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Immunocore: Continuing To Improve The Bottom Line, But Needing A Big Catalyst
Seeking Alpha· 2025-11-08 04:28
Core Insights - The article expresses enthusiasm for Immunocore's (IMCR) commercial and developmental pipeline of immunotherapeutic agents, highlighting the potential despite the inherent risks associated with developmental projects [1]. Company Analysis - Immunocore is recognized for its innovative approach in the field of immunotherapy, which is a growing sector within biotechnology [1]. - The author emphasizes the importance of understanding the science behind the business, indicating a focus on educating investors about the complexities of the biotech industry [1]. Industry Context - The biotech industry, particularly in immunotherapy, is characterized by high risk and potential reward, necessitating thorough due diligence from investors [1].
Evaxion presents new immune data from phase 2 trial with AI-designed personalized cancer vaccine EVX-01
Globenewswire· 2025-11-07 22:10
Core Insights - Evaxion A/S has presented new data on its AI-designed personalized cancer vaccine EVX-01 at the Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting, highlighting immune responses following treatment [1][8] - The vaccine targets multiple neoantigens and aims to induce a clinically relevant immune response, particularly in patients with advanced melanoma when combined with MSD's KEYTRUDA® [2][4] Company Overview - Evaxion is a clinical-stage TechBio company that utilizes its AI-Immunology™ platform to develop innovative vaccines for cancer and infectious diseases [6] - The company is focused on transforming patient care through targeted treatment options, leveraging AI to decode the human immune system [6] Clinical Data - The new biomarker and immune data presented is derived from a phase 2 trial of EVX-01 in combination with KEYTRUDA®, showing promising immune responses in patients [2][8] - Longitudinal blood samples were analyzed to understand treatment-induced changes in immune cell populations, revealing a rapid and sustained induction of EVX-01-specific T-cells in some patients [3] Market and Community Response - The presentation of the new data at SITC follows the recent disclosure of two-year clinical efficacy data from the same phase 2 trial, indicating strong interest from the medical community [4][8]
Coherus Oncology Presents at SITC Clinical Multiomic Biomarker Data for CHS-114, a Highly Selective anti-CCR8 Cytolytic Antibody
Globenewswire· 2025-11-07 14:00
Core Insights - Coherus Oncology's CHS-114 shows promising results in selectively depleting CCR8+ Tregs and enhancing immune response in patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) [1][2][3] Clinical Trial Results - The Phase 1b clinical trial of CHS-114 demonstrated a greater than 50% increase in intratumoral CD8 T cells, indicating a shift towards a "hot" tumor microenvironment [1][2] - CHS-114 treatment resulted in a 74% reduction in CCR8+ Treg density and a 73% increase in CD8+ T cell density, showcasing effective immune remodeling [5][6] Safety and Efficacy - The combination of CHS-114 with toripalimab has shown a manageable safety profile and early signs of antitumor activity in HNSCC patients [2][3] - A partial response was observed in a refractory head and neck cancer patient during initial safety testing of the combination therapy [3] Development Strategy - The data supports advancing CHS-114 in combination with toripalimab or other immune activators, aligning with the company's development plan [3][4] - Ongoing enrollment in the dose optimization arm aims to address the FDA's Project Optimus and define a phase 2 dose for CHS-114 [3][7] Company Overview - Coherus Oncology is focused on developing innovative oncology therapies, including the next-generation PD-1 inhibitor LOQTORZI and CHS-114, targeting various cancers [9][10]
Barinthus Bio Reports Third Quarter 2025 Financial Results and Updates on Corporate Developments
Globenewswire· 2025-11-07 12:30
Core Insights - Barinthus Biotherapeutics plc reported its financial results for Q3 2025, highlighting a net loss of $14.6 million, or $(0.36) per share, an improvement from a net loss of $21.1 million, or $(0.52) per share, in Q2 2025 [11][21] - The company announced a proposed merger with Clywedog Therapeutics, aiming to create a diversified portfolio targeting metabolic and autoimmune diseases, with the transaction expected to close in the first half of 2026 [2][6][7] Recent Corporate Developments - The merger with Clywedog is anticipated to strengthen Barinthus Bio's pipeline and broaden its investor base, with four clinical data milestones expected within 18 months post-transaction [6][7] - The company is actively seeking partners for its VTP-300 program in chronic hepatitis B and VTP-850 program in prostate cancer [7] Financial Highlights - As of September 30, 2025, Barinthus Bio had cash and cash equivalents of $75.7 million, down from $87.8 million as of June 30, 2025, primarily due to operating expenses [7][11] - Research and development expenses decreased to $5.4 million in Q3 2025 from $8.0 million in Q2 2025, attributed to reduced activity in infectious disease and oncology programs [8][11] - General and administrative expenses were $5.2 million for Q3 2025, significantly lower than $15.4 million in Q2 2025, mainly due to reduced unrealized losses on foreign exchange [11][21] Clinical Developments and Upcoming Milestones - The single ascending dose data readout for VTP-1000 is expected before the end of 2025, with enrollment in the multiple ascending dose part of the AVALON trial ongoing [6][7] - The company anticipates that research and development expenses related to autoimmune programs will continue at current levels or increase as clinical development progresses [8]
HCW Biologics Presents Preclinical Data for TRBC-Based T-Cell Engager Program at the Society for Immunotherapy of Cancer’s (SITC) 40th Annual Meeting
Globenewswire· 2025-11-07 12:00
Core Insights - HCW Biologics has presented data on its tetra-valent, second-generation T-Cell Engager (TCE) Program at the SITC 40 Annual Meeting, showcasing advancements over first-generation products [1][2] - The lead TCE product candidate, HCW11-018b, demonstrated significant efficacy in preclinical studies, achieving 100% survival in tumor-bearing mice, particularly in models of pancreatic cancer and glioblastoma [2] Company Overview - HCW Biologics Inc. is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies aimed at treating diseases linked to chronic inflammation, including various cancers and autoimmune diseases [4] - The company utilizes its proprietary TRBC platform technology to create immunotherapeutics that activate immune responses and target cancerous cells [6] Product Development - The second-generation TCE program is designed to address limitations of bi-specific T-cell engagers, including manufacturability and safety, while expanding treatment options for solid tumors and potentially autoimmune diseases [1][2] - HCW Biologics has constructed over 50 molecules using the TRBC platform, with ongoing preclinical evaluations for selected candidates [6] Clinical and Preclinical Findings - The tetra-valent TCE construct has shown broad coverage for human solid tumor indications, with high potency and precision in xenograft models, including Patient-Derived Xenograft (PDX) models [5] - The product candidate HCW11-018b has a favorable tolerability profile and long serum half-life, with a streamlined GMP manufacturing process similar to therapeutic monoclonal antibodies [5] Presentation and Availability - A poster detailing the TCE program will be presented at the SITC meeting, with the ePoster available on the company's website following the presentation [2][3]
HCW Biologics Presents Preclinical Data for TRBC-Based T-Cell Engager Program at the Society for Immunotherapy of Cancer's (SITC) 40th Annual Meeting
Globenewswire· 2025-11-07 12:00
Core Insights - HCW Biologics Inc. presented data on its tetra-valent, second-generation T-Cell Engager (TCE) Program at the SITC 40th Annual Meeting, showcasing advancements in immunotherapy aimed at extending healthspan by addressing inflammation-related diseases [1][2] Company Overview - HCW Biologics is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies to treat diseases associated with chronic inflammation, particularly age-related conditions [4] - The company has developed a new drug discovery technology, the TRBC platform, which allows for the creation of various classes of immunotherapeutic compounds targeting cancer and autoimmune diseases [4] Product Development - The lead T-cell engager product candidate, HCW11-018b, demonstrated significant efficacy in preclinical studies, achieving 100% survival in tumor-bearing mice, while untreated mice showed no survival [2] - The second-generation TCE program is designed to enhance treatment options for a range of solid tumors, including pancreatic cancer and glioblastoma, and may also address autoimmune diseases [2][4] Research Findings - The preclinical evaluation highlighted the unique features of HCW11-018b, including its ability to shrink established tumors in xenograft models and its favorable tolerability profile in non-human primates [2][5] - The tetra-valent construct is designed to overcome immunosuppressive tumor microenvironments and activate exhausted T cells, showing long serum half-life and favorable pharmacokinetics [5] Future Directions - The company is conducting ongoing preclinical evaluation studies for selected molecules based on promising data and has established licensing programs for some proprietary molecules [6]
PDS Biotech Announces Conference Call and Webcast for Third Quarter 2025 Financial Results
Globenewswire· 2025-11-06 13:00
Core Viewpoint - PDS Biotechnology Corporation is set to host a conference call on November 13, 2025, to report its financial results for Q3 2025 and provide updates on its clinical programs [1][2]. Company Overview - PDS Biotechnology is a late-stage immunotherapy company focused on enhancing the immune system's ability to target and eliminate cancers [3]. - The company has initiated a pivotal clinical trial for its lead program targeting advanced HPV16-positive head and neck squamous cell cancers [3]. - PDS0101 (Versamune HPV), the company's lead investigational targeted immunotherapy, is being developed in combination with a standard immune checkpoint inhibitor and in a triple combination with PDS01ADC and a standard immune checkpoint inhibitor [3]. - PDS01ADC, an IL-12 fused antibody drug conjugate, is currently being evaluated in multiple phase 2 trials across various cancer indications [3]. Conference Call Details - The conference call is scheduled for November 13, 2025, at 8:00 a.m. Eastern Time [2]. - Dial-in numbers are provided for both domestic and international participants [2]. - The event will be archived on the company's website for six months following the live webcast [2]. Contact Information - Investor contact is Mike Moyer from LifeSci Advisors, reachable at +1 (617) 308-4306 [7]. - Media contact is David Schull from Russo Partners, reachable at +1 (858) 717-2310 [7].
Corvus Pharmaceuticals Provides Business Update and Reports Third Quarter 2025 Financial Results
Globenewswire· 2025-11-04 21:01
Core Insights - Corvus Pharmaceuticals is advancing the development of its ITK inhibitor, soquelitinib, for treating atopic dermatitis and T cell lymphomas, with significant clinical trials underway [3][4][5] Clinical Development - Enrollment in the Phase 1 trial extension cohort 4 for soquelitinib in atopic dermatitis has been completed, involving 24 patients receiving a 200 mg BID dose over an 8-week treatment period, with data expected in January 2026 [7] - The Phase 2 trial for atopic dermatitis is set to begin in early Q1 2026, targeting approximately 200 patients who have not responded to prior therapies [7] - The Phase 3 registrational trial for soquelitinib in relapsed/refractory peripheral T cell lymphoma (PTCL) is currently enrolling patients across multiple sites, with the final Phase 1/1b results to be presented at the American Society of Hematology Annual Meeting [6][8] Financial Overview - As of September 30, 2025, Corvus reported cash, cash equivalents, and marketable securities totaling $65.7 million, an increase from $52.0 million at the end of 2024, with expectations to fund operations into Q4 2026 [9] - Research and development expenses for Q3 2025 were $8.5 million, up from $5.2 million in Q3 2024, primarily due to increased clinical trial and manufacturing costs [10] - The net loss for Q3 2025 was $10.2 million, a significant reduction from a net loss of $40.2 million in the same period of 2024, which included a non-cash loss related to warrant liability [11] Strategic Collaborations - Corvus is collaborating with the National Institute of Allergy and Infectious Diseases (NIAID) for a Phase 2 clinical trial of soquelitinib in Autoimmune Lymphoproliferative Syndrome (ALPS), aiming to enroll up to 30 patients [5] Product Information - Soquelitinib is an investigational oral small molecule designed to selectively inhibit ITK, which plays a crucial role in T cell immune function, potentially benefiting patients with various cancers and autoimmune diseases [14][18]
Candel Therapeutics to highlight immunotherapy advances at SITC 2025
Proactiveinvestors NA· 2025-11-04 14:54
Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The news team covers medium and small-cap markets, as well as blue-chip companies, commodities, and broader investment stories [3] - Proactive's content includes insights across various sectors such as biotech, pharma, mining, natural resources, battery metals, oil and gas, crypto, and emerging technologies [3] Group 2 - Proactive is committed to adopting technology to enhance workflows and content production [4] - The company utilizes automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]
Compass Therapeutics Presents Preclinical Data on CTX-10726, a Differentiated PD-1 x VEGF-A Bispecific Antibody, at the 40th Society for Immunotherapy of Cancer (SITC) Annual Meeting
Globenewswire· 2025-11-04 14:00
Core Insights - Compass Therapeutics, Inc. is presenting its preclinical development of CTX-10726, a bispecific antibody targeting PD-1 and VEGF-A, at the 40th Society for Immunotherapy of Cancer Annual Meeting [1][3] Company Overview - Compass Therapeutics is a clinical-stage biopharmaceutical company focused on oncology, developing proprietary antibody-based therapeutics to treat various human diseases [4][7] - The company emphasizes the interplay between angiogenesis, the immune system, and tumor growth, aiming to create a robust pipeline of product candidates targeting critical biological pathways for effective anti-tumor responses [4][7] Product Development - CTX-10726 is designed for patients with metastatic or locally advanced tumors, enhancing anti-tumor responses by targeting both immune checkpoints and tumor vasculature [3][5] - The bispecific antibody has shown potent anti-tumor activity in preclinical mouse models, outperforming competitive antibodies like ivonescimab in controlling tumor growth [5][6] - IND submission for CTX-10726 is on track for Q4 2025 [5] Preclinical Data Highlights - In vitro, CTX-10726 demonstrated high-affinity binding to VEGF-A and PD-1, effectively blocking their interactions in a dose-dependent manner [6] - In vivo studies showed superior anti-tumor efficacy in various cancer models, including human lung and colon cancer, with significant tumor size reduction compared to other treatments [6]