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Clinical Trial News

BioInvent's BI-1206 Shows Promising Phase 1 Results in Combination with Pembrolizumab for Solid Tumors

Monoclonal AntibodyOncology
  • BioInvent's Phase 1 study of BI-1206 combined with pembrolizumab demonstrated encouraging clinical activity in heavily pre-treated solid tumor patients, with one complete response and one partial response among 36 evaluable patients.
  • The combination therapy was well-tolerated and showed potential to overcome resistance mechanisms to anti-PD-1 treatment by targeting FcγRIIB expressing immune cells.
  • Based on these promising results, BioInvent plans to initiate Phase 2a expansion cohorts in H2 2025 for treatment-naïve patients with advanced NSCLC and uveal melanoma.
  • The study supports transitioning from intravenous to subcutaneous formulation of BI-1206, which may enhance therapeutic impact and improve safety profiles.

A Study of BI-1206 in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors (KEYNOTE-A04)

NCT04219254RecruitingPhase 1
BioInvent International AB
Posted 6/29/2020

Solvonis Therapeutics Launches AI-Powered CNS Drug Discovery Platform for Depression and Addiction

AIDrug Discovery
  • Solvonis Therapeutics has initiated an artificial intelligence-supported drug discovery programme targeting its proprietary central nervous system compound library acquired through the Awakn Life Sciences acquisition.
  • The AI platform will focus on data-driven asset prioritisation and structure-activity relationship analysis to accelerate identification of development candidates for depression and stimulant use disorders.
  • Under Professor David Nutt's scientific leadership, the programme complements Solvonis' existing clinical pipeline, which includes Phase 3 trials for alcohol use disorder affecting over 80 million people across the UK, US, and EU4.
  • The initiative represents a strategic expansion into earlier-stage innovation while maintaining focus on high-burden neuropsychiatric conditions with significant unmet medical need.

Daewoong Pharmaceutical Partners with Salipro Biotech to Target Challenging Membrane Proteins for Drug Discovery

Drug DiscoveryOrphan Drug
  • Daewoong Pharmaceutical has entered into a strategic research collaboration with Swedish biotech Salipro Biotech to develop novel small molecule therapeutics targeting challenging membrane proteins.
  • The partnership provides Daewoong access to Salipro's proprietary platform technology that stabilizes membrane proteins in their native forms, addressing a major barrier in drug discovery.
  • This marks Salipro's first collaboration with a Korean company, following previous partnerships with major pharmaceutical firms including Boehringer Ingelheim, Sanofi, and Sumitomo.
  • Membrane proteins account for over 60 percent of known drug targets but have been difficult to research due to their structural instability in laboratory conditions.

GenePoweRx Partners with MGI Tech to Advance AI-Powered Genomic Solutions for Personalized Medicine

AIPrecision Medicine
  • GenePoweRx, an Indian AI-driven personalized medicine startup, has formed a strategic co-marketing partnership with China-based MGI Tech to deliver AI-powered genomic solutions for predictive healthcare and precision medicine.
  • The collaboration integrates MGI's robust sequencing platforms with GenePoweRx's advanced bioinformatics and AI engine to provide rapid, accurate, and clinical-grade genomic services to individuals and institutions worldwide.
  • The partnership aims to democratize access to advanced healthcare technologies by embedding precision genomics into everyday medical decision-making and making personalized preventive healthcare more accessible and actionable.

Cadila Pharmaceuticals Launches Biscado (Bisoprolol) to Address India's Cardiovascular Disease Burden

  • Cadila Pharmaceuticals has launched Biscado (Bisoprolol), a highly cardioselective beta-1 adrenergic blocker, marking its entry into the beta-blocker therapy segment for cardiovascular disease management.
  • The launch is particularly significant for India, where individuals are predisposed to higher sympathetic activity and elevated resting heart rates, with studies showing a 10 beats per minute increase in resting heart rate associated with a 20% increase in cardiovascular death risk.
  • Clinical evidence from the landmark CIBIS-II study demonstrates Biscado's efficacy with a 34% reduction in all-cause mortality, 44% reduction in sudden cardiac death, and 36% reduction in heart failure hospitalizations.
  • The drug will be available in both monotherapy and fixed-dose combinations with other antihypertensive agents, providing comprehensive cardiovascular management options for physicians.

Hemab Therapeutics Advances Bleeding Disorder Pipeline with Promising Clinical Data at ISTH 2025

Monoclonal AntibodyOrphan Drug
  • Sutacimig (formerly HMB-001) demonstrates promising interim Phase 2 safety and efficacy results for Glanzmann thrombasthenia, receiving WHO International Non-Proprietary Name designation.
  • HMB-002 shows initial proof of mechanism clinical data in Von Willebrand disease patients through the ongoing VELORA Pioneer study, supported by comprehensive preclinical data.
  • Natural history studies reveal significant disease burden, with 88% of Glanzmann thrombasthenia patients reporting at least one bleed weekly and 34% requiring medical treatment.
  • Hemab will present 11 abstracts across multiple bleeding disorder programs at the International Society on Thrombosis and Haemostasis Congress in Washington, DC.

A Phase 1/2 Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of HMB-001 in Glanzmann Thrombasthenia

NCT06211634Active, Not RecruitingPhase 1
Hemab ApS
Posted 12/13/2022

A Study Assessing HMB-002 in Participants With Von Willebrand Disease

NCT06754852RecruitingPhase 1
Hemab ApS
Posted 2/6/2025

A Study of Bleeding and Treatment in Participants With Von Willebrand Disease

NCT06610201Recruiting
Hemab ApS
Posted 8/30/2024

XL-protein Grants Worldwide License to Grifols for PASylation-Enhanced Biopharmaceutical Development

  • XL-protein has entered into a worldwide licensing agreement with Grifols to develop long-acting biopharmaceuticals using proprietary PASylation technology.
  • The collaboration will leverage XL-protein's clinical-stage PASylation technology to extend circulation time of Grifols therapeutics for more effective treatments.
  • Under the agreement, XL-protein will receive upfront payments plus milestone payments and tiered royalties, while Grifols gains worldwide exclusive marketing rights.

XPro™ Shows Promise in Reducing Alzheimer's Pathology Following Traumatic Brain Injury in Preclinical Study

  • INmune Bio's XPro™ (XPro1595, pegipanermin) significantly reduced amyloid formation and improved brain function in transgenic mice following traumatic brain injury.
  • The study demonstrated that XPro™ treatment administered 30 minutes post-injury prevented elevations in key Alzheimer's disease markers including TNFR1, BACE1, and Aβ42 levels.
  • Research findings support XPro™ as a promising therapeutic approach to reduce Alzheimer's disease pathology risk in patients who experience traumatic brain injury.
  • The drug works by selectively neutralizing soluble TNF without affecting transmembrane TNF or TNF receptors, targeting neuroinflammation linked to neurodegeneration.

Femasys Partners with Carolinas Fertility Institute to Expand FemaSeed Access Across North Carolina Network

  • Femasys Inc. announced a partnership with Carolinas Fertility Institute to offer FemaSeed intratubal insemination across CFI's network of more than 8 locations in North Carolina.
  • FemaSeed achieved over double the pregnancy rates of traditional intrauterine insemination (IUI) in cases of low male sperm count according to pivotal clinical trial data.
  • The partnership expands access to FemaSeed as a less invasive and cost-effective first-line fertility treatment option before patients consider IVF.
  • Carolinas Fertility Institute serves patients across North Carolina and the Southeast with locations in Winston-Salem, Greensboro, and Charlotte.

Prospective Multi-Center Trial for FemBloc Permanent Birth Control

NCT05977751RecruitingNot Applicable
Femasys Inc.
Posted 10/31/2023

Weekly Oral Risperidone Shows Promise for Schizophrenia Treatment in Phase 3 Trial

  • LYN-005, a once-weekly oral formulation of risperidone, demonstrated therapeutic drug levels comparable to daily dosing in the first successful Phase 3 trial of long-acting oral technology for psychiatric disorders.
  • The STARLYNG-1 trial showed that weekly dosing maintained stable drug concentrations throughout the week with efficacy and safety profiles similar to immediate-release risperidone.
  • Despite promising results, the study faced significant limitations including a 43% dropout rate, short duration of five weeks, and occurrence primarily in structured inpatient settings.
  • This breakthrough could address medication adherence challenges in schizophrenia treatment by offering an alternative to daily pills or monthly injections for patients who struggle with current dosing regimens.

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