5 of 8 patients (62.5%) achieved Undetectable MRD (uMRD) LEXINGTON, Mass., Dec. 9, 2025 /PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 and FLT3 inhibitor, yesterday provided updated clinical data from the ongoing frontline Acute Myeloid Leukemia (AML) triplet study (CA-4948-104) in a poster presentation at the 67th ASH Annual Meeting (ASH). The AML triplet study is evaluating the addition of ...

Core Viewpoint - PDS Biotechnology Corporation has received a new patent in Japan for PDS0101, enhancing its intellectual property portfolio and providing market exclusivity for the product into the 2040s [2][4]. Group 1: Patent and Intellectual Property - The Japan Patent Office has issued Patent No. 7783866 for PDS0101, granting broad composition of matter and methods of use claims [2]. - This new patent expands previously granted patents in Japan and adds to the company's existing patents in the United States, China, Australia, and Hong Kong [2]. - The company has additional patent applications pending in several other countries, reinforcing its global intellectual property position [4][5]. Group 2: Market Context and Product Development - The incidence of HPV16-related cancers is rapidly increasing in the US and Europe, which highlights the potential market for PDS0101 [3]. - PDS0101 is currently being studied in a Phase 3 trial in combination with pembrolizumab for HPV16-positive recurrent/metastatic head and neck cancer [3][6]. - The company aims to advance broad intellectual property protections for PDS0101 and its other investigational agents in development [5].

Core Insights - Terns Pharmaceuticals presented updated data from the CARDINAL trial of TERN-701 for chronic myeloid leukemia (CML) patients, showing promising efficacy and safety results [1][3]. Efficacy Data - Among 38 efficacy-evaluable patients, the overall major molecular response (MMR) rate was 74% (28 out of 38) at 24 weeks, with 64% (18 out of 28) achieving MMR and 100% (10 out of 10) maintaining MMR [2][3]. - The deep molecular response (DMR) achievement rate was 29% by 24 weeks, with no patients losing MMR at the data cutoff [3][5]. - The reported MMR achievement rate of 64% is significantly higher than that of approved treatments like Scemblix and investigational agents, which reported rates of 24%-32% [8]. Safety Profile - The safety profile of TERN-701 was encouraging, with 87% (55 out of 63) of patients remaining on treatment as of the data cutoff [3]. - No dose-limiting toxicities were observed, and a maximum tolerated dose was not reached, indicating a favorable safety profile [3][4]. - The majority of treatment-emergent adverse events were low grade, with no apparent dose relationship [4]. Recommended Doses - The higher MMR achievement rate of 75% at doses of 320mg and above supports the selection of 320mg and 500mg QD as the recommended phase 2 doses for expansion [4][6]. Market Potential - Analysts believe TERN-701 has the potential to disrupt the CML treatment landscape, which has a global total addressable market (TAM) of approximately $5 billion [7]. - The consistency of efficacy data from the trial adds to the bullish sentiment among analysts regarding TERN-701's market prospects [9].

Core Insights - Lunai Bioworks has identified three clinically relevant subtypes of Parkinson's disease and prioritized drug targets, which may enhance proof-of-concept programs and facilitate strategic partnerships in a growing $13 billion market [1][6]. Company Overview - Lunai Bioworks is an AI-powered biotechnology company focused on developing precision therapeutics [1][7]. - The company utilizes its proprietary Augusta Platform to integrate large-scale proteomic data with clinical phenotyping to uncover subtypes of Parkinson's disease [2][6]. Research Findings - The analysis involved longitudinal clinical and proteomic data from over 650 participants, utilizing 4,500 proteomic probes over a median of 2.5 years, with some participants tracked for up to 5 years [3]. - Three patient subtypes linked to outcomes were identified, which can improve trial success rates and asset valuation [4][6]. - Progression-linked targets and biomarker candidates were identified to support patient stratification and treatment response assessment [5][6]. Market Potential - The current market for Parkinson's disease therapies is estimated at $6-8 billion, projected to exceed $13 billion by the 2030s due to rising prevalence and unmet medical needs [6][7]. Strategic Initiatives - The company is pursuing co-development and partnership opportunities with biopharmaceutical companies to enhance therapeutic development [6][8]. - By integrating molecular biology with clinical phenotyping, the company aims to identify precision targets that could transform Parkinson's therapy development [6][8].

OS Therapies Announces Successful pre-Marketing Authorisation Application Meeting with UK MHRA Regarding the Phase 2b Clinical Trial of OST-HER2 in the Prevention or Delay of Recurrent, Fully Resected, Pulmonary Metastatic OsteosarcomaDecember 09, 2025 7:40 AM EST | Source: OS TherapiesAlignment achieved on all key points surrounding non-clinical, CMC and post-market authorization confirmatory study designBiomarker data advanced as key pre-specified surrogate clinical efficacy endpoint, with p ...

Over 230 patients screened and over 160 patients enrolled in BriaCell’s pivotal Phase 3 study in metastatic breast cancer (MBC)Enrollment exceeding expectations with strong clinical site and patient interestTopline interim data readout expected in 1H2026 Phase 3 combination regimen continues under FDA Fast Track designation PHILADELPHIA and VANCOUVER, British Columbia, Dec. 09, 2025 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-st ...

Core Insights - BriaCell Therapeutics Corp. is advancing its Phase 3 clinical study for Bria-IMT in metastatic breast cancer, having screened over 230 patients and enrolled over 160, with topline data expected in the first half of 2026 [1][9]. Group 1: Clinical Study Details - The pivotal Phase 3 study evaluates Bria-IMT combined with an immune checkpoint inhibitor against physician's choice therapy in advanced metastatic breast cancer [2][4]. - An interim analysis will occur once 144 patient events (deaths) are recorded, focusing on overall survival as the primary endpoint [5][9]. - The study has received FDA Fast Track designation, which may expedite the approval process for Bria-IMT if positive results are obtained [5][9]. Group 2: Company Statements and Expectations - Dr. William V. Williams, President & CEO, highlighted the strong engagement from clinical sites and patient interest, indicating that enrollment has exceeded expectations [3][9]. - The company is committed to sharing Phase 3 data with the U.S. FDA in the coming months, aiming to provide hope to patients with metastatic breast cancer [3][9].

I have been sanguine on the prospects of the Daiichi Sankyo ( DSKYF ) ( DSNKY ) investment thesis, reiterating a "Buy" sentiment last September that has not returned gangbusters, in part due to setbacks in lungI have my PhD in biochemistry and have worked for years analyzing clinical trials and biotech companies. It is my passion to educate everyone possible on the science behind the businesses that we invest in, and it's my mission to help you do your due diligence and not get burned by the pitfalls of inv ...

Core Insights - The biotech industry is showing resilience, particularly due to investment in APAC markets and shifts in R&D priorities, with China emerging as a significant player [2][3] - A strong majority of biotech leaders (92%) are optimistic about reaching their next investment milestones, and 75% plan to increase R&D spending in the next two years [3] - Funding challenges persist, with 41% of organizations actively seeking additional R&D funding, a 27% increase since 2023 [3] Global Biotech Trends - The global biotech survey included 163 respondents and indicates that cell therapy has become the most prominent modality, comprising 40% of pipelines, followed by antibody drug conjugates (ADCs) at 31% [5] - Neurology (44%), cardiovascular (39%), and immune disorders (32%) are now the leading therapeutic focus areas, surpassing oncology [5] - The complexity of drug development is the biggest operational risk, with 73% of respondents ranking it among their top five concerns [6] Digital Transformation - Biotech companies are increasingly adopting digital technologies, with 76% of respondents believing that AI and other technologies will significantly accelerate R&D processes in the next two years [7] - AI-enabled asset selection in drug discovery is seen as a key factor to accelerate drug development, with 41% of respondents highlighting its potential, up from 26% in 2023 [7] Chinese Biotech Market - A separate survey of 100 China-based biotechs revealed that they face similar challenges as their global counterparts, particularly in funding and drug development complexity [8] - Cardiovascular and oncology remain the primary therapeutic focus areas in China, contrasting with the global trend towards neurology [8] - Chinese respondents express less concern about geopolitical issues and show greater confidence in investment and product success [8]

Core Insights - The U.S. FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to Senti Biosciences' SENTI-202, a potential first-in-class CAR-NK cell therapy for relapsed/refractory hematologic malignancies, including AML [1][2][7] - This designation highlights the urgent need for improved treatments for relapsed/refractory AML and the potential of SENTI-202 to significantly impact the treatment landscape for this aggressive cancer [2][3] Company Overview - Senti Biosciences is a clinical-stage biotechnology company focused on developing next-generation cell and gene therapies using its proprietary Gene Circuit platform [1][10] - The company aims to engineer therapies that can precisely target and kill cancer cells while sparing healthy cells, enhancing specificity and control in treatment [10] Product Development - SENTI-202 is currently in a Phase 1 clinical trial targeting adult patients with relapsed/refractory CD33 and/or FLT3 expressing hematologic malignancies, including AML [2][8] - The therapy utilizes a Logic Gated approach, featuring an OR GATE for activating CAR that targets CD33 and/or FLT3, and a NOT GATE to protect healthy cells [8] - Clinical data presented at the ASH Annual Meeting indicated a 50% Overall Response Rate (ORR) and a 42% Complete Remission (CR) rate at the Recommended Phase 2 Dose (RP2D), with a median duration of composite Complete Remission of 7.6 months [7][8] Regulatory Milestones - The RMAT designation is the second FDA recognition for SENTI-202 in 2025, following the Orphan Drug Designation received in June [2][9] - RMAT designation facilitates closer collaboration with the FDA, providing guidance on data generation to support product approval [4][7] Clinical Progress - Recent presentations at the ASH Annual Meeting showcased updated clinical data, reinforcing SENTI-202's efficacy, safety, and durability in treating relapsed/refractory AML [2][3] - The company is actively enrolling patients for the ongoing Phase 1 trial, which could lead to a first-in-class allogeneic treatment option for AML/MDS patients [8]