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Bezuclastinib Achieves 87% Response Rate in Pivotal Trial for Non-Advanced Systemic Mastocytosis

Rare DiseasePrecision MedicineOncology
  • Cogent Biosciences' bezuclastinib demonstrated superior symptom improvement with a placebo-adjusted difference of 8.91 points in total symptom score at 24 weeks (p=0.0002) in the SUMMIT trial.
  • The drug showed remarkable efficacy on mast cell burden, with 87.4% of patients achieving at least 50% reduction in serum tryptase compared to 0% in the placebo group.
  • Bezuclastinib exhibited a favorable safety profile with most adverse events being low-grade, supporting its potential for chronic use in systemic mastocytosis patients.
  • The company plans to submit a New Drug Application to the FDA by the end of 2025 based on these positive results from the registration-directed trial.

(Summit) a Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients with Indolent or Smoldering Systemic Mastocytosis

NCT05186753Active, Not RecruitingPhase 2
Cogent Biosciences, Inc.
Posted 6/27/2022

BioSapien Secures $8 Million in Extended Pre-Series A Round for Revolutionary Cancer Treatment Platform

Precision Medicine
  • BioSapien has extended its pre-Series A funding round to over $8 million, adding Globivest as a new investor alongside existing backers Global Ventures, Golden Gate Ventures, and Dara Holdings.
  • The company's flagship product MediChip™ is a 3D-printed, slow-release drug delivery platform that can be attached to any tissue with minimal systemic side effects for localized cancer treatment.
  • The funding will support product development and global expansion, with 12 new executives hired across R&D, medical affairs, regulatory, and operations including key appointments of Joseph Borrello as CTO and Sonia Ramamoorthy as Head of Medical Affairs.
  • Founded in 2018 by Dr. Khatija Ali, BioSapien aims to make precision medicine both globally impactful and locally accessible through its innovative drug delivery technology.

Quebec Expands Public Reimbursement of Pluvicto Radioligand Therapy for Advanced Prostate Cancer

Targeted TherapyPrecision Medicine
  • Quebec implemented public reimbursement of Pluvicto (lutetium-177 vipivotide tetraxetan) as of July 2, 2025, for eligible patients with PSMA-positive metastatic castration-resistant prostate cancer.
  • The radioligand therapy is now publicly funded in Canada's four most populous provinces, significantly expanding access to this precision cancer treatment for patients who have undergone prior androgen receptor pathway inhibition and taxane-based chemotherapy.
  • Pluvicto represents the first targeted radioligand therapy approved by Health Canada for PSMA-positive mCRPC, combining a targeting compound with a therapeutic radioisotope to deliver targeted radiation to cancer cells.
  • Healthcare leaders emphasize this milestone closes a longstanding treatment gap and provides new hope for patients with advanced prostate cancer who have exhausted multiple treatment lines.

Novel Tiancimycin-Based Antibody-Drug Conjugate Shows Promise Against Aggressive Lymphoma

Precision Medicine
  • Scientists at The Herbert Wertheim UF Scripps Institute developed a novel antibody-drug conjugate combining tiancimycin, a natural compound from soil microbes, with a "double-decker" antibody targeting CD79b for diffuse large B cell lymphoma treatment.
  • The ADC demonstrated potent and selective activity against multiple CD79b-expressing cell lines and patient-derived primary chronic lymphocytic leukemia cells while sparing healthy, non-cancerous cells in blood samples from cancer patients.
  • The research team's conjugation platform required two years of chemistry work and successfully linked keto-TNM A, the most potent tiancimycin variant, to anti-CD79b DVD IgG1 antibodies using site-specific conjugation methods.
  • The study, published in the Journal of the American Chemical Society Au, represents a promising next-generation immunotherapy approach for lymphoma patients, with mouse studies planned as the next development step.

Primo Biotechnology Raises NT$220M Series A to Advance Radioligand Theranostics Platform

Precision Medicine
  • Primo Biotechnology completed a NT$220 million Series A funding round, bringing total capital raised to over NT$500 million to accelerate radioligand theranostics development.
  • The Taiwan-based company obtained authorization from ABX to manufacture and distribute Radelumin ([18F]PSMA-1007) for prostate cancer diagnostics in Taiwan, beginning clinical supply in June 2025.
  • Primo is advancing pipeline candidates PB011 and PB012 through clinical trials while leveraging Taiwan's Category 2 registration pathway for faster market approval.
  • The company plans to launch its IPO in 2026 on Taiwan's TPEx Emerging Stock Board to expand R&D capabilities and international reach.

Australia Opens First Antibody-Drug Conjugate Manufacturing Facility to Advance Precision Cancer Treatment

Precision MedicineOncology
  • IDT Australia has opened the nation's first facility dedicated to manufacturing antibody-drug conjugates (ADCs) for oncology therapies, establishing the Ehrlich Bioconjugation Centre in Victoria.
  • The facility represents a $3.8 million investment and will create 88 highly skilled local jobs while positioning Australia as a global leader in advanced cancer treatment manufacturing.
  • ADCs significantly improve patient survival rates and quality of life by delivering potent chemotherapy agents directly to cancer cells with high specificity, particularly benefiting breast cancer patients.
  • The global ADC market is forecast to reach US$140 billion over the next 15 years and is expected to displace 30-50% of the traditional chemotherapy market.

RedHill Biopharma Launches Precision Medicine Phase 2 Trial Combining Opaganib with Darolutamide for Advanced Prostate Cancer

Precision MedicineOncology
  • RedHill Biopharma has initiated patient recruitment for a Phase 2 study evaluating opaganib plus darolutamide in men with metastatic castrate-resistant prostate cancer, sponsored by ANZUP and supported by Bayer.
  • The innovative 60-patient trial uses a precision medicine approach with the PCPro lipid biomarker test to identify patients with poor prognosis who may benefit most from the combination therapy.
  • The study aims to overcome resistance to standard androgen receptor pathway inhibition treatment, with opaganib targeting three sphingolipid-metabolizing enzymes to enhance darolutamide efficacy.
  • Prostate cancer represents a significant global burden with 1.5 million new cases annually and a $12 billion market, making this precision medicine approach particularly valuable for advanced disease management.

Addition of Opaganib to Androgen Antagonists in Patients With mCRPC

NCT04207255Active, Not RecruitingPhase 2
Medical University of South Carolina
Posted 3/27/2020

Adiposs Secures CHF 4 Million Series A to Advance Brown Fat Imaging Technology for Cancer Treatment Prediction

Precision Medicine
  • Geneva-based biotech Adiposs has closed a CHF 4 million Series A funding round to advance clinical development of ImageBAT, a novel contrast agent for brown fat imaging in cancer patients.
  • The company's first-in-class technology uses standard CT scans to detect hypermetabolism, which indicates poor treatment response and precedes cachexia in cancer patients.
  • Following successful Phase I safety trials in 2023, Adiposs has initiated the IBT-002 proof-of-principle trial in June 2025, with topline results expected in Q1 2026.
  • The technology addresses a critical unmet medical need by enabling early identification of non-responding cancer patients to facilitate personalized treatment strategies.

Pixelgen Technologies Secures $14.7M EIC Funding to Advance Single-Cell Protein Interactome Analysis Platform

Precision Medicine
  • Pixelgen Technologies received $14.7 million in blended grant and equity financing from the European Innovation Council Accelerator to expand its single-cell protein analysis platform.
  • The funding will accelerate development of the Pixelgen Proxiome Kit, the first commercial product for high-throughput protein interactome analysis at the single-cell level.
  • The company's proprietary Proximity Network Assay technology enables nanoscale spatial mapping of cell surface proteins with applications in cancer, immunology, and cell therapy research.
  • Pixelgen plans to expand platform applications to include cell-to-cell interaction analysis and formalin-fixed paraffin-embedded tissue samples for precision medicine applications.

Imagene AI Secures $23M Series B Led by Larry Ellison to Advance Multi-Modal Foundation Models for Precision Medicine

AIPrecision Medicine
  • Imagene AI completed a $23 million Series B funding round led by Oracle Chairman Larry Ellison, bringing total funding to $45 million for developing multi-modal foundation models in precision medicine.
  • The company's platform integrates histopathology, molecular profiles, and clinical data through proprietary foundation models to enable real-time analysis and personalized treatment decisions.
  • Imagene AI has developed a digital pathology foundation model trained on over 1.5 million biopsy images and launched the OI Suite platform for biomarker discovery and patient identification.
  • The company is expanding strategic collaborations, including a partnership with Tempus to deliver predictive assays for treatment guidance in clinical settings.

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