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Clinical Trial News

HELP Therapeutics Partners with China Resources Sanjiu to Advance iPSC-Derived Heart Failure Therapy HiCM-188

  • HELP Therapeutics and China Resources Sanjiu have formed a strategic partnership to co-develop and commercialize HiCM-188, the world's first iPSC-derived regenerative therapy for advanced heart failure with IND clearance in both China and the United States.
  • HiCM-188 is currently in Phase II clinical trials in China and Phase I/II trials in the U.S., Singapore, and Thailand, demonstrating robust safety and efficacy across more than five years of long-term follow-up.
  • The partnership addresses a critical unmet medical need as heart failure prevalence increases at double-digit rates with aging populations, while heart transplantation remains limited by donor deficiency.
  • Professor Junbo Ge noted that this collaboration represents a milestone in China's Cell and Gene Therapy landscape and has the potential to reshape treatment paradigms for patients worldwide.

Cresilon Expands VETIGEL Distribution to Canadian Veterinary Market Through McCarthy Vet Partnership

  • Cresilon Inc. has entered into a distribution agreement with McCarthy Vet to make VETIGEL, a revolutionary plant-based hemostatic gel, available to veterinary surgeons across Canada.
  • VETIGEL has been used in more than 60,000 surgical procedures worldwide since its 2021 debut, providing instant bleeding control during veterinary surgeries including dental extractions, tumor removals, and complex procedures.
  • The partnership with McCarthy Vet, a family-owned company serving Canadian veterinarians for over 60 years, represents Cresilon's first veterinary distribution agreement in Canada.
  • The biocompatible, non-animal derived gel forms an instant mechanical barrier to stop bleeding on contact and can be easily removed or left to resorb naturally in the body.

Lantern Pharma Reports Complete Response in Advanced NSCLC Patient After Failed Standard Therapies

  • A 70-year-old never-smoker with advanced non-small cell lung cancer achieved complete response with LP-300 plus chemotherapy after failing three prior treatment lines including Keytruda, radiation, and Tagrisso.
  • The patient experienced 57% initial tumor reduction followed by complete resolution of lung and adrenal lesions, remaining progression-free for nearly two years across 21 treatment cycles.
  • The sustained response demonstrates LP-300's potential to address critical unmet needs in never-smoker NSCLC patients who have exhausted targeted kinase therapy options.
  • Never-smoker NSCLC represents 15-20% of U.S. lung cancer cases with significantly higher rates in Asian populations, yet no therapies are specifically approved for this patient subset.

A Study of LP-300 With Carboplatin and Pemetrexed in Never Smokers With Advanced Lung Adenocarcinoma

NCT05456256RecruitingPhase 2
Lantern Pharma Inc.
Posted 3/1/2023

Shasqi Achieves First-in-Human Success with Click Chemistry Cancer Therapy, Delivering 12-Fold Higher Doxorubicin Doses

Targeted Therapy
  • Shasqi has published landmark results from the first-in-human clinical trial of SQ3370, marking the inaugural use of click chemistry-based cancer therapeutics in patients with advanced solid tumors.
  • The company's CAPAC® platform enabled delivery of 12-fold higher doses of doxorubicin per cycle compared to conventional approaches while reducing systemic toxicity and myelosuppression.
  • The breakthrough demonstrates that click chemistry can be safely harnessed inside the human body to concentrate cancer drugs at tumor sites while sparing healthy tissues.
  • Nobel Prize winner Carolyn Bertozzi emphasized that this study unlocks a new frontier for oncology innovation by proving biorthogonal chemical groups are tolerated in humans.

GeoVax Receives EMA Approval to Skip Phase 1/2 Trials for Mpox Vaccine, Accelerating Path to Market

  • GeoVax Labs received positive Scientific Advice from the European Medicines Agency for GEO-MVA, a Modified Vaccinia Ankara-based vaccine targeting Mpox and smallpox prevention.
  • The EMA confirmed that Phase 1 and Phase 2 trials can be omitted, allowing GeoVax to proceed directly to a single Phase 3 immuno-bridging trial against the approved MVA vaccine Imvanex.
  • This regulatory guidance comes as the World Health Organization declared Mpox a Public Health Emergency of International Concern for the fourth time, highlighting urgent global vaccine supply needs.
  • The streamlined approval pathway could significantly accelerate GEO-MVA's regulatory timeline and provide an alternative vaccine source to address current supply constraints from single-supplier dependency.

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

Patent Extensions Drive $200 Billion in Excess U.S. Drug Spending, I-MAK Analysis Reveals

  • The Initiative for Medicines, Access, and Knowledge (I-MAK) published a data brief revealing how pharmaceutical companies exploit patent extensions to delay generic competition and inflate drug prices for blockbuster medications.
  • Eliquis received a four-year Patent Term Extension moving expiration to 2026, with follow-on patents delaying generic entry until 2028, generating an expected $50.7 billion in additional U.S. sales.
  • Novo Nordisk filed over 320 patent applications for semaglutide, extending market exclusivity for Ozempic, Rybelsus, and Wegovy through 2042, projected to generate $166 billion in additional revenue between 2026-2031.
  • U.S. patients pay dramatically more than international counterparts, with Eliquis costing $521 monthly versus $84-109 in other countries, while Ozempic costs $936 versus $69-169 internationally.

Clarametyx's CMTX-101 Shows Promise in Cystic Fibrosis Infection Trial, Advances to Next Phase

Monoclonal Antibody
  • Clarametyx Biosciences announced positive interim results from its Phase 1b/2a trial of CMTX-101, an immune-enabling antibody therapy for cystic fibrosis-associated pulmonary infections.
  • The interim analysis of 21 participants demonstrated a reduction in Pseudomonas aeruginosa burden with both 5 and 30 mg/kg doses, while maintaining a favorable safety profile.
  • The Independent Data Monitoring Committee approved continuation of the trial without modifications, with full enrollment of approximately 41 participants expected by end of 2025.
  • CMTX-101 targets bacterial biofilms to enhance antibiotic effectiveness and immune response, representing a novel approach to treating chronic respiratory infections.

A Study To Evaluate The Safety Of CMTX-101 In People With Cystic Fibrosis

NCT06159725RecruitingPhase 1
Clarametyx Biosciences, Inc.
Posted 6/24/2024

Eolo Pharma's SANA Demonstrates Novel Energy-Burning Mechanism for Obesity Treatment in First-in-Human Study

  • Eolo Pharma published first-in-human data in Nature Metabolism showing SANA, a first-in-class compound, safely activates creatine-dependent thermogenesis to increase energy expenditure rather than suppress appetite.
  • The Phase 1a/b study demonstrated statistically significant weight loss and metabolic improvements in patients with obesity after just 15 days of treatment, with no serious adverse events reported.
  • Unlike GLP-1 receptor agonists that cause muscle loss, preclinical data shows SANA preserves and increases lean muscle mass while reducing fat mass through enhanced mitochondrial respiration.
  • The company plans to initiate Phase 2 trials in 2025 to evaluate SANA's potential as both standalone and combination therapy for metabolic diseases.

Integrated CDMO-CRO Services Can Reduce Drug Development Timelines by Nearly Three Years, Tufts Study Finds

  • A new Tufts Center for the Study of Drug Development study demonstrates that integrated CDMO and CRO services can reduce Phase I-III drug development timelines by up to 34 months.
  • The research shows integrated services can generate up to $63 million in net financial benefits for drug sponsors, representing a return on investment of up to 113 times the initial investment.
  • Each month of delay in Phase III clinical trials can result in up to $8 million in lost revenue from shortened market exclusivity and deferred market entry.
  • More than 120 biotech and biopharma companies have utilized Thermo Fisher's integrated solutions across over 350 protocols spanning multiple therapeutic areas.

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