Cancer Genetics, Inc. Announces Pricing of $3.5 Million Public Offering of Common Stock

On January 28, 2019 Cancer Genetics, Inc. (Nasdaq: CGIX), a leader in enabling precision medicine for immuno-oncology and genomic medicine through molecular markers and diagnostics, reported the pricing of a public offering of 15,217,392 shares of its common stock, offered at a price to the public of $0.23 per share, for gross proceeds of approximately $3.5 million, before deducting placement agent fees and other offering expenses payable by Cancer Genetics (Press release, BioServe Biotechnologies, JAN 28, 2019, View Source [SID1234534253]). The offering is expected to close on or about January 31, 2019, subject to customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering. The offering is being conducted as a "best efforts" offering and the placement agent is not obligated to purchase any securities.

Cancer Genetics intends to use the net proceeds from this offering to pay any amounts required by its lenders, and if any proceeds remain available, to pay certain costs previously incurred in connection with its strategic initiatives and to fund working capital and other general corporate purposes.

A shelf registration statement on Form S-3 relating to the public offering of the shares of common stock described above was filed with the Securities and Exchange Commission ("SEC") and was declared effective on June 5, 2017. A preliminary prospectus supplement describing the terms of the offering has been filed with the SEC. The final terms of the offering will be disclosed in a final prospectus supplement and accompanying prospectus to be filed with the SEC. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, from H.C. Wainwright & Co., LLC, 430 Park Avenue 3rd Floor, New York, NY 10022, or by calling (646) 975-6996 or by emailing [email protected] or at the SEC’s website at View Source

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, 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. 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.

Cancer Genetics, Inc. Announces Proposed Public Offering of Common Stock

On January 28, 2019 Cancer Genetics, Inc. (Nasdaq: CGIX), a leader in enabling precision medicine for immuno-oncology and genomic medicine through molecular markers and diagnostics, reported that it intends to offer and sell, subject to market and other conditions, shares of its common stock in a public offering (Press release, Cancer Genetics, JAN 28, 2019, View Source [SID1234533045]). 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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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering. The offering is being conducted as a "best efforts" offering and the placement agent is not obligated to purchase any securities.

Cancer Genetics intends to use the net proceeds from this offering to pay any amounts we are required to pay to our lenders, and if any proceeds remain available, to pay certain costs previously incurred by us in connection with our strategic initiatives and to fund working capital and other general corporate purposes.

A shelf registration statement on Form S-3 relating to the public offering of the shares of common stock described above was filed with the Securities and Exchange Commission ("SEC") and was declared effective on June 5, 2017. A preliminary prospectus supplement describing the terms of the offering will be filed with the SEC and will form a part of the effective registration statement. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, from H.C. Wainwright & Co., LLC, 430 Park Avenue 3rd Floor, New York, NY 10022, or by calling (646) 975-6996 or by emailing [email protected] or at the SEC’s website at View Source The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, 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. 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.

Evelo Biosciences Announces Dosing of First Patient in Investigator-Sponsored Phase 2a Clinical Trial of EDP1503 in Combination with KEYTRUDA® in Patients with Metastatic Melanoma

On January 28, 2019 Evelo Biosciences, Inc. (Nasdaq: EVLO) ("Evelo"), a biotechnology company developing monoclonal microbials, a new modality of oral biologic medicines, reported that the University of Chicago has dosed the first patient in an investigator-sponsored Phase 2a clinical trial evaluating EDP1503 in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy (Press release, Evelo Biosciences, JAN 28, 2019, View Source [SID1234532941]). EDP1503 is an orally delivered monoclonal microbial product candidate being developed for the treatment of cancer.

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This open-label clinical trial, led by Dr. Jason J. Luke, M.D., FACP, will evaluate the safety, tolerability, and efficacy of EDP1503 in combination with KEYTRUDA in up to 70 patients with metastatic melanoma who are previously untreated or who have relapsed following treatment with an anti-PD-1 inhibitor. Evelo will provide and retain all rights to EDP1503.

Patients will receive daily EDP1503 monotherapy for two weeks followed by treatment with daily EDP1503 in combination with KEYTRUDA. The study will evaluate biomarkers identified from paired biopsies taken before and after the two-week run-in, as well as clinical outcomes observed over the course of the trial, and potential alterations to the intestinal microbiome. Evelo anticipates initial clinical data from the trial in the second half of 2020.

In preclinical studies orally delivered EDP1503 shows activation of multiple clinically validated systemic immune pathways which are complementary to and potentially synergistic with checkpoint inhibitors. Effects include increased CXCL9 and CXCL10 production in the tumor microenvironment, augmentation of NK and T cell infiltration to the tumor site as well as upregulation of MHC Class I expression in tumors.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Corvus Pharmaceuticals Announces Appointment of New Member of Board of Directors and Hiring of Chief Medical Officer

On January 28, 2019 Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of precisely targeted oncology therapies, reported the appointment of Linda S. Grais, M.D., J.D., to the Company’s Board of Directors and Mehrdad Mobasher, M.D., M.P.H., as Vice President and Chief Medical Officer, effective immediately (Press release, Corvus Pharmaceuticals, JAN 28, 2019, View Source [SID1234532933]).

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Dr. Grais has more than 20 years of experience with emerging companies in the biopharmaceutical industry. As a member of Corvus’ Board of Directors, she is replacing Peter Moldt, Ph.D., who has served as a director since January 2015 and resigned his position. Dr. Mobasher, a board-certified medical oncologist, joins Corvus from Genentech/Roche, where he spent more than eight years in hematology/oncology drug development, including holding the position of Venetoclax Global Development Team Leader and Global Clinical Leader. At Corvus, Dr. Mobasher will oversee the Company’s pipeline of precisely-targeted investigational oncology therapies.

"Dr. Grais is a highly-trained physician with extensive operational, clinical, business development and drug development experience in the biopharmaceutical industry," said Richard A. Miller, M.D., an oncologist and co-founder, president and chief executive officer of Corvus. "Her background is particularly relevant for Corvus as we continue to advance and expand our pipeline of therapies for patients with difficult-to-treat cancers. With her broad expertise, Dr. Grais will broaden the scope of talent on our Board and provide important insights and perspective. We also would like to thank Dr. Moldt for his many contributions to Corvus."

Dr. Miller added, "As Corvus continues to advance the clinical and preclinical development of our five proprietary product candidates with differentiated mechanisms of action across a range of hematologic malignancies and solid tumors, with some nearing late-stage clinical development, it is necessary to deepen our clinical and regulatory capabilities. Dr. Mobasher is ideally suited to be our chief medical officer given his training in hematology and oncology and his recent leadership role in the development and approval of venetoclax at Genentech. We are thrilled to add him to our executive team as we continue to evaluate our two most advanced investigational medicines, which target the adenosine pathway, in ongoing Phase 1/1b and Phase 1b/2 clinical trials, and expect to initiate a Phase 1/1b trial of our ITK inhibitor in lymphoma in the first quarter of 2019."

Dr. Grais currently serves on the Board of Directors of PRA Health Sciences, a large contract research organization, and also serves on its Audit Committee. She also is on the Board of Directors of ARCA biopharma and Zosano Pharma. Previously, Dr. Grais served as president and chief executive officer of Ocera Therapeutics, Inc., a biopharma company developing new treatments for serious liver disease, until its acquisition by Mallinckrodt. Prior to that, she served as a partner at InterWest Partners, a venture capital firm focused on biotechnology and medical device companies. Previously, Dr. Grais was a founder and executive vice president of Structural GenomiX, Inc., a drug discovery company focusing on new treatments for cancer that was acquired by Eli Lilly & Co. Earlier in her career, she was a corporate attorney at Wilson Sonsini Goodrich & Rosati, where she represented life science companies in venture financings, public offerings and strategic partnerships. Before practicing law, Dr. Grais worked as an assistant professor in the Department of Internal Medicine at the University of California, San Francisco. Dr. Grais received a B.A. in philosophy from Yale University, an M.D. from Yale Medical School, and a J.D. from Stanford Law School.

"I’m excited to join Corvus’ Board and look forward to collaborating with the other Board members and the talented leadership team," said Dr. Grais. "During my career in the life sciences industry, I’ve had numerous opportunities to help companies grow. I look forward to bringing my experience and expertise to Corvus to help it advance its pipeline of promising oncology therapies, which have the potential to improve the lives of patients with cancer."

Dr. Mobasher joined Genentech in 2010 and has held several positions of increasing responsibility. Most recently, he was a Group Medical Director and Venetoclax Development Lead, where he oversaw and led the strategy for the global development of venetoclax with several phase 1, 2, and 3 clinical trials in numerous hematologic cancers, as well as solid tumors. Dr. Mobasher led the clinical development efforts for venetoclax, a novel drug through four successful Breakthrough Therapy designations from the U.S. Food and Drug Administration (FDA) and three approvals granted under FDA’s priority review, two of which were under accelerated approval. Venetoclax is approved in more than 50 countries for the treatment of several types of hematologic malignancies. He also was an adjunct clinical faculty member in the Division of Medical Oncology at Stanford University. Dr. Mobasher is the author of numerous papers published in peer-reviewed medical journals, including The New England Journal of Medicine, Lancet Oncology and the Journal of Clinical Oncology, and multiple abstracts presented at medical conferences. He is a member of the American Society of Hematology (ASH) (Free ASH Whitepaper), the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), the American College of Physicians (ACP), and the American Public Health Association (APHA). Dr. Mobasher received an M.D. from Tehran University of Medical Sciences in Iran, and an M.P.H. in general epidemiology from the School of Public Health at the University of Michigan. He completed an internship and residency in internal medicine at the University of California, Irvine, Medical Center, and post-doctoral fellowships in hematology and medical oncology at Stanford University.

"I’m excited to take on the role of Chief Medical Officer for Corvus as it’s a rare opportunity to join a young company with such a deep and diverse pipeline of product candidates, strong research capability, and a team of talented and experienced executives with proven track records," said Dr. Mobasher. "Having worked in hematology/oncology drug development for nearly a decade, I’ve seen many different approaches, but I’m truly impressed by Corvus’ focus on developing medicines that precisely modulate molecular targets that are well-defined and measurable. I’m excited about the clinical data I’ve seen to date for Corvus’ lead investigational drugs, CPI-444 and CPI-006, and look forward to potentially bringing them to patients in need, while advancing our other pipeline products into the clinic."

CStone receives CTA approval in China to start Phase I trial for FGFR4 inhibitor BLU-554 (CS3008)

On January 28, 2019 CStone Pharmaceuticals (CStone) reported that the National Medical Products Administration (NMPA) recently approved the clinical trial application (CTA) to start a Phase I clinical trial in China for BLU-554 (CS3008), an inhibitor of fibroblast growth factor receptor 4 (FGFR4) discovered by the company’s partner Blueprint Medicines (Press release, CStone Pharmaceauticals, JAN 28, 2019, View Source [SID1234532931]). CStone has exclusive rights to develop and commercialize BLU-554 in Mainland China, Hong Kong, Macau and Taiwan.

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The trial is part of a global Phase I trial for BLU-554 in patients with advanced hepatocellular carcinoma (HCC) not previously treated with a tyrosine kinase inhibitor (TKI). The aim is to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of BLU-554 in this patient subset. CStone and Blueprint Medicines expect to enroll the first patient in the Phase I clinical trial in China soon.

HCC is the most common form of liver cancer. In China, HCC is the third most significant cause of cancer-related death, with approximately 466,000 new diagnoses and 422,000 deaths caused by the disease each year. It is estimated that approximately 30% of patients with HCC have tumors with aberrantly activated FGFR4 signaling. The majority of Chinese HCC patients (55%) are not diagnosed until the advanced stages of the disease. Currently, treatment options for advanced HCC patients remain limited.

BLU-554 is a potent and highly selective small-molecule inhibitor of FGFR4. Blueprint Medicines announced preliminary Phase I clinical data of BLU-554 at the European Society of Clinical Oncology (ESMO) (Free ESMO Whitepaper) 2017 Congress, as of a data cutoff date of August 18, 2017. In heavily pre-treated patients with FGFR4-driven HCC (n=38), the data showed an objective response in 6 patients (16%; 1 complete response and 1 partial response pending confirmation), while disease control was achieved by 26 patients (68%), and 18 patients (49%) had a reduced tumor burden. In 5 patients who had not previously received TKI therapy, preliminary evidence of prolonged disease control was observed. BLU-554 was well-tolerated and most adverse events reported by investigators were Grade 1 or 2.

Dr. Frank Jiang, CEO and chairman of CStone, commented: "Compared with current treatments, BLU-554 has produced encouraging data in terms of tolerability and disease control rates. We also plan to conduct a Phase I trial of BLU-554 in combination with CS1001 for the treatment of advanced HCC patients in China in the second half of 2019. Our hope is to make more effective treatment options available to HCC sufferers."

About BLU-554

BLU-554 is an oral, highly selective and irreversible inhibitor of FGFR4 developed by Blueprint Medicines, with a precise selectivity for FGFR4 that spares the paralog kinases FGFR1, FGFR2 and FGFR3. Blueprint Medicines is developing BLU-554 for the treatment of HCC caused by FGFR4 activation, estimated to account for approximately 30% of patients with HCC tumors. BLU-554 has been granted orphan drug status by the U.S. Food and Drug Administration.

In June 2018, CStone and Blueprint Medicines entered into a license and collaboration agreement in which Blueprint Medicines granted CStone exclusive rights to develop and commercialize BLU-554 in Greater China. Blueprint Medicines retains development and commercial rights for BLU-554 in the rest of the world.