August 13, 2024 - 🧬 [nGram] Today’s Oncology Scoop: Biosyngen's FDA Approval, Junshi's New Drug Application, Citius Merger

1. Biosyngen's BRG01 receives FDA approval for Phase II clinical trial

   • The FDA has approved Biosyngen's BRG01, an EBV-specific CAR-T cell therapy, for a Phase II clinical trial.
   • This is the first cell therapy to enter Phase II trials in both the U.S. and China for relapsed/metastatic EBV-positive nasopharyngeal carcinoma.
   • The Phase I trial showed exceptional safety and preliminary efficacy, with 75% of high-dose group patients showing tumor necrosis and metabolic reduction.
   • Biosyngen aims to expedite BRG01's clinical development and commercial availability, offering new hope for nasopharyngeal cancer patients.
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2. Junshi Biosciences announces acceptance of supplemental new drug application for toripalimab as first-line treatment of unresectable/metastatic melanoma

   • The National Medical Products Administration (NMPA) has accepted the supplemental new drug application (sNDA) for toripalimab for first-line treatment of unresectable or metastatic melanoma.
   • The application is based on the MELATORCH study, a Phase III clinical trial comparing toripalimab with dacarbazine, which showed significant improvement in progression-free survival.
   • Toripalimab has previously been approved for second-line treatment of advanced melanoma in China and is now poised to become the first immunotherapy for melanoma in the country.
   • Detailed data from the MELATORCH study will be presented at an upcoming international academic conference.
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3. Registrational phase III study of lisaftoclax in newly-diagnosed patients with higher-risk myelodysplastic syndrome cleared by China CDE

   • Ascentage Pharma has received clearance from the China CDE to initiate a registrational Phase III study of lisaftoclax in combination with azacitidine for newly-diagnosed higher-risk myelodysplastic syndrome (MDS).
   • The study, named GLORA-4, is a multi-center, randomized, double-blind, pivotal Phase III trial.
   • Lisaftoclax is an orally administered Bcl-2 selective inhibitor aimed at restoring normal apoptosis in cancer cells.
   • This marks the fourth registrational Phase III study of lisaftoclax, highlighting its potential in treating malignancies.
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4. Biotech innovations: revolutionary treatments aim to boost pancreatic cancer survival rates

   • Pancreatic cancer is one of the deadliest cancers, with up to 80% of patients diagnosed at advanced stages.
   • Oncolytics Biotech presented two abstracts at ASCO related to their novel immunotherapy, pelareorep, for metastatic pancreatic ductal adenocarcinoma (PDAC).
   • The GOBLET study will explore the effectiveness of combining pelareorep with modified FOLFIRINOX, with and without atezolizumab.
   • Halozyme Therapeutics announced an updated FDA goal date for the subcutaneous formulation of Opdivo, potentially making it the first subcutaneously administered PD-1 inhibitor.
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5. Mabwell's novel nectin-4 targeting ADC 9MW2821 granted breakthrough therapy designation by China's NMPA

   • Mabwell's ADC 9MW2821 has been granted Breakthrough Therapy Designation by China's NMPA for treating advanced urothelial carcinoma.
   • The designation aims to expedite the development process for drugs showing significant efficacy or safety advantages in early trials.
   • 9MW2821 is the first Nectin-4 targeting ADC developed by a Chinese company to enter clinical study and show efficacy in multiple cancers.
   • The drug has also received Fast Track and Orphan Drug Designations from the FDA for various cancer treatments.
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6. Predictive Oncology expands live-cell tumor platform to de-risk drug discovery

   • Predictive Oncology has enhanced its AI-driven platform to account for patient heterogeneity, aiming to reduce drug discovery risks and speed up pipeline development.
   • The platform leverages a biobank of over 150,000 cryogenically preserved patient-derived tumor samples across 137 tumor types.
   • By introducing patient heterogeneity early in the drug discovery process, the platform increases the Probability of Technical Success (PTS) in clinical trials.
   • The company has released a new white paper detailing these capabilities, accessible on their website.
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7. Altamira Therapeutics enhances immune checkpoint inhibition therapy with Zbtb46 mRNA in animal tumor models

   • Altamira's SemaPhore™ technology delivers Zbtb46 mRNA, significantly reducing tumor growth in animal models.
   • Combination with anti-PD1 therapy shows synergistic control of tumor growth and long-term remission.
   • Study published in Nature Immunology highlights the role of Zbtb46 in tumor angiogenesis and immunity.
   • Next steps include further research and potential clinical trials to explore broader applications.
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8. Citius Pharmaceuticals completes merger of subsidiary with TenX Keane to form Citius Oncology, Inc.

   • Citius Pharmaceuticals has merged its oncology subsidiary with TenX Keane Acquisition to form Citius Oncology, Inc.
   • Citius Oncology will begin trading on Nasdaq under the ticker 'CTOR' on August 13, 2024.
   • Citius Pharma holds approximately 90% of the newly public company.
   • LYMPHIR, approved by the FDA for treating cutaneous T-cell lymphoma, is Citius Oncology's primary asset.
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