1stOncology™: Cancer Intelligence Service – Page 11472 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Ashion Analytics announces innovative cancer treatment partnership with Elevation Oncology

On July 22, 2020 Ashion Analytics LLC reported a partnership with Elevation Oncology, a clinical stage biopharmaceutical company, focused on the matching of patients with tumors harboring an NRG1 gene fusion identified using Ashion’s proprietary GEM ExTra test with CRESTONE, a registration-directed Phase 2 study sponsored by Elevation Oncology (Press release, Ashion Analytics, JUL 22, 2020, View Source [SID1234562266]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

Schedule Your 30 min Free Demo!

NRG1 gene fusions are a rare genomic alteration implicated as a driver of tumorigenesis and growth across many types of solid tumors, including lung, breast, pancreatic, ovarian, and colorectal cancers. CRESTONE — or Clinical study of REsponse to Seribantumab in TumOrs with NEuregulin 1 (NRG1) fusions — provides an investigational treatment opportunity for patients with any advanced solid tumor who have not responded or are no longer responding to standard cancer treatment, and whose tumor has tested positive for an NRG1 fusion.

This partnership creates a new dynamic in the way cancer patients can be matched to precision medicine therapeutics. By first identifying a genetic driver that has an available targeted therapy option, in this case an NRG1 fusion and the investigational therapy seribantumab, the diagnostic technology, data insights, and network reach at Ashion Analytics can be leveraged to efficiently identify and directly match eligible patients to the CRESTONE trial using test results that are already available today, while also maximizing the value of every additional test.

"The comprehensive nature of the GEM ExTra test means that its value grows directly with each new genomic driver that is identified and each new precision therapy under development," said Laurie Goodman, Ph.D., Ashion Analytics Director of Business Development and Medical Affairs. "Partnerships like this enable us to continuously facilitate the ability for our patients to receive the most up-to-date information about the emerging treatment opportunities available to them today."

Ashion Analytics recently announced that Medicare has approved coverage of its proprietary cancer profiling test, GEM ExTra, one of the nation’s most comprehensive genomic cancer analysis tests. Medicare coverage enables potentially 44 million more patients to afford this test, which aims to match patients with best available treatments for their disease.

GEM ExTra detects tumor-specific mutations in both DNA and RNA, allowing physicians to make the best-available treatment recommendations for patients with advanced solid tumors. An Ashion study poster presented at the 2020 annual meeting of the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) details the importance of using RNA as part of the analysis to give cancer physicians the best possible options for treating their patients: Employing RNA Sequencing to Enhance Treatment Options for Cancer Patients.

This leading-edge test provides treating physicians with vital interpreted information needed to understand changes to a patient’s genomic profile. It outlines a therapeutic treatment plan best suited for each patient. Conditions that may benefit from this approach include treatment of refractory, rare or aggressive cancers.

"We are partnering with Ashion Analytics because we recognize the sensitivity and continuing potential of their GEM ExTra cancer profiling test," said Shawn Leland, PharmD, RPh, Founder and Chief Business Officer of Elevation Oncology. "Elevation Oncology is committed to expanding the benefit of precision medicine to all patients with cancer by developing therapies that make results from tests like GEM ExTra clinically actionable, no matter how rare the finding. Close collaboration between diagnostic and therapeutic developers is critical to re-thinking our approach to clinical trial enrollment as an industry and finding more efficient ways to bring the right treatment opportunities to the patients that need them."

BioNTech Announces Pricing of Upsized Underwritten Offering and Terms of Rights Offering

On July 22, 2020 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported the pricing of its previously announced underwritten offering and terms of its previously announced rights offering (Press release, BioNTech, JUL 22, 2020, View Source [SID1234562265]).

BioNTech announced the pricing of a firm commitment underwritten offering (the "Underwritten Offering") of 5,500,000 American Depositary Shares ("ADSs"), each representing one of its ordinary shares, at a public offering price of $93.00 per ADS, for gross proceeds of $511.5 million. The size of the offering was increased from the previously announced offering size of 5,000,000 ADSs. For stabilization purposes, in connection with the Underwritten Offering, an existing shareholder has granted the underwriters a 30-day option to purchase up to 825,000 additional ADSs at the same public offering price. BioNTech will not receive any of the proceeds from the sale of ADSs by the selling shareholder. The Underwritten Offering is expected to close on July 27, 2020, subject to the satisfaction of customary closing conditions.

BioNTech announced the terms of a rights offering (the "Rights Offering") of rights to subscribe for up to 7,505,596 ordinary shares, including ordinary shares represented by ADSs, extended to holders of its ordinary shares and ADSs. Certain ordinary shareholders representing 74.83% of the Company’s outstanding ordinary shares have irrevocably agreed not to transfer or exercise their rights in this offering, and the shares underlying those rights are being offered in the Underwritten Offering. ADSs purchased in the Underwritten Offering will not be entitled to receive rights in the Rights Offering.

Pursuant to the rights offering, holders of ADSs will receive one ADS right for each ADS owned of record as of 5:00 p.m. (New York City time) on July 24, 2020 and holders of ordinary shares will receive one ordinary share right for each ordinary share owned of record as of one minute after 11:59 p.m (Mainz, Germany time) on July 29, 2020. 31 ADS rights will entitle a holder of such rights to subscribe for and purchase one new ADS, at a subscription price of $93.00 per new ADS. 31 ordinary share rights will entitle a holder of such rights to subscribe for and purchase one new ordinary share, at a subscription price of €80.32 per new ordinary share, which is the Euro equivalent of the U.S. dollar price per new ADS, translated based on the exchange rate in effect as of July 22, 2020, or $93.00 per new ordinary share. No fractional ADSs or ordinary shares will be issued.

The ADS rights exercise period is from 12:01 a.m. (New York City time) on July 28, 2020 through 12:01 a.m. (New York City time) on August 14, 2020. The ordinary share rights exercise period is from one minute before 12:01 a.m. (Mainz, Germany time) on July 28, 2020 through one minute after 11:59 p.m. (Mainz, Germany time) on August 14, 2020. Rights to purchase ADSs are not transferable and all exercises of ADS rights are irrevocable. ADS rights and ordinary share rights that are not exercised within the applicable period will expire and have not further value. Delivery of the ordinary shares and the ADSs in the Rights Offering is expected to be made on or about August 27, 2020.

J.P. Morgan, BofA Securities and Berenberg are acting as lead joint book-running managers for the Underwritten Offering and as joint dealer-managers and subscription agents for the Rights Offering. UBS Investment Bank is acting as joint book-running manager and Canaccord Genuity is acting as lead manager for the Underwritten Offering. COMMERZBANK, Wolfe Capital Markets and Advisory and Bryan, Garnier & Co. are acting as co-managers for the Underwritten Offering.

A registration statement on Form F-1 relating to the securities offered in the Underwritten Offering has been filed with the United States Securities and Exchange Commission (the "SEC") and was declared effective on July 22, 2020. A registration statement on Form F-1 relating to the securities offered in the Rights Offering has been filed with the SEC but has not yet become effective. The securities offered in the Rights Offering may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective.

The Underwritten Offering and the Rights Offering will each be made only by means of a prospectus, copies of which may be obtained, when available, for free by visiting EDGAR on the SEC’s website at www.sec.gov. Alternatively, copies of the prospectuses, when available, may be obtained from J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, or by telephone at +1 (866) 803-9204, or by e-mail at [email protected]; BofA Securities, Inc., NC1-004-03-43; 200 North College Street, 3rd Floor, Charlotte, North Carolina 28255-0001, Attention: Prospectus Department, or by e-mail at [email protected]; or Berenberg Capital Markets LLC, Attention: Investment Banking, 1251 Avenue of the Americas, 53rd Floor, New York, New York 10020, or by telephone at +1 (646) 949-9000, or by e-mail at [email protected].

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

Aurinia Prices US$200 Million Public Offering of Common Shares

On July 22, 2020 Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) ("Aurinia" or the "Company"), a late-stage clinical biopharmaceutical company focused on advancing voclosporin in multiple indications, reported the pricing of its underwritten public offering of 13,333,334 common shares (the "Offering") (Press release, Aurinia Pharmaceuticals, JUL 22, 2020, View Source [SID1234562264]). The shares are being sold at a public offering price of US$15.00 per share. The gross offering proceeds to the Company from this Offering are expected to be approximately US$200 million, before deducting underwriting discounts and commissions and other offering expenses. All of the shares are being offered by the Company. The Offering is expected to close on or about July 27, 2020, subject to the satisfaction of customary closing conditions.

Jefferies and SVB Leerink are acting as joint book-running managers for the Offering. Cantor is acting as lead manager for the Offering. Oppenheimer & Co. and H.C. Wainwright & Co. are acting as co-managers for the Offering. The Company has granted the underwriters an option exercisable, in whole or in part, in the sole discretion of the underwriters, to purchase 2,000,000 additional common shares, for a period of up to 30 days.

The Company intends to use the net proceeds of the Offering for pre-commercialization and launch activities, research and development, as well as working capital and general corporate purposes.

The Offering is subject to customary closing conditions, including NASDAQ and TSX approvals. For the purposes of the TSX approval, the Company intends to rely on the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible interlisted issuers on a recognized exchange, such as NASDAQ.

The Offering is being made pursuant to a U.S. registration statement on Form F-10, declared effective by the U.S. Securities and Exchange Commission (the "SEC") on June 19, 2020 (the "Registration Statement"), and the Company’s existing Canadian short form base shelf prospectus (the "Base Shelf Prospectus") dated June 17, 2020. A preliminary prospectus supplement relating to the Offering has been filed with the securities commissions in the provinces of British Columbia, Alberta and Ontario in Canada, and with the SEC in the United States (the "Preliminary Prospectus"), and a final prospectus supplement relating to the Offering (together with the Preliminary Prospectus, Base Shelf Prospectus and the Registration Statement, the "Offering Documents") will be filed with the securities commissions in the provinces of British Columbia, Alberta and Ontario in Canada, and with the SEC in the United States. The Offering Documents will contain important detailed information about the securities being offered. Before you invest, you should read the Offering Documents and the other documents the Company has filed for more complete information about the Company and the Offering. Copies of the Offering Documents will be available for free by visiting the Company’s profiles on the SEDAR website maintained by the Canadian Securities Administrators at www.sedar.com or the SEC’s website at www.sec.gov, as applicable. Alternatively, copies of the prospectus supplement will be available upon request in the United States by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022; by phone at (877) 821-7388; or by e-mail at [email protected]; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525, ext. 6218, or by email at [email protected]; and in Canada by contacting Jefferies Securities, Inc., attention: Steven Latimer, 161 Bay Street, Suite 2700 Toronto, Ontario M5J 2S1, by telephone at 416-572-2215.

BioInvent’s BI-1206 could improve treatment in several cancers

On June 22, 2020 BioInvent reported that Alexander Eggermont, MD, PhD, Chief Scientific Officer at the Princess Máxima Center and renowned expert in immunotherapy showcased the broad potential of BI-1206 in enhancing checkpoint inhibitors in solid cancers in a KOL event hosted by BioInvent on July 21 (Press release, BioInvent, JUL 22, 2020, View Source [SID1234562260]).

Professor Eggermont discussed the clinical challenges associated with the use of checkpoint inhibitors in solid tumors and the potential for an enhanced response with immune-modulatory antibodies, specifically those targeting FcγRIIB, such as BI-1206.

"The most important message to take away from this presentation – BI-1206 has the potential to go across multiple tumor types, much like pembrolizumab which is approved in over 20 different cancer types," said professor Eggermont.

BioInvent’s lead pipeline candidate BI-1206 is a first-in-class monoclonal antibody that targets FcγRIIB – the only inhibitory Fcγ receptor that acts as a "brake" on the innate immune system – to unleash antibody-mediated reactivation of the immune response against cancer.

"We are thrilled with the strong support for the potential broad use of BI-1206 in many different cancers from such a renowned expert as professor Eggermont," said Martin Welschof, CEO of BioInvent.

Professor Eggermont highlighted three main advantages of BI-1206.

To begin with, BI-1206 can give better and prolonged anti-PD1 blocking and thus, it has the potential to be used in many first line indications across multiple tumor types.

Furthermore, BI-1206 can overcome resistance to anti-PD1. It enhances the activity of, for example rituximab and overcomes resistance to those agents. It is an enhancer that has potential to go across multiple tumor types in refractory settings by blocking FcγRIIB interaction.

Last but not least. Dosing of BI-1206 may be different in 1st and 2nd line and be different in different tumor types. BI-1206 can be optimized and dosed as needed which gives a big potential for a wide development pathway.

"The simplicity of the BI-1206 model is very attractive. BI-1206 has an additive or synergistic, further enhancement of anti-PD-1 function. It has tremendous potential as it can be used in multiple indications," concluded professor Eggermont.

For further detail please listen to the call: link

Prof. Alexander M.M. Eggermont, MD, PhD is an internationally recognized expert in surgical oncology, immunotherapy, melanoma, sarcoma and cancer drug development. He currently holds roles as Chief Scientific Officer at the Princess Máxima Center for Pediatric Oncology, the Netherlands; Professor of Oncology (Classe Exceptionelle) at Paris-Saclay University, France; Coordinator, Comprehensive Cancer Center Program for Deutsche KrebsHilfe; and Strategic Advisor at the German Cancer Consortium (DKFZ).

Prof. Eggermont was previously Director General of Gustave Roussy Comprehensive Cancer Center, Villejuif, France (2010-2019); and Professor of Surgical Oncology (2003-2016) and Endowed Professor of International Networking in Cancer Research (2011-2018) at Erasmus University MC, Rotterdam, the Netherlands. He holds a PhD in tumor immunology from Erasmus University and is Fellow of the National Institutes of Health’s National Cancer Institute (NIH-NCI). Prof. Eggermont has served as President of ECCO, President of the EORTC, was a member of the Board of Directors of ASCO (Free ASCO Whitepaper), served on the Editorial Board of the Journal of Clinical Oncology, and is currently Editor-in-Chief of the European Journal of Cancer. Prof. Eggermont has published more than 900 peer-reviewed papers and his expertise has been acknowledged by many professional awards throughout his career.

Ultivue and OracleBio partner to help advance personalized tumor characterization and clinical oncology research using multiplex immunofluorescence

On July 22, 2020 Ultivue, Inc. reported a collaborative partnership with OracleBio to help further insights and advance personalized tumor characterization in translational and clinical oncology research and drug development using multiplex immunofluorescence staining and imaging (Press release, Ultivue, JUL 22, 2020, View Source [SID1234562259]).

The deal connects the histopathology image analysis expertise of OracleBio and the tissue staining capabilities of Ultivue, with the goal of providing pharmaceutical companies with an end-to-end workflow for gaining valuable insights from biomarkers in situ.

OracleBio, a contract research organization based in Scotland, is known for its quantitative digital pathology services, delivering high-quality image analysis while leveraging multiple software platforms in supporting clinical and pre-clinical research.

"OracleBio aim to deliver robust quantitative histopathology data deployed within a quality framework, and that analysis can be heavily dependent on the quality of sample preparation and staining," says Lorcan Sherry, CSO of OracleBio. "Being able to partner with Ultivue means we can be confident in the staining of the tissue we’re quantifying, which ultimately means more precise data."

The Cambridge, Massachusetts-based Ultivue develops reagents for staining tissues used for multiplex immunofluorescence imaging and analysis. Its proprietary InSituPlex technology is designed for fast and comprehensive exploration of biologically-relevant markers in tissue samples.

"We’ve developed reagents that are workflow-agnostic and can plug-and-play in most customers’ existing laboratory infrastructure, so it makes sense to partner with a like-minded imaging and analysis CRO like you have in OracleBio. At the end of the day, our goal is always to offer our customers relevant and meaningful biological insights from their samples, regardless of their preferred hardware or software," says Jacques Corriveau, President and CEO of Ultivue.