On April 5, 2018 SignalRx Pharmaceuticals Inc., a clinical-stage company developing novel small-molecules therapeutics via in-silico design to simultaneously inhibit multiple key orthogonal and synergistic oncotargets for the treatment of cancer, reported the presentation of its novel triple CDK4-6/PI3K/BRD4 inhibitor program and first-in-class triple inhibitor SRX3177 (Press release, SignalRx, APR 5, 2018, http://www.ireachcontent.com/news-releases/signalrx-to-present-on-its-first-in-class-triple-cdk4-6pi3kbrd4-inhibitor-srx3177-for-treating-cancer-at-the-13th-annual-drug-discovery-chemistry-2018-meeting-678885923.html [SID1234527318]). The presentation by Donald L. Durden, MD, PhD, senior scientific advisor for SignalRx, will be at 2:20 pm on Thursday April 5th, 2018, in the Small Molecules for Cancer Immunotherapy session at the Drug Discovery Chemistry 2018 meeting in San Diego, CA. Data related to combinatorial small molecules which strike multiple immune-oncology cancer targets and activate the innate and adaptive anti-tumor immune response will be presented. The Small Molecules for Cancer Immunotherapy session will also be chaired by Dr. Durden.

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Using SignalRx’s proprietary CRIMP technology platform, the company designed SRX3177 to inhibit three key cancer-driving oncotargets with one drug: CDK4/6, PI3K and BRD4. SRX3177 results in synergistic synthetic lethality in cancer cells (e.g., breast cancer, mantle cell lymphoma) because this novel anticancer agent addresses the following critical cancer-driving facts:

PI3K inhibition abrogates resistance to CDK4/6 inhibition.
BRD4 inhibition decreases transcription of cyclin D1 and MYC.
MYC inhibition decreases levels of immuno-oncology targets CD47 and PD-L1.
CDK4/6 inhibition activates the AKT pathway.
"SignalRx designs all its novel chemotypes and drugs in silico. Because not a single chemotype comes from screening commercially available compounds, SignalRx has built and continues to build a strong and proprietary pipeline" said Dr. Donald L. Durden, founder and senior scientific advisor of SignalRx Pharmaceuticals and Professor and Associate Director of Pediatric Oncology at the Moores UCSD Cancer Center.

The profile of in silico designed small-molecule triple inhibitor SRX3177 includes:

Picomolar CDK4 inhibition potency.
Double-digit nM PI3K and BRD4 inhibitory potency.
BRD4-BD1 selective (5 X) vs BRD4-BD2.
5 Fold more potent than Palbociclib as CDK4 inhibitor.
19-80 Fold more potent than Palbociclib in 3 in vitro cancer cell assays.
40 Fold less toxic in normal epithelial cells vs corresponding combination of three separate inhibitors (Palbociclib + BKM120 + JQ1).
Induction of cell cycle arrest and increased apoptosis.
Lethal in 85% of the cancer cell lines tested in NCI 60 cancer-cell panel.
"All our chemotypes are small molecules (no linking moieties used). Because we rationally design all our anticancer agents from the beginning, we know how to tune in and out target affinity in our compounds. We are in an excellent position to also explore CDK4/6-BRD4 and CDK4/6-PI3K single small-molecule inhibitors for cancer and other applications" said Dr. Joseph Garlich, SignalRx’s Chief Scientific Officer.

SignalRx is also seeking partnering opportunities to accelerate the development of its programs and advance novel anticancer therapeutics into first-in-man clinical trials based on the promising profile and mode of action of its inhibitors. Since these are single molecules with a single PK/PD and toxicity profile, there is a great opportunity to streamline their development alone and in combination therapies.

On April 5, 2018 Oncolytics Biotech Inc. (TSX: ONC) (OTCQX: ONCYF), a biotech company developing REOLYSIN (pelareorep), an intravenously delivered immuno-oncolytic virus creating an inflamed phenotype, reported that it will be presenting at the MicroCap Conference, being held at the Essex House in New York City on April 9 – 10, 2018 (Press release, Oncolytics Biotech, APRIL 5 2018, View Source [SID1234525207]). The Company’s presentation will be on April 10th at 8:30 am ET.

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Dr. Matt Coffey, President & Chief Executive Officer, will present a corporate overview, focusing on pelareorep’s mechanism of action and the Company’s lead program in HR+/HER2- metastatic breast cancer. The presentation will also describe Oncolytics’ pipeline expansion programs, focusing on combination therapies of REOLYSIN with other immuno-oncology drugs, including Merck’s Keytruda and targeted immunomodulatory drugs, including Celgene’s Revlimid and Imnovid.

The MicroCap Conference is an exclusive event for investors who specialize in small and microcap stocks. It is an opportunity for investors to be introduced to and speak with management at some of the most attractive small companies, learn from various expert panels, and mingle with other microcap investors.

A live audio link to the webcast session will be available on the Company’s website at View Source It is recommended that listeners log on 10 minutes in advance of a live session to register and download any necessary software. An audio replay will be accessible approximately two hours following the presentation on the Oncolytics website.

On April 5, 2018 Oncoceutics, Inc. reported that the first patient has been treated in a clinical trial of ONC201 for patients with certain types of advanced endometrial and breast cancer (Press release, Oncoceutics, APR 5, 2018, View Source [SID1234558370]). The Phase II trial is led by Alexandra Zimmer, MD, Assistant Research Physician at the Women’s Malignancies Branch at the National Cancer Institute (NCI) Center for Cancer Research, part of the National Institutes of Health (NIH). The study will enroll up to 94 adult patients using ONC201 as a single-agent and will require tumor biopsies to enable direct evaluation of the activity of ONC201 within the tumor (Trials.cancer.gov Identifier#NCT03394027).

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Early results from ongoing clinical trials with ONC201 in high grade gliomas has shown promising single-agent activity that is related to the ability to target dopamine receptors. This study will extend the evaluation of ONC201 beyond glioma to include additional tumor types. This is the first clinical trial to launch out of a consortium of multiple investigators across different divisions at the NIH who are working with Oncoceutics to create, understand, and translate its novel class of therapies called imipridones to address unmet medical needs in oncology.

Endometrial and breast cancers have emerged as tumors that are sensitive to ONC201 in preclinical models through unique mechanisms of action that will be investigated in this clinical trial. Preclinical findings from a team of NCI investigators led by Stan Lipkowitz, MD, PhD, Chief of the Women’s Malignancies Branch in the NCI’s Center for Cancer Research, have shown that ONC201 has unique deleterious effects on the mitochondria of breast cancer cells. These findings are described in a recent publication (Greer et al., Oncotarget, In Press). This Phase II study continues the effort to understand the mechanism of ONC201, and to provide therapies to patients with metastatic breast cancer that are in need of new treatments.

Independent work led by Victoria Bae-Jump, MD, PhD, at UNC Lineberger Comprehensive Cancer Center, has found that dysregulated expression of dopamine receptors targeted by ONC201 induce tumor cell death in endometrial cancer. These findings were disclosed as an oral presentation at the recent annual meeting of the Society of Gynecological Oncology meeting in New Orleans.

"Unlike many other cancers, endometrial cancer has not gained targeted therapy treatment options despite the clear need for patients who have failed chemotherapy," said Dr. Bae-Jump. "Our recent work shows that endometrial cancer cells harbor altered expression of dopamine receptors that can be targeted by ONC201, creating the potential for an actionable molecular target for this disease."

On April 5, 2018 Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE), a clinical-stage biotechnology company that designs and develops innovative human enzyme therapeutics for patients with rare genetic diseases and cancer, reported that it will present Phase 1 dose escalation data regarding the use of the Company’s pegzilarginase in patients with advanced solid tumors at the 2018 Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in Chicago, Illinois on Sunday, April 15 (Press release, Aeglea BioTherapeutics, APR 5, 2018, View Source [SID1234525187]).

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Title: Phase I Dose Escalation Trial of Pegzilarginase in Patients with Advanced Solid Tumors

Session Title: Phase I Clinical Trials 1

Session Date and Time: Sunday, April 15, 1:00 p.m. to 5:00 p.m. CT

Session Location: McCormick Place South, Hall A, Poster Section 42

Poster Board Number: 23

Permanent Abstract Number: CT030

An electronic version of the presentation will be available for download from the Presentations & Events section of the Company’s investor relations website after the poster presentation.

About Pegzilarginase (AEB1102) in Cancer
Pegzilarginase is an enhanced human arginase that enzymatically degrades the amino acid arginine. In some cancers, tumor cells stop producing specific amino acids and must acquire them from the blood, making the tumor cells susceptible to starvation through depletion of those amino acids. Aeglea is developing pegzilarginase to exploit vulnerabilities in some cancers that lead to an increased dependency on extracellular arginine. Pegzilarginase targets these arginine dependent cancers by depleting blood arginine levels to below the normal range. Preclinical data demonstrated that the resulting arginine starvation inhibits proliferation, induces cell death, increases turnover of cell components and promotes anti-tumor immune responses. The Company’s Phase 1 data in advanced solid tumors demonstrated that pegzilarginase was well tolerated at doses that produced marked and sustained reductions in blood arginine levels below the normal range.

On April 5, 2018 FORMA Therapeutics reported that it has successfully completed a critical objective under its strategic collaboration agreement with Celgene Corporation, triggering an undisclosed payment from Celgene (Press release, Forma Therapeutics, APR 5, 2018, View Source [SID1234525190]). Previously, FORMA and Celgene entered into a collaboration in the promising area of protein homeostasis to discover, develop and commercialize innovative drug candidates. This collaboration enables Celgene to evaluate select therapeutic candidates and programs in protein homeostasis during preclinical development.

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Jim Winkler, Ph.D., Vice President, Biology at FORMA Therapeutics said, "We are pleased with Celgene’s continued confidence in FORMA’s discovery research. This program represents a potential first-in-class therapeutic mechanism, by conferring both anti-tumor and immune-modulatory effects. We believe the field of protein homeostasis will deliver a promising pipeline of drugs, moving beyond cancer into immuno-oncology, inflammation and neurodegeneration."

About Protein Homeostasis

Protein homeostasis, which is important in oncology, neurodegenerative and other disorders, involves a tightly regulated network of pathways controlling the biogenesis, folding, transport and degradation of proteins. Exploring the maintenance and regulation of such competing, yet integrated, biological pathways using a chemical biology approach, should directly contribute to the understanding of diseases associated with excessive protein misfolding, aggregation and degradation