On May 17, 2022 Aravive, Inc. (Nasdaq: ARAV), a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease reported that Gail McIntyre, Ph.D, DABT, Chief Executive Officer will present at the H.C. Wainwright Annual Global Investment Conference being held at the Fontainebleau Miami Beach Hotel May 23-26, 2022 (Press release, Aravive, MAY 17, 2022, https://ir.aravive.com/news-releases/news-release-details/aravive-participate-hc-wainwright-global-investment-conference [SID1234614718]).

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What: H.C. Wainwright Annual Global Investment Conference
Where: Fontainebleau Miami Beach Hotel
When: May 25, 2022, 10:00 am ET – 10:30 am ET
Live and archived webcast: View Source

On May 17, 2022 MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of therapeutic products for people living with endocrine and orphan lung diseases, reported that it has entered into an agreement with Zealand Pharma A/S (Nasdaq: ZEAL) to acquire V-Go for $10 million, with additional sales-based milestones plus the cost of certain inventory (Press release, Mannkind, MAY 17, 2022, View Source [SID1234614717]). The acquisition of V-Go allows MannKind to expand its portfolio and strengthen its commitment to providing innovative mealtime diabetes solutions.

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"MannKind is passionate about being a leader in mealtime control to address this unmet need within the diabetes community," said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. "This acquisition strategically leverages our infrastructure in the diabetes space and positions MannKind’s endocrine business for additional growth."

"This transaction is an important step forward in executing on the strategic changes we announced at the end of March, to find partners for our commercial products and refocus our priorities on R&D," said Adam Steensberg, MD, Chief Executive Officer of Zealand Pharma. "We believe we have found the right partner to fully leverage the value of V-Go and ensure continued availability of the product by patients and prescribers."

V-Go is a once-daily, wearable, insulin delivery device that helps provide blood sugar control for everyday lifestyles. Designed to be patient-friendly, V-Go is worn like a patch and eliminates the need for taking multiple daily shots.

"The easy click-and-go mechanism of V-Go and its ability to be flexibly placed on your body each day aligns with our mission of providing products that allow patients living with diabetes to experience life without limits," said Alejandro Galindo, Executive Vice President, Endocrine Business Unit for MannKind Corporation. "V-Go joins our ultra rapid-acting inhaled insulin product, Afrezza, in expanding MannKind’s portfolio of products that change the way diabetes is treated."

The acquisition of V-Go by MannKind is anticipated to close in May 2022, subject to the satisfaction of certain closing conditions.

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.