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Clinical Trial News

Memgen Initiates Phase 1 Combination Trial of MEM-288 Plus Docetaxel for Advanced NSCLC

  • Memgen has dosed the first patient in a Phase 1 combination cohort evaluating intratumoral MEM-288 plus docetaxel in patients with advanced non-small cell lung cancer.
  • The trial targets patients whose disease has progressed after first-line immune checkpoint inhibitor therapy, addressing a significant unmet medical need.
  • MEM-288 is an investigational oncolytic immunotherapy designed to prime dendritic cells and activate effector T cells to promote immunogenic tumor cell lysis.
  • Previous clinical experience showed MEM-288 produced clinically meaningful tumor reductions in advanced NSCLC patients refractory to standard therapies.

MEM-288 Oncolytic Virus Alone and in Combination With Standard of Care Therapy in Advanced Solid Tumors

NCT05076760RecruitingPhase 1
Memgen, Inc.
Posted 4/21/2022

RMTG Subsidiary Opens Advanced Cell Therapy Manufacturing Facility in Mexico

  • Regenerative Medical Technologies Group's subsidiary Cellgenic will host a soft opening of its COFEPRIS-licensed cell therapy manufacturing facility in Cancun, Mexico during September 2025.
  • The facility will produce investigational and regulated cell-based therapies including mesenchymal stem cells, exosomes, and natural killer cells for orthopedics, neurology, pain management, and aesthetic medicine applications.
  • Full-scale operations are expected by January 2026, adding manufacturing revenue streams to RMTG's existing affiliate network spanning over 30 countries.
  • The facility features ISO-classified cleanrooms, cryopreservation systems, and GMP-aligned workflows to support global distribution within regulatory frameworks.

Propanc Biopharma Advances Novel Cancer Drug PRP to Phase 1B Human Trials Following $4M Nasdaq IPO

  • Propanc Biopharma completed a $4 million IPO and Nasdaq listing, positioning the company to advance its lead cancer drug PRP into Phase 1B human trials in 2026.
  • PRP, a bovine pancreatic proenzyme mixture, targets solid tumors by reprogramming cancer cells through EMT modulation, potentially avoiding severe side effects of standard treatments.
  • The company plans to conduct the first-in-human study at Peter Mac Cancer Center in 30-40 advanced cancer patients to determine maximum tolerated dose.
  • The combined market opportunity for PRP's target indications in pancreatic and ovarian cancers is projected to reach $18.1 billion by 2029.

Xeris Secures Additional Orange Book Patent Protection for Recorlev Through 2040

Rare Disease
  • Xeris Biopharma received FDA Orange Book listing for a new patent covering Recorlev (levoketoconazole) therapeutic methods that minimize drug-drug interactions with MATE1 substrates, extending protection to March 2040.
  • The patent strengthens intellectual property protection for the FDA-approved treatment of endogenous Cushing's syndrome in adult patients for whom surgery is not an option or has not been curative.
  • Recorlev now holds four Orange Book-listed patents, providing enhanced market exclusivity and generic drug monitoring capabilities for this rare endocrine disease therapy.

Roche Breaks Ground on $700M North Carolina Manufacturing Facility for Next-Generation Obesity Treatments

  • Genentech, Roche's US subsidiary, has broken ground on a $700 million state-of-the-art manufacturing facility in Holly Springs, North Carolina, marking the company's first East Coast manufacturing site.
  • The 65,000 m² facility is strategically designed to support production of next-generation metabolic medicines, including obesity treatments, and will create more than 1,900 jobs by 2029.
  • This investment is part of Roche's broader $50 billion commitment to US manufacturing infrastructure and R&D, positioning the company to capitalize on the rapidly growing obesity treatment market projected to reach $100 billion by 2030.

FDA Expands Repatha Indication to Include Adults at High Risk for Cardiovascular Events Without Prior Disease Diagnosis

Monoclonal AntibodyDrug Approval
  • The FDA has expanded Repatha's (evolocumab) indication to include adults at increased risk for major adverse cardiovascular events due to uncontrolled LDL cholesterol, removing the requirement for prior cardiovascular disease diagnosis.
  • Real-world data from over 1.3 million patients showed a 1.4% incidence of major adverse cardiovascular events within one year, rising to 6.9% at four years among at-risk patients.
  • Repatha, a PCSK9 inhibitor, has demonstrated 54% to 77% LDL cholesterol reduction compared to placebo in clinical trials spanning 15 years of research across 50 studies involving more than 57,000 patients.

MannKind Acquires scPharmaceuticals for Up to $360M to Expand Cardiorenal Portfolio

  • MannKind Corporation announced the acquisition of scPharmaceuticals for up to $360 million, marking its strategic expansion into cardiorenal medicine with FUROSCIX as the key asset.
  • The deal includes an upfront payment of $5.35 per share plus contingent value rights worth up to $1.00 per share, representing a 36% premium to scPharmaceuticals' 90-day trading average.
  • FUROSCIX demonstrated strong commercial momentum with net sales of $27.8 million for the first half of 2025, representing 96% year-over-year growth.
  • The acquisition is expected to diversify MannKind's revenue base and accelerate double-digit growth goals, with the combined company targeting an annualized run rate exceeding $370 million.

FDA Transitions to Daily Adverse Event Reporting for Drugs and Biologics

  • The FDA has shifted from quarterly to daily publication of adverse event reports for prescription drugs and therapeutic biologics through its FAERS database system.
  • FDA Commissioner Marty Makary criticized the previous "clunky" system that required months-long waits for safety information to become publicly available.
  • The change aims to provide healthcare professionals and researchers with near-real-time access to drug safety data, though database limitations remain.
  • Daily updates will particularly benefit those who monitor specific drugs or biologics frequently, supporting improved post-market safety surveillance efforts.

Catalyst Pharmaceuticals Secures Patent Protection for FIRDAPSE Until 2035 Through Lupin Settlement

Rare Disease
  • Catalyst Pharmaceuticals and SERB S.A. reached a settlement agreement with Lupin that prevents generic competition for FIRDAPSE (amifampridine) until February 25, 2035.
  • The settlement resolves patent litigation stemming from Lupin's attempt to market a generic version of the rare disease treatment before patent expiration.
  • Catalyst has now settled similar patent disputes with Teva Pharmaceuticals and Inventia Life Science, with ongoing litigation against Hetero remaining.
  • The agreement ensures continued market exclusivity for FIRDAPSE, a treatment for patients with rare and difficult-to-treat diseases, extending commercial protection by over a decade.

I-Mab Strengthens Leadership Team with Three New Board Appointments and R&D Committee Formation

  • I-Mab appointed three seasoned biotech executives to key leadership positions, including Dr. Robert Lenz and Ms. Xin Liu to the Board of Directors and Dr. Ken Takeshita to the Scientific Advisory Board.
  • The company established a new Research and Development Committee chaired by Dr. Lenz to accelerate innovation and guide strategic development of its immuno-oncology pipeline.
  • These leadership changes come as I-Mab advances givastomig, a bispecific antibody targeting Claudin 18.2-positive gastric cancers that showed strong anti-tumor activity in Phase 1 trials.

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