On May 17, 2022 QIAGEN reported the launch of the therascreen EGFR Plus RGQ PCR Kit, a new in-vitro diagnostic test for sensitive EGFR mutation analysis, detecting all currently known activating and resistance EGFR mutations (Press release, Qiagen, MAY 17, 2022, View Source [SID1234614716]). The real-time qPCR test builds on the established therascreen EGFR RGQ PCR Kit and provides improved limits of detection, quicker turnaround times, automated sample extraction options and automated results analysis.

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In addition to the T790M mutation, the new kit now also detects C797S. This key biomarker indicates resistance to third-generation EGFR tyrosine kinase inhibitor [TKI], giving oncologists additional insights to adjust EGFR treatment for NSCLC patients. The kit also delivers next-day results and automated analysis, making it an ideal choice for labs that require a high-performing test solution for either tissue or plasma with a rapid turnaround.

"The therascreen EGFR Plus RGQ PCR Kit combines sensitivity in mutation detection with the flexibility to test both tissue and liquid samples, helping oncologists to make confident, informed treatment decisions for patients with advanced NSCLC", said Kai te Kaat, Vice President, Head of Global R&D Molecular Diagnostics at QIAGEN. "With this launch, we continue to further advance our Precision Medicine portfolio by covering new clinically relevant mutations such as C797S that further improve patient outcomes."

Genomic testing is instrumental for patient management in non-small cell lung cancer, and testing for driver mutations in EGFR aids oncologists to make informed treatment decisions for patients. The therascreen EGFR Plus RGQ PCR Kit is a more cost-effective and simpler alternative to NGS for routine follow-up testing once an EGFR mutation is known. The kit can test FFPE and plasma samples within the same run, allowing for matched testing of FFPE and plasma and removing the need for laboratories to batch samples of either type before a run. The decreased invasiveness of plasma sampling allows clinicians to schedule routine testing of patients on treatment to track treatment effectiveness and establish whether resistance is occurring.

Extraction can be performed manually or automated on the QIAsymphony SP for walkaway sample processing. Sensitive real-time PCR is then performed on the Rotor-Gene Q MDx 5plex HRM instrument with automated data analysis using Rotor-Gene AssayManager software. The software displays qualitative results informing the operator if one or more of the 42 EGFR mutations are present. The Sample to Insight workflow can be completed in under 8 hours, providing next-day results and informing earlier treatment decisions.

QIAGEN is a pioneer in Precision Medicine, particularly through its therascreen assay portfolio that allow the detection of clinically relevant genetic alterations to provide insights that guide clinical decision-making in diseases such as cancer.

To learn more about EGFR mutation testing in NSCLC, visit www.qiagen.com/EGFR-Plus.

On May 17, 2022 Sanofi reported that New research at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from June 3-7 underscores it’s commitment to improving care across its core focus areas, including multiple myeloma, lung and breast cancers (Press release, Sanofi, MAY 17, 2022, View Source [SID1234614715]).

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Dietmar Berger
Chief Medical Officer, Global Head of Development at Sanofi
"Oncology is a core area for Sanofi, as evidenced by the doubling of our pipeline between 2019 and 2022. As we continue to pursue transformative research to develop advanced medicines for people living with cancer, our portfolio has grown to more than ten therapies in clinical trials. In parallel, we continue to leverage external innovation through strategic collaborations and investments in cutting edge technologies. Over ten value-creating acquisitions and business development deals in the past two years have reshaped our footprint in oncology, expanding our capacities with leading talent, as well as state-of-the-art molecules and technologies in immuno-oncology, molecular oncology, and genomic medicine."

Safety and efficacy data for tusamitamab ravtansine add to growing body of evidence for our potential first-in-class therapy for the treatment of nonsquamous non-small cell lung cancer (NSQ NSCLC) with CEACAM5 expression*

Abstract 9039: Safety and efficacy of tusamitamab ravtansine (SAR408701) in long-term treated patients with NSQ NSCLC expressing carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5)

Early clinical data for Sarclisa (isatuximab) in combination with pomalidomide-dexamethasone highlight potential for subcutaneous administration by an on-body delivery system for the treatment of relapsed refractory multiple myeloma (RRMM)

Abstract 8025: Subcutaneous (SC) isatuximab administration by an on-body delivery system (OBDS) in combination with pomalidomide-dexamethasone (Pd) in patients with RRMM: Interim phase 1b study results

Updates on trials for amcenestrant, an oral selective estrogen receptor degrader (SERD), for the potential treatment of breast cancer*

Abstract TPS607: Adjuvant study of amcenestrant (SAR439859) versus tamoxifen for patients with hormone receptor-positive (HR+) early breast cancer (EBC), who have discontinued adjuvant aromatase inhibitor therapy due to treatment-related toxicity (AMEERA-6)
Abstract 528: AMEERA-4: A preoperative window-of-opportunity (WOO) study to assess the pharmacodynamic (PD) activity of amcenestrant or letrozole in postmenopausal patients with ER+/HER2- primary breast cancer
Biomarker research for SAR444881, a potential first-in-class anti-ILT2 monoclonal antibody*

Abstract 2571: Evaluation of pharmacodynamic and patient enrichment biomarkers for SAR444881, a first-in-class anti-ILT2 monoclonal antibody for cancer immunotherapy

Trial in progress for investigational use of Libtayo (cemiplimab) in patients with high-risk cutaneous squamous cell carcinoma (CSCC)

Abstract TPS9592: C-POST protocol update: A Phase 3, randomized, double-blind study of adjuvant cemiplimab versus placebo post surgery and radiation therapy (RT) in patients with high-risk CSCC

Libtayo is being jointly developed by Sanofi and Regeneron under a global collaboration agreement.

Safety and efficacy data for SAR439459, a transforming growth factor beta (TGF-β) inhibitor*

Abstract 2524: Safety and efficacy results from the expansion phase of the first-in-human study evaluating TGFβ inhibitor SAR439459 alone and combined with cemiplimab in adults with advanced solid tumors

Immunogenomic analysis for IL-2-based immunotherapies*

Publication Only: Detailed immunogenomic analysis of high dose IL-2 pharmacodynamic effects: A benchmark for next-generation IL-2-based immunotherapies

Health economics and outcomes research in NSCLC

Publication Only: Insights into the advanced non-small cell lung cancer patient journey: Treatment decision-making, preferences, and quality of life considerations

Click here to view these abstracts located in the ASCO (Free ASCO Whitepaper) Meeting Library.

*These assets are currently under investigation and their safety and efficacy has not been fully evaluated by any health authority.

On May 17, 2022 SOM Biotech reported that it has signed a licensing agreement with the University of Minnesota (Press release, SOM Biotech, MAY 17, 2022, View Source;utm_medium=rss&utm_campaign=som-biotech-licensing-agreement [SID1234614710]).

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This license agreement follows the completion of research under a sponsored research agreement (SRA) signed in 2019, in which the University of Minnesota conducted a series of in vitro studies on potential pre-clinical product candidates for Duchenne and Becker muscular dystrophy identified using SOM Biotech’s exclusive platform, SOMAIPRO. The work under the SRA resulted in inventions covering nine potential product candidates, which SOM chose to license exclusively from the University of Minnesota. SOM is currently conducting additional preclinical studies at the University of Minnesota to select the best potential candidates to take forward into development for Duchenne and Becker muscular dystrophy. The project was performed with the support of the Duchenne Parent Project Spain.

Raúl Insa, Chief Executive Officer of SOM Biotech, said: "This agreement with the University of Minnesota, a leading global research university, shows the exceptional value provided by our SOMAIPRO platform and its unique approach to AI-based drug discovery. The research that has already been conducted by the University of Minnesota is very encouraging and we are looking forward to continuing that at SOM Biotech in order to bring innovative potential treatments to patients with high unmet medical needs."

SOM Biotech successfully uses SOMAIPRO to identify drugs effective for the treatment of a specific disease, to discover new mechanisms of action and new applications for a drug, and to predict the toxicity of the compounds, as well as the molecular scaffolds for compounds active on a given target. While other AI-based approaches use methods based on data mining, structural similarity, or the target structure, SOMAIPRO uses molecular fields, allowing for an increased rate of success, with results achieved in the shortest possible time and considerably reducing the costs associated with drug discovery.

On May 17, 2022 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) and Sernova Corp. (TSX-V: SVA; OTCQB: SEOVF; FSE: PSH), a clinical-stage company and leader in regenerative medicine cell therapeutics reported a partnership in the field of diabetes (Press release, Evotec, MAY 17, 2022, View Source [SID1234614703]). Both Companies will leverage their respective strengths to develop an implantable iPSC-based beta cell replacement therapy for the treatment of insulin-dependent diabetes, including type 1 and 2 .

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The partnership leverages iPSC-based beta cells from Evotec’s QRbeta initiative. Evotec reliably produces human iPSC-based beta cells in islet-like clusters in a quality controlled ("QC") scalable bioreactor process. Those islet-like clusters are functionally equivalent to primary human islets in their ability to normalise blood glucose levels in in vivo models over several months.

Evotec’s iPSC-based beta cells will be combined with Sernova’s proprietary Cell Pouch, which is the leading implantable and scalable medical device in its class. In particular, it enables vascularisation of the cell implant and thus ensures long-term survival and optimal function in patients. The combination of primary donor islets and Cell Pouch has achieved long-lasting therapeutic results in patients enrolled in Sernova’s US-based Phase I/II clinical trial, including sustained insulin-independence in high-risk Type 1 Diabetes patients who previously required insulin injections for survival. Moreover, Sernova will evaluate local immune protection technology to protect non-modified beta cells and avoid the requirement for immunosuppressive treatment. The goal of the partnership is the development of an off-the-shelf iPSC-based beta cell replacement therapy device for the treatment of patients living with insulin-dependent diabetes.

Sernova has acquired an option for an exclusive global license to Evotec’s Induced Pluripotent Stem Cell (iPSC)-based Beta cells for use with its Cell Pouch system to treat diabetes. From an operational perspective, the pre-clinical development programme(s) will be jointly funded until IND acceptance. Sernova has the right to exercise its option for an exclusive global license upon IND filing. Evotec will contribute cell manufacturing through commercialisation and decide in the future on joint funding of clinical development. Upon commercialisation, there will be a profit-sharing arrangement between the two companies, with the split dependent upon Evotec’s participation in the clinical development programme.

In conjunction with the agreement, Evotec has committed to a strategic € 20 m equity investment in Sernova (approx. CAD$ 27 m at an €/CAD$ fx rate of 1.355).

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: "We searched long and hard for the right partner. Sernova clearly ticks all boxes with their clinically validated Cell Pouch technology, which fits perfectly to Evotec’s iPSC-based beta cells. Together we will progress a highly differentiated first-in-class beta cell therapy into clinical development with the common goal to bring a truly transformative therapy to insulin-dependent diabetic patients. The operational synergies of Evotec’s and Sernova’s technologies puts Sernova in position to become the world’s leader in beta cell replacement therapy. Our equity investment underlines our strategic interest in this collaboration with Sernova. We are very much looking forward to collaborate with them on the project as well as to be part of their Supervisory Board."

Dr Philip Toleikis, President, and Chief Executive Officer of Sernova, commented: "In tandem with our current clinical islet cell programme, Sernova entered into multiple pharmaceutical research collaborations to identify the highest quality and most compatible iPSC cell technology, and validate the cells pre-clinically within our Cell Pouch System. Evotec is an iPSC powerhouse having dedicated many years and substantial resources to developing high quality and stable stem cell technologies for multiple therapeutic applications. In every sense, both as a global strategic partner and as an iPSC expert, Evotec has exceeded all our expectations and we welcome them to join our advisory board. Today’s announcement of this joint iPSC beta-cell partnership completes the three pillars of our diabetes cell therapy platform. Alongside our clinically validated Cell Pouch System and recently acquired conformal coating immune protection technology, this now establishes a total regenerative medicine cell therapy solution for insulin-dependent diabetes."

Sernova and Evotec are going to hold a joint conference call on the transaction. The conference call will be held in English.

On May 17, 2022 Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") reported that the first patient has been randomized in the company’s proof-of-concept Phase 2 study in patients with squamous cell carcinoma of the head and neck (SCCHN) with the NOX 1 and 4 inhibitor, setanaxib (Press release, Calliditas Therapeutics, MAY 17, 2022, View Source [SID1234614701]).

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The trial is a randomized, placebo-controlled, double-blind, proof-of-concept Phase 2 study. It will investigate the effect of setanaxib 800 mg twice daily in conjunction with pembrolizumab 200mg IV, administered every 3 weeks (the standard treatment regimen for this immunotherapy), in approximately 50 patients with moderate or high CAF-density tumours. A tumour biopsy will be taken prior to randomization and then again after at least 9 weeks of treatment. Treatment will continue until unacceptable toxicity or progression, as is typical for oncology trials.

"Today marks an important milestone for Calliditas, with the enrolment of the first patient into our proof-of-concept study in SCCHN. We believe that a successful translation into the clinic of the promising pre-clinical observations of co-administration of setanaxib and check point inhibitors, could result in important new treatment approaches for patients with CAF rich solid tumors, and we look forward to working with our clinical trial sites, investigators and site staff to successfully execute the study," said CMO Richard Philipson.

Interim biomarker analysis is targeted for Q4 2022, and the study is expected to read out final data (including impact on tumour size) in 2023. Further details of this study can be found at www.clinicaltrials.gov, with the reference NCT05323656.