On July 22, 2020 Experts at City of Hope and the Translational Genomics Research Institute (TGen) reported that they are using one of the world’s most comprehensive genomic analysis tools to map out personalized treatment plans for metastatic kidney cancer patients (Press release, TGen, JUL 22, 2020, View Source [SID1234562374]).

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While the physician-scientists are at the beginning of this long journey, they believe they’re on the right path. They recently published a study in the Journal of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) that suggests mutations in the TERT gene predicts that a patient may not be receptive to immune checkpoint inhibitors such as nivolumab or pembrolizumab.

"The hope is to one day identify patients who will benefit from immunotherapy and those who will not. Eventually we may be able to distinguish which patient is better suited for other treatments, like targeted therapy," said Sumanta Pal, M.D., one of the study’s senior authors and co-director of the Kidney Cancer Program at City of Hope, a world-renowned independent research and treatment center for cancer, diabetes and other life-threatening diseases. Examples of targeted therapy include vascular endothelial growth factor (VEGF) tyrosine kinase inhibitors like cabozantinib.

Nearly 74,000 new cases of kidney cancer will be diagnosed this year, and about 14,800 people will die from the disease, according to the American Cancer Society. Ironically, experts know patients who have certain genetic mutations are more susceptible to specific drugs, but most doctors are not genetically sequencing each kidney cancer patient’s tumors, Pal said.

"It’s a paradox: We don’t use targeted therapy in a targeted fashion," he added. "At City of Hope, we have begun to provide comprehensive genome and exome sequencing for all patients with Stage 4 cancer, regardless of their cancer site."

City of Hope is on pace to be the only major cancer center in the United States to genetically profile the tumors of every single patient, regardless of cancer type. The goal is to enable patients to receive effective targeted therapies or to enroll people in innovative clinical trials as early as possible so that they can fight their disease.

In the study, Pal and his colleagues sent samples of 91 patients’ tumors to TGen’s clinical laboratory, Ashion Analytics, so that the specimens could be sequenced by GEM ExTra a leading-edge tool that features tumor-normal whole exome sequencing and tumor whole transcriptome sequencing. These are molecular-level analyses of each patient’s entire protein-coding DNA and RNA.

"The goal was to identify genomic alterations that correlated with therapy response," said Sara Byron, Ph.D., assistant professor in TGen’s Integrated Cancer Genomics Division and co-senior author of the study. "We wanted to use this ‘real-world evidence’ to explore potential molecular and genomic features associated with response." (Ashion Analytics recently announced that Medicare has approved coverage of GEM ExTra, potentially providing 44 million more patients access to this test, which aims to match patients with the best available treatments for their disease.)

Kidney cancer treatment regimens involving either targeted therapy or immunotherapy have burgeoned since 2015. Because new treatments sprouted so rapidly, scientists have not yet discovered the ideal strategy to sequence regimens for optimal outcomes. Moreover, the current way treatment risk is assessed tends to be subjective with ingrained bias, the study reported. City of Hope and TGen are working to develop objective laboratory-based biomarkers for kidney cancer.

Only patients whose genomic profiling was performed prior to systemic treatment were included in the study. Patients received either targeted therapy known as VEGF tyrosine kinase inhibitors (sunitinib, cabozantib, lenvatinib/everolimus) or immunotherapy (nivolumab, ipilimumab, pembrolizumab). They were divided into those who received no clinical benefit, meaning their disease progressed, or those who received clinical benefit, meaning the disease shrunk or stabilized for more than six months. Some 19,396 genes and nucleic sequences were analyzed to tease out a therapeutic treatment plan that would have best suited each patient based on their specific tumor mutations. More research in larger sample sizes are needed, but the scientists are off to a good start.

"Stage 4 cancer is often considered incurable, but that doesn’t always have to be the case," Pal said. "By sequencing all protein-coding DNA, that is by sequencing the whole exome, we may be able to identify new therapeutic targets, and that’s a very exciting prospect."

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 that it has commenced a registered underwritten public offering of its common shares (the "Offering") (Press release, Aurinia Pharmaceuticals, JUL 22, 2020, View Source [SID1234562296]).

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Jefferies and SVB Leerink are acting as joint book-running managers for the Offering.

The Company will grant the underwriters an option exercisable, in whole or in part, in the sole discretion of the underwriters, to purchase up to an additional 15% of common shares, for a period of up to 30 days. The Offering is subject to market conditions, and there can be no assurance as to whether or when the Offering may be completed, or as to the actual size or terms of the Offering.

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 United States 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. The prospectus supplements relating to the Offering (together with the 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.

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

On July 22, 2020 Alkermes plc (Nasdaq: ALKS) reported that it will host a conference call and webcast presentation at 8:00 a.m. ET (1:00 p.m. BST) on Wednesday, July 29, 2020 to discuss the company’s second quarter 2020 financial results (Press release, Alkermes, JUL 22, 2020, https://www.prnewswire.com/news-releases/alkermes-to-host-conference-call-to-discuss-second-quarter-2020-financial-results-301098230.html [SID1234562295]). Management will also provide an update on the company.

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The webcast player and accompanying slides may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers.

A replay of the conference call will be available from 11:00 a.m. ET (4:00 p.m. BST) on Wednesday, July 29, 2020, through Wednesday, Aug. 5, 2020, and may be accessed by visiting Alkermes’ website or by dialing +1 877 660 6853 for U.S. callers and +1 201 612 7415 for international callers. The replay access code is 13707215.

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]).

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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."

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]).

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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.