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Kelun-Biotech's Next-Generation RET Inhibitor A400/EP0031 Receives NDA Acceptance in China for NSCLC Treatment

Targeted TherapyOncologyTargeted TherapyOncologyTargeted TherapyOncologyTargeted TherapyOncologyTargeted TherapyOncologyTargeted TherapyOncologyTargeted TherapyOncologyTargeted TherapyOncologyTargeted TherapyOncology
  • Sichuan Kelun-Biotech announced that China's NMPA accepted its New Drug Application for A400/EP0031, a next-generation selective RET inhibitor for treating RET-fusion positive non-small cell lung cancer.
  • The acceptance is based on positive Phase 2 results from the KL400-I/II-01 study, which demonstrated favorable efficacy in both treatment-naïve and pretreated NSCLC patients, including those with brain metastases.
  • A400/EP0031 previously received FDA Fast Track designation in March 2024 and is being developed globally through a partnership with Ellipses Pharma for markets outside Greater China.
  • The drug addresses an unmet medical need for RET-fusion positive NSCLC patients, who represent 1.4% to 2.5% of Chinese NSCLC cases and derive limited benefit from conventional treatments.

A Study of EP0031 in Patients With Advanced RET-altered Malignancies

NCT05443126RecruitingPhase 1
Ellipses Pharma
Posted 9/30/2022

A Study of KL590586 in Patients With Advanced Solid Tumors

NCT05265091Active, Not RecruitingPhase 1
Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
Posted 6/1/2021

FDA Approves First Subcutaneous PD-1 Inhibitor as MSD Launches Keytruda QLEX

Drug ApprovalOncology
  • MSD secured FDA approval for Keytruda QLEX, the first subcutaneous PD-1 blocker, covering 38 solid tumor indications including NSCLC, triple-negative breast cancer, and melanoma.
  • The subcutaneous formulation offers faster administration in minutes versus hours for IV infusion, providing patients more treatment location choices and enhanced convenience.
  • Despite the approval, analysts remain skeptical about market impact due to combination therapy limitations and the looming 2028 patent cliff for Keytruda.
  • MSD projects 30-40% of patients will switch to the subcutaneous version within two years, with sales expected to exceed $1 billion by 2026 in NSCLC alone.

A Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) Coformulated With Berahyaluronidase Alfa (MK-3475A) in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (rrcHL) or Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)(MK-3475A-F65)

NCT06504394RecruitingPhase 2
Merck Sharp & Dohme LLC
Posted 10/14/2024

Avenzo Therapeutics Secures $60 Million Series B to Advance Next-Generation Oncology Pipeline

Oncology
  • Avenzo Therapeutics closed a $60 million Series B financing led by OrbiMed and SR One, bringing total capital raised to $446 million following a $386 million Series A/A-1 round in November 2024.
  • The clinical-stage biotechnology company has expanded its pipeline from one to four clinical-stage assets, including CDK2/CDK4 inhibitors and bispecific antibody-drug conjugates targeting solid tumors.
  • Proceeds will support advancement of potential best-in-class oncology therapies, including AVZO-021 and AVZO-023 small molecule inhibitors and AVZO-1418 EGFR/HER3 bispecific ADC currently in Phase 1/2 studies.

Alkem Laboratories Launches Affordable Pertuzumab Biosimilar for HER2-Positive Breast Cancer in India

Monoclonal AntibodyOncology
  • Alkem Laboratories has launched Pertuza injection 420mg/14mL, an indigenously developed pertuzumab biosimilar for HER2-positive breast cancer treatment in India.
  • The biosimilar demonstrated equivalence in efficacy, safety, and immunogenicity to the reference product in pivotal phase 3 clinical trials conducted by Alkem's biotech subsidiary.
  • The launch addresses significant accessibility challenges for pertuzumab therapy in India, where cost barriers have limited treatment options for HER2-positive breast cancer patients.
  • Alkem aims to make this critical therapy available to thousands of women annually who would otherwise be excluded from treatment due to financial constraints.

Nuclide Therapeutics Secures £5M to Advance ALDH1A1-Targeted Radiotheranostics for Therapy-Resistant Cancers

Targeted TherapyOncology
  • King's College London spin-out Nuclide Therapeutics has closed a £5 million investment round from Marathon Beteiligungs AG to advance radiotheranostic treatments for therapy-resistant cancers.
  • The funding will support development of ALDH1A1-targeted radiotheranostics, radioactive drugs designed to identify and eliminate cancer cells that have evaded conventional therapies.
  • The company's pipeline has demonstrated exceptional preclinical data in lung and ovarian cancers, with plans to progress lead candidates into first-in-human trials.
  • The milestone-based investment will enable expansion into additional cancer indications and acceleration of other assets in the discovery pipeline.

Hetero Healthcare and Enzene Launch Perzea, India's Most Affordable Pertuzumab Biosimilar for HER2-Positive Breast Cancer

Monoclonal AntibodyOncology
  • Hetero Healthcare Limited has launched Perzea, its most cost-effective biosimilar of pertuzumab, through a semi-exclusive collaboration with Enzene Biosciences Limited to expand affordable breast cancer treatment access in India.
  • The biosimilar targets HER2-positive breast cancer patients and aims to reduce economic barriers that have restricted access to this globally recognized monoclonal antibody therapy.
  • Perzea is designed to be used in combination with trastuzumab and chemotherapy, following the established standard of care for HER2-positive breast cancer treatment.
  • The launch aligns with the Government of India's healthcare vision to ensure equitable access to life-saving medications and represents a significant step toward democratizing advanced cancer therapies.

Myricx Bio Appoints New CEO as Company Advances Novel ADC Platform Toward Clinical Trials

OncologyLeadership Change
  • Myricx Bio has appointed Mohit Rawat as CEO, bringing extensive biopharma experience from Fusion Pharmaceuticals, which was acquired by AstraZeneca for $2.4 billion in 2024.
  • The company is developing a novel class of ADC payloads based on N-myristoyltransferase inhibitors to address payload resistance and toxicity issues affecting current ADC therapies.
  • Following a £90 million Series A financing, Myricx expects to initiate human clinical trials with its lead NMTi-ADC candidate in 2026.
  • Current ADCs face significant challenges with retreatment showing >50% reduction in objective response rates and >50% of leading ADCs requiring treatment interruptions or dose reductions due to adverse effects.

FDA Approves Injectable Keytruda, Marking New Era in Cancer Treatment Convenience

Drug ApprovalOncology
  • The U.S. Food and Drug Administration has approved an injectable subcutaneous form of Merck's blockbuster immunotherapy Keytruda, representing a significant advancement in cancer treatment administration.
  • This new formulation promises enhanced patient experiences and streamlined clinic operations by offering a more convenient mode of drug delivery compared to traditional intravenous administration.
  • The approval marks what the FDA describes as "a new era in cancer treatment," potentially improving accessibility and patient compliance for this widely-used immunotherapy.
  • The development comes as part of broader healthcare sector evolution, with companies reevaluating treatment delivery methods to optimize patient care and operational efficiency.

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