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Genenta Announces Long-Term Follow-Up Observations in Brain Tumor (GBM) Study with Emerging Survival Signals
Globenewswire· 2025-07-01 09:00
Genitourinary Tumor Study Ongoing with Active Screening and EnrollmentMILAN and NEW YORK, July 01, 2025 (GLOBE NEWSWIRE) -- Genenta Science (Nasdaq: GNTA), a pioneer in immuno-oncology, today announced that a total of 38 patients were enrolled in newly diagnosed glioblastoma multiforme (TEM-GBM) study, with 25 patients receiving Temferon. Two patients have been enrolled in the TEM-LT long-term follow-up study, surviving three years from the time of 1st surgery. One of these long-term survivors has not exper ...
Aptose Announces Deferral of Interest Payment
Globenewswire· 2025-06-30 21:00
SAN DIEGO and TORONTO, June 30, 2025 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc. ("Aptose" or the "Company") (TSX: APS; OTC: APTOF), a clinical-stage precision oncology company developing a tuspetinib (TUS) based triple drug frontline therapy to treat patients with newly diagnosed acute myeloid leukemia (AML), announced that it has entered into an Interest Deferral Agreement (the “Agreement”) with Hanmi Pharmaceutical Co., Ltd. (“Hanmi”), whereby Hanmi has agreed to further defer the interest payment due un ...
I-Mab Announces Publication of Givastomig Monotherapy Data in Clinical Cancer Research
Globenewswire· 2025-06-30 20:01
Monotherapy efficacy and safety profile provided backbone for clinical development strategy in 1L combination with nivolumab plus chemotherapy ROCKVILLE, MD, June 30, 2025 (GLOBE NEWSWIRE) -- I-Mab (NASDAQ: IMAB) (the Company), a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer, today announced publication of the first-in-human monotherapy data for givastomig, a bispecific Claudin 18.2 x 4-1BB antibody, in Clinical Cancer Research ...
I-Mab Highlights Positive Givastomig Phase 1b Dose Escalation Data in Combination with Immunochemotherapy in Patients with 1L Gastric Cancers at ESMO GI 2025
Globenewswire· 2025-06-26 10:30
71% objective response rate (ORR) (12/17) per RECIST v1.1, with a favorable safety profile 83% ORR (10/12) in patients across doses selected for ongoing dose expansion study Responses observed in patients with low PD-L1 and/or CLDN18.2 expression Updated results to be presented at ESMO GI on July 2nd Company to host investor event on July 8th ROCKVILLE, Md., June 26, 2025 (GLOBE NEWSWIRE) -- I-Mab (NASDAQ: IMAB) (the “Company”), a U.S.-based, global biotech company, focused on the development of precision i ...
Will New Drugs Enable BMY to Offset the Impact of Generic Competition?
ZACKS· 2025-06-25 15:05
Key Takeaways BMY faces generic pressure on key drugs like Revlimid and Pomalyst, plus Medicare Part D headwinds. New drugs like Reblozyl, Opdualag and Breyanzi are driving growth amid strong uptake and new approvals. BMY trades at 7.34x forward earnings, below its average and the broader large-cap pharma industry.Bristol Myers (BMY) depends on newer drugs like Opdualag, Reblozyl and Breyanzi to stabilize its revenue base as its legacy drugs face generic competition.Legacy Portfolio is adversely impacted ...
Aprea Reports Anti-Proliferative Results and Promising Early-Stage Clinical Data for Next-Generation WEE1 Inhibitor, APR-1051, in HPV+ Head and Neck Squamous Cell Carcinoma (HNSCC) in Collaboration with MD Anderson Cancer Center
Globenewswire· 2025-06-25 13:00
Core Insights - Aprea Therapeutics announced promising preclinical data and an initial clinical update for APR-1051, a next-generation oral WEE1 inhibitor targeting HPV+ head and neck squamous cell carcinoma (HNSCC) [1][2] - The findings suggest that APR-1051 may provide significant differentiation in oncology, both as a single agent and in combination with checkpoint inhibitors [2] Preclinical Data - Preclinical studies conducted in collaboration with MD Anderson Cancer Center demonstrated robust antiproliferative effects of APR-1051 across various human and murine head and neck cancer cell lines, with IC₅₀ values ranging from 8.9 to 230 nM [6] - Significant anti-tumor synergy was observed when combining APR-1051 with anti–PD-1 therapies in HPV+ HNSCC models, indicating its potential for combination-based clinical trials [6] - Mechanistically, APR-1051 activates cGAS/STING-mediated immunogenic cell death and exploits the HPV E6-driven G2 checkpoint dependency in HPV+ tumors, highlighting a biomarker-driven strategy for patient selection [6] Clinical Update - In the Phase 1 ACESOT-1051 trial, a 62-year-old male patient with advanced HPV-positive oropharyngeal squamous cell carcinoma showed stable disease and a 5% tumor reduction after treatment with a subtherapeutic 70 mg oral dose of APR-1051 [7] - The patient tolerated the therapy well, with no dose-limiting toxicities reported [7] Future Development - Experts from MD Anderson Cancer Center expressed optimism regarding APR-1051 as a promising addition to the treatment portfolio for HPV-associated head and neck cancers, supported by robust preclinical data [8] - Aprea is committed to advancing APR-1051 as a precision oncology agent, leveraging biomarker insights to optimize patient outcomes [8][9] - Enrollment in the ACESOT-1051 trial is ongoing, with plans to evaluate APR-1051 in combination with checkpoint inhibitors for distinct patient populations [12]
Akari Therapeutics Releases Virtual Investor “What This Means” Segment Highlighting its Recently Granted India Patent
GlobeNewswire News Room· 2025-06-25 13:00
Company Overview - Akari Therapeutics is an oncology biotechnology company focused on developing novel immuno-oncology payload antibody drug conjugates (ADCs) for cancer treatment [2][4] - The company has developed its first novel payload, PH1, which is a spliceosome inhibitor designed to disrupt RNA splicing within cells, differentiating it from current ADC payloads [4] Recent Developments - Akari Therapeutics recently participated in a Virtual Investor segment where CEO Abizer Gaslightwala discussed the issuance of India Patent No. 562,919 for "Thailanstatin Analogs," which covers claims for its PH1 payload and ADC technology [3] - The PH1 payload has shown significant activity in preclinical studies, inducing cancer cell death and activating immune cells, leading to robust and durable activity [4] Product Pipeline - The lead candidate, AKTX-101, targets the Trop2 receptor on cancer cells and utilizes a proprietary linker to deliver the PH1 payload directly into tumors [4] - AKTX-101 has demonstrated significant activity and prolonged survival in preclinical studies compared to traditional ADCs, and it has potential synergistic effects with checkpoint inhibitors [4]
Portage Biotech Regains Full Compliance with Nasdaq Continued Listing Requirements
Globenewswire· 2025-06-25 11:00
DOVER, Del., June 25, 2025 (GLOBE NEWSWIRE) -- Portage Biotech Inc. (“Portage” or the “Company”) (NASDAQ: PRTG), a clinical-stage immuno-oncology company formed under the laws of the British Virgin Islands (“Portage”), announced today that on June 24, 2025, the Company received formal notice from The Nasdaq Stock Market LLC that the Company has evidenced compliance with all applicable requirements for continued listing on The Nasdaq Capital Market. About Portage BiotechPortage Biotech is a clinical-stage im ...
Syndax Announces FDA Priority Review of sNDA for Revuforj® (revumenib) in Relapsed or Refractory mNPM1 Acute Myeloid Leukemia
GlobeNewswire News Room· 2025-06-24 20:01
– PDUFA action date set for October 25, 2025 – – sNDA being reviewed under FDA’s RTOR program – – Revumenib has the potential to become the first and only menin inhibitor approved in both R/R mNPM1 AML and R/R KMT2Ar acute leukemia – NEW YORK, June 24, 2025 (GLOBE NEWSWIRE) -- Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for its supplemen ...
EXEL Stock Rises on Positive Data From Colorectal Cancer Study
ZACKS· 2025-06-24 14:41
Key Takeaways More on EXEL's STELLAR-303 Study on Zanzalintinib Zanzalintinib is a third-generation oral tyrosine kinase inhibitor that inhibits the activity of receptor tyrosine kinases implicated in cancer growth and spread, including VEGF receptors, MET, AXL and MER. The STELLAR-303 study met one of its two dual primary endpoints, demonstrating a statistically significant improvement in overall survival (OS) for the intent-to-treat (ITT) population when treated with zanzalintinib in combination with Tece ...