ONO PHARMACEUTICAL CO., LTD.

Ono Pharma to Present Positive Phase 2 Data for Tirabrutinib in PCNSL and ONO-4578 in Rectal Cancer at ASCO 2025

a month ago

• Ono Pharmaceutical will present positive results from the Phase 2 PROSPECT study of tirabrutinib for relapsed or refractory primary central nervous system lymphoma at ASCO 2025 in Chicago. • The company will also showcase data on ONO-4578, an investigational EP4 antagonist, in combination with nivolumab for locally advanced resectable rectal cancer during a poster session. • These presentations represent significant progress in Ono's oncology pipeline, reinforcing their commitment to developing innovative treatment options for patients with difficult-to-treat cancers.

Vanda Pharmaceuticals Battles FDA Over Gastroparesis Drug Hearing Delays

a month ago

• Vanda Pharmaceuticals has accused FDA officials of unlawfully delaying a hearing on its gastroparesis drug tradipitant, claiming the agency is using recent staff reductions as a false excuse for a six-month postponement. • The company alleges FDA bureaucrats have systematically avoided scrutiny by denying all new drug approvability hearing requests for at least a decade, calling for Commissioner Makary to intervene. • The dispute centers on tradipitant for gastroparesis, which the FDA rejected in September 2024, claiming the drug failed to demonstrate statistically significant treatment effects.

Roche and Zealand Pharma Forge $5.3 Billion Partnership to Develop Novel Obesity Treatments

2 months ago

• Roche has entered into a $5.3 billion collaboration with Zealand Pharma to co-develop petrelintide, a promising amylin analog for obesity treatment, both as monotherapy and in combination with Roche's incretin asset CT-388. • The partnership includes upfront payments of $1.65 billion to Zealand Pharma, with profits and losses to be shared 50/50 in the US and Europe, while Roche gains exclusive commercialization rights for the rest of the world. • Clinical data suggests petrelintide could deliver weight loss comparable to GLP-1 receptor agonists but with improved tolerability, potentially addressing unmet needs in the obesity market that is projected to affect 4 billion people globally by 2035.

Ionis and Ono Forge $940 Million Deal for Sapablursen in Polycythemia Vera Treatment

2 months ago

• Ionis Pharmaceuticals has licensed sapablursen, an RNA-targeted medicine for polycythemia vera, to Ono Pharmaceutical in a deal worth up to $940 million including $280 million upfront. • Sapablursen, currently in Phase 2 trials, has received FDA Fast Track and Orphan Drug designations and works by increasing hepcidin production to regulate iron homeostasis in PV patients. • Ono will gain exclusive global rights for development and commercialization, while Ionis will complete the ongoing IMPRSSION study before transferring responsibilities.

Seikagaku Launches Phase III Trials for Single-Injection Osteoarthritis Treatment in Japan

3 months ago

• Seikagaku Corporation has initiated three Phase III clinical studies in Japan for Gel-One®, evaluating its efficacy in both knee and hip osteoarthritis patients. • The treatment utilizes a unique cross-linked hyaluronate hydrogel technology, designed to provide long-term pain relief through a single intra-articular injection. • Already available in the US, Taiwan, and Italy for knee osteoarthritis since 2012, the Japanese trials aim to expand treatment options to include hip osteoarthritis.

FDA Approves Vimseltinib for Tenosynovial Giant Cell Tumor Treatment, Showing 40% Response Rate

3 months ago

• The FDA has granted approval to vimseltinib (DCC-3014) for treating symptomatic tenosynovial giant cell tumor (TGCT), based on positive Phase 3 MOTION trial results. • The pivotal MOTION study demonstrated a significant 40% objective response rate for vimseltinib compared to 0% for placebo, with notable improvements in patient mobility and pain. • The twice-weekly oral medication showed a manageable safety profile, with mostly grade 1-2 adverse events, providing a new therapeutic option for TGCT patients.

FDA Gears Up for Critical Decisions on Alzheimer's, Breast Cancer, and Neurological Therapies in Early 2025

5 months ago

• The FDA is set to decide on Biogen and Eisai's Leqembi for monthly intravenous maintenance in early Alzheimer's disease, potentially improving patient convenience. • AstraZeneca and Daiichi Sankyo await a decision on Dato-DXd for metastatic HR-positive, HER2-negative breast cancer, offering a new antibody-drug conjugate approach. • Vertex's suzetrigine, a non-opioid analgesic for moderate-to-severe acute pain, anticipates FDA verdict, representing a novel drug class for pain management. • SpringWorks' mirdametinib is under priority review for neurofibromatosis type 1-associated plexiform neurofibromas, addressing a significant unmet need.

Pfizer's Braftovi Combo Shows Survival Benefit in BRAF-Mutated Metastatic Colorectal Cancer

5 months ago

• Pfizer's Braftovi, combined with cetuximab and mFOLFOX6, significantly improved progression-free survival in metastatic colorectal cancer patients with BRAF V600E mutation. • The BREAKWATER trial demonstrated a clinically meaningful improvement in overall survival with the Braftovi regimen compared to chemotherapy. • The FDA granted accelerated approval to the Braftovi combination in December 2024, marking it as a first-line targeted therapy option. • Pfizer plans to share the BREAKWATER data with regulatory authorities to support full approval and broader use of the Braftovi combination.

Fate Therapeutics Shifts Focus to Autoimmune Diseases with Promising Cell Therapies

5 months ago

• Fate Therapeutics is expanding its focus to autoimmune diseases, leveraging its cell therapy platform with programs like FT819 and FT522. • Clinical progress includes dosing the first SLE patient in a Phase I study with FT819, with preliminary data expected later this year. • The company's strong financial position, with a cash runway extended to the end of 2026, supports ongoing research and development activities. • Upcoming data readouts from FT819 in SLE and FT522 in B-cell malignancies are expected to be critical catalysts for the company.

Merus' Petosemtamab and Mersana's Emi-Le Show Promise in Cancer Treatment

6 months ago

• Merus' petosemtamab demonstrates a 36% overall response rate in recurrent/metastatic head and neck squamous cell carcinoma, with median overall survival of 11.4 months. • Mersana Therapeutics' Emi-Le receives Fast Track designation for HER2-negative breast cancer, showing promising monotherapy activity in multiple tumors. • Petosemtamab's clinical trials are ongoing, including phase 3 studies in HNSCC and expanded evaluation in metastatic colorectal cancer, with data updates planned for 2025.

Advancements in Tenosynovial Giant Cell Tumors Clinical Trials Highlighted for 2024

6 months ago

The Tenosynovial Giant Cell Tumors (TGCT) clinical trials landscape for 2024 showcases significant progress, with over 5 key companies developing more than 5 treatment therapies. Notable developments include the FDA's priority review for vimseltinib, a CSF1R inhibitor, and the EMA's acceptance of its Marketing Authorization Application, signaling a promising future for TGCT treatment.

FDA Accepts Abeona Therapeutics' BLA Resubmission for Prademagene Zamikeracel in RDEB Treatment

6 months ago

• The FDA has accepted Abeona Therapeutics' resubmitted Biologics License Application (BLA) for prademagene zamikeracel (pz-cel) for recessive dystrophic epidermolysis bullosa (RDEB). • Pz-cel, an autologous cell-based gene therapy, aims to address the unmet needs of RDEB patients by providing collagen VII expression at wound sites. • The BLA is supported by data from the Phase 3 VIITAL study and a Phase 1/2a study with up to 8 years of follow-up, showcasing clinical efficacy and safety. • The FDA has set a PDUFA target action date of April 29, 2025, with potential for Abeona to receive a Priority Review Voucher upon approval.

Fate Therapeutics' FT825 Shows Promise in HER2-Targeting CAR T-Cell Therapy for Solid Tumors

6 months ago

• Fate Therapeutics presented initial Phase 1 data for FT825 / ONO-8250, a HER2-targeting CAR T-cell therapy, showing a favorable safety profile in advanced solid tumors. • Preclinical data highlights FT825's cancer-selective HER2 recognition, potentially reducing off-target toxicities compared to existing HER2-directed therapies. • The Phase 1 study observed CAR T-cell expansion and activation in patients' peripheral blood, indicating potential for effective tumor targeting. • FT825 incorporates novel synthetic controls designed to enhance safety and efficacy in treating solid tumors, addressing limitations of current CAR T-cell therapies.

Fate Therapeutics Presents Promising Early Data for FT825/ONO-8250 CAR-T Therapy in Solid Tumors

6 months ago

• Fate Therapeutics' FT825/ONO-8250, a HER2-targeting CAR-T cell therapy, shows a favorable safety profile in an early-stage trial for advanced solid tumors. • Preclinical data highlights the therapy's cancer-selective HER2 targeting, reducing off-tumor toxicities compared to traditional HER2-directed treatments. • Initial results from the Phase 1 study indicate CAR T-cell expansion and activation in patients, suggesting potential for clinical efficacy. • The FT825 / ONO-8250 incorporates seven novel synthetic controls of CAR T-cell function designed to overcome multiple mechanisms.

Shattuck Labs Prioritizes SL-325, a DR3 Antagonist, for Inflammatory Bowel Disease

8 months ago

• Shattuck Labs discontinues the clinical program for SL-172154 after modest survival improvements in TP53m AML and HR-MDS patients compared to azacitidine monotherapy. • The company will now focus on SL-325, a first-in-class DR3 antagonist antibody, targeting the TL1A/DR3 signaling pathway for inflammatory bowel disease (IBD) treatment. • An Investigational New Drug (IND) application for SL-325 is expected to be filed in Q3 2025, with preclinical studies showing high affinity binding and superior efficacy over TL1A antibodies. • Restructuring, including a 40% workforce reduction, extends Shattuck's cash runway into 2027, supporting the development of SL-325 through Phase 1 clinical trials.

BMI Thresholds Impact Mortality Risk in NSCLC Immunotherapy vs. Chemotherapy

8 months ago

• A study of over 500,000 lung cancer patients reveals that BMI affects mortality risk differently in immunotherapy versus chemotherapy. • For NSCLC patients with a BMI under 28, immunotherapy was associated with lower mortality compared to chemotherapy. • In patients with a BMI of 28 or higher, chemotherapy showed a continued decrease in mortality risk, while immunotherapy's risk increased. • Findings suggest BMI should be considered when selecting treatment for advanced non-small cell lung cancer.