On April 7, 2021 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported the launch of the Elecsys Anti-p53 immunoassay for the in vitro quantitative determination of anti-p53 antibodies (Press release, Hoffmann-La Roche, APR 7, 2021, View Source [SID1234577658]). This test is used to aid physicians to diagnose throat cancer, bowel cancer and breast cancer in patients, in conjunction with other diagnostic tests. The assay is now available for all markets accepting the CE Mark.

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"The addition of our Elecsys Anti-p53 immunoassay will help clinicians to quickly and reliably diagnose several prevalent cancers and might assist in leading to a better prognosis for many patients.", said Thomas Schinecker, CEO Roche Diagnostics. "Beyond breakthrough cancer medicines, Roche also offers a growing number of testing solutions to help physicians diagnose and treat people with cancer.

p53 is protein which, when active, helps to regulate processes which stop tumors from developing. A mutation of p53 is present in half of solid tumor cancers and is the most common genetic change identified so far in human cancers.1 Certain mutations of p53 can lead to a build up of p53 which results in the formation of anti-p53 autoantibodies. Autoantibodies are antibodies that mistakenly target and react with a person’s own tissues. Between 20-50% of patients with mutated p53 will produce anti-p53 autoantibodies.2 This mutation causes the tumor suppressive function of p53 to switch to a tumor-promoting function and thus cancer development.

Early appearance of anti-p53 antibodies during tumour development may have potential to detect malignant changes.3 The Elecsys Anti-p53 immunoassay detects these anti-p53 antibodies and, when used with other diagnostic tests, can help to diagnose certain cancers, at an earlier stage, which may help to improve patient outcomes. Determining the presence of anti-p53 antibodies may also be useful for monitoring cancerous cells that are still in the body following treatment.4 In addition, the Elecsys Anti-p53 test could aid in determining which patients may require less invasive treatment procedures, as part of their cancer treatment.

About Elecsys Anti-p53
Elecsys Anti-p53 immunoassay for the in vitro quantitative determination of anti-p53 autoantibodies in human serum and plasma. Elecsys Anti-p53 is a high precision immunoassay, with a low turn-around time for testing, complementing our overall tumor marker portfolio. The new Elecsys Anti-p53 immunoassay uses the well-established electrochemiluminescence immunoassay "ECLIA" technology and is intended for use on cobas e immunoassay analyzers.

On April 7, 2021 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative medicines worldwide, reported approval from the China National Medical Products Administration (NMPA) for BeiGene to begin manufacturing commercial supply of its approved anti-PD-1 antibody, tislelizumab, at its state-of-the-art biologics facility in Guangzhou, China (Press release, BeiGene, APR 7, 2021, https://ir.beigene.com/news-releases/news-release-details/beigene-announces-first-commercial-manufacturing-approval-its [SID1234577680]). At over one million square feet (100,000 square meters) and 8,000 liters of biologics capacity approved for commercial supply, this wholly owned facility will immediately begin production of commercial supply of tislelizumab for the China market. An additional phase of construction currently in progress to bring total capacity to 64,000 liters is expected to be completed by the end of 2022.

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"We started building this large-scale, commercial biologics manufacturing facility in 2017 to meet our expected future demand. Since that time, tislelizumab has been approved in several indications in China, included in the National Reimbursement Drug List (NRDL), and licensed to Novartis in Europe, North America, and Japan," commented Xiaobin Wu, Ph.D., President, Chief Operating Officer, and General Manager of China at BeiGene. "With significantly expanded capacity for tislelizumab and for other biologics in our pipeline, we are continuing our strong commitment to the quality, safety, and compliance of our products."

BeiGene’s Guangzhou manufacturing facility has been designed to operate in compliance with current Good Manufacturing Practice (cGMP) standards adopted by the U.S. Food & Drug Administration (FDA), the China National Medical Products Administration (NMPA), and the European Medicines Agency (EMA). The Guangzhou site is expected to be the first paperless biological manufacturing facility in China and integrates new technologies such as 3D modeling, digital twin, augmented interfaces, and artificial intelligence to improve quality and efficiency.

About Tislelizumab

Tislelizumab (BGB-A317) is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is the first drug from BeiGene’s immuno-oncology biologics program and is being developed internationally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.

The China National Medical Products Administration (NMPA) has granted tislelizumab full approval for first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy. Tislelizumab has also received conditional approval from the NMPA for the treatment of patients with classical Hodgkin’s lymphoma (cHL) who received at least two prior therapies, and for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Full approval for these indications is contingent upon results from ongoing randomized, controlled confirmatory clinical trials.

In addition, three supplemental Biologics License Applications for tislelizumab have been accepted by the Center for Drug Evaluation (CDE) of the NMPA and are under review for first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy, for the second- or third-line treatment of patients with locally advanced or metastatic NSCLC who progressed on prior platinum-based chemotherapy, and for previously treated unresectable hepatocellular carcinoma.

Currently, 16 potentially registration-enabling clinical trials are being conducted in China and globally, including 13 Phase 3 trials and three pivotal Phase 2 trials.

In January 2021, BeiGene and Novartis entered into a collaboration and license agreement granting Novartis rights to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan.

Tislelizumab is not approved for use outside of China.

On April 7, 2021 Fortress Biotech, Inc. (NASDAQ: FBIO) ("Fortress"), an innovative biopharmaceutical company focused on acquiring, developing and commercializing or monetizing promising biopharmaceutical products and product candidates cost-effectively, reported that Lindsay A. Rosenwald, M.D., Chairman, President and Chief Executive Officer, will participate in the 20th Annual Needham Virtual Healthcare Conference, taking place April 12-15, 2021 (Press release, Fortress Biotech, APR 7, 2021, View Source [SID1234577696]). The company will present on Monday, April 12, 2021, at 4:30 p.m. ET and will also participate in one-on-one meetings during the conference. A webcast of the company’s presentation will be available on the Events page under the News & Media section of Fortress’ website: www.fortressbiotech.com for approximately 30 days following the presentation.

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On April 7, 2021 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, reported the pricing of an underwritten public offering of 4,562,044 shares of its common stock at a price to the public of $16.44 per share (Press release, Crinetics Pharmaceuticals, APR 7, 2021, View Source [SID1234577728]). All of the shares to be sold in the offering are being sold by Crinetics. The gross proceeds to Crinetics from the offering, before deducting the underwriting discounts and commissions and other offering expenses, are expected to be approximately $75.0 million. The offering is expected to close on or about April 12, 2021, subject to the satisfaction of customary closing conditions.

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Crinetics intends to use the net proceeds from the proposed offering to fund the development of paltusotine and its other research and development programs, and for working capital and general corporate purposes.

SVB Leerink is acting as sole bookrunning manager for the offering.

The securities described above are being offered by Crinetics pursuant to a shelf registration statement previously filed and declared effective by the Securities and Exchange Commission (SEC). A final prospectus supplement relating to this offering will be filed with the SEC. The offering may be made only by means of a prospectus supplement and accompanying prospectus. When available, copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained from: SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 800-808-7525, ext. 6105 or by email at [email protected]. Electronic copies of the final prospectus supplement and accompanying prospectus will also be available on the website of the SEC at www.sec.gov.

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 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 April 7, 2021 BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) reported that the company will present at the 20th Annual Needham Virtual Healthcare Conference on Wednesday, April 14, 2021 at 8:45 a.m. ET (Press release, BioCryst Pharmaceuticals, APR 7, 2021, View Source [SID1234577660]).

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Links to a live audio webcast and replay of this presentation may be accessed in the Investors section of BioCryst’s website at http://www.biocryst.com.