Core Insights - Intensity Therapeutics, Inc. is presenting two posters at the San Antonio Breast Cancer Symposium, focusing on its investigational drug INT230-6 for treating Triple Negative Breast Cancer (TNBC) [1][2] Study Observations - The INVINCIBLE-4 study, initiated in 2024, has treated 14 patients, with 7 in each cohort, showing favorable safety data [3][6] - Cohort A (INT230-6 plus standard of care) exhibited 50% fewer grade 3 or higher adverse events compared to Cohort B (standard of care alone) [5][6] - Specific adverse events included 9 grade 3 or higher events in Cohort A versus 20 in Cohort B [6] Clinical Trial Details - The ongoing Phase II randomized clinical trial is evaluating INT230-6's safety and efficacy in early-stage TNBC patients [5][11] - A potential Phase 3 study design may include INT230-6 with standard of care, with and without the anthracycline doxorubicin, aiming for improved safety and efficacy [8][9] Drug Mechanism and Composition - INT230-6 is designed for direct intratumoral injection, combining cisplatin and vinblastine sulfate with a diffusion enhancer to improve drug delivery within tumors [13] - The drug aims to elicit an immune response while minimizing systemic toxicity, a common issue with traditional chemotherapy [13][14] Market Context - TNBC represents a significant challenge in breast cancer treatment, with approximately 56,000 new cases diagnosed annually in the U.S. and 420,000 worldwide [11] - Current standard treatments often involve high toxicity, with 80% of patients experiencing severe adverse events [11] Regulatory Pathway - The FDA's Accelerated Approval Program may facilitate INT230-6's approval based on pathological complete response (pCR) as a surrogate endpoint [12] - If successful, this could lead to a safer treatment regimen for TNBC patients, potentially avoiding the use of highly toxic agents like doxorubicin [11][12]

Core Viewpoint - Pliant Therapeutics is gaining attention due to promising interim trial results for its cancer therapy, PLN-101095, despite a significant decline in its stock price [1][8]. Group 1: Trial Results - Pliant Therapeutics released interim data from its Phase 1 dose escalation trial of PLN-101095, which was evaluated in combination with Merck's Keytruda for patients with immune checkpoint inhibitor-refractory advanced or metastatic solid tumors [2]. - In a heavily pretreated patient population, PLN-101095 demonstrated antitumor activity, with four responders identified, including one confirmed complete response and three partial responses [3][4]. - Clinical responses were observed in various cancer types, including cholangiocarcinoma, melanoma, head and neck squamous cell carcinoma, and non-small cell lung cancer [4]. Group 2: Patient Outcomes - The median time on treatment for patients was 15 months, with 60% of secondary refractory patients showing stable disease or tumor reduction [5]. - All responding patients exhibited significant increases in plasma interferon gamma (IFN-γ) levels after a 14-day monotherapy run-in period, while non-responders did not show meaningful increases [5]. Group 3: Safety and Future Plans - PLN-101095 was generally well tolerated across all tested doses and exhibited a dose-dependent pharmacokinetic profile [6]. - Pliant plans to accelerate the development of PLN-101095 with a Phase 1b indication expansion trial set to begin in 2026, focusing on non-small cell lung cancer and other tumor types [7].

Core Insights - Intensity Therapeutics, Inc. is a late-stage clinical biotechnology company focused on developing proprietary cancer therapies using non-covalent drug-conjugation technology aimed at killing tumors and enhancing immune system recognition of cancers [1][4] Presentations - The company will present two studies at the 2025 San Antonio Breast Cancer Symposium, including a focus on a new drug offering safer breast cancer therapy combinations and early observations from a Phase II randomized clinical trial involving intratumoral injections of INT230-6 [2][3] Product Overview - INT230-6 is the lead investigational product candidate designed for direct intratumoral injection, combining cisplatin and vinblastine sulfate with a diffusion enhancer to improve drug dispersion within tumors, leading to effective tumor killing and immune engagement without immunosuppression [3][4] Clinical Trials - Intensity has completed two clinical studies with over 200 patients using INT230-6, including a Phase 1/2 study in metastatic cancers and a Phase 2 randomized control trial in locally advanced breast cancer, with ongoing trials evaluating INT230-6 in soft tissue sarcoma and presurgical triple-negative breast cancer [4][5]

(Exact name of registrant as specified in its charter) FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 SHUTTLE PHARMACEUTICALS HOLDINGS, INC. As filed with the Securities and Exchange Commission on November 18, 2025 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 401 Professional Drive, Suite 260 Gaithersburg, MD 20879 (240) 430-4212 (Address, including zip code, and telephone number, including area code, of registrant's principal executive offi ...

Group 1 - Antibody-drug conjugates (ADCs) are specialized antibodies designed to target specific proteins while delivering active agents, primarily utilized in cancer therapy [1] - ADCs enhance the precision of cancer treatment by targeting proteins expressed by cancer cells, allowing for the delivery of potent therapeutic agents directly to the tumor [1] Group 2 - ELAM1 provides financial professionals and investors with the necessary scientific and clinical expertise to navigate the healthcare sector, focusing on uncovering hidden value and assessing risks [1]

Core Insights - Aprea Therapeutics, Inc. has provided an update on the Phase 1 ACESOT-1051 study, showing promising results for its WEE1 inhibitor, APR-1051, in patients with advanced solid tumors [1][2][5] Study Results - At the 100 mg dose level of APR-1051, 3 out of 4 patients achieved stable disease according to RECIST v1.1 criteria [1][5][6] - Disease stabilization was observed in patients with tumors harboring mutations relevant to WEE1 kinase inhibition, specifically FBXW7, CCNE1, KRAS, and TP53 [5][6][11] - The trial is currently progressing to a higher dose level of 150 mg following successful results from the 100 mg cohort [5][6] Presentation and Data - Preliminary results from the ACESOT-1051 trial will be presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics [2][5] - The poster presentation will summarize updated data with a cutoff date of September 17, 2025 [2] Company Overview - Aprea Therapeutics focuses on developing innovative cancer therapies that target specific vulnerabilities in cancer cells while minimizing damage to healthy cells [7] - The company's clinical programs include APR-1051, an oral small-molecule inhibitor of WEE1 kinase, and ATRN-119, a macrocyclic small molecule ATR inhibitor [7]

Core Insights - Aprea Therapeutics, Inc. announced the acceptance of two abstracts for poster presentations at the EORTC-NCI-AACR International Conference on Molecular Targets and Cancer Therapeutics, scheduled for October 22 - 26, 2025 [1] Group 1: Clinical Programs - The first abstract focuses on APR-1051, a novel WEE1 inhibitor, detailing early safety and efficacy data from the ACESOT-1051 phase 1 trial [2] - The second abstract presents updated data from the ABOYA-119 trial, which involves ATRN-119, a macrocyclic ATR inhibitor, in patients with advanced solid tumors [2] Group 2: Company Mission and Approach - Aprea's mission is to develop innovative cancer therapies that specifically target cancer cells while minimizing damage to healthy cells, aiming to reduce toxicity associated with conventional treatments [3] - The company is currently developing APR-1051 and ATRN-119 for solid tumor indications, utilizing unique vulnerabilities in cancer cell mutations [3]

Core Insights - Moderna is planning to launch up to 10 new marketed products over the next four years, targeting a market opportunity exceeding $30 billion, which is crucial for driving revenue growth and reducing reliance on the COVID-19 vaccine Spikevax [1][8] Product Portfolio and Market Strategy - Spikevax, Moderna's first marketed product, significantly boosted its profitability but has seen a sharp decline in sales as pandemic demand wanes. The company introduced a second product, the RSV vaccine mResvia, but its uptake was weaker than anticipated. Recently, Moderna received approval for a third product, mNexspike, a next-generation version of Spikevax [2][8] - To counteract declining COVID-19 vaccine sales, Moderna is advancing a late-stage pipeline focused on respiratory, infectious diseases, and oncology. Key vaccine programs include mRNA-1647 for CMV, mRNA-1083 for COVID-19 plus influenza, and mRNA-1010 for standalone influenza, with data expected from the CMV study and a regulatory resubmission for the COVID/flu combination vaccine by the end of 2025 [3][8] Cancer Therapy Development - A significant candidate in Moderna's pipeline is intismeran autogene (formerly mRNA-4157), a personalized cancer therapy developed in collaboration with Merck. This therapy is undergoing evaluation in three pivotal phase III studies for melanoma and non-small cell lung cancer, with additional mid-stage studies for high-risk bladder cancers and other indications. A potential launch is targeted for 2027 [4][8] Competitive Landscape - Moderna faces stiff competition from Pfizer and BioNTech, both of which have experienced revenue fluctuations due to declining demand for their jointly developed COVID-19 vaccine, Comirnaty. These companies are also diversifying into adjacent vaccine and therapeutic areas, including a COVID-19 and influenza combination vaccine [5][6] - BioNTech is focusing on oncology as a long-term growth driver, with key candidates like BNT327, an investigational antibody targeting PD-1 and VEGF, being evaluated across various cancer indications [7]

Welcome back. Mark getting FDA approval for an injectable version of its blockbuster cancer therapy. Kitruda Angelica Peoples here with the story fresh off an interview with the CEO.Angelica. Hey Leslie. Well, MK thinks that this shot will be an attractive option for patients since it could be administered in about a minute in a doctor's office versus 30 minutes at a hospital or an infusion center.And the shot's also a way for Merc to manage the IV form of Kruda going off patent in 2028. And Merc hasn't spe ...

Core Insights - The U.S. Food and Drug Administration has approved a new formulation of Merck's cancer therapy Keytruda, allowing for subcutaneous administration, which enhances convenience for patients [1] Company Summary - Merck's Keytruda is a leading cancer therapy, and the new formulation is expected to improve patient compliance and comfort [1] Industry Summary - The approval of the subcutaneous formulation reflects ongoing innovation in cancer treatment delivery methods, potentially influencing market dynamics and competitive positioning within the oncology sector [1]