On December 12, 2018 Apexian Pharmaceuticals reported is shedding light on the question of how pre-leukemic cells transform into full-blown leukemia (Press release, Apexian Pharmaceuticals, DEC 12, 2018, View Source [SID1234532134]).

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Genetic mutations by themselves are rarely enough to flip the switch. Inflammation also plays a role. But, until now, the question of "how" remained unanswered.

Apexian Chief Science Officer Mark Kelley, PhD, and his colleagues presented their findings at the American Society of Hematology (ASH) (Free ASH Whitepaper)’s December 1, 2018 meeting in San Diego, California. When a putative tumor-suppressor gene called TET2 does not function well, acute inflammation or infection can enhance the production of myeloid stem and progenitor cells in the bone marrow that are precursors to circulating mature myeloid cells. The TET2 loss of function amplifies; inflammatory proteins increase, and myeloid cells rapidly mature, increasing in sheer numbers as well as developing resistance to programmed cell death.

Myeloid cells, which contribute to immunity, are normally very short-lived. However, when those cells live too long or become too numerous, dangerous levels of inflammation can result. Using a mouse model, Kelley and his colleagues demonstrated that Apexian’s flagship compound APX3330 can prevent precancerous cells from proliferating and block cells from making inflammatory proteins.

Such anti-inflammatory therapy could be of clinical value in people carrying TET2 mutations.

"Apexian continues to develop a robust portfolio of APE1/Ref-1 compounds that have broad utility in oncology, hematology and other diseases", says Steve Carchedi, President and CEO. "We are excited by the recent scientific findings and continue to expand our research and development beyond solid tumors"

APX3330 also has clinical utility with solid tumors. A Phase 1 trial for patients with advanced solid tumors is concluding.

On December 12, 2018 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, reported that it has commenced an underwritten public offering of its common shares (Press release, VBI Vaccines, DEC 12, 2018, View Source [SID1234532101]). VBI also intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the number of common shares offered in the public offering. The offering is subject to market and other 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.

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BMO Capital Markets, Canaccord Genuity LLC, and Oppenheimer & Co. Inc. are acting as joint book-runners for the underwritten public offering.

VBI intends to use the net proceeds from the offering to progress its research and development programs, which include, among other things, funding the continued clinical development of Sci-B-Vac, including the ongoing Phase 3 clinical program in the United States, Europe and Canada; the Phase 1/2a clinical study of the therapeutic vaccine candidate, VBI-1901, for glioblastoma (GBM); the prophylactic vaccine candidate, VBI-1501, for cytomegalovirus (CMV); and the immuno-therapeutic candidate, VBI-2601, for hepatitis B. The net proceeds will also be used for general corporate purposes, including working capital and capital expenditures.

A shelf registration statement relating to the common shares was previously filed with the Securities and Exchange Commission (the "SEC") and declared effective on June 8, 2017. A preliminary prospectus supplement and accompanying prospectus relating to the underwritten public offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement (when available) and accompanying prospectus may be obtained from BMO Capital Markets Corp., Attention: Equity Syndicate Department, 3 Times Square, 25th Floor, New York, NY 10036 or by e-mail at [email protected], or from Canaccord Genuity LLC, Attention: Equity Syndicate Department 99 High Street, 12th Floor, Boston, MA 02110 or by e-mail at [email protected], or from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY 10004 or by e-mail at [email protected].

This press release shall not constitute an offer to sell or the 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. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement.

The securities will not be offered or sold, directly or indirectly, in Canada or to any resident of Canada.

On December 12, 2018 Idera Pharmaceuticals, Inc. (NASDAQ: IDRA), a clinical-stage biopharmaceutical company focused on the development and ultimate commercialization of drug candidates for both oncology and rare disease indications characterized by small, well-defined patient populations with serious unmet needs, reported that it plans to release an update on clinical data from the ongoing Phase 2 trial of the combination of intratumoral tilsotolimod and ipilimumab for unresectable or metastatic melanoma following failure of anti-PD-1 inhibitor treatment prior to the opening of the U.S. financial markets on Friday, December 14, 2018 (Press release, Idera Pharmaceuticals, DEC 12, 2018, View Source [SID1234532053]).

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The company will host a conference call and live webcast, Friday, December 14 at 10:00 A.M. EST to review the data being presented along with a questions and answers session.

Investor Webcast Details
To participate in the conference call, please dial (844) 882-7837 (domestic) and (574) 990-9824 (international). The webcast can be accessed live or in archived form in the "Investors" section of the company’s website at www.iderapharma.com. The company will be posting a slide presentation to the Idera corporate website in the "Investors" section which will be referenced during the conference call.

Live audio webcast of Idera’s presentations will be accessible in the Investors and Media section of Idera’s website at View Source Archived versions will also be available on the Company’s website after the event for 90 days.

On December 12, 2018 Zai Lab Limited (NASDAQ: ZLAB), a Shanghai-based innovative commercial stage biopharmaceutical company, reported that the China National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for ZEJULA (niraparib, or ZL-2306) as a Category 1 drug for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal ovarian cancer who are in a complete or partial response to platinum-based chemotherapy (Press release, Zai Laboratory, DEC 12, 2018, View Source [SID1234532051]). ZEJULA is a potent and highly selective PARP1/2 inhibitor that does not require BRCA mutation or other biomarker testing prior to administration.

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"The NMPA’s acceptance of our NDA submission for ZEJULA represents a major milestone for Zai Lab as this is our first ever NDA submission in Mainland China," said Dr. Samantha Du, Founder and Chief Executive Officer of Zai Lab. "ZEJULA will offer an important, new treatment option to more than 50,000 Chinese patients who suffer from ovarian cancer every year and we are grateful that NMPA recognizes this critical medical need and the promise of ZEJULA. Zai is a leader in the field of innovative oncology treatments in China and we have a deep and highly-differentiated pipeline, including three U.S. FDA-approved products and four other assets in late stage clinical development. As a result, we expect additional regulatory submissions in the coming years as we continue to advance our pipeline."

Dr. Yong-Jiang Hei, Chief Medical Officer for Oncology of Zai Lab said, "We believe ZEJULA is a best-in-class PARP inhibitor due to its compelling efficacy, once-daily dosing and superior pharmacokinetic properties including its ability to cross the blood brain barrier. The NDA submission based on the Category 1 designation of ZEJULA is a result of China-based clinical trials and manufacturing conducted by Zai Lab. We plan to expand our development efforts in collaboration with our partner Tesaro across several additional indications including, but not limited to, first-line maintenance treatment of ovarian cancer, lung cancer and gastric cancer."

William Liang, Chief Commercial Officer noted, "The Zai Lab commercial team is very excited about the attractive profile of ZEJULA and plans to leverage ZEJULA’s recent Hong Kong approval and commercial launch to prepare for the launch in China. If approved, we believe ZEJULA will provide a differentiated treatment option to benefit more ovarian cancer patients. We also intend to closely collaborate with local authorities and NGOs to develop patient assistant programs to increase access to more women who could benefit from this treatment. Zai Lab is committed to making a meaningful impact on the way cancer is treated in China and will continue to develop and bring new innovative oncology treatment options to patients in need."

About Ovarian Cancer

Ovarian cancer is one of the most common gynecologic cancers in China with approximately 51,000 newly diagnosed cases and 23,000 deaths in China in 2014. The 5-year overall survival rate of ovarian cancer patients is 46% across all stages, but only 29% in patients are diagnosed with distant metastatic disease. While platinum-based chemotherapy is effective at inducing an initial response in ovarian cancer, the disease will recur in the majority of women. Effective treatment options for patients with platinum-sensitive recurrent ovarian cancer remain limited. New agents that prolong the duration of response following platinum-based treatment and delay the inevitable relapse of ovarian cancer will benefit patients with ovarian cancer in China.

About ZEJULA

ZEJULA (niraparib, ZL-2306) is a highly potent and selective oral, once-daily small molecule poly (ADP-ribose) PARP 1/2inhibitor. It was approved in March 2017 by the FDA in the United States and in November 2017 by the EMA in the European Union under the trade name ZEJULA 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 United States and European Union by our partner, Tesaro, Zai Lab has obtained the approval for marketing ZEJULA in Hong Kong in October 2018.

On December 12, 2018 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company discovering and developing innovative immuno-oncology protein therapeutics, reported that Aron Knickerbocker, Chief Executive Officer, will present at the 37th Annual J.P. Morgan Healthcare Conference, Wednesday, January 9, 2019 at 2:00 pm PT (Press release, Five Prime Therapeutics, DEC 12, 2018, View Source [SID1234532039]).

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The presentation will be webcast and may be accessed at the "Events & Presentations" section of the Company’s website at View Source Five Prime will maintain an archived replay of the webcast on its website for 30 days after the conference.