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 ...
Kymera Stock Up 130% as $135 Million Buy Boosts Immunology Bet
Yahoo Finance· 2026-02-23 18:57
Baker Bros. Advisors reported a buy of 2,005,813 Kymera Therapeutics (NASDAQ:KYMR) shares in its February 17, 2026, SEC filing, an estimated $135.45 million trade based on quarterly average pricing. What happened According to a February 17, 2026 SEC filing, Baker Bros. increased its holding in Kymera Therapeutics (NASDAQ:KYMR) by 2,005,813 shares. The estimated trade value was $135.45 million, based on the average closing price during the fourth quarter of 2025. The fund’s quarter-end position value in K ...
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
Core Insights - C4 Therapeutics has initiated the Phase 2 MOMENTUM trial for cemsidomide in combination with dexamethasone, targeting relapsed/refractory multiple myeloma patients, with enrollment expected to complete by Q1 2027 [1][7] - The Phase 1b trial of cemsidomide in combination with elranatamab is set to begin in Q2 2026, supporting a regulatory strategy for accelerated approvals in multiple myeloma [2][3] Company Overview - C4 Therapeutics is a clinical-stage biopharmaceutical company focused on targeted protein degradation science, aiming to develop innovative therapies for difficult-to-treat diseases [10] - The company's lead candidate, cemsidomide, is an investigational oral IKZF1/3 degrader, showing promising safety and efficacy profiles in prior trials [4][10] Trial Details - The Phase 2 MOMENTUM trial is an open-label, single-arm study enrolling approximately 100 patients, evaluating cemsidomide at a dose of 100 µg, administered in a 14 days on and 14 days off schedule [2][5] - The primary endpoint of the trial is the overall response rate as per International Myeloma Working Group criteria, assessed by an independent review committee [5][9] Upcoming Milestones - Further analysis of the completed Phase 1 trial of cemsidomide in combination with dexamethasone is anticipated in mid-2026 [7] - The Phase 1b trial of cemsidomide with elranatamab will explore safety and preliminary efficacy, contributing to the broader development strategy for cemsidomide [6][3] Industry Context - Multiple myeloma is a rare blood cancer with approximately 36,000 new diagnoses annually in the U.S., highlighting the need for new therapeutic options as most patients eventually relapse [9] - IKZF1/3 degraders are foundational therapies in multiple myeloma treatment, and cemsidomide aims to enhance treatment efficacy and patient outcomes [9]
Arvinas to Report Fourth Quarter and Full Year 2025 Financial Results on February 24, 2026
Globenewswire· 2026-02-17 12:00
Core Viewpoint - Arvinas, Inc. is set to review its fourth quarter and full year 2025 financial results and provide a corporate update on February 24, 2026, at 8:00 a.m. ET [1] Company Overview - Arvinas, Inc. is a clinical-stage biotechnology company focused on developing a new class of drugs based on targeted protein degradation [3] - The company utilizes its PROTAC (PROteolysis TArgeting Chimera) platform to create therapies that degrade disease-causing proteins by leveraging the body's natural protein disposal system [3] - Arvinas is advancing multiple investigational drugs through clinical development, including: - ARV-102, targeting LRRK2 for neurodegenerative disorders - ARV-806, targeting KRAS G12D for mutated cancers, including pancreatic and colorectal cancers - ARV-393, targeting BCL6 for relapsed/refractory non-Hodgkin Lymphoma - Vepdegestrant, targeting the estrogen receptor for patients with locally advanced or metastatic ER+/HER2- breast cancer [3]
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].