On September 26, 2018 ai Lab Limited (NASDAQ:ZLAB), a Shanghai-based innovative biopharmaceutical company, presented results of its open-label study to evaluate the pharmacokinetic (PK) profile of ZL-2306 (niraparib) made in China in Chinese ovarian cancer patients (Press release, Zai Laboratory, SEP 26, 2018, View Source;p=RssLanding&cat=news&id=2368996 [SID1234530330]). Results from the study show comparable PK profile of the Chinese patients administered ZL-2306 to that of patients evaluated in Tesaro’s global PK study. These data were presented at the 21st Annual Meeting of the Chinese Society of Clinical Oncology (CSCO) on Sept. 21, 2018, at the Xiamen International Conference and Exhibition Center (XICEC) in Xiamen, China.

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The open-label PK Study enrolled 36 Chinese patients with stage III or IV epithelial ovarian, fallopian tube or primary peritoneal cancer. Patients had received no more than two lines of platinum-based therapy and were responsive to the most recent platinum-based treatment. Subjects were randomly assigned to dose levels of 100mg, 200mg and 300mg. The primary objective of the study was to assess the PK profile of ZL-2306 in Chinese patients following both single and multiple doses. The secondary objective was a safety assessment.

The study demonstrated that the drug exposure increased proportionally from 100mg to 300mg, with a Tmax of approximately three hours. Systemic exposure of ZL-2306, as measured by Cmax and AUC, increased approximately proportionally with increased dose. The half-life is 31-37 hrs. There were no unexpected safety issues noted during the trial. All key PK and safety parameters were comparable to those in global studies. The study results and population PK data did not identify ethnicity differences between Chinese and non-Chinese patients.

The positive outcome of this PK study will further enhance ZL-2306 application package in China.

About ZL-2306

ZL-2306 (niraparib) is a highly potent and selective oral, once-daily small molecule poly (ADP-ribose) PARP 1/2 inhibitor. Niraparib was approved in March 2017 by the FDA in the U.S. and by the EMA in the EU under the trade name ZEJULA in November 2017 as a maintenance treatment for women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Based on the approval status in the U.S. and EU, Zai Lab submitted a market registration application for niraparib in Hong Kong and plans to launch and commercialize niraparib in Hong Kong in the second half of 2018. Zai Lab believes ZL-2306 has the potential to be a first-in-class Category 1 drug for treatment across multiple solid tumor types in China.

On September 26, 2018 Avelas Biosciences, Inc., a clinical stage oncology-focused platform technology company that is developing products to advance a new standard-of-care for cancer surgery and therapeutic intervention, reported that Ms. Kyri Van Hoose, Head of Finance, will present at the 2018 Cantor Global Healthcare Conference on Wednesday, October 3, 2018, at 8:35 a.m. EDT (5:35 a.m. PDT) in New York City (Press release, Avelas Biosciences, SEP 26, 2018, View Source [SID1234530225]).

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On September 26, 2018 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, reported that Emil D. Kakkis, M.D., Ph.D., the company’s Chief Executive Officer, will present at the Jefferies Gene Therapy Summit on Thursday, September 27, 2018 at 8:00am ET in New York (Press release, Ultragenyx Pharmaceutical, SEP 26, 2018, View Source [SID1234530054]).

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The live and archived webcast of the company presentation will be accessible from the company’s website at View Source The replay of the webcast will be available for 90 days.

On September 26, 2018 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported that it will be presenting at Cantor Fitzgerald’s Global Healthcare Conference on Wednesday, October 3, 2018, at 5:10 p.m. ET at the Intercontinental New York Barclay Hotel in New York, NY (Press release, Infinity Pharmaceuticals, SEP 26, 2018, View Source [SID1234529883]). A live webcast of the presentation will be available on the Investors/Media section of Infinity’s website at www.infi.com, and will be available for 30 days following the event.

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On September 26, 2018 AnaptysBio, Inc. (NASDAQ: ANAB), a clinical stage biotechnology company developing first-in-class antibody product candidates focused on unmet medical needs in inflammation, reported the pricing of its underwritten public offering of 2,200,000 shares of common stock at a public offering price of $94.46 per share. In addition, AnaptysBio has granted the underwriters a 30-day option to purchase up to an additional 330,000 shares of its common stock at the public offering price less the underwriting discounts and commissions (Press release, AnaptysBio, SEP 26, 2018, View Source [SID1234529739]). All of the shares are being offered by AnaptysBio. The offering is expected to close on or about September 28, 2018 subject to customary closing conditions.

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Gross proceeds to AnaptysBio from the offering are expected to be approximately $207.8 million, excluding any exercise of the underwriters’ option to purchase additional shares. AnaptysBio intends to use the net proceeds from this offering to fund research and development activities for its clinical development programs, including, but not limited to, its ongoing and planned clinical trials for etokimab and ANB019, including related manufacturing costs, its ongoing preclinical, discovery and research programs, and for working capital and other general corporate purposes.

Credit Suisse, J.P. Morgan and Jefferies are acting as joint book-running managers for the offering. Cantor, Guggenheim Securities and Wedbush PacGrow are acting as co-managers.

The public offering is being made pursuant to a shelf registration statement on Form S-3 that was filed by AnaptysBio with the Securities and Exchange Commission ("SEC") and became automatically effective on February 5, 2018. A final prospectus supplement and accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the final prospectus supplement and the accompanying prospectus may be obtained from Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, One Madison Avenue, New York, NY 10010, or by telephone at (800) 221-1037, or by email at [email protected]; J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; or Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by email at [email protected], or by phone at (877) 821-7388.

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 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.