Initiation of Phase 2 clinical trial MATISSE

On February 24, 2023 OREGA Biotech, the biotech company committed to the discovery of novel immuno-oncology targets for cancer immunotherapy, reported the initiation of IPH5201 CD39 blocking antibody phase 2 trial (MATISSE) (Press release, OREGA BIOTECH, FEB 24, 2023, View Source [SID1234627733]). The study entitled "Phase II Multicenter, Open Label, Non-randomized Study of Neoadjuvant and Adjuvant Treatment With IPH5201 and Durvalumab in Patients With Resectable, Early-stage (II to IIIA) Non-Small Cell Lung Cancer (MATISSE)" is an open-label, single-arm multicenter study (NCT05742607). As announced in 2022 (press release), the study will enroll 70 patients treated with IPH5201 (CD39 antibody) and Durvalumab (PDL1 antibody) plus standard of care chemotherapy before surgery followed by IPH5201 and Durvalumab.

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About IPH5201 antibody

IPH5201 is a humanized CD39 blocking antibody. OREGA Biotech entered into an exclusive and worldwide License Agreement with Innate Pharma in 2016. The lead antibody has been further partnered with AstraZeneca in 2018. AstraZeneca conducted a multicenter, open-label, dose-escalation Phase 1 trial in advanced solid tumors (NCT04261075) with IPH5201 alone or in combination with durvalumab (anti PD-L1 antibody).

Agilent Announces Cell Analysis Workflow Automation for Immuno-Oncology, Virology, and Vaccine Development Markets

On February 24, 2023 Agilent Technologies Inc. (NYSE: A) reported their xCELLigence RTCA HT (real-time cell analysis high-throughput) platform now integrates with the BioTek BioSpa 8 Automated Incubator (Press release, Agilent, FEB 24, 2023, View Source [SID1234627692]). Developed in response to market needs, this combination enables a higher level of workflow automation that provides novel functionality for the development of label-free high-throughput potency assays for the immuno-oncology space and high-throughput viral cytopathic effects (CPE) assays for the vaccine market.

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Faced with fierce competition to fulfill the promise of immuno-oncology therapeutics, pharma researchers are rapidly evolving the approaches used to accelerate clinical success. Similarly, vaccine developers are under unprecedented pressure in light of constantly shifting public health threats. Automated workflows offer the promise of increasing drug candidate screening as a means to more quickly and efficiently translate research into discovery. However, many existing automated workflow solutions still rely on substantial manual intervention steps that hinder throughput and limit the scope of assay development.

The xCELLigence RTCA HT – BioSpa 8 integration offers a label-free, non-invasive, kinetic readout of cell proliferation and cytotoxicity that allows researchers to analyze up to eight 384-well E-Plates, increasing throughput and decreasing sample sizes. The BioSpa 8 incubator provides real-time temperature and CO2/O2 control with humidity monitoring. The xCELLigence instrument is equipped with a heated cradle, so cells are protected against unnecessary perturbances and fluctuation of culture conditions during the automated transfer from the incubator. User-friendly software facilitates automated assays and data analysis, making this a true walk-away system for identifying therapeutics to fight disease and providing a degree of automation that is unique to this combination of technologies.

"This is an innovative solution for immuno-oncology therapeutic and vaccine development, demonstrating Agilent’s ongoing commitment to fight cancer and infectious diseases," said Todd Christian, vice president and general manager of Agilent’s Cell Analysis Division. "Integrating our non-invasive and real-time cell analysis measurement capabilities and physiological incubation provides a simple, automated workflow for increased throughput and screening flexibility under physiological conditions."

"The xCELLigence RTCA HT technology has been key to facilitating high-throughput, rapid, and quantitative cytopathic effect (CPE) monitoring as a tool to assess neutralizing activity and potency," said Dr. Robert Carnahan, associate director of the Vanderbilt Vaccine Center at the Vanderbilt University Medical Center. "We were able to bypass a multitude of hands-on, multistep processes required by plaque or focus-forming assays to measure viral activity."

Agilent provides products and services that facilitate drug discovery across a broad range of disciplines and approaches, including tools for real-time cell and metabolic analysis, as well as flow cytometric, plate-based, and imaging/microscopy platforms. Announcement of this new integrated solution reinforces our commitment as a partner for solving real-world challenges in the drug development space.

Natera to Participate in Upcoming Investor Conferences

On February 24, 2023 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, reported that members of its management team will present at the following investor conferences (Press release, Natera, FEB 24, 2023, View Source [SID1234627691]).

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Raymond James 44th Annual Institutional Investors Conference on Tuesday, March 7 at 2:50 p.m. ET in Orlando, FL
Cowen 43rd Annual Health Care Conference on Wednesday, March 8 at 11:10 a.m. ET in Boston, MA
A live webcast and audio archive of each event may be accessed through the investor relations section of the Natera website at investor.natera.com. A replay of each event will be available shortly following the conferences.

Quanterix Fourth Quarter Earnings and Full Year 2022 Financial Results Conference Call

On February 24, 2023 Quanterix Corporation (NASDAQ: QTRX), a company fueling scientific discovery through ultrasensitive biomarker detection, reported it will host a conference call on Monday, March 6, 2023, to discuss its fourth quarter earnings and full year 2022 financial results (Press release, Quanterix, FEB 24, 2023, View Source [SID1234627690]). The call will begin at 8:30 AM Eastern Time. It will be hosted by Masoud Toloue, the Company’s President and Chief Executive Officer, and Michael Doyle, the Company’s Chief Financial Officer.

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Quanterix will issue a press release regarding the fourth quarter 2022 earnings prior to the conference call. The press release will be posted on the Quanterix website at View Source

Click here to pre-register for the conference call and obtain your dial-in number and passcode. You can also visit this link to listen to the call via live webcast. You may also access the live webcast by visiting the News & Events page within the Investors section of the Quanterix website at www.quanterix.com. The webcast will be available on the Company’s website for one year following completion of the call.

Servier receives a positive CHMP opinion for Tibsovo® in IDH1-mutated Acute Myeloid Leukemia (AML) and Cholangiocarcinoma (CCA) patients

On February 24, 2023 Servier, a global pharmaceutical company, reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting a marketing authorization for Tibsovo (ivosidenib tablets) – an inhibitor of the mutated isocitrate dehydrogenase-1 (IDH1) enzyme – for two indications (Press release, Servier, FEB 24, 2023, View Source [SID1234627689]).

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in combination with azacitidine, for the treatment of adult patients with newly diagnosed IDH1-mutated Acute Myeloid Leukemia and not eligible for standard induction chemotherapy,
in monotherapy, for the treatment of adult patients with locally advanced or metastatic IDH1-mutated Cholangiocarcinoma, previously treated by at least one prior line of systemic therapy.
Claude Bertrand, Executive Vice President R&D of Servier, said: "The positive CHMP opinion is a further step towards the availability, in the European Union, of Tibsovo which is the first IDH1 inhibitor to be recommended for approval in Europe for patients with Acute Myeloid Leukemia and Cholangiocarcinoma for whom therapeutic options are very limited. Tibsovo is an illustration of the Group’s transformation and commitment in oncology which focuses its research on hard-to-treat cancers with the development of targeted therapies being a promising path for patients."

The positive CHMP opinion is based on clinical data from the AGILE (AML) and ClarIDHy (CCA) studies.

The CHMP’s positive opinion on Tibsovo in IDH1 mutated AML and CCA patients will be referred to the European Commission (EC) which will deliver a final decision in the coming months. The decision will be applicable to all 27 EU member states plus Iceland, Norway, Northern Ireland and Liechtenstein.