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.

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 Incyte (Nasdaq:INCY) reported that it has scheduled its fourth quarter and year-end 2019 financial results conference call and webcast for 8:00 a.m. ET on Thursday, February 13, 2020 (Press release, Incyte, JAN 23, 2020, View Source [SID1234553467]).

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The schedule for the press release and conference call/webcast is as follows:

Q4 & YE 2019 Press Release:
February 13, 2020 at 7:00 a.m. ET

Q4 & YE 2019 Conference Call:
February 13, 2020 at 8:00 a.m. ET

Domestic Dial-In Number:
877-407-3042

International Dial-In Number:
201-389-0864

Conference ID Number:
13698234

If you are unable to participate, a replay of the conference call will be available for thirty days. The replay dial-in number for the U.S. is 877-660-6853 and the dial-in number for international callers is 201-612-7415. To access the replay you will need the conference ID number 13698234.

The live webcast with slides can be accessed at Investor.Incyte.com and will be available for replay for 30 days.

On January 23, 2020 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company reported that the Company’s immuno-oncology product candidate, ALT-702, met a key pre-clinical efficacy milestone with the demonstration of systemic antitumor activity following intra-tumoral injection in an individual solid tumor (Press release, Altimmune, JAN 23, 2020, View Source [SID1234553466]).

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The aggressive tumor model is based on the murine CT26 colorectal carcinoma cell line and involved the establishment of a tumor in each flank of a mouse. In the study, three doses of ALT-702 were injected into one tumor mass over 5 days with concomitant treatment with an anti-CTLA4 antibody immune checkpoint inhibitor administered intraperitoneally. Tumor regression was noted in both injected (88%) and non-injected (38%) lesions, and overall survival in the ALT-702 + anti-CTLA4 group was markedly better than either agent alone.

"These data represent a key milestone for the development of ALT-702 and are highly supportive of the immune-mediated antitumor activity of ALT-702," said Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune. "ALT-702 represents a platform technology designed to be used with a variety of immune stimulants and we are excited about the potential of this approach in multiple tumor types."

Additionally, the United States Patent and Trademark Office (USPTO) granted US Patent No. 10,434,183 (the ‘183 patent) entitled "Immunogenic Compound." The ‘183 patent provides coverage for important elements of the Company’s ALT-702 cancer immunotherapy product candidate. The issued patent will expire no earlier than 2034. "The ‘183 patent is the second granted patent supporting ALT-702 and will provide further IP coverage for the ALT-702 development program. The Company was previously granted U.S. Patent No. 9,962,453 covering immunostimulatory compounds, including ALT-702.

About ALT-702

ALT-702 is a targeted tumor immunostimulant designed to act locally to reverse local immunosuppression within the tumor microenvironment and stimulate systemic antitumor immune responses. The ALT-702 technology is a novel synthetic peptide conjugate technology platform designed to retain and concentrate immunostimulants within a tumor leading to enhanced immune stimulation without the safety risk of systemic inflammation. ALT-702 represents a new approach in immuno-oncology that can act alone or improve the effectiveness of immune checkpoint inhibitors, oncolytic viruses or other approaches in immuno-oncology.

On January 23, 2020 Orion Corporation reported the Japanese Ministry of Health, Labor and Welfare (MHLW) has granted marketing authorization for darolutamide, under the brand name Nubeqa, for the treatment of men with non-metastatic castration-resistant prostate cancer (nmCRPC) (Press release, Orion , JAN 23, 2020, View Source [SID1234553465]).

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The approval is based on the Phase III ARAMIS trial evaluating the efficacy and safety of darolutamide plus androgen deprivation therapy (ADT) compared to placebo plus ADT, showing a highly significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS), with a median 40.4 months for darolutamide plus ADT versus 18.4 months for placebo plus ADT (HR=0.41, 95% CI 0.34-0.50; P<0.001). The androgen receptor inhibitor (ARi), which is jointly developed by Orion and Bayer is already approved in the U.S. and Brazil and filings in the European Union and other regions are underway or planned by Bayer.

"Patients with nmCRPC are usually asymptomatic, but have a rising blood prostate specific antigen (PSA) despite ADT treatment, and it is important to prevent their cancer from becoming metastatic and symptomatic. The overarching goals of treatment in this setting are to delay the spread of prostate cancer and limit the burdensome side effects of therapy. Darolutamide provides nmCRPC patients now also in Japan a new therapeutic option that addresses these questions" said Christer Nordstedt, Senior Vice President, Research and Development, Orion Corporation.

In Japan, over 89,000 men are estimated to be diagnosed with prostate cancer annually, making it the second most-common cancer diagnosis in Japanese men after stomach cancer. Prostate cancer that is treated with ADT but keeps progressing even when the amount of testosterone is reduced to very low levels in the body is known as castration-resistant prostate cancer (CRPC).1 In men with progressive nmCRPC, a rapid prostate specific antigen (PSA) doubling time has been consistently associated with reduced time to first metastasis and death.1

In the ARAMIS trial, overall survival (OS) and time to pain progression were additional secondary efficacy endpoints. At the time of final MFS analysis, a positive trend in OS was observed; OS data were not yet mature. The MFS result was additionally supported by a delay in time to pain progression as compared to placebo plus ADT. All other secondary endpoints, time to cytotoxic chemotherapy, and time to a symptomatic skeletal event (SSE), demonstrated a benefit in favor of darolutamide.

Adverse reactions occurring more frequently in the darolutamide plus ADT arm (≥2% absolute increase in frequency compared to placebo plus ADT) were fatigue (16% vs. 11%), pain in extremity (6% vs. 3%), and rash (3% vs. 1%). Discontinuation due to adverse events occurred in 9% of patients in both arms of the study.

About the ARAMIS trial
The approval of darolutamide in Japan is based on the results of the ARAMIS trial, a randomized (2:1), double-blind, placebo-controlled, multi-center Phase III study which evaluated the safety and efficacy of the compound in patients with nmCRPC who are currently being treated with androgen deprivation therapy (ADT) and are at high risk for developing metastatic disease. In the clinical study, 1,509 patients were randomized in a 2:1 ratio to receive 600 mg of darolutamide orally twice daily or placebo along with ADT. Patients with a history of seizure were allowed in the study.

About darolutamide
Darolutamide is an androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells. Darolutamide is also being investigated in a Phase III study in metastatic hormone-sensitive prostate cancer (ARASENS trial). Information about these trials can be found at www.clinicaltrials.gov.

The product is also approved in the U.S. and Brazil under the brand name Nubeqa. It is currently not approved by the European Medicines Agency.

About castration-resistant prostate cancer (CRPC)
Prostate cancer is the second most commonly diagnosed malignancy in men worldwide.2 In 2018, an estimated 1.2 million men were diagnosed with prostate cancer, and about 358,000 died from the disease worldwide.2 Prostate cancer is the fifth leading cause of death from cancer in men.2 Prostate cancer results from the abnormal proliferation of cells within the prostate gland, which is part of a man’s reproductive system.3 It mainly affects men over the age of 50, and the risk increases with age.4

Treatment options range from surgery to radiation treatment to therapy using hormone-receptor antagonists, i.e., substances that stop the formation of testosterone or prevent its effect at the target location.5 However, in nearly all cases, the cancer eventually becomes resistant to conventional hormone therapy.6

CRPC is an advanced form of the disease where the cancer keeps progressing despite ADT treatment, even when the amount of testosterone is reduced to very low levels in the body.1,7 In men with progressive nmCRPC, a rapid prostate specific antigen (PSA) doubling time has been consistently associated with reduced time to first metastasis and death.1