Latest news with #PROTAC
Yahoo
28-04-2025
- Business
- Yahoo
Arvinas to Report First Quarter 2025 Financial Results on Thursday, May 1, 2025
NEW HAVEN, Conn., April 28, 2025 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company working to develop a new class of drugs based on targeted protein degradation, today announced that management will review first quarter 2025 financial results and provide a corporate update during a live webcast on Thursday, May 1, 2025, at 8:00 a.m. ET. The webcast can be accessed under 'Events and Presentations' on the investor page of the Arvinas website. A replay of the webcast will be available on the Arvinas website at following the completion of the event. About ArvinasArvinas (Nasdaq: ARVN) is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases. Through its PROTAC® (PROteolysis Targeting Chimera) protein degrader platform, the Company is pioneering the development of protein degradation therapies designed to harness the body's natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. Arvinas is currently progressing multiple investigational drugs through clinical development programs, including vepdegestrant, targeting the estrogen receptor for patients with locally advanced or metastatic ER+/HER2- breast cancer; ARV-393, targeting BCL6 for relapsed/refractory non-Hodgkin Lymphoma; and ARV-102, targeting LRRK2 for neurodegenerative disorders. Arvinas is headquartered in New Haven, Connecticut. For more information about Arvinas, visit and connect on LinkedIn and X. Contacts Investors:Jeff Boyle+1 (347) Media: Kirsten Owens+1 (203) in to access your portfolio
Yahoo
04-04-2025
- Health
- Yahoo
Arvinas' PROTAC halves protein suspected to play role in Parkinson's
A first-in-human trial of Arvinas' investigational Parkinson's' disease therapy, ARV-102, has been able to demonstrate a drop in the multifunctional protein that has been associated with the disease whilst also surpassing the blood-brain barrier. The Phase I single ascending dose (SAD) and multiple ascending dose (MAD) trial (EUCT-2023-507910-28-00) found ARV-102, a proteolysis targeting chimaera (PROTAC) therapy, led to a drop in leucine-rich repeat kinase 2 (LRRK2) across healthy volunteers. LRRK2 is associated with an increased risk of both autosomal dominant Parkinson's disease and Crohn's disease. In the SAD cohort, a single oral dose of at least 60mg of ARV-102, alongside further once daily repeated oral doses of at least 20mg, achieved greater than 50% LRRK2 reduction in the volunteer's cerebral spinal fluid. As well as a more than 90% LRRK2 reduction in the peripheral blood mononuclear cells (PBMCs). Investigation in the MAD cohort is still ongoing. Additional results from the SAD cohort found that ARV-102 at single doses of more than 30mg induced more than 50% decrease in peripheral phosphor-Rab10, a biomarker used to determine the therapy's ability to impact downstream of the blood-brain barrier. Noah Berkowitz, CMO at Arvinas, said: 'The ability of ARV-102 to cross the blood-brain barrier and degrade the LRRK2 protein offers a potentially transformative therapeutic approach in the treatment of devastating neurodegenerative diseases. 'We believe these results support continuing our ARV-102 clinical program and building upon our body of evidence for this lead PROTAC degrader candidate in our neuroscience pipeline.' Results from the randomised, double-blind, placebo-controlled were initially announced as part of the 2025 International Conference on Alzheimer's and Parkinson's Diseases (AD/PD) in Vienna, Austria. In the Phase I trial, the therapy was relatively well tolerated, with some adverse events (AEs) reported. Approximately 47 volunteers were recruited across all SAD dose levels with headaches reported in 17.1% of patients. Procedural pain associated with the lumbar puncture occurred in 28.6% of treated volunteers compared to 41.7% in placebo controls. This comes weeks after Arvinas' stock took a 51% after its PROTAC therapy for human epidermal growth factor receptor 2 (HER2) negative breast cancer therapy, being developed with pharma giant Pfizer, saw mixed results as it was only able to extend progression-free survival (PFS) in certain patients. The trial was conducted as part of a $2.4bn partnership between the companies. This latest Parkinson's data gives renewed hope to Arvinas for PROTAC therapies. Elsewhere in the field of Parkinson's disease therapies, Cerevance is continuing an ongoing pivotal study of its Parkinson's candidate despite it showing no benefit compared to placebo in a Phase II study. "Arvinas' PROTAC halves protein suspected to play role in Parkinson's" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Yahoo
14-03-2025
- Business
- Yahoo
Biotech Alert: Searches spiking for these stocks today
These names in the biotech sector are seeing a substantial increase in search activity today, as determined by InvestingChannel. They include: Easily identify stocks' risks and opportunities. Discover stocks' market position with detailed competitor analyses. Arvinas (ARVN), 924% surge in interest Janux Therapeutics (JANX), 479% surge in interest Fortress Biotech (FBIO), 440% surge in interest Dogwood Therapeutics (DWTX), 248% surge in interest Hepion Pharmaceuticals (HEPA), 219% surge in interest Tenaya Therapeutics (TNYA), 209% surge in interest Coherus BioSciences (CHRS), 185% surge in interest Aligos Therapeutics (ALGS), 165% surge in interest Beam Therapeutics (BEAM), 131% surge in interest NKGen Biotech (NKGN), 130% surge in interest Pipeline and key clinical candidates for these companies: Arvinas is a clinical-stage biotechnology company that says it is 'dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins.' In addition to its preclinical pipeline of PROTAC protein degraders against validated and 'undruggable' targets, the company has four investigational clinical-stage programs: vepdegestrant for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer; ARV-766 and bavdegalutamide for the treatment of men with metastatic castration-resistant prostate cancer; and ARV-102 for the treatment of patients with neurodegenerative disorders. Janux is a clinical-stage biopharmaceutical company developing tumor-activated immunotherapies for cancer. Janux's proprietary technology enabled the development of two distinct bispecific platforms: TRACTr and TRACIr. The goal of both platforms is to provide cancer patients with safe and effective therapeutics that direct and guide their immune system to eradicate tumors while minimizing safety concerns. Janux is currently developing a broad pipeline of TRACTr and TRACIr therapeutics directed at several targets to treat solid tumors. Janux has two TRACTr therapeutic candidates in clinical trials, the first targeting PSMA is in development for prostate cancer, and the second targeting EGFR is being developed for colorectal carcinoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, renal cell carcinoma, small cell lung cancer, pancreatic ductal adenocarcinoma and triple-negative breast cancer. Fortress Biotech is focused on acquiring, developing and commercializing high-potential marketed and development-stage drugs and drug candidates. The company has nine marketed prescription pharmaceutical products and over 30 programs in development at Fortress, at its majority-owned and majority-controlled partners and subsidiaries and at partners and subsidiaries it founded and in which it holds significant minority ownership positions. Such product candidates span six large-market areas, including oncology, rare diseases and gene therapy. Dogwood Therapeutics is a development-stage biopharmaceutical company focused on developing new medicines to treat pain and fatigue-related disorders. The Dogwood research pipeline includes two separate mechanistic platforms with a non-opioid analgesic program and an antiviral program. The proprietary non-opioid, Nav 1.7 analgesic program is centered on our lead development candidate, Halneuron which is a highly specific voltage-gated sodium channel modulator, a mechanism known to be effective for reducing pain transmission. The antiviral program includes IMC-1 and IMC-2, which are novel, proprietary, fixed dose combinations of anti-herpes antivirals and the anti-inflammatory agent, celecoxib. These combination antiviral approaches are being applied to the treatment of illnesses believed to be related to reactivation of previously dormant herpesviruses, including fibromyalgia and Long-COVID. Hepion Pharmaceuticals is a clinical stage biopharmaceutical company that has been developing a treatment for non-alcoholic steatohepatitis, hepatocellular carcinoma, and other chronic liver diseases. Hepion's lead drug candidate, rencofilstat, is a potent inhibitor of cyclophilins, which are involved in many disease processes. Rencofilstat has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental disease models and is currently in Phase 2 clinical development for the treatment of NASH. Tenaya Therapeutics is a clinical-stage biotechnology company committed to a bold mission: to discover, develop and deliver potentially curative therapies that address the underlying drivers of heart disease. Tenaya employs a suite of integrated internal capabilities, including modality agnostic target validation, capsid engineering and manufacturing, to generate a portfolio of genetic medicines aimed at the treatment of both rare genetic disorders and more prevalent heart conditions. Tenaya's pipeline includes TN-201, a gene therapy for MYBPC3-associated hypertrophic cardiomyopathy, TN-401, a gene therapy for PKP2-associated arrhythmogenic right ventricular cardiomyopathy, TN-301, a small molecule HDAC6 inhibitor intended for heart failure with preserved ejection fraction, and multiple early-stage programs in preclinical development. Coherus is a commercial-stage biopharmaceutical company focused on the research, development and commercialization of immunotherapies to treat cancer. Coherus' immuno-oncology pipeline includes multiple antibody immunotherapy candidates focused on enhancing the innate and adaptive immune responses to enable a robust immunologic response and enhance outcomes for patients with cancer. Aligos Therapeutics is a clinical stage biotechnology company founded with the mission to improve patient outcomes by developing best-in-class therapies for the treatment of liver and viral diseases. Aligos applies its science driven approach and deep R&D expertise to advance its purpose-built pipeline of therapeutics for high unmet medical needs such as chronic hepatitis B virus infection, metabolic dysfunction-associated steatohepatitis, and coronaviruses. Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform with integrated gene editing, delivery and internal manufacturing capabilities. Beam's suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of potential therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. NKGen is a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic NK cell therapeutics. Recent news on these stocks: March 12 Dogwood Therapeutics entered into a securities purchase agreement with certain institutional investors to purchase 578,950 shares of common stock at an offering price of $8.26 per share, in a registered direct offering priced at-the-market under Nasdaq rules. The gross proceeds for the offering are expected to be approximately $4.8M before deducting placement agent fees and other offering expenses. This offering is expected to close on March 14, 2025, subject to customary closing conditions. Dogwood intends to use the net proceeds of this offering to further advance the clinical development of its lead development candidate, Halneuron, and for working capital and general corporate purposes. Maxim Group is acting as sole placement agent in connection with the offering. March 11 Arvinas and Pfizer (PFE) announced topline results from the Phase 3 VERITAC-2 clinical trial evaluating vepdegestrant monotherapy versus fulvestrant in adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative dvanced or metastatic breast cancer whose disease progressed following prior treatment with cyclin-dependent kinase 4/6 inhibitors and endocrine therapy. These are the first pivotal data for vepdegestrant, a potential first-in-class investigational oral PROteolysis TArgeting Chimera ER degrader. The trial met its primary endpoint in the estrogen receptor 1-mutant population, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival compared to fulvestrant. The results exceeded the pre-specified target hazard ratio of 0.60 in the ESR1m population. The trial did not reach statistical significance in improvement in PFS in the intent-to-treat population. Overall survival was not mature at the time of the analysis, with less than a quarter of the required number of events having occurred. The trial will continue to assess overall survival as a key secondary endpoint. In the trial, vepdegestrant was generally well tolerated and its safety profile was consistent with what has been observed in previous studies. March 10 Checkpoint Therapeutics and Sun Pharmaceutical Industries announced on March 9 that they have entered into an agreement by which Sun Pharma will acquire the immunotherapy and targeted oncology company. Upon completion of the transaction, Sun Pharma will acquire all outstanding shares of Checkpoint and Checkpoint stockholders will receive, for each share of common stock they hold, an upfront cash payment of $4.10, without interest, and a non-transferable contingent value right, or CVR, entitling the stockholder to receive up to an additional 70c in cash, without interest, if cosibelimab is approved prior to certain deadlines in the European Union pursuant to the centralized approval procedure or in Germany, France, Italy, Spain or the United Kingdom, subject to the terms and conditions in the contingent value rights agreement. Tenaya reported better-than-expected Q4 earnings per share. 'Throughout 2024, Tenaya made important advances across our cardiovascular gene therapy development pipeline that have positioned us for a data-rich 2025. We look forward to sharing data from both the TN-201 MyPEAK-1 clinical trial for MYBPC3-associated HCM and the RIDGE-1 clinical trial of TN-401 for PKP2-associated ARVC in the months ahead,' said Faraz Ali, Chief Executive Officer of Tenaya. 'The recent financing with support from existing and new shareholders allows us to maintain our focus on driving our gene therapy programs for cardiomyopathies toward later-stage development. In the first half of next year, we expect to have greater than one-year of follow-up in the high-dose cohort of MyPEAK-1, as well as one-year follow-up for the first few patients enrolled in the RIDGE-1 clinical trial.' Coherus Biosciences reportetd mixed Q4 results and announced it would reduce its headcount by 30%. The company said, 'Coherus projects post-UDENYCA-close cash of approximately $250 million and cash runway projections exceeding two years, past key data readouts expected in 2026. Approximately 50 employees associated with UDENYCA are expected to transfer to Accord BioPharma, Inc. as part of the asset purchase agreement and Coherus' headcount will be reduced by approximately 30% following the transaction to approximately 155.' Aligos reported a year-over-year decline in Q4 earnings per share, thtough revenue was higher year-over-year. '2024 was a pivotal year for the company, paving the way for the future of Aligos,' stated Lawrence Blatt, Ph.D., MBA, Chairman, President, and Chief Executive Officer of Aligos Therapeutics. 'That future looks bright as we move ALG-000184 closer towards a Phase 2 clinical study, which is expected to begin in mid-2025. We continue to believe our CAM-E has the potential to be a first- and best-in-class candidate, by acting as a disease modifying agent for patients in need of better outcomes. Our recent fundraising is backed by investors supportive of our vision for ALG-000184, which has the potential to replace standard of care and become the backbone of treatment for next-generation therapies for chronic hepatitis B virus infection.' Beam Therapeutics announced initial safety and efficacy data from its Phase 1/2 trial of BEAM-302, establishing clinical proof-of-concept as a potential treatment for alpha-1 antitrypsin deficiency and for in vivo base editing. Preliminary results from the first three single-ascending dose cohorts demonstrated that BEAM-302 was well tolerated, with single doses of BEAM-302 leading to durable dose-dependent correction of the disease-causing mutation. Treatment with BEAM-302 was well tolerated with an acceptable safety profile at all dose levels explored to date. All adverse events were mild to moderate, with no serious AEs reported and no dose-limiting toxicities as of the data cutoff. Grade 1 asymptomatic alanine transaminase and aspartate aminotransferase elevations and transient Grade 1 infusion-related reactions were observed in some patients and did not require treatment. Following a single infusion of BEAM-302, rapid, durable, and dose-dependent increases in total AAT, new production of corrected M-AAT, and decreases in mutant Z-AAT were observed in circulation. Changes in total AAT were observed by turbidimetry assays as early as Day 7, plateaued around Day 21 and were maintained for the duration of follow-up. Increased total AAT was functional as determined by both neutrophil elastase inhibition and neutrophil elastase binding assays. Hear more from InvestingChannel by signing up for The Spill. About 'Biotech Alert' The Fly will report on a selection of biotech stocks seeing a surge in interest from retail and financial professional investors, based on data from InvestingChannel. This Fly exclusive recap reveals the biotech stocks that are seeing a spike in searches among the 20-plus million retail and financial professional investors through InvestingChannel's online financial news media ecosystem. This increased attention from the investors may be in response to, or advance of, outsized moves for stocks in the biotech sector, which tend to be volatile and prone to sharp swings in share price around binary events such as clinical study results and FDA approvals. Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See the top stocks recommended by analysts >> Read More on PFE: Questions or Comments about the article? Write to editor@ Arvinas price target lowered to $12 from $48 at Morgan Stanley ViiV announces new study data showing zero HIV cases with Apretude ViiV Healthcare announces data from EMBRACE Phase IIb study Arvinas, Pfizer announce VERITAC-2 achieved primary endpoint in Phase 3 trial Pfizer, Walmart, Super Micro, Salesforce, AbbVie: Insider Moves Unveiled! Sign in to access your portfolio
Yahoo
11-03-2025
- Business
- Yahoo
Pfizer and Arvinas's HER2-breast cancer drug extends PFS in certain patients
Pharma giant Pfizer and Arvinas's human epidermal growth factor receptor 2 (HER2) negative breast cancer therapy, vepdegestrant, has seen mixed results after it was only able to extend progression-free survival (PFS) in certain patients in a Phase III trial. Topline results from the company's Veritac-2 trial (NCT05654623) showed a clinically meaningful improvement in PFS in patients with oestrogen receptor 1-mutant (ESR1m) breast cancer. However, the company said that it was not able to improve PFS in the intent-to-treat (ITT) population. The global randomised study enrolled 624 patients at sites in 26 countries who had previously received treatment with cyclin-dependent kinase (CDK) 4/6 inhibitors alongside endocrine therapy. The trial pitted vepdegestrant against AstraZeneca's Faslodex (fulvestrant). Data on overall survival (OS), a key secondary endpoint, was not yet mature with less than a quarter of the required number of events having occurred. Pfizer describes vepdegestrant as a potential first-in-class investigational oral proteolysis targeting chimera (PROTAC) oestrogen receptor degrader. Developed as part of a $2.4bn partnership between Pfizer and Arvinas, the oral drug was designed for a natural protein disposal system to specifically target and degrade oestrogen receptors. Following the announcement of the mixed results, Arvinas' stock price dropped more than 51% from $17.70 per share down to $8.59 at the time of publication (11 March 10am EST). Arvinas president John Houston said: 'The first Phase III data readout for a PROTAC degrader represents a significant achievement and these data show that vepdegestrant has the potential to provide clinically meaningful outcomes for thousands of patients with metastatic breast cancer whose tumours harbour oestrogen receptor 1 mutations.' It follows after the US Food and Drug Administration (FDA) granted fast track designation for the investigation of vepdegestrant as a monotherapy. Research by GlobalData estimates that by the end of next year, the breast cancer therapy could bring in as much as $75m for the two companies, with that figure expected to rise to $841m by the end of 2030. The World Health Organization (WHO) found that breast cancer caused 670,000 deaths globally in 2022. GlobalData is the parent company of Clinical Trials Arena. Pfizer oncology chief development officer Megan O'Meara said: 'Patients with advanced ER+/HER2- metastatic breast cancer face significant clinical challenges, with limited treatment options following disease progression and the development of resistance to available endocrine therapies. 'This data from the Veritac-2 trial supports the potential of vepdegestrant to give patients whose tumours harbour ESR1 mutations additional time without disease progression, compared to Faslodex.' Elsewhere in the field of HER2 breast cancer, NiKang Therapeutics has concluded the first cohort dosing in the open-label Phase I trial of NKT3964. Meanwhile, Phoenix Molecular Designs has started dosing in the Phase II arm of a trial examining its metastatic breast cancer candidate, PMD-026. "Pfizer and Arvinas's HER2-breast cancer drug extends PFS in certain patients" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Yahoo
11-03-2025
- Business
- Yahoo
Arvinas and Pfizer Announce Positive Topline Results from Phase 3 VERITAC-2 Clinical Trial
– VERITAC-2 achieved its primary endpoint in the estrogen receptor 1-mutant population, demonstrating statistically significant and clinically meaningful improvement in progression-free survival – – Vepdegestrant is the first PROTAC degrader to demonstrate clinical benefit in a Phase 3 trial – NEW HAVEN, Conn. and NEW YORK, March 11, 2025 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN) and Pfizer Inc. (NYSE: PFE) today announced positive topline results from the Phase 3 VERITAC-2 clinical trial (NCT05654623) evaluating vepdegestrant monotherapy versus fulvestrant in adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced or metastatic breast cancer whose disease progressed following prior treatment with cyclin-dependent kinase (CDK) 4/6 inhibitors and endocrine therapy. These are the first pivotal data for vepdegestrant, a potential first-in-class investigational oral PROteolysis TArgeting Chimera (PROTAC) ER degrader. The trial met its primary endpoint in the estrogen receptor 1-mutant (ESR1m) population, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to fulvestrant. The results exceeded the pre-specified target hazard ratio of 0.60 in the ESR1m population. The trial did not reach statistical significance in improvement in PFS in the intent-to-treat (ITT) population. 'The first Phase 3 data readout for a PROTAC degrader represents a significant achievement and these data show that vepdegestrant has the potential to provide clinically meaningful outcomes for thousands of patients with metastatic breast cancer whose tumors harbor estrogen receptor 1 mutations,' said John Houston, Ph.D., Chairperson, Chief Executive Officer and President at Arvinas. 'We want to thank the patients and investigators who participated in this trial, and we look forward to sharing these data with health authorities as well as at a medical conference in 2025.' Overall survival was not mature at the time of the analysis, with less than a quarter of the required number of events having occurred. The trial will continue to assess overall survival as a key secondary endpoint. In the trial, vepdegestrant was generally well tolerated and its safety profile was consistent with what has been observed in previous studies. Detailed results from VERITAC-2 will be submitted for presentation at a medical meeting later this year, and these data will be shared with global regulatory authorities to potentially support regulatory filings. 'Patients with advanced ER+/HER2- metastatic breast cancer face significant clinical challenges, with limited treatment options following disease progression and the development of resistance to available endocrine therapies,' said Megan O'Meara, M.D., Interim Chief Development Officer, Pfizer Oncology. 'These data from VERITAC-2 support the potential of vepdegestrant to give patients whose tumors harbor ESR1 mutations additional time without disease progression, compared to fulvestrant.' Vepdegestrant is an investigational oral PROTAC ER degrader for ER+/HER2- breast cancer being jointly developed by Arvinas and Pfizer and is designed to harness the body's natural protein disposal system to specifically target and degrade the ER. In February 2024, the companies announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for the investigation of vepdegestrant for monotherapy in the treatment of adults with ER+/HER2- advanced or metastatic breast cancer previously treated with endocrine-based therapy. About Metastatic Breast CancerAbout 2.3 million new breast cancer diagnoses were reported globally in 2022,1 and it is estimated there will be nearly 320,000 people diagnosed with breast cancer in the U.S. in 2025.2 Estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer accounts for approximately 70% of all cases.3 Nearly 30% of women initially diagnosed with early-stage breast cancer will ultimately develop metastatic breast cancer (MBC),4 the most advanced stage in which the disease has spread beyond the breast to other parts of the body. Treatment advances have helped those with MBC better manage symptoms, slow tumor growth, and may allow them to live longer, but most patients ultimately develop resistance to current standard-of-care treatments in the first-line setting and experience disease progression. ESR1 mutations are a common cause of acquired resistance and are found in approximately 40% of patients in the second-line setting.5 6 7 About the VERITAC-2 Clinical TrialThe Phase 3 VERITAC-2 clinical trial (NCT05654623) is a global randomized study evaluating the efficacy and safety of vepdegestrant (ARV-471) as a monotherapy compared to fulvestrant in patients with ER+/HER2- advanced or metastatic breast cancer. The trial enrolled 624 patients at sites in 26 countries who had previously received treatment with a CDK4/6 inhibitor plus endocrine therapy. Patients were randomized to receive either vepdegestrant once daily, orally on a 28-day continuous dosing schedule, or fulvestrant, administered intramuscularly on Days 1 and 15 of Cycle 1 and then on Day 1 of each 28-day cycle starting from Day 1 of Cycle 2. The primary endpoint was progression-free survival (PFS) in the intent-to-treat and ESR1m populations as determined by blinded independent central review. Overall survival is a key secondary endpoint. About VepdegestrantVepdegestrant is an investigational, orally bioavailable PROTAC (PROteolysis TArgeting Chimera) protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of patients with ER-positive (ER+)/human epidermal growth factor receptor 2 (HER2)-negative (ER+/HER2-) breast cancer. Vepdegestrant is being developed as a potential monotherapy and as part of combination therapy across multiple treatment settings for ER+/HER2- metastatic breast cancer. In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialization of vepdegestrant; Arvinas and Pfizer will share worldwide development costs, commercialization expenses, and profits. The U.S. Food and Drug Administration (FDA) has granted vepdegestrant Fast Track designation as a monotherapy in the treatment of adults with ER+/HER2- advanced or metastatic breast cancer previously treated with endocrine-based therapy. About ArvinasArvinas (Nasdaq: ARVN) is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases. Through its PROTAC (PROteolysis TArgeting Chimera) protein degrader platform, the Company is pioneering the development of protein degradation therapies designed to harness the body's natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. Arvinas is currently progressing multiple investigational drugs through clinical development programs, including vepdegestrant, targeting the estrogen receptor for patients with locally advanced or metastatic ER+/HER2- breast cancer; ARV-393, targeting BCL6 for relapsed/refractory non-Hodgkin Lymphoma; and ARV-102, targeting LRRK2 for neurodegenerative disorders. Arvinas is headquartered in New Haven, Connecticut. For more information about Arvinas, visit and connect on LinkedIn and X. About Pfizer OncologyAt Pfizer Oncology, we are at the forefront of a new era in cancer care. Our industry-leading portfolio and extensive pipeline includes three core mechanisms of action to attack cancer from multiple angles, including small molecules, antibody-drug conjugates (ADCs), and bispecific antibodies, including other immune-oncology biologics. We are focused on delivering transformative therapies in some of the world's most common cancers, including breast cancer, genitourinary cancer, hematology-oncology, and thoracic cancers, which includes lung cancer. Driven by science, we are committed to accelerating breakthroughs to help people with cancer live better and longer lives. About Pfizer: Breakthroughs That Change Patients' LivesAt Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at In addition, to learn more, please visit us on and follow us on X at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Arvinas Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties, including statements regarding: vepdegestrant having the potential to provide clinically meaningful outcomes for thousands of patients with metastatic breast cancer whose tumors harbor estrogen receptor 1 mutations; Arvinas' and Pfizer's plans to share data from the Phase 3 VERITAC-2 clinical trial with health authorities, including to potentially support regulatory filings, as well as at a medical conference in 2025; and vepdegestrant's development as a potential monotherapy and as part of combination therapy across multiple treatment settings for estrogen receptor positive, human epidermal growth factor receptor 2 negative metastatic breast cancer. All statements, other than statements of historical fact, contained in this press release, including statements regarding Arvinas' strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words 'anticipate,' 'believe,' 'estimate,' 'expect,' 'intend,' 'may,' 'plan,' 'target,' 'goal,' 'potential,' 'will,' 'would,' 'could,' 'should,' 'look forward,' 'continue,' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Arvinas may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on such forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements Arvinas makes as a result of various risks and uncertainties, including but not limited to: whether Arvinas and Pfizer will successfully perform their respective obligations under the collaboration between Arvinas and Pfizer; whether Arvinas and Pfizer will be able to successfully conduct and complete clinical development for vepdegestrant as a monotherapy and as part of combination therapy; whether Arvinas will be able to successfully conduct and complete development for its other product candidates, including ARV-393 and ARV-102; whether Arvinas and Pfizer, as appropriate, will be able to obtain marketing approval for and commercialize vepdegestrant and other product candidates on current timelines or at all; Arvinas' ability to protect its intellectual property portfolio; Arvinas' reliance on third parties; whether Arvinas will be able to raise capital when needed; whether Arvinas' cash and cash equivalent resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; and other important factors discussed in the 'Risk Factors' section of Arvinas' Annual Report on Form 10-K for the year ended December 31, 2024 and subsequent other reports on file with the U.S. Securities and Exchange Commission. The forward-looking statements contained in this press release reflect Arvinas' current views with respect to future events, and Arvinas assumes no obligation to update any forward-looking statements, except as required by applicable law. These forward-looking statements should not be relied upon as representing Arvinas' views as of any date subsequent to the date of this release. Pfizer Disclosure Notice:The information contained in this release is as of March 11, 2025. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about Pfizer Oncology and vepdegestrant, including its potential benefits, vepdegestrant's potential for adults with ER+/HER2- advanced or metastatic breast cancer whose disease progressed following prior treatment with CDK 4/6 inhibitors and endocrine-based therapy and plans to share these data with global regulatory authorities to potentially support regulatory filings, that involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; whether the VERITAC-2 trial will meet the secondary endpoint for overall survival; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when drug applications may be filed in any jurisdictions for any potential indication for vepdegestrant; whether and when any such applications that may be filed for vepdegestrant may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy, and, if approved, whether vepdegestrant will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of vepdegestrant; whether the collaboration between Pfizer and Arvinas will be successful; uncertainties regarding the impact of COVID-19 on our business, operations and financial results; and competitive developments. A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned 'Risk Factors' and 'Forward-Looking Information and Factors That May Affect Future Results', as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at and 1 World Health Organization. (2024, March 13). Breast cancer. World Health Organization. 2 Siegel RL, Kratzer TB, Giaquinto AN, Sung H, Jemal A. Cancer statistics, 2025. CA Cancer J Clin. 2025 Jan-Feb;75(1):10-45. doi: 10.3322/caac.21871. Epub 2025 Jan 16. PMID: 39817679; PMCID: PMC11745215.3 Surveillance, Epidemiology, and End Results Program Data, Redig AJ, McAllister SS. Breast cancer as a systemic disease: a view of metastasis. J Intern Med. 2013;274(2):113-126. doi:10.1111/joim.12084.5 Bidard F-C, et al. Elacestrant (oral selective estrogen receptor degrader) Versus Standard Endocrine Therapy for Estrogen Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Advanced Breast Cancer: Results From the Randomized Phase III EMERALD Trial. Journal of Clinical Onoclogy. 2022 May Kalinsky, K. Abemaciclib Plus Fulvestrant in Advanced Breast Cancer After Progression on CDK4/6 Inhibition: Results From the Phase III postMONARCH Trial. Journal of Clinical Oncology. 2024 Dec. Tolaney, S. et al. AMEERA-3: Randomized Phase II Study of Amcenestrant (Oral Selective Estrogen Receptor Degrader) Versus Standard Endocrine Monotherapy in Estrogen Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Advanced Breast Cancer. Journal of Clinical Oncology. Media Contact: +1 (212) 733-1225 PfizerMediaRelations@ InvestorContact: +1 (212) 733-4848 IR@ Arvinas MediaContact: Kirsten Owens+1 (203) 586-0307 Arvinas InvestorContact: Jeff Boyle+1 (347) 247-5089 Sign in to access your portfolio
