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Clinical Trial News

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.

ASC2ESCALATE Trial Shows Promising Results for Asciminib in Second-Line CML Treatment

  • The ASC2ESCALATE phase 2 trial demonstrates asciminib's efficacy in second-line chronic myeloid leukemia treatment, with 82.5% of patients achieving significant molecular response at 24 weeks.
  • The study features an innovative dose escalation strategy, allowing increases from 80 mg to 200 mg daily at 6 months if molecular response targets are not met.
  • Safety profile remains favorable with headache and nausea as most common adverse events, and only four patients discontinuing due to adverse effects.
  • High treatment persistence was observed with 91.1% of patients remaining on asciminib therapy at data cutoff, supporting its tolerability in this patient population.

Asciminib Monotherapy, With Dose Escalation, for 2nd and 1st Line Chronic Myelogenous Leukemia

NCT05384587Active, Not RecruitingPhase 2
Novartis Pharmaceuticals
Posted 11/11/2022

Personalized mRNA Cancer Vaccine Shows Promise in Groundbreaking Bowel Cancer Trial

  • A 43-year-old bowel cancer patient became one of the first people globally to receive a personalized mRNA cancer vaccine designed to prevent cancer recurrence.
  • The vaccine uses genetic analysis of tumor samples to identify abnormal proteins and employs mRNA technology similar to COVID vaccines to train the immune system.
  • Early results from similar approaches in advanced skin cancers show promise, with researchers expecting clearer efficacy data within two to five years.
  • The patient received nearly 20 doses over a year, with initial side effects including fever and shaking that diminished over time.

Supernus Pharmaceuticals Acquires Sage Therapeutics for $795 Million, Strengthening Neuropsychiatry Portfolio

Drug Approval
  • Supernus Pharmaceuticals announced a definitive agreement to acquire Sage Therapeutics for $8.50 per share upfront plus contingent payments up to $3.50 per share, totaling up to $795 million.
  • The acquisition adds ZURZUVAE (zuranolone), the first and only FDA-approved oral treatment for postpartum depression, to Supernus' neuropsychiatry portfolio.
  • The deal is expected to be significantly accretive in 2026 with potential cost synergies of up to $200 million annually and strengthen Supernus' CNS discovery platforms.
  • ZURZUVAE generated $36.1 million in collaboration revenue for 2024, with Supernus receiving 50% of net revenue recorded by partner Biogen in the U.S.

Solu Therapeutics Appoints Enda Moran as COO to Scale CyTAC Platform Operations

Monoclonal Antibody
  • Solu Therapeutics has appointed Enda Moran, PhD, MBA as Chief Operating Officer to lead operational functions as the company advances its Phase 1 clinical trial of STX-0712.
  • Dr. Moran brings over three decades of biomanufacturing experience from Pfizer, GSK, and other major pharmaceutical companies to support Solu's CyTAC and TicTAC platforms.
  • The appointment comes as Solu progresses STX-0712 through Phase 1 development for resistant/refractory chronic myelomonocytic leukemia and other hematologic malignancies.
  • Dr. Moran will oversee chemistry manufacturing and controls, quality, program management, and infrastructure development to support multiple clinical and regulatory milestones.

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