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Clinical Trial News

Harbour BioMed Appoints Yajie Li as Chief Medical Officer to Advance Antibody Therapeutics Pipeline

Monoclonal AntibodyOncology
  • Harbour BioMed has appointed Yajie Li as Chief Medical Officer to lead clinical development and regulatory strategy for the company's immunology and oncology programs.
  • Li brings over a decade of pharmaceutical experience from multinational corporations including Merck and Johnson & Johnson, plus nine years at China's National Medical Products Administration.
  • The appointment strengthens Harbour BioMed's capabilities as it advances its pipeline using proprietary antibody technologies including Harbour Mice, HBICE, and HBICA platforms.
  • Li will evaluate early-stage assets based on unmet medical needs and scientific differentiation while reporting directly to CEO Dr. Jingsong Wang.

Metformin Shows Potential Survival Benefit in HER2-Positive Breast Cancer Patients

  • A comprehensive scoping review of 40 clinical trials published in BMC Cancer reveals that metformin may modestly increase pathologic complete response rates in HER2-positive breast cancer patients when added to standard treatment regimens.
  • Observational evidence demonstrates that breast cancer patients with diabetes who received metformin showed improved survival outcomes, with hazard ratios suggesting nearly a 50% reduction in breast cancer-specific mortality compared to non-users.
  • Metformin's mechanism involves activating AMP-activated protein kinase (AMPK) and inhibiting the mTOR pathway, potentially enhancing the effectiveness of HER2-targeted therapies like trastuzumab and pertuzumab.
  • Despite promising preliminary results, most phase 3 trials have not yet shown statistically significant survival improvements, highlighting the need for more rigorous, subtype-focused investigations in HER2-positive disease.

Akums Drugs Partners with Zambian Government to Establish $50 Million Pharmaceutical Manufacturing Facility

  • Akums Drugs and Pharmaceuticals Limited has announced a joint venture with the Government of Zambia to establish a state-of-the-art pharmaceutical manufacturing facility, with Akums holding a 51% majority stake.
  • The facility, expected to be completed by 2028, will manufacture tablets, capsules, liquids, injectables, and beta-lactam products to serve Zambia's growing pharmaceutical market projected to exceed $300 million by 2030.
  • The Zambian government has committed to purchasing $25 million worth of medicines annually from Akums' Indian facilities in 2026 and 2027, while the new facility will also export to neighboring Southern African nations.
  • This partnership represents Akums' first international manufacturing venture and aims to reduce Zambia's 75% import dependency for essential medicines while supporting the country's move toward healthcare self-reliance.

Biogen Advances Litifilimab Development with Phase 3 Extension Study and Novel Drug Delivery Research for Lupus Treatment

  • Biogen is conducting a Phase 3 long-term extension study evaluating litifilimab's continuous safety and efficacy in adults with active systemic lupus erythematosus, with completion expected in August 2025.
  • The company is simultaneously testing three different subcutaneous delivery devices for litifilimab to improve patient compliance and address administration challenges for those with limited dexterity or needle phobia.
  • These parallel studies represent Biogen's comprehensive approach to developing litifilimab as a potential lupus treatment, combining long-term efficacy data with innovative delivery solutions.

Defence Therapeutics Raises Up to $1.2M Through Convertible Debenture Financing to Advance ADC Platform

Oncology
  • Defence Therapeutics announced a non-brokered private placement of debenture units for up to $1.2 million in gross proceeds to fund its ADC development programs.
  • Each $1,000 unit includes an 8.0% convertible debenture and 1,666 warrants, with conversion at $0.60 per share and warrant exercise at $0.75 per share.
  • The company specializes in developing next-generation antibody-drug conjugates using its proprietary ACCUM® technology platform for precision cancer therapy delivery.
  • The financing structure provides Defence with flexible capital while offering investors potential equity upside through conversion and warrant features over a two-year term.

Tempus AI Acquires Paige to Build World's Largest Oncology Foundation Model

AIPrecision MedicineOncologyDrug Discovery
  • Tempus AI has acquired Paige, an AI company specializing in digital pathology with FDA-cleared cancer detection applications and nearly 7 million digitized pathology slides.
  • The $81.25 million stock acquisition positions Tempus to build the largest oncology foundation model in history by combining datasets and AI capabilities.
  • The strategic move strengthens Tempus' position in the digital pathology market projected to reach $10 billion by 2030, enhancing drug discovery and personalized medicine capabilities.
  • Paige's global dataset from 45 countries and partnership with Memorial Sloan Kettering Cancer Center adds significant credibility and diversity to Tempus' AI platform.

Anlon Healthcare Sets IPO Price Band at ₹86-91 Per Share for ₹121 Crore Public Offering

  • Anlon Healthcare, a pharmaceutical intermediates and API manufacturer, has set its IPO price band at ₹86-91 per share for a ₹121 crore public offering scheduled to open on August 26, 2025.
  • The company reported strong financial performance with 81% revenue growth and 112% profit increase in fiscal 2025, demonstrating robust business expansion in the pharmaceutical manufacturing sector.
  • Proceeds from the IPO will fund manufacturing plant expansion (₹30.7 crore), working capital requirements (₹43.15 crore), debt repayment, and general corporate purposes.
  • The shares are expected to list on BSE and NSE on September 3, 2025, with the company competing against established players like Kronox Lab Sciences, AMI Organics, and Supriya Lifescience.

AstraZeneca Partners with Philippines to Establish First Pharmaceutical Innovation Hub in PEZA Ecozone

AIOncology
  • The Philippine Economic Zone Authority (PEZA) and AstraZeneca Pharmaceuticals Philippines have signed an agreement to create the country's first pharmaceutical innovation hub within the PEZA ecozone network.
  • The hub will serve as a regional center for digital health technology, research and development collaboration, and patient-centered healthcare solutions across ASEAN.
  • The initial project will be an Oncology Innovation Center using artificial intelligence for early cancer detection, modeled after AstraZeneca's pharma hub in the United Kingdom.
  • The partnership aims to make medicines more affordable and accessible while positioning the Philippines as a hub for healthcare-related investments and medical research.

FDA Rejects Blu Disposable E-Cigarette Marketing Application Over Dual-Use Concerns

FDA Approval
  • The FDA denied marketing authorization for Fontem US's Blu disposable classic tobacco-flavored 2.4% nicotine e-cigarette on August 19, citing insufficient evidence of public health benefits.
  • The agency determined that users would likely continue smoking cigarettes while using the Blu product, potentially exposing them to higher toxicant levels than exclusive cigarette use.
  • Fewer than 30 vaping products have received FDA marketing approval, with only four brands currently authorized: Juul, Altria's Njoy, Reynolds American's Vuse, and Japan Tobacco's Logic.
  • The FDA emphasized that authorized e-cigarettes must demonstrate complete switching from cigarettes or significant reduction in cigarette consumption to receive approval.

BlossomHill Therapeutics Advances EGFR-Mutant NSCLC Treatment with First-in-Class OMNI-EGFR Inhibitor BH-30643

Targeted TherapyOncology
  • BlossomHill Therapeutics has dosed the first patient in expansion cohorts of the SOLARA Phase 1/2 trial evaluating BH-30643, a first-in-class OMNI-EGFR inhibitor for advanced EGFR-mutant non-small cell lung cancer.
  • BH-30643 demonstrates sub-nanomolar potency against classical and atypical EGFR mutations while maintaining activity against T790M and C797S resistance mutations that commonly limit current therapies.
  • The expansion cohorts will assess objective response rates across diverse EGFR mutation subtypes, including treatment-naive patients, following successful dose escalation that showed favorable pharmacokinetics and preliminary anti-tumor activity.
  • The drug's broad-spectrum approach aims to address multiple EGFR mutations with a single agent while sparing wildtype EGFR and HER2 inhibition for improved tolerability.

A Study of BH-30643 in Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations

NCT06706076RecruitingPhase 1
BlossomHill Therapeutics
Posted 1/9/2025

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