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Senti Bio to Present Updated Clinical Results of First-in-Class Logic Gated CD33/FLT3 Cell Therapy, SENTI-202, at the American Society of Hematology (ASH) Annual Meeting 2025
Globenewswire· 2025-11-03 14:05
Core Insights - Senti Biosciences, Inc. is set to present its SENTI-202 clinical program at the 67th American Society of Hematology Annual Meeting, showcasing advancements in its Logic Gate technology for treating relapsed/refractory Acute Myeloid Leukemia (AML) [1][4] Company Overview - Senti Bio is a clinical-stage biotechnology company focused on developing next-generation cell and gene therapies using its proprietary Gene Circuit platform [1][8] - The company aims to engineer Gene Circuits that can precisely target and kill cancer cells while sparing healthy cells, enhancing specificity and control in treatment [8] Product Details - SENTI-202 is the first Logic Gated off-the-shelf CAR-NK cell therapy designed to selectively target and eliminate CD33 and/or FLT3 expressing hematologic malignancies, such as AML and myelodysplastic syndrome (MDS) [3][5] - The therapy incorporates an OR GATE for activating CAR that targets CD33 and FLT3, and a NOT GATE to protect healthy cells expressing EMCN, potentially widening the therapeutic window [5] - SENTI-202 also includes calibrated-release IL-15 to enhance cell persistence and activity [5] Clinical Program - The upcoming presentations will provide updated clinical results, demonstrating deep and durable remission rates and a strong safety profile for SENTI-202 in treating relapsed/refractory AML [4] - The oral session will present promising results from an ongoing Phase I multicenter study, while the poster session will provide correlative data consistent with clinical activity [2][4] Market Context - AML is a prevalent blood cancer with an estimated 22,010 new cases in the U.S. in 2025, and a five-year survival rate of approximately 32.9% at diagnosis [7] - There is a significant unmet need for effective treatments for relapsed/refractory AML, where median overall survival is typically around five months [7]
IGC Pharma Expands AI-Powered Drug Discovery In-Silico Pipeline
Accessnewswire· 2025-11-03 13:52
Core Insights - IGC Pharma is expanding its AI-powered in-silico drug discovery platform to enhance the development of treatments for Alzheimer's disease [1] Company Developments - The company is integrating additional methodologies such as retrosynthetic analysis, molecular docking, toxicology and genotoxic assessments, and predictive bioactivity modeling [1] - This expansion aims to accelerate the identification and optimization of therapeutic candidates for Alzheimer's disease and related disorders [1]
P2P Group Announces Leading Investment Group Underwriting
Prnewswire· 2025-11-03 13:30
Accessibility StatementSkip Navigation (CSE: PPB / OTC: PPBGF / FSE: 3QG)[email protected] Key Highlights VANCOUVER, BC, Nov. 3, 2025 /PRNewswire/ - P2P Group Ltd. ("P2P" or the "Company") (CSE: PPB) (OTC: PPBGF) (FSE: 3QG) is pleased to announce that the Company is electing to accelerate the expiry of outstanding common share purchase warrants (the "Warrants") issued on November 20, 2024 (the "November 2024 Warrants"), pursuant to the Company's non-brokered private placement (the "Offering"). In parallel ...
Immutep Receives A$4.6 million R&D Tax Incentive from French Government
Globenewswire· 2025-11-03 13:00
Core Insights - Immutep Limited has received a cash payment of €2,588,954 (~ A$4,567,769) from the French Government under the Crédit d'Impôt Recherche (CIR) scheme, which supports R&D activities [1][3] - The CIR allows French companies to be reimbursed 30% of their eligible R&D expenditures, benefiting Immutep through its subsidiary in France [2][3] - The funds will be allocated to the global clinical development of Immutep's products, specifically eftilagimod alfa and IMP761 [4] Company Overview - Immutep is a late-stage biotechnology company focused on developing immunotherapies for cancer and autoimmune diseases, particularly leveraging LAG-3 therapeutics [5] - The company aims to provide innovative treatment options and maximize shareholder value through its diversified product portfolio [5]
Elicio Therapeutics to Present Clinical and Preclinical Data at the SITC 2025 Annual Meeting
Globenewswire· 2025-11-03 13:00
Core Insights - Elicio Therapeutics is presenting new immunogenicity data from its Phase 2 AMPLIFY-7P trial of ELI-002 for mKRAS-driven pancreatic cancer at the SITC Annual Meeting [1] - The company aims to develop off-the-shelf immunotherapies targeting prevalent cancers, leveraging its proprietary AMP technology to enhance T cell responses [3][4] Company Overview - Elicio Therapeutics is a clinical-stage biotechnology company focused on novel immunotherapies for high-prevalence cancers, including mKRAS-positive pancreatic and colorectal cancers [3] - The company's lead product candidate, ELI-002, targets common KRAS mutations found in approximately 25% of all solid tumors [4][5] - Elicio's AMP technology is designed to improve the education and activation of cancer-specific T cells, promoting durable cancer immunosurveillance [3][7] Clinical Trials and Data - ELI-002 is currently being studied in a randomized clinical trial for patients with mKRAS-positive pancreatic cancer who are at high risk of relapse after standard therapy [3][5] - The AMPLIFY-201 Phase 1 trial data showed a median recurrence-free survival of 16.3 months and a median overall survival of 28.9 months for the full study population [3] - Elicio plans to expand ELI-002 to other indications, including mKRAS-positive lung cancer [3] Presentation Details - The late-breaking abstract presentation titled "AMPLIFY-7P Phase 2: T cell responses induced by ELI-002 7P" will be presented by Dr. Lisa McNeil on November 7, 2025 [2] - Another poster presentation titled "AMP-Immunomodulator therapy controls growth and eradicates syngeneic solid tumors" will be presented by Dr. Martin Steinbuck on November 8, 2025 [3]
Kraig Biocraft Laboratories Confirms Spider Silk Production Operations Unaffected by Southeast Asia Typhoons due to Strategic Relocations to Highland Over Last 24 Months
Globenewswire· 2025-11-03 12:05
Core Insights - Kraig Biocraft Laboratories, Inc. has confirmed that its production operations in Vietnam remain secure and uninterrupted despite recent typhoons affecting Southeast Asia [1][2] - The company's strategic relocation of operations to the highlands in 2024 has proven beneficial for operational resilience and long-term stability [2][4] - Kraig Labs is committed to contributing to relief efforts for those affected by the storms while ensuring its facilities and personnel are safe and operational [3] Company Operations - The spider silk production facilities and infrastructure of Kraig Labs sustained no damage from the severe weather events, including mulberry feedstock supplies [2] - The former facility in Quang Nam province was closed and relocated successfully before the storms, ensuring no disruption to production [3] - The company has adopted a strategy of maintaining multiple, parallel production facilities to enhance scalability and safeguard against potential disruptions [4] Strategic Investments - Investments in infrastructure, redundancy, and strategic location have positioned Kraig Labs in a strong operational stance [5] - The company aims to advance its spider silk production capacity and meet market demand for innovative materials [5]
Unicycive Therapeutics to Participate in a Fireside Chat at the Guggenheim 2nd Annual Healthcare Innovation Conference
Globenewswire· 2025-11-03 12:05
Core Insights - Unicycive Therapeutics, Inc. is participating in the Guggenheim 2nd Annual Healthcare Innovation Conference on November 10, 2025, where CEO Shalabh Gupta will engage in a fireside chat [1] - The company is focused on developing therapies for kidney diseases, with its lead investigational treatment, oxylanthanum carbonate, currently under FDA review for hyperphosphatemia in chronic kidney disease patients on dialysis [3] - Unicycive's second investigational treatment, UNI-494, is aimed at treating conditions related to acute kidney injury and has received orphan drug designation from the FDA for preventing Delayed Graft Function in kidney transplant patients [3] Company Overview - Unicycive Therapeutics is a clinical-stage biotechnology company specializing in novel treatments for kidney diseases [3] - The company is developing oxylanthanum carbonate as a phosphate binding agent and has completed a Phase 1 safety study for UNI-494 [3] - More information about the company can be found on its website and social media platforms [3]
Iovance Biotherapeutics Reports Potential Best-in-Class Clinical Data for Lifileucel TIL Cell Therapy in Advanced Non-Small Cell Lung Cancer (NSCLC)
Globenewswire· 2025-11-03 12:00
Core Insights - Iovance Biotherapeutics announced interim data from the Phase 2 IOV-LUN-202 trial of lifileucel monotherapy in previously treated advanced nonsquamous NSCLC, showing a 25.6% objective response rate (ORR) and a disease control rate of 71.8% [2][3][4] - The median duration of response (mDOR) was not reached after a median follow-up of 25.4 months, indicating potential long-term efficacy [3][4] - Lifileucel is expected to launch in the second half of 2027, following a supplemental Biologics License Application [4][7] Clinical Data - The trial reported an ORR of 25.6%, with 10 out of 39 patients showing an objective response, including 2 complete responses and 7 partial responses [3][5] - The safety profile of lifileucel was consistent with the underlying disease, showing improvements in overall safety without affecting efficacy [6][7] Regulatory and Market Context - The FDA provided positive feedback on the trial design, which aligns with guidance for accelerated approvals in conditions with unmet medical needs [4][5] - Current treatment options for advanced NSCLC are limited, with standard docetaxel monotherapy showing an ORR of only 12.8% and an mDOR of 5.6 months [5][6] Industry Background - Lung cancer is the most commonly diagnosed cancer globally, with approximately 2.5 million new cases and 1.8 million deaths each year [8][9] - Non-small cell lung cancer (NSCLC) accounts for about 85% of lung cancer cases, with nonsquamous NSCLC representing approximately 75% of those cases [9][10] Company Overview - Iovance Biotherapeutics focuses on developing tumor infiltrating lymphocyte (TIL) therapies, aiming to be a leader in this innovative treatment space [12][13] - The company is committed to continuous innovation in cell therapy, including gene-edited therapies, to improve patient outcomes [13]
Krystal Biotech Announces Third Quarter 2025 Financial and Operating Results
Globenewswire· 2025-11-03 12:00
Financial Performance - The company reported $97.8 million in net product revenue for VYJUVEK in Q3 2025, an increase from $83.8 million in Q3 2024, reflecting a growth of approximately 16.7% year-over-year [3][23][37] - Gross margin for the quarter was 96%, indicating strong profitability from product sales [3] - Net income for Q3 2025 was $79.4 million, or $2.74 per common share (basic), compared to $27.2 million, or $0.95 per common share (basic) in Q3 2024, representing a significant increase [23][36] Product Development and Market Expansion - VYJUVEK was launched in Germany in Q3 2025, with approximately 20 patients prescribed the therapy across over 10 centers [3] - The product was also launched in France and Japan in Q4 2025, following successful pricing negotiations [3][4] - The FDA approved a label update for VYJUVEK, expanding the eligible patient population to include DEB patients from birth and allowing for home application by patients or caregivers [3][24] Pipeline and Future Prospects - The company is advancing its pipeline with multiple near-term readouts, including interim results for cystic fibrosis expected in Q4 2025 [2][6] - The company is preparing regulatory filings for the UK and Switzerland and is initiating pricing discussions in other key Western European markets [3][4] - The company continues to enroll in clinical trials for KB407 and KB408, with interim data readouts expected in late 2025 and early 2026 [6][11] Financial Guidance - The company provided guidance for FY 2025, estimating non-GAAP combined R&D and SG&A expenses to be between $145 million and $155 million [20]
Abpro Announces 1-for-30 Reverse Stock Split Effective November 3, 2025
Globenewswire· 2025-11-03 12:00
Core Insights - Abpro Holdings, Inc. has implemented a 1-for-30 reverse stock split to maintain compliance with Nasdaq and position the company for future growth [1][4] - The company has achieved approximately 60% reduction in operating costs compared to the same period in 2024 through a focused cost optimization plan [1][4] - Abpro's partnership with Celltrion is a strategic advantage, as Celltrion funds all development expenses for Abpro's lead antibody program ABP-102, with a first-in-human trial anticipated in 2026 [5][4] Company Actions - The reverse stock split became effective on October 31, 2025, reducing the number of outstanding shares from approximately 81.2 million to 2.7 million [2] - The company's transfer agent, Continental Stock Transfer & Trust Company, will act as the exchange agent for the reverse stock split [3] Strategic Positioning - Abpro is focused on unlocking additional value through its DiversImmune® and MultiMabTM platforms, which facilitate the rapid creation of bispecific and multispecific antibodies [6] - The company aims to create long-term value for shareholders by executing more effectively with a leaner cost structure and a major global partner [4] Company Overview - Abpro is dedicated to improving lives through next-generation antibody therapies targeting severe diseases, utilizing its proprietary DiversImmune® platform [7]