On September 23, 2019 Phoenix Molecular Designs (PhoenixMD), a clinical stage biotechnology company developing precise cancer therapeutics targeting essential kinases, reported clearance from the Food and Drug Administration (FDA) for PhoenixMD’s Investigational New Drug (IND) application for its proprietary PMD-026 (Press release, PhoenixMD, SEP 23, 2019, View Source [SID1234539723]. That clearance permits PhoenixMD to begin patient enrollment into its Phase 1/1b clinical trial, which is expected to start in the United States during the fourth quarter of 2019.

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"Our IND clearance marks an important developmental milestone for PhoenixMD," said Sandra Dunn, Ph.D., chief executive officer of PhoenixMD. "To our knowledge, PMD-026 is the only purpose-built agent designed specifically to treat triple-negative breast cancer (TNBC). Additionally, we will be assessing the potential of PMD-026 to extend beyond TNBC and into other forms of advanced breast cancer."

PMD-026 is a proprietary first-in-class orally-available RSK (kinase) inhibitor being developed to treat certain forms of breast cancer. The Phase 1/1b clinical trial will evaluate safety, tolerability, pharmacokinetics and anti-tumor activity of PMD-026 in patients with advanced disease and a sub-group of women with TNBC. Importantly, this trial will include a CAP/CLIA certified companion diagnostic designed to detect RSK2 activation in breast tumors and to then correlate it with response to PMD-026. This is a new approach for the treatment of cancer that hinges on precision medicine and functional kinomics.

"TNBC patients with metastatic disease have limited treatment options and new drugs have not generally been specifically developed based on the biology of this type of tumor," said Gerrit Los, Ph.D., chief scientific officer of PhoenixMD. "We have had substantial interest from some of the top clinical oncology centers eager to participate in our upcoming trial, underscoring the need for treatment options for women with advanced disease."

About PMD-026
PhoenixMD’s lead candidate, PMD-026, is the first RSK inhibitor being developed for the treatment of TNBC. PMD-026 was precisely designed for TNBC because RSK2 was specifically identified as the key kinase, out of 519 kinases, that drives the growth of this breast cancer subtype. Preclinical data shows the potential for PMD-026 to be effective alone or in combination with conventional chemotherapies. It has the potential to be a platform technology for chemotherapy, hormone therapy and/or immunotherapy sensitization for a wide range of refractory cancers in the future.

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 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 Nektar Therapeutics (Nasdaq: NKTR) reported that new data from a cohort of patients with metastatic triple-negative breast cancer who were enrolled in the PIVOT-02 study will be presented at the upcoming 5th CRI-CIMT-EATI-AACR Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper), which is being held from September 25 to September 28, 2019, at the Espace Grand Arche de la Defense in Paris, France (Press release, Nektar Therapeutics, SEP 23, 2019, View Source [SID1234539720]). The PIVOT-02 study is evaluating bempegaldesleukin (bempeg, NKTR-214) in combination with nivolumab in a range of advanced and/or metastatic solid tumor settings.

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Poster Presentation:

Abstract #A001: "Clinical activity of BEMPEG plus NIVO observed in metastatic TNBC: preliminary results from the TNBC cohort of the Ph1/2 PIVOT-02 study", Tolaney, S., et al.

Session Date and Time: Thursday, September 26th from 1:00 p.m. – 3:00 p.m. and 6:30 p.m. – 8:00 p.m. Central European Time

Company to Host Webcast Conference Call at CRI-CIMT-EATI-AACR:
The company will host a webcast conference call with Dr. Sara M. Tolaney, MPH, Associate Director of the Susan F. Smith Center for Women’s Cancers and Assistant Professor of Medicine at Harvard Medical School and company management on Thursday, September 26th at 8:30 a.m. Eastern time during the CRI-CIMT-EATI-AACR conference following presentation of data. The webcast conference call will be accessible from the Investor Events page of Nektar’s website at View Source

On September 23, 2019 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage biopharmaceutical company focused on creating innovative cancer therapies, reported that the Company will be presenting updated data from the ongoing Phase 1 dose-escalation trials of AB928, a potential best-in-class dual antagonist of adenosine receptors A2aR and A2bR, in a poster display session at the 2019 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting taking place in Barcelona, Spain from September 27-October 1, 2019 (Press release, Arcus Biosciences, SEP 23, 2019, View Source [SID1234539719]).

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Poster presentation details

Title: Phase 1 evaluation of AB928, a novel dual adenosine receptor antagonist, combined with chemotherapy or AB122 (anti-PD-1) in patients (pts) with advanced malignancies
Presentation Number: 1206P
Session Name: Poster Display Session
Date and Time: Monday, September 30, 12:00 p.m. – 1:00 p.m. Central European Summer Time (CEST)
Location: Poster Area (Hall 4), Fira Gran Via, Barcelona, Spain

A copy of the poster will be available on the "Publications" section of the Arcus website at www.arcusbio.com.

About AB928

AB928 is a dual antagonist of adenosine receptors A2aR and A2bR designed to block adenosine-mediated impairment of intra-tumoral immune cells, mainly lymphocytes (CD8+ T cells and NK cells) and myeloid cells (dendritic cells, macrophages). Developed specifically for the oncology setting, AB928 achieves high penetration of tumor tissue, robust potency in the presence of high adenosine concentrations, and minimal shift in potency from non-specific protein binding. Among agents in the clinic, AB928 is the only antagonist of A2bR, found on both myeloid cells and cancer cells. AB928 thereby uniquely blocks adenosine’s immunosuppressive and cancer cell-intrinsic effects in the tumor microenvironment. AB928 has demonstrated a favorable safety profile with a variety of combination regimens and exhibits pharmacokinetics / pharmacodynamics consistent with once-daily dosing. AB928 is currently in several ongoing Phase 1/1b expansion trials across multiple indications.

About AB122

AB122 is a fully human IgG4 antibody that potently and selectively blocks PD-1. The biochemical, biological and preclinical properties of AB122 have been shown to be similar to those of marketed anti-PD-1 antibodies. The Company is evaluating AB122 both as monotherapy and in combination as a core component for the Company’s intra-portfolio combinations. AB122 is progressing into a Phase 1b biomarker-selected trial across advanced solid tumors in collaboration with Strata Oncology utilizing Strata’s precision drug development platform and proprietary biomarkers. AB122 is also in Phase 1/1b expansion trials in combination with AB928, a dual antagonist of adenosine receptors A2aR and A2bR, in combination with AB154, its anti-TIGIT antibody, and in combination with AB680, its small-molecule CD73 inhibitor, plus chemotherapy.