Aurinia to Present at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco

On December 19, 2018 Aurinia Pharmaceuticals Inc., (NASDAQ:AUPH)(TSX:AUP) reported its Chairman and Chief Executive Officer, Richard M. Glickman, will present a company overview at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco, CA on Thursday, January 10, 2019 at 10:00am PST, 1pm EST (Press release, Aurinia Pharmaceuticals, DEC 19, 2018, View Source [SID1234532132]).

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The presentation will be webcast live and can be accessed via the investor section of the Aurinia website, www.auriniapharma.com. A replay of will also be archived on the site following the event.

Immedica gains the right to anti-tumor agent Yondelis®in the United Kingdom

On December 18, 2018 Immedica is reported that from 1 September 2018, it has become the exclusive distributor for the innovative anti-cancer drug Yondelis in the United Kingdom (Press release, Immedica Pharma, DEC 18, 2018, View Source [SID1234555253]). Yondelis is an established treatment for patients suffering from soft tissue sarcomas (STS) and platinum sensitive ovarian cancer. "I believe Immedica will fill an important role as a facilitator for making Yondelis available for patients in the United Kingdom", says Anders Edvell, CEO of Immedica.

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About YONDELIS (trabectedin)
YONDELIS (trabectedin) is a multimodal, synthetically produced antitumor agent, originally derived from the sea squirt, Ecteinascidia turbinata. The drug exerts its activity by targeting the transcriptional machinery and impairing DNA repair. It is approved in close to 80 countries in North America, Europe, South America and Asia for the treatment of advanced soft tissue sarcomas as a single-agent and for relapsed ovarian cancer in combination with DOXIL/CAELYX (doxorubicin HCl liposome injection) in the European Union. Under a licensing agreement with PharmaMar, Janssen Products, L.P. has the rights to develop and sell YONDELIS globally except in Europe, where PharmaMar holds the rights, and in Japan, where PharmaMar has granted a license to Taiho Pharmaceuticals.

Erasca Launches with $42 Million Series A Financing to Support Bold Mission of Erasing Cancer

On December 18, 2018 Erasca, a company dedicated to advancing exceptional scientific approaches to erase cancer, reported that it has completed a $42 million Series A financing round co-led by founding investors City Hill Ventures and Cormorant Asset Management, joined by additional institutional and individual investors (Press release, Erasca, DEC 18, 2018, View Source [SID1234534176]). Proceeds of the financing will support development of a new generation of oncology drugs intended to not just treat, but actually cure cancer.

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"Cancer is a pervasive disease that has impacted nearly everyone I know in some way. Individuals continue to be seriously afflicted and in need of healing beyond what can be provided by available treatments," said Jonathan E. Lim, M.D., Erasca’s executive chairman and co-founder. "Erasca was borne out of a mission to address this significant patient need and, one day, erase cancer. We recognize that this is an ambitious goal, as cancer is a formidable foe. But no mission worth taking is ever easy."

Erasca has multiple discovery programs underway for undisclosed targets that are biological drivers of cancer. The company anticipates it will disclose more about these programs as it moves into human clinical studies. Erasca is also pursuing additional opportunities for pipeline expansion through academic and biopharmaceutical collaborations.

"Founded on exciting new discoveries around key molecular drivers of cancer, and having assembled a team of executives with a legacy of multiple prior successes, Erasca is the company that stands an excellent chance of deftly overcoming multiple obstacles along this exciting, yet long, journey of bringing a breakthrough medicine to patients," said Bihua Chen, Portfolio Manager, Cormorant Asset Management. "Tackling a mission this large requires a combination of passion for the patient and strong business acumen. Jonathan’s background as a physician and biotech company leader who has led multiple successful companies, along with the outstanding team he has assembled, position Erasca well in executing on its mission."

Since 2003, the serial venturepreneur has been a leader and founding investor of four other biotechnology startups that delivered novel therapies for the benefit of patients globally, raised a combined $1 billion in capital and generated more than $4 billion of shareholder value. Dr. Lim’s most recent operational role was as chairman, president, CEO and co-founder of Ignyta, acquired by Roche in February 2018 for $1.7 billion. He has co-founded, funded and led several other successful ventures, including Bonti (acquired by Allergan), Eclipse Therapeutics (acquired by Bionomics) and Halozyme Therapeutics. He also is dedicated to building world-class, mission-driven ventures as managing partner for City Hill Ventures, an impact-minded investment firm he founded in December 2010, and as Venture Partner at ARCH Venture Partners, one of the largest seed and early stage technology venture firms in the U.S. Dr. Lim’s full bio can be accessed here.

Joining Dr. Lim on Erasca’s founding leadership team are business and finance veteran, Gary Yeung, CFA, who serves as the company’s Chief Business Officer, and highly regarded computational biologist, Robert Shoemaker, Ph.D., who is Vice President of Biology.

VBI Vaccines Announces Closing of Public Offering of Common Stock and Partial Exercise of Underwriter’s Option to Purchase Additional Shares for Aggregate Gross Proceeds of $42.9 Million

On December 18, 2018 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, reported the closing of its previously announced underwritten public offering of 26,800,000 common shares at a public offering price of US$1.40 per share, and the partial exercise by the underwriters of their option to purchase an additional 4,020,000 common shares, with 3,865,304 additional common shares purchased at US$1.40 per share (Press release, VBI Vaccines, DEC 18, 2018, View Source [SID1234532184]). As a result, the company has issued a total of 30,665,304 common shares in the offering and has received aggregate gross proceeds, before deducting the underwriting discounts and commissions and estimated offering expenses, of approximately US$42.9 million.

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Immediately following the closing of the underwritten public offering, the number of outstanding common shares of the company is 97,343,777.

BMO Capital Markets, Canaccord Genuity LLC, and Oppenheimer & Co. Inc. acted as joint book-runners for the underwritten public offering. National Securities Corporation acted as a financial advisor to VBI in connection with the 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 was filed with the SEC on December 12, 2018. A final prospectus supplement and accompanying prospectus relating to the offering was filed with the SEC on December 17, 2018, and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement 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.

Oncology Venture receives positive feed-back from the FDA on approval pathway for LiPlaCis and DRP in the US

On December 18, 2018 Oncology Venture A/S ("OV" or the Company) reported that the US Food and Drug Administration, FDA has responded positively on questions posed by the company in a Pre-IND/IDE package for the approval pathway for LiPlaCis and its companion diagnostic DRP – Drug Response Predictor – in metastatic breast cancer (Press release, Oncology Venture, DEC 18, 2018, View Source [SID1234532169]).

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The FDA agreed that the 505(b)(2) pathway is an acceptable registration route for LiPlaCis and that no further toxicology studies are needed. Based on current good data the number of patients to be treated is in line with previous guidance in the upcoming pivotal phase 3 trial of LiPlaCis and its DRPÒ for the treatment of patients with advanced breast cancer.
The FDA accepts objective response rate (ORR) as the primary endpoint but asked for further characterization of sub-groups in the breast cancer population aimed for treatment with LiPlaCis.
LiPlaCis is an intelligent, target controlled liposome formulation of one of the world’s most widely used chemotherapies, cisplatin. The specific LiPlaCis formulation allows delivery of LiPlaCis directly at tumor site. The specific LiPlaCis DRP selects the patients whom are expected to benefit from the treatment. LiPlaCis has shown very promising results in an ongoing phase 2 trial, a study that will continue as planned. Recruitment timelines of the pivotal phase 3 study will be updated following the FDA approval of the Investigational New Drug Application (IND) and the Investigational Device Exemption (IDE) expectedly in H1 2019.

"Oncology Venture in-licensed LiPlaCis as a phase 1 project in 2016. The 505(b)(2) strategy allows us to refer to data for a listed drug and will save us important time and resources. Our team has done a remarkable job by moving this project from an early stage to a late stage project in only two years. The discussions with the FDA gave no barrier for proceeding with our pivotal development plans for a fast route to commercialization and we can now increase our partnering activities with pharma," comments Peter Buhl Jensen, M.D., CEO of Oncology Venture.

Data from the ongoing Phase 2 LiPlaCis study in patients with metastatic breast cancer shows a
50% objective response rate (five out of ten patients) in the upper one third of DRP selected patients and a 24% objective response rate (6 out of 25 patients) in the upper two thirds of DRP selected patients. These data should be compared with historical response rates to the established cancer drugs in metastatic breast cancer with a 10-12% objective response rate of eribulin, vinorelbine and gemcitabine and 10% of conventional cisplatin.

If the ongoing phase 2 study will continue to show strong efficacy data, Oncology Venture aims for a Break through designation. This application is planned for filing shortly after the IND and its IDE application for LiPlaCis.

Oncology Venture’s regulatory strategy is to first obtain approval in the US. The aim is then to run randomized pivotal studies in Europe and Asia.