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Evotec and Bristol Myers Squibb Achieve Major Milestone in Molecular Glue Degrader Collaboration, Triggering $75M Payment

Oncology
  • Evotec SE announced significant progress in its strategic protein degradation collaboration with Bristol Myers Squibb, triggering performance-based payments totaling $75 million.
  • The partnership combines Evotec's multi-omics screening and AI-supported analytics with Bristol Myers Squibb's industry-leading cereblon E3 ligase modulators (CELMoDs™) to develop molecular glue degraders.
  • Molecular glue degraders represent a breakthrough approach that can target previously "undruggable" proteins, potentially expanding the druggable proteome beyond conventional small molecules.
  • The collaboration, initiated in 2018 and expanded in 2022 for an additional eight years, continues to build a promising pipeline targeting high-value oncology and other therapeutic areas.

GeoVax Advances Gedeptin Gene Therapy for Solid Tumors with Expanded Patent Portfolio and Promising Clinical Data

Oncology
  • GeoVax has strengthened its Gedeptin therapy platform with newly allowed patent claims covering the synergistic combination of gene therapy with radiation for treating various solid tumors.
  • Clinical data presented at AACR 2025 demonstrated Gedeptin's safety profile and efficacy in heavily pretreated head and neck cancer patients, with median progression-free and overall survival of 7.0 months.
  • The company is advancing to a Phase 2 trial combining Gedeptin with pembrolizumab (Keytruda) as a neoadjuvant therapy for relapsed head and neck cancer, leveraging potential synergy with immune checkpoint inhibitors.

Alembic Pharma Shares Surge Following USFDA Clearance of Panelav Oncology Facility

Drug ApprovalOncology
  • Alembic Pharmaceuticals received an Establishment Inspection Report (EIR) from the USFDA for its Panelav oncology formulation facility following a clean inspection conducted from October 7-8, 2024.
  • The company's shares surged 4.21% to ₹1,246.65 on the NSE following the announcement, adding approximately ₹1,000 crore to its market capitalization.
  • The clean EIR with no Form 483 observations reinforces Alembic's regulatory compliance and strengthens its position in the US generics and oncology markets.
  • This marks the second successful USFDA inspection at Panelav facilities in 2024, following a clean EIR for the F-1 facility in September 2024.

HonorHealth Launches First Global Trial of Novel T Cell Therapy Targeting Aggressive Melanoma

Oncology
  • HonorHealth Research Institute has treated the first patient in a 50-site international Phase III clinical trial testing IMA203 TCR-T, the world's first T cell receptor therapy targeting PRAME in melanoma.
  • The innovative ACTengine® therapy, developed by Immatics, engineers a patient's own T cells to target PRAME peptides commonly found in melanoma tumors, requiring only a single dose with a two-week manufacturing turnaround.
  • Previous Phase I results published in Nature Medicine showed a 54% response rate with median response duration exceeding one year, offering new hope for patients with advanced melanoma who have exhausted other treatment options.

ACTengine® IMA203/IMA203CD8 as Monotherapy or in Combination With Nivolumab in Recurrent and/or Refractory Solid Tumors

NCT03686124RecruitingPhase 1
Immatics US, Inc.
Posted 5/14/2019

RAGE Inhibitor Pipeline Shows Promise for Inflammatory Diseases with 5+ Companies Advancing Novel Therapeutics

Oncology
  • A comprehensive pipeline analysis reveals over five companies developing RAGE inhibitors across multiple clinical stages, with promising applications in chronic inflammatory diseases and neurodegenerative disorders.
  • vTv Therapeutics leads the field with azeliragon in Phase II trials targeting Alzheimer's disease and glioblastoma, demonstrating the therapeutic potential of blocking RAGE-ligand interactions.
  • RAGE inhibitors show clinical promise in diabetic nephropathy, atherosclerosis, and neurodegenerative conditions by halting inflammatory pathways through receptor blockade.
  • The emerging therapeutic class faces development challenges including target specificity and off-target effects, but ongoing research continues to optimize selectivity and safety profiles.

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.

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