Odonate Therapeutics Announces Public Offering of Shares of Common Stock

On August 26, 2020 Odonate Therapeutics, Inc. (NASDAQ: ODT), a pharmaceutical company dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer, reported that it has commenced an underwritten public offering of shares of its common stock (Press release, Odonate Therapeutics, AUG 26, 2020, View Source [SID1234564063]). In addition, Odonate has granted the underwriters a 30-day option to purchase additional shares of its common stock. All of the shares of common stock to be sold in the underwritten public offering are being offered by Odonate.

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Odonate intends to use the proceeds from the proposed underwritten public offering of its shares of common stock for development, regulatory and commercial preparation activities relating to tesetaxel, as well as for working capital and general corporate purposes.

Jefferies is acting as book-running manager, and LifeSci Capital is acting as lead manager for the offering.

A registration statement relating to these securities has been filed with the Securities and Exchange Commission (SEC) and became effective on October 18, 2019.

A preliminary prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering will be filed with the SEC. The securities described above have not been qualified under any state blue sky laws. 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 other 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 other jurisdiction. The offering can be made only by means of a prospectus, copies of which may be obtained at the SEC’s website at www.sec.gov, or by request to Jefferies LLC (Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022; telephone: 877-821-7388; email: [email protected]).

Silverback Therapeutics Initiates Phase 1 Clinical Study of SBT6050

On August 26, 2020 Silverback Therapeutics ("Silverback"), a biopharmaceutical company advancing a pipeline of therapies that are systemically delivered but locally active, reported initiation of a Phase 1 clinical study of SBT6050, a novel therapeutic comprising a specific small molecule toll-like receptor 8 (TLR8) agonist conjugated to a HER2-directed monoclonal antibody (Press release, Silverback Therapeutics, AUG 26, 2020, View Source [SID1234564061]).

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TLR8 is highly expressed in myeloid cells that are prevalent in human tumors and TLR8 agonism can potently activate a broad spectrum of anti-tumor immune mechanisms. SBT6050 is designed to activate human myeloid cells in tumors expressing moderate or high levels of HER2. Myeloid cell activation and reprogramming in the tumor microenvironment has emerged as a promising approach to harness the innate immune system to drive anti-tumor responses, including in tumors lacking T cells, as these tumors are often replete with myeloid cells.

"SBT6050 is designed for systemic administration and tumor-localized activation of myeloid cells, in order to circumvent toxicities associated with untargeted myeloid cell agonists," said Valerie Odegard, Ph.D., Silverback’s chief scientific officer. "In preclinical studies, SBT6050 demonstrated a broad therapeutic window and this profile has enabled the selection of a first-in-human starting dose projected to be pharmacologically active."

Dosing has initiated in the Phase 1 clinical study, an open-label, multicenter, dose escalation and expansion cohort study that will evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of SBT6050 in adults with HER2-expressing solid tumors.

"Our preclinical data highlight SBT6050’s potential to maximize anti-tumor immune responses, even in tumors lacking T cells. This is important because the majority of cancer patients, including those whose tumors express HER2, do not respond to checkpoint inhibitors," said Laura Shawver, Ph.D., president and chief executive officer of Silverback Therapeutics. "We look forward to working with our investigators to evaluate SBT6050 as an innovative precision immunotherapeutic for these patients."

PREEMPT CRC™ Trial for Blood-Based Test to Detect Colon Cancer Has Expanded to Enroll Patients From Anywhere in the Continental U.S. During COVID-19 Pandemic

On August 26, 2020 Freenome, a privately held biotechnology company that has pioneered a comprehensive multiomics platform for early cancer detection with a routine blood draw, reported that it has expanded the access to its PREEMPT CRC registrational clinical trial to enroll patients from nearly any zip code, as part of initiatives to adapt to the COVID-19 pandemic in the U.S (Press release, Freenome, AUG 26, 2020, View Source [SID1234564060]). All eligible 45- to 85-year old patients in the continental U.S. can participate in the clinical study validating Freenome’s multiomics blood test for colorectal cancer (CRC) screening. Freenome is implementing virtual tools, logistics, and communications to enroll patients nationwide in response to the dramatic decline of standard-of-care screening colonoscopies during the global pandemic.

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"The COVID-19 pandemic has posed unique challenges for colon and rectal cancer screening that will have a direct impact on health outcomes," said Gary Reedy, CEO of the American Cancer Society. "Usually, there are 800,000 to 1,000,000 screening colonoscopies per month in the U.S., whereas during the pandemic these numbers have dropped to a fraction of the monthly average. We are concerned that more people will experience poor outcomes and death from colorectal cancer as a result of delaying or foregoing screening, so we encourage people to schedule their screening."

PREEMPT CRC is Freenome’s prospective clinical trial that is enrolling up to 14,000 individuals to validate the company’s multiomics blood test for CRC screening to support approval by the U.S. Food and Drug Administration (FDA). The study includes asymptomatic, average-risk patients between the ages of 45 and 85 who are also undergoing a screening colonoscopy. Patients across the U.S. can participate in the trial with their local physicians and within their local healthcare processes without having to travel to specific trial sites.

"Colorectal cancer is the third most commonly diagnosed cancer and the second leading cause of cancer death in men and women in the United States," said Michael Sapienza, CEO of the Colorectal Cancer Alliance. "And incidence is 20% higher in African Americans, who have also been more severely impacted by COVID-19. The pandemic has only highlighted the need for more accessible and patient-friendly technologies that could significantly increase the number of screenings for CRC, one of the most preventable cancers if more people participated in early screenings."

"We have adapted our clinical trial during the COVID-19 pandemic to meet the needs of patients, as many elective and diagnostic procedures were placed on hold and pandemic hotspots have shifted around the country," said Freenome CEO Gabriel Otte. "We are grateful for the commitment of the clinical trial collaborators and investigators for working with us to enroll patients to improve accessibility and adherence to cancer screening with a simple blood test."

Today, Freenome also announced a $270 million Series C financing from a range of investors including financial institutions, healthcare companies and cancer organizations, such as the American Cancer Society and the Colorectal Cancer Alliance. The funding will be used to accelerate the PREEMPT CRC clinical trial, fund the company’s product pipeline, and continue building Freenome’s multiomics platform for a range of cancer types, in addition to colorectal cancer.

For more information about the PREEMPT CRC clinical trial or to enroll, please visit www.PREEMPTCRC.com.

About Colorectal Cancer (CRC) and Screening
According to the U.S. Centers for Disease Control (CDC), colorectal cancer (CRC) is the second leading cause of cancer death in the United States of cancers that affect both men and women. Both CRC incidence and mortality have declined steadily over the past 30 years, attributable in part to the increasing percentage of adults aged 50–75 years who are up to date with recommended CRC screening. However, only 68.8% of adults aged 50–75 years were up to date with CRC screening in 2018. A CDC study shows that compliance varies based on income, access to health insurance and other factors, including lack of awareness of the need to be screened, being offered colonoscopy only instead of a choice of tests, fear, expense, inability to take time off work and the perceived undesirable nature of screening tests.1

Aptorum Group Limited to Present at The LD 500 Virtual Conference and H.C. Wainwright 22nd Annual Global Life Sciences Conference

On August 26, 2020 Aptorum Group Limited (NASDAQ: APM, Euronext Paris: APM) ("Aptorum Group"), a biopharmaceutical company focused on the development of novel therapeutics to address global unmet medical needs, reported that Mr. Darren Lui, President and Executive Director of Aptorum Group, and Dr. Herman Weiss, CEO and Executive Director of Claves Life Sciences Limited and Senior Medical Advisor of Aptorum Group, will present at the LD 500 investor conference and H.C. Wainwright 22nd Annual Global Life Sciences Conference in September (Press release, Aptorum, AUG 26, 2020, View Source [SID1234564059]). To RSVP for the virtual conferences, please click through: View Source and View Source

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The LD 500 Virtual Conference

Date: Tuesday, September 1, 2020
Time: 9:20 AM Eastern Time (6:20 AM Pacific Time)

To book 1-on-1 investor meetings with Aptorum Group, please register for the virtual event here: https://ld-micro-conference.events.issuerdirect.com/signup

If you can’t attend the live presentation, the Company’s presentation webcast will be available on the conference event platform under the "Schedule" tab at https://ld-micro-conference.events.issuerdirect.com/presenting-companies

H.C. Wainwright 22nd Annual Global Life Sciences Conference

Date: Tuesday, September 15, 2020
Time: 9:30 AM Eastern Time (6:30 AM Pacific Time)

To book 1-on-1 investor meetings with Aptorum Group, please register for the virtual event here: View Source

Oncology Venture A/S Invites Investors for Q2 2020 Report Conference Call

On August 26, 2020 Oncology Venture A/S ("Oncology Venture") (OV:ST) reported that its executive management will host a live webcast on August 28, 2020, at 5:00 p.m. CEST to discuss the company’s second quarter 2020 results and provide a business and financial update (Press release, Oncology Venture, AUG 26, 2020, https://oncologyventure.com/press-release/oncology-venture-a-s-invites-investors-for-q2-2020-report-conference-call/ [SID1234564058]). The webcast will follow the publication of Oncology Venture’s Q2 2020 report, also scheduled for release on August 28, 2020.

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Interested parties may register for the event via the Events and Presentations section of the Oncology Venture website at View Source." target="_blank" title="View Source." rel="nofollow">View Source Please connect to the web-conference application prior to the start of the conference call to ensure adequate time for any software downloads that may be necessary to listen to the webcast.

Agenda:

General business update by CEO Steve Carchedi
Financial update by CFO Henrik Moltke
Q&A
Pre-submitted questions will be prioritized for the Q&A. To pre-submit a question, please email it to [email protected], no later than 3 pm CEST on 28 August.

Online webcast/conference call:

Attendees are encouraged to pre-register in order to be able to watch the presentation slides using this link:
·View Source