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Cytovation Announces Dosing of First Patient in its Phase I/II CICILIA Trial Investigating CyPep-1 in Patients with Solid Cancers

On May 27, 2020 Cytovation AS ("Cytovation"), a clinical-stage biotechnology company focused on developing CyPep-1, a next-generation lytic immunotherapy, reported that the first patient has today been successfully dosed in its Phase I/II CICILIA clinical trial (Press release, Cytovation, MAY 27, 2020, View Source [SID1234558591]). The CICILIA trial will investigate CyPep-1 in patients with advanced solid cancers (ClinicalTrials.gov Identifier: NCT04260529).

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The aim of the open-label, dose-escalation Phase I/II trial is to evaluate the safety, efficacy and pharmacokinetics of CyPep-1 given as intratumoral injection. Up to 21 patients with advanced (unresectable Stage III) or metastatic (Stage IV) solid tumor malignancies will be recruited. Two renowned clinical centers in the Netherlands are currently open for recruitment: the Netherlands Cancer Institute (NKI) in Amsterdam and Erasmus MC (EMC) in Rotterdam. Three additional university medical centers in the Netherlands will be opened shortly: the UMCU in Utrecht, the LUMC in Leiden and the MUMC in Maastricht.

This marks the first time a patient suffering from an advanced solid tumor will be dosed in a clinical trial with a lytic agent specifically targeting and lysing tumor cell membranes based on their altered molecular composition compared to healthy cells. CyPep-1’s mode of action enables it to selectively bind to and disrupt cancer cells by forming pores that destabilize and rupture the membrane to kill the cell. Upon lysis, tumor antigens are released into the circulation and induce a systemic, tumor-specific immune response by in-situ immunization, which offers the possibility of long-lasting immunity against the tumor.

Mr. Kjell-Inge Arnevig, CEO of Cytovation said: "We are thrilled about the progress we are making enrolling the first patient into the CICILIA trial. Treatment strategies that aim at recruiting the immune system to attack and kill tumor cells hold great promise and are currently a main focus in global oncology research. CyPep-1 may represent a unique, dual, tumor-agnostic approach that has a direct tumor-killing effect and boosts the effect of established immunotherapies across multiple tumor types. CICILIA is our first clinical trial in malignant tumors and we have an ongoing clinical trial investigating CyPep-1 in benign tumors, which is expected to read out in the coming months. We expect the result from this study to provide important support for the clinical proof-of-concept of this novel candidate. We look forward to providing updates on the clinical development of CyPep-1 in due course."

"Today’s announcement defines the first major milestone in the clinic for CyPep-1." commented Veroni Baas, Project Director of the CICILIA trial at CATO SMS, the CRO supporting Cytovation in this trial. "Our dedicated team supported the start-up of Cytovation’s first-in-human trial. Given these COVID-19 times, this encouraging start is extraordinary. We are glad to closely support Cytovation and to see how CyPep-1 progresses in the upcoming months."

ESSA Pharma to Present at Jefferies Virtual Healthcare Conference

On May 27, 2020 ESSA Pharma Inc. (Nasdaq: EPIX; TSX-V: EPI; ) ("ESSA" or the "Company"), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer reported the Company will be presenting at the Jefferies Virtual Healthcare Conference on Thursday June 4, 2020 at 3:30pm Eastern (Press release, ESSA, MAY 27, 2020, View Source [SID1234558590]).

Dr. David. R. Parkinson, Chief Executive Officer, will provide a corporate overview of the Company’s business and will be available for one-on-one meetings from June 2 – 4, 2020. ESSA’s Chief Operating Officer, Peter Virsik, and Chief Financial Officer, David S. Wood, will also be in attendance.

The presentation will be webcast live and can be accessed through the Investor Relations page at www.essapharma.com. A replay of the presentation will be available on the Company’s website for 90 days.

Presentation Details :

Presentation Date:

Thursday June 4, 2020

Presentation Time:

3:30pm Eastern Time

Zimmer Biomet Holdings to Present at Goldman Sachs 41st Annual Global Healthcare Conference

On May 27, 2020 Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, reported that President and CEO Bryan Hanson and Executive Vice President and Chief Financial Officer Suky Upadhyay will be participating in a fireside chat at the Goldman Sachs 41st Annual Global Healthcare Conference on Tuesday, June 9, at 4:40 p.m. Eastern Time (Press release, Zimmer Holdings, MAY 27, 2020, View Source [SID1234558589]).

A live webcast of the presentation can be accessed via Zimmer Biomet’s Investor Relations website at https://investor.zimmerbiomet.com. The webcast will be archived for replay following the conference.

Imaging Endpoints Supports FDA Approvals For Two New Cancer Treatments

On May 27, 2020 Imaging Endpoints reported that it has supported two additional U.S. Food and Drug Administration (FDA) approvals this month for new, life-saving therapies (Press release, Imaging Endpoints, MAY 27, 2020, View Source [SID1234558588]). The two New Drug Application (NDA) approvals, for two of the Company’s pharmaceutical company clients, included indications for adult patients with non-small cell lung cancer (NSCLC), adult and pediatric patients with thyroid cancer, and adult patients with advanced gastrointestinal stromal tumors (GIST).

Imaging Endpoints serves as the imaging CRO that performed the blinded independent central review of imaging for these new cancer treatments. The large, global clinical trials that supported these approvals included complex imaging requirements, a double read paradigm with real-time reporting, and included imaging within the primary endpoint.

Imaging Endpoints’ robust processes are designed to meet or exceed industry standards. All inspections to date, including inspections in 2018, 2019 and 2020 by FDA and the European Medicines Agency (EMA), have resulted in zero observations, clearly demonstrating the Company’s leadership in quality and compliance.

Doug Dean Burkett, PhD., Chief Executive Officer and President of Imaging Endpoints added: "We are honored to have supported the FDA approval of these two additional life-saving therapeutics as part of our relentless endeavor to Connect Imaging to the CureTM. Our rapid growth and success is the result of our dedication to provide industry-leading expertise, technologies and services through our amazing global team."

Seneca Biopharma Announces the Closing of its $5 Million Registered Direct Offering

On May 27, 2020 Seneca Biopharma, Inc. (Nasdaq:SNCA), a clinical-stage biopharmaceutical company developing novel treatments for various diseases of high unmet medical need, reported the closing of its previously announced $5 million registered direct offering (Press release, Seneca Biopharma, MAY 27, 2020, View Source [SID1234558587]). Pursuant to the terms of the offering, Seneca sold an aggregate of 5 million shares of its common stock at a sales price $1.00 per share. Seneca intends to use the net proceeds from the offering for general working capital.

H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The shares of common stock are registered pursuant to a registration statement on Form S-3 (File No. 333-218608) which became effective by the Securities and Exchange Commission (SEC) on June 23, 2017. The offering was made by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the securities being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at [email protected].

This press release shall not constitute an offer to sell or a 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.