On April 29, 2021 Allarity Therapeutics A/S ("Allarity" or the "Company") reported at the Company has been selected for e-Poster presentation at the European Association for Cancer Research (EACR) 2021 Virtual Congress to be held from 9 – 12 June 2021 (Press release, Allarity Therapeutics, APR 29, 2021, View Source [SID1234578831]).

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The e-Poster provides new details of the Dovitinib-DRP companion diagnostic, which is used to select cancer patients most likely to respond to the pan-targeted kinase inhibitor (pan-TKI) dovitinib. The Dovitinib-DRP confirms many of the cell signaling pathways previously known to be targeted by the drug, as well as identifying additional, novel mechanisms of drug response.

Dovitinib is a post-Phase 3 small molecule, pan-TKI in-licensed from Novartis, and is Allarity’s most advanced clinical asset. Allarity plans to file a New Drug Application ("NDA") with the U.S. Food and Drug Administration (FDA) for the approval of dovitinib for the treatment of renal cell carcinoma (RCC, kidney cancer) during 2021. The Company previously submitted, in April 2021, a premarket approval application (PMA) to the U.S. FDA for use of the Dovitinib-DRP as a companion diagnostic to select RCC patients most likely to respond to dovitinib. The Dovitinib-DRP, if approved by the U.S. FDA, will be the first clinically validated, complex gene expression signature used as a companion diagnostic to select patients most likely to respond to a given cancer therapeutic.

Presentation details:

e-Poster title: A novel drug response predictor (DRP) mRNA biomarker for the multi tyrosine kinase inhibitor dovitinib
Presenter: Marie Foegh, M.D., D.Sc., Chief Medical Officer of Allarity Therapeutics
Date and Time: 9 – 12 June 2021

Additional information on the congress can be found on the EACR 2021 Virtual Congress website: View Source

The CEO of Allarity Therapeutics, Steve Carchedi, noted, "We are pleased every time that Allarity is given the opportunity to contribute to scientific conferences, particularly in the area of personalized cancer care and companion diagnostics. We are honored to be invited to present our poster at this important EACR conference, detailing our Dovitinib-DRP companion diagnostic, which aligns with our ongoing efforts to file a New Drug Application (NDA) for dovitinib, following our PMA filing for the Dovitinib-DRP earlier this year. We remain committed to improving therapeutic options for RCC patients by securing approval of dovitinib together with its DRP companion diagnostic to help realized the promise of personalized cancer care."

About the Drug Response Predictor – DRP Companion Diagnostic
Allarity uses its drug specific DRP to select those patients who, by the genetic signature of their cancer, are found to have a high likelihood of responding to the specific drug. By screening patients before treatment, the response rate can be significantly increased. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including genomic information from cell lines combined with clinical tumor biology and prior clinical trial outcomes. DRP is based on messenger RNA from the patient’s biopsies. DRP has proven its ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients in nearly 40 clinical studies that were examined, including an ongoing, prospective Phase 2 trial. The DRP platform can be used in all cancer types and is patented for more than 70 anti-cancer drugs.

On April 29, 2021 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported the upcoming launch of the EZ2 Connect product line, a next-level automated sample-processing platform whose simplicity, flexibility and speed will benefit biomedical research, forensics and clinical diagnostics (Press release, Qiagen, APR 29, 2021, View Source [SID1234578841]).

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The EZ2 Connect instruments use pre-filled cartridges and magnetic bead technology to process up to 24 samples in parallel in as little as 20 minutes, ensuring process safety and efficiency of nucleic acid extraction. The new platform builds on QIAGEN’s groundbreaking EZ1 instrument line, which set new standards in the automation of sample preparation and sample-data management and has seen more than 4,500 devices installed worldwide at the end of 2020.

"Expanding on the strength of our sample-processing portfolio, we are paving the way to a new era of laboratory automation," said Thomas Schweins, Senior Vice President, Business Area Life Sciences of QIAGEN. "The EZ2 Connect platform makes standardized and efficient nucleic acid purification accessible for any lab – without the need for specialized training or previous experience with automation platforms, while providing a new level of connectivity for ease-of-use and reliability of results."

The EZ2 Connect platform has a broad range of application areas, and will be tailored to three different key versions. The EZ2 Connect for use in research and pharmaceutical laboratory and the EZ2 Connect Fx for use in forensics and human identification (HID) will be launched in July. The release of the EZ2 Connect MDx for use in molecular diagnostic workflows is planned for early 2022, with regulatory approval in the U.S., the European Union and other markets worldwide.

Addressing a wide range of sample types and applications for biomedical research, the EZ2 Connect comes with an elaborate kit portfolio. In-tip separation, onboard heating and reagent pipetting, as well as large volume capabilities enable an unprecedented level of benchtop automation. With new approaches for cell free circulating DNA (cfDNA) and nucleic acid extraction from a range of sample types such as FFPE, EZ2 Connect catalyzes analytical quality, a valuable tool for example in cancer research.

The EZ2 Connect Fx is tailored to Human ID and forensics customer requirements, ensuring performance, process safety and reliability. It was designed and developed on the experiences and user feedback of the EZ1’s exceptional success in the HID market and offers a failure-safe method to isolate DNA even from smallest traces with highest efficiency. Increased capacity, full traceability, and maximum sample integrity allow labs to stand ready 24/7.

The EZ2 Connect MDx will address the challenges of medium throughput clinical diagnostics labs: dealing with fluctuating numbers of sample, large variety of sample types and quality, and less experienced staff. A single-use cartridge per sample and easy push-button operation minimizes the risk of sampling errors.

The EZ2 Connect platform complements QIAGEN’s leading offering of automation solutions including the QIAcube Connect and the QIAsymphony. The QIAcube Connect platform allows for a seamless transfer of QIAGENs wide range of manual spin column protocols to flexible and medium throughput automation, with the dedicated QIAcube Connect MDx version for molecular diagnostics workflows.

At the end of 2020, more than 9,800 QIAcube platform had been cumulatively placed with customers worldwide. The QIAsymphony provides fully automated high throughput with features such as continuous loading and primary tube handling, and had a cumulative installed base of over 2,900 systems at the end of 2020.

The newly introduced EZ2 Connect platform allows for medium- to high-throughput sample processing, combining flexibility with maximum process safety in dedicated instrument versions tailored to the individual needs of QIAGEN’s diverse customer base.

The new versions also allow for connection to QIAsphere, a digital laboratory ecosystem that enables additional remote features like instrument management and real-time status reporting. As a result, EZ2 Connect enables optimization of workflows and greater lab productivity with the next level of daily lab routine automation.

For more information about the EZ2 Connect platform, please visit View Source or see the product video at View Source;ab_channel=QIAGEN

On April 29, 2021 Werewolf Therapeutics, Inc. (NASDAQ: HOWL), an innovative biopharmaceutical company pioneering the development of conditionally activated therapeutics engineered to stimulate the body’s immune system for the treatment of cancer, reported the pricing of its upsized initial public offering of 7,500,000 shares of common stock at a public offering price of $16.00 per share (Press release, Werewolf Therapeutics, APR 29, 2021, View Source [SID1234578871]). The gross proceeds of the offering, before deducting underwriting discounts and commissions and offering expenses payable by Werewolf, are expected to be approximately $120.0 million. Werewolf has granted the underwriters a 30-day option to purchase up to an additional 1,125,000 shares of common stock at the initial public offering price, less underwriting discounts and commissions. All of the shares are being offered by Werewolf.

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The shares are expected to begin trading on the Nasdaq Global Select Market on April 30, 2021 under the ticker symbol "HOWL." The offering is expected to close on May 4, 2021, subject to the satisfaction of customary closing conditions.

Jefferies, SVB Leerink and Evercore ISI are acting as joint book-running managers for the offering. H.C. Wainwright & Co. is acting as lead manager for the offering.

A registration statement relating to the offering of these securities was filed with the Securities and Exchange Commission ("SEC") and was declared effective on April 29, 2021. The offering will be made only by means of a prospectus. Copies of the final prospectus, when available, may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at 877-821-7388 or by email at [email protected]; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or by telephone at 800-808-7525 ext. 6105 or by email at [email protected]; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, or by telephone at 888-474-0200, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

On April 29, 2021 Corcept Therapeutics Incorporated (NASDAQ: CORT) reported it will report first quarter financial results and provide a corporate update on May 6, 2021 (Press release, Corcept Therapeutics, APR 29, 2021, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announce-first-quarter-financial-results-6 [SID1234578762]). The company will also host a conference call that day at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time).

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Conference Call Information

To participate, click the link below and enter your information. The link will become active 15 minutes prior to the scheduled start time.

Click to Join Meeting

Alternatively, you may dial 1-888-204-4368 from the United States or 1-313-209-4906 internationally approximately 15 minutes before the start of the call. The passcode will be 8720277.
A replay will be available through May 20, 2021 at 1-888-203-1112 from the United States and 1-719-457-0820 internationally. The passcode will be 8720277.

On April 29, 2021 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading genome editing company focused on developing curative therapeutics using CRISPR/Cas9 technology both in vivo and ex vivo, reported that it will present its first quarter 2021 financial results and operational highlights in a conference call on May 6 at 8 a.m. E.T (Press release, Intellia Therapeutics, APR 29, 2021, View Source [SID1234578805]).

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To join the call:

U.S. callers should dial 1-833-316-0545 and international callers should dial 1-412-317-5726, approximately five minutes before the call.
All participants should ask to be connected to the Intellia Therapeutics conference call.
A replay of the call will be available through the Events and Presentations page of the Investors & Media section of the company’s website at www.intelliatx.com, beginning on May 6 at 12 p.m. E.T.