On October 29, 2019 RhoVac AB ("RhoVac") reported, on 29th October, 2019, that the company has received approval from FIMEA (Finnish Medicines Agency) for starting the clinical phase IIb study in prostate cancer, a multicenter study entitled RhoVac-002 ("BRaVac") (Press release, RhoVac, OCT 29, 2019, View Source [SID1234550006]). The phase IIb study is an international, multicenter study, which is expected to recruit more than 175 patients in six European countries (Denmark, Finland, Sweden, the UK, Belgium and Germany), as well as in the United States.

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BRaVac is a randomized, placebo-controlled and double-blind study, with the primary objective of evaluating if and to what extent treatment with the drug candidate RV001 can prevent or limit the development of cancer measured as a limited development of PSA (Prostate Specific Antigene) in prostate cancer patients compared to the control group (placebo group). The Phase IIb study is an international multicenter study, which is expected to recruit more than 175 patients in six European countries (Denmark, Finland, Sweden, the United Kingdom, Belgium and Germany), as well as in the United States. The ambition is for all patients to be recruited by end Q3 2020. The results reporting on the primary objective of the study is expected during H2 2021. RhoVac has, after obtaining approval, received it in two countries, Denmark and Finland.

For further information, please contact:

Anders Månsson – CEO, RhoVac AB
Phone number: +46-73-751-72-78
E-mail: [email protected]

This information is such that RhoVac AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, on 29th October 2019.

On October 29, 2019 Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system, reported that it will release its financial results for the third quarter 2019 and business update on Thursday, November 7th, 2019 (Press release, Protalix, OCT 29, 2019, View Source [SID1234550005]). The Company’s management will host a conference call to discuss its financial results and provide a general business update at 8:30 a.m. Eastern Standard Time (EST).

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Conference Call Details
Thursday, November 7th at 8:30 a.m. Eastern Standard Time
Domestic (USA): 888-224-1005
International: 323-994-2093
Conference ID: 1931108
Webcast: http://bit.ly/2BSCaiY

The conference call will also be broadcast live and available for replay for two weeks on the Company’s website, www.protalix.com, in the Events Calendar of the Investors section. Please access the Company’s website at least 15 minutes ahead of the conference to register, download and install any necessary audio software.

On October 29, 2019 Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) reported that it will report its third quarter 2019 financial results after market close on Tuesday, November 5, 2019 (Press release, Rigel, OCT 29, 2019, View Source [SID1234550004]). Rigel senior management will follow the announcement with a live conference call and webcast at 4:30pm Eastern Time (1:30pm Pacific Time) to discuss the financial results.

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Participants can access the live conference call by dialing (877) 407-3088 (domestic) or (201) 389-0927 (international). The conference call and accompanying slides will also be webcast live and can be accessed from Rigel’s website at www.rigel.com. The webcast will be archived and available for replay for 90 days after the call via the Rigel website.

On October 29, 2019 Caprion is reported its leadership role in a Pre-Conference Workshop at the upcoming AAPS PharmaSci 360 conference, San Antonio, Texas (Press release, Caprion, OCT 29, 2019, View Source [SID1234550002]).

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The workshop initiated by Caprion’s team and led by Dr. Virginia Litwin, Vice-President of Flow Cytometry, will include pharmaceutical, biotech and regulatory leaders in biomarker research.

The workshop entitled "Best Practices for the Development and Fit-for-Purpose Validation of Biomarker Methods" will consist of presentations and break-out sessions, leading to consensus on the best practice for biomarker assay development and minimum validation requirements based on intended use. As a result of the workshop, a white paper will propose recommendations for the industry and regulatory agencies.

"Caprion’s involvement in this pre-conference workshop reflects its commitment to be an active player and a leader in defining the industry standards when it comes to the development of robust assay validation strategies", stated Dr. Lorella Di Donato, Senior Vice-President and Chief Operating Officer. "

Dr. Litwin is a frequent speaker, moderator, and panelist at pharmaceutical industry, scientific, and clinical conferences, and was recently recognized at the 2019 WRIB meeting for her outstanding contribution. She is the chair of the Document Development Committee for the new CLSI guidance document H62: The Validation of Assay Performed by Flow Cytometry, which will be open for public comment until November 18.

On October 29, 2019 Linnaeus Therapeutics, Inc. (Linnaeus), a privately held clinical-stage biopharmaceutical company focused on the development and commercialization of novel small molecule oncology therapeutics, reported that it has dosed the first patient in its phase 1/2 clinical trial of LNS8801 in patients with advanced solid and hematologic cancers (Press release, Linnaeus Therapeutics, OCT 29, 2019, View Source [SID1234550001]). This marks the first time any company has dosed a patient in a clinical trial specifically targeting the G protein-coupled estrogen receptor (GPER). The initiation of the study follows U.S. Food and Drug Administration (FDA) clearance of the company’s investigational new drug application (IND) for LNS8801 in late September.

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LNS8801 is an orally bioavailable small molecule that is a highly specific and potent agonist of the GPER.

"We are thrilled to begin testing LNS8801 in patients with advanced cancer. We will have six outstanding academic comprehensive cancer centers all enthusiastically recruiting patients for this promising study," commented Patrick Mooney, MD, chief executive officer of Linnaeus. "LNS8801 has very real potential to provide meaningful and lasting clinical benefit for patients with cancer, and we look forward to providing updates over the course of the study."

The study entitled, "A Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of LNS8801 in Patients with Advanced Cancer," is designed in two parts. The phase 1 dose-escalation portion of the trial will assess the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of LNS8801. After a recommended phase 2 dose is established, dose expansion cohorts are anticipated.

About LNS8801
LNS8801 is an orally bioavailable and highly specific agonist of GPER whose activity is dependent on the expression of GPER. GPER activation suppresses well-known tumor-associated genes, such as c-Myc and PD-L1. In preclinical cancer models, LNS8801 displays potent antitumor activities across a wide range of tumor types, rapidly shrinking tumors and inducing immune memory. LNS8801 monotherapy has shown significant antitumor activity, including inducing complete responses that are immune to rechallenge. LNS8801 also has shown effects when combined with targeted therapies and immunotherapies. Preclinical toxicology studies have established a wide safety margin.