On March 1, 2023 Celanese Corporation (NYSE: CE), a global specialty materials and chemical company, and Alessa Therapeutics reported their collaboration for developing a new oncology drug product leveraging Alessa’s expertise on sustained localized drug delivery and the Celanese VitalDose EVA drug delivery platform (Press release, Celanese, MAR 1, 2023, View Source [SID1234628022]). The collaboration will focus on developing a localized and sustained-release drug delivery system for oncology patients that will limit systemic side effects and improve overall treatment.

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"The commercial flexibility, responsiveness and technical support provided by Celanese has enabled the rapid progression of our drug candidate," says Maithili Rairkar, Vice President of Technical Operations at Alessa Therapeutics. "We look forward to progressing this innovative local drug delivery approach beginning with human studies later this year."

"Our new collaboration with Alessa Therapeutics underscores our commitment to optimize therapeutics through drug delivery innovation for oncology patients," said Karen Chen, Global Business Strategy Leader for Oncology at Celanese. "Delivery can be a fundamental, and oftentimes overlooked, part of a drug’s success, and we believe that our contribution to Alessa’s work can make a meaningful difference in the lives of cancer patients."

On March 1, 2023 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a biopharmaceutical company focused on the localized treatment of solid tumors, reported that Shaun Bagai, Chief Executive Officer, will be presenting at the 35th Annual Roth Conference, to be held March 12-14, 2023, in Dana Point, California (Press release, Renovorx, MAR 1, 2023, View Source [SID1234628021]). To register for the event, visit the conference website.

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During the presentation, Mr. Bagai will discuss the company’s mission to become a leading provider in oncology therapy by disrupting the standard of care (intravenous systemic chemotherapy) treatment of difficult-to-treat cancers. Mr. Bagai will review how its lead product candidate, RenovoGem , which utilizes RenovoRx’s proprietary therapy platform, RenovoTAMP, may provide a potential targeted intra-arterial treatment option to solid tumors. The goals of the Company’s therapy platform are to improve quality of life for patients diagnosed with cancer by reducing the debilitating side effects typical of the standard of care treatment and to extend patient survival. Additionally, Mr. Bagai will give an update on the Company’s pivotal Phase III TIGeR-PaC clinical trial which has its first interim analysis targeted for reporting early this year.

Conference Details
Event Name: 35th Annual Roth Conference
Date: March 13, 2023
Presentation: 2:00 PM Pacific Time (11:00 AM Eastern Time)
Location: Dana Point, CA

RenovoRx leadership will be available during the conference for one-on-one meetings with the investment community. To schedule a meeting please reach out to your Roth representative or by emailing KCSA Strategic Communications: [email protected].

The live audio webcast and replay will be available in the investor relations section of the Company’s website.

On March 1, 2023 Novocure (NASDAQ: NVCR) reported that the final patient has enrolled in the pivotal METIS study evaluating the efficacy of Tumor Treating Fields (TTFields) therapy following stereotactic radiosurgery (SRS) for treatment of patients with brain metastases resulting from non-small cell lung cancer (NSCLC) (Press release, NovoCure, MAR 1, 2023, View Source [SID1234628020]).

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"We are pleased to announce the completion of enrollment in the METIS study, our fourth pivotal study to complete enrollment in the last 17 months and our second study addressing non-small cell lung cancer," said William Doyle, Novocure’s Executive Chairman. "Beginning with the top-line readout from the LUNAR study earlier this year, we expect a steady cadence of meaningful pivotal datasets through 2024. This is a transformational period for Novocure and, potentially, for the treatment of solid tumor cancers."

Following the completion of enrollment, patients will be followed for a minimum of 12 months.

METIS is a randomized, open-label pivotal study which was designed to enroll 270 adult patients with between 1 and 10 brain metastases resulting from NSCLC. Following SRS, patients were randomized to receive either TTFields therapy and supportive treatment or supportive treatment alone. The primary endpoint is time to first intracranial progression. Secondary endpoints include, but are not limited to, time to neurocognitive failure, overall survival, radiological response rate, time to second intracranial progression, quality of life and adverse events.

About Brain Metastases

Metastatic cancer is cancer that has spread from the place where it first started to another place in the body. In metastasis, cancer cells break away from where they first formed (the primary cancer), travel through the blood or lymph system, and form new tumors (the metastatic tumors) in other parts of the body. The exact incidence of brain metastases is unknown because no national cancer registry documents brain metastases, and estimates from scientific literature vary greatly based on the study methodology applied. It is estimated that between 100,000 and 240,000 new cases are diagnosed in the U.S. each year with brain metastases estimated to occur in between 10% to 40% of all cancer patients.

Brain metastases are commonly treated with a combination of surgery and radiation. Chemotherapy is often given for the primary tumor, but many chemotherapy agents do not cross the blood brain barrier and are thus ineffective in the treatment of brain metastases. When brain metastases appear, they are either surgically removed or treated with radiation using SRS when possible. Whole brain radiation therapy, although effective in delaying progression or recurrence of brain metastases when given either before or after SRS, is associated with neurotoxicity and a significant decline in cognitive functioning. Thus, whole brain radiation therapy is often delayed until later in the disease course and is often used as a last resort. This practice results in a window of unmet need after localized surgery and SRS are used and before whole brain radiation therapy is administered to delay or prevent the additional spread of brain metastases.

About Tumor Treating Fields Therapy

Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. The multiple, distinct mechanisms of TTFields therapy work together to selectively target and kill cancer cells. Due to its multimechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or PARP inhibition in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors. To learn more about Tumor Treating Fields therapy and its multifaceted effect on cancer cells, visit tumortreatingfields.com.

On March 1, 2023 OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) (Paris:OSE) reported that the Spanish Drug Agency (Agencia Espanola de Medicamentos y Productos Sanitarios, AEMPS) has made available a new early access program that will allow access to Tedopi through a Special Situation Authorization(1) in the treatment of advanced or metastatic non-small cell lung (NSCLC) after immune checkpoint inhibitor (ICI) failure (Press release, OSE Immunotherapeutics, MAR 1, 2023, View Source [SID1234628019]). This Special Situation Authorization is based on the positive clinical data from the initial phase 3 trial of Tedopi (ATALANTE-1) in third line treatment and the high unmet need for these patients.

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Tedopi is the first cancer vaccine to show positive and clinically meaningful efficacy results with significant gain in survival associated with a better safety and quality of life profile in advanced NSCLC patients, administered in monotherapy versus active comparator (chemotherapy-based standard of care), in third line with secondary resistance to immune checkpoint inhibitor (ICI).

OSE Immunotherapeutics is committed to provide Tedopi through early access and compassionate use programs across European countries to address patients’ needs alongside physicians’ engagement. Patients can benefit from Tedopi through compassionate use programs in third or further lines of treatment (post chemotherapy and immunotherapy) currently approved in France and Italy.

In Spain, following the earlier nominative compassionate use program for patients that were included in the phase 3 ATALANTE-1 trial, the Health Authorities are now expecting applications for the early access to Tedopi through an unlimited Special Situation program, confirming thereby the significant medical need for new therapeutic alternatives in this patient population.

Dr. Santiago Viteri, investigator in ATALANTE-1 study and Medical Director of UOMI Cancer Center, Clinica Mi Tres Torres, Barcelona, comments:

"The decision of the Spanish Health Agency to approve Tedopi under a Special Situation Authorization for use will facilitate early access to treatment until Marketing Authorization and represent a significant benefit for patients in third line in secondary resistance post-sequential chemotherapy and immunotherapy. Indeed, there is a high unmet need for these patients as there are no therapeutic options yet approved after failure to immunotherapies and last resort chemotherapies are associated with multiple side effects and a poor quality of life."

Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, comments: "Following the positive recommendations from the US Food and Drug Administration (FDA) "Type C" meeting and the European Medicines Agency (EMA) scientific advice, OSE Immunotherapeutics is continuing the clinical development for Tedopi in second line treatment to support its regulatory registration in secondary resistance to immunotherapy. We are preparing a new confirmatory phase 3 clinical trial versus standard of care for HLA-A2+ patients in advanced in non-small cell lung cancer (NSCLC)."

(1) The Special Situation Authorization (Real Decreto 1015/2009) is intended to provide early access to medicines for patients with a severe or rare disease with high unmet need and for which no authorized therapeutic alternatives available.

On March 1, 2023 Novocure (NASDAQ:NVCR) reported the reimbursement and availability of Optune together with temozolomide (TMZ) for the treatment of adult patients with newly diagnosed glioblastoma (GBM) in France (Press release, NovoCure, MAR 1, 2023, View Source [SID1234628018]). The order registering Optune on the List of Reimbursable Products and Services (LPPR) provided for in Article L165-1 of the Social Security Code was published in the Official Journal on February 28, 2023 and will become effective March 15, 2023.

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"We are pleased to make Optune available to French patients and healthcare professionals for the treatment of glioblastoma," said Anne Calixte de Lembeye, General Manager of Novocure France. "GBM is one of the most common and most aggressive forms of primary brain cancer with a poor prognosis. We are energized and prepared to support patients in France as they begin to use our therapy as an additional treatment choice for newly diagnosed GBM."

Optune is a medical device that works by creating Tumor Treating Fields (TTFields), which are electric fields that disrupt cancer cell division. Optune delivers TTFields therapy to the region of the tumor. Optune is small and light, weighing 2.7 pounds. This makes Optune wearable and portable, so continuous treatment can be received almost anywhere. Globally, more than 27,000 patients have been treated with Optune, to date.

The favorable opinion of the CNEDIMTS (Commission Nationale d’Evaluation des Dispositifs Médicaux et des Technologies de Santé) was obtained on July 20, 2021. It highlights a sufficient expected service and a level III expected service improvement (ASA) for the use of Optune in combination with TMZ after surgery and radio-chemotherapy in adult patients with newly diagnosed GBM.

Novocure’s phase 3 pivotal EF-14 study compared Optune plus TMZ to TMZ alone in 695 patients with newly diagnosed GBM1. Median progression-free survival from randomization was 6.7 months in the TTFields-TMZ group and 4.0 months in the TMZ-alone group (HR, 0.63; 95% CI, 0.52-0.76; P < .001). Median overall survival was 20.9 months in the TTFields-TMZ group versus 16.0 months in the TMZ-alone group (HR, 0.63; 95% CI, 0.53-0.76; P < .001). Optune was used together with TMZ with no significant increase in serious adverse events compared with TMZ alone. The most common side effect related to Optune alone was mild to moderate skin irritation.

Optune has the CE mark and is commercially available as a treatment for GBM in multiple countries in North America, Europe and Asia. In addition to France, Optune is reimbursed in Austria, Germany, Israel, Japan, Sweden, Switzerland and the United States.

"At Novocure, we feel a daily responsibility to bring our therapy to as many patients who can benefit throughout the world," said Novocure CEO Asaf Danziger. "We are proud that Optune is now a treatment choice for newly diagnosed GBM patients in France. We look forward to supporting patients and physicians in France as they begin to use our therapy, and continue to work diligently to bring our therapy to patients in additional markets."

About Optune

Optune is a noninvasive, antimitotic cancer treatment for glioblastoma (GBM). Optune delivers Tumor Treating Fields (TTFields) therapy to the region of the tumor.

Tumor Treating Fields therapy uses electric fields to disrupt cell division. Tumor Treating Fields does not stimulate or heat tissue and targets dividing cancer cells of a specific size. Tumor Treating Fields causes minimal damage to healthy cells. Mild to moderate skin irritation is the most common side effect reported. Tumor Treating Fields therapy is approved in certain countries for the treatment of adult patients with glioblastoma, malignant pleural mesothelioma and pleural mesothelioma, some of the most difficult cancer types to treat. The therapy shows promise in multiple solid tumor types – including some of the most aggressive forms of cancer.