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.

On April 29, 2021 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune T-cell activating technology, reported that initial efficacy and safety data from the National Cancer Institute’s (NCI) Phase 2 clinical study of PDS0101 for the treatment of advanced human papillomavirus (HPV)-associated cancers that have progressed or returned after treatment (NCT04287868) has been accepted for oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Annual Meeting taking place June 4-8.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The accepted abstract summarizes initial findings from the ongoing trial, which studies PDS0101 in combination with two investigational immune-modulating agents: bintrafusp alfa (M7824), a bifunctional "trap" fusion protein targeting TGF-β and PD-L1, and NHS-IL12 (M9241), a tumor-targeting immunocytokine. Earlier this year, it was announced that the trial had achieved its preliminary efficacy threshold of an objective response in 3 or more of the first 8 patients as measured by RECIST 1.1. The trial subsequently expanded enrollment to both checkpoint inhibitor naïve patients and patients who have failed prior therapy with checkpoint inhibitors. "We are encouraged by the data and look forward to the presentation of initial findings from the study," said Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. "ASCO provides an important opportunity to share the potential of both PDS0101 and the Versamune platform with the research and medical community."

Abstract Number: 2501
Abstract Title: Phase II evaluation of the triple combination of PDS0101, M9241, and bintrafusp alfa in patients with HPV 16 positive malignancies.

Presenting Author: Julius Strauss, MD, National Cancer Institute
Session: Developmental Therapeutics—Immunotherapy
Date: June 7, 2021
Time: 3:00 PM-6:00 PM EDT

The abstract will be available on Wednesday, May 19 at 5:00 PM EDT on ASCO (Free ASCO Whitepaper).org.

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 Ziopharm Oncology, Inc. (Nasdaq: ZIOP), reported that it will report first quarter 2021 financial results on Thursday, May 6, 2021 after the financial markets close, and host its annual shareholder meeting on May 19, 2021 (Press release, Ziopharm, APR 29, 2021, View Source [SID1234578746]). Details for each is as follows:

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Earnings Conference Call and Webcast

Ziopharm will host a conference call and webcast for the investment community on May 6, 2021, at 4:30 p.m. EDT. The conference call can be accessed by dialing 855-327-6837 (U.S. and Canada) or 631-891-4304 (International). The passcode for the conference call is 10013973. A live webcast may be accessed using the link here, or by visiting the "Investors" section of the Ziopharm website at www.ziopharm.com. The call will be recorded and available for replay on the Company’s website for approximately 90 days after the call.

Annual Meeting of Stockholders

Ziopharm will host its annual meeting virtually on May 19, 2021 at 9:00 am EDT. Shareholders and interested stakeholders may attend the meeting by visiting www.virtualshareholdermeeting.com/ZIOP2021. Shareholders can submit questions and vote their shares electronically during the meeting using the same link.