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Clinical Trial News

Biocon Receives Indian Regulatory Approval for Generic Liraglutide, Expanding GLP-1 Diabetes Treatment Access

Drug Approval
  • Biocon Limited has received approval from India's CDSCO for its generic version of Victoza (liraglutide), marking the company's first vertically integrated GLP-1 diabetes therapy clearance in the country.
  • The approval covers both the drug substance and a 6 mg/ml solution for injection in pre-filled pens and cartridges, indicated for Type 2 diabetes treatment in adults, adolescents, and children aged 10 years and above.
  • With over 77 million people living with diabetes in India, this regulatory milestone addresses a critical unmet medical need and aligns with Biocon's mission to provide affordable access to lifesaving medications.
  • The company is preparing to launch the product through commercialization partners as part of its strategic focus on GLP-1 therapies as a future growth driver.

Regeneron Licenses Chinese GLP-1/GIP Dual Agonist in $2 Billion Obesity Deal with Hansoh Pharma

  • Regeneron acquired exclusive rights to HS-20094, a dual GLP-1/GIP receptor agonist from Hansoh Pharmaceuticals, for $80 million upfront and up to $1.93 billion in milestone payments.
  • The weekly subcutaneous injection has been studied in over 1,000 patients and demonstrates a potentially similar profile to the only FDA-approved GLP-1/GIP receptor agonist.
  • Regeneron plans to combine HS-20094 with its proprietary muscle-preserving antibodies to address muscle loss and obesity comorbidities.
  • The deal marks Regeneron's official entry into the GLP-1 space following recent setbacks with its Dupixent follow-up program.

A Study of HS-20094 in Chinese Adults with Overweight or Obesity

NCT06839664RecruitingPhase 3
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Posted 11/11/2024

XNW27011 Study of Advanced Solid Tumor Subjects Who Failed Standard Therapies.

NCT06792435RecruitingPhase 1
Evopoint Biosciences Inc.
Posted 7/27/2023

A Study of HS-20094 in Patients With T2DM

NCT06901648CompletedPhase 2
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Posted 2/6/2024

China Patent Board Upholds RNAi Therapeutic Patents Despite Broad Claim Challenges

  • China's Patent Re-examination Board has upheld multiple RNAi therapeutic patents, including inclisiran compositions targeting PCSK9 for cholesterol reduction, despite challenges to broad claim language and sufficiency of disclosure.
  • The Board determined that RNAi sequences and delivery ligands address independent technical problems, allowing broader patent claims when skilled practitioners can reasonably combine different components while maintaining therapeutic efficacy.
  • These landmark decisions establish precedent for RNAi patent protection in China, recognizing the unpredictable nature of the field and the inventiveness required to identify effective therapeutic sequences.

Coya Therapeutics Secures Key Patent for IL-2 Liquid Formulation, Advances ALS Combination Therapy

  • Coya Therapeutics received U.S. Patent 12,312,389 B2 covering methods for producing highly stable liquid formulations of IL-2 (aldesleukin), strengthening its intellectual property portfolio.
  • The company plans to submit an IND for COYA 302, combining low-dose rhIL-2 with CTLA4-Ig, by the end of June to initiate a Phase 2b study in ALS patients.
  • Coya's therapeutic pipeline focuses on regulatory T cell biology to target systemic inflammation and neuroinflammation across neurodegenerative, metabolic, and autoimmune diseases.
  • The patent protection enhances Coya's strategic positioning as it continues expanding its rhIL-2 and combination therapy intellectual property portfolio.

Neoadjuvant Nivolumab Plus Chemotherapy Demonstrates 10% Survival Advantage in Resectable NSCLC at 5-Year Follow-up

  • The CheckMate 816 phase 3 trial demonstrates that patients with resectable non-small cell lung cancer who received nivolumab plus chemotherapy before surgery had approximately 10% higher survival rates at 5 years compared to chemotherapy alone.
  • Among the 24% of patients achieving pathologic complete response with the combination therapy, no patient died from lung cancer by 5 years, highlighting the potential for cure in this subset.
  • The findings led to global regulatory approval of neoadjuvant nivolumab plus chemotherapy as standard treatment for eligible patients, including in Ireland.
  • The NeoCOAST-2 trial results published in Nature Medicine suggest that adding antibody drug conjugates to standard chemo-immunotherapy may further improve pathologic response rates.

"Study of chemotherapy vs immunotherapy for patients with lung cancer bounded in the thorax and completely resected"

2024-513730-38-00Active, Not RecruitingPhase 3
Fundacion GECP

DLL3-Targeted CAR-T Therapy LB2102 Shows Promise in Relapsed/Refractory Small Cell Lung Cancer

CAR-T
  • LB2102, a DLL3-directed autologous CAR-T cell therapy, demonstrated preliminary antitumor activity with a 16.7% objective response rate and 66.7% disease control rate in patients with relapsed/refractory small cell lung cancer and large cell neuroendocrine carcinoma.
  • The phase 1 dose-escalation trial found no dose-limiting toxicities up to dose level 4, with responses deepening at higher dose levels, supporting continued dose escalation.
  • Treatment-related adverse events were manageable, with only mild cytokine release syndrome observed in 2 patients and no deaths due to adverse events reported in the study.

Sutro Biopharma Appoints Greg Chow as CFO to Advance ADC Pipeline

Oncology
  • Sutro Biopharma appointed Greg Chow as Chief Financial Officer effective June 2, 2025, bringing over 25 years of executive leadership experience in biotech finance and operations.
  • Chow previously served as CFO at multiple biotech companies including Freenome Holdings and Frontier Medicines, where he guided major financing rounds and strategic collaborations.
  • The appointment aims to strengthen Sutro's financial position as the company advances its pipeline of novel exatecan-based and dual-payload antibody drug conjugates through clinical milestones.
  • Sutro granted Chow equity compensation including 100,000 restricted stock units and options for 275,000 shares under the company's 2021 Equity Inducement Plan.

Instil Bio Appoints Veteran Oncologist Jamie Freedman as Chief Medical Officer to Advance PD-L1xVEGF Bispecific

Oncology
  • Instil Bio has appointed Jamie Freedman, M.D., Ph.D., as Chief Medical Officer to lead development of AXN-2510, a novel PD-L1xVEGF bispecific antibody for solid tumors.
  • Dr. Freedman brings over 20 years of biopharmaceutical leadership experience and has contributed to 15 drug approvals across multiple therapeutic areas.
  • The appointment strengthens Instil Bio's clinical leadership as the company advances AXN-2510, which Dr. Freedman believes has potential to redefine standard of care for solid tumors.

Lilly's Next-Generation ADC Shows 55% Response Rate in Platinum-Resistant Ovarian Cancer

Oncology
  • Eli Lilly's investigational folate receptor alpha-targeting ADC LY4170156 demonstrated a 55% overall response rate at the recommended Phase 2 dose in heavily pre-treated platinum-resistant ovarian cancer patients.
  • The therapy showed anti-tumor activity across all folate receptor alpha expression levels, including in patients previously treated with mirvetuximab soravtansine, addressing a significant unmet medical need.
  • The Phase 1 study enrolled 95 patients who received a median of five prior systemic regimens, with encouraging safety profile and no treatment-emergent neuropathy or ocular toxicity observed.
  • Lilly plans to rapidly advance the compound into registrational Phase 3 clinical trials based on these promising initial results presented at the 2025 ASCO Annual Meeting.

A Study of LY4170156 in Participants With Selected Advanced Solid Tumors

NCT06400472RecruitingPhase 1
Eli Lilly and Company
Posted 5/20/2024

Oxford Cancer Biomarkers Partners with Mira Precision Health to Advance ToxNav® Test for 5FU/Capecitabine Toxicity Prediction in US Market

Precision Medicine
  • Oxford Cancer Biomarkers has partnered with Mira Precision Health to advance its ToxNav® test in the United States, a precision oncology diagnostic that identifies patients at high risk of severe toxicity from 5FU/capecitabine treatment.
  • The ToxNav® test enhances clinical decision-making through comprehensive genetic profiling and aligns with recent NCCN Guidelines updates recommending DPYD testing for colorectal cancer patients receiving fluoropyrimidine-based treatments.
  • The partnership aims to establish substantial market presence in the US, with ToxNav® already backed by multiple peer-reviewed studies and CE-IVD certification in the UK, potentially saving patient lives by preventing avoidable treatment toxicity.

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