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Clinical Trial News

Sucralose Artificial Sweetener Reduces Cancer Immunotherapy Effectiveness Through Gut Microbiome Disruption

  • University of Pittsburgh researchers found that sucralose consumption is associated with worse overall response and progression-free survival in cancer patients receiving anti-PD-1 immunotherapy.
  • The artificial sweetener disrupts gut microbiota, leading to depletion of arginine, an amino acid essential for T-cell function and anticancer activity.
  • Mouse studies demonstrated that arginine or citrulline supplementation can restore immunotherapy effectiveness even when sucralose consumption continues.
  • The findings, published in Cancer Discovery, suggest a potential therapeutic strategy to counteract dietary interference with cancer treatment without requiring patients to eliminate artificial sweeteners.

Spine BioPharma's SB-01 Fails to Meet Primary Endpoint in Phase 3 Trial for Chronic Low Back Pain

  • Spine BioPharma's Phase 3 MODEL trial evaluating SB-01, a TGF-β antagonist for chronic low back pain associated with degenerative disc disease, failed to meet its primary endpoint despite showing clinically meaningful improvements.
  • The 417-patient randomized controlled trial achieved a 67% success rate with SB-01 at Month 6, but this did not reach statistical significance compared to sham control due to unexpectedly high placebo response rates.
  • In sites with anticipated sham control responses, SB-01 nearly achieved statistical significance (p=0.051), suggesting the treatment may be effective when placebo effects are controlled.
  • The company plans to meet with the FDA to discuss potential approval pathways based on the Phase 3 results combined with earlier Phase 1 and 2 trial data.

Moderate - Severe Degenerative Disc Disease Evaluation of the Lumbar Spine

NCT05516992Active, Not RecruitingPhase 3
Spine BioPharma, Inc
Posted 8/19/2022

FDA Issues Second Rejection for Regeneron's Lymphoma Therapy Odronextamab Due to Manufacturing Issues

  • The FDA declined to approve Regeneron's lymphoma therapy odronextamab for the second time, citing manufacturing issues at a third-party Catalent facility rather than safety or efficacy concerns.
  • The rejection stems from problems discovered during an FDA inspection at Catalent's Indiana facility, which handles final drug preparation and packaging for odronextamab.
  • Despite FDA setbacks, odronextamab received European Union approval in August 2024 for treating relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma.
  • Regeneron must address the manufacturing concerns and resubmit its biologics license application while continuing its phase 3 OLYMPIA-1 trial.

Ozempic Shows Anti-Aging Effects in First Clinical Trial, Reversing Biological Age by 3.1 Years

  • A randomized controlled trial of 108 people with HIV-associated lipohypertrophy found that weekly Ozempic treatment for 32 weeks reversed biological age by an average of 3.1 years.
  • The study used epigenetic clocks to measure biological aging, showing the most pronounced anti-aging effects in the inflammatory system and brain, where aging was delayed by almost 5 years.
  • Researchers believe the anti-aging effects stem from semaglutide's ability to improve fat distribution and reduce inflammation, both major drivers of cellular aging.
  • While the study focused on a specific patient population, the biological pathways affected by semaglutide suggest similar anti-aging effects could occur in other populations.

Allogene Therapeutics Modifies ALPHA3 Trial Design Following Patient Death, Adopts Standard Lymphodepletion Protocol

CAR-T
  • Allogene Therapeutics has discontinued the FC plus ALLO-647 lymphodepletion arm in its ALPHA3 trial after a patient death from hepatic failure attributed to disseminated adenovirus infection.
  • The company will proceed with standard fludarabine and cyclophosphamide (FC) lymphodepletion for cemacabtagene ansegedleucel (cema-cel) in first-line consolidation for large B-cell lymphoma.
  • This strategic shift eliminates ALLO-647 from all current trials and accelerates focus on the company's next-generation Dagger Platform Technology for future CAR-T development.
  • The modified ALPHA3 trial continues as a two-arm randomized study comparing cema-cel after standard FC to observation, with futility analysis scheduled for first half 2026.

Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL

NCT06500273RecruitingPhase 2
Allogene Therapeutics
Posted 6/18/2024

Everest Medicines Invests $30.9M in I-Mab Following Promising 83% Response Rate for Gastric Cancer Bispecific Antibody

CAR-T
  • Everest Medicines has made a strategic $30.9 million equity investment in I-Mab, bringing its total ownership to 16.1% of the U.S.-based biotech company.
  • I-Mab's lead bispecific antibody givastomig demonstrated an impressive 83% overall response rate in combination with immunotherapy in a Phase 1b trial for first-line gastric cancer.
  • The strategic partnership combines I-Mab's 4-1BB receptor targeting platform with Everest's mRNA cancer vaccines and CAR-T therapies, creating synergistic development opportunities.
  • The collaboration leverages I-Mab's clinical translational capabilities in the U.S. with Everest's strong presence in Asian markets for accelerated global expansion.

I-Mab Raises $65 Million to Advance Givastomig Phase 2 Trial for Gastric Cancer

  • I-Mab completed a $65 million underwritten offering of American Depositary Shares at $1.95 per share to fund clinical development programs.
  • The proceeds will primarily support a randomized Phase 2 trial of givastomig, a bispecific Claudin 18.2 x 4-1BB antibody for gastric cancer treatment.
  • Givastomig has demonstrated strong tumor-binding and anti-tumor activity in Phase 1 trials while minimizing toxicities associated with other 4-1BB agents.
  • The Phase 2 trial is designed to generate clinically meaningful progression-free survival data by the end of 2027.

Mabwell's CDH17-Targeting ADC 7MW4911 Receives Dual IND Acceptance from FDA and NMPA

  • Mabwell's investigational antibody-drug conjugate 7MW4911 has received IND application acceptance from both the FDA and China's NMPA, marking a significant regulatory milestone for this CDH17-targeting therapy.
  • The ADC demonstrates superior efficacy against multidrug-resistant gastrointestinal cancers, outperforming existing MMAE/DXd-based ADCs in preclinical models of colorectal, gastric, and pancreatic cancers.
  • 7MW4911 features an optimized molecular design with a homogeneous drug-to-antibody ratio of 4 and incorporates a proprietary DNA topoisomerase I inhibitor payload designed to overcome treatment resistance.
  • Preclinical data published in Cell Reports Medicine shows the therapy maintains activity even in tumors with low-to-moderate CDH17 expression, potentially expanding patient eligibility for treatment.

ESTEVE CDMO Acquires Chicago-Based Regis Technologies to Expand US Manufacturing Capabilities

  • ESTEVE CDMO has acquired Regis Technologies, a 65-year-old Chicago-based contract development and manufacturing organization, establishing its first physical presence in the United States.
  • The acquisition expands ESTEVE's contract development and manufacturing solutions for small-molecule active pharmaceutical ingredients across the entire drug development lifecycle from pre-clinical to commercial manufacturing.
  • Regis Technologies brings approximately 70 skilled professionals and comprehensive services including process research & development, analytical & stability testing, cGMP API manufacturing, and chromatography products.
  • The strategic move enhances ESTEVE's early-stage development capabilities and global manufacturing footprint, allowing for integrated service offerings to better serve pharmaceutical innovators.

Kazia Therapeutics Secures $2 Million Private Placement to Advance Brain Cancer and Breast Cancer Drug Development

  • Kazia Therapeutics raised $2 million through a private placement priced at a 5% premium to market, demonstrating strong investor confidence in the company's oncology pipeline.
  • The funding will support continued clinical development of paxalisib, a brain-penetrant PI3K/mTOR inhibitor in trials for brain cancer and advanced triple-negative breast cancer.
  • The company is also advancing EVT801, a selective VEGFR3 inhibitor currently in Phase 1 trials for advanced solid tumors.

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