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BJ Bioscience Announces First Patient Dosed in FIH Trial of BJ-001 in Patients with Locally Advanced/Metastatic Solid Tumors

On December 9, 2019 BJ Bioscience Inc. (the ‘company’) reported that the first patient was successfully dosed on December 4, 2019 in the first-in-human (FIH) trial of the company’s BJ-001 program at NEXT ONCOLOGY in San Antonio, Texas (Press release, BJ Bioscience, DEC 9, 2019, View Source [SID1234552188]).

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"We were so excited to learn the successful dosing of the first patient for our BJ-001 program. It marked a significant milestone for BJ Bioscience and for the BJ-001 program. With its tumor targeting property, BJ -001 is expected to benefit many cancer patients with integrin overexpression. The successful dosing of the first patient is a small but key step of testing this promising investigational drug," said Joe Zhang, MD. Ph.D., DABT, the co-founder and CEO of BJ Bioscience. "With strong support from our investor, we will soon initiate trials in China to speed up the development of this drug candidate globally."

The ongoing first-in-human study is an open-label, Phase 1a trial in locally advanced/metastatic or relapsed/refractory solid tumors utilizes an accelerated dose escalation design followed by a traditional 3+3 dose escalation algorithm to assess the safety and tolerability of BJ-001, to identify the MTD, and/or and RP2D of BJ-001 as a single agent and in combination with an anti-PD-1 antibody.

"We achieved this milestone with approximately 3 months after we received the ‘green light’ from the FDA. More proudly, we achieved FPI milestone with 3 days after the site was activated. It is exceptional based on my past experience in multinational pharmaceutical companies," commented Grace Yu, MD., VP of Clinical Development at BJ Bioscience. "It is a great example of successful team work. The team had been working diligently for this milestone. Thanks go to our colleagues at Next Oncology as well as the patient. We cannot achieve this milestone without the hard work and collaboration of each of the members."

"As of 08 Dec 2019, the patient has been completed C1D5. No CRS and no other adverse events have been observed." said Dr. Raghad Abdul Karim, Medical Oncologist, Hematologist, Principle Investigator of BJ-001-01-001US study, NEXT Oncology.

About BJ-001

BJ-001 is the first tumor targeting IL-15 fusion protein in the world. It is designed to target cancer cells that overexpress integrins such as αvβ3, αvβ5, and αvβ6 by its tumor targeting motif and to stimulate anti-cancer immunity by its IL-15 motif. Such design has a potent to increase anti-cancer effects and reduce systemic toxicity by localizing IL-15’s effects in tumor microenvironment. Many cancer types such as NSCLC, stomach cancer, and pancreatic cancer have been shown to overexpress integrin.

Corporate Presentation furnished by SpringWorks Therapeutics, Inc.

On December 9, 2019 SpringWorks Therapeutics presented the corporate presentation (Presentation, SpringWorks Therapeutics, DEC 9, 2019, View Source [SID1234552182]).

Aurinia Prices US$166.7 Million Public Offering of Common Shares

On December 9, 2019 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 11,115,165 common shares (the "Offering") (Press release, Aurinia Pharmaceuticals, DEC 9, 2019, View Source [SID1234552178]). 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$166.7 million, before deducting underwriting discounts and commissions and other estimated offering expenses. All of the shares are being offered by the Company. The Offering is expected to close on or about December 12, 2019, subject to the satisfaction of customary closing conditions.

Jefferies LLC and SVB Leerink LLC are acting as joint book-running managers for the Offering. H.C. Wainwright & Co. LLC, Oppenheimer & Co. Inc., and Bloom Burton Securities Inc. 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 1,667,274 additional shares, for a period of up to 30 days.

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

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 March 29, 2018 (the "Registration Statement"), and the Company’s existing Canadian short form base shelf prospectus (the "Base Shelf Prospectus") dated March 26, 2018. 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 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. 6132, or by email at [email protected].

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.

Horizon Therapeutics plc to Present at the 38th Annual J.P. Morgan Healthcare Conference

On December 9, 2019 Horizon Therapeutics plc (Nasdaq: HZNP) reported that the Company will participate in the 38th Annual J.P. Morgan Healthcare Conference (Press release, Horizon Therapeutics, DEC 9, 2019, View Source [SID1234552172]). Timothy Walbert, chairman, president and chief executive officer will present at 5 p.m. PT on Jan. 15, 2020.

The conference presentation will be webcast live and may be accessed by visiting Horizon’s website at View Source A replay of the webcast will be available for the event.

Advaite Inc. Enters into Exclusive License Option Agreement with the George Washington University for Novel AMES Negative HDAC6 Inhibitor Technology

On December 9, 2019 Advaite Inc., a Chicago, IL based oncology-focused biotech company developing novel therapeutics and diagnostics to help patients suffering from debilitating diseases, has reported that it has entered into an exclusive license option agreement with the George Washington University with respect to the intellectual property of a novel AMES Negative HDAC6 inhibitor (Press release, Advaite, DEC 9, 2019, View Source [SID1234552171]). Histone Deacetylases modulate a multitude of cellular processes and are part of the regulation of cellular pathways involved in anti-tumor immunologic responses. Selective inhibition of HDAC6 slows tumor growth in various cancer models. Under terms of this agreement, Advaite has the option to exclusively license intellectual property covering methods of use and pharmaceutical compositions.

"We look forward to future success by advancing the development of this novel HDAC6 inhibitor to treat a multitude of cancers, to ease suffering and extend life. This epigenetic regulator can have a potentially enormous therapeutic effect on patients who continue to suffer from debilitating cancer, as there is a great need for therapies that deliver an effective response, and specifically ones which are not limited by their toxicity profile. George Washington University’s expertise with HDACs provide a perfect relationship for Advaite to advance truly viable, state of the art, impactful technology," said Karthik Musunuri, CEO & Co-Founder of Advaite.

"The quest for newer and more effective ways of treating cancer has now led to an extensive focus on the involvement of the immune system and its capacity to recognize and engage tumor cells. Recent findings from several research groups have demonstrated that ultra-selective HDAC6 inhibitors have the unique capacity of remodeling of the cellular composition of tumors, favoring the recognition and killing of cancer cells by the immune system. Our novel HDAC6 inhibitor has shown to have reduced toxic effects, thus clearly differentiating from previous HDAC inhibitors used in the clinic," said Alejandro Villagra, Ph.D., Member of the Immunology and Microbial Oncology Research Program at the GW Cancer Center and Assistant Professor of Biochemistry and Molecular Medicine at the GW School of Medicine and Health Sciences.