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MEDiC Life Sciences Acquires Clinical-Stage Oncology Program Using SLS Biomarker Platform for Precision Medicine

Precision MedicineOncology
  • MEDiC Life Sciences announced its first acquisition of a clinical-stage therapeutic program that completed Phase 1 dose escalation studies, marking the company's strategic pivot toward building a therapeutic pipeline.
  • The acquisition was validated through MEDiC's proprietary SLS (Synthetic-Lethal-Gene Signature) biomarker platform, which generates millions of biomarker combinations in 3D cancer models to optimize patient selection criteria.
  • The program targets a key oncogenic driver where the field has struggled to identify the correct patient cohort, with MEDiC planning to initiate biomarker-driven clinical development next year.
  • This acquisition serves as proof of concept for MEDiC's platform to identify undervalued therapeutic assets and advance precision medicines faster and at lower cost for cancer patients.

Myriad Genetics and SOPHiA GENETICS Partner to Develop Global Liquid Biopsy Companion Diagnostic Platform

Precision MedicineOncology
  • Myriad Genetics and SOPHiA GENETICS announced a strategic collaboration to develop an innovative global liquid biopsy companion diagnostic test for pharmaceutical companies.
  • The partnership will leverage Myriad's advanced U.S. laboratory capabilities and SOPHiA GENETICS' decentralized network of over 800 connected institutions across 70+ countries.
  • The collaboration initially focuses on MSK-ACCESS® powered with SOPHiA DDM™, a liquid biopsy test that detects actionable genomic alterations from circulating tumor DNA.
  • This hybrid regulatory approach aims to provide pharmaceutical partners with access to key regulated markets globally while expanding patient access to personalized cancer care.

Percheron Therapeutics Appoints CMO and CTO to Advance HMBD-002 Cancer Immunotherapy Toward Phase II Trial

Monoclonal AntibodyOncology
  • Percheron Therapeutics has appointed Dr Eugene Kennedy as Chief Medical Officer and Valentina Dubljevic as Chief Technology Officer to strengthen leadership ahead of HMBD-002's phase II trial.
  • HMBD-002 is a monoclonal antibody targeting the immune checkpoint regulator VISTA that has completed phase I testing with favorable safety and tolerability data.
  • The company plans to commence recruitment for the phase II trial of HMBD-002 in calendar year 2026, marking a critical advancement in the oncology program.
  • Dr Kennedy brings over a decade of immuno-oncology experience from roles at Johns Hopkins and Carisma Therapeutics, while Dubljevic will focus on manufacturing and regulatory compliance.

Aurobindo Pharma Advances Denosumab Biosimilar Following Phase 3 Success, Eyes $7 Billion Market Entry

Monoclonal AntibodyOncology
  • Aurobindo Pharma completed successful Phase 3 clinical trials for its denosumab biosimilar, targeting osteoporosis and cancer-related bone treatments in a $7 billion global market.
  • The company plans regulatory filings in the US, EU, and other key markets starting January 2026, with European approval expected by end of 2026 and US approval by 2027.
  • Biosimilars are projected to capture 30-50% of the innovator market by 2030, representing initial sales potential of $1.5-1.6 billion across five to six major players.

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

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