On January 29, 2020 Geneos Therapeutics reported that its personalized neoantigen-targeting vaccine, GNOS-PV02 (based on its proprietary GT-EPIC platform), will be evaluated in a clinical trial for patients with advanced Hepatocellular Carcinoma (HCC) (Press release, Geneos Therapeutics, JAN 29, 2020, View Source [SID1234553675]). GNOS-PV02 is a tumor-specific DNA plasmid product designed and manufactured for each patient based on the unique tumor variations (neoantigens) identified by sequencing each patient’s tumors. In the trial, GNOS-PV02 will be combined with a DNA plasmid encoded cytokine immunomodulator IL-12 (INO-9012) and standard of care PD-1 checkpoint inhibitor (pembrolizumab).

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This innovative trial is an open-label, non-randomized, exploratory study designed to assess the safety, immunogenicity, and antitumor activity of the combination treatment in advanced HCC patients who have progressed on or are intolerant to first-line treatment with a Tyrosine Kinase Inhibitor (TKI). The primary study goals are to evaluate safety, biomarkers of immune activity, with special emphasis on CD8+ T cell responses, and clinical outcomes.

Geneos has exclusively licensed the DNA Medicines platform, INO-9012 and CELLECTRA device for in vivo delivery of DNA plasmids from Inovio Pharmaceuticals (NASDAQ: INO) for use in the development of personalized cancer treatments. The two DNA based products, GNOS-PV02 and INO-9012, will be administered to cancer patients via intradermal (ID) administration using the CELLECTRA 2000 ID device.

Dr. Niranjan Y. Sardesai, Founder and Chief Executive Officer of Geneos Therapeutics, said "We are excited about this first clinical trial for the Geneos GT-EPIC neoantigen-targeting platform. This trial will seek to demonstrate that Geneos can produce personalized neoantigen-targeting immunotherapies in a clinically meaningful time frame, which drive strong T cell responses (both CD4+ and CD8+) and that these immunotherapies can enhance the efficacy of a PD-1 inhibitor alone. Enabled by our industry leading rapid biopsy to treatment turnaround time and the unique design of this study, the Geneos personalized therapy will be initiated at the same time the patient receives the first dose of the PD-1 inhibitor – we believe this is a critical success factor for neoantigen-based combination trials."

Dr. Mark Yarchoan, Assistant Professor of Oncology at Johns Hopkins and Investigator for the GT-30 advanced HCC study said "Checkpoint inhibitors and other immunotherapies have advanced the cancer treatment field and have had a significant impact on clinical outcomes. However, every patient’s tumor is unique and in order to further improve outcomes, I believe that personalized approaches are critical. I’m excited about this clinical trial utilizing Geneos’ innovative personalized treatment approach in combination with an approved immunotherapy for the treatment of advanced HCC. HCC is one of the fastest growing cancers in the U.S., and a significant unmet need exists to find more efficacious treatments."

HCC accounts for the majority of primary liver cancers. Globally, liver cancers are the fourth most common cause of cancer-related death and rank sixth in terms of annual incidence. The rate of death from liver cancer in the U.S. has increased 43% from 2000 to 2016 and with a 5-year survival rate of 18% for advanced liver cancer, it is the second most deadly tumor behind pancreatic. To date, immunotherapies have shown limited efficacy with two PD-1 inhibitors (pembrolizumab and nivolumab) approved as second line treatments following a tyrosine kinase inhibitor.

On January 29, 2020 Aptose Biosciences Inc. (Nasdaq: APTO; TSX: APS), a clinical-stage company developing highly differentiated therapeutics that target the underlying mechanisms of cancer, reported that the company will host a key opinion leader (KOL) event on Wednesday, February 5th, 2020 in New York City (Press release, Aptose Biosciences, JAN 29, 2020, View Source [SID1234553641]). In addition, William G. Rice, Ph.D., Chairman, President and Chief Executive Officer, Gregory K. Chow, Executive Vice President and Chief Financial Officer and Jotin Marango, M.D., Ph.D, Senior Vice President and Chief Business Officer, will present at the upcoming BIO CEO & Investor Conference on Monday, February 10th, 2020 in New York City.

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Presentation Details:

·KOL Symposium on CG-806 FLT3/BTK Inhibitor for Acute Myeloid Leukemia
Date: Wednesday, February 5, 2020
Time: 12:00 PM – 1:30 PM
Location: Lotte New York Palace
Webcast: LINK
The luncheon symposium will feature renowned hematology leaders including Brian J. Druker, M.D., Eytan M. Stein, M.D. and Aaron Goldberg, M.D., Ph.D. Dr. Druker is Professor of Medicine, Division of Hematology/Medical Oncology; Director, Knight Cancer Institute, Oregon Health & Science University and Chair of the Aptose Scientific Advisory Board; Eytan M. Stein, M.D. is a Hematologic Oncologist, Assistant Professor on the Leukemia Service at Memorial Sloan Kettering Cancer Center (MSKCC); and Aaron Goldberg, M.D., Ph.D. is a Hematologic Oncologist, Assistant Attending Physician, Leukemia Service, MSKCC. The hematology experts will review the treatment landscape and the evolution of kinase inhibitors as anticancer drugs in myeloid leukemias, particularly acute myeloid leukemia (AML), and highlight the potential for the mutation-agnostic FLT3/BTK inhibitor CG-806 to address unmet medical needs in these patient populations.

Additionally, Rafael Bejar M.D., Ph.D., Aptose’s Chief Medical Officer, will serve as moderator and provide an overview of the rationale and strategy for the development of CG-806 in myeloid malignancies. CG-806 is currently in an ongoing Phase 1a/b clinical trial for the treatment of patients with relapsed / refractory B-cell malignancies, including CLL and NHL, and in 1H / 2020 is planned to enter a separate clinical trial in patients with relapsed / refractory AML and high-risk MDS.

·BIO CEO & Investor Conference
Date: Monday, February 10, 2020
Time: 1:15 PM EST
Location: Presentation Room Odets, New York Marriott Marquis
Webcast: LINK
The Company also will be hosting institutional investor and partnering meetings at the conference that can be requested through BIO One-on-One Partnering.

On January 29, 2020 Trovagene, Inc. (Nasdaq: TROV), a clinical-stage, Precision Cancer Medicine oncology therapeutics company developing drugs that target cell division (mitosis) for the treatment of various cancers including prostate, colorectal and leukemia, reported that it has received approximately $1.45 million in proceeds from holders exercising common stock purchase warrants at an exercise price of $1.56 per share (Press release, Trovagene, JAN 29, 2020, View Source [SID1234553658]). The warrants were issued as part of the units sold to certain institutional investors in October, 2019.

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Trovagene intends to use the proceeds to continue funding its clinical development activities and for working capital and general corporate purposes.

"We continue to see clinical benefit in patients receiving onvansertib as part of combination therapy in all three of our clinical development programs," said Dr. Thomas Adams, CEO and Chairman of Trovagene. "Earlier this week, we presented positive data from our Phase 1b/2 study in patients with difficult-to-treat KRAS-mutated metastatic colorectal cancer (mCRC); all of whom are achieving a meaningful clinical response which has been confirmed by shrinking of tumors seen on radiographic scans. Additionally, on February 13th, we will be presenting data from our ongoing Phase 2 trial in patients with metastatic castrate-resistant prostate cancer (mCRPC) at the ASCO (Free ASCO Whitepaper)-GU conference."

On January 29, 2020 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, reported the pricing of an upsized underwritten public offering of 8,350,000 shares of its common stock at a price of $25.00 per share pursuant to a registration statement on Form S-1 filed previously with the U.S. Securities and Exchange Commission (SEC) (Press release, Alector, JAN 29, 2020, View Source [SID1234553676]). The offering was upsized to 8,350,000 shares of Alector’s common stock from the original offering size of 5,095,000 shares of common stock. The gross proceeds to Alector from the offering, before deducting underwriting discounts and commissions and other offering expenses, are expected to be $208,750,000. The offering is expected to close on or about February 3, 2020, subject to customary closing conditions. In addition, Alector has granted the underwriters a 30-day option to purchase up to 1,252,500 additional shares of common stock. All of the shares in the proposed offering will be sold by Alector.

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Morgan Stanley, Goldman Sachs & Co. LLC, BofA Securities, and Cowen are acting as joint book-running managers for the offering.

A registration statement relating to the securities has been filed with, and declared effective by, the SEC. 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 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.

The offering is being made only by means of a prospectus. When available, copies of the final prospectus relating to the offering may be obtained from:

Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014 or by email at [email protected];
Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, or by email at [email protected];
BofA Securities, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attn: Prospectus Department, or by email [email protected]; or
Cowen and Company, LLC c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, by email at [email protected] or by telephone at (833) 297-2926.

On January 29, 2020 Trillium Therapeutics Inc. ("Trillium" or the "Company") (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported the closing of its previously announced underwritten public offering of 41,279,090 common shares of the Company and 1,250,000 Series II Non-Voting Convertible First Preferred Shares of the Company (the "Offering") (Press release, Trillium Therapeutics, JAN 29, 2020, View Source [SID1234553642]). The common shares and preferred shares were sold at a public offering price of US$2.75 per share. The number of shares sold includes the full exercise by the underwriters of their option to purchase up to an additional 5,547,272 common shares.

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The gross proceeds from the Offering were approximately US$116,955,000, before deducting underwriting commissions and other offering expenses. The Company intends to use the net proceeds of the Offering towards: 1) the clinical development of its CD47 programs; and 2) research, manufacturing and regulatory activities, and working capital and general corporate purposes.

Key investors in the Offering included the Company’s existing significant shareholder New Enterprise Associates, as well as new investors Boxer Capital, Logos Capital, Vivo Capital, and Venrock Healthcare Capital Partners, among others.

"Trillium’s mission is to redefine the oncology treatment paradigm by developing and delivering to patients next-generation immunotherapies. We believe we have two potentially best-in-class CD47 molecules, a clear strategy targeting hematologic malignancies with great unmet medical needs, and now also funding from the top healthcare investors in this country to pursue that mission," said Dr. Jan Skvarka, Trillium’s President and Chief Executive Officer.

Cowen acted as the sole book-running manager for the Offering. Bloom Burton Securities Inc. acted as co-manager for the Offering.