine monophosphate dehydrogenase (IMPDH), and B-cell activating factor (BAFF), among others. Potential G-protein-coupled receptor (GPCR) family targets for the disease include melanocortin receptors, S1PR1, CXCR5, CXCR4, and others. CenerimodAlthough the exact etiology of Systemic Lupus Erythematosus (SLE) has not been fully elucidated, T cells and B cells are considered to be the key immune cells contributing to the development of the disease. In SLE patients, both T cells and B cells are in a state of overactivity. The primary consequence of this hyperactivity is the infiltration of these immune cells into different tissues and the production of autoantibodies, which in turn leads to inflammation and organ damage. T cells and B cells have S1P1 receptors on their surface, which allow the lymphocytes to recognize the signaling molecule sphingosine-1-phosphate (S1P), a critical mediator in the regulation of lymphocyte egress from lymph nodes to the bloodstream. Cenerimod is a selective S1PR1 modulator developed by Idorsia for clinical use in the treatment of systemic lupus erythematosus and liver injury. As an S1P1 receptor modulator, Cenerimod can inhibit the outflow of T cells and B cells from the lymph nodes. This prevents their migration and infiltration into various organs, thereby influencing the immune response that leads to the multisymptom manifestation of lupus at a fundamental level of the immune cascade. According to preclinical study data published in 2017, Cenerimod is a novel, highly efficient, and selective S1P1 receptor modulator that possesses unique S1P1 receptor signaling properties and has not observed side effects that cause bronchoconstriction or vasoconstriction in in vitro and in vivo experiments. Administered orally, Cenerimod can dose-dependently reduce the number of circulating lymphocytes in rats and mice. Additionally, in the experimental autoimmune encephalomyelitis (EAE) model in mice, Cenerimod was able to effectively improve disease-related parameters and alleviate symptoms. Therefore, Cenerimod holds promise as a new therapeutic agent with an improved safety profile for the treatment of autoimmune diseases, which have a significant medical need and currently lack effective treatment options. Based on the results of phase II clinical trials, cenerimod not only reduces the migration of T cells and B cells but also diminishes the process by which professional antigen-presenting cells transport self-antigens to the lymph nodes, thereby reducing the presentation of self-antigens and the activation of lymphocytes. Additionally, cenerimod can decrease the levels of pro-inflammatory cytokines, thereby minimizing the inflammatory response. As a result, cenerimod will disrupt the vicious cycle involved in the pathogenesis of SLE. Therefore, the uniqueness of cenerimod lies in its simultaneous targeting of T cells, B cells, antigen-presenting cells, and the inflammation, offering an effective therapeutic approach for addressing multiple aspects of the pathogenesis in lupus.

Poster on VIP943, a novel CD123-targeted antibody-drug conjugate (ADC) from our VersAptx™ platform, showcases selectivity, activity, and safety of VIP943 Poster on VIP924, a first-in-class CXCR5-targeted ADC from our VersAptx platform, shows superior activity and safety compared with commercially available B-cell targeted ADCs PALO ALTO, Calif., Dec. 10, 2023 (GLOBE NEWSWIRE) -- Vincerx Pharma, Inc. (Nasdaq: VINC)(“Vincerx”), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, today announced the presentation of two preclinical posters at the 65th Annual Meeting of the American Society for Hematology (ASH 2023) for VIP943, for leukemias and myelodysplastic syndrome, and VIP924, for B-cell malignancies. “We are excited to share new preclinical data for VIP943 and VIP94 with our stakeholders,” said Ahmed Hamdy, M.D., Chief Executive Officer of Vincerx. “The compelling data from these studies underscore the differentiation of our next-generation ADCs and the power of VersAptx, our versatile and adaptable bioconjugation platform used to develop these ADCs.” “The preclinical data from the VIP943 poster highlight the on-target selectivity and activity of VIP943 in acute myeloid leukemia (AML) cell lines, including those with common AML mutations such as TP53. We also show that repeat dosing of VIP943 in cynomolgus monkeys has good overall tolerability without the myelosuppression and hepatotoxicity typically associated with ADCs, which is consistent with the favorable safety profile seen to date in our VIP943 Phase 1 dose-escalation trial. The first dosing cohort enrolled rapidly and completed the 28-day safety evaluation without evidence of drug-related adverse events. One of the three patients from this cohort continues treatment, and the second cohort is enrolling.” “The preclinical data from the VIP924 poster highlight the superior efficacy of VIP924 when compared with two commercially available ADCs, Polivy® and Zynlonta®, in a mouse model of mantle cell lymphoma. In this study, VIP924 shows significant efficacy (i.e., significant tumor growth inhibition and increased survival) with no substantial change in body weight, an indication of safety, while Polivy and Zynlonta show no improvement in tumor growth inhibition or survival. Based on the side-effect profile of current ADC and CAR-T therapies for B-cell malignancies, we believe VIP924 may have the potential to be used in earlier lines of therapy, either as a monotherapy or in combination with other targeted drugs (e.g., BTK or BCL2 inhibitors), to improve efficacy and safety,” concluded Dr. Hamdy. Poster Highlights VIP943: CD123-KSPi ADC for leukemias and myelodysplastic syndrome Poster #1435: Selectivity and Safety of VIP943: A novel CD123 Targeting Antibody-Drug Conjugate (ADC) Using a Proprietary Linker and Payload Class. Objective: The poster outlines a series of assays used to characterize the preclinical properties of VIP943, including biochemistry, pharmacology, on-target selectivity and activity, safety, and toxicokinetics. Results: On-target selectivity and activity show that VIP943 is highly selective for the kinesin spindle protein (KSP) target, aka EG5, versus other members of the related KIF super family. This on-target activity translates to cell cycle arrest at the G2/M phase of mitosis, resulting in apoptosis in AML cell lines.In vitro cytotoxicity assays show that most hematologic cell lines (n=56) are sensitive to VIP943’s payload and that DNA alterations (including common AML mutations such as TP53) did not reduce its cytotoxicity.Nonhuman primate safety and toxicokinetic studies show that repeat dosing of VIP943 in cynomolgus monkeys has good overall tolerability without the myelosuppression and hepatotoxicity seen with other ADCs. This is consistent with the favorable safety profile seen to date in the VIP943 Phase 1 dose-escalation trial. VIP924: CXCR5-KSPi ADC for B-cell malignancies Poster #2809: Comparison of the CXCR5-Antibody Drug Conjugate (ADC; VIP924) to a CD19-ADC and a CD79b-ADC in a Humanized REC-1 Mantle Cell Lymphoma (MCL) Mouse Model. Objective: To evaluate target expression (CXCR5, CD19, and CD79b) in human patient samples and to compare the activity of VIP924 to two commercially available, B-cell targeted ADCs, Polivy (a CD19-ADC, polatuzumab vedotin) and Zynlonta (CD79b-ADC, loncastuximab tesirine), in a humanized mouse model of MCL by evaluating in vivo activity, immunophenotyping of key tissues, and complete blood counts. VIP924 data are based on a dose level of 10 mg/kg compared with 3 mg/kg for Polivy and 0.66 mg/kg for Zynlonta. Doses were selected based on the literature as effective doses in mouse xenograft experiments and higher doses lead to toxicity in these models. Tumor growth was measured at day 25; blood work was assessed at days 0, 5, and 18. Results: Target expression analysis in a panel of 20 human MCL samples shows that CXCR5 and CD19 expression was medium to high in all samples, while CD79b showed slightly lower expression.In vivo activity in a humanized mouse model shows that VIP924 demonstrates significant efficacy (i.e., tumor growth inhibition and increased survival) with no substantial change in body weight (an indication of safety). In comparison, the commercially available ADCs, Polivy and Zynlonta, show no improvement in tumor growth inhibition or survival in this setting. Immunophenotyping of key immune tissues show that: VIP924 treatment yielded no difference in the percent of CD45+ cells versus the control, while the other two ADCs showed a clear reduction in CD45+ cells.VIP924 treatment reduced T-follicular helper cells (Tfhs) in the blood, tumor and spleen; significantly increased T-regs; and had no meaningful impact on myeloid-derived suppressor cells (MDSCs) compared with controls. Zynlonta also reduced peripheral blood Tfhs and significantly increased MDSCs compared with control. Complete blood counts (CBCs) show that VIP924 had minimal impact on the six elements of the CBC reported in these studies. Zynlonta reduced the levels of all cell populations in the CBC, except for platelets. About VIP943 VIP943, the first ADC from our VersAptx platform, consists of an anti-CD123 antibody, a unique linker cleaved intracellularly by legumain, and a novel kinesin spindle protein inhibitor (KSPi) payload enhanced with our CellTrapper® technology. Our proprietary effector chemistry (linker + payload) was designed to reduce non-specific release of the payload and ensure payload accumulation in cancer cells versus healthy cells. The increased therapeutic index has the potential to address challenges associated with many ADCs by improving efficacy and reducing severe toxicities. VIP943 is in a Phase 1 dose-escalation trial evaluating patients with relapsed/refractory acute myeloid leukemia, myelodysplastic syndrome, and B-cell acute lymphoblastic leukemia who have exhausted standard therapeutic options (NCT06034275). We expect to expand into these CD123-positive indications, including TP53 mutated AML both as monotherapy and in combination, as safety and efficacy data are generated. Preliminary Phase 1 data are expected in mid-2024. About VIP924 VIP924, the second ADC from our VersAptx Platform, consists of an anti-CXCR5 antibody, a unique linker cleaved intracellularly by legumain, and a novel KSPi payload enhanced with our CellTrapper technology. Our proprietary effector chemistry (linker + payload) was designed to reduce non-specific release of the payload and ensure payload accumulation in cancer cells versus healthy cells. The increased therapeutic index has the potential to address challenges associated with many ADCs by improving efficacy and reducing severe toxicities. VIP924 has the potential to be evaluated in B-cell malignancies, such as mantle cell lymphoma, follicular lymphoma, diffuse large B-cell lymphoma (DLBCL), and chronic lymphocytic leukemia, both as monotherapy and in combination. We continue to judiciously pace our investment in VIP924 to focus resources on VIP236 and VIP943. About VersAptx Platform VersAptx is our versatile and adaptable, next-generation bioconjugation platform. The modular nature of this innovative platform allows us to combine different targeting, linker, and payload technologies to develop bespoke bioconjugates to address different cancer biologies. With this platform (i) antibodies and small molecules can be used to target different tumor antigens (ii) linkers can be designed to reduce non-specific release of the payload, cleave intracellularly or extracellularly, and conjugate to single or multiple payloads, and (iii) payloads can be designed with reduced permeability using our CellTrapper technology to ensure accumulation in cancer cells or to be permeable for release in the tumor microenvironment. The VersAptx platform allows us to optimize these technologies to a specific target and develop bioconjugates designed to address the safety and efficacy challenges of many ADCs and the needs of cancer patients. About Enitociclib Enitociclib is a highly selective CDK9 inhibitor that prevents activation of RNA polymerase II, resulting in reduction of known oncogenes MYC and MCL1. It is currently in a dose-escalation Phase 1 trial (NTC05371054) in collaboration with the National Institutes of Health evaluating the combination of enitociclib, venetoclax, and prednisone in DLBCL and peripheral T-cell lymphoma (PTCL). The first dose level completed enrollment with no drug-related safety signal (n=3; 1=DLBCL, 2=PTCL). The first patient on the second dose level (n=1; 1=PTCL) remains on study with a partial response due to an 80% reduction in the pulmonary lesion on computerized tomography (CT) scan and resolved skin lesions. Investigators are pleased with the safety profile of this novel combination and continue with enrollment. Early-stage clinical studies in patients with hematologic malignancies and solid tumors provided monotherapy proof-of-concept. Additional combination studies will be determined based on financing/partnering support. 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 has assembled a seasoned management team with a proven track record of successful oncology drug development, approvals, and value creation. Vincerx’s diverse pipeline consists of the next-generation antibody-drug conjugate, VIP943, in Phase 1; small molecule-drug conjugate, VIP236, in Phase 1; preclinical antibody-drug conjugate, VIP924; CDK9 inhibitor, enitociclib, in an NIH-sponsored Phase 1; and VersAptx, its versatile and adaptable, next-generation bioconjugation platform. Vincerx is based in Palo Alto, California, and has a research facility in Monheim, Germany. For more information, please visit www.vincerx.com. Forward-Looking Statement This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be covered by the “safe harbor” created by those sections. Forward-looking statements, which are based on certain assumptions and describe future plans, strategies, expectations and events, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “would,” “could,” “suggest,” “seek,” “intend,” “plan,” “goal,” “potential,” “on-target,” “on track,” “project,” “estimate,” “anticipate,” or other comparable terms. All statements other than statements of historical facts included in this press release are forward-looking statements. Forward-looking statements include, but are not limited to: Vincerx’s business model, pipeline, strategy, timeline, product candidates and attributes, and preclinical and clinical development, timing, and results. Forward-looking statements are neither historical facts nor assurances of future performance or events. Instead, they are based only on current beliefs, expectations, and assumptions regarding future business developments, future plans and strategies, projections, anticipated events and trends, the economy, and other future conditions. Forward-looking statements are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict and many of which are outside of Vincerx’s control. Actual results, conditions, and events may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause actual results, conditions, and events to differ materially from those indicated in the forward-looking statements include, but are not limited to: general economic, financial, legal, political, and business conditions; risks associated with preclinical or clinical development and trials, including those conducted prior to Vincerx’s in-licensing; failure to realize the benefits of Vincerx’s license agreement with Bayer; risks related to the rollout of Vincerx’s business and the timing of expected business and product development milestones; changes in the assumptions underlying Vincerx’s expectations regarding its future business or business model; Vincerx’s ability to successfully develop and commercialize product candidates; Vincerx’s capital requirements and availability and uses of capital; and the risks and uncertainties set forth in Form 10-Q for the quarter ended September 30, 2023 and other reports filed with the Securities and Exchange Commission by Vincerx. Forward-looking statements speak only as of the date hereof, and Vincerx disclaims any obligation to update any forward-looking statements. Vincerx, the Vincerx logo, CellTrapper, and VersAptx are our trademarks. This press release also contains trademarks and trade names that are the property of their respective owners. Contacts Joyce LonerganLifeSci Advisors, LLC781-528-5276jlonergan@lifesciadvisors.com