On September 23, 2019 Precision Optics Corporation, Inc. (OTCQB: PEYE) (the "Company") reported that it has scheduled a conference call to discuss fourth quarter and fiscal 2019 financial results on Thursday, September 26, 2019 at 5:00pm ET (Press release, Precision Optics, SEP 23, 2019, View Source [SID1234539721]).

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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 26, 2019 followed by the conference call.

Conference Call Details

Date and Time: Thursday, September 26, 2019 at 5:00pm ET

Call-in Information: Interested parties can access the conference call by dialing (877) 317-6789 or (412) 317-6789.

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 3, 2019 at (877) 344-7529 or (412) 317-0088, confirmation #10135010. A webcast replay will be available at View Source

On September 23, 2019 Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported that the Company’s Medical Director, Dr. Michael Silverman, has delivered a presentation titled "The Safety and Efficacy of Namodenoson in the Second Line Treatment of Advanced Hepatocellular Carcinoma (HCC) Patients with Underlying Child-Pugh B (CPB) Liver Cirrhosis: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study" at the International Liver Cancer Association (ILCA) annual conference on September 22, 2019 during the Novel Targets and Prognostic Markers Session (Press release, Can-Fite BioPharma, SEP 23, 2019, View Source [SID1234539689]). The ILCA’s 13th Annual Conference took place from September 20 to 22, 2019 in Chicago, Illinois. While the Phase II study did not achieve its primary endpoint of overall survival in the whole population (n=78), superiority in overall survival was found in the largest study subpopulation of patients who were classified Child Pugh B7 (CPB7, n=56) based on severity of the underlying cirrhosis, as compared to the placebo treated group. The Phase III study protocol which has already been designed by the Company will include CPB7 patients and will be presented to the U.S. FDA in a scheduled End of Phase II Meeting.

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Highlights from Dr. Silverman’s presentation included:

●Median overall survival in the CPB7 population of 6.8 months for those treated with Namodenoson as compared to 4.3 months for those treated with placebo

●A partial response rate of 9% in the Namodenoson group versus 0% in the placebo group

●1-year survival in the CPB7 population was 44% for the Namodenoson treated group, as compared to 18% for patients dosed with placebo (p=0.028)

●Subgroup analyses using a variety of demographic and baseline disease characteristics, such as sex, performance status, and HCC disease status indicate the overall survival advantage of Namodenoson over placebo persists in the vast majority of the subgroups

●The safety profile of Namodenoson continues to be highly favorable, and adverse events related to Namodenoson were generally mild or moderate and transitory, and did not require dose reduction or drug withdrawal

"These results attest to the robustness of Namodenoson activity in treating liver cancer. We have designed the Phase III trial to focus on the CPB7 subpopulation, and we look forward to meeting with the FDA soon to present the protocol and move forward with patient recruitment," stated Dr. Silverman.

The ILCA is the only international organization devoted exclusively to liver cancer research for experts from all related disciplines. Its mission is to lead a global community of physicians, scientists and allied professionals through education and research with the goal to better prevent and treat liver cancer.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being evaluated as a second line treatment for hepatocellular carcinoma, with a recently completed Phase II trial and planned Phase III trial in this indication. The drug is currently in an ongoing Phase II trial as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

On September 23, 2019 Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company focused on the development of female-specific oncology products in the precision medicine metastatic breast cancer arena, reported the enrollment and dosing of the first patient into a Phase 2 clinical trial of its lead investigational drug, lasofoxifene (Press release, Sermonix Pharmaceuticals, SEP 23, 2019, View Source [SID1234539705]).

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The open-label, randomized, multi-center Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE, NCT03781063) study will assess the efficacy of oral lasofoxifene versus intramuscular fulvestrant for the treatment of postmenopausal women with locally advanced or metastatic estrogen receptor-positive (ER+)/HER2- breast cancer with an ESR1 mutation and progression-free survival as the primary endpoint.

"To address this unique population, the landmark ELAINE study of women with advanced metastatic breast cancer is the first of its kind to select all patients for participation prospectively based on ESR1 mutation status," said Paul Plourde, M.D., vice president of clinical oncology development at Sermonix. "A potential targeted therapy for ER+/HER2- breast cancer patients could greatly advance our approach to this complex disease."

Assessment of ESR1 mutations is difficult in patients with advanced disease, as molecular heterogeneity can confound results and tissue biopsies of multiple tumor sites are impractical. To address this challenge, Sermonix partnered with Sysmex Inostics to identify appropriate study participants using the OncoBEAM ESR1 test. The liquid biopsy test has demonstrated proven clinical performance in screening patient plasma for ESR1 mutations.

"The OncoBEAM ESR1 technology allows us to determine if a mutation exists in the binding domain of the tumor’s estrogen receptor gene via a minimally invasive peripheral blood draw," said Dr. Plourde. "We are delighted to collaborate with Sysmex Inostics to quickly and accurately identify appropriate study candidates."

Sermonix’s mission to develop lasofoxifene as a precision medicine for women in great medical need is one important step closer to fruition with the initiation of the ELAINE study, according to Dr. David Portman, Sermonix founder and chief executive officer.

"The dosing of our first patient, which closely follows the completion of our Series A financing, marks a pivotal milestone and truly gratifying moment for Sermonix," said Dr. Portman. "ESR1 mutations are highly prevalent in ER+ metastatic breast cancer and confer a poor prognosis. We are encouraged to be able to offer women the opportunity to participate in the ELAINE study, and for Sermonix to deliver on the promise of demonstrating lasofoxifene’s potential as a novel endocrine treatment option in the fight against this incurable disease."

About Lasofoxifene
Lasofoxifene is an investigational, nonsteroidal selective estrogen receptor modulator (SERM), which Sermonix licensed from Ligand Pharmaceuticals Inc. (NASDAQ: LGND) and has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide. Lasofoxifene’s bioavailability and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance and ESR1 mutations, a common mutation in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations was recently discovered at Duke University and Sermonix has exclusive rights to develop and commercialize it in this area. Lasofoxifene, a potent, oral SERM could, if approved, play a critical role in the targeted precision medicine treatment of advanced ER+ breast cancer.

On September 23, 2019 Menarini Silicon Biosystems, the pioneer of liquid biopsy and rare cell technologies, reported that it will host a symposium on the importance of liquid biopsy and circulating tumor cells (CTCs) in advancing precision medicine for patients with metastatic breast and prostate cancer (Press release, Menarini, SEP 23, 2019, View Source [SID1234539722]).

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The pro+gram will take place at the 2019 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress and will feature some of the world’s leading clinical researchers in the field of liquid biopsy and CTCs. They will present summaries of available data supporting the clinical impact of prognostic value of CTCs in both early and advanced breast cancer, as well as in advanced prostate cancer. The researchers will also discuss potential clinical applications for liquid biopsy technologies and provide recommendations for using CTC enumeration to manage patients.

"Liquid biopsy plays an increasingly important role in bringing personalized medicine to patients with metastatic breast and prostate cancer," said symposium co-chair Wolfgang Janni, MD, University of Ulm, Germany. "The goal of this symposium is to define the role of CTCs and other blood-based markers in helping physicians better understand cancer evolution and progression. This is the future of precision medicine."

In addition to Dr. Janni, the distinguished presenters include co-chair Massimo Cristofanilli, MD, Robert H. Lurie Comprehensive Cancer Center, Feinberg School of Medicine, Chicago, IL; as well as faculty members Jean-Yves Pierga, MD, PhD, Institut Curie & Universite Paris Descartes, France, and Johann De Bono, MD, PhD, The Institute of Cancer Research and Royal Marsden, London, UK.

"The liquid biopsy field has grown tremendously in the past 15 years, thanks to the initial fundamental demonstration of the ability to detect circulating tumor cells in the blood of cancer patients and the continual improvements in CTC detection and characterization technology," said Dr. Cristofanilli. "Attendees can expect to get a comprehensive overview of state-of-the-art technology for CTC analysis. In addition, they will take part in discussions with the faculty about the future of this field and how we can move toward liquid biopsy as a standard of care for patients with advanced disease."

New Clinical Perspectives of CTCs in the Era of Precision Medicine will take place 28 September 2019, 18:30-20:00 in Santander Auditorium, Hall 3, Fira Gran Via, Barcelona Spain. The presentations are:

A single baseline CTC count for staging of metastatic Breast Cancer: Beyond anatomical description – M Cristofanilli
Prognostic and predictive value of CTC count in the management of HR+ Metastatic Breast Cancer – JY Pierga
Prognostic role of CTC detection in HR+ Early Breast Cancer – W Janni
CTC count and single cells evaluation in metastatic Prostate Cancer – J De Bono
The program will conclude with a 30-minute roundtable discussion between the faculty and audience members to discuss the current value of CTC enumeration for patient management and its potential future impact on clinical practice.

To learn more, ESMO (Free ESMO Whitepaper) attendees can visit Menarini Silicon Biosystems at Booth #311.

ESMO is the leading professional organization for medical oncology in Europe. The 2019 ESMO (Free ESMO Whitepaper) Congress will take place 27 September – 1 October, 2019, Barcelona, Spain.

On September 23, 2019 Forbius, a clinical-stage protein engineering company that develops biotherapeutics to treat fibrosis and cancer, reported presentations highlighting AVID200’s immuno-oncology mode of action at the Fifth CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) (CICON) in Paris (Sep. 25 – 28) and European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Annual Congress in Barcelona (Sep. 27 – Oct. 1) (Press release, Forbius, SEP 23, 2019, View Source [SID1234539690]).

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The presentations describe the selective targeting of TGF-beta by AVID200 to increase T-cell-mediated cytotoxicity and immune cell infiltration, resulting in enhanced efficacy of immune checkpoint inhibitors when combined with AVID200 in syngeneic mouse tumor models.

Details of the Presentations Are as Follows:

CICON

Date: Friday, Sep. 27, 2019

Time: 1:00 – 3:00 PM and 6:30 – 8:00 PM CEST (Poster Session B)

Abstract #B041

The full abstract will be available online on Sep. 25

ESMO

Date: Saturday, Sep. 28, 2019

Time: 12:00 – 1:00 PM CEST

Location: Hall 4

Abstract #3582, Presentation Number 504P

Link to online Program here (search for AVID200 to see full abstract)

About Forbius: Targeting TGF-beta and EGFR Pathways in Fibrosis and Cancer

Forbius is a clinical-stage protein engineering company that develops biotherapeutics to treat fibrosis and cancer. We are focused on the transforming growth factor-beta (TGF-beta) and epidermal growth factor receptor (EGFR) pathways.

Forbius’ team of TGF-beta biology experts have designed a proprietary platform of TGF-beta inhibitors with best-in-class potency and selectivity against the principal disease-driving isoforms 1 & 3. This novel class of TGF-beta inhibitors has proven highly active in preclinical models of fibrosis and cancer and was well-tolerated in long-term toxicology studies. Forbius’ lead TGF-beta 1 & 3 inhibitor, AVID200, is undergoing Phase 1 clinical trials in two fibrotic indications as well as in solid tumors.

Forbius’ lead program targeting EGFR is AVID100. AVID100 is an anti-EGFR antibody-drug conjugate (ADC) with a novel tumor-selective mode of action. This program is undergoing Phase 2a clinical trials in EGFR-overexpressing solid tumors.

About TGF-beta 1 & 3

TGF-beta 1 & 3 are the main oncogenic TGF-beta isoforms expressed by many solid tumors. They are believed to play a major role in T-cell suppression, fibrosis, and resistance to anti-PD-(L)1 therapies such as nivolumab (Opdivo) and pembrolizumab (Keytruda) (Chakravarthy et al., Nature Comm., 2018; Tauriello et al., Nature, 2018; Mariathasan et al., Nature, 2018).