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

On January 14, 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 closing and funding of its previously announced underwritten public offering of 13,333,334 shares of its common stock ("Common Stock") at a public offering price of $0.225 per share (Press release, BioServe Biotechnologies, JAN 14, 2019, View Source [SID1234532671]). The Company has also granted the underwriter an option for 45 days to purchase an additional 2,000,000 shares, at a price to the public of $0.225 per share. The Company’s Chairman, John Pappajohn; board director, Geoffrey Harris and President and Chief Executive Officer, John A. Roberts, each purchased shares in the offering. The gross proceeds from the offering, before deducting the underwriting discounts and commissions and estimated offering expenses are $3.0 million.

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H.C. Wainwright & Co. acted as the sole book-running manager for the offering.

Cancer Genetics intends to use the net proceeds from this offering to pay lender fees and other costs incurred in connection with the potential forbearance agreements Cancer Genetics is negotiating with its banks, to pay certain costs previously incurred in connection with its on-going strategic initiatives, and if any proceeds remain available, 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 prospectus supplement describing the terms of the offering was filed with the SEC on January 9, 2019, and is available on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained 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.

ASLAN PHARMACEUTICALS ANNOUNCES STUDY RESULTS FROM PHASE 2 STUDY OF VARLITINIB IN FIRST-LINE GASTRIC CANCER

On January 14, 2019 ASLAN Pharmaceuticals (NASDAQ:ASLN, TPEx:6497), a clinical-stage biopharmaceutical company targeting cancers that are both highly prevalent in Asia and orphan indications in the United States and Europe, reported an update on its global placebo-controlled, double-blind phase 2 clinical study of varlitinib as a first-line therapy in HER1/HER2 co-expressing advanced or metastatic gastric cancer patients, comparing varlitinib plus mFOLFOX6 to placebo plus mFOLFOX6 (Press release, ASLAN Pharmaceuticals, JAN 14, 2019, View Source [SID1234532652]). In the recently completed study, varlitinib did not meet the primary endpoint of significant reductions in tumour size after 12 weeks of treatment.

Based on independent central review, patients treated with varlitinib plus mFOLFOX6 had an average tumour shrinkage of 22.0% after 12 weeks compared to 12.5% for patients treated with mFOLFOX6 alone. This difference did not reach statistical significance. Upon review of 17 progression free survival (PFS) events to date, there was a trend towards an improvement in PFS in patients treated with varlitinib.

Overall patient characteristics were well-balanced between the two arms with the exception of baseline ECOG status. The proportion of patients with the best performance status (ECOG of 0) was substantially higher in the control arm (46.2%) than in the varlitinib arm (19.2%).

Varlitinib in combination with mFOLFOX6 was very well-tolerated with 73.1% of patients taking varlitinib experiencing a grade 3 or higher adverse event compared to 88.5% of patients taking mFOLFOX6 alone.

Dr Mark McHale, Chief Operating Officer, ASLAN Pharmaceuticals, said: "First-line gastric cancer is a very challenging indication to treat and the majority of patients present with advanced disease at initial diagnosis. To date, no targeted therapies have been approved to treat gastric cancer with low HER-family expression. Whilst we are disappointed by the study findings, we are encouraged by the positive safety data and remain confident that varlitinib’s potent pan-HER inhibition has the potential to yield benefits in biliary tract cancer where HER family expression is known to be high. We look forward to presenting the upcoming data in first-line biliary tract cancer at ASCO (Free ASCO Whitepaper) GI later this week and delivering topline data from our pivotal TreeTopp study in second-line biliary tract cancer which is expected in the second half of 2019."

ASLAN will continue to analyse data from this study, working with study investigators on the future publication of these results, and will focus on development in biliary tract cancer and other indications where varlitinib has shown activity.

Ends

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About varlitinib (ASLAN001)

Varlitinib (ASLAN001) is a highly potent, oral, reversible, small molecule pan-HER inhibitor that targets the human epidermal growth factor receptors HER1, HER2 and HER4. These receptors can be mutated or overexpressed in many tumours, which can cause excessive proliferative activity and uncontrolled growth. Therefore, by inhibiting the activation of the HER receptors, varlitinib could inhibit proliferation and control tumour growth. Varlitinib is currently being studied in gastric, biliary tract, breast and colorectal cancers. Varlitinib has been granted orphan drug designation in the United States for gastric cancer and cholangiocarcinoma, a sub-type of biliary tract cancer, and was awarded orphan drug designation for the treatment of biliary tract cancer by the Ministry of Food and Drug Safety in South Korea.

Alnylam Pharmaceuticals Prices Public Offering of Common Stock

On January 14, 2019 Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, reported the pricing of an underwritten public offering of 5,000,000 shares of its common stock at a public offering price of $77.50 per share (Press release, Alnylam, JAN 14, 2019, View Source [SID1234532650]). The gross proceeds to Alnylam from the offering, before deducting the underwriting discounts and commissions and other estimated offering expenses, are expected to be approximately $387,500,000. The offering is expected to close on or about January 17, 2019, subject to the satisfaction of customary closing conditions. In addition, Alnylam has granted the underwriter a 30-day option to purchase up to an additional 750,000 shares of its common stock solely to cover over-allotments. All of the shares in the offering are to be sold by Alnylam.

Barclays Capital Inc. is acting as sole book-running manager for the offering.

Alnylam intends to use the net proceeds from this offering for general corporate purposes, including advancing the ongoing commercialization of ONPATTRO (patisiran) in the United States and Europe and, assuming favorable regulatory reviews, the potential expansion into additional countries, development efforts directed towards the potential expansion of the ONPATTRO label in the United States, continuing to advance its late stage clinical pipeline and preparing for the potential global launch of several additional products, continuing investment in its early stage pipeline, including its CNS and ocular programs, clinical trial costs and other research and development expenses, continued growth of its manufacturing, quality, commercial and medical affairs capabilities to support its commercialization efforts, potential acquisitions, investments or licenses in businesses, products or technologies that are complementary to Alnylam’s business, working capital, capital expenditures and general and administrative expenses.

The securities described above are being offered by Alnylam pursuant to an automatically effective shelf registration statement that Alnylam previously filed with the Securities and Exchange Commission (SEC).

A registration statement (including a base prospectus and a preliminary prospectus supplement) relating to these securities has been filed with the SEC and has become effective. Before you invest, you should read these and other documents Alnylam has filed with the SEC for more complete information about Alnylam and this offering. You may get these documents for free by visiting EDGAR on the SEC website at www.sec.gov.

The offering will be made only by means of a prospectus supplement and related prospectus. Copies of the preliminary prospectus supplement and, when available, the final prospectus supplement and the accompanying base prospectus relating to the offering may be obtained by contacting Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717; [email protected] (phone 888-603-5847).

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities nor shall there be any sale of these securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state.

Compugen’s Phase 1 Trial of COM701 Featured as a Trial-in-Progress at The ASCO-SITC Clinical Immuno-Oncology Symposium

On January 14, 2019 Compugen Ltd. (NASDAQ: CGEN), a clinical-stage cancer immunotherapy company and leader in predictive target discovery, reported that its Phase 1 clinical trial evaluating COM701, a first-in-class therapeutic antibody targeting PVRIG, will be featured in a trial-in-progress poster at The ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium, taking place February 28-March 2, 2019, in San Francisco, CA (Press release, Compugen, JAN 14, 2019, View Source [SID1234532648]).

The poster titled "A Phase 1 Study Evaluating COM701 in Patients With Advanced Solid Tumors," will be presented by Drew W. Rasco, M.D, Associate Director of Clinical Research at the South Texas Accelerated Research Therapeutics (START), San Antonio, TX and a Principal Investigator in the Phase 1 COM701 study.

The poster abstract is expected to be published on the conference website on February 25, 2019, and will reflect enrolment information as of the date of the abstract submission. The poster presentation will take place on Thursday, February 28, 2019, and will include updated enrolment information.

The poster will be available on Compugen’s website at www.cgen.com following the conference presentation.

Leap Therapeutics Announces an Investigator-Initiated Study of DKN-01 in Patients with DKK1+ Advanced Prostate Cancer

On January 14, 2019 Leap Therapeutics, Inc. (Nasdaq: LPTX), a biotechnology company developing targeted and immuno-oncology therapeutics, reported an investigator-initiated study led by David R. Wise, M.D., Ph.D. of the Perlmutter Cancer Center at NYU Langone Health to study DKN-01, as a monotherapy and in combination with docetaxel in patients with advanced prostate cancer (Press release, Leap Therapeutics, JAN 14, 2019, View Source [SID1234532649]). This clinical trial is specifically targeting a biomarker-selected patient population in metastatic castration-resistant prostate cancer (mCRPC) with elevated Dickkopf-1 (DKK1) levels.

"DKK1 can promote prostate cancer growth through suppressing the anti-tumor immune response. We have discovered that DKK1 is upregulated in the substantial portion of advanced prostate cancers that lack expression of androgen receptor," commented Dr. Wise. "Patients with this type of prostate cancer have a very poor prognosis and may benefit from this new immunotherapy strategy targeting DKK1 therapy with DKN-01."

"An important part of our DKN-01 development strategy is to target biomarker-selected patient populations," said Cynthia Sirard, M.D., Vice President, Clinical Development of Leap Therapeutics. "In our esophagogastric cancer study, we have identified DKK1 levels measured by RNAScope as a potential predictor of response to DKN-01-based therapy. We are looking forward to treating mCRPC patients with elevated DKK1 levels in this study, building on our and Dr. Wise’s work."

The study is expected to begin enrolling patients in the first quarter of 2019. mCRPC patients who have progressed on one or more androgen receptor (AR) therapies (Xtandi or Zytiga) will be screened for DKK1 elevation in their plasma or in a tumor sample. Up to 97 patients will be enrolled in a dose-escalation and then dose expansion cohorts. DKK1+ mCRPC patients who have not received prior taxane chemotherapies will be treated with DKN-01 and docetaxel. DKN-01 will be given as a monotherapy to DKK1+ mCRPC patients who have progressed on or refused docetaxel treatment.

About Prostate Cancer

Prostate cancer is the leading type of non-skin cancer in the US, and the second leading cause of cancer worldwide. Approximately 1 in 9 men will be diagnosed with prostate cancer at some point in their lives. Androgen receptor (AR)-targeted therapy can be highly effective for the treatment of prostate cancer. Unfortunately, most patients will eventually develop resistance and progress to castration-resistant prostate cancer (CRPC), an incurable form of the disease.

Disclosure

Dr. Wise is compensated to serve as a consulant to Leap Therapeutics. Also, Dr. Wise’s involvement in this upcoming study does not constitute an institutional endorsement from NYU Langone Health or its Perlmutter Cancer Center of the drug DKN-01 being studied.