Targeted protein degradation
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FDA Accepts Bristol Myers Squibb (BMY) NDA for Iberdomide With Priority Review
Yahoo Finance· 2026-02-24 07:11
Bristol-Myers Squibb Company (NYSE:BMY) is one of the best value stocks to buy now. On February 17, Bristol Myers Squibb announced that the FDA accepted its NDA for iberdomide, which is an investigational treatment for patients with relapsed or refractory multiple myeloma/RRMM. If approved, iberdomide would become the first in a new class of oral medicines known as cereblon E3 ligase modulator agents. The FDA granted the application Priority Review and Breakthrough Therapy Designation, setting a target act ...
C4 Therapeutics Announces First Patient Dosed in Phase 2 MOMENTUM Trial of Cemsidomide, an Oral IKZF1/3 Degrader, in Combination with Dexamethasone for Relapsed/Refractory Multiple Myeloma
Globenewswire· 2026-02-23 12:00
Enrollment for Phase 2 MOMENTUM Trial Expected to Be Completed in Q1 2027 Phase 1b Trial of Cemsidomide in Combination with Elranatamab on Track to Initiate in Q2 2026 WATERTOWN, Mass., Feb. 23, 2026 (GLOBE NEWSWIRE) -- C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, today announced that the first patient has been dosed in the Phase 2 MOMENTUM trial evaluating cemsidomide in combination with dexamethasone fo ...
Arvinas to Report Fourth Quarter and Full Year 2025 Financial Results on February 24, 2026
Globenewswire· 2026-02-17 12:00
NEW HAVEN, Conn., Feb. 17, 2026 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today announced that management will review fourth quarter and full year 2025 financial results and provide a corporate update during a live webcast on Tuesday, February 24, 2026 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 webc ...
Arvinas Announces Appointment of Randy Teel, Ph.D., as President, Chief Executive Officer, and Director
Globenewswire· 2026-02-12 12:00
Core Viewpoint - The appointment of Randy Teel, Ph.D., as President and CEO of Arvinas is expected to drive the company's strategy and innovation, positioning it for continued growth and momentum in the biotechnology sector [1][3]. Leadership Transition - Randy Teel succeeds John Houston, Ph.D., who is retiring but will remain on the Board and provide consulting services [2]. - Briggs Morrison, M.D., has been elected as the new Chair of the Arvinas Board of Directors [2]. Executive Background - Dr. Teel has been with Arvinas since 2018 and has over 20 years of experience in the biopharmaceutical industry, playing a key role in the company's IPO and strategic initiatives [3]. - His previous roles include Chief Business Officer and interim Chief Financial Officer, with experience at Alexion Pharmaceuticals and McKinsey & Company [3]. Strategic Focus - Dr. Teel aims to build on the existing momentum and focus on earlier stage clinical programs that have the potential to transform treatment paradigms for serious diseases [4]. - Under Dr. Houston's leadership, Arvinas achieved significant milestones, including the first positive pivotal results for a PROTAC degrader and raising over $2 billion through various funding avenues [4]. Pipeline and Future Goals - The company is advancing multiple investigational drugs, including ARV-102 for neurodegenerative disorders, ARV-393 for non-Hodgkin Lymphoma, and ARV-806 for mutated cancers [6]. - Anticipated critical milestones later this year include important clinical data from several drug candidates [5].
Ascentage Pharma Announces IND Clearance by the China CDE for BTK Degrader APG-3288
Globenewswire· 2026-02-05 23:30
Core Viewpoint - Ascentage Pharma has received investigational new drug (IND) application clearance for its novel BTK-targeted protein degrader, APG-3288, from the China Center for Drug Evaluation (CDE), following similar clearance from the U.S. FDA, marking a significant milestone in its clinical development for patients with relapsed/refractory hematologic malignancies [1][6]. Group 1: Drug Development and Clinical Trials - APG-3288 is set to enter a multicenter, open-label Phase I study to evaluate its safety, tolerability, pharmacokinetic profile, and preliminary efficacy in patients with relapsed/refractory hematologic malignancies [2]. - The IND clearance for APG-3288 enhances Ascentage Pharma's pipeline in hematologic malignancies, complementing existing products like Olverembatinib and Lisaftoclax, which have already been approved in China [5]. Group 2: Mechanism of Action and Innovation - APG-3288 utilizes Ascentage Pharma's proprietary PROTAC technology to induce the degradation of BTK, overcoming resistance associated with conventional BTK inhibitors by blocking the BCR-BTK signaling axis at its source [4]. - The drug is designed to provide a novel therapeutic strategy by inducing rapid and sustained degradation of both wild-type BTK and multiple BTK mutants, addressing the urgent clinical need for new treatment options in B-cell malignancies [3][4]. Group 3: Company Background and Strategy - Ascentage Pharma is a global biopharmaceutical company focused on developing innovative therapies for cancer, with a strong presence in hematologic malignancies and a diverse pipeline of drug candidates [8]. - The company has established partnerships with leading biotechnology and pharmaceutical firms, enhancing its research and development capabilities and expanding its global reach [11].
Ascentage Pharma Announces IND Clearance by the China CDE for BTK Degrader APG-3288
Globenewswire· 2026-02-05 23:30
Core Viewpoint - Ascentage Pharma has received investigational new drug (IND) application clearance for its novel BTK-targeted protein degrader, APG-3288, from both the U.S. FDA and the China CDE, marking a significant milestone in its clinical development for treating relapsed/refractory hematologic malignancies [1][6]. Group 1: Drug Development and Clinical Trials - APG-3288 is set to enter a multicenter, open-label Phase I study to evaluate its safety, tolerability, pharmacokinetic profile, and preliminary efficacy in patients with relapsed/refractory hematologic malignancies [2]. - The IND clearance from the China CDE follows the earlier approval from the U.S. FDA, indicating strong global development capabilities in targeted protein degradation [1][6]. Group 2: Mechanism of Action and Clinical Need - APG-3288 is a highly potent and selective BTK degrader developed using Ascentage Pharma's proprietary PROTAC technology, designed to induce degradation of both wild-type BTK and multiple BTK mutants associated with resistance to existing BTK inhibitors [4]. - There is a significant clinical need for new drugs with novel mechanisms of action due to the limitations of current BTK inhibitors, which often face issues of acquired resistance [3][4]. Group 3: Company Background and Pipeline - Ascentage Pharma has established a strong presence in the field of hematologic malignancies, with a portfolio that includes approved products like Olverembatinib and Lisaftoclax, enhancing its pipeline in this area [5][9]. - The company is focused on developing innovative therapies to address unmet medical needs in cancer, leveraging its robust R&D capabilities and global partnerships with leading biotechnology and pharmaceutical companies [8][11].
Kazia Therapeutics Announces Compelling Preclinical and Translational Data for Nuclear PD-L1 Degrader (NDL2)
Prnewswire· 2026-01-30 13:00
Core Insights - Kazia Therapeutics has announced preclinical and translational data supporting NDL2, a first-in-class protein degrader targeting nuclear PD-L1, which is linked to immunotherapy resistance and metastatic progression [1][3][11] Group 1: Mechanism and Efficacy - NDL2 targets a newly discovered intracellular PD-L1 species that drives immune evasion and resistance to checkpoint inhibitors, differentiating itself from existing PD-1/PD-L1 antibodies [3][5] - In preclinical models of triple-negative breast cancer (TNBC), NDL2 reduced primary tumor volume by 49% as a monotherapy and by 73% in combination with anti-PD-1 therapy, with a 50% reduction in lung metastases in the combination setting [4][9] - NDL2 treatment led to a shift towards a less aggressive tumor state and enhanced anti-tumor immune response, including increased CD8+ T-cell infiltration and reduced markers of T-cell exhaustion [8][9] Group 2: Clinical Development and Strategic Positioning - Kazia plans to initiate first-in-human clinical trials for NDL2 in 2027, focusing on immunotherapy-refractory solid tumors where PD-L1 biology and resistance are well established [13][14] - The company is advancing IND-enabling studies and will present data at an oncology-focused scientific meeting in the second quarter of 2026 [14][15] - The strategic focus on protein degradation aligns with industry trends, as large pharmaceutical companies are increasingly investing in degrader technologies to tackle therapeutic resistance [10][16] Group 3: Translational Evidence and Biomarkers - Research indicates that nuclear PD-L1 is enriched in resistant and metastatic tumors, including TNBC, melanoma, non-small cell lung cancer (NSCLC), and colorectal cancer [6][7] - Longitudinal liquid biopsy analysis showed that reductions in nuclear PD-L1 could serve as an early predictive biomarker of treatment benefit [7]
Nurix Therapeutics Reports Fourth Quarter and Fiscal Year 2025 Financial Results and Provides a Corporate Update
Globenewswire· 2026-01-28 21:01
Core Insights - Nurix Therapeutics has initiated the DAYBreak™ registrational program for bexobrutideg in relapsed/refractory chronic lymphocytic leukemia (CLL), supported by promising Phase 1 clinical data showing an 83% objective overall response rate and a median progression-free survival of 22.1 months [1][4][5] - The company reported financial results for the fiscal quarter ending November 30, 2025, highlighting a revenue increase to $84 million for the year, primarily due to $30 million in license revenue from Sanofi [2][19] - Nurix has a strong cash position with $592.9 million in cash and marketable securities, enabling continued investment in clinical programs and pipeline expansion [1][23] Clinical Development - Bexobrutideg demonstrated durable therapeutic effects in heavily pretreated CLL patients, achieving a median duration of response of 20.1 months across all doses tested [4] - The ongoing Phase 1b cohort showed higher response rates and a favorable trend toward longer progression-free survival at the 600 mg dose, which has been selected as the recommended Phase 2 dose [4][5] - Encouraging Phase 1 data for bexobrutideg in Waldenström macroglobulinemia (WM) showed a 75% objective response rate, reinforcing its potential as a therapeutic option across BTK-driven B-cell malignancies [6][7] Financial Performance - Revenue for the fiscal year ended November 30, 2025, was $84 million, up from $54.5 million in the previous year, driven by collaboration milestones and license revenue [19] - Research and development expenses increased to $316.9 million for the year, reflecting accelerated clinical trial activities [20] - The net loss for the year was $264.5 million, compared to $193.6 million in the previous year, with a net loss per share of $3.05 [23] Strategic Collaborations - Nurix is advancing its IRAK4 degrader program (GS-6791) in collaboration with Gilead, with promising preclinical data supporting its potential in autoimmune and inflammatory diseases [9] - The company continues to strengthen its collaborations with Sanofi and Pfizer, focusing on the development of targeted protein degradation medicines [21] Upcoming Initiatives - Nurix plans to initiate a global randomized confirmatory Phase 3 trial in the first half of 2026 to support full approval of bexobrutideg [14] - The company is also enrolling patients in a Phase 1b cohort for bexobrutideg in autoimmune hemolytic anemia, aiming to expand its therapeutic applications [15]
New nanoparticle technology offers hope for hard-to-treat diseases
Globenewswire· 2026-01-22 04:12
Core Insights - The article discusses a groundbreaking nanoparticle technology developed to eliminate harmful proteins linked to diseases like dementia and brain cancer, representing a significant advancement in targeting "undruggable" proteins [2][4]. Research and Development - The research is led by Professor Bingyang Shi from the University of Technology Sydney, in collaboration with international experts from Columbia University and Henan University [3]. - The technology involves engineered nanoparticles called nanoparticle-mediated targeting chimeras (NPTACs), which can be customized to bind and degrade specific disease-related proteins [4][5]. Market Potential - Targeted protein degradation is a rapidly growing sector in biotechnology, with significant commercial prospects, as evidenced by industry leaders like Arvinas raising over $1 billion and forming multi-billion-dollar partnerships with major pharmaceutical companies [6]. - The targeted protein degradation market is projected to exceed $10 billion by 2030, indicating a robust opportunity for innovative therapies [10]. Technological Advantages - The new technology allows for the degradation of both intra- and extracellular proteins, with specific targeting capabilities across the blood-brain barrier [8]. - It features plug-and-play modularity for rapid adaptation to various protein targets and is scalable and clinically translatable, utilizing FDA-approved nanomaterials [8]. - NPTACs have shown promising preclinical results against critical disease targets such as EGFR and PD-L1, which are significant in cancer treatment [9]. Strategic Development - The company is actively seeking strategic industry partners to expedite clinical development and prepare for regulatory approval across therapeutic fields [11].
Nurix Therapeutics (NasdaqGM:NRIX) FY Earnings Call Presentation
2026-01-13 00:30
Bexobrutideg Clinical Trial and Data - Bexobrutideg achieved an 83% objective response rate (ORR) in relapsed/refractory CLL patients in Phase 1a trials[8, 26, 32, 40] - The median progression-free survival (PFS) for Bexobrutideg was 22.1 months across all doses tested in the Phase 1a study[8, 26, 32, 40] - In a Phase 1b randomized cohort, the 600 mg dose of Bexobrutideg showed an 83.3% objective response rate[37, 38] - Nurix initiated the pivotal DAYBreak-201 Phase 2 study to support accelerated approval of bexobrutideg in relapsed/refractory CLL[8, 43] - A confirmatory Phase 3 trial is planned to start in 2026 to position Bexobrutideg for full approval[58] Pipeline and Partnerships - Nurix has a strengthened financial position with $663.8 million in pro forma cash/investments[8] - Nurix earned $47 million in non-dilutive capital through discovery partnerships[8] - The IRAK4 degrader is in an ongoing Phase 1 SAD/MAD study with partner Gilead[8, 9] - The STAT6 degrader advanced to IND-enabling studies with partner Sanofi[8, 9] Bexobrutideg Mechanism and Advantages - Bexobrutideg is a BTK degrader that removes both BTK enzymatic activity and scaffolding functions, unlike BTK inhibitors[10, 12] - Bexobrutideg demonstrates superior mutational coverage compared to BTK inhibitors[19, 20] - Bexobrutideg is the only BTK degrader to demonstrate clinical activity in patients with CNS disease, including complete responses[22] Market and Strategy - The current BTK inhibitor market is annualizing at $12.5 billion, with approximately $9.5 billion in CLL[55] - Nurix has a clinical development plan addressing large segments of the CLL market as both a mono- and combo- therapy[54]