Aelis Farma Announces Completion of Patient Randomization for Phase 2b Study with AEF0117 for the Treatment of Cannabis Addiction

• As planned, 333 patients have been randomized at end of December 2023 across 11 clinical centers in the United States

• This major milestone confirms the announced availability of the first results of the study for the end of the second quarter of 2024

Bordeaux, January 9, 2024 - Aelis Farma (ISIN: FR0014007ZB4 – Ticker: AELIS), a clinical-stage biopharmaceutical company specializing in the development of treatments for brain disorders, announces to have reached a key milestone by successfully completing the recruitment of 333 patients suffering from cannabis addiction in its Phase 2b clinical study with AEF0117.

AEF0117 is the first of a new class of proprietary drugs developed by Aelis Farma, the Signaling Specific inhibitors of the CB1 receptor of the endocannabinoid system (CB1-SSi). The ongoing multicenter Phase 2b study aims to demonstrate the effectiveness of this "first-in-class" compound in treating cannabis addiction, currently defined as CUD (Cannabis Use Disorder) in the DSM-5, the reference diagnostic manual of mental disorders

The recruitment and randomization of the 333 study patients were accomplished across 11 clinical centers in the United States, under the coordination of Pr. Frances Levin from Columbia University (New York). The double-blind, placebo-controlled trial involves the administration of either placebo or one of the three tested doses of AEF0117 (0.1 mg, 0.3 mg, and 1 mg) once daily for 3 months. The primary objective of the study is to assess whether AEF0117 reduces cannabis consumption by demonstrating an increase in the proportion of subjects consuming cannabis ≤1 day per week compared to the placebo. The proportion of patients achieving other levels of reduced consumption, along with the potential improvement in their quality of life, will also be examined as secondary endpoint. Initial results are expected in line with the timeline previously announced for the second quarter of 2024... Aelis Farma's Press Release - 

echOpen, a start-up spun off from AP-HP, unveils its ultraportable ultrasound probe to make medical imaging accessible to all caregivers around the world

The ultrasound probe echOpen O1, connected to the healthcare professional's smartphone, makes it possible to visualize the inside of the body, thus increasing the clinical examination in order to better guide patients, reduce diagnostic doubt and speed up treatment. 

Access to medical imaging remains a major issue in the French healthcare system, with only 4% of general practitioners equipped (vs. 60% in Germany). The initial investment remains the main obstacle to the equipment. By making its device accessible with a price that will allow each doctor to equip himself with a personal probe, echOpen wants to massively disseminate this technology to improve the health of populations on a large scale. 

echOpen has chosen a strong positioning by creating the first personal ultraportable ultrasound probe that concentrates the essential medical needs for the practice of clinical ultrasound. 

From the outset, the AP-HP wanted to support this project, which would provide a large number of clinicians with a new tool to better care for patients. Thus the project echOpen It was incubated in 2015 in the heart of the oldest hospital in Paris, the Hôtel-Dieu AP-HP, close to caregivers and patients. In 2021, once echOpen Having become a start-up in its own right, AP-HP has acquired a stake in the company – a first in the institution's history. 

The partnership established by the AP-HP and echOpen testifies to the fruitful relationship that can be established between a university hospital and a start-up: in addition to the permanent dialogue between clinicians and engineers in order to understand the needs and design the probe, this close relationship has also resulted in the realization of two clinical trials conducted within AP-HP hospitals, which have proven the robustness and potential of the probe. 

This partnership will continue in 2024, with the deployment of ultrasound probes echOpen O1 in a first series of pilot services of the AP-HP as part of a pre-deployment phase to assess all the impacts.

The AP-HP and echOpen will also jointly carry out the Echo93 project, selected and funded by the Ile-de-France Regional Health Agency, in order to improve the city-hospital care pathway by allowing an initial imaging diagnosis to be made during general clinical examinations in a rapid diagnostic unit in the hospital or in a city practice. This project strongly involves the Jean-Verdier AP-HP hospital and is supported by the @Hôtel-Dieu team... echOpen's Press Release -

Valneva Vaccinates First Participant in Pediatric Trial of Single-Shot Chikungunya Vaccine

Saint-Herblain (France), January 10, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA)  announced that the first participant has been vaccinated in the Phase 2 clinical trial evaluating the safety and Immunogenicity in children of two different dose levels of Valneva’s single-shot chikungunya vaccine. The Company reported positive pivotal Phase 3 data in adolescents two months ago confirming the immunogenicity and safety profile observed in adults.

There is currently no approved chikungunya vaccine for children and Valneva’s vaccine IXCHIQ® is currently the only licensed chikungunya vaccine to address this unmet medical need in adults aged 18 years and older who are at increased risk of exposure to the virus. Once available, the Phase 2 pediatric data are intended to support a Phase 3 pivotal study in children with the objective to extend the label in this age group following initial regulatory approvals in adults and possibly in adolescents.

The multicenter, prospective, randomized, observer-blinded, Phase 2 clinical trial is planned to enroll approximately 300 healthy children one to eleven years of age at three trial sites in the Dominican Republic and Honduras. Following a safety run-in phase, participants will be randomized to receive either a full dose formulation of the vaccine (120 participants), a half dose formulation (120 participants) or a control vaccine (60 participants).

Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said, “This pediatric trial is extremely important. Given the significant threat that chikungunya poses to individuals living in or traveling to endemic areas, it is crucial to make the vaccine accessible to all age groups. By doing so, we can broaden the protection against and reduce the impact of this debilitating disease.”

Valneva was granted approval from the U.S. Food and Drug Administration (FDA) for its chikungunya vaccine IXCHIQ® in November 2023. Three marketing applications are currently under review by the European Medicines Agency, Health Canada and the Brazilian Health Regulatory Agency (Anvisa) with potential approvals in 2024... Valneva's Press Release - Phase 2 Trial VLA1553-221 (Identifier: NCT06106581) - 

TheraVectys announces IND clearance from the US FDA enabling Phase 1 initiation for its therapeutic vaccine candidate Lenti-HPV-07 against oropharyngeal and cervical cancers

 - Targeting to initiate dosing of Phase 1 clinical trial in Q1 2024 to evaluate Lenti-HPV-07 in patients having oropharyngeal or cervical cancers induced by HPV16 or 18.

- The multicenter, open-label Phase 1 trial will evaluate the safety of ascending doses of Lenti-HPV-07 in 36 patients

- Lenti-HPV-07 preclinical profile and clinical development carried out by the PasteurTheraVectys joint laboratory were published in EMBO Molecular Medicine journal on September 7, 2023

On November 27, 2023, TheraVectys a lentiviral vector immunotherapy company focused on developing vaccine candidates to drive the widespread treatment and prevention of cancer and infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has completed its safety review of the Investigational New Drug (IND) application and concluded that TheraVectys’proposed clinical study may proceed to evaluate the oncotherapeutic vaccine Lenti-HPV-07 for the treatment of human papillomavirus (HPV)-induced cancers.

The lentiviral vector-based intramuscular vaccine candidate has already demonstrated 100% preclinical efficacy against HPV-induced cancers. The results of the pre-clinical development work carried out by the Pasteur-TheraVectys joint laboratory were published in EMBO Molecular Medicine journal on September 7, 2023, in an article entitled : "Full eradication of pre-clinical human papilloma virus-induced tumors by a lentiviral vaccine”.

The clinical trial, scheduled to begin in the first quarter of 2024, will be conducted in the U.S. at four cancer centers, including Florida's Moffitt Cancer Institute.

The multicenter, open-label Phase 1 trial will evaluate the safety of ascending doses of LentiHPV-07 and determine its immunogenicity profile. It will include 36 patients with oropharyngeal or cervical cancers induced by HPV16 or 18. Group A will consist of patients with recurrent/metastatic cancers who have received multiple lines of treatment, including immunotherapies, and Group B of patients with newly diagnosed, treatment-naïve, locally advanced cancers. Patients in Group B will receive a single intramuscular injection of Lenti-HPV-07, while those in Group A will receive two intramuscular injections one month apart. They will be monitored clinically and immunologically for one year. [...]

About TheraVectys

TheraVectys, with more than 20 years of research into lentiviral vectors, brings innovative technologies to the fields of immunotherapies and vaccinology... TheraVectys' Press Release [PDF] -