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Medscape
2 days ago
- Business
- Medscape
Which Class of ER Degrader Is Better?
Vepdegestrant, an investigational estrogen receptor (ER) degrader, known as a proteolysis-targeting chimera (PROTAC ), outshone the commonly used selective estrogen receptor degrader (SERD) fulvestrant in a phase 3 trial of second-line treatment for a subset of patients with breast cancer. The VERITAC-2 trial included patients with ER-positive/human epidermal growth factor receptor 2-negative (ER+/HER2-), locally advanced or metastatic disease who had failed prior treatment with cyclin-dependent kinase 4/6 (CDK 4/6) inhibitors and endocrine therapy, and no exposure to chemotherapy in the advanced setting. Only a subset of the study cohort, those with estrogen receptor 1-mutant disease, experienced a statistically significant and clinically meaningful improvement in progression-free survival (PFS) when treated with vepdegestrant compared with patients treated with fulvestrant. 'These results support vepdegestrant as a potential monotherapy treatment option for patients with previously treated ESR1 -mutant ER+/HER2- advanced breast cancer,' said lead author Erika P. Hamilton, MD, a medical oncologist and director of Breast Cancer and Gynecologic Cancer Research at Sarah Cannon Research Institute, Nashville, Tennessee, during a press conference for the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The findings were simultaneously published in the New England Journal of Medicine . Vepdegestrant is not approved by the US Food and Drug Administration, but received fast-track status in February 2024 as monotherapy for this patient population. It is the first and only PROTAC ER degrader to be evaluated in a phase 3 clinical trial in breast cancer. PROTACs represent a novel class of therapeutic agents that harness the proteasome to selectively degrade target proteins. 'There's no established consensus for patients getting treatment in the second-line setting after progression on endocrine therapy and a CDK 4/6 inhibitor,' explained Hamilton. 'One of the mainstays of our treatment really has been fulvestrant, which clearly has some challenges. First, it's administered intramuscularly, and second, in a post-CDK 4/6 landscape, we know that progression-free survival is very short — on the order of less than 2 months.' Besides fulvestrant, the oral SERD elacestrant was FDA-approved in January 2023, and other oral SERDs are in development, she noted. Trial Design The new trial included 624 patients with advanced ER+/HER2- disease that had progressed following one or two lines of endocrine therapy and a CDK 4/6 inhibitor. 'They could not have received fulvestrant already or chemotherapy, and patients had to have benefited from their previous line of endocrine therapy for at least 6 months to enter the study,' Hamilton noted. Study participants were also stratified by the presence or absence of visceral disease, as well as the presence of an ESR1 mutation (n = 270). Such mutations are a common cause of acquired resistance found in approximately 40% of patients in the second-line setting, according to a press release from the drug developer. Patients were randomly assigned 1:1 to 28-day treatment cycles of either 200 mg oral vepdegestrant once daily, or 500 mg intramuscular fulvestrant on day 1 and day 15 of the first cycle, and then on day 1 of each subsequent cycle. The primary endpoint was PFS by blinded, independent central review, first in patients with ESR1 mutations and then in the entire cohort. Key secondary endpoints were overall survival, objective response rate, and clinical benefit rate, which was defined as the rate of confirmed clinical or partial response at any time, or stable disease, nonclinical response, or nonprogressive disease for at least 24 weeks. Vepdegestrant vs Fulvestrant The study met its key primary endpoint, showing a median PFS of 5.0 months with vepdegestrant compared with 2.1 months with fulvestrant (hazard ratio [HR] 0.57; P < .001) in the 270 patients with ESR1 mutations. At 6 months, twice as many patients in the vepdegestrant arm remained progression-free compared with those in the fulvestrant arm (45.2% vs 22.7%). However, this primary endpoint was not significantly different between groups when calculated for the entire patient population (HR, 0.83; P = .07). For the key secondary endpoints, among patients with ESR1 mutations, the clinical benefit rate was more than double in patients receiving vepdegestrant (42.1% vs 20.2%). Similarly, the objective response rate was more than four times higher (18.6% vs 4%) Commenting in a press release, ASCO breast cancer expert Jane Lowe Meisel, MD, said that although the trial found that vepdegestrant worked better than fulvestrant in patients with ESR1 mutations, 'on average, patients did not have prolonged responses on either agent, highlighting the need for combination therapies and continued development in this space.' Meisel is co-director of Breast Medical Oncology at the Winship Cancer Institute of Emory University School of Medicine in Atlanta, Georgia. 'Overall survival was very immature at the time of this analysis, with only 20% of the anticipated events occurring,' added lead investigator Hamilton. Treatment-emergent adverse events (TEAEs) led to discontinuation in 3% of patients taking vepdegestrant and 1% of patients taking fulvestrant. TEAEs leading to dose reductions occurred in 2% of the vepdegestrant group and none in the fulvestrant group. The three most common AEs of any grade were fatigue (27% in vepdegestrant group, 16% fulvestrant group) and increased aspartate aminotransferase and alanine aminotransferase levels of any grade (14% vepdegestrant group, 10% fulvestrant group). Oral SERDS vs Vepdegestrant Side Effects Compared to oral SERDs, vepdegestrant has a favorable side effect profile, Hamilton said. 'Oral SERDs have prominent GI side effects as their most frequent side effect.' But, across all grades, rates of both vomiting and diarrhea were only 6% with vepdegestrant. GI side effects tend to be more common, 'in the 30% or 40% range with oral SERDs,' she told Medscape Medical News . Study discussant William John Gradishar, MD, emphasized the importance of reducing side effects. ' Vepdegestrant now joins a growing list of drugs that perform better than current standard of care monotherapy' in the ESR1 -mutant population, he noted in the session. But the reality is that most of these drugs are being developed to be used in combination with targeted therapies, 'and increased toxicity can be expected with doublet therapy…Quality of life measures as experienced and reported by patients are critical, and even modest changes in symptom and functional domains should not be minimized,' said Gradishar, professor of breast oncology at Northwestern University Feinberg School of Medicine, Chicago, Illinois. 'Vepdegestrant has demonstrated compelling preclinical activity and encouraging early clinical data supporting its efficacy in degrading ER,' said Albert Grinshpun, MD, in an interview with Medscape Medical News . Grinshpun, head of the Breast Cancer Service at Shaare Zedek Medical Center and The Hebrew University, Jerusalem, Israel, said his initial takeaway from the study is that 'vepdegestrant now stands alongside other oral SERDs, such as elacestrant and imlunestrant, in demonstrating superiority over fulvestrant, specifically in the context of ESR1 -mutant [disease].' 'Importantly, the treatment landscape for patients progressing on CDK 4/6 inhibitors is rapidly evolving, with a growing shift toward combination therapies rather than fulvestrant monotherapy,' he said. 'In my view, vepdegestrant has established itself as a promising endocrine backbone for future combination strategies. Its favorable toxicity profile makes it particularly well-suited for pairing with a range of targeted agents or even antibody-drug conjugates, including inhibitors of PIK3CA and KAT6 , in the pursuit of more effective therapeutic regimens.' The study was jointly funded by Arvinas Estrogen Receptor, Inc. and Pfizer. Hamilton disclosed consulting or advisory roles with Accutar Biotechnology (Inst), Arvinas (Inst), AstraZeneca (Inst), Circle Pharma (Inst), Daiichi Sankyo (Inst), Ellipses Pharma (Inst), Entos (Inst), Fosun Pharma (Inst), Genentech/Roche (Inst), Gilead Sciences (Inst), Janssen (Inst), Jazz Pharmaceuticals (Inst), Jefferies (Inst), Johnson & Johnson (Inst), Lilly (Inst), Medical Pharma Services (Inst), Mersana (Inst), Novartis (Inst), Olema Pharmaceuticals (Inst), Pfizer (Inst), Stemline Therapeutics (Inst), Tempus (Inst), Theratechnologies (Inst), Tubulis GmbH (Inst), Verascity Science (Inst), and Zentalis (Inst). Hamilton has also received research funding from AbbVie (Inst), Accutar Biotech (Inst), Acerta Pharma (Inst), ADC Therapeutics (Inst), Akeso Biopharma (Inst), Amgen (Inst), Aravive (Inst), ArQule (Inst), Artios (Inst), Arvinas (Inst), AstraZeneca (Inst), AtlasMedx (Inst), BeiGene (Inst), Black Diamond Therapeutics (Inst), Bliss Biopharmaceutical (Inst), Boehringer Ingelheim (Inst), Bristol-Myers Squibb (Inst), Cascadian Therapeutics (Inst), Clovis Oncology (Inst), Compugen (Inst), Context Therapeutics (Inst), Cullinan Oncology (Inst), Curis (Inst), CytomX Therapeutics (Inst), Daiichi Sankyo (Inst), Dana-Farber Cancer Institute (Inst), Dantari (Inst), Deciphera (Inst), Duality Biologics (Inst), eFFECTOR Therapeutics (Inst), Eisai (Inst), Ellipses Pharma (Inst), Elucida Oncology (Inst), EMD Serono (Inst), Fochon Pharmaceuticals (Inst), Fujifilm (Inst), G1 Therapeutics (Inst), Genentech/Roche (Inst), Gilead Sciences (Inst), H3 Biomedicine (Inst), Harpoon (Inst), Hutchison MediPharma (Inst), Immunogen (Inst), Immunomedics (Inst), Incyte (Inst), Infinity Pharmaceuticals (Inst), Inspirna (Inst), InventisBio (Inst), Jacobio (Inst), K-Group Beta (Inst), Karyopharm Therapeutics (Inst), Kind Pharmaceuticals (Inst), Leap Therapeutics (Inst), Lilly (Inst), Loxo (Inst), Lycera (Inst), MabSpace Biosciences (Inst), Macrogenics (Inst), MedImmune (Inst), Mersana (Inst), Merus (Inst), Millennium (Inst), Molecular Templates (Inst), Myriad Genetics (Inst), Novartis (Inst), Nucana (Inst), Olema Pharmaceuticals (Inst), OncoMed (Inst), Oncothyreon (Inst), ORIC Pharmaceuticals (Inst), Orinove (Inst), Orum Therapeutics (Inst), Pfizer (Inst), PharmaMar (Inst), Pieris Pharmaceuticals (Inst), Pionyr (Inst), Plexxikon (Inst), Prelude Therapeutics (Inst), ProfoundBio (Inst), Radius Health (Inst), Regeneron (Inst), Relay Therapeutics (Inst), Repertoire Immune Medicines (Inst), Rgenix (Inst), Seagen (Inst), Sermonix Pharmaceuticals (Inst), Shattuck Labs (Inst), Silverback Therapeutics (Inst), Stem CentRx (Inst), Stemline Therapeutics (Inst), Sutro Biopharma (Inst), Syndax (Inst), Syros Pharmaceuticals (Inst), Taiho Pharmaceutical (Inst), TapImmune Inc. (Inst), Tesaro (Inst), Tolmar (Inst), Torque (Inst), Treadwell Therapeutics (Inst), Verastem (Inst), Zenith Epigenetics (Inst), and Zymeworks (Inst). Meisel disclosed consulting or advisory roles with AstraZeneca, GE Healthcare, Genentech, Novartis, Olema Oncology, Pfizer, SeaGen, Sermonix Pharmaceuticals, and Stemline, and research funding from AstraZeneca (Inst), Olema Oncology (Inst), Pfizer (Inst), Seagen (Inst), and Sermonix Pharmaceuticals (Inst). Grinshpun disclosed honoraria from GSK, Lilly, Novartis, and AstraZeneca, and travel from Roche, Pfizer, and AstraZeneca. Gradishar disclosed consulting or advisory roles with AstraZeneca , Genentech/Roche, Gilead Sciences, Merck, Novartis, Pfizer.
Business Wire
6 days ago
- Business
- Business Wire
Sarah Cannon Research Institute Announces Strategic Alliance With AbbVie to Advance Novel Cancer Therapies
NASHVILLE, Tenn.--(BUSINESS WIRE)--Today, Sarah Cannon Research Institute (SCRI), one of the world's leading oncology research organizations conducting community-based clinical trials, announced a strategic alliance with AbbVie. The alliance aims to accelerate the development of innovative therapies for patients with cancer through collaborative scientific engagement and operational synergies to enhance the delivery of clinical trials. "By combining SCRI's scientific and operational expertise in conducting clinical trials in the community with AbbVie's innovative drug development approach, we can further strengthen our mission to advance novel therapies for patients," said Dee Anna Smith, Chief Executive Officer, SCRI. "Working together, we can expedite the development of more treatment options and transform clinical trial delivery, providing greater access to cutting-edge therapies for patients close to home.' SCRI's research network brings together more than 1,300 physicians who are enrolling patients to clinical trials at over 200 locations in more than 20 states across the U.S. Through the alliance, SCRI and AbbVie will enhance scientific connectivity, enabling collaboration with SCRI's physician leadership and contract research organization, SCRI Development Innovations, to drive clinical development. 'We are encouraged about the opportunity to establish a strategic scientific alliance with SCRI as we work together on initiatives aimed to address high unmet needs for patients battling cancer," said Svetlana Kobina, MD., PhD., Vice President of AbbVie Oncology, Global Medical Affairs. "Through close collaboration with SCRI and its community sites, we hope to gain a more comprehensive understanding of the treatment paths and health needs of patients living with cancer to provide tailored, patient-centered scientific solutions. This partnership enables us to delve deeper into the challenges faced by medical oncologists, hematologists, patients and caregivers to help us design clinical studies that more accurately represent all patient communities.' The collaboration will leverage SCRI's advanced research operational capabilities through its Accelero model, which maximizes site contributions, optimizes site activation timelines, and synchronizes end-to-end clinical research management. The Accelero model utilizes SCRI's robust Personalized Medicine program, including centralized screening services to enable more seamless identification and enrollment of patients on studies. Additionally, through SCRI's streamlined data delivery solutions, SCRI can ensure timely access to data to inform drug development and optimize clinical trial delivery. About Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is one of the world's leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. It has conducted more than 850 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA in the past decade. SCRI's research network brings together more than 1,300 physicians who are enrolling patients to clinical trials at over 200 locations in more than 20 states across the U.S. Visit to learn more.
Yahoo
20-05-2025
- Business
- Yahoo
IQVIA and SCRI partner to enhance oncology trials
IQVIA has partnered with SCRI Development Innovations, the contract research organisation branch of the Sarah Cannon Research Institute (SCRI), aimed at transforming oncology clinical trials for biopharma collaborators worldwide. This partnership is said to improve trial processes, remove operational challenges, expedite data delivery, and enhance the availability of new therapies to individuals. It claims to use IQVIA's worldwide reach, trial management, and data integration capabilities. SCRI will contribute its community oncology knowledge and Accelero, an operational model that accelerates trial activation and improves recruitment at SCRI sites within the US. The model also claims to integrate information from electronic health records directly into electronic capture systems for clinical trials data collection within the US. This integration is expected to provide sponsors with a pathway to operationalise the treatment development for individuals. Sarah Cannon Research Institute CEO Dee Anna Smith said: 'We are enthusiastic about the impact we can make in transforming clinical trial delivery through our collaboration with IQVIA. 'Through our accelerated operations model, Accelero, SCRI can alleviate the operational burden on research sites, enhance enrolment, and expedite data delivery through our cutting-edge technology solutions.' IQVIA is a clinical research service and healthcare intelligence provider, and says that its solution portfolio is powered by IQVIA Connected Intelligence. SCRI is an oncology research organisation conducting community-based trials. IQVIA research and development solutions president Richard Staub said: 'This collaboration embodies our commitment to innovation, efficiency, and delivering superior outcomes for patients by bringing together the best of both organisations and eliminating the complexities often associated with multiple vendors.' Last June, IQVIA introduced a new trial technology platform, One Home for Sites. This platform simplifies clinical trial management by providing a single sign-on and dashboard for various tasks and systems. "IQVIA and SCRI partner to enhance oncology trials" 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. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
27-04-2025
- Business
- Yahoo
Senti Bio Participates in a Virtual Investor KOL Connect Segment
Moderated discussion with Stephen Strickland, MD, MSCI, internationally respected leukemia researcher, Director of Leukemia Research for Sarah Cannon Research Institute and Kanya Rajangam, MD, PhD, President, Head of R&D and Chief Medical Officer of Senti Bio KOL Connect segment now available here SOUTH SAN FRANCISCO, Calif., April 21, 2025 (GLOBE NEWSWIRE) -- Senti Biosciences, Inc. (Nasdaq: SNTI) ('Senti Bio' or the 'Company'), a clinical-stage biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, today announced the release of a Virtual Investor KOL segment featuring Stephen Strickland, MD, MSCI, leukemia researcher, Director of Leukemia Research for Sarah Cannon Research Institute (SCRI). As part of the segment, Kanya Rajangam, MD, PhD, President, Head of R&D and Chief Medical Officer of Senti Bio and Dr. Strickland discussed acute myeloid leukemia (AML), the current treatment landscape and areas of unmet need, highlighting Senti Bio's lead program, SENTI-202, and the clinical and preclinical data released by Senti to date. The Virtual Investor KOL Segment featuring Senti Bio is now available here. About Senti BioSenti Bio is a clinical-stage biotechnology company developing a new generation of cell and gene therapies for patients living with incurable diseases. To achieve this, Senti Bio is leveraging a synthetic biology platform called Gene Circuits to create therapies with enhanced precision and control. These Gene Circuits are designed to precisely kill cancer cells, spare healthy cells, increase specificity to target cells and control the expression of drugs even after administration. Senti Bio's wholly-owned pipeline includes off-the-shelf CAR-NK cells, outfitted with Gene Circuits, to target challenging liquid and solid tumor indications. Senti Bio's lead program SENTI-202, a Logic Gated CD33 and/or FLT3-targeting hematologic cancer therapeutic candidate, is currently enrolling patients in a Phase I clinical trial. Senti Bio has also preclinically demonstrated that its Gene Circuits can function in T cells, for example Logic Gates that enable selective targeting of solid tumors. Additionally, Senti Bio has preclinically demonstrated the potential breadth of Gene Circuits in other cell and gene therapy modalities, diseases outside of oncology, and continues to advance these capabilities through StatementsThis press release contains certain statements that are not historical facts and are considered forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements generally are identified by the words 'believe,' 'could,' 'predict,' 'continue,' 'ongoing,' 'project,' 'expect,' 'anticipate,' 'estimate,' 'intend,' 'strategy,' 'future,' 'opportunity,' 'plan,' 'may,' 'should,' 'will,' 'would,' 'will be,' 'will continue,' 'will likely result,' 'forecast,' 'seek,' 'target' and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Forward-looking statements are predictions, projections, and other statements about future events that are based on current expectations of Senti Bio's management and assumptions, whether or not identified in this document, and, as a result, are subject to risks and uncertainties. Forward-looking statements include, but are not limited to, statements regarding future events, including the success of our future clinical development and ability to create shareholder value. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on by any investor as, a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Senti Bio. Many factors could cause actual future results to differ materially from the forward-looking statements in this document, including but not limited to: (i) changes in domestic and foreign business, market, financial, political and legal conditions, (ii) changes in the competitive and highly regulated industries in which Senti Bio operates, variations in operating performance across competitors, changes in laws and regulations affecting Senti Bio's business, (iii) the ability to implement business plans, forecasts and other expectations, (iv) the risk of downturns and a changing regulatory landscape in Senti Bio's highly competitive industry, (v) risks relating to the uncertainty of any projected financial information with respect to Senti Bio, (vi) risks related to uncertainty in the timing or results of Senti Bio's clinical trial initiation and the progress of clinical trials, patient enrollment, and GMP manufacturing activities, (vii) Senti Bio's dependence on fourth parties in connection with clinical trial startup, clinical studies, and GMP manufacturing activities, (viii) risks related to delays and other impacts from macroeconomic and geopolitical events, increasing rates of inflation and rising interest rates on business operations, (ix) risks related to the timing and utilization of Senti Bio's grant from CIRM and net proceeds of the PIPE financing, and (x) the success of any future research and development efforts by Senti Bio. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the 'Risk Factors' section of Senti Bio's most recent Quarterly Report on Form 10-Q, filed with the U.S. Securities and Exchange Commission ('SEC'), and other documents filed by Senti Bio from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements in this document. There may be additional risks that Senti Bio does not presently know, or that Senti Bio currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements in this document. Forward-looking statements speak only as of the date they are made. Senti Bio anticipates that subsequent events and developments may cause Senti Bio's assessments to change. Except as required by law, Senti Bio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events, or otherwise. Investor Contact:JTC Team, LLCJenene Thomas(908) 824-0775SNTI@ in to access your portfolio
