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Alvotech Expands European Presence with Successful Nasdaq Stockholm Listing

Oncology
  • Alvotech's Swedish Depository Receipts (SDRs) offering was multiple times oversubscribed, attracting over 3,000 new shareholders and raising approximately SEK 39 million.
  • The biosimilar developer's strategic expansion includes acquiring Xbrane's R&D operations at the Karolinska life-science hub, strengthening its research capabilities and establishing a footprint in Sweden's biotech sector.
  • Trading of Alvotech's SDRs on Nasdaq Stockholm commenced on May 19, 2025, under the ticker "ALVO SDB," enhancing the company's access to Nordic and European investors and capital markets.

Remedy Plan Therapeutics Secures $18 Million to Advance Novel NAMPT Inhibitor for AML and MDS Treatment

Oncology
• Gaithersburg-based Remedy Plan Therapeutics has raised $18 million in an oversubscribed insider financing round, bringing their total funding to $55 million to date.
• The funding will accelerate the development of RPT1G, their first-in-class NAMPT inhibitor, into Phase 1/2 clinical trials for acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS).
• Remedy Plan's innovative "hyperbolic" approach to NAMPT inhibition avoids the on-target toxicities that have hindered previous development efforts, potentially addressing over 20 diseases spanning oncology, autoimmunity, and metabolic disorders.

A Study of RPT1G After Single and Multiple Doses in Healthy Adult Participants

NCT06667765CompletedPhase 1
Remedy Plan, Inc.
Posted 11/18/2024

Revolution Medicines Advances First-in-Class KRAS(G12D) Molecular Glue Inhibitor RMC-9805 with Novel Cyclophilin A Mechanism

OncologyTargeted Therapy
  • Revolution Medicines has developed RMC-9805, a first-in-class covalent KRAS(G12D)(ON) molecular glue inhibitor that targets the previously "undruggable" KRAS(G12D) mutant using a cyclophilin A-recruiting tricomplex mechanism.
  • The compound employs a finely tuned aziridine covalent handle to engage a poorly nucleophilic mutant Asp residue, representing a breakthrough in targeting this challenging oncogenic mutation.
  • Preclinical data presented at AACR 2024 demonstrated that RMC-9805 synergizes with PD-1 inhibitors, and the compound is making progress in clinical development.
  • The discovery leveraged structural and modeling insights to overcome the technical challenges of inhibiting KRAS(G12D), which has been considered one of the most difficult cancer targets to drug.

A Study of BMS-986449 With and Without Nivolumab in Participants With Advanced Solid Tumors

NCT05888831Active, Not RecruitingPhase 1
Bristol-Myers Squibb
Posted 6/6/2023

Moderna Advances Oncology Pipeline with First Dosing in Phase 1 Trial of Novel mRNA Cancer Therapy

Oncology
  • Moderna has initiated dosing of mRNA-4106, an innovative cancer therapy candidate, in a Phase 1 clinical trial, marking a significant step in expanding its oncology pipeline beyond vaccines.
  • The advancement comes amid financial challenges for the company, with analysts projecting continued negative earnings for the next three years despite the potential for new revenue streams.
  • Despite a 3% stock decline last week contrary to broader market gains, analysts maintain a consensus price target of $46.96, suggesting potential upside if the company's oncology strategy proves successful.

Novartis Receives CDSCO Approval for Phase IIIb Trial of Asciminib in Chronic Myeloid Leukemia

OncologyTargeted Therapy
  • Novartis Healthcare has secured approval from India's CDSCO expert committee to conduct a Phase IIIb roll-over study of asciminib for patients with Philadelphia chromosome-positive chronic myeloid leukemia.
  • Asciminib (ABL001) functions as a novel allosteric inhibitor targeting the BCR-ABL1 kinase's myristoyl pocket, distinguishing it from traditional ATP-competitive tyrosine kinase inhibitors used in CML treatment.
  • The multi-center, open-label study will assess long-term safety in patients who have completed previous Novartis-sponsored asciminib trials and are deemed to benefit from continued treatment.

A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP

NCT04971226Active, Not RecruitingPhase 3
Novartis Pharmaceuticals
Posted 10/6/2021

Study of Efficacy of CML-CP Patients Treated With ABL001 Versus Bosutinib, Previously Treated With 2 or More TKIs

NCT03106779CompletedPhase 3
Novartis Pharmaceuticals
Posted 10/26/2017

A Phase I Study of Oral Asciminib (ABL001) in Patients With CML or Ph+ ALL

NCT02081378CompletedPhase 1
Novartis Pharmaceuticals
Posted 4/24/2014

A Study to Investigate Tolerability and Efficacy of Asciminib (Oral) Versus Nilotinib (Oral) in Adult Participants (≥18 Years of Age) With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP)

NCT05456191Active, Not RecruitingPhase 3
Novartis Pharmaceuticals
Posted 11/21/2022

ROSALINE Trial: Neoadjuvant Letrozole/Entrectinib Shows Limited Efficacy in Invasive Lobular Breast Cancer

Targeted TherapyOncology
  • The phase 2 ROSALINE trial found that combining entrectinib with letrozole failed to meet its primary endpoint, with no efficacy-evaluable patients achieving residual cancer burden (RCB) of 0 or 1 in invasive lobular breast cancer.
  • Despite the primary endpoint failure, the treatment showed a 49% objective response rate by MRI assessment, with 10% complete responses and 39% partial responses among the 41 evaluable patients.
  • ROSALINE represents the first neoadjuvant endocrine therapy trial dedicated exclusively to invasive lobular breast cancer, demonstrating the feasibility of subtype-specific trials while researchers continue biomarker analyses.

A Neoadjuvant Study of Abemaciclib (LY2835219) in Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Breast Cancer

NCT02441946CompletedPhase 2
Eli Lilly and Company
Posted 8/1/2015

Neoadjuvant Study of Targeting ROS1 in Combination With Endocrine Therapy in Invasive Lobular Carcinoma of the Breast (ROSALINE)

NCT04551495Active, Not RecruitingPhase 2
Jules Bordet Institute
Posted 1/14/2021

Skin Cancer Awareness Month: Multimodal Approaches and Prevention Strategies Highlighted by Experts

Oncology
  • Approximately 90% of skin cancers are preventable, with limiting sun exposure in the first 20 years of life being crucial as most lifetime UV damage occurs by age 20.
  • Advancements in skin cancer treatment include immunotherapy for metastatic melanoma, targeted agents for large basal cell cancers, and multimodality approaches where specialists collaborate on complex cases.
  • Radiation therapy remains an underutilized option for elderly or frail patients with skin cancer, particularly in cases where surgery might cause functional or structural damage.

BlueSphere Bio Appoints Immunotherapy Pioneer Alan Korman as Chief Scientific Officer

Drug DiscoveryOncology
  • BlueSphere Bio has appointed Alan Korman, Ph.D., a veteran immunotherapy researcher with over 30 years of experience, as Chief Scientific Officer to advance its T cell-based therapy pipeline.
  • Dr. Korman, who has served on BlueSphere's board since 2020, previously led groundbreaking immune checkpoint inhibitor research at Bristol-Myers Squibb and Medarex, directing the preclinical development of Yervoy and Opdivo.
  • The appointment strengthens BlueSphere's clinical programs, which include BSB-1001 for leukemias and the upcoming TCX-102 program targeting mutant NPM-1 in AML, with an IND expected in Q2 2025.

Mestastop Solutions Seeks Approval for Phase II Trial Targeting Colorectal Cancer Metastasis

Oncology
  • Bengaluru-based Mestastop Solutions has applied to CDSCO for approval of a Phase II clinical trial to delay metastasis in colorectal cancer patients following surgery or chemotherapy.
  • The randomized controlled, double-blind trial will involve 60 patients and is expected to run for at least two years, with patient recruitment beginning upon approval.
  • Mestastop's approach focuses on preventing cancer cells from colonizing secondary sites, potentially transforming cancer treatment paradigms from damage control to disease containment.

IQVIA and Sarah Cannon Research Institute Partner to Transform Global Oncology Clinical Trials

Oncology
  • IQVIA and SCRI Development Innovations have formed a strategic collaboration aimed at revolutionizing oncology clinical trials through improved operations, faster data delivery, and accelerated patient access to advanced therapies.
  • The partnership combines IQVIA's global reach and experience managing 20% of U.S. oncology trials with SCRI's community oncology expertise and Accelero operational model, which streamlines trial activation and data collection.
  • This collaboration creates a unified, efficient model for delivering oncology trials globally, reducing vendor complexity and operational hurdles while expediting the development of innovative cancer treatments.

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