Juvisé Pharmaceuticals Acquires Multiple Sclerosis Drug PONVORY® (ex-US/Canada)

PARIS-- March 26, 2024--The French pharmaceutical company, Juvisé Pharmaceuticals, announces the acquisition of global commercial rights (excluding the United States and Canada) to Ponvory® (ponesimod) from Actelion Pharmaceuticals Ltd., a Johnson & Johnson Company (Johnson & Johnson). Ponvory® is indicated for the treatment of adults with active forms of relapsing multiple sclerosis (RMS); it is protected by several patents, the latest of which expires in 2035. To fund this acquisition, the French sovereign fund Bpifrance and Pemberton Asset Management (‘Pemberton’), a leading European private credit manager, have acquired a minority stake in Juvisé Pharmaceuticals. Financial details of these transactions remain undisclosed.

“We are very excited about Ponvory® and its potential to have a very positive impact on the lives of patients with multiple sclerosis” announces Frédéric Mascha, founder and President of Juvisé Pharmaceuticals. “This acquisition is a strategic step for Juvisé as it expands our portfolio with the first patent protected product with strong development potential over the coming years. It is in line with what we have been doing for the past 16 years, which is providing essential medications to patients and specialist doctors. Following our latest partnerships established with Novartis, AstraZeneca and AbbVie, we are proud to establish a new partnership with a major pharmaceutical company and to have two strong partners such as Bpifrance and Pemberton enter our capital to support our future growth.”

The acquisition of Ponvory®: a strategic move in Juvisé Pharmaceuticals' growth strategy

Multiple Sclerosis (MS) is a chronic autoimmune pathology affecting over 2.5 million patients worldwide and enjoys therapeutic innovation.

Ponvory® (ponesimod) is a first-line treatment option in active forms of relapsing multiple sclerosis (RMS), which is the most common form of the disease (approximately 80% of patients), affecting particularly women around the age of 30-years-old. Ponvory® is the first oral Disease Modifying Treatment (DMT) to demonstrate superior efficacy compared to teriflunomide in a large head-to-head Phase III study (OPTIMUM) in adult patients with active RMS. Ponvory® demonstrated a 30.5% reduction in Annualized Relapse Rate (primary endpoint), as well as reduction in MRI activity and fatigue (secondary endpoints). (1)

Juvisé Pharmaceuticals will leverage its expertise in medical affairs, marketing, and distribution to commercialize and develop Ponvory® outside of the United States and Canada, with a focus on Europe, skills that the company has already demonstrated with the successful European relaunch of Pylera® in 2023. Juvisé Pharmaceuticals will work closely with Johnson & Johnson to ensure a seamless transition and continuous availability of Ponvory® for patients. Ponvory® is currently available in 30 countries, with the objective of expanding this scope. Finally, Juvisé Pharmaceuticals will assume the worldwide manufacturing duties for Ponvory® from sites based in France and Switzerland...  Juvisé Pharmaceuticals' Press Release [PDF] -

1. Kappos L, Fox RJ, Burcklen M, Freedman MS, Havrdová EK, Hennessy B, Hohlfeld R, Lublin F, Montalban X, Pozzilli C, Scherz T, D'Ambrosio D, Linscheid P, Vaclavkova A, Pirozek-Lawniczek M, Kracker H, Sprenger T. Ponesimod Compared With Teriflunomide in Patients With Relapsing Multiple Sclerosis in the Active-Comparator Phase 3 OPTIMUM Study: A Randomized Clinical Trial. JAMA Neurol. 2021 May 1;78(5):558-567. doi: 10.1001/jamaneurol.2021.0405. PMID: 33779698; PMCID: PMC8008435

Ipsen’s Onivyde® regimen, a potential new standard-of-care first-line therapy in metastatic pancreatic adenocarcinoma, approved by FDA

Ipsen’s Onivyde® regimen, a potential new standard-of-care first-line therapy in metastatic pancreatic adenocarcinoma, approved by FDA

• Approval based on Phase III NAPOLI 3 clinical trial in which Onivyde® regimen (NALIRIFOX) demonstrated statistically significant superiority and clinically meaningful improvements in overall survival and progression-free survival versus nab-paclitaxel and gemcitabine
• NAPOLI 3 represents the first positive Phase III trial in first-line metastatic pancreatic adenocarcinoma (mPDAC) to demonstrate superior overall survival versus the currently approved regimen of nab-paclitaxel and gemcitabine
• Onivyde is the only FDA-approved treatment regimen to demonstrate efficacy in two Phase III trials across lines of therapy in mPDAC

PARIS, FRANCE, 13 February 2024 – Ipsen (Euronext: IPN; ADR: IPSEY) announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application for Onivyde® (irinotecan liposome injection) plus oxaliplatin, fluorouracil and leucovorin (NALIRIFOX) as a first-line treatment in adults living with metastatic pancreatic adenocarcinoma (mPDAC). This is the second approval for an Onivyde regimen in mPDAC, following the FDA’s approval in 2015 of Onivyde plus fluorouracil and leucovorin following disease progression with gemcitabine-based therapy.

“The results from the Phase III NAPOLI 3 trial represent the first positive data for an investigational regimen in first-line metastatic pancreatic adenocarcinoma versus the currently approved nab-paclitaxel and gemcitabine regimen,” said Christelle Huguet, EVP and Head of Research and Development, Ipsen. “With today’s approval, this Onivyde (NALIRIFOX) regimen can now offer a potential new standard-of-care treatment option with proven survival benefits for people living with metastatic pancreatic adenocarcinoma in the U.S.”

Pancreatic adenocarcinoma (PDAC) is the most common type of cancer that forms in the pancreas, with more than 60,000 people diagnosed in the U.S. each year and nearly 500,000 people globally. Since there are no specific symptoms in the early stages, PDAC is often detected late and after the disease has spread to other parts of the body (metastatic or stage IV). Characterized as a complex cancer due to rapid tumor progression, limited genetic targets and multiple resistance mechanisms, mPDAC has a poor prognosis with fewer than 20% of people surviving longer than one year. Overall, pancreatic cancer has the lowest five-year survival rate of all cancer types globally and in the U.S... Ipsen's Press Release -

BariaTek Medical Announces the First-in-Human Implantation of Its BariTon™ Device, a Non-Surgical Gastro-Intestinal Medical Device Aiming to Replicate the Efficacy of Obesity Surgery Without the Invasiveness

PARIS--February 06, 2024--BariaTek Medical, a privately held medical device company dedicated to the development of minimally invasive endoscopically delivered solutions to treat obesity and diabetes, founded by Truffle Capital, announced it has initiated enrollment of patients in its First-in-human clinical trial in both Australia and Uzbekistan, and has successfully performed its first-in-human implantation.

Obesity is a chronic and debilitating disease affecting more than one billion people worldwide. It bears a tremendous economic burden to healthcare systems surpassing that of cardiovascular diseases and cancer and its prevalence is increasing worldwide. It often leads to diabetes, high blood pressure, heart disease and reduced life expectancy.

Bariatric surgery currently remains the most effective approach to treat obesity and limits the resulting complications, but surgery is poorly perceived, alters anatomy permanently, is costly, and can result in severe adverse events. Obesity pharmaceutical therapies could provide an effective alternative solution for some patients, but they are very expensive and poorly tolerated in many, resulting in their cessation and corresponding regain of the lost weight. Furthermore, they could be associated with multiple under-reported side-effects and off-label prescriptions. As for available minimally invasive endoscopic solutions, they enjoy variable safety but lack efficacy.

BariaTek Medical’s product candidate, the BariTon™, is a soft, atraumatic, reversible implant that is delivered via a simple endoscopy through the mouth within a few minutes and in an outpatient setting. It consists of a gastric part and an intestinal part, thereby having a dual effect: reduced food intake and calorie absorption. The BariTon™ is expected to be the first implant of its kind to potentially mimic the efficacy of sleeve gastrectomy and bypass surgery1 and offer superior safety, ease of use, reversibility, and lower cost... BariaTek Medical’s Press Relase - 

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] -