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Hoth Therapeutics Secures Japanese Patent for Novel Mast Cell-Targeting Platform HT-KIT

Orphan DrugOncology
  • Hoth Therapeutics received Japan Patent No. 7677628 for its HT-KIT platform, providing exclusive protection until August 27, 2039.
  • The patented technology uses splice-switching oligonucleotides to selectively disrupt KIT gene expression in mast cells implicated in chronic hives and rare cancers.
  • The patent positions HT-KIT for orphan indications and expedited regulatory pathways, with potential applications in mast cell-driven inflammatory and oncologic conditions.
  • The company sees strategic licensing opportunities across Asia as it advances this novel therapeutic platform.

FDA Approves New Tablet Formulation of BRUKINSA for All Indications, Reducing Pill Burden for B-Cell Cancer Patients

Drug ApprovalOncology
  • The U.S. FDA has approved a new tablet formulation of BRUKINSA (zanubrutinib) for all five approved indications, reducing daily pill burden from four capsules to two tablets while maintaining the same 320 mg daily dose.
  • The new 160 mg tablets demonstrate bioequivalence to the existing capsules based on Phase 1 crossover studies and offer improved patient convenience with smaller size and film coating for easier swallowing.
  • BRUKINSA has achieved market leadership as the top BTK inhibitor in the U.S. and leads in new chronic lymphocytic leukemia patient starts across all therapy lines.
  • The tablet formulation will replace capsules starting in October 2025, with European regulatory approval expected later this year.

A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma

NCT03332017CompletedPhase 2
BeiGene
Posted 11/14/2017

Safety and Tolerability Study of PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia

NCT01109069CompletedPhase 2
Pharmacyclics LLC.
Posted 6/1/2010

Study of Ibrutinib in Patients With Symptomatic, Previously Untreated Waldenstrom's Macroglobulinemia, and Impact on Tumor Genomic Evolution Using Whole Genome Sequencing

NCT02604511CompletedPhase 2
Dana-Farber Cancer Institute
Posted 1/1/2016

A Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

NCT01578707CompletedPhase 3
Pharmacyclics LLC.
Posted 6/1/2012

Ibrutinib With Rituximab in Adults With Waldenström's Macroglobulinemia

NCT02165397CompletedPhase 3
Pharmacyclics LLC.
Posted 7/7/2014

Bioequivalence of a Zanubrutinib Tablet Compared to Capsules in Healthy Adult Participants

NCT05767398CompletedPhase 1
BeiGene
Posted 3/7/2023

Ibrutinib (PCI-32765) in Waldenstrom's Macroglobulinemia

NCT01614821CompletedPhase 2
Dana-Farber Cancer Institute
Posted 5/1/2012

Open-label Phase 3 BTK Inhibitor Ibrutinib vs Chlorambucil Patients 65 Years or Older With Treatment-naive CLL or SLL

NCT01722487CompletedPhase 3
Pharmacyclics LLC.
Posted 3/1/2013

Relative Bioavailability of Zanubrutinib Tablets Compared to Capsules and Effects of Food on the Pharmacokinetics of the Tablet in Healthy Adults

NCT05547399CompletedPhase 1
BeiGene
Posted 6/7/2022

Bristol Myers Squibb Acquires Novel Prostate Cancer Radiopharmaceutical for $1.35 Billion

Targeted TherapyOncology
  • Bristol Myers Squibb agreed to pay $350 million upfront to Philochem for worldwide rights to OncoACP3, an experimental radiopharmaceutical targeting the ACP3 protein for prostate cancer diagnosis and treatment.
  • OncoACP3 targets ACP3, a biomarker highly expressed in prostate cancer that potentially exceeds PSMA expression levels, offering an alternative pathway to current PSMA-targeted therapies.
  • The deal includes up to $1 billion in additional milestone payments and royalties, positioning Bristol Myers to compete with Novartis in the rapidly expanding radiopharmaceutical market.
  • RayzeBio, Bristol Myers' radiopharmaceutical subsidiary acquired for $4.1 billion, will lead development of OncoACP3 through Phase 1 therapeutic testing.

Oncolytics Biotech Appoints $2B Deal Architect as CEO to Advance Pelareorep Immunotherapy

Oncology
  • Oncolytics Biotech has appointed Jared Kelly as CEO, leveraging his expertise from orchestrating the $2 billion sale of Ambrx Biopharma to Johnson & Johnson.
  • The company's lead immunotherapy pelareorep has achieved FDA Fast Track designation for metastatic pancreatic and breast cancers, with >60% objective response rates in pancreatic cancer trials.
  • Pelareorep demonstrated survival benefits 4-6 times higher than historical controls in pancreatic cancer and meaningful survival improvements in over 100 metastatic breast cancer patients.
  • The appointment aims to accelerate pelareorep's development toward registrational studies and potential strategic partnerships in the immunotherapy space.

Cantargia's Nadunolimab Receives FDA Fast Track Designation for Metastatic Pancreatic Cancer

Monoclonal AntibodyOncology
  • The FDA has granted Fast Track Designation to nadunolimab, Cantargia's anti-IL1RAP antibody, for treating previously untreated metastatic pancreatic ductal adenocarcinoma with high IL1RAP expression levels.
  • The designation follows strong clinical data from the CANFOUR study showing 35% two-year survival, 14.2 months overall survival, and 48% overall response rate in patients with high IL1RAP expression.
  • Fast Track Designation provides benefits including more frequent FDA meetings, eligibility for Accelerated Approval and Priority Review, and rolling review opportunities for the Biologic License Application.
  • The recognition addresses the high unmet medical need in metastatic pancreatic cancer, where current treatment options are limited and overall survival after first-line treatment is typically less than 12 months.

A First-in-Human Study of CAN04 in Patients With Solid Malignant Tumors

NCT03267316CompletedPhase 1
Cantargia AB
Posted 9/19/2017

Nadunolimab in Combination with Gemcitabine Plus Carboplatin in Patients with Advanced Triple Negative Breast Cancer.

NCT05181462Active, Not RecruitingPhase 1
Cantargia AB
Posted 1/11/2022

BioInvent's BI-1206 Shows Promising Phase 1 Results in Combination with Pembrolizumab for Solid Tumors

Monoclonal AntibodyOncology
  • BioInvent's Phase 1 study of BI-1206 combined with pembrolizumab demonstrated encouraging clinical activity in heavily pre-treated solid tumor patients, with one complete response and one partial response among 36 evaluable patients.
  • The combination therapy was well-tolerated and showed potential to overcome resistance mechanisms to anti-PD-1 treatment by targeting FcγRIIB expressing immune cells.
  • Based on these promising results, BioInvent plans to initiate Phase 2a expansion cohorts in H2 2025 for treatment-naïve patients with advanced NSCLC and uveal melanoma.
  • The study supports transitioning from intravenous to subcutaneous formulation of BI-1206, which may enhance therapeutic impact and improve safety profiles.

A Study of BI-1206 in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors (KEYNOTE-A04)

NCT04219254RecruitingPhase 1
BioInvent International AB
Posted 6/29/2020

Day One Biopharmaceuticals Appoints Michael Vasconcelles as Head of R&D to Drive Pipeline Expansion

OncologyTargeted TherapyLeadership Change
  • Day One Biopharmaceuticals has appointed Michael Vasconcelles, M.D., as Head of Research and Development, bringing over 25 years of oncology research and development expertise to the company.
  • Dr. Vasconcelles will oversee the company's research, development, and medical affairs infrastructure while supporting OJEMDA's growth and expanding the pipeline of targeted therapies.
  • The appointment comes at a pivotal time for Day One as it transitions from focusing primarily on pediatric cancer to developing transformative medicines for patients of all ages with life-threatening diseases.
  • Dr. Vasconcelles previously served as Executive Vice President at ImmunoGen, where he led the transformation into a global biotech enterprise and optimized ELAHERE's commercialization strategy.

Curadev and Memorial Sloan Kettering Expand Collaboration to Advance Novel STING Agonist CRD3874-SI

Oncology
  • Curadev Pharma and Memorial Sloan Kettering Cancer Center are expanding their collaboration through MSK's Therapeutics Accelerator program to advance development of CRD3874-SI, a first-in-class allosteric STING agonist.
  • The collaboration builds on an ongoing Phase 1a/b clinical trial for sarcoma and Merkel cell carcinoma patients and aims to explore CRD3874-SI's potential in additional cancer types.
  • CRD3874-SI has demonstrated encouraging safety and efficacy profiles in first-in-human studies and is moving forward into multiple solid-tumor expansion cohorts.
  • The expanded partnership provides Curadev with MSK's expertise and institutional resources, including medical, clinical, and regulatory advice to accelerate drug development.

A Study of CRD3874-SI in People With Solid Tumors

NCT06021626RecruitingPhase 1
Memorial Sloan Kettering Cancer Center
Posted 8/25/2023

Silicogenix Partners with BioDuro to Accelerate AI-Driven Drug Discovery for Complex Diseases

AIDrug DiscoveryOncology
  • Silicogenix, a pioneer in AI-powered small molecule design technology, has formed a strategic partnership with global CRDMO BioDuro to streamline drug discovery for complex and rare diseases.
  • The collaboration combines SGX's proprietary polypharmacology frameworks with BioDuro's integrated drug discovery platform to reduce development costs and timelines from concept to preclinical stages.
  • SGX's technology enables access to the majority of the human proteome and supports novel therapeutic approaches including combination therapies with standard-of-care treatments.
  • The partnership aims to accelerate development of first-in-class oncology and immunology therapeutics that address significant unmet medical needs in complex disease areas.

Antares Therapeutics Launches with $177 Million Series A to Advance First-in-Class Cancer Precision Medicines

Precision MedicineOncology
  • Antares Therapeutics launched with $177 million in Series A financing co-led by five major healthcare investment firms to develop first-in-class precision medicines for cancer and other serious diseases.
  • The company is a spin-out of Scorpion Therapeutics, which recently sold its PI3Kα inhibitor program STX-478 to Eli Lilly for up to $2.5 billion in March 2025.
  • Led by Scorpion's former executive team, Antares plans to advance its first new product candidate into clinical trials in 2026, focusing on previously undruggable targets including transcription factors.
  • Pierre Fabre Laboratories acquired global rights to two clinical-stage mutant EGFR inhibitor programs for non-small cell lung cancer treatment from the company's pipeline.

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