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Clinical Trial Activity Plummets 20% as Funding Crisis Grips Biotech Sector

Oncology
  • Clinical trial registrations have declined by 20% year-over-year according to analysis of ClinicalTrials.gov and Australian/New Zealand registries, with oncology trials experiencing the most severe impact at approximately 60% reduction.
  • Biotech companies are increasingly shifting early-phase trials to ex-US locations including Australia, Asia-Pacific, Eastern Europe, and China due to favorable regulatory environments, reduced costs, and faster timelines.
  • The funding environment has returned to 2019 levels following the post-COVID bubble, with an 18% reduction in publicly traded biotechs over the past 40 months making it extremely difficult to raise capital for Phase II and III studies.
  • Despite the overall decline, obesity and RNA-based therapeutics continue to retain investor interest and show resilience in the current challenging market conditions.

AstraZeneca's Surovatamig Shows Promise as Next-Generation BiTE Therapy for Relapsed/Refractory B-ALL

CAR-TOncology
  • AstraZeneca's surovatamig demonstrated promising efficacy in the Phase I/II SYRUS trial, achieving complete remission rates of 46%, 58%, and 83% at dose levels 1, 2, and 3 respectively in patients with relapsed/refractory B-cell acute lymphoblastic leukemia.
  • The next-generation CD19xCD3 bispecific T-cell engager showed a manageable safety profile with cytokine release syndrome occurring in 31% of patients at dose level 1, and no patients discontinued treatment due to drug-related adverse events.
  • Surovatamig's Fc-engineered design enables intermittent dosing and controlled T-cell activation, offering a potentially more convenient alternative to Blincyto's continuous infusion requirement.
  • Despite promising results, surovatamig faces significant market competition with projected global sales of $138 million by 2031 compared to Blincyto's $1.7 billion, though Blincyto's patent expiry may create opportunities.

A trial to understand if AZD0486 is safe and helps in people with Relapsed or Refractory B-cell acute lymphoblastic leukemia (B-ALL)

2023-505840-20-00RecruitingPhase 1/2
Astrazeneca AB
Posted 12/29/2023

Liso-cel Achieves 95.5% Response Rate in Relapsed/Refractory Marginal Zone Lymphoma

CAR-TOncology
  • Lisocabtagene maraleucel (liso-cel) demonstrated a 95.5% overall response rate and 62.1% complete response rate in 66 patients with relapsed/refractory marginal zone lymphoma in the TRANSCEND FL trial.
  • The therapy showed durable responses with 24-month duration of response, progression-free survival, and overall survival rates of 88.6%, 85.7%, and 90.4%, respectively.
  • Safety profile remained consistent with previous reports, with 76% experiencing any-grade cytokine release syndrome and only 4% experiencing grade 3 events.
  • The results address a significant unmet need for patients with marginal zone lymphoma, where median overall survival after multiple relapses is currently 3 to 5 years.

Study Evaluating the Safety and Pharmacokinetics of JCAR017 in B-cell Non-Hodgkin Lymphoma (TRANSCEND-NHL-001)

NCT02631044CompletedPhase 1
Juno Therapeutics, a Subsidiary of Celgene
Posted 1/6/2016

A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)

NCT04245839RecruitingPhase 2
Celgene
Posted 7/14/2020

Teva and Fosun Pharma Form Strategic Partnership for Novel Anti-PD1-IL2 Cancer Immunotherapy TEV-56278

Oncology
  • Teva Pharmaceutical and Fosun Pharma announced a strategic partnership to develop TEV-56278, an anti-PD1-IL2 ATTENUKINE therapy currently in Phase 1 trials for various cancers including melanoma.
  • Under the agreement, Fosun Pharma receives exclusive rights to develop, manufacture and commercialize TEV-56278 in China, Hong Kong, Macau, Taiwan and select Southeast Asian countries while Teva retains global rights elsewhere.
  • TEV-56278 represents a novel cancer immunotherapy approach designed to selectively deliver IL-2 to PD-1+ T cells within tumors, potentially amplifying anti-tumor activity while minimizing systemic toxicities.
  • Preclinical data has demonstrated tumor regression, enhanced T-cell infiltration, and durable immune memory, with the therapy being evaluated both as monotherapy and in combination with pembrolizumab.

Debiopharm Initiates First-in-Human Trial of CD37-Targeted ADC Debio 1562M for Relapsed/Refractory AML

Monoclonal AntibodyOncologyTargeted Therapy
  • Debiopharm has dosed the first patient in a Phase 1/2 trial of Debio 1562M, a first-in-class CD37-targeted antibody-drug conjugate for relapsed/refractory acute myeloid leukemia patients.
  • The compound utilizes Debiopharm's proprietary Trifecta approach, combining naratuximab antibody, MultiLink™ linker technology, and a microtubule inhibitor payload to target CD37 antigens on leukemic cells.
  • AML represents a significant unmet medical need with only 32% five-year overall survival and median survival as low as 7 months in certain populations.
  • Preclinical studies demonstrated Debio 1562M showed anti-leukemic activity across all AML subtypes and superior activity compared to current standard-of-care therapies.

A Study to Assess the Safety, Tolerability, and Antileukemic Activity of Debio 1562M in Participants With Acute Myeloid Leukemia (AML)

NCT06969430RecruitingPhase 1
Debiopharm International SA
Posted 5/30/2025

NextCure and Simcere Zaiming Form Strategic Partnership for CDH6-Targeting ADC SIM0505

Oncology
  • NextCure gains global rights to SIM0505, a novel antibody-drug conjugate targeting CDH6 for solid tumors, while Simcere Zaiming retains Greater China rights.
  • The partnership includes potential milestone payments up to $745 million plus tiered royalties, with U.S. Phase 1 trials expected to begin in Q3 2025.
  • SIM0505 features a proprietary topoisomerase 1 inhibitor payload designed for broad anti-tumor activity with high systemic clearance to improve the therapeutic window.
  • Initial Phase 1 clinical data is anticipated in the first half of 2026, following ongoing dose escalation studies in China.

Pierre Fabre Acquires Global Rights to Next-Generation EGFR Inhibitors for NSCLC Treatment

Targeted TherapyPrecision MedicineOncology
  • Pierre Fabre Laboratories acquired worldwide rights to PFL-721 and PFL-241 from Antares Therapeutics, expanding their oncology pipeline with mutant-specific EGFR inhibitors targeting unmet needs in non-small cell lung cancer.
  • PFL-721 is a dual EGFR exon 20 and HER2 exon 20 inhibitor transitioning to dose optimization in first-in-human trials, while PFL-241 is a brain-penetrant fourth-generation EGFR inhibitor addressing C797S resistance mutations.
  • EGFR mutations drive approximately 14-38% of NSCLC tumors globally, representing a significant patient population with substantial therapeutic needs.
  • The acquisition consolidates Pierre Fabre's complete ownership of their R&D portfolio including exarafenib and PFL-002, positioning the company to advance precision medicine development for cancer patients.

Onco-Innovations Partners with University of Alberta to Advance PNKP Inhibitor Research for Glioblastoma Treatment

Oncology
  • Onco-Innovations has entered into a research agreement with the University of Alberta and Cross Cancer Institute to expand preclinical studies of its PNKP inhibitor technology for hard-to-treat cancers, beginning with glioblastoma multiforme.
  • The study will focus on evaluating the therapeutic potential of the company's second-generation nanoparticle formulation of PNKP inhibitors against GBM, which accounts for approximately 50% of all primary malignant brain tumors and affects over 200,000 individuals worldwide annually.
  • Research will be led by Dr. Michael Weinfeld, the original discoverer of the PNKP inhibitor technology, with the preclinical program scheduled to begin in the third quarter of 2025.
  • Key investigation areas will include pharmacological characteristics, DNA damage enhancement in tumor models, effects on normal brain tissue, and potential combination strategies with standard-of-care therapies.

Johnson & Johnson's Dual-Targeting CAR-T Therapy Achieves 80% Complete Response Rate in Lymphoma Trial

CAR-TOncology
  • Johnson & Johnson's investigational dual-targeting CAR-T therapy JNJ-4496 demonstrated 75-80% complete response rates in patients with relapsed or refractory large B-cell lymphoma at the recommended Phase 2 dose.
  • The therapy targets both CD19 and CD20 antigens on malignant B-cells, potentially addressing resistance mechanisms that limit current single-antigen CAR-T treatments to 40% long-term remission rates.
  • Safety data showed no Grade 3 or 4 cytokine release syndrome cases, with neutropenia being the most common severe adverse event affecting 72% of patients.
  • The Phase 1b study results were presented at the 2025 European Hematology Association Congress, marking a significant advancement in treating the most common aggressive lymphoma type.

A Study of JNJ-90014496 in Participants With B-Cell Non-Hodgkin Lymphoma

NCT05421663RecruitingPhase 1
Janssen Research & Development, LLC
Posted 8/12/2022

A Study of C-CAR039 in Subjects With Relapsed and/or Refractory B Cell Non-Hodgkin's Lymphoma

NCT05149391RecruitingPhase 1
Peking University
Posted 7/20/2021

Panavance Therapeutics Reports Promising Phase 1 Results for Misetionamide in Pancreatic Cancer

Oncology
  • Panavance Therapeutics announced interim Phase 1 results for misetionamide (GP-2250) combined with gemcitabine in advanced pancreatic cancer patients.
  • The combination demonstrated a 42% response rate with partial response or stable disease in 55 enrolled patients across seven US sites.
  • Misetionamide showed excellent tolerability with no new toxicities compared to gemcitabine alone, targeting multiple oncogenic transcription factors including c-MYC and NFκB.
  • The company plans additional trials in platinum-resistant ovarian cancer and first-line maintenance therapy for non-BRCA mutated pancreatic cancer patients.

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