On January 11, 2021 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage biotechnology company focused on discovering and developing novel small molecule drugs for the treatment of cancer and other life-threatening diseases, reported that preliminary safety and efficacy data from a trial evaluating the arginase inhibitor INCB001158, which is being developed by Incyte Pharmaceuticals, reported that it will be presented in a virtual poster session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Gastrointestinal Cancers Virtual Symposium taking place January 15-17, 2021 (Press release, Calithera Biosciences, JAN 11, 2021, View Source [SID1234573819]).

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Presentation details:

Date: Available starting on Friday, January 15 at 5:00 a.m. Pacific Time

Title: A phase I/II study of safety and efficacy of the arginase inhibitor INCB001158 plus chemotherapy in patients with advanced biliary tract cancers

Lead Author: Milind Javle, M.D., University of Texas MD Anderson Cancer Center

Poster Session: Hepatobiliary Cancer, Abstract 311

Additional meeting information and accepted abstracts can be found at the ASCO (Free ASCO Whitepaper) website www.asco.org.

On January 11, 2021 Acorda Therapeutics, Inc. (NASDAQ: ACOR) reported that Ron Cohen, M.D., President and Chief Executive Officer, will present during the January 11th -14th H.C. Wainwright BIOCONNECT Virtual Conference (Press release, Acorda Therapeutics, JAN 11, 2021, View Source [SID1234573818]). An audio webcast of the presentation can be accessed under "Investor Events" in the Investor section of the Acorda website at www.acorda.com.

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For more information about the conference, please visit the event website at www.hcwevents.com/bioconnect.

On January 11, 2021 Harpoon Therapeutics, Inc. (Nasdaq: HARP) reported the closing of its underwritten public offering of 6,764,704 shares of its common stock, which includes 882,352 shares sold upon the underwriters’ full exercise of their option to purchase additional shares, resulting in aggregate gross proceeds of approximately $115.0 million, before deducting underwriting discounts and commissions and offering expenses payable by Harpoon Therapeutics (Press release, Harpoon Therapeutics, JAN 11, 2021, View Source [SID1234573817]).

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SVB Leerink and Piper Sandler acted as joint bookrunning managers for the offering. Baird and Truist Securities acted as co-lead managers for the offering. Roth Capital Partners acted as co-manager for the offering.

The shares of common stock were offered pursuant to a "shelf" registration statement previously filed with and declared effective by the Securities and Exchange Commission (SEC). The offering is being made only by means of a prospectus supplement and accompanying prospectus, copies of which 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. 6132 or by email at [email protected] or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924 or by email at [email protected].

This press release shall not constitute an offer to sell, or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state 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 or jurisdiction. Any offer, if at all, will be made only by means of a prospectus supplement and accompanying prospectus, which are a part of the effective registration statement.

On January 11, 2021 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for population sequencing and cancer, reported unaudited preliminary revenue for the fourth quarter and full year ended December 31, 2020 (Press release, Personalis, JAN 11, 2021, View Source [SID1234573816]).

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Personalis estimates revenue of approximately $20.2 million for the fourth quarter of 2020 compared with $18.2 million in the fourth quarter of 2019, representing an increase of 11%. For the full year 2020, revenue is estimated to be approximately $78.6 million compared with $65.2 million for 2019, representing an increase of 21%.

Fourth Quarter Highlights

Preliminary revenue from biopharma and all other customers of an estimated $7.6 million in the fourth quarter of 2020 compared with $4.4 million in the fourth quarter of 2019, a 73% increase
Preliminary revenue from the U.S. Department of Veterans Affairs Million Veterans Program (VA MVP) of an estimated $12.6 million in the fourth quarter of 2020 compared with $13.8 million in the fourth quarter of 2019, a decrease of 9%
Preliminary cash, cash equivalents, and short-term investments were estimated to be $203 million as of December 31, 2020
A total of 45 customers have placed orders for NeXT as of December 31, 2020, with 6 of those customers placing their first orders in the fourth quarter of 2020
Achieved milestone of completing more than 100,000 whole human genomes sequenced under the VA MVP contract
Launch of SHERPA and NEOPS (neoantigen prediction capability) in the fourth quarter of 2020
"I’m proud to say that we were able to report record revenue once again this quarter and achieved our first $20 million revenue quarter, despite the impact from the COVID-19 pandemic. Biopharma revenue was strong and customer orders were once again above revenue reported," said John West, Chief Executive Officer. "In addition, we have several customers that have placed orders for our liquid biopsy offering, which we expect will be an important driver of growth in the future."

The above information is preliminary and subject to Personalis’ normal quarter and year-end accounting procedures and external audit by the company’s independent registered public accounting firm.

Webcast and Conference Call Information

Personalis will issue a press release with final financial results and host a conference call to discuss the fourth quarter and full year 2020 financial results after market close on Thursday, February 25, 2021 at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. The conference call can be accessed live over the phone by dialing (866) 220-8061 for U.S. callers or (470) 495-9168 for international callers, using the conference ID: 5065084. The live webinar can be accessed at View Source

On January 11, 2021 Novartis reporrted that it has signed a strategic collaboration agreement to in-license tislelizumab from BeiGene, Ltd. in major markets outside of China, accelerating the potential for Novartis to enter the large and growing checkpoint inhibitor field (Press release, Novartis, JAN 11, 2021, View Source [SID1234573815]). Tislelizumab is an 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.

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Under the terms of the agreement, Novartis will obtain the development and commercialization rights to tislelizumab in the United States, Canada, Mexico, the European Union, United Kingdom, Norway, Switzerland, Iceland, Liechtenstein, Russia, and Japan in exchange for an upfront payment of USD 650 million plus royalties and milestone payments. BeiGene will retain the rights to tislelizumab in China and other countries. The transaction has been approved by the Boards of Directors of both companies.

More than 7,700 patients have been enrolled in 15 potentially registration-enabling clinical trials with tislelizumab in a dozen indications, including non-small cell lung cancer (NSCLC), hepatocellular carcinoma (HCC), esophageal squamous cell carcinoma, gastric cancer and nasopharyngeal carcinoma. The first ex-China regulatory filing is expected in 2021. In addition, Novartis and BeiGene have identified multiple tislelizumab plus Novartis therapy combination clinical trial opportunities in solid tumors.

"Novartis has a bold ambition to reimagine medicine and find new cures for cancer and blood disorders. This agreement expands on our strategy as the only company pursuing four different approaches to treating cancer: targeted therapy, radioligand therapy, cell and gene therapy, and immunotherapy. No other company has this range of therapeutic approaches, and the opportunity to combine them to offer the best outcomes for each patient," said Susanne Schaffert, PhD, President, Novartis Oncology. "We are excited about collaborating with BeiGene, a leading global biotechnology company with roots in China, to bring tislelizumab to patients around the world, and pair it with our extensive portfolio and pipeline to develop transformative combination therapies for patients."

Tislelizumab is approved by the China National Medical Products Administration (NMPA) as a treatment for certain patients with classical Hodgkin’s lymphoma and metastatic urothelial carcinoma. In addition, BeiGene has filed three supplemental new drug applications for tislelizumab in China for first-line treatment of patients with advanced squamous NSCLC in combination with chemotherapy, first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy, and previously treated unresectable HCC.

Closing of the transaction is subject to expiration or early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.