On October 10, 2024 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported "The PI3K pathway plays a pivotal role in disease progression and has been challenging to target," said Komal Jhaveri, M.D., section head for the endocrine therapy research portfolio and clinical director of the early drug development service at Memorial Sloan Kettering Cancer Center, and one of the principal investigators of the INAVO120 study (Press release, Genentech, OCT 10, 2024, View Source [SID1234647149]). "The Itovebi-based regimen more than doubled progression-free survival and maintained a manageable safety and tolerability profile, adding a new standard in how PIK3CA-mutated breast cancers are treated."

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"With the approval of this Itovebi-based regimen, we continue our long-standing track record of cancer therapeutic discovery by offering an important new first-line option for people living with HR-positive breast cancer with a PIK3CA mutation," said Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development. "Despite the high prevalence of PIK3CA mutations in this setting, treatment options have thus far remained limited, which makes today’s approval all the more significant."

This approval is based on results of the pivotal Phase III INAVO120 study, which showed that the Itovebi-based regimen reduced the risk of disease worsening or death by 57% compared with palbociclib and fulvestrant alone (15.0 months vs. 7.3 months; hazard ratio [HR]=0.43, 95% CI: 0.32-0.59, p<0.0001) in the first-line setting, demonstrating a statistically significant and clinically meaningful benefit. Overall survival (OS) data were immature at the time of primary analysis, but a clear positive trend was observed (stratified HR=0.64, 95% CI: 0.43-0.97, p=0.0338 [boundary of 0.0098]). Follow-up for OS is continuing to the next analysis.

"We are thrilled by the approval of the Itovebi-based regimen, which is a huge step forward for advanced breast cancer patients with a PIK3CA mutation," said Jean Sachs, CEO of Living Beyond Breast Cancer. "It remains critical that all patients have access to early, comprehensive biomarker testing so they can better understand what treatment options may be most beneficial for them and their tumor type."

The Itovebi-based regimen was granted FDA Priority Review and Breakthrough Therapy Designation in May 2024 based on the INAVO120 study results. Data from INAVO120 are also being used for filing submissions to other global health authorities, including the European Medicines Agency. Itovebi will be available in the U.S. in the coming weeks. Early, comprehensive biomarker testing with an FDA-approved test, such as Foundation Medicine’s FoundationOneLiquid CDx, can help identify people with HR-positive, HER2-negative breast cancer with a PIK3CA mutation.

Itovebi is currently being investigated in various combinations across three company-sponsored Phase III clinical studies (INAVO120, INAVO121, INAVO122) in PIK3CA-mutated locally advanced or metastatic breast cancer. We continue to evaluate opportunities to expand our clinical development program to address patient unmet needs in various tumor types across oncology.

About the INAVO120 study

The INAVO120 study [NCT04191499] is a Phase III, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of Itovebi (inavolisib) in combination with palbociclib and fulvestrant versus placebo plus palbociclib and fulvestrant in people with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer whose disease progressed during treatment or within 12 months of completing adjuvant endocrine therapy and who have not received prior systemic therapy for metastatic disease.

The study included 325 patients, who were randomly assigned to either the investigational or control treatment arm. The primary endpoint is progression-free survival, as assessed by investigators, defined as the time from randomization in the clinical trial to the time when the disease progresses, or a patient dies from any cause. Secondary endpoints include overall survival, objective response rate, and clinical benefit rate.

Beyond INAVO120, Itovebi is currently being investigated in two additional company-sponsored Phase III clinical studies in PIK3CA-mutated locally advanced or metastatic breast cancer in various combinations:

in combination with fulvestrant versus alpelisib plus fulvestrant in HR-positive/HER2-negative breast cancer post cyclin-dependent kinase 4/6 inhibitor and endocrine combination therapy (INAVO121; NCT05646862), and
combination with dual HER2 blockade versus dual HER2 blockade and optional physician’s choice of endocrine therapy as a maintenance treatment in HER2-positive disease (INAVO122; NCT05894239).
About Hormone Receptor (HR)-Positive Breast Cancer

HR-positive breast cancer is the most prevalent type of all breast cancers, accounting for approximately 70% of cases. A defining feature of HR-positive breast cancer is that its tumor cells have receptors that attach to one or both hormones – estrogen or progesterone – which can contribute to tumor growth. People diagnosed with HR-positive metastatic breast cancer often face the risk of disease progression and treatment side effects, creating a need for additional treatment options. The PI3K signaling pathway is commonly dysregulated in HR-positive breast cancer, often due to activating PIK3CA mutations, which have been identified as a potential mechanism of intrinsic resistance to standard of care endocrine therapy in combination with cyclin-dependent kinase 4/6 inhibitors.

What is Itovebi?

Itovebi (inavolisib) is a prescription medicine used in combination with the medicines palbociclib and fulvestrant to treat adults who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has an abnormal phosphatidylinositol-3-kinase catalytic subunit alpha (PIK3CA) gene, and has spread to nearby tissue or lymph nodes (locally advanced), or to other parts of the body (metastatic), and has come back after hormone (endocrine) therapy.

Your healthcare provider will test your cancer for abnormal PIK3CA genes to make sure that Itovebi is right for you.

It is not known if Itovebi is safe and effective in children.

Important Safety Information

What are the possible side effects of Itovebi?
Itovebi may cause serious side effects, including:

High blood sugar levels (hyperglycemia). High blood sugar is common with Itovebi and may be severe. Your healthcare provider will monitor your blood sugar levels before you start and during treatment with Itovebi. Your blood sugar levels may be monitored more often if you have a history of Type 2 diabetes. Your healthcare provider may also ask you to self-monitor and report your blood sugar levels at home. This will be required more frequently in the first 4 weeks of treatment. If you are not sure how to test your blood sugar levels, talk to your healthcare provider. You should stay well-hydrated during treatment with Itovebi. Tell your healthcare provider right away if you develop symptoms of high blood sugar, including:
difficulty breathing
blurred vision
nausea and vomiting (lasting more than 2 hours)
unusually increased appetite
stomach pain
weight loss
excessive thirst
fruity-smelling breath
dry mouth
flushed face and dry skin
more frequent urination than usual or a higher amount of urine than normal
feeling unusually sleepy or tired
confusion
Mouth sores (stomatitis). Mouth sores are common with Itovebi and may be severe. Tell your healthcare provider if you develop any of the following in your mouth:
pain
swelling
redness
ulcers
Diarrhea. Diarrhea is common with Itovebi and may be severe. Severe diarrhea can lead to the loss of too much body water (dehydration) and kidney injury. Tell your healthcare provider right away if you develop diarrhea, stomach-area (abdominal pain), or see mucus or blood in your stool during treatment with Itovebi. Your healthcare provider may tell you to drink more fluids or take medicines to treat your diarrhea.
Your healthcare provider may tell you to decrease your dose, temporarily stop your treatment, or completely stop your treatment with Itovebi if you develop certain serious side effects.

The most common side effects and abnormal blood test results of Itovebi when used in combination with palbociclib and fulvestrant include:

decreased white blood cell counts, red blood cell counts, and platelet counts
decreased blood levels of calcium, potassium, sodium, and magnesium
increased creatinine blood levels
tiredness
increased blood levels of the liver enzyme alanine transaminase (ALT)
nausea
rash
loss of appetite
COVID-19 infection
headache
Itovebi may affect fertility in males and in females who are able to become pregnant. Talk to your healthcare provider if this is a concern for you.

These are not all the possible side effects of Itovebi. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or View Source You may also report side effects to Genentech at (877) 436-3683.

Before you take Itovebi, tell your healthcare provider about all of your medical conditions, including if you:

have a history of diabetes or high blood sugar
have kidney problems
are pregnant or plan to become pregnant. Itovebi can harm your unborn baby.
Females who are able to become pregnant:

Your healthcare provider will check to see if you are pregnant before you start treatment with Itovebi.
You should use effective non-hormonal birth control (contraception) during treatment and for 1 week after your last dose of Itovebi. Talk to your healthcare provider about what birth control method is right for you during this time.
Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Itovebi.
Males with female partners who are able to become pregnant:

You should use effective birth control (contraception) during treatment with Itovebi and for 1 week after your last dose.
are breastfeeding or plan to breastfeed. It is not known if Itovebi passes into your breastmilk. Do not breastfeed during treatment with Itovebi and for 1 week after your last dose. Talk to your healthcare provider about the best way to feed your baby during treatment with Itovebi.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. that the U.S. Food and Drug Administration (FDA) approved Itovebi (inavolisib), in combination with palbociclib (Ibrance) and fulvestrant, for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy. The PIK3CA mutation is found in approximately 40% of HR-positive metastatic breast cancers.

On October 10, 2024 Oncoinvent, a clinical stage, radiopharmaceutical company developing innovative treatments for solid cancers, reported that the first patient has been dosed in its Phase 2 study of Radspherin in patients with peritoneal carcinomatosis from ovarian cancer (Press release, Oncoinvent, OCT 10, 2024, View Source [SID1234647148]). Radspherin is a novel alpha-radiation therapy candidate designed for targeted, local treatment of cancers that have spread to body cavities. The Phase 2 trial is a randomized controlled study designed to assess progression-free survival (PFS) in primary advanced ovarian cancer patients treated with Radspherin following complete surgical resection and pre-operative chemotherapy.

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"We are pleased to announce the dosing of the first patient in our Phase 2 study of Radspherin in ovarian cancer patients, representing another pivotal achievement that underscores the potential of our clinical program," said Oystein Soug, Chief Executive Officer of Oncoinvent. "This milestone builds upon the highly encouraging data from our Phase 1/2a trials in ovarian and colorectal cancer patients, where Radspherin demonstrated promising safety and efficacy. This follows the FDA’s recently granted Fast Track designation, bringing us closer to demonstrating the therapeutic potential of Radspherin. We look forward to advancing this clinical study as part of our mission to improve outcomes for patients suffering from peritoneal carcinomatosis."

The Phase 2 trial (NCT06504147) is a randomized controlled study assessing the efficacy and safety of Radspherin in patients with peritoneal metastasis from ovarian cancer. The primary objective is to compare PFS between patients who receive Radspherin after complete surgical resection following pre-operative chemotherapy, and patients who only undergo pre-operative chemotherapy and surgery. The study is being conducted at six centers in the US, UK, Norway, Spain and Belgium. Positive Phase 1/2a data from the safety interim analysis demonstrated that Radspherin was well tolerated with no dose-limiting toxicity observed at the recommended dose of 7MBq.

On October 10, 2024 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that its research collaborators will present at the upcoming 2024 EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics being held October 23-25, 2024 in Barcelona, Spain (Press release, Genprex, OCT 10, 2024, View Source [SID1234647147]). The collaborators will present posters on positive preclinical data from studies of its lead drug candidate, Reqorsa Gene Therapy (quaratusugene ozeplasmid), for the treatment of Ras inhibitor resistant lung cancer, mesothelioma and glioblastoma.

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"The compelling data made available today validates the potential of REQORSA as a therapeutic treatment for some of the most difficult to treat cancers and diseases, including Ras inhibitor resistant lung cancer, mesothelioma and glioblastoma," said Ryan Confer, President and Chief Executive Officer at Genprex. "We are very encouraged to see the data support potential new indications for REQORSA, which could address unmet medical need for many patient populations. We look forward to continuing our preclinical programs studying REQORSA to explore how we could expand our clinical development pipeline with future clinical studies."

Genprex has filed two provisional patent applications based on data from two of the presentations. One application involves using REQORSA to treat mesothelioma and the other uses REQORSA to treat glioblastoma. Genprex is a co-owner of the applications along with the respective institutions. TUSC2 is the tumor suppressor gene used in REQORSA.

Featured Genprex-supported posters to be presented at the 2024 EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics include:

Title: "TUSC2 Gene Therapy in KRASG12C Mutant NSCLC Overcomes Acquired Resistance to Sotorasib"
Collaborator: The University of Texas MD Anderson Cancer Center
Catalog Number: 384
Presentation Number: PB372

Acquired resistance (AR) to Lumakras (sotorasib), the first FDA-approved KRASi, poses a significant challenge in the treatment of KRASG12C mutant non-small cell lung cancer (NSCLC). Despite an initial response rate of up to 40%, patients invariably develop resistance, necessitating alternative therapeutic strategies. The mechanisms of AR include the emergence of additional mutations in the KRAS gene, reactivation of KRAS pathway, or activation of alternative signaling pathways. TUSC2, a potent tumor suppressor gene, exhibits multifunctional activities including multikinase inhibition, inhibition of growth & proliferation, induction of cell death and activation of both innate and adaptive immune responses. In this study, researchers demonstrated that TUSC2 gene therapy (REQORSA) effectively overcomes sotorasib AR in KRASG12Cmutant NSCLC mouse xenografts.

The data indicates that TUSC2 transfection significantly reduced colony formation in two AR cell lines. Transfection of TUSC2 also markedly increased apoptosis in AR cells. H23AR xenograft tumors exhibited significantly lower sensitivity to sotorasib than their parental counterparts. However, treatment with REQORSA alone or in combination with sotorasib was highly effective in controlling H23AR tumor growth in mouse xenografts. REQORSA alone also exhibited significantly strong antitumor effect on TC314AR patient-derived xenografts (PDXs) where sotorasib alone showed no significant antitumor activity. However, a synergistic antitumor effect was observed when TC314AR PDX tumors were treated with the combination of REQORSA and sotorasib.

In conclusion, researchers demonstrated that TUSC2 therapy, alone or in combination with sotorasib inhibited colony formation, induced apoptosis, and showed significant antitumor efficacy in KRASG12C mutant acquired resistant xenografts and in PDX tumor xenografts.

Title: "TUSC2 Suppresses Tumorigenic Properties in Malignant Pleural Mesothelioma Cells"
Collaborator: New York University Langone Health
Catalog Number: 364
Presentation Number: PB352

Malignant Pleural Mesothelioma (MPM) is a rare, highly aggressive, asbestos-associated neoplasm with a median survival of 10-12 months. TUSC2 is frequently deleted in multiple cancers and at least one allele is absent in 36% of MPM. Researchers investigated whether TUSC2 transfection could modulate MPM aggressive properties.

In this study, four MPM cell lines and tert-transformed mesothelial LP9 cells were treated with REQORSA and control liposomes for 48h. Treated cells were then evaluated for TUSC2 expression by semi quantitative RT-PCR, Western blot analysis, and functional assays including cell proliferation, invasion, and apoptosis.

The researchers demonstrated that REQORSA treatment resulted in a significant decrease in cell proliferation, cell invasion, and a significant increase in cell apoptosis in all four MPM cell lines. Data also demonstrated potent tumor suppressive activity of the TUSC2 gene delivered by REQORSA, and thus, its re-expression could serve as a potential therapeutic strategy for the treatment of MPM.

Title: "Efficacy of Quaratusugene Ozeplasmid (REQORSA) TUSC2 Gene Therapy in Glioblastoma"
Collaborator: The University of Texas Health Science Center at Houston
Catalog Number: 130
Presentation Number: PB118

Research collaborators previously reported TUSC2 as a novel tumor suppressor for glioblastoma, the most common and deadliest primary brain tumor in adults which is associated with a poor prognosis. In their latest study, patient-derived glioblastoma (GBM) cell lines and patient-derived glioma stem cell (PD-GSC) lines were used. REQORSA was used to restore TUSC2 expression.

Researchers observed that REQORSA significantly reduced GBM cell viability, and the results of a migration assay demonstrated that REQORSA suppressed GBM cell migration independent of its ability to suppress cell viability. In conclusion, REQORSA demonstrates promising in vitro efficacy in GBM and PD-GSCs, and these results support further evaluation of its in vivo anti-tumor efficacy in malignant gliomas using mouse models.

About Reqorsa Gene Therapy
REQORSA (quaratusugene ozeplasmid) consists of a plasmid containing the TUSC2 gene encapsulated in non-viral lipid-based nanoparticles in a lipoplex form (the Company’s Oncoprex Delivery System), which has a positive charge. REQORSA is injected intravenously and specifically targets cancer cells. REQORSA is designed to deliver the functioning TUSC2 gene to negatively charged cancer cells while minimizing uptake by normal tissue. Laboratory studies conducted at MD Anderson show that the uptake of TUSC2 in tumor cells in vitro after REQORSA treatment was 10 to 33 times the uptake in normal cells.

On October 10, 2024 Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that overcome tumor immune evasion and drug resistance, reported it has been selected for a poster presentation at the 36th European Organization for Research and Treatment of Cancer, National Cancer Institute, American Association for Cancer Research (AACR) (Free AACR Whitepaper) (EORTC-NCI-AACR) (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics (the "Triple Meeting") held October 23-25, 2024 in Barcelona, Spain (Press release, Purple Biotech, OCT 10, 2024, View Source;id=322854&p=2344395&I=1206939-c7Z3G6f3m8 [SID1234647146]).

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Purple Biotech’s poster titled "CAPTN-3: A novel platform of conditionally activated T cell and NK cell engagers" (Abstract # 450, poster board number: PB438) will be presented by Dr. Hadas Reuveni, VP R&D of Purple Biotech, during a ‘New therapies in immuno oncology’ poster session on Friday, 25 October 2024.

CAPTN-3 is a First-in-class platform of conditionally activated tri-specific antibodies engaging both T cells and NK cells with the tumor to create an immune synapse with enhanced anti-tumor efficacy. The NK engager arm (aNKG2A) of our lead compound also acts as a checkpoint inhibitor for both NK cells and highly cytotoxic T cell subsets, unleashing both innate and adaptive immune subsets against the tumor.

Purple Biotech’s lead CAPTN-3 platform candidate, IM1240, targets 5T4 as a tumor associated antigen (TAA), which is overexpressed in a variety of solid tumors and is correlated with advanced disease, increased invasiveness, and poor clinical outcome. 5T4, also known as trophoblast glycoprotein (TPBG), is an oncofetal surface protein that is not found on adult healthy tissues but is abnormally expressed in several cancer types. This specific expression pattern as well as the correlation with poor prognosis in different cancer diseases such as lung, gastric, head and neck and other cancers makes it an ideal TAA for various therapeutic approaches.

On October 10, 2024 XENOTHERA, a Nantes-based biotech developing innovative treatments using multi-specific polyclonal glyco-humanized antibodies (GH-pAb), reported the recruitment of the first patient in its new clinical trial in onco-hematology. PALT1 is a multicenter phase I/II trial evaluating the safety and efficacy of its antibody directed against tumoral T-cells in patients with relapsed/refractory PTCL (NCT 06495723) (Press release, Xenothera, OCT 10, 2024, View Source [SID1234647145]). The PALT1 trial started at the beginning of July in five French centers.

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Meanwhile, the company received orphan drug designation (ODD) for this antibody in PTCL from the European Medicines Agency (EMA), in addition to the ODD already granted by the Food and Drug Administration (FDA).

Peripheral T-cell lymphomas (PTCL) are a heterogeneous group of non-Hodgkin’s lymphomas for which there is a great medical need. PTCL are aggressive hematological tumors with a poor prognosis. Patients are generally treated with CHOP chemotherapy as first line, which unfortunately has limited efficacy, like other treatments, which response rate is usually less than 30%.

XENOTHERA’s antibody is derived from its platform of multi-specific glyco-humanized antibodies. In preclinical studies, it recognizes most PTCL, is more effective than CHOP on T lymphoma cells, and has a significant anti-tumor effect, reducing tumor size by up to 90% in preclinical in vivo models.

The EMA granted the clinical trial authorization for PALT1 in April 2024 and the orphan drug designation (ODD) in June 2024, confirming its interest in this innovative treatment for a serious disease. ODD provides XENOTHERA with benefits at every stage of development, including assistance with the development process, tax credit, technical assistance in preparing the application, streamlined administrative procedures, intellectual property protection and a marketing exclusivity clause once marketing authorization has been obtained. Orphan designation had already been obtained from the FDA in 2023.

The first centers to take part in the trial are the university hospitals of Caen (Professor Damaj), Clermont-Ferrand (Professor Tournilhac), Bordeaux (Professor Bouabdallah), AP-HP (Hôpital Henri-Mondor, Professor Lemonnier) and the Hospices Civils de Lyon (Hôpital Lyon-Sud, Professor Bachy). The first patient was recruited at Caen University Hospital by Professor Damaj’s teams.

PALT1 is a non-randomized, open-label phase I/II trial conducted in two stages in volunteer patients: a dose escalation phase to assess safety and tolerability and identify the maximum tolerated dose (MTD), followed by an expansion phase to assess the efficacy of PTCL treatment in relapsed/refractory patients.

"The start of this trial strengthens our position in oncology. We currently have another antibody in the clinic in solid tumors, in the FIPO trial. By entering the field of onco-hematology with the PALT1 trial, we maintain our focus on patients for whom medicine currently has no solution. I would like to thank this first patient and Professor Damaj’s teams for their confidence, and I sincerely hope that the expected benefits will be confirmed. PALT1 also supports the quality of the work done by XENOTHERA’s scientific and medical teams. Moreover, the agencies – EMA in 2024 and FDA in 2023 – are supporting our approach to patients’ needs, and reinforcing our credibility", comments Odile Duvaux, Chairman and co-founder of XENOTHERA.