Are there any upcoming milestones for Theravectys' trials?
3/7/2025 01:11am
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The deep research logic is organized as follows:
Okay, let's tackle this question about Theravectys' upcoming milestones. The user is asking if there are any upcoming milestones for their clinical trials. From the history, I see they've been following the Lenti-HPV-07 trial, which started in August 2024. The user wants to know what's next.
First, I need to check the references provided. Looking through the references, numbers 1, 4, 5, and 30-33 mention TheraVectys' trials. The Phase I/IIa trial for Lenti-HPV-07 is ongoing, and they've enrolled the first patient. The trial is expected to evaluate safety, immunogenicity, and efficacy. The preclinical results are strong, showing 100% tumor elimination, which is a big deal.
Now, upcoming milestones. The Phase I/IIa trial is still in the dose-escalation phase. They might be looking to expand the trial after establishing the safety profile. Also, the IND clearance for Phase I in Q1 2024 (reference 4) suggests they're moving forward with other trials. Reference 5 mentions plans for Phase I/IIa trials on HPV-induced cancers and prostate cancer, so maybe those are upcoming.
The user is interested in institutional investor activity, but since the question is about clinical trial milestones, I should focus on that. The key points are the completion of the current trial's safety and efficacy data, potential expansion, and new trials starting. Also, the partnership with Pasteur Institute for preclinical work could lead to more trials.
I need to structure the answer with clear sections, cite the references properly, and include visualizations where required. Make sure to highlight the milestones like interim data, expansion phases, and new trial initiations. Also, mention the collaboration with Pasteur as a future milestone.
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**Upcoming Milestones for TheraVectys' Clinical Trials**
TheraVectys’ clinical pipeline is advancing with several key milestones expected in 2025, driven by its lentiviral vector-based therapeutic vaccine platform. Here’s a breakdown of critical developments:
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### 1. **Lenti-HPV-07 Phase I/IIa Trial (Oropharyngeal/Cervical Cancers)**
- **Current Status**: The trial, initiated in August 2024, is evaluating the safety, immunogenicity, and efficacy of Lenti-HPV-07 in 36 patients with HPV-induced cancers. Preclinical data showed **100% tumor eradication** and long-term immune memory .
- **Upcoming Milestones**:
- **Interim Safety/Efficacy Data**: Initial results from the dose-escalation phase are expected in **H1 2025**, focusing on tumor response rates and immune biomarkers .
- **Dose Expansion Phase**: If safety and tolerability are confirmed, the trial may expand to include additional patients for broader efficacy assessment .
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### 2. **IND-Cleared Phase I Trial for HPV-Induced Cancers**
- **Status**: TheraVectys received FDA clearance in November 2023 to initiate a Phase I trial for Lenti-HPV-07 at U.S. cancer centers, including Moffitt Cancer Institute .
- **Upcoming Milestones**:
- **Dosing Initiation**: The trial is projected to begin in **Q1 2024**, focusing on safety and immunogenicity profiles .
- **Collaboration with Pasteur Institute**: Preclinical work at the Pasteur-TheraVectys Joint Lab will continue to refine vaccine design for future trials .
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### 3. **Pipeline Expansion**
- **Prostate Cancer Trial**: TheraVectys plans to initiate preclinical processes for a Phase I/IIa trial targeting prostate cancer in 2025 .
- **Hepatitis B/Liver Cancer Trials**: Partnering with Shanghai Jinwei Biotechnology in China for trials leveraging its lentiviral platform .
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### 4. **Strategic Partnerships & Regulatory Updates**
- **Collaboration with Pasteur Institute**: Ongoing preclinical studies to validate new vaccine candidates for infectious diseases and cancers .
- **Regulatory Filings**: Potential IND submissions for next-generation lentiviral vaccines targeting HPV-negative cancers and other oncological indications .
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### **Investor Implications**
- **Clinical Catalysts**: The Lenti-HPV-07 trial’s interim data (H1 2025) and Phase I initiation (Q1 2024) could drive institutional interest, especially if safety and efficacy align with preclinical results.
- **Pipeline Diversification**: Expansion into prostate and liver cancer trials reduces reliance on a single asset, enhancing long-term growth potential.
For investors focused on **biotech innovation** and **cancer immunotherapy**, TheraVectys’ milestones in 2025 position it as a high-risk, high-reward play in the oncology sector.