Patients with metastatic bladder cancer are usually treated with chemotherapy. If their cancers do not progress after chemotherapy, they can be enrolled into this study and receive a standard-of-care immunotherapy medication named avelumab plus a study drug named copanlisib.

Start Date02 Jun 2025

Sponsor / Collaborator

VA Office of Research and Development

[+1]

NCT06869473

/ RecruitingPhase 2IIT

A Single-arm Phase II Study of Cetuximab Plus Platinum and Taxane-based Chemotherapy Followed by AVElumab and Cetuximab As First-line Therapy for Recurrent/metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) Patients with PD-L1 Combined Positive Score (CPS)≥1≤19: the Immunotherapy Sequenc

This phase II interventional clinical trial aims to evaluate whether combining cetuximab and avelumab, after three cycles of platinum and taxane-based chemotherapy, can improve treatment outcomes for patients with recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) with a PD-L1 combined positive score (CPS) between 1 and 19. Specifically, the study seeks to determine if this approach can increase the 6-month progression-free survival (PFS) rate from 40% to 55%.
The trial will include adult patients with confirmed R/M HNSCC, who have not previously received systemic therapy for their advanced disease. By testing this sequential treatment strategy, researchers hope to improve outcomes for this specific patient population, which has shown poorer responses to existing immunotherapy options compared to those with higher PD-L1 expression levels.
Participants will first undergo an induction phase, consisting of three cycles of chemotherapy with paclitaxel, platinum (cisplatin or carboplatin), and cetuximab. After this initial treatment, they will move to a maintenance phase, where they will receive avelumab and cetuximab every two weeks until disease progression or the occurrence of unacceptable side effects.
The study aims to answer several key questions:
Can this treatment approach improve progression-free survival at 6 months? What impact does it have on overall survival, response rates, and the duration of response? Is this combination therapy safe and well-tolerated? In addition to the treatment itself, participants will be asked to provide blood and tumor tissue samples for translational research, helping scientists better understand how biomarkers influence treatment response. Regular follow-up assessments will also be conducted to monitor disease progression and overall health.
By testing this innovative treatment sequence, researchers hope to bridge the gap between different PD-L1 subgroups, potentially offering a more effective and personalized approach for patients with R/M HNSCC.

Start Date20 Feb 2025

Sponsor / Collaborator

Gruppo Oncologico del Nord-Ovest

[+2]

NCT06820255

/ RecruitingPhase 4

Prospective Evaluation of the DDR Genes Alteration to Predict Response to Platinum-based Chemotherapy in Advanced Urothelial Cancer.

This study aims to prospectively observe whether certain alterations in some genes related to the DNA repair mechanism are related to better response to platinum-based chemotherapy used to treat metastatic bladder or urothelial cancers.

Start Date07 Jan 2025

Sponsor / Collaborator

University Hospital Agostino Gemelli

100 Clinical Results associated with Avelumab

100 Translational Medicine associated with Avelumab

100 Patents (Medical) associated with Avelumab

1,082

Literatures (Medical) associated with Avelumab

01 Apr 2025·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Optimization of immunotherapy-based combinations for metastatic renal cell carcinoma: A network meta-analysis

Review

Author: Rhie, Sandy Jeong ; Park, Sohyeon ; Park, Kalynn ; Kim, Chaeyoon

BACKGROUND:

Despite numerous meta-analyses comparing the efficacy and safety of immunotherapy-based combination therapies, the optimal therapeutic combinations remain unclear. This study aims to evaluate the optimal application of all immunotherapy-based combination therapy for advanced/metastatic renal cell carcinoma, focusing on efficacy and safety.

METHODS:

We systemically searched the Web of Science, Cochrane Library, and PubMed for studies regarding the first-line immunotherapy-based combination therapy in patients with advanced or metastatic renal cell carcinoma until April 15, 2024. We used network meta-analysis using a random effect model to facilitate direct and indirect treatment comparisons across outcomes.

RESULTS:

Seven clinical studies, including 5542 patients with metastatic renal cell carcinoma, were included in the network meta-analysis analysis. Regarding progression-free survival and overall survival, combined Toripalimab + Axitinib significantly outperformed other immunotherapy-based combination therapies. This regimen significantly improved progression-free survival in the intermediate/poor risk group when stratified by prognosis prediction risks compared to sunitinib alone. For the objective response rate, Avelumab + Axitinib was the most preferred strategy in the favorable-risk group, while Nivolumab + Cabozantinib was favored in the intermediate/poor-risk group compared to other immunotherapy-based combinations. The combinations of Nivolumab + Ipilimumab and Atezolizumab + Bevacizumab had favorable safety profiles.

CONCLUSIONS:

Immunotherapy-based combination therapies significantly improved progression-free survival, overall survival and objective response rate in patients with metastatic renal cell carcinoma compared to sunitinib monotherapy. However, careful monitoring and personalized treatment strategies are required to balance efficacy and safety in patients with underlying conditions. Future research should focus on optimizing treatment protocols and elucidating the mechanisms of adverse events.

03 Mar 2025·CLINICAL CANCER RESEARCH

Activity and Safety of Avelumab in High-Grade Neuroendocrine Tumors and Poorly Differentiated Neuroendocrine Carcinomas Progressive after Chemotherapy (AveNEC Trial)

Article

Author: Rinke, Anja ; Ruckes, Christian ; Galle, Peter R. ; Apostolidis, Leonidas ; Wagner, Daniel-Christoph ; Krug, Sebastian ; Michl, Patrick ; Mettler, Esther ; Topsch, Jana ; Weber, Matthias M. ; Fottner, Christian ; Roth, Wilfried ; Gress, Thomas M. ; Grün, Barbara

Abstract:

Purpose::

Neuroendocrine neoplasms grade 3 (NEN G3) are rare tumors with poor prognosis and no established second-line therapy. The role of immune checkpoint blockade in these aggressive tumors remains unclear.

Patients and Methods::

The phase II AveNEC study evaluated the effect of avelumab (AVE, 10 mg/kg i.v. every 2 weeks) in 60 patients with well-differentiated high-grade neuroendocrine tumors (N = 22) or poorly differentiated neuroendocrine carcinomas (N = 38) progressing after ≥1 prior chemotherapy (excluding Merkel cell carcinoma and small cell lung cancer).

Results::

The best overall response according to immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) was partial response (PR) in three (5%) and stable disease (SD) in nine (15%) patients, with a disease control rate at 16 weeks of 15% (3 PRs; 6 SDs) and a median duration of response of 4.3 months. Six (10%) patients achieved SD or PR for >6 months and two for >1 year. Response rates were similar regardless of differentiation, Ki-67 expression, or primary localization. The median progression-free survival was 1.9 months, and the overall survival was 6.6 months. After a median follow-up of 3.6 years, only four (7%) patients were still alive; 1- and 2-year survival rates were 33% and 17%, respectively. Responders had a significantly longer overall survival of 30.2 months compared with 4.8 months in nonresponders. AVE was well tolerated, with few treatment-related grade 3/4 adverse events, and the quality of life remained stable during treatment.

Conclusions::

In patients with progressive high-grade NEN G3, AVE was well tolerated and provided disease control with significant clinical benefit in 15% of heavily pretreated patients.

01 Mar 2025·CANCER TREATMENT REVIEWS

Individualizing first-line treatment for advanced urothelial carcinoma: A favorable dilemma for patients and physicians

Review

Author: Birtle, Alison ; Hussain, Syed A ; Barthélémy, Philippe ; Benjamin, David J ; Hoffman, Jason ; Giannatempo, Patrizia ; Grande, Enrique ; Kanesvaran, Ravindran

The treatment landscape for patients with advanced urothelial carcinoma (UC) has evolved rapidly in recent years. In current guidelines, combination treatment with enfortumab vedotin plus pembrolizumab is the first-line (1L) standard of care, and other recommended 1L treatment options are platinum-based chemotherapy followed by avelumab as switch-maintenance treatment in patients without progression, or combination treatment with nivolumab, cisplatin, and gemcitabine for cisplatin-eligible patients only. Individual patients differ in terms of their health status, disease characteristics, expected toxicities, and treatment preferences; thus, a "one-size-fits-all" approach to treatment is unlikely to be optimal. The availability of several treatment options creates the potential for individualized treatment. In this review, we discuss factors that may be considered when selecting 1L treatment for patients with advanced UC, including efficacy and safety data from phase 3 trials and real-world studies, quality of life, patient priorities for treatment, patient and disease characteristics, treatment sequencing, biomarkers, and treatment access and cost. Patients and physicians should discuss the benefit-risk balance of all available 1L options to enable shared decision-making. Longer follow-up from clinical trials and additional real-world studies are needed to further inform treatment selection.

280

News (Medical) associated with Avelumab

10 Mar 2025

·www.prnewswire.com

BAVENCIO Continues to Strengthen Its Position in the Immuno-Oncology Landscape | DelveInsight

With the rising adoption of checkpoint inhibitors and combination therapies, BAVENCIO's market growth is driven by expanding indications and strategic partnerships. However, competition from KEYTRUDA and TECENTRIQ poses challenges, making differentiation through combination strategies key to its success. LAS VEGAS, March 10, 2025 /PRNewswire/ -- DelveInsight's " BAVENCIO Market Size, Forecast, and Market Insight Report" highlights the details around BAVENCIO, a human IgG1 lambda monoclonal antibody that targets programmed death-ligand 1 (PD-L1). The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of BAVENCIO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Pfizer/Merck/EMD Sereno's BAVENCIO (avelumab) Overview BAVENCIO is a human antibody targeting programmed death ligand-1 (PD-L1). Preclinical studies have demonstrated its ability to activate both adaptive and innate immune responses. By inhibiting the interaction between PD-L1 and PD-1 receptors, BAVENCIO helps restore T cell-mediated antitumor immunity in preclinical models. In November 2014, Merck KGaA, Darmstadt, Germany, and Pfizer formed a strategic partnership to jointly develop and commercialize BAVENCIO. In the U.S., BAVENCIO is approved for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma that has not progressed after first-line platinum-based chemotherapy. It is also indicated for patients with locally advanced or metastatic UC who experience disease progression during or after platinum-based chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-based treatment. Additionally, BAVENCIO in combination with axitinib is approved in the U.S. for the first-line treatment of patients with advanced renal cell carcinoma. The FDA has also granted accelerated approval for BAVENCIO in the treatment of adults and pediatric patients (12 years and older) with metastatic Merkel cell carcinoma, based on tumor response rate and duration of response. Continued approval may depend on further clinical trials confirming its benefits. Currently, BAVENCIO is approved in 50 countries for at least one indication. Learn more about BAVENCIO projected market size for merkel cell carcinoma, urothelial carcinoma, and renal cell carcinoma @ BAVENCIO Market Potential Urothelial carcinoma is the most common cancer of the urinary system, arising from urothelial cells and primarily affecting individuals over the age of 50. It is more prevalent in males, with an incidence rate two to three times higher than in females. According to DelveInsight's analysis, approximately 41 million new cases of urothelial carcinoma were reported across the 7MM in 2023. The standard treatment primarily involves chemotherapy, particularly cisplatin-based regimens. For patients who do not respond to initial systemic therapy, immunotherapy—using agents such as atezolizumab and pembrolizumab—serves as a secondary option. In some cases, surgical interventions like nephroureterectomy are also performed. Approved treatment options for urothelial carcinoma include OPDIVO (nivolumab), PADCEV (enfortumab vedotin-ejfv), KEYTRUDA (pembrolizumab), and BAVENCIO (avelumab), among others. The urothelial carcinoma treatment market is projected to experience substantial growth, rising from USD 900 million in 2023 at a notable CAGR through 2034, driven by the introduction of innovative therapies currently in clinical trials. However, challenges such as treatment complications in elderly patients and dependence on blood transfusions may pose barriers to market expansion. Dive deep into an in-depth assessment of the Urothelial Carcinoma Market Merkel cell carcinoma is a rare and aggressive neuroendocrine skin cancer that originates from Merkel cells—specialized mechanoreceptors located at the dermo-epidermal junction responsible for touch sensation. According to DelveInsight's estimates, approximately 9,000 new cases of MCC were reported in the 7MM in 2023, with the United States accounting for 37% of these cases. Several approved treatments for MCC are currently available, primarily focusing on immune modulation. Notable therapies include BAVENCIO, a monoclonal antibody developed by Merck KGaA; KEYTRUDA (pembrolizumab), a PD-1 inhibitor from Merck; and ZYNYZ (retifanlimab-dlwr), a PD-1 inhibitor co-developed by Incyte Corporation and MacroGenics. DelveInsight's analysis estimates that the MCC treatment market in the 7MM was valued at approximately USD 411 million in 2023. Over the forecast period from 2024 to 2034, this market is expected to grow at a CAGR of 8.7%, driven by the introduction of innovative therapies. Discover more about the Merkel cell carcinoma market in detail @ Merkel Cell Carcinoma Market Report Renal cell carcinoma is the most prevalent form of kidney cancer, comprising approximately 90% of all cases. It ranks among the ten most common cancers worldwide. The prognosis for advanced RCC remains poor, with a five-year survival rate of around 11-12%. Research indicates that RCC accounts for the vast majority of kidney cancer cases. Over the past decade, the treatment landscape for advanced RCC has evolved significantly, driven by the introduction of novel therapies and advancements in surgical and ablative techniques. Treatment approaches have become increasingly personalized, with prognostic groups established to tailor interventions based on disease severity. For patients in good health with isolated metastases, surgical excision, radiotherapy, or ablative therapy may be recommended to postpone systemic treatment. Meanwhile, those ineligible for surgical removal may benefit from alternatives such as cryoablation, thermal ablation, or stereotactic ablative body radiation therapy. Additionally, targeted treatments like tyrosine kinase inhibitors (TKIs) and anti-VEGF antibodies have become essential in both first- and second-line therapy, offering effective management options for advanced RCC. The market outlook for advanced RCC appears promising, driven by ongoing innovations and the expansion of therapeutic options. As investigational treatments advance through clinical trials, they have the potential to significantly improve patient outcomes and address existing gaps in care. The competitive landscape is rapidly evolving, with developments in targeted therapies, immunotherapies, and combination treatments aiming to enhance survival rates and quality of life for patients with advanced RCC. For more insights on the evolving landscape of renal cell carcinoma, visit @ Advanced Renal Cell Carcinoma Market Emerging Competitors of BAVENCIO The urothelial carcinoma pipeline is highly dynamic, with promising new therapies in development, including IMFINZI + IMJUDO + SoC (AstraZeneca), Disitamab vedotin (Pfizer), Vactosertib + IMFINZI (MedPacto), TYRA-300 (Tyra Biosciences), LYTGOBI + KEYTRUDA (Taiho Oncology), UGN-104 (UroGen Pharma), and others. In the Merkel cell carcinoma space, the potential emerging competitors of BAVENCIO include IFx-2.0 (TuHURA Biosciences), NIDLEGY (L19-IL2/L19-TNF) (Philogen), ITI 3000 (Immunomic Therapeutics), PH 762 (Phio Pharmaceuticals/AgonOx), KT 253 (Kymera Therapeutics), MCLA 145 (Merus N.V.), and others. Key companies such as Exelixis/Bristol-Myers Squibb (Zanzalintinib (XL092) + Nivolumab), AstraZeneca/ HUTCHMED (Savolitinib + Durvalumab), Corvus Pharmaceuticals (Ciforadenant (CPI-444)), Xynomic Pharmaceuticals (Abexinostat), NiKang Therapeutics (NKT2152), and others are involved in developing drugs for advanced RCC. To know more about the number of competing drugs in development, visit @ BAVENCIO Market Positioning Compared to Other Drugs Key Milestones of BAVENCIO In January 2021, EMD Serono and Pfizer Inc. announced that the European Commission (EC) approved BAVENCIO as a monotherapy for first-line maintenance in adult patients with locally advanced or metastatic urothelial carcinoma who have remained progression-free after undergoing platinum-based chemotherapy. In December 2020, EMD Serono and Pfizer Inc. announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of BAVENCIO as a monotherapy for first-line maintenance in adult patients with locally advanced or metastatic urothelial carcinoma who have remained progression-free after undergoing platinum-based chemotherapy. In June 2020, EMD Serono and Pfizer Inc. announced that the FDA has approved the supplemental Biologics License Application (sBLA) for BAVENCIO as a maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma whose disease has not progressed following first-line platinum-based chemotherapy. In June 2020, Merck KGaA and Pfizer Inc. announced that the European Medicines Agency (EMA) had accepted for review the Type II variation application for BAVENCIO as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma. In April 2020, EMD Serono and Pfizer Inc. finalized the submission of a supplemental Biologics License Application (sBLA) to the FDA for BAVENCIO as a first-line maintenance therapy for patients with locally advanced or metastatic urothelial carcinoma. In October 2019, Merck KGaA and Pfizer Inc. announced that the European Commission (EC) has granted approval for BAVENCIO in combination with axitinib as a first-line treatment for adults with advanced renal cell carcinoma (RCC). In May 2019, Merck KGaA and Pfizer Inc. announced that the FDA granted approval for BAVENCIO in combination with INLYTA as a first-line treatment for patients with advanced renal cell carcinoma (RCC). In December 2017, Merck KGaA and Pfizer Inc. announced that the FDA had awarded Breakthrough Therapy Designation to avelumab in combination with INLYTA (axitinib) for newly diagnosed patients with advanced renal cell carcinoma (RCC). In September 2017, Merck KGaA and Pfizer Inc. announced that the European Commission (EC) has approved BAVENCIO as a standalone treatment for adult patients with metastatic Merkel cell carcinoma (mMCC), a rare and aggressive form of skin cancer. In September 2017, Merck KGaA and Pfizer Inc. announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved BAVENCIO as the first and only treatment for curatively unresectable Merkel cell carcinoma (MCC), a rare and aggressive cancer, in Japan. In May 2017, EMD Serono and Pfizer Inc. announced that the FDA approved BAVENCIO Injection to treat patients with locally advanced or metastatic urothelial carcinoma whose disease has progressed during or after platinum-based chemotherapy or within 12 months of receiving neoadjuvant or adjuvant platinum-based treatment. In March 2017, EMD Serono and Pfizer Inc. announced that the FDA has approved BAVENCIO Injection 20 mg/mL, an intravenous treatment for adults and pediatric patients aged 12 and older with metastatic Merkel cell carcinoma (mMCC). In November 2014, Merck KGaA, Darmstadt, Germany, and Pfizer formed a strategic partnership to jointly develop and market BAVENCIO. Discover how BAVENCIO is shaping the merkel cell carcinoma, urothelial carcinoma, and renal cell carcinoma treatment landscape @ BAVENCIO Injection BAVENCIO Market Dynamics BAVENCIO, co-developed by Merck KGaA and Pfizer, is an anti-PD-L1 checkpoint inhibitor primarily approved for urothelial carcinoma and Merkel cell carcinoma. Its key differentiation lies in its first-in-class approval for maintenance therapy in locally advanced or metastatic urothelial carcinoma, setting it apart from competitors like KEYTRUDA (pembrolizumab) and TECENTRIQ (atezolizumab). However, in the broader immuno-oncology (IO) landscape, BAVENCIO faces stiff competition from other PD-1/PD-L1 inhibitors that dominate indications in lung, renal, and other cancers. BAVENCIO's market uptake has been driven by its unique approval in the urothelial carcinoma maintenance setting, where it demonstrated a significant survival benefit. The drug has gained traction in major markets like the U.S., Europe, and Japan, benefiting from increased awareness and inclusion in treatment guidelines. However, its adoption has been tempered by physician familiarity with established IO therapies and payer considerations around cost-effectiveness, especially in competitive oncology segments. One of BAVENCIO's primary challenges is its limited label expansion compared to blockbuster PD-1 inhibitors like OPDIVO (nivolumab) and KEYTRUDA. While its urothelial carcinoma approval has a strong foothold, its lack of widespread use in high-incidence cancers like NSCLC constrains its market potential. Nonetheless, ongoing clinical trials exploring novel combination strategies with other immunotherapies and targeted agents could enhance its market positioning. Additionally, emerging markets and label expansions offer opportunities for future growth. The future of BAVENCIO will largely depend on its ability to secure new indications and differentiate itself in the crowded IO space. With increasing competition and biosimilar threats on the horizon, strategic partnerships, real-world evidence generation, and market access strategies will be crucial in sustaining its commercial success. Dive deeper to get more insight into BAVENCIO's strengths & weaknesses relative to competitors @ BAVENCIO Market Drug Report Table of Contents Related Reports Urothelial Carcinoma Market Urothelial Carcinoma Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key urothelial carcinoma companies including Pfizer, Merck, Eisai Inc, AstraZeneca, Seagen Inc, Bayer, Incyte Corporation, Acerta Pharma BV, among others. Urothelial Carcinoma Pipeline Urothelial Carcinoma Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key urothelial carcinoma companies, including MedPacto, AstraZeneca, Helsinn, QED Therapeutics, Inovio Pharmaceuticals, Abbisko Therapeutics, Bayer, 4D pharma plc, RemeGen, Infinity Pharmaceuticals, Kyowa Kirin, Inc., Ikena Oncology, Vyriad, Seagen, RemeGen, Pfizer, Incyte Corporation, Prestige BioPharma, TARIS Biomedical, Janssen Research and Development, among others. Merkel Cell Carcinoma Market Merkel Cell Carcinoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key merkel cell carcinoma companies including TuHURA Biosciences, Philogen, Immunomic Therapeutics, Phio Pharmaceuticals, AgonOx, Kymera Therapeutics, Merus N.V., among others. Renal Cell Carcinoma Market Renal Cell Carcinoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key renal cell carcinoma companies including AstraZeneca, Ipsen, Novartis, Pfizer, Amgen, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalImmunotherapyBreakthrough Therapy

10 Mar 2025

·www.pharmaceutical-technology.com

Vaccinex plans Nasdaq exit as Alzheimer market pressure grows

Vaccinex’s lead asset is being evaluated in neurodegenerative and oncological indications. Image credit: Shutterstock/interstid. Despite reporting positive Phase II results for its lead candidate last year, Vaccinex will soon no longer be a publicly traded company after falling short of Nasdaq requirements. The US-based company will delist its shares of common stock from Nasdaq via a Form 25 it intends to submit to the Securities and Exchange Commission on or around the 17 March. Form 25s are used by public company to officially delist their securities from a stock exchange, with delisting becoming effective 10 days after the document is filed. Vaccinex, currently listed on Nasdaq under the ticker VCNX, had its common stock trading suspended in December 2024 following a hearings panel from Nasdaq amidst financial shortcomings. Nasdaq notified Vaccinex of delisting intentions after equity requirements for companies trading on the stock exchange were not met. Vaccinex went public in 2018, raising around $40m to advance its pipeline of neurodegenerative disease therapies. The initial public offering (IPO) was priced at $12 per share, though share prices have since plummeted – arriving at $3.82 by the start of December 2024. Vaccinex’s market cap is currently just shy of $2.5m. As with many early-stage companies, Vaccinex funnelled the majority of its resources into a lead candidate. The asset, called pepinemab, is an antibody being evaluated in neurogenerative diseases and cancer indications. As pepinemab advanced through studies, Vaccinex’s research and development expenses grew. As per its most recent quarterly results ending September 2024, Vaccinex was left with just $2.9m in cash. Vaccinex affirmed it “plans to continue to focus on development of its lead product, pepinemab, to treat Alzheimer’s disease and cancer through partnerships, grants and other financing avenues.” Pepinemab, previously called pepinemabin, has shown promise, producing positive topline results in a Phase Ib/II trial (NCT04381468) in patients with Alzheimer’s disease in July 2024. Vaccinex reported that its asset, given as a monotherapy, resulted in a statistically significant increase in FDG-PET signal in areas of the brain known to be affected by early disease progression. The drug was also investigated in Huntington’s disease, with similar Phase II safety profile and brain metabolic activity effects. Judging by lack of investor enthusiasm in the company, Vaccinex has found the pressures from already-marketed Alzheimer’s therapies hard to repel. Eisai and Biogen’s Leqembi (lecanemab) and Eli Lilly’s Kisunla (donanemab) dominate the landscape, winning approvals in the US in 2023 and 2024 respectively. Leqembi is forecast to see $5.3bn in global revenues by 2030, with Kisunla expected to generate $1.7bn by the same year, according to GlobalData’s Pharma Intelligence Centre. GlobalData is the parent company of Pharmaceutical Technology . Despite its delisting, Vaccinex will also continue to focus on pepinemab in oncology indications. The antibody is evaluated in combination with MSD’s Keytruda in the Phase Ib/II KEYNOTE-B84 study (NCT04815720) in recurrent or metastatic head and neck cancer (HNSCC). Vaccinex has also teamed up with Merck KGaA to test pepinemab in combo with Bavencio (avelumab) in a Phase Ib/II study in patients with metastatic pancreatic adenocarcinoma (PDAC).

Phase 2Drug ApprovalIPOClinical Result

07 Mar 2025

·ir.vaccinex.com

Vaccinex Plans to Delist its Common Stock from The Nasdaq Stock Market

ROCHESTER, N.Y., March 07, 2025 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (OTC: VCNX) (“Vaccinex” or the “Company”), a clinical-stage biotechnology company pioneering a differentiated approach to treating neurodegenerative disease by blocking astrogliosis and neuroinflammation through the inhibition of SEMA4D, today announced that it has notified the Nasdaq Stock Market (“Nasdaq”) of its decision to delist the Company’s shares of common stock, par value $0.0001 per share (the “Common Stock”), from Nasdaq. Trading in the Common Stock on Nasdaq has been suspended since December 18, 2024. Vaccinex intends to file a Form 25 with the Securities and Exchange Commission on or about March 17, 2025 to remove its Common Stock from listing on Nasdaq. The Company’s decision to delist follows its receipt of notice dated December 16, 2024, that the Nasdaq Hearings Panel had determined to delist the Company’s securities from Nasdaq, and the subsequent suspension of trading. Nasdaq would have otherwise filed a Form 25 in due course. The Company plans to continue to focus on development of its lead product, pepinemab, to treat Alzheimer’s disease and cancer through partnerships, grants and other financing avenues. 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 was 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. Vaccinex believes pepinemab could also 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. 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. About Pepinemab Pepinemab is a humanized IgG4 monoclonal antibody designed to block SEMA4D, which can bind to plexin-B1 receptors to trigger collapse of the actin cytoskeleton in cells and lead to loss of homeostatic functions of astrocytes and other glial cells in the brain and of dendritic cells in immune tissue. Pepinemab appears to have been well-tolerated with a favorable safety profile in multiple clinical trials in different neurological and cancer indications. Forward Looking Statements To the extent that statements contained in this press release are not descriptions of historical facts regarding Vaccinex, Inc. (“Vaccinex,” “we,” “us,” or “our”), they may be forward-looking statements reflecting management’s current beliefs and expectations. Such statements include, but are not limited to, statements identified by words such as “may,” “will,” “intends,” “plans,” “expects,” and similar expressions or their negatives (as well as other words and expressions referencing future events, conditions, or circumstances). These statements include, among others, those regarding the expected timing of the delisting from Nasdaq and expected benefits of delisting. These statements are based on our current expectations and beliefs and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. 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 and the other risks and uncertainties described in Vaccinex’s most recent year-end Annual Report on Form 10-K and subsequent SEC filings. Investor Contact Elizabeth Evans, PhD Chief Operating Officer, Vaccinex, Inc. (585) 766-2033 eevans@vaccinex.com Source: Vaccinex, Inc.

Phase 2

100 Deals associated with Avelumab

External Link

KEGG	Wiki	ATC	Drug Bank
D10817	Avelumab	L01XC31	DB11945

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Renal Cell Carcinoma	AU	Merck Healthcare Pty Ltd.	03 Jan 2018
Advanced Renal Cell Carcinoma	EU	Merck Europe BV	18 Sep 2017
Advanced Renal Cell Carcinoma	IS	Merck Europe BV	18 Sep 2017
Advanced Renal Cell Carcinoma	LI	Merck Europe BV	18 Sep 2017
Advanced Renal Cell Carcinoma	NO	Merck Europe BV	18 Sep 2017
Locally Advanced Urothelial Carcinoma	EU	Merck Europe BV	18 Sep 2017
Locally Advanced Urothelial Carcinoma	IS	Merck Europe BV	18 Sep 2017
Locally Advanced Urothelial Carcinoma	LI	Merck Europe BV	18 Sep 2017
Locally Advanced Urothelial Carcinoma	NO	Merck Europe BV	18 Sep 2017
Metastatic Merkel Cell Carcinoma	EU	Merck Europe BV	18 Sep 2017
Metastatic Merkel Cell Carcinoma	IS	Merck Europe BV	18 Sep 2017
Metastatic Merkel Cell Carcinoma	LI	Merck Europe BV	18 Sep 2017
Metastatic Merkel Cell Carcinoma	NO	Merck Europe BV	18 Sep 2017
Metastatic urothelial carcinoma	EU	Merck Europe BV	18 Sep 2017
Metastatic urothelial carcinoma	IS	Merck Europe BV	18 Sep 2017
Metastatic urothelial carcinoma	LI	Merck Europe BV	18 Sep 2017
Metastatic urothelial carcinoma	NO	Merck Europe BV	18 Sep 2017
Transitional Cell Carcinoma	US	EMD Serono, Inc.	09 May 2017
Merkel Cell Carcinoma	US	EMD Serono, Inc.	23 Mar 2017

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced cancer	Phase 3	US	Pfizer Inc.	29 Sep 2021
Advanced cancer	Phase 3	JP	Pfizer Inc.	29 Sep 2021
Advanced cancer	Phase 3	AU	Pfizer Inc.	29 Sep 2021
Advanced cancer	Phase 3	BE	Pfizer Inc.	29 Sep 2021
Advanced cancer	Phase 3	CA	Pfizer Inc.	29 Sep 2021
Advanced cancer	Phase 3	DK	Pfizer Inc.	29 Sep 2021
Advanced cancer	Phase 3	FR	Pfizer Inc.	29 Sep 2021
Advanced cancer	Phase 3	HU	Pfizer Inc.	29 Sep 2021
Advanced cancer	Phase 3	IL	Pfizer Inc.	29 Sep 2021
Advanced cancer	Phase 3	IT	Pfizer Inc.	29 Sep 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04322643 (CTgov)	Phase 2	Advanced Urothelial Carcinoma	4	nivolumab+Avelumab+Atezolizumab+pembrolizumab+Durvalumab	lowafdaere(vkhganxprn) = iluzoodasb omomqceakh (ckzxptsjsa, xiwwmonrgy - rbziiueoli) View more	-	25 Feb 2025
ASCO_GU2025 Manual	Not Applicable	Transitional Cell Carcinoma First line \| Maintenance	107	Avelumab 1L maintenance treatment	trddslpfub(ihypwggexj) = Not reached ueqrcwcjhb (ytvnueikbc )	Positive	13 Feb 2025
JAVELIN Bladder 100 (ASCO_GU2025) Manual	Not Applicable	Advanced Urothelial Carcinoma Maintenance \| First line	106	Avelumabavelumabaintenance therapy (From avelumab initiation)	dpnqitdhdx(rnzaojbvju) = hexdttjotq tkzqzyhzjl (avfslqlrmv, 11.6 - 23.4) View more	Negative	13 Feb 2025
				Avelumab 1L maintenance therapy (the start of 1L PBC in this population without disease progression after 1L PBC)	dpnqitdhdx(rnzaojbvju) = jgsmwecebu tkzqzyhzjl (avfslqlrmv, 17.0 - 28.9)
NCT04698213 (Tide-A, ASCO_GU2025) Manual	Phase 2	Metastatic Renal Cell Carcinoma First line \| Maintenance	75	avelumab plus intermittent axitinib	fescktthtd(tngozqtafm) = yqzefamugm radqimmtrj (twpwolfoty ) View more	Positive	13 Feb 2025
				avelumab plus intermittent axitinib (interrupted Axi at W36)	fescktthtd(tngozqtafm) = lrqckqkyki radqimmtrj (twpwolfoty ) View more
ASCO_GU2025	Not Applicable	Transitional Cell Carcinoma First line	290	avelumab (Nonvisceral Metastases)	utoltnaefc(mujlapxzyt) = xetmctdxsb ttcinhiiap (lhdkrdglwb ) View more	-	13 Feb 2025
				avelumab (Visceral Metastases)	utoltnaefc(mujlapxzyt) = fdeaoxcysu ttcinhiiap (lhdkrdglwb ) View more
JAVELIN Bladder 100 (ASCO_GU2025)	Phase 3	Advanced Urothelial Carcinoma Maintenance	453	Gemcitabine + Cisplatin (GC)	qjvsoclbea(fmocdjwusz) = Median OS was not reached in any subgroup; the 1-year OS rate was 77.9% (95% CI, 73.7-81.5) overall, and 79.6% (95% CI, 74.3-84.0), 73.8% (95% CI, 66.2-80.0), and 88.9% (95% CI, 43.3-98.4) in subgroups jejgdnfymp (timgxxospg )	Positive	13 Feb 2025
				Gemcitabine + Carboplatin (GCa)
NCT04068831 (CTgov)	Phase 2	Metastatic Renal Cell Carcinoma \| Fumarate Hydratase-Deficient Renal Cell Carcinoma \| Mitochondrial Complex II Deficiency	18	Avelumab+Talazoparib (Talazoparib and Avelumab (VHL-deficiency) (Closed to Accrual))	qayvwucqgx(cpxadmmdwq) = qdrhtmsvpj owqyvtdxgg (capjwbdbes, umthdqdfbz - hscshuuvbf) View more	-	27 Dec 2024
				Avelumab+Talazoparib (Talazoparib and Avelumab (FH- or SDH-deficiency))	qayvwucqgx(cpxadmmdwq) = lqbfaprknn owqyvtdxgg (capjwbdbes, shuaedikfo - rhbcnugxhq) View more
AVePEm (ESMO_IO2024) Manual	Not Applicable	Advanced Urothelial Carcinoma Maintenance \| Second line	30	Avelumab	pcljwrvgxi(ywpmtxyyrz) = fkuldwfzsx xsznqybyjk (uyhysuozuw ) View more	Similar	12 Dec 2024
				Pembrolizumab	pcljwrvgxi(ywpmtxyyrz) = hvpjuqatqm xsznqybyjk (uyhysuozuw ) View more
ESMO_ASIA2024 Manual	Phase 3	Advanced Urothelial Carcinoma Maintenance	453	Avelumab maintenance therapy	ddhuurupdd(ziwyzjlkgo) = qnvxwmwauc hbboyvmrpy (yawjiedhbl, 73.7 - 81.5) View more	Positive	07 Dec 2024
				Avelumab maintenance therapy (Age ≤64 years)	ddhuurupdd(ziwyzjlkgo) = tywltvrbth hbboyvmrpy (yawjiedhbl, 66.1 - 85.6) View more
NCT02684006 (JAVELIN renal 101, ESMO_ASIA2024) Manual	Phase 3	Advanced Renal Cell Carcinoma First line	-	Avelumab + Axitinib (IMDC risk 0)	cxopghxgto(ygbamjsvey) = ojxorwrepl wrqnfsdoow (wnlhteiclu, 79.4 (59.4 - NE) View more	Positive	07 Dec 2024
				Sunitinib (IMDC risk 0)	cxopghxgto(ygbamjsvey) = fhpgzrsnei wrqnfsdoow (wnlhteiclu, 65.5 (53.4 - 78.6) View more

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