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Godavari Biorefineries Secures European Patent for Novel Anticancer Molecule Targeting Cancer Stem Cells

  • Godavari Biorefineries Ltd has obtained a European patent for a novel anticancer molecule with proven efficacy against both cancer cells and cancer stem cells, validated in Spain, the UK, and under the Unitary Patent system.
  • The patented compound falls under the company's Anti-Cancer Research Segment and represents a significant advancement in targeting cancer stem cells, a crucial focus area in modern oncology research.
  • This patent milestone strengthens Godavari Biorefineries' global footprint in biotech innovation and reinforces its commitment to developing breakthrough solutions in cancer therapy.

AstraZeneca and Summit Therapeutics in Advanced Talks for $15 Billion Ivonescimab Licensing Deal

  • AstraZeneca is negotiating with Summit Therapeutics for a potential $15 billion licensing deal for ivonescimab, an experimental lung cancer drug that has shown promising results in late-stage trials.
  • The deal could include an upfront payment of several billion dollars plus milestone payments, representing one of the largest pharmaceutical licensing agreements in recent years.
  • Ivonescimab demonstrated statistically significant improvement in progression-free survival when combined with chemotherapy in previously treated lung cancer patients, though it failed to achieve statistical significance for overall survival.
  • Summit secured rights to ivonescimab through a $5 billion deal with China-based Akeso in 2022, and the drug is already approved in China as of May 2023.

Jacobio Pharma Receives IND Acceptance for BET Inhibitor JAB-8263 in Autoimmune Diseases

  • Jacobio Pharma's Phase I/II IND application for BET inhibitor JAB-8263 in autoimmune diseases has been accepted by China's Center for Drug Evaluation, with review expected within 30 working days.
  • The oral BET inhibitor represents a potential breakthrough for autoimmune diseases, which affect 5%-9% of the global population and are currently treated primarily with intravenous monoclonal antibodies.
  • JAB-8263 previously demonstrated good tolerability in Phase I trials for solid tumors and hematological malignancies, with data presented at the 2024 ASH Annual Meeting.
  • This regulatory milestone marks Jacobio's expansion of JAB-8263 from oncology into autoimmune diseases, potentially benefiting a broader patient population with an oral therapeutic option.

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

  • 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.

Lixte Biotechnology Secures $5 Million Private Placement to Advance Cancer Therapy Development

  • Lixte Biotechnology Holdings completed a $5 million private placement on June 30, 2025, with proceeds designated for general corporate purposes and working capital to support ongoing cancer therapy development.
  • The company's lead compound LB-100, a first-in-class PP2A inhibitor, has demonstrated tolerability in cancer patients at doses associated with anti-cancer activity and represents a pioneering approach in activation lethality cancer biology.
  • Proof-of-concept clinical trials for LB-100 are currently underway for colon, small cell lung, and sarcoma cancers, with the compound showing potential to enhance both chemotherapies and immunotherapies.

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

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

Celltrion Advances Pembrolizumab Biosimilar Development as Herceptin Copy Nears European Launch

  • Celltrion has initiated development of a biosimilar version of Merck's pembrolizumab (Keytruda), starting work 10 years ahead of the drug's patent expiration in June 2028.
  • The company's trastuzumab biosimilar Herzuma has gained EU approval and is expected to be priced up to 50% cheaper than Roche's subcutaneous Herceptin.
  • Biosimilar competitors will primarily target the intravenous Herceptin market, representing less than $1 billion in total European sales as most patients have switched to the more convenient subcutaneous formulation.

Sigvotatug Vedotin Shows Promise in NSCLC as Novel Integrin Beta-6 Targeted ADC Advances to Phase 3

  • The novel integrin beta-6 directed antibody-drug conjugate sigvotatug vedotin demonstrated a confirmed overall response rate of 19.0% as monotherapy in NSCLC patients, with higher efficacy in nonsquamous, taxane-naive patients at 31.0%.
  • Combination therapy with pembrolizumab showed enhanced activity with a confirmed overall response rate of 42.9% in frontline NSCLC treatment, supporting the agent's potential for immune checkpoint inhibitor synergy.
  • The drug has advanced to the phase 3 Be6A Lung-01 trial comparing sigvotatug vedotin to docetaxel in previously treated NSCLC patients, bypassing phase 2 development due to encouraging early results.
  • Integrin beta-6 represents an attractive therapeutic target as it is minimally expressed in healthy tissues but upregulated in carcinogenesis and associated with poor prognosis in multiple cancer types.

Avacta Strengthens Leadership Team with Appointment of Chief Medical Officer and Business Development Advisor

  • Avacta Group plc has appointed David Liebowitz, M.D., Ph.D. as Chief Medical Officer to lead clinical strategy and execution for its targeted cancer therapy pipeline.
  • Liebowitz brings over 30 years of experience in oncology drug development and has contributed to more than 25 Investigational New Drug applications throughout his career.
  • The company also appointed Yulii Bogatyrenko as business development advisor to strengthen corporate growth strategy and pipeline advancement.
  • These appointments come at a pivotal time as Avacta continues to advance its pre|CISION platform for targeted oncology drug delivery.

FDA Clears IND for IKS014 HER2-Targeted ADC, Enabling US Clinical Trial Expansion

  • The FDA has approved Iksuda Therapeutics' IND application for IKS014, a HER2-targeted antibody drug conjugate, allowing expansion of ongoing Phase 1 clinical trials to include US sites alongside existing locations in Australia, New Zealand, and Singapore.
  • Preliminary clinical data from the dose-escalation study demonstrates promising activity across multiple solid tumor types including breast, ovarian, gallbladder, and esophageal cancers, with notable efficacy in patients who relapsed after prior Enhertu treatment.
  • The Phase 1 trial is nearing completion of its dose-escalation phase and will proceed to expansion cohorts targeting HER2-positive breast cancer patients refractory to Enhertu, HER2-low breast cancer patients, and HER2-positive gastric cancer patients.
  • IKS014 utilizes a tumor-selective payload release mechanism with monomethyl auristatin F (MMAF) and showed impressive preclinical activity in both high- and low-HER2 expressing tumors with a favorable therapeutic index.
NCT05872295RecruitingPhase 1
Iksuda Therapeutics Ltd.
Posted 9/14/2023

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