On May 26, 2020 Freenome, a privately held biotechnology company that has pioneered a comprehensive multiomics platform for early cancer detection with a routine blood draw, reported that several new developments: initiating its PREEMPT CRC clinical trial; adding Gary Reedy, CEO of the American Cancer Society, to the Board of Directors; and appointing William Quirk as the Chief Financial Officer (Press release, Freenome, MAY 26, 2020, View Source [SID1234558491]).

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"Following strong data presented at ASCO (Free ASCO Whitepaper)-GI, which demonstrated 91% sensitivity (94% in Stage I/II patients) with 94% specificity for colorectal cancer (CRC), we are initiating the pivotal trial for our blood-based CRC test," said CEO, Gabriel Otte. "More recent studies using our multiomics platform have revealed that different biomarkers are required for the detection of precancerous polyps versus CRC, and the availability of a blood test with adenoma detection rates as good or better than any known fecal test will meaningfully improve patient adherence and revolutionize CRC screening," added Chief Medical Officer, Dr. Girish Putcha.

PREEMPT CRC is Freenome’s prospective clinical trial that will enroll 14,000 individuals to validate its multiomics blood test for CRC screening and FDA approval. The study will include asymptomatic, average-risk patients between the ages of 45 and 85 undergoing a screening colonoscopy.

"In conjunction with the initiation of PREEMPT CRC, we are delighted that Gary Reedy has joined our Board of Directors as an observer," said Mr. Otte. "Gary’s 40+ years of fighting cancer makes him an ideal partner in our mission of making cancer screening tests accessible for everyone and improving patient adherence to cancer screening guidelines."

"It is incredibly important to improve CRC screening rates as much as possible," said Reedy. "The National Colorectal Cancer Roundtable has set a goal of 80% screening adherence in every community. If Freenome’s multiomics approach can help us achieve that goal, it would be wonderful. This is why our BrightEdge impact fund has chosen to invest in Freenome’s work."

Mr. Reedy became Chief Executive Officer of the American Cancer Society in April 2015, but his work with the organization began more than 20 years ago, when he first became a volunteer leader with the organization. Prior to his work with the ACS, Mr. Reedy had a distinguished 37-year career as a healthcare business and advocacy leader, most recently as Worldwide Vice President, Government Affairs and Policy, at Johnson & Johnson. Previously, Mr. Reedy held senior leadership positions with SmithKline Beecham, Centocor, and Johnson & Johnson. Mr. Reedy is a graduate of Emory & Henry College and holds an honorary Doctor of Humane Letters degree from Arcadia University.

"We are also happy to announce Bill Quirk has joined Freenome as our CFO," said Mr. Otte. "Bill’s extensive background covering the diagnostics industry for nearly 20 years, including his experience in helping growth companies raise capital, makes him a great addition to our team."

"Freenome has the rare combination of exceptional science and a mission-driven culture, which positions us to have a profound impact on human health," said Mr. Quirk. "I’m excited to join Freenome at such a meaningful point in our development."

Prior to joining Freenome, Mr. Quirk served as a managing director in the equity research division of Piper Sandler, a full-service investment bank. Mr. Quirk received a Bachelor’s of Business Administration from Saint Norbert College, an MBA from the University of Minnesota’s Carlson School of Management, and holds the CFA designation.

On May 26, 2020 AmerisourceBergen, a global healthcare solutions leader, reported that it has been selected by Deciphera Pharmaceuticals (Deciphera) to support QINLOCK (ripretinib) (Press release, AmerisourceBergen, MAY 26, 2020, View Source [SID1234558490]). AmerisourceBergen is providing a unified commercialization approach for QINLOCK which was approved by the U.S. Food and Drug Administration (FDA) on Friday, May 15, 2020. QINLOCK is an orally administered kinase switch control inhibitor approved for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.

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In the United States, there are an estimated 4,000 to 6,000 cases of GIST, a rare form of cancer, diagnosed annually.1 The gastrointestinal cancer is characterized by disease-related symptoms, including vague abdominal pain, early feelings of fullness, vomiting and fatigue due to anemia.2 About 40-70% of GISTs are found in the stomach, 20-40% in the small intestine, 5-15% in the colon and rectum, and in rare cases, the esophagus (<5%).3 QINLOCK is a tyrosine kinase switch control inhibitor that was engineered to broadly inhibit KIT and PDGFRα mutated kinases, where genetic mutations or alterations in these kinases play a crucial role in the biology of these tumors leading to drug-resistance and disease progression.4

"At AmerisourceBergen, we believe we have a responsibility to help create healthier futures – for patients and our partners. The opportunity to work with Deciphera and support the launch of QINLOCK is the perfect example of how our integrated services work together to fulfill that purpose," said Jenny Fallone, Director, Global Branded & Specialty Sourcing, AmerisourceBergen. "We are proud that Deciphera selected us to help ensure patients affected by this rare disease – who have exhausted other treatments – have a new therapeutic option. By working together, we can accelerate product performance but, most importantly, increase patient access to this innovative treatment."

AmerisourceBergen’s established expertise in supporting rare disease treatments helps ensure that critical medications are safely delivered from manufacturers to patients every day. AmerisourceBergen is supporting QINLOCK through:

Specialty distribution: ASD Healthcare – one of the nation’s largest specialty pharmaceutical distributors that provides services to 95 percent of U.S. hospitals, as well as specialty pharmacies, outpatient dialysis clinics, hemophilia treatment centers, home healthcare companies and retail pharmacies – will support the distribution of QINLOCK to approved hospitals, specialty pharmacies and government entities. Oncology Supply, also a part of AmerisourceBergen, provides specialty distribution to independent oncology practices nationwide and will support the distribution of QINLOCK to oncology practices and clinics for in office dispensing.
GPO contracting for community oncology: AmerisourceBergen provides GPO contracting, integrated dispensing solutions and expertise through ION Solutions, the largest physician service organization and group purchasing organization specializing in the support of independent, community oncology practices.
Third-party logistics: ICS, a pharmaceutical third-party logistics provider, aims to increase supply chain efficiency and ensure commercial success for this product. ICS will support distribution to specialty pharmacies and distributors and provide full order-to-cash services.
Dispensing: AmerisourceBergen’s specialty pharmacy US Bioservices has more than 25 years of experience supporting small patient populations and is dispensing QINLOCK. The pharmacy also provides customized clinical care, focused on supporting adherence and patient outcomes. Physicians may submit prescriptions for this medication to US Bioservices via phone (877-757-0667), fax (888-899-0067), ePrescribe or the MyPathpoint Prescriber Portal.
AmerisourceBergen’s unified approach is supported by world-class commercialization support services – from global clinical trial and specialty logistics to patient access and adherence. By offering assistance at all stages of the product life cycle, AmerisourceBergen enables manufacturers to stay focused on developing life-saving therapies, while also having the confidence that their developments are expertly commercialized and brought to patients in need.

On May 26, 2020 Kronos Bio, Inc., dedicated to drugging transcriptional regulatory networks in cancer, reported that Norbert Bischofberger, Ph.D., President and Chief Executive Officer will present at the Jefferies Virtual Healthcare Conference taking place June 2-4, 2020 (Press release, Kronos Bio, MAY 26, 2020, View Source [SID1234558489]).

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Presentation Date: Wednesday, June 3, 2020
Presentation Time: 4:30 PM ET

A webcast will be made available on the Company’s website at www.kronosbio.com in the News and Events section. Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.

On May 26, 2020 Imago BioSciences, Inc. ("Imago"), a clinical stage biopharmaceutical company developing innovative treatments for myeloid diseases, reported that positive Phase 2 data from its lead pipeline program bomedemstat (IMG-7289), will be presented at the Virtual Edition of the 25th EHA (Free EHA Whitepaper) Annual Congress beginning June 12, 2020 (Press release, Imago BioSciences, MAY 26, 2020, View Source [SID1234558488]).

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Title: A PHASE 2 STUDY OF BOMEDEMSTAT (IMG-7289), A LYSINE-SPECIFIC DEMETHYLASE-1 (LSD1) INHIBITOR, FOR THE TREATMENT OF LATER-STAGE MYELOFIBROSIS (MF)

Session Topic: 16. Myeloproliferative Neoplasms

Final Abstract Code: EP1080

The data demonstrates the potential of bomedemstat as a monotherapy in intermediate-2 and high-risk patients with myelofibrosis who have become intolerant of, or resistant to, or are ineligible for a Janus Kinase (JAK) inhibitor.

Imago is currently conducting a Phase 2 study of bomedemstat in five countries. Clinical endpoints include spleen volume reduction, reduction in total symptom scores, and improvement in circulating inflammatory cytokines, anemia, bone marrow fibrosis and blast count. For additional information, visit cliniciatrials.gov (NCT03136185).

About Bomedemstat (IMG-7289)

Bomedemstat is being evaluated in an open-label Phase 2 clinical trial for the treatment of advanced myelofibrosis (MF), a bone marrow cancer that interferes with the production of blood cells. The endpoints include spleen volume reduction and symptom improvement at 12 and 24 weeks of treatment. Bomedemstat is used as monotherapy in patients who are resistant to, intolerant of, or ineligible for a Janus Kinase (JAK) inhibitor.

Bomedemstat is a small molecule developed by Imago BioSciences that inhibits lysine-specific demethylase 1 (LSD1 or KDM1A), an enzyme shown to be vital in cancer stem/progenitor cells, particularly neoplastic bone marrow cells. In non-clinical studies, IMG-7289 demonstrated robust in vivo anti-tumor efficacy across a range of myeloid malignancies as a single agent and in combination with other chemotherapeutic agents. Bomedemstat (IMG-7289) is an investigational agent currently being evaluated in ongoing clinical trials (ClinicalTrials.gov Identifier: NCT03136185 and NCT02842827). Bomedemstat has FDA Orphan Drug and Fast Track Designation for the treatment of myelofibrosis and essential thrombocythemia, and Orphan Drug Designation for treatment of acute myeloid leukemia.

On May 26, 2020 Qurient Co. Ltd. (KRX: 115180), a clinical stage biotech company in Korea, reported that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for Q702, orally available immuno-oncology therapeutic small molecule targeting Axl, Mer and CSF1 receptor tyrosine kinases (Press release, Qurient Therapeutics, MAY 26, 2020, View Source [SID1234558487]).

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Under this IND, Qurient plans to initiate a Phase 1 clinical study in patients with advanced solid tumors for whom standard of care therapies are currently ineffective. The Phase 1 study is expected to begin in 3Q2020 and is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of Q702. The study will be conducted at multiple clinical centers in the United States.

"IND clearance for Q702 is an important milestone presenting a novel drug candidate that not only boosts immune cells in the tumor microenvironment but also makes tumor cells more visible to the immune system," said Kiyean Nam, Ph.D., CEO of Qurient. "We believe Q702 may have an important role in the cancer immunotherapy, improving clinical responses in patients who are unresponsive and/or refractory to currently available immunotherapy."

Q702 is an orally available, selective Axl/Mer/CSF1R triple kinase inhibitor showing significant in vivo activity as monotherapy as well as in combination with anti-PD-1 antibody. Q702 not only modulates innate immune components such as myeloid derived suppressor cell (MDSC), tumor associated macrophage (TAM) in tumor micro-environment (TME), but also increases MHC I expression in tumor cell.

The Axl inhibitor program was licensed from Lead Discovery Center (LDC) and the Max-Planck Society at lead stage and further optimized by Qurient. The research program initially originated from Professor Axel Ullrich’s laboratory from the Max Planck Institute of Biochemistry, Martinsried/Germany.

"We are excited to see the progress in this project and are looking forward to the application in humans in the near future. With Qurient, we have identified an ideal partner for this project and we are more than happy about the results of our strategic partnership with them," said Matthias Stein-Gerlach, Senior Patent and Licensing Manager at Max-Planck Innovation GmbH.

"Reaching a clinical candidate for development is one of the most important milestones in our partnerships," adds Bert Klebl, CEO and CSO of the LDC. "Starting an early-stage collaboration with Ullrich’s lab from Max Planck, leading to a licensing agreement with Qurient, we jointly mastered the pharmaceutical research phase and are now very eager to receive the results from this drug candidate in patients. Starting with this program, we have since built a sustainable and strong partnership with our partner Qurient, focusing on the translation of innovative biology and drug discovery programs from LDC’s academic network."