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X-Chem and Orion Pharma Expand Collaboration to Accelerate Small Molecule Drug Discovery

Drug DiscoveryAIOncology
  • X-Chem and Orion Pharma have expanded their strategic collaboration from hit identification to candidate selection, leveraging DNA-encoded library technology and AI-driven approaches for multiple early-stage programs.
  • The new Technology Access Agreement enables Orion to utilize X-Chem's integrated discovery capabilities, including DEL screening, AI-driven hit triage, and medicinal chemistry support to advance small molecule discovery.
  • This partnership combines X-Chem's ArtemisAI platform with computational and medicinal chemistry expertise to help partners make informed decisions earlier in the discovery process, reducing risk and improving outcomes.

Bold Therapeutics Presents Breakthrough Data on BOLD-100's Neuroprotective Effects at AACR 2025

Oncology
  • Bold Therapeutics presented late-breaking data at AACR 2025 demonstrating BOLD-100's ability to significantly reduce oxaliplatin-induced peripheral neuropathy while maintaining anticancer efficacy.
  • Phase 2 clinical data showed dramatically lower neuropathy rates across 109 patients with gastrointestinal cancers treated with BOLD-100 plus FOLFOX compared to historical benchmarks.
  • Preclinical rat studies confirmed the neuroprotective mechanism, with BOLD-100 treatment significantly reducing neuropathic pain symptoms that returned when treatment stopped.
  • The dual benefit positions BOLD-100 for potential first-line metastatic colorectal cancer treatment, addressing up to 85% of patients and representing a multibillion-dollar commercial opportunity.

BOLD-100 in Combination With FOLFOX for the Treatment of Advanced Solid Tumours

NCT04421820RecruitingPhase 1
Bold Therapeutics, Inc.
Posted 8/28/2020

FDA Clears Path for Ingenium's NK Cell Therapy Gengleucel to Enter Phase 2 Trials for MRD+ AML

Oncology
  • Ingenium Therapeutics has received FDA clearance to proceed directly to Phase 2 trials for Gengleucel in measurable residual disease-positive acute myeloid leukemia, bypassing the typical Phase 1 requirement.
  • The allogeneic NK cell therapy has already demonstrated promising safety and efficacy in South Korean trials involving over 140 AML patients, including a Phase 2 randomized trial with long-term survival data.
  • Gengleucel is positioned to become the first NK cell therapy in AML using MRD negativity as a primary endpoint, with the multicenter U.S. trial expected to begin in early 2026.

TriSalus Life Sciences Secures $22 Million Private Placement to Advance Oncology Drug Delivery Platform

Oncology
  • TriSalus Life Sciences raised $22 million in a private placement led by Nantahala Capital and Broadfin Holdings to accelerate its oncology drug delivery technology applications.
  • The company reported preliminary Q1 2025 revenue of $9.2 million from its TriNav Infusion System, representing 42% growth compared to the same period in 2024.
  • TriSalus plans to simplify its capital structure through a preferred stock exchange offer and expects the funding to support operations through profitability.
  • The company's proprietary PEDD technology platform targets liver and pancreatic tumors, with investigational immunotherapy nelitolimod completing phase 1 trials.

FDA Approves J&J's Akeega for BRCA-Positive Metastatic Prostate Cancer

Drug ApprovalPrecision MedicineOncology
  • Johnson & Johnson received FDA approval for Akeega, a combination tablet containing niraparib and abiraterone acetate, for first-line treatment of adults with BRCA-positive metastatic castration-resistant prostate cancer.
  • The approval is based on the MAGNITUDE phase 3 trial, which demonstrated a 47% improvement in radiographic progression-free survival compared to standard of care in BRCA1/2 mutation patients.
  • The FDA approval restricts Akeega's use to patients with BRCA1 or BRCA2 mutations, affecting 10-15% of mCRPC patients who typically experience poorer outcomes and shorter survival times.
  • Akeega competes with AstraZeneca and MSD's Lynparza combination and Pfizer's Talzenna, all targeting the same BRCA-mutated patient population in the US market.

PharmaMar Seeks EU Fast-Track Status for Lurbinectedin-Tecentriq Combination in Extensive-Stage SCLC

Oncology
  • PharmaMar has applied for accelerated assessment from the European Medicines Agency for lurbinectedin in combination with Roche's Tecentriq (atezolizumab) for extensive-stage small cell lung cancer.
  • The company describes the combination therapy as "practice-changing" for ES-SCLC patients, potentially offering a new treatment option for this aggressive cancer with historically poor outcomes.
  • The lurbinectedin-Tecentriq combination represents a strategic partnership between PharmaMar and Jazz Pharmaceuticals, with Roche providing the immunotherapy component.

Atossa Therapeutics Unveils SMART 2.0 Study to Reduce Interval Breast Cancer in High-Risk Women

Oncology
  • Atossa Therapeutics has proposed a pioneering Phase 3 clinical study called SMART 2.0 to investigate if oral (Z)-endoxifen can reduce interval breast cancer in high-risk women identified through advanced mammographic screening.
  • The company's low-dose (1mg) (Z)-endoxifen reduced mammographic breast density by nearly 20 percent at six months in the Phase 2 KARISMA trial, with systemic side effects not statistically different from placebo.
  • Unlike tamoxifen, which has limiting adverse effects despite its effectiveness, (Z)-endoxifen appears to offer similar or greater bone benefits with minimal endometrial proliferative effects, potentially providing a safer preventive option.

Novel BTK Inhibitor Combination Shows Promise in Primary CNS Lymphoma Trial

Targeted TherapyOncology
  • A phase II trial of orelabrutinib combined with rituximab and high-dose methotrexate achieved a 71.4% overall response rate in newly diagnosed primary central nervous system lymphoma patients.
  • The combination demonstrated favorable safety with manageable toxicity, including 25% grade 3 adverse events and no treatment-related deaths in the 28-patient study.
  • At median follow-up of 21.6 months, median progression-free survival reached 35.3 months with 1-year survival rates of 64.3% for progression-free and 96.3% for overall survival.

Sequential Treatment With RO-MTX After Pomalidomide, Orelabrutinib, Rituximab (POR) in Newly-diagnosed PCNSL

NCT05390749RecruitingPhase 2
Peking Union Medical College Hospital
Posted 4/11/2022

Orelabrutinib Maintenance Therapy After ASCT in Primary Central Nervous System Lymphoma

NCT05334238RecruitingPhase 3
Ruijin Hospital
Posted 12/1/2021

Orelabrutinib,Rituximab and Methotrexate in Newly-diagnosed Primary Central Nervous System Lymphoma(PCNSL)

NCT05549284RecruitingPhase 2
Affiliated Hospital to Academy of Military Medical Sciences
Posted 6/1/2022

Orelabrutinib in Combination With Thiotepa in Refractory and Relapsed Primary CNS Lymphoma

NCT05021770Unknown StatusPhase 1
Huiqiang Huang
Posted 12/1/2021

A Dose-escalating Pilot Study of Orelabrutinib for Newly-diagnosed PCNSL

NCT05036577Active, Not RecruitingPhase 1
Huashan Hospital
Posted 10/10/2021

Orelabrutinib,Rituximab and Methotrexate in Newly Diagnosed Primary Central Nervous System Lymphoma

NCT05600660RecruitingPhase 2
Second Affiliated Hospital, School of Medicine, Zhejiang University
Posted 8/1/2022

Henlius and Sandoz Partner on Ipilimumab Biosimilar in $301 Million Deal to Expand Global Access

Oncology
  • Henlius has granted Sandoz exclusive commercialization rights for its ipilimumab biosimilar HLX13 across major markets including North America, Europe, Japan, and Australia.
  • The agreement includes a $31 million upfront payment to Henlius, with potential milestone payments bringing the total deal value to $301 million.
  • This strategic partnership aims to accelerate patient access to an important immuno-oncology therapy, leveraging Sandoz's global leadership in biosimilars and Henlius's development and manufacturing capabilities.

Integrated PK/efficacy, safety, and immunogenicity study to demonstrate similarity of JPB898, a proposed biosimilar to nivolumab, to Opdivo® in combination with Yervoy®

2023-507865-24-00RecruitingPhase 3
H e x a l AG

A Study to Compare the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profile of HLX13 with YERVOY As a First-Line Treatment for Patients with Unresectable Hepatocellular Carcinoma

NCT06841185Not Yet RecruitingPhase 3
Shanghai Henlius Biotech
Posted 4/30/2025

Flatiron Health to Showcase AI-Powered Real-World Oncology Data Research at ISPOR 2025

Real World EvidenceAIOncologyPrecision Medicine
• Flatiron Health will present over 15 research studies at ISPOR 2025, demonstrating how machine learning and AI can transform real-world oncology data into valuable evidence for regulatory decisions.
• Key presentations include validation of ML-extracted response data from EHRs, analysis of real-world evidence acceptance by FDA and EMA, and introduction of a novel Japanese breast cancer database.
• The company's research highlights the growing importance of real-world data in complementing traditional clinical trials and informing precision medicine approaches across diverse healthcare systems.

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