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Citius Pharmaceuticals Closes $15.8M Direct Offering to Fund LYMPHIR Commercial Launch

Drug ApprovalOncology
  • Citius Pharmaceuticals completed a $15.8 million registered direct offering with $6 million raised upfront and potential additional $9.8 million from warrant exercises.
  • The company plans to use proceeds to support the commercial launch of LYMPHIR, an FDA-approved targeted immunotherapy for cutaneous T-cell lymphoma.
  • The offering included 4.92 million shares at $1.22 per share with accompanying warrants exercisable at $1.00 per share over 24 months.
  • Citius maintains a late-stage pipeline including Mino-Lok for catheter-related infections and CITI-002 for hemorrhoid treatment, both having completed pivotal trials.

RadioMedix Launches RAHA-100 Bench Top Generator to Expand Lead-212 Supply for Targeted Alpha Therapy

Oncology
  • RadioMedix has launched the RAHA-100, a proprietary bench top generator designed to provide on-demand supply of Lead-212 isotope for targeted alpha therapy research and clinical development.
  • The generator features a fully automated process with multiple high-activity modular columns and proprietary purification steps, making Lead-212 more accessible compared to earlier-generation systems requiring specialized facilities.
  • Lead-212 offers potential advantages over conventional beta-emitting isotopes, including a shorter half-life and alpha-emitting profile that may enable more selective tumor cell destruction while limiting exposure to healthy tissue.
  • The technology aims to democratize Lead-212 availability and accelerate development of targeted alpha therapies for hard-to-treat cancers, addressing historical supply limitations that have restricted clinical adoption.

NHS Becomes First Health System Globally to Approve 'Trojan Horse' Cancer Therapy for Multiple Myeloma

Drug ApprovalTargeted TherapyOncology
  • The NHS in England has become the first health system worldwide to approve belantamab mafodotin (Blenrep), a novel antibody-drug conjugate therapy for multiple myeloma patients.
  • Clinical trials demonstrated the treatment delayed disease progression by an average of three years compared to just over one year with standard daratumumab therapy.
  • Approximately 1,500 patients annually with relapsed or refractory multiple myeloma will be eligible for this targeted therapy through the NHS Cancer Drugs Fund.
  • The "Trojan horse" mechanism allows the drug to infiltrate cancer cells and release lethal molecules from within, representing a significant advancement in myeloma treatment.

Australian Researchers Launch World-First Clinical Trial of PMR-116 to Target 'Undruggable' MYC-Driven Cancers

Oncology
  • A world-first clinical trial targeting MYC-driven cancers will begin later this year, led by researchers from The Australian National University and funded by the Medical Research Future Fund.
  • The experimental drug PMR-116 targets approximately 70% of all cancers by inhibiting a pathway downstream of the MYC protein, which has long been considered 'undruggable' due to its disordered structure.
  • The basket trial design will include patients with multiple cancer types including prostate, breast, ovarian, and haematological cancers, all unified by MYC protein involvement rather than cancer type.
  • Clinical trials will be conducted across major Australian cancer centers including Canberra Hospital, Peter MacCallum Cancer Centre, and St Vincent's Hospital Sydney.

FDA Approves First Non-Surgical Treatment for Non-Muscle Invasive Bladder Cancer

Drug ApprovalOncology
  • The FDA approved UroGen Pharma's Zusduri as the first drug to treat non-muscle invasive bladder cancer that hasn't spread beyond the inner layers of the organ.
  • In a late-stage trial with 223 patients, 78% showed complete response with all signs of cancer disappearing after treatment.
  • The gel-based formulation offers a non-surgical alternative to traditional procedures, administered as a simple drug instillation in a doctor's office.
  • The approval addresses a significant unmet need for approximately 82,000 Americans affected by this type of bladder cancer annually, with 59,000 experiencing recurrence.

BBOT's BBO-10203 Shows Broad Anti-Tumor Activity in Science Publication, Advances to Phase 1 Trial

Oncology
  • BBOT published preclinical data in Science demonstrating that BBO-10203, a first-in-class oral inhibitor, effectively blocks RAS-PI3Kα interaction without inducing hyperglycemia across multiple tumor types.
  • The compound showed significant tumor growth inhibition in preclinical models and enhanced efficacy when combined with targeted therapies including CDK4/6 inhibitors and HER2 inhibitors.
  • BBO-10203 is currently being evaluated in the Phase 1 BREAKER-101 study for patients with HER2+ breast cancer, HR+/HER2- breast cancer, KRAS mutant colorectal cancer, and KRAS mutant non-small cell lung cancer.

Dose Escalation and Dose Expansion Study of BBO-10203 in Subjects with Advanced Solid Tumors

2024-519445-29-00RecruitingPhase 1
Theras Inc.
Posted 10/29/2024

Specialised Therapeutics Expands Incyte Partnership to Bring Two Novel Cancer Therapies to Asia-Pacific

Monoclonal AntibodyRare DiseaseOncology
  • Specialised Therapeutics has expanded its partnership with Incyte to include axatilimab and retifanlimab for distribution in Australia, New Zealand, and Singapore, with potential expansion to other Asia-Pacific countries.
  • Axatilimab, a first-in-class CSF-1R-blocking antibody approved by the FDA in August 2024, treats chronic graft-versus-host disease after failure of at least two prior systemic therapies.
  • Retifanlimab, a PD-1 inhibitor, is approved for treating squamous cell carcinoma of the anal canal and Merkel cell carcinoma, with Australia having the highest global incidence of the latter condition.
  • Both therapies are expected to undergo regulatory and reimbursement approval submissions in the region during 2025.

A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease

NCT06388564RecruitingPhase 2
Incyte Corporation
Posted 10/11/2024

MAXPIRe: Study to Evaluate Axatilimab in Participants With Idiopathic Pulmonary Fibrosis (IPF)

NCT06132256RecruitingPhase 2
Syndax Pharmaceuticals
Posted 12/11/2023

A Study of Axatilimab at 3 Different Doses in Participants With Chronic Graft Versus Host Disease (cGVHD)

NCT04710576Active, Not RecruitingPhase 2
Syndax Pharmaceuticals
Posted 3/4/2021

A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

NCT06585774RecruitingPhase 3
Incyte Corporation
Posted 1/21/2025

Phase III Study Assessing the Efficacy and Safety of Pegcetacoplan in Patients With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis

NCT05067127CompletedPhase 3
Apellis Pharmaceuticals, Inc.
Posted 11/12/2021

Hoth Therapeutics Secures Japanese Patent for Novel Mast Cell-Targeting Platform HT-KIT

Orphan DrugOncology
  • Hoth Therapeutics received Japan Patent No. 7677628 for its HT-KIT platform, providing exclusive protection until August 27, 2039.
  • The patented technology uses splice-switching oligonucleotides to selectively disrupt KIT gene expression in mast cells implicated in chronic hives and rare cancers.
  • The patent positions HT-KIT for orphan indications and expedited regulatory pathways, with potential applications in mast cell-driven inflammatory and oncologic conditions.
  • The company sees strategic licensing opportunities across Asia as it advances this novel therapeutic platform.

FDA Approves New Tablet Formulation of BRUKINSA for All Indications, Reducing Pill Burden for B-Cell Cancer Patients

Drug ApprovalOncology
  • The U.S. FDA has approved a new tablet formulation of BRUKINSA (zanubrutinib) for all five approved indications, reducing daily pill burden from four capsules to two tablets while maintaining the same 320 mg daily dose.
  • The new 160 mg tablets demonstrate bioequivalence to the existing capsules based on Phase 1 crossover studies and offer improved patient convenience with smaller size and film coating for easier swallowing.
  • BRUKINSA has achieved market leadership as the top BTK inhibitor in the U.S. and leads in new chronic lymphocytic leukemia patient starts across all therapy lines.
  • The tablet formulation will replace capsules starting in October 2025, with European regulatory approval expected later this year.

A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma

NCT03332017CompletedPhase 2
BeiGene
Posted 11/14/2017

Safety and Tolerability Study of PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia

NCT01109069CompletedPhase 2
Pharmacyclics LLC.
Posted 6/1/2010

Ibrutinib (PCI-32765) in Waldenstrom's Macroglobulinemia

NCT01614821CompletedPhase 2
Dana-Farber Cancer Institute
Posted 5/1/2012

Study of Ibrutinib in Patients With Symptomatic, Previously Untreated Waldenstrom's Macroglobulinemia, and Impact on Tumor Genomic Evolution Using Whole Genome Sequencing

NCT02604511CompletedPhase 2
Dana-Farber Cancer Institute
Posted 1/1/2016

A Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

NCT01578707CompletedPhase 3
Pharmacyclics LLC.
Posted 6/1/2012

Open-label Phase 3 BTK Inhibitor Ibrutinib vs Chlorambucil Patients 65 Years or Older With Treatment-naive CLL or SLL

NCT01722487CompletedPhase 3
Pharmacyclics LLC.
Posted 3/1/2013

Bioequivalence of a Zanubrutinib Tablet Compared to Capsules in Healthy Adult Participants

NCT05767398CompletedPhase 1
BeiGene
Posted 3/7/2023

Relative Bioavailability of Zanubrutinib Tablets Compared to Capsules and Effects of Food on the Pharmacokinetics of the Tablet in Healthy Adults

NCT05547399CompletedPhase 1
BeiGene
Posted 6/7/2022

Ibrutinib With Rituximab in Adults With Waldenström's Macroglobulinemia

NCT02165397CompletedPhase 3
Pharmacyclics LLC.
Posted 7/7/2014

Bristol Myers Squibb Acquires Novel Prostate Cancer Radiopharmaceutical for $1.35 Billion

Targeted TherapyOncology
  • Bristol Myers Squibb agreed to pay $350 million upfront to Philochem for worldwide rights to OncoACP3, an experimental radiopharmaceutical targeting the ACP3 protein for prostate cancer diagnosis and treatment.
  • OncoACP3 targets ACP3, a biomarker highly expressed in prostate cancer that potentially exceeds PSMA expression levels, offering an alternative pathway to current PSMA-targeted therapies.
  • The deal includes up to $1 billion in additional milestone payments and royalties, positioning Bristol Myers to compete with Novartis in the rapidly expanding radiopharmaceutical market.
  • RayzeBio, Bristol Myers' radiopharmaceutical subsidiary acquired for $4.1 billion, will lead development of OncoACP3 through Phase 1 therapeutic testing.

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