On May 28, 2020 Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs), reported that two abstracts will be published at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Meeting to be held from May 29 to May 31 (Press release, TYME, MAY 28, 2020, View Source [SID1234558635]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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CMBTs are proprietary investigational compounds that leverages cancer’s altered metabolism and associated vulnerabilities to specifically disrupt fundamental cellular processes. This can include altering protein synthesis, increasing oxidative stress, decreasing pH levels, and compromising protein or lipid barriers. In addition, CMBTs may target select survival mechanisms including autophagy, as well as altering the tumor microenvironment to improve immune recognition of the cancer.

In clinical trials, our lead cancer metabolism-based compound, SM-88 (racemetyrosine), has demonstrated encouraging tumor responses across 15 different cancers, including pancreatic, prostate, sarcoma, breast, lung, and lymphoma cancers with minimal serious grade 3 or higher adverse events.

Radiomics Abstract:

SM-88 is an oral dysfunctional tyrosine derivative. Previous studies reported a well-tolerated profile with encouraging efficacy. Recently, advances in image analysis using quantitative textural analysis have uncovered noninvasive biomarkers that correlate with molecular drivers of cancer and prognostic signatures of response. Earlier radiomic data from patients treated with SM-88 showed a positive correlation between circulating tumor cells and tumor radiomics at baseline. This study extends those findings to focus on radiomic changes associated with SM-88 in a Phase II dose escalation trial (NCT03512756).

Health Economic Outcomes Research Abstract:

Over the past 20 years, innovative cancer medicines have contributed to increased life expectancy, reduced mortality, decreased hospitalization and decreased use of medical services. Recently, a health economic study presented at ASCO (Free ASCO Whitepaper) GI 2020 cited that for every additional $1 spent on innovative medicines for pancreatic cancer between 2009 and 2016, there was a reduction in non-medicine spending of $8 to $9, thereby lowering the total cost of care for pancreatic cancer patients. Accordingly, the commercial opportunity of a new disease-altering therapy should be measured by some combination of the clinical, economic and social value created. This study demonstrates the value of a novel pancreatic cancer therapy from this perspective.

Additional information on the meeting can be found on the ASCO (Free ASCO Whitepaper) website at: View Source

Details for the abstracts are as follows

Title: Radiomic texture analysis correlates with PDAC patient outcomes on SM-88
Virtual Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic and Hepatobiliary
Virtual Session Date: May 29-31, 2020
Virtual Session Location: ASCO (Free ASCO Whitepaper) Virtual Scientific Program
Abstract Number: e16776

Title: Value-Based Estimate of Market Size and Opportunity for Economic Benefit Through Innovative Pancreatic Cancer Therapies
Virtual Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic and Hepatobiliary
Virtual Session Date/Time: May 29-31, 2020
Virtual Session Location: ASCO (Free ASCO Whitepaper) Virtual Scientific Program
Abstract Number: e16790

About SM-88

SM-88 is an oral investigational modified proprietary tyrosine derivative that is believed to interrupt the metabolic processes of cancer cells by breaking down the cells’ key defenses and leading to cell death through oxidative stress and exposure to the body’s natural immune system. Clinical trial data have shown that SM-88 has demonstrated encouraging tumor responses across 15 different cancers, including pancreatic, lung, breast, prostate and sarcoma cancers with minimal serious grade 3 or higher adverse events.

On May 28, 2020 bluebird bio, Inc. (NASDAQ: BLUE) reported that the company will host a live webcast to review new data presented at the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting on Friday, June 12 at 8:00 am ET (Press release, bluebird bio, MAY 28, 2020, View Source [SID1234558634]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Investors may listen to the call on June 12, 2020 at 8:00 am ET by dialing (844) 825-4408 from locations in the United States or +1 (315) 625-3227 from outside the United States. Please refer to conference ID number 2796099.

In addition, members of the management team will participate in the following upcoming investor conferences:

Jefferies Virtual Healthcare Conference, Thursday, June 4, at 3:30 pm ET
Goldman Sachs 41st Annual Global Healthcare Conference, Wednesday, June 10, at 9:40 am ET
To access the live webcasts of bluebird bio’s presentations, please visit the "Events & Presentations" page within the Investors & Media section of the bluebird bio website at View Source Replays of the webcasts will be available on the bluebird bio website for 90 days following the events.

On May 28, 2020 DURECT Corporation (Nasdaq: DRRX) reported that James E. Brown, President and CEO, will be presenting at the Jefferies 2020 Virtual Health Care Conference, Wednesday, June 3, 2020 at 10:00 a.m. EDT / 7:00 a.m. PDT (Press release, DURECT, MAY 28, 2020, https://investors.durect.com/news-releases/news-release-details/durect-present-jefferies-2020-virtual-health-care-conference?field_nir_news_date_value[min]=2020 [SID1234558633]). Institutional investors and analysts that are participating in the conference may request a virtual one-on-one meeting through the conference coordinators.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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A live audio webcast of the presentation will be available by accessing View Source

The live audio webcast of the presentation will also be available by accessing DURECT’s homepage at www.durect.com and clicking on the "Investors" tab. If you are unable to participate during the live webcast, the call will be archived on DURECT’s website in the "Event Calendar" of the "Investors" section.

On May 28, 2020 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage oncology therapeutics company developing drugs to treat cancers with the greatest medical need for new treatment options, including KRAS-mutated colorectal cancer, Zytiga-resistant prostate cancer and leukemia, reported that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to onvansertib, its oral and highly-selective Polo-like Kinase 1 (PLK1) inhibitor, for the second-line treatment of patients with KRAS-mutated metastatic colorectal cancer (mCRC) (Press release, Cardiff Oncology, MAY 28, 2020, View Source [SID1234558632]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"We are very pleased with the FDA’s decision to grant Fast Track designation for development of onvansertib to treat patients with KRAS-mutated mCRC," said Dr. Mark Erlander, Chief Executive Officer of Cardiff Oncology. "This designation is a significant validation of not only our onvansertib clinical program, which is now eligible for priority review and accelerated approval, but it also signifies recognition of the medical need for new effective treatment options. The efficacy of current second-line therapy in terms of response and survival prolongation remains very limited, particularly in the KRAS-mutated population, and we are confident that onvansertib, in combination with FOLFIRI/bevacizumab, represents a promising new treatment option."

Fast Track is a designation granted by the FDA that is intended to facilitate development and expedite review of drugs to address an unmet medical need in the treatment of a serious life-threatening condition, and for which nonclinical or clinical data has demonstrated the potential of the drug to address this medical need.

A drug that receives Fast track Designation is eligible for some, or all, of the following:

Eligibility for accelerated approval and priority review, if relevant criteria are met
Rolling review, enabling Cardiff Oncology to submit completed sections of its New Drug Application (NDA) for review by the FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed (NDA review usually does not begin until the Company has submitted the entire NDA to the FDA)
More frequent meetings with the FDA to discuss the drug’s development plan and ensure collection of appropriate data to support drug approval
More frequent written communication from the FDA about such things as the design of the proposed clinical trials and use of biomarkers
About the Phase 1b/2 Clinical Trial of Onvansertib in KRAS-Mutated mCRC

In this open-label, Phase 1b/2 trial, onvansertib in combination with standard-of-care FOLFIRI and Avastin (bevacizumab) is being evaluated for safety and efficacy for second-line treatment of patients with KRAS-mutated mCRC. The trial, A Phase 1b/2 Study of Onvansertib (PCM-075) in Combination with FOLFIRI and Bevacizumab for Second‑Line Treatment of Metastatic Colorectal Cancer in Patients with a KRAS Mutation, will enroll up to 44 patients with a KRAS mutation and histologically confirmed metastatic and unresectable disease. In addition, patients must have failed treatment or be intolerant of FOLFOX (fluoropyrimidine and oxaliplatin) with or without bevacizumab. The trial is being conducted at two prestigious cancer centers: USC Norris Comprehensive Cancer Center and The Mayo Clinic Arizona.

About Onvansertib

Onvansertib is a first-in-class, third-generation, oral and highly-selective adenosine triphosphate (ATP) competitive inhibitor of the serine/threonine polo-like-kinase 1 (PLK1) enzyme, which is over-expressed in multiple cancers including leukemias, lymphomas and solid tumors. Onvansertib targets the PLK1 isoform only (not PLK2 or PLK3), is orally administered and has a 24-hour half-life with only mild-to-moderate side effects reported. Cardiff Oncology believes that targeting only PLK1 and having a favorable safety and tolerability profile, along with an improved dose/scheduling regimen will significantly improve on the outcome observed in previous studies with a former panPLK inhibitor in AML.

Onvansertib has demonstrated synergy in preclinical studies with numerous chemotherapies and targeted therapeutics used to treat leukemias, lymphomas and solid tumor cancers, including irinotecan, FLT3 and HDAC inhibitors, taxanes and cytotoxins. Cardiff Oncology believes the combination of onvansertib with other compounds has the potential to improve clinical efficacy in acute myeloid leukemia (AML), metastatic castration-resistant prostate cancer (mCRPC), non-Hodgkin lymphoma (NHL), colorectal cancer and triple-negative breast cancer (TNBC), as well as other types of cancer.

Cardiff Oncology has three ongoing clinical trials of onvansertib: A Phase 2 trial of onvansertib in combination with Zytiga (abiraterone acetate)/prednisone in patients with mCRPC who are showing signs of early progressive disease (rise in PSA but minimally symptomatic or asymptomatic) while currently receiving Zytiga (NCT03414034); a Phase 1b/2 Study of onvansertib in combination with FOLFIRI and Avastin for second-line treatment in patients with mCRC with a KRAS mutation (NCT03829410; and a Phase 2 clinical trial of onvansertib in combination with decitabine in patients with relapsed or refractory AML (NCT03303339).

Cardiff Oncology licensed onvansertib (also known as NMS-1286937 and PCM-075) from Nerviano Medical Sciences (NMS), the largest oncology-focused research and development company in Italy, and a leader in protein kinase drug development. NMS has an excellent track record of licensing innovative drugs to pharma/biotech companies, including Array (recently acquired by Pfizer), Ignyta (acquired by Roche) and Genentech.

On May 28, 2020 Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) reported that it is scheduled to participate in the following upcoming events (Press release, Arrowhead Pharmaceuticals, MAY 28, 2020, View Source [SID1234558631]):

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Jefferies Virtual Healthcare Conference– June 2-4, 2020

June 4, 2:00 p.m. EDT – Chris Anzalone, Ph.D., Arrowhead’s president and CEO, will participate in a fireside chat presentation

Goldman Sachs 41st Annual Global Healthcare Conference – June 9-11, 2020

June 10, 11:20 a.m. EDT – Dr. Anzalone will participate in a fireside chat presentation

A copy of the presentation materials and webcast links, if the presentation is being webcast, may be accessed on the Events and Presentations page under the Investors section of the Arrowhead website.