Apexian Pharmaceuticals preclinical studies with APX3330 shuts down inflammatory signaling in leukemia

On December 19, 2018 An obscure sliver of RNA with a grim-sounding name is unexpectedly taking center stage as a linchpin in transforming pre-leukemic cells into full-blown leukemia (Press release, Apexian Pharmaceuticals, DEC 19, 2018, View Source [SID1234532135]). Apexian Pharmaceuticals’ reported that latest studies in collaboration with Indiana University’s Simon Cancer Center investigator Dr. Reuben Kapur show promise for halting that transformation.

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These results, published December 6, 2018, in Cell Stem Cell, explain how a long noncoding RNA called Morrbid becomes hyperactivated after an acute inflammatory insult. Morrbid’s overzealous signaling functionally alters the bone marrow’s myeloid cells (precursors to white blood cells) when those cells are deficient in a tumor-suppressor gene called TET2. The cells mature rapidly, increase in absolute numbers, become resistant to programmed cell death, and churn out high levels of inflammatory proteins in a sustained, self-perpetuating response.

Inflammation has long been suspected of contributing to cancer, but these results establish a causative link. Dr. Kapur’s and Apexian’s results also support others’ findings that Morrbid controls myeloid cell lifespan.

Using a mouse model that mimics human acute myeloid leukemia, Dr. Kapur and Apexian’s Chief Science Officer, Mark Kelley, PhD demonstrated that Apexian’s flagship compound APX3330 could reduce Morrbid’s activity. Blocking both the precancerous cells’ growth and the cells’ production of inflammatory proteins.

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

"Our ongoing pre-clinical research continues to identify the role that APX3330 plays in impacting disease including hematological disorders, said Dr. Mark Kelley, Chief Scientific Officer. "Inflammation plays a critical role in the growth and survival of blood stem cells with pre-leukemia mutations such as TET2 and increases the risk of blood related cancers. APX3330 blocked this change from pre-leukemia to leukemia in the mouse models

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.