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.

On October 29, 2019 Tolero Pharmaceuticals, Inc., a clinical-stage company focused on developing novel therapeutics for hematological and oncological diseases, reported the presentation of preclinical data of TP-1287, an investigational oral cyclin-dependent kinase 9 (CDK9) inhibitor, in castration-sensitive and resistant prostate cancer models and TP-1454, an investigational small-molecule pyruvate kinase M2 isoform (PKM2) activator, in colorectal cancer models (Press release, Tolero Pharmaceuticals, OCT 29, 2019, View Source;in-colorectal-cancer-models-300947320.html [SID1234550000]). These data were shared at the 2019 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), being held October 26-30, 2019, in Boston, Massachusetts.

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"We are pleased to present data on our early-stage investigational agents, TP-1287 and TP-1454. These results are a testament to our commitment to develop novel therapeutics and expand the combined oncology portfolio of Tolero and its parent company, Sumitomo Dainippon Pharma," said David J. Bearss, Ph.D., Chief Executive Officer of Tolero Pharmaceuticals, Inc. "Furthermore, these data improve our understanding of these assets and provide insight into the potential role CDK9 inhibition and PKM2 activation may play in the treatment of prostate and colorectal cancer."

Data from a preclinical prostate cancer model, showed TP-1287 as monotherapy and in combination with venetoclax or docetaxel enhanced tumor growth inhibition. Additionally, TP-1287 combined with docetaxel alone showed tumor growth inhibition.

In a separate preclinical colorectal cancer model, TP-1454 in combination with anti-PD1 and anti-CTLA4 therapies showed tumor regression, tumor growth inhibition and an acceptable safety profile.

Below are the details for the Tolero presentations:

Abstract Title

Details

Presenter

PKM2 Activation Modulates
Metabolism and Enhances
Immune Response in Solid
Tumor Models

Abstract #B080

October 28, 2019

12:30 – 04:00 p.m. ET

Poster Presentation

Satya Pathi, Ph.D., Study
Director in Pre-clinical
Oncology, Crown Bioscience,
Inc

Targeting CDK9 and Mcl-1 in
Castration-sensitive and
Resistant Prostate Cancer
Models

Abstract #C081

October 29, 2019

12:30 – 04:00 p.m. ET

Poster Presentation

Tetyana V. Forostyan,
Graduate Research
Assistant, Oncological
Sciences, University of Utah

About TP-1287
TP-1287 is an investigational oral cyclin-dependent kinase 9 (CDK9) inhibitor under evaluation in a Phase 1 study in patients with advanced solid tumors (NCT03604783). TP-1287 has shown favorable oral bioavailability in preclinical models.

About TP-1454
TP-1454 is an investigational oral pyruvate kinase M2 isoform (PKM2) activator, under preclinical evaluation in cell-based and animal models of solid tumors.

On October 29, 2019 Aethlon Medical, Inc. (Nasdaq: AEMD), a medical device technology company focused on unmet needs in global health, reported that it will issue financial results for its second quarter fiscal year 2020, ended September 30, 2019, at 4:15pm Eastern time on Friday, November 1, 2019 (Press release, Aethlon Medical, OCT 29, 2019, https://www.prnewswire.com/news-releases/aethlon-medical-to-release-second-quarter-financial-results-and-host-conference-call-on-november-1-2019-300947523.html [SID1234549999]).

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Management will host a conference call on Friday, November 1, 2019 at 4:30pm Eastern time to review financial results and recent corporate developments. Following management’s formal remarks, there will be a question and answer session.

To listen to the call by phone, interested parties within the U.S. should call 1-844-836-8741 and International callers should call 1-412-317-5442. All callers should ask for the Aethlon Medical, Inc., conference call.

A replay of the call will be available approximately one hour after the end of the call through November 8, 2019. The replay can be accessed via Aethlon Medical’s website or by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international) or Canada Toll Free at 1-855-669-9658. The replay conference ID number is 10136640.