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Karyopharm's Phase 3 SENTRY Trial in Myelofibrosis Met First Co-Primary Endpoint, Demonstrating Statistically Significant Improvement in Spleen Volume Reduction
Prnewswire· 2026-03-24 11:00
– While Similar Symptom Improvement Was Observed Across the Two Arms Relative to Baseline, SENTRY Did Not Meet its Second Co-Primary Endpoint of Abs-TSS – – SENTRY Demonstrated a Rapid and Near Doubling of Patients Achieving SVR35 at Week 24, versus Ruxolitinib – – Promising Overall Survival Signal with >50% Reduction of Risk of Death versus Ruxolitinib – – Evidence of Potential Disease Modification with More Patients Achieving 20% Reductions in VAF as Early as Week 24 versus Ruxolitinib – – No New Safety S ...
AIM ImmunoTech Stock Gains Over Final Approval Of Novel Cancer Therapy Patent In Japan
RTTNews· 2026-03-18 16:26
Shares of AIM ImmunoTech Inc. (AIM) are climbing about 80 percent on Wednesday morning trading after the Japan Patent Office approved a Japanese patent covering the company's proprietary use of Ampligen (rintatolimod) in combination with checkpoint inhibitors for the treatment of cancer.The company's shares are currently trading at $1.28 on the New York Stock Exchange American, up 80.28 percent. The stock opened at $1.45 and has climbed as high as $1.62 so far in today's session. Over the past year, it has ...
AIM ImmunoTech Announces Final Approval of Novel Cancer Therapy Patent in Japan Combining Ampligen with Checkpoint Inhibitors
Globenewswire· 2026-03-18 12:36
Core Viewpoint - AIM ImmunoTech Inc. has received full approval for a Japanese patent covering the use of Ampligen in combination with checkpoint inhibitors for cancer treatment, particularly pancreatic cancer, which is expected to see a significant increase in burden by 2030 [1][2]. Group 1: Patent and Intellectual Property - The Japanese patent covers the use of Ampligen in combination with checkpoint inhibitors for treating various cancer types, including pancreatic cancer [2]. - AIM holds additional patents in the U.S. and the Netherlands for similar uses of Ampligen, with expiration dates in August 2039 and December 2039, respectively [2]. - The company plans to expand its intellectual property portfolio by pursuing orphan drug designation in Japan for Ampligen in treating pancreatic cancer, complementing existing designations in the U.S. and EU [3]. Group 2: Market Context and Strategy - Japan is identified as a key global market for health, with significant expected increases in pancreatic cancer cases by 2030 [1]. - The company emphasizes its commitment to developing Ampligen for late-stage pancreatic cancer, addressing a critical unmet health need [3]. - The patent's approval is part of AIM's broader development and commercialization strategy [3]. Group 3: Product Information - Ampligen (rintatolimod) is described as a dsRNA and highly selective TLR3 agonist immuno-modulator that has demonstrated broad-spectrum activity in clinical trials [4].
SELLAS Life Sciences to Present Preclinical Data Highlighting Potent Activity of SLS009 in AML at the 2026 AACR Conference
Globenewswire· 2026-03-17 20:30
- Preclinical data show that SLS009 lowers the apoptotic threshold in AML cells by suppressing critical survival pathways -NEW YORK, March 17, 2026 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced that preclinical data on SLS009 (tambiciclib), a potent, selective CDK9 inhibitor, will be presented in a poster ses ...
Ascentage Pharma to Participate in Three Upcoming Investor Conferences
Globenewswire· 2026-02-23 13:00
Core Viewpoint - Ascentage Pharma Group International is actively participating in investor conferences to enhance its visibility and engagement with investors, showcasing its innovative therapies for cancer treatment [1][8]. Company Overview - Ascentage Pharma is a global, commercial stage biopharmaceutical company focused on discovering, developing, and commercializing novel therapies to meet unmet medical needs in cancer [3]. - The company has developed a robust pipeline of innovative drug products, including inhibitors targeting key proteins in the apoptotic pathway and next-generation kinase inhibitors [3]. Key Products - The lead asset, Olverembatinib, is the first third-generation BCR-ABL1 inhibitor approved in China for treating chronic myeloid leukemia (CML) with T315I mutations and is included in the China National Reimbursement Drug List [4]. - The second approved product, Lisaftoclax, is a novel Bcl-2 inhibitor for treating various hematologic malignancies and is currently being commercialized in China [5]. Clinical Trials - Ascentage Pharma is conducting a global registrational Phase III trial, POLARIS-2, for Olverembatinib in CML, along with additional Phase III trials for newly diagnosed Ph+ acute lymphoblastic leukemia (ALL) and SDH-deficient gastrointestinal stromal tumors (GIST) [4]. - The company is also running four global registrational Phase III trials for Lisaftoclax, including studies in chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and acute myeloid leukemia (AML) [5]. Partnerships and Collaborations - Ascentage Pharma has established a portfolio of global intellectual property rights and formed partnerships with leading biotechnology and pharmaceutical companies, including Takeda, AstraZeneca, Merck, and Pfizer [6].
Intensity Therapeutics, Inc. to Present Two Posters at the 2025 San Antonio Breast Cancer Symposium
Prnewswire· 2025-12-11 12:47
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]
Pliant Cancer Drug Boosts Responses When Paired With Merck's Blockbuster Keytruda In Tough-To-Treat Tumors
Benzinga· 2025-12-04 18:53
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].
Intensity Therapeutics Announces Two Presentations at the Upcoming 2025 San Antonio Breast Cancer Symposium
Prnewswire· 2025-12-04 12:47
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]
Shuttle Pharmaceuticals (SHPH) - Prospectus
2025-11-18 22:00
(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 ...
Targeting Adhesion Molecules With ADC's: The Bet Of CytomX
Seeking Alpha· 2025-11-11 09:04
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]