On September 17, 2020 RhoVac AB ("RhoVac")reported, on September 17 2020, that the first patient in Sweden is enrolled in the company’s clinical phase IIb study in prostate cancer, a study named RhoVac-002 ("BRaVac") (Press release, RhoVac, SEP 17, 2020, View Source [SID1234565324]).

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The first patient in Sweden is enrolled in the clinical study, called BRaVac. This clinical trial phase IIb-study is a randomized, placebo-controlled and double-blind study, with the primary objective of evaluating if treatment with the drug candidate RV001 can prevent or limit the development of advanced prostate cancer after curative intent treatment. The clinical phase IIb study is an international, multicenter study, which will recruit over 175 patients in six European countries (Denmark, Finland, Sweden, Belgium, Germany and Great Britain) and the US. In Sweden, the study will be conducted at university hospitals all around Sweden.

CEO Anders Månsson comments: "As a Swedish company we think it is particularly rewarding to note that we now start enrolling patients in Sweden. It is an important milestone in the RV001 project".

On September 17, 2020 Menarini Ricerche, the R&D division of the Menarini Group, reported the results of the dose escalation part of its B-PRECISE-01 clinical trial (NCT03767335) which is evaluating MEN1611, a potent and selective phosphatidylinositol 3-kinase (PI3K) inhibitor in development for the treatment of breast cancer (Press release, Menarini, SEP 17, 2020, View Source [SID1234565323]).

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The poster entitled "Results of the phase 1b dose escalation study of MEN1611, a PI3K Inhibitor, combined with trastuzumab (T) ± fulvestrant (F) for HER2+/PIK3CA mutant (mut) advanced or metastatic (a/m) breast cancer (BC)" (ID number: 347P) will be presented at the 2020 Virtual Annual Congress of the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper), which will take place on September 19-21.

B-PRECISE-01 is an open-label, multicenter, phase Ib, dose escalation and expansion study conducted in patients with HER2-positive, PIK3CA mutated, advanced or metastatic breast cancer, which has progressed after at least two lines of anti-HER2-based therapy. The primary objectives of the study were to determine the safety and the recommended Phase 2 dose (RP2D) of MEN1611 in combination with trastuzumab +/- fulvestrant. Secondary objectives include assessing preliminary clinical activity, pharmacokinetics and pharmacodynamics.

The combination of MEN1611 + trastuzumab +/- fulvestrant has shown an acceptable tolerability profile with no dose-limiting toxicities during the escalation phase, and most treatment emergent adverse events were reversible and manageable with supportive care. The RP2D was established at 48 mg BID. Promising antitumor activity in heavily pretreated patients, together with prolonged disease control, provided the rationale for continuing with the cohort expansion phase of the B-PRECISE-01 study, to test the RP2D in patients with HER2-positive, PIK3CA mutated, advanced or metastatic breast cancer.

On September 17, 2020 Protagonist Therapeutics, Inc. (NASDAQ:PTGX) reported that Dinesh V. Patel, Ph.D., President and Chief Executive Officer, will participate in a fireside chat at the upcoming Jefferies Next Generation IBD Therapeutics Virtual Summit 2020 (Press release, Protagonist, SEP 17, 2020, View Source [SID1234565322]).

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Presentation details:
Date: Wednesday, September 23, 2020
Time: 8 a.m. EDT

A live and archived webcast will be available at View Source and in the Investors section of the Protagonist Therapeutics website at View Source

On September 17, 2020 Precision Optics Corporation, Inc. (OTCQB: PEYE) (the "Company") reported that it has scheduled a conference call to discuss fourth quarter and fiscal year 2020 financial results on Thursday, September 24, 2020 at 5:00pm ET (Press release, Precision Optics, SEP 17, 2020, View Source [SID1234565321]).

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The Company intends to release its financial results and to file its 10-K after the close of the market on September 24, 2020 followed by the conference call.

Conference Call Details

Date and Time: Thursday, September 24, 2020 at 5:00pm ET

Call-in Information: Interested parties can access the conference call by dialing (844) 735-3662 or
(412) 317-5705.

Live Webcast Information: Interested parties can access the conference call via a live Internet webcast, which is available at View Source

Replay: A teleconference replay of the call will be available until October 1, 2020 at (877) 344-7529 or (412) 317-0088, confirmation # 10147933. A webcast replay will be available at View Source

On September 17, 2020 ESSA Pharma Inc. (Nasdaq: EPIX) (TSX-V: EPI), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported the presentation of data of ESSA’s clinical candidate, EPI-7386, at the ESMO (Free ESMO Whitepaper) Virtual Congress 2020 (Press release, ESSA, SEP 17, 2020, View Source [SID1234565320]).

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The oral poster presentation titled, "Preclinical profile of EPI-7386, a second-generation N-terminal domain androgen receptor inhibitor for the treatment of prostate cancer" was published on Thursday, September 17th.

The studies highlight new information about EPI-7386 including:

In vitro cellular gene expression analyses demonstrate that EPI-7386:
In an in vitro VCaP model, combination treatment of EPI-7386 with enzalutamide, apalutamide or darolutamide display broader and deeper inhibition of AR-associated transcriptional activity than higher doses of each single agent alone.
Shows superior activity to enzalutamide in an AR-V7-driven cellular model by modulating both AR-FL and AR-V7-driven gene expression with or without the addition of an external androgen such as R1881.
"Previously, we presented in vitro data demonstrating that combination treatment of EPI-7386 with enzalutamide displays broader and deeper inhibition of AR-associated transcriptional activity than higher doses of each single agent alone. These newest transcriptomic analyses demonstrate a similar effect on inhibiting AR-regulated genes by combining EPI-7386 with apalutamide and darolutamide. These data provide additional rationale for studying the potential benefit of combining EPI-7386 with a variety of second-generation anti-androgens in earlier line prostate cancer patients," said Dr. David R. Parkinson, President & Chief Executive Officer.