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Endevica Bio Advances TCMCB07 to Phase 2 Trial for Preventing Chemotherapy-Induced Weight Loss

  • Endevica Bio has received FDA authorization to begin a Phase 2 clinical trial of TCMCB07 (B07), a peptide designed to prevent weight loss in stage 4 metastatic colorectal cancer patients undergoing chemotherapy.
  • The trial will enroll 100 patients who will receive B07 before and during chemotherapy, targeting cachexia - a life-threatening wasting syndrome affecting millions of cancer patients worldwide.
  • TCMCB07, a melanocortin-3/4 antagonist peptide, has shown promising results in Phase 1 trials and preclinical studies, demonstrating its ability to preserve lean muscle mass and improve appetite in cancer treatment settings.

PeproMene Bio Secures $11 Million Investment to Advance BAFF-R CAR T-Cell Therapy for Follicular Lymphoma

  • PeproMene Bio has received an $11 million investment from the Institute for Follicular Lymphoma Innovation to develop PMB-CT01, a novel BAFF-R CAR T-cell therapy for relapsed/refractory follicular lymphoma.
  • Early clinical results show promising efficacy with a 100% complete response rate in six non-Hodgkin lymphoma patients and minimal side effects, including in patients who relapsed after CD19 CAR T-cell therapy.
  • PMB-CT01 targets the BAFF-R receptor, which is crucial for B-cell survival, potentially making it difficult for tumor cells to escape therapy through antigen loss, a common limitation of current CD19-targeted therapies.

Glenmark's Blood Cancer Drug ISB 2001 Shows 83% Response Rate in Phase 1 Multiple Myeloma Trial

  • Glenmark Pharmaceuticals' trispecific antibody ISB 2001 demonstrated an 83% overall response rate in heavily pretreated multiple myeloma patients during Phase 1 clinical trials.
  • The study showed that 20% of the 18 patients achieved complete cancer remission, with the drug displaying a favorable safety profile and durable responses.
  • Clinical experts suggest ISB 2001 could revolutionize treatment for patients who have exhausted currently approved therapies, potentially comparing favorably with existing bispecific options.
  • The positive results led to a 4% surge in Glenmark's stock price, with the company's shares outperforming the broader pharmaceutical index.

Immunochemotherapy Shows Promise for Borderline Resectable Esophageal Cancer Conversion Surgery

  • A retrospective study of 40 patients with borderline resectable esophageal squamous cell carcinoma demonstrated that PD-1 inhibitors combined with chemotherapy achieved a 67.5% conversion surgery rate and 57.5% R0 resection rate.
  • The immunochemotherapy approach showed significantly lower toxicity compared to conventional regimens, with only 10% grade 3-4 adverse events versus 31.9-79.4% reported with traditional protocols.
  • Patients achieving clinical downstaging after induction therapy experienced significantly better overall survival and progression-free survival outcomes compared to those without downstaging.
  • The pathological complete remission rate of 27.5% was notably higher than the 14.8-18.5% typically seen with conventional chemotherapy alone for this challenging patient population.

Aktis Oncology's First-in-Class Nectin-4 Radiopharmaceutical AKY-1189 Shows Promising Tumor Uptake Across Multiple Cancer Types

  • Aktis Oncology's AKY-1189, the industry's only Nectin-4-directed radioligand therapy, demonstrated significant tumor uptake across multiple solid tumor types in first human data from 15 evaluable patients.
  • The novel miniprotein radiopharmaceutical showed excellent uptake in ER-positive breast cancer and bladder cancer, with potential applications beyond current Nectin-4 therapy Padcev.
  • Dosimetry analysis in eight patients revealed a wide therapeutic index with transient kidney uptake and no treatment-emergent adverse events, supporting progression to formal clinical trials.
  • The company is preparing to initiate phase 1 studies in South Africa and the US in 2025, following a recent $60 million deal with Lilly and $175 million Series B financing.

AI Support Significantly Improves HER2 Scoring Accuracy in Breast Cancer Diagnosis

• A new study published in JCO Precision Oncology demonstrates that Ibex Medical Analytics' AI technology significantly improves pathologists' accuracy and consistency in HER2 biomarker scoring for breast cancer.
• The multi-center study showed AI-assisted pathologists achieved higher inter-observer agreement (83.7% vs 75%) and improved accuracy in identifying challenging HER2-low cases, which is critical for determining eligibility for new targeted therapies.
• The "zero-click" decision support tool demonstrated exceptional robustness across multiple labs, antibodies, scanners, and patient demographics, offering particular value in distinguishing between HER2 0 and 1+ cases.

Bristol Myers Squibb Initiates Two Phase I Trials Testing Novel Therapies for Advanced Solid Tumors and Relapsed/Refractory Lymphomas

  • Bristol Myers Squibb has launched two Phase I clinical trials evaluating experimental therapies BMS-986408 for advanced solid tumors and BMS-986458 for relapsed/refractory non-Hodgkin lymphoma.
  • The BMS-986408 study targets patients with histologically confirmed, advanced, unresectable or metastatic solid malignancies who have exhausted existing treatment options.
  • The BMS-986458 trial focuses on patients with relapsed/refractory DLBCL and follicular lymphoma who have received at least two prior lines of therapy.
  • Both studies exclude patients with autoimmune diseases and require specific performance status criteria for enrollment.

POSITIVE Trial Demonstrates Safe Breastfeeding During Endocrine Therapy Break for HR+ Breast Cancer Patients

  • The POSITIVE trial showed that breastfeeding is feasible for young patients with hormone receptor-positive breast cancer who conceived during a planned interruption of endocrine therapy, with a median breastfeeding duration of 4.4 months.
  • Among 196 patients who breastfed, breast cancer recurrence rates remained low at 1.1% at 12 months and 3.6% at 24 months, comparable to those who did not breastfeed.
  • The study represents the largest prospective evaluation of breastfeeding patterns in young HR-positive breast cancer survivors, supporting the incorporation of breastfeeding counseling into individualized patient care.
NCT02308085Active, Not RecruitingNot Applicable
ETOP IBCSG Partners Foundation
Posted 12/4/2014

GV20 Therapeutics Reports First Clinical Data for AI-Designed Checkpoint Inhibitor GV20-0251 in Advanced Solid Tumors

  • GV20 Therapeutics presented Phase 1 data for GV20-0251, marking the first clinical results for an AI-designed antibody targeting an AI-predicted immune checkpoint IGSF8.
  • The study enrolled 38 heavily pre-treated patients and demonstrated favorable safety with no dose-limiting toxicities across all dose levels from 0.5 to 20 mg/kg.
  • Two confirmed partial responses were observed in 12 evaluable metastatic cutaneous melanoma patients, with 14 of 29 patients showing stable disease including tumor shrinkage.
  • The drug showed dose-proportional pharmacokinetics with a 25.6-day half-life and full target occupancy on circulating T cells at doses ≥3 mg/kg.

McKesson Acquires $2.49 Billion Controlling Stake in Florida Cancer Specialists to Expand Community Oncology Platform

  • McKesson Corporation agreed to purchase a 70% controlling stake in Florida Cancer Specialists' Core Ventures for approximately $2.49 billion in cash to strengthen its oncology platform.
  • The acquisition brings Florida Cancer Specialists, with over 250 physicians and 280 advanced practice providers across nearly 100 Florida locations, into McKesson's US Oncology Network.
  • The transaction aims to advance community-based cancer care by combining operational expertise to increase access to high-quality, affordable oncology services and treatments.
  • Florida Cancer Specialists will maintain independent ownership while gaining access to McKesson's differentiated oncology care products, services, and clinical trial capabilities through Sarah Cannon Research Institute.
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