On January 24, 2020 University Hospitals Seidman Cancer Center reported that it treated its first patient in a new clinical trial to validate the groundbreaking effects of the poliovirus on glioblastoma (GBM), a deadly Grade IV cancer of the brain (Press release, University Hospitals, JAN 24, 2020, View Source [SID1234553527]).

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UH is the only Midwest site participating in this clinical trial, which was initiated at Duke Cancer Institute in Durham, NC. The original study, which ran from 2012-2017, was published in New England Journal of Medicine in July 2018 as well as highlighted on "60 Minutes" in 2015 and again in 2018. The study found that survival rates were significantly higher in glioblastoma patients who received an intratumoral infusion of a modified viral chimera combining the polio and rhinoviruses (PVSRIPO immunotherapy) compared to patients receiving standard treatment at the same institution.

"We are proud that University Hospitals was selected as one of a handful of top brain tumor centers such as the Massachusetts General Hospital and UCSF to participated in this Phase II clinical trial based on our expertise in immunotherapy and reputation for treating brain tumors," said Andrew E. Sloan, MD, FAANS, FACS, Director of the Brain Tumor and Neuro-Oncology Center and the Center of Excellence in Translational Neuro-Oncology at UH Seidman Cancer Center and the UH Neurological Institute. "We want to offer this treatment opportunity to patients with recurrent glioblastomas who want to pursue groundbreaking alternatives that may improve their chances of survival from the most challenging of brain cancers."

The 59-year-old man first enrolled in this trial suffered from glioblastoma that recurred after initial surgery and treatment. Following a biopsy to verify the progression of the brain tumor, Dr. Sloan placed a catheter into the tumor and the modified attenuated poliovirus was convected through the catheter into the tumor the next morning. Through this process, known as convection enhanced delivery (CED) and performed in the NeuroIntensive Care Unit at UH Cleveland Medical Center, the poliovirus attacks the tumor creating an anti-tumor immune response. The patient went home the next day.

"This trial uses a polio virus modified to specifically target a receptor (CD155) found only on tumor cells," Dr. Sloan said. "While it only kills a small number of tumor cells directly, the virus and the immune response it exerts exposes these tumor cells, which have been hiding from the immune system and creates a significant anti-tumor immune response that takes over and kills the rest of the tumor that the virus has not destroyed. Unlike the native polio virus, the modified virus does not attack neurons."

Traditionally, survival from a GBM is less than a year, and patients typically live less than six months after recurrence. The survival rate among those receiving PVSRIPO immunotherapy was 21 percent at 24 and 36 months, much higher than the 4 percent survival rate among historical controls treated at Duke, according to the article published in the New England Journal of Medicine on July 12, 2018.

Researchers at Duke first discovered that the poliovirus delivered directly into intracranial tumors was able to trigger a positive immune reaction, which led to a longer survival rate from the notoriously difficult-to-treat cancer. In Phase I of the clinical trial, doctors determined the correct dose of the virus to administer while mitigating side effects. In Phase II, researchers will compare outcomes in patients.

"The body has an amazing immunological memory," Dr. Sloan said. "If you’ve received the polio vaccine as a child, your immune system remembers that polio is a bad thing. The injection of the polio virus jump-starts the immune response, which in turn attacks the cancer."

On January 24, 2020 Bionetix, a biotech company developing novel oncology drugs; ProQinase, an oncology-focused contract research organization (CRO) recently acquired by Reaction Biology Corporation (Malvern/PA, USA); and MercachemSyncom, a chemistry CRO specializing in medicinal chemistry and comprehensive medicinal chemistry (CMC), reported they have signed a joint multiyear integrated drug-discovery project, starting from target identification (TI) up to clinical candidate selection on an undisclosed target aimed at acute myeloid leukemia (AML) (Press release, Mercachem, JAN 24, 2020, View Source [SID1234553571]). The goal of the three-party team is to advance the project to the clinical phase by 2023. The total investment sum is "significant, of multimillion Euros", but details are not being disclosed.

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"We are excited to start this new project with MercachemSyncom and ProQinase," said Dr. DooYoung Jung, CEO of Bionetix. "They have proven their quality in another project of ours, which is currently in the early development phase. When this new opportunity came up, our decision was quick and easy. We are convinced that the team will advance this program very efficiently."

Dr. Frank Leemhuis, Managing Director of MercachemSyncom, commented: "Our skilled and experienced team has a proven track record in medicinal chemistry and CMC and built valuable research assets, as the result of a consistent innovation strategy. This research project is an opportunity to build on these qualities, with the goal of serving and creating value for our client. ProQinase is ourtrusted biology partner, through years of collaboration. Together with Bionetix, we look forward to making essential contributions to this oncology program."

"We are very grateful for our long-lasting partnership with MercachemSyncom, which enables us to deliver combined top-class scientific expertise to Bionetix," said Dr. Sebastian Dempe, Chief Executive Officer of ProQinase. "This new opportunity of a multiyear collaboration, utilizing our entire breadth of oncology preclinical services, aims to develop a high-value asset for our mutual client. Working together on solid but flexible research plans, combined with efficiency, allow for short lead times and robust datageneration processes, which are key to the success of such integrated drug-discovery projects. With MercachemSyncom, we will make sure that our promises to Bionetix are met."

On January 23, 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 that it has priced its previously announced underwritten public offering of 35,731,818 common shares (the "Common Shares") of the Company and 1,250,000 Series II Non-Voting Convertible First Preferred Shares (the "Series II First Preferred Shares") of the Company (the "Offering") (Press release, Trillium Therapeutics, JAN 23, 2020, View Source [SID1234553468]). The Common Shares are being sold at a public offering price of US$2.75 per Common Share and the Series II First Preferred Shares are being sold at a public offering price of US$2.75 per Series II First Preferred Share.

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In connection with the Offering, Trillium has granted the underwriters a 30-day option to purchase up to an additional 5,547,272 Common Shares.

The Series II First Preferred Shares are being offered to investors whose purchase of Common Shares in the Offering may result in such investor, together with its affiliates and certain related parties, beneficially owning more than 4.99% of the Company’s outstanding common shares following the consummation of the Offering.

The gross proceeds to the Company from the Offering are expected to be approximately US$101,700,000, before deducting underwriting discounts and commissions and other estimated offering expenses. The Offering is expected to close on or around January 28, 2020, subject to the satisfaction of customary closing conditions.

The Company intends to use the net proceeds of the Offering for: (i) the clinical development of its CD47 programs; and (ii) research, manufacturing and regulatory activities, and working capital and general corporate purposes.

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

No Common Shares or Series II First Preferred Shares will be offered or sold in Canada as part of this Offering. The Offering is subject to market conditions, as well as a number of closing conditions, including NASDAQ Capital Market ("NASDAQ") and Toronto Stock Exchange ("TSX") approvals, and there can be no assurance as to whether or when the Offering may be completed. For the purposes of TSX approval, the Company intends to rely on the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible inter-listed issuers on a recognized exchange, such as NASDAQ.

The Offering is being made to purchasers outside of Canada pursuant to a U.S. registration statement on Form F-10, declared effective by the United States Securities and Exchange Commission (the "SEC") on January 8, 2018 (the "Registration Statement") and the Company’s existing Canadian short form base shelf prospectus (the "Base Shelf Prospectus") dated January 5, 2018. A preliminary prospectus supplement dated January 22, 2020 has been filed relating to the Offering and a final prospectus supplement relating to the Offering (together with the Base Shelf Prospectus and the Registration Statement, the "Offering Documents") will be filed with the securities commissions in the provinces of British Columbia, Alberta, Manitoba, Ontario and Nova Scotia in Canada, and with the SEC in the United States.

The Offering Documents will contain important detailed information about the securities being offered. Before you invest, you should read the Offering Documents and the other documents the Company has filed for more complete information about the Company and the Offering. Copies of the Offering Documents will be available for free by visiting the Company’s profiles on the SEDAR website maintained by the Canadian Securities Administrators at www.sedar.com or the SEC’s website at www.sec.gov, as applicable. Alternatively, copies of the prospectus supplement will be available upon request by contacting 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.

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

On January 23, 2020, Genprex, Inc. (the "Company") reported that it has entered into a securities purchase agreement (the "Securities Purchase Agreement") with four institutional accredited investors identified on the signature page thereto (the "Purchasers") pursuant to which the Company agreed to issue and sell to the Purchasers an aggregate of 7,620,000 shares (the "Shares") of its common stock, par value $0.001 per share (the "Common Stock"), in a registered direct offering (the "Registered Direct Offering") (Filing, 8-K, Genprex, JAN 23, 2020, View Source [SID1234553528]). The Shares were offered by the Company pursuant to its shelf registration statement on Form S-3 (File No. 333-233774) filed with the Securities and Exchange Commission (the "Commission") on September 16, 2019, as amended on October 4, 2019 (as amended, the "Registration Statement") and declared effective on October 28, 2019.

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The purchase price for one Share in the Registered Direct Offering was $1.05. The closing of the Registered Direct Offering is anticipated to occur on January 27, 2020, subject to customary closing conditions. The Company expects the aggregate net proceeds from the Offerings, after deducting estimated offering expenses, to be approximately $7.2 million. The Company intends to use the aggregate net proceeds for working capital and other general corporate purposes.

The Securities Purchase Agreement contains customary representations, warranties and agreements by the Company and customary conditions to closing.

The foregoing description of the material terms of the Securities Purchase Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Securities Purchase Agreement, a copy of which is filed herewith as Exhibit 10.1 and is incorporated herein by reference.

The representations, warranties and covenants contained in the Securities Purchase Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to the Securities Purchase Agreement and may be subject to limitations agreed upon by the contracting parties. Accordingly, the Securities Purchase Agreement is incorporated herein by reference only to provide investors with information regarding the terms of the Securities Purchase Agreement and not to provide investors with any other factual information regarding the Company or its business, and should be read in conjunction with the disclosures in the Company’s periodic reports and other filings with the Commission.

The legal opinion, including the related consent, of Sheppard, Mullin, Richter & Hampton LLP relating to the issuance and sale of the Shares is filed as Exhibit 5.1 hereto.

In connection with the Registered Direct Offering, the Company entered into a Placement Agency Agreement with registered broker-dealers (the "Placement Agents"), pursuant to which the Company paid an aggregate cash fee of $640,080 to the Placement Agents (eight percent (8.0%) of gross proceeds from the Registered Direct Offering). The Company will also reimburse the Placement Agents for their expenses incurred by them in connection with the Registered Direct Offering.

The foregoing description of the material terms of the Placement Agency Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Placement Agency Agreement, a copy of which is filed herewith as Exhibit 1.1 and is incorporated herein by reference.

This Current Report on Form 8-K does 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 the registration or qualification under the securities laws of any such state or jurisdiction.

On January 23, 2020 Freenome, a privately-held biotechnology company that has pioneered a comprehensive multiomics platform for early cancer detection through a routine blood draw, reported that is presenting data from their prospective, multi-center clinical study AI-EMERGE (Press release, Freenome, JAN 23, 2020, View Source [SID1234553469]). The colorectal cancer (CRC) study will be featured at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s Gastrointestinal Cancers Symposium (ASCO GI) on Saturday, January 25th in San Francisco. "We’re delighted to present results from the first prospective clinical study with our multiomics blood test that achieved high sensitivity and specificity in early-stage CRC," said Gabriel Otte, Chief Executive Officer of Freenome. "This represents a significant step forward in our efforts to bring an effective early detection test to as many people as possible."

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Freenome to present promising prospective data of its multiomics blood test for CRC screening at the ASCO (Free ASCO Whitepaper) 2020 Gastrointestinal Cancers Symposium

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Freenome’s poster, Blood-Based Detection of Early-Stage Colorectal Cancer Using Multiomics and Machine Learning, highlights the performance of their multiomics blood test, which combines tumor- and non-tumor-derived (such as immune) signals from cell-free DNA (cfDNA), epigenetic, and protein biomarkers into a machine learning-based classifier, to detect early-stage CRC. This study, which included average-risk screening and case-control subjects (n=574) and an analyte training set (n=17) drawn from a statistically-driven subset of AI-EMERGE, demonstrated a sensitivity of 94% and specificity of 94% for early-stage (I/II) colorectal adenocarcinoma. "The current study shows exciting multiomics data demonstrating high sensitivity and specificity for detecting early-stage CRC," said Aasma Shaukat, MD, MPH, GI Section Chief at Minneapolis VAHCS and Professor of Medicine, University of Minnesota. "Early detection is key to improving survival and these results give us hope that in the future we may have a highly sensitive and specific blood test to screen patients for early disease." The Company expects to validate these results in a prospective, multi-center registrational study that will begin enrollment this year.

Freenome’s multiomics blood test sensitivity and specificity by early (I/II) and late (III/IV) stage CRC

Sensitivity

Specificity

Early (Stage I/II)

Late (Stage III/IV)

94%

94%

91%

Freenome’s multiomics blood test was also compared to a leading fecal immunochemical test (FIT). Subjects enrolled in the study were asked to provide both a blood and stool sample for a head-to-head comparison. However, only 52% of study subjects provided a stool sample for analysis, reinforcing the well-characterized challenges with patient willingness to perform stool-based testing. In subjects with paired blood and stool samples, Freenome’s multiomics blood test demonstrated 100% sensitivity and 96% specificity for CRC, whereas FIT achieved 67% sensitivity and 96% specificity. "The performance of FIT in our study is consistent with that shown in other large prospective studies, which makes our results even more encouraging," said Girish Putcha, MD, PhD, Chief Medical Officer of Freenome, "since we believe such a blood test can help more people get screened for CRC than existing options, which will improve the detection of early disease and enable better clinical outcomes."

Posters will be available online at View Source at the time of presentation. The following information provides details to all of the posters Freenome will be presenting at the conference:

Abstract 66:

Presenter and Title: Girish Putcha et al., Blood-based detection of early-stage colorectal cancer using multiomics and machine learning.

Poster Session C: Anal and Colorectal Cancer: Saturday, January 25: 6:30 am – 7:55 am and 12:15 pm – 1:45 pm

Poster Walk: Novel Diagnostics and Population Health: Saturday, January 25: 12:30 pm – 1:15 pm

Poster Board C16

Abstract 207:

Presenter and Title: Francesco Vallania et al., Exploratory longitudinal analysis of cfDNA to reveal potential biomarkers of CRC progression and treatment response.

Poster Session C: Anal and Colorectal Cancer Saturday, January 25, 6:30 am – 7:55 am and 12:15 pm – 1:45 pm

Poster Board K7

About Colorectal Cancer and AI-EMERGE

Despite population screening efforts and the availability of several stool-based, non-invasive tests, more than one-third of eligible adults remain unscreened for colorectal cancer (CRC), which is the second deadliest form of cancer in the U.S. However, when detected at an early stage, the five-year relative survival rate for CRC is 90% versus 14% when detected at a late stage according to data from the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) Program. AI-EMERGE is a clinical study that will advance the development of a blood-based test to detect colorectal cancer early. The study is a prospective, multi-center CRC screening clinical study being conducted in patients ages 50-84 that are at average risk for CRC. The study collected blood and stool samples from healthy patients undergoing routine screening colonoscopy and from patients recently diagnosed with colorectal cancer or advanced adenomas. The study has recently closed enrollment.