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INmune Bio’s CaRe PC Trial of INKmune™ in Metastatic Castration-Resistant Prostate Cancer Meets Endpoints and Is Closed to Enrollment
GlobeNewswire· 2025-08-04 12:00
Core Insights - INmune Bio Inc. has successfully completed its Phase I/II trial of INKmune™ for men with metastatic castration-resistant prostate cancer (mCRPC), meeting both primary and secondary endpoints, and is now closed to further enrollment [1][2] - INKmune™ demonstrated an excellent safety profile across all three dose levels, with significant improvements in NK cell activation biomarkers observed in patients with low NK cell activation [2][3] - The company plans to advance the INKmune™ program by designing a randomized Phase 2b trial targeting patients with less severe disease to better measure the drug's effects and potential clinical benefits [3] Product Overview - INKmune™ is a pharmaceutical-grade, replication-incompetent human tumor cell line that primes resting NK cells to become tumor-killing memory-like NK cells, with effects persisting for over 100 days [4] - The treatment is patient-friendly, requiring no pre-medication or additional cytokine therapy, and can be administered via simple intravenous infusion as an outpatient procedure [5] - INKmune™ is tumor agnostic, applicable to various NK-resistant tumors, including leukemia, lymphoma, myeloma, and several solid tumors [5] Company Background - INmune Bio Inc. is a publicly traded clinical-stage biotechnology company focused on developing treatments that target the innate immune system to combat diseases [6] - The company has three product platforms: DN-TNF for chronic inflammation and cognitive disorders, Natural Killer Cell Priming Platform including INKmune™, and CORDStrom™ for regenerative medicine [6]
Anavex Life Sciences Announces Positive Precision Medicine Results from up to 4-Years of Oral Blarcamesine Treatment in Phase IIb/III Open-Label Extension Trial in Early Alzheimer's Disease
Globenewswire· 2025-07-31 11:30
Core Insights - Anavex Life Sciences Corp. announced significant findings regarding its drug blarcamesine for early Alzheimer's disease, demonstrating up to 84.6 weeks (19.5 months) of 'time saved' through early treatment initiation [3][4][5] Group 1: Clinical Trial Results - The ATTENTION-AD Phase IIb/III trial showed that patients treated with blarcamesine continued to accrue cognitive and functional benefits over a period of up to 192 weeks [3] - In the intent-to-treat population, significant differences were observed in cognitive function (ADAS-Cog13) and daily living activities (ADCS-ADL) between early-start and late-start treatment groups at Week 192 [3] - The GWAS-identified population ABCLEAR24 showed even greater improvements in cognition (ADAS-Cog13: LS mean difference −5.43, P = 0.0035) and function (ADCS-ADL: LS mean difference +9.50, P < 0.0001) [3] Group 2: Mechanism of Action - Blarcamesine is confirmed to restore impaired autophagy by activating SIGMAR1, acting upstream of amyloid and tau pathologies [5][6] - The drug's mechanism was established through both in vitro and in vivo studies, demonstrating enhanced autophagic flux and increased proteostasis capacity [6][7] Group 3: Safety Profile - Blarcamesine exhibited a favorable safety profile with no treatment-related deaths reported during the trials [4][5] - Common treatment-emergent adverse events included transient dizziness, mostly mild to moderate in severity [8] Group 4: Future Implications - The findings suggest that earlier initiation of treatment with blarcamesine may significantly impact disease progression and provide sustained benefits for patients with early Alzheimer's disease [5][9] - The company emphasizes the importance of a long-term therapeutic strategy for chronic diseases like Alzheimer's, with blarcamesine's convenient once-daily oral dosing potentially enhancing patient adherence [9]
INmune Bio Inc. to Report Second Quarter 2025 Financial Results and Provide Corporate Update on Thursday, August 7th
Globenewswire· 2025-07-31 11:00
Core Viewpoint - INmune Bio Inc. will host a conference call on August 7, 2025, to discuss its financial results for the quarter ended June 30, 2025, and provide a corporate update [1]. Company Overview - INmune Bio Inc. is a clinical-stage biotechnology company focused on developing treatments targeting the innate immune system to combat diseases [3]. - The company has three product platforms: - The Dominant-Negative Tumor Necrosis Factor (DN-TNF) platform aims to neutralize soluble TNF, which is linked to various diseases, with candidates in clinical development for Alzheimer's disease and other indications [3]. - The Natural Killer Cell Priming Platform includes INKmune®, which is designed to enhance NK cell activity against minimal residual disease in cancer patients, currently in trials for metastatic castration-resistant prostate cancer [3]. - The CORDStrom™ platform utilizes pooled human umbilical cord-derived mesenchymal stromal cells (hucMSCs) and has recently completed a trial for recessive dystrophic epidermolysis bullosa [3]. - The company employs a precision medicine approach for diseases associated with chronic inflammation and cancer [3]. Conference Call Information - The conference call is scheduled for August 7, 2025, at 4:30 PM Eastern Time, with participant dial-in numbers provided for both domestic and international callers [2]. - A live audio webcast will be available, and a transcript will be released approximately 24 hours after the call [2]. Contact Information - The company contact for inquiries includes David Moss, Chief Financial Officer, and Daniel Carlson, Head of Investor Relations, with provided phone numbers and email addresses [6].
Tempus AI, Inc. Investors: Please contact the Portnoy Law Firm to recover your losses. August 12, 2025 Deadline to file Lead Plaintiff Motion
GlobeNewswire News Room· 2025-07-28 20:43
Core Viewpoint - Tempus AI, Inc. is facing a class action lawsuit due to allegations of misleading statements and undisclosed material information during the specified Class Period, which has led to significant investor losses [1][3][4]. Group 1: Allegations Against Tempus AI - The lawsuit claims that Tempus AI inflated the value of certain contract agreements, many of which involved related parties and were non-binding or self-funded [3]. - It is alleged that the joint venture with SoftBank Group Corporation raised credibility concerns due to the appearance of "round-tripping" capital to artificially inflate revenue [3]. - The acquisition of Ambry Genetics Corporation is said to have operated under a business model that relied on aggressive and potentially unethical billing practices, exposing it to regulatory and financial risks [3]. - AstraZeneca PLC reportedly reduced its financial support to Tempus AI through a questionable "pass-through payment" structure involving a joint agreement with Pathos AI, Inc. [3]. - These issues are indicative of broader weaknesses in Tempus AI's core operations and long-term revenue outlook [3]. Group 2: Impact of Research Report - On May 28, 2025, Spruce Point Capital Management, LLC published a research report that raised serious concerns regarding Tempus AI's management, operations, and financial disclosures [4]. - Following the release of this report, Tempus AI's stock price experienced a decline of over 19% [4].
GeneDx CFO Sells More Than Half of His Shares
The Motley Fool· 2025-07-25 18:40
Company Overview - GeneDx Holdings is a healthcare technology company that integrates AI and machine learning with clinical and genomic data, focusing on precision medicine and individualized patient care [7] - The company has a market capitalization of $2.29 billion and reported a revenue of $330 million with a net income of -$38.6 million for the trailing twelve months [6] Recent Financial Performance - GeneDx Holdings shares have appreciated by 141.5% over the past year as of July 11, 2025 [5] - The company reported a 42% year-over-year increase in revenue for the first quarter, driven by high volumes of exome and genome tests [9] - Revenue from exome and genome tests accounted for 82% of GeneDx's total Q1 revenue, with the net loss for the quarter shrinking to $6.5 million from $20 million in the prior-year period [10] Insider Activity - On July 11, 2025, Kevin Feeley, CFO of GeneDx Holdings, sold 5,278 shares, reducing his holdings to 3,392 shares, which represents approximately 0.01% of total shares outstanding [1][4] - This sale is consistent with Feeley's recent trading patterns, as it is near the median trade size for him over the last several quarters [3] Growth Catalysts - GeneDx has strong growth prospects, particularly following its acquisition of Fabric Genomics, which enhances its AI-driven test interpretations and expands its genomics testing portfolio [12] - The company is targeting a larger patient population by expanding testing to outpatient pediatrics, NICU patients, and newborns [11] - Management has raised its full-year revenue guidance to a range of $360 million to $375 million, up from the previous forecast of $350 million to $360 million [10]
PacBio HiFi Sequencing Powers First Arab Human Pangenome, Published in Nature Communications
Globenewswire· 2025-07-24 13:05
Core Insights - The study published the first Arab human pangenome, significantly advancing global genomic equity and highlighting the importance of population-specific genomic data [1][3] - The research identified millions of new variants and over 111 million base pairs of previously unsequenced DNA, enhancing the understanding of genetic diversity in Arab populations [2][4] Company Contributions - PacBio's HiFi long-read sequencing technology was instrumental in assembling high-resolution genomes from diverse Arab populations, showcasing the company's leadership in genomic research [1][3][7] - The Arab pangenome, or UAE Pangenome Reference (UPR), improves mapping rates and variant recall, providing a valuable tool for precision medicine in underrepresented populations [5][6] Implications for Research - The findings from the study have significant implications for understanding disease risk, diagnosing rare conditions, and improving representation in global health research [4][6] - The UPR is freely available to support ongoing research into genetic disorders and population health, potentially increasing variant detection accuracy in Arab genomes [6]
Caris Life Sciences Validates and Extends Findings on Tumor-Infiltrating Clonal Hematopoiesis
Prnewswire· 2025-07-22 12:30
Core Insights - Caris Life Sciences published original data in the New England Journal of Medicine validating findings on tumor-infiltrating clonal hematopoiesis (TI-CH), reinforcing its leadership in precision oncology [1][2] - The study highlighted the clinical challenge of TI-CH, which involves blood-derived mutations infiltrating tumor tissue, potentially leading to misinterpretation and inappropriate treatment decisions [2][3] Company Overview - Caris Life Sciences is a leading AI TechBio company focused on precision medicine, developing innovative solutions to transform healthcare through comprehensive molecular profiling and advanced AI applications [5][6] - The company has built a large-scale clinico-genomic database of over 500,000 samples, enabling the analysis of molecular complexity in diseases [5] Research Findings - The analysis included 3,255 matched tumor-blood NGS samples, confirming that TI-CH is prevalent across solid tumors, particularly in non-small cell lung cancer (NSCLC), where approximately 23% of patients are affected [3] - Patients with TI-CH face a 30% higher risk of death compared to those without TI-CH, emphasizing the importance of accurate treatment decisions based on true tumor biology [3][4] Leadership Statements - David Spetzler, President of Caris, emphasized the importance of collaboration in validating studies to enhance clinically meaningful insights for oncologists and patients [3] - George W. Sledge, Jr., Chief Medical Officer, noted that understanding clonal hematopoietic mutations is critical for improving treatment responses and patient outcomes [4]
Betting Big on Cancer: 3 Oncology Stocks Set to Surge in 2025
ZACKS· 2025-07-21 14:46
Industry Overview - The global cancer treatment market is experiencing rapid growth due to rising cancer incidence, an aging population, and increasing demand for safer, more effective therapies, with over 2 million new cancer cases and 618,000 related deaths projected in the U.S. for 2025 [1] - Breakthroughs in immunotherapy, targeted treatments, and personalized cancer vaccines are reshaping the oncology landscape, offering greater precision and improved outcomes [2] - The oncology market is poised for robust, long-term growth, presenting compelling opportunities for investors [4] Major Companies and Developments - Major pharmaceutical companies such as Novartis, AstraZeneca, Johnson & Johnson, Pfizer, AbbVie, Bristol Myers Squibb, and Eli Lilly are heavily investing in advanced approaches like antibody-drug conjugates and immuno-oncology agents, while smaller biotechs are driving innovation and becoming attractive acquisition targets [3] - Johnson & Johnson's oncology segment accounts for approximately 27% of its total revenues, with oncology sales rising 22.3% to $6.3 billion in Q2 2025, driven by strong market growth and key product share gains [6] - Johnson & Johnson expects its oncology sales to reach $50 billion by the end of the decade, citing strong growth in marketed cancer drugs and the potential of upcoming launches [7] - Novartis has a diverse oncology portfolio, with significant contributions from drugs like Kisqali, which recorded sales of $1.1 billion in Q2 2025, up 64% year over year [9][10] - Novartis' oncology sales rose 20% in constant currency terms to $4.3 billion in Q2 2025, bolstered by new drug approvals and acquisitions [10] Emerging Companies and Innovations - Allogene Therapeutics is focused on developing allogeneic CAR T therapies for cancer treatment, particularly in hematologic indications with high unmet needs [11] - Allogene Therapeutics has multiple clinical-stage pipeline candidates, including cema-cel for large B-cell lymphoma and ALLO-316 for advanced renal cell carcinoma, showing promising early anti-tumor activity [12][13]
MVP Health Care and Renalytix Partner to Bring Life-Changing Kidney Disease Testing to Local Communities
Prnewswire· 2025-07-21 11:00
Core Insights - Renalytix Plc and MVP Health Care have formed a partnership to enhance access to kidney care for individuals with type 2 diabetes and chronic kidney disease, aiming to improve health outcomes and reduce health disparities [1][2] - The collaboration will implement the kidneyintelX.dkd™ FDA-approved test across MVP's network, facilitating earlier interventions and personalized care plans for patients [2][3] - The kidneyintelX.dkd™ test will be available to all MVP customers in New York, including those with Medicare or Medicaid, and is endorsed by KDIGO, the international clinical guideline organization for kidney disease [3] Company Overview - Renalytix is an AI-enabled in vitro diagnostics company focused on improving clinical management of kidney disease, with FDA approval and Medicare reimbursement for the kidneyintelX.dkd test [5] - MVP Health Care is a not-for-profit health insurer serving New York and Vermont, dedicated to enhancing the well-being of its members and communities [6] Impact on Patient Care - The partnership aims to identify patients at higher risk for kidney function decline earlier, allowing for targeted resources and therapeutic options, which can lead to better management of cardiovascular and metabolic conditions [1][4] - The use of kidneyintelX.dkd has shown measurable improvements in patient outcomes and quality metrics, particularly in managing blood pressure and HbA1c levels in high-risk populations [4]
IDEAYA Biosciences to Participate in Upcoming July 2025 Investor Relations Event
Prnewswire· 2025-07-21 10:00
Group 1 - IDEAYA Biosciences, Inc. is participating in the 2025 BTIG Virtual Biotechnology Conference on July 29, 2025, at 4:40 PM ET, featuring a fireside chat with CEO Yujiro S. Hata [1] - The conference will be accessible via a live audio webcast on the IDEAYA website, with a replay available for 30 days post-event [1] Group 2 - IDEAYA is focused on precision medicine in oncology, aiming to discover, develop, and commercialize transformative therapies for unmet medical needs in cancer [2] - The company integrates small molecule drug discovery, structural biology, and bioinformatics to develop targeted therapies, including synthetic lethality and antibody-drug conjugates (ADCs) [2] - IDEAYA has established a robust pipeline of targeted therapies aimed at improving clinical outcomes for cancer patients [2]