Kura Oncology Announces Preliminary Data for Menin Inhibitor KO-539 Accepted for Oral Presentation at ASH

On October 7, 2020 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for the treatment of cancer, reported that an abstract reporting preliminary data from KOMET-001, an ongoing clinical trial of the Company’s oral, potent and selective menin inhibitor, KO-539, has been accepted for oral presentation at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (Press release, Kura Oncology, OCT 7, 2020, View Source [SID1234568184]).

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The following abstract will be posted on the ASH (Free ASH Whitepaper) website at 9:00 a.m. ET on November 5, 2020. Updated data will be presented at the meeting.

Title: Preliminary Data on a Phase 1/2A First in Human Study of the Menin-KMT2A (MLL) Inhibitor KO-539 in Patients with Relapsed or Refractory Acute Myeloid Leukemia
Publication Number: 115
Session Name: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Novel promising therapies for relapsed/refractory AML
Session Date: Saturday, December 5, 2020
Session Time: 9:30 AM – 11:00 AM
Presentation Time: 10:30 AM

About KOMET-001

KOMET-001 (Kura Oncology Menin Inhibitor Trial) is a Phase 1/2A study to determine the safety, tolerability and recommended Phase 2 dose of KO-539 in patients with refractory or relapsed acute myeloid leukemia (AML). A planned expansion phase in specific genetic subgroups, including NPM1 mutant AML and KMT2A rearranged AML, is expected to further evaluate anti-leukemic activity and tolerability of KO-539. Additional information about the Phase 1/2A study of KO-539 can be found at kuraoncology.com/clinical-trials-komet.

About KO-539

KO-539, an oral investigational drug candidate, is a novel compound targeting the menin-KMT2A (MLL) interaction for treatment of genetically defined AML patients with high unmet need. In preclinical models, KO-539 inhibits the KMT2A (MLL) protein complex and has downstream effects on HOXA9/MEIS1 expression. KO-539 has received Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of AML.

Genprex to Present at Zooming with LD Micro on October 14, 2020

On October 7, 2020 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company developing potentially life-changing technologies for patients with cancer and diabetes, reported that it will be presenting virtually at the upcoming Zooming with LD Micro event on Wednesday, October 14 at 11 a.m. ET (Press release, Genprex, OCT 7, 2020, View Source [SID1234568183]). Genprex’s President and Chief Executive Officer, Rodney Varner, will be delivering the company’s corporate presentation followed by a Q&A session with participants.

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Event: Zooming with LD Micro

Date: Wednesday, October 14, 2020

Time: 11 a.m. ET

Registration Link: https://bit.ly/34v3Sk3

Investors and other individuals may access the virtual presentation by registering for the event.

Oncolytics Biotech® to Participate in BIO Investor Forum Digital

On October 7, 2020 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported that the Company will be participating in the BIO Investor Forum Digital, which is taking place virtually from October 13-15, 2020 (Press release, Oncolytics Biotech, OCT 7, 2020, View Source [SID1234568182]).

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The Company’s profile for the forum is available here. Registered attendees will be able to view an on-demand corporate overview provided by President and Chief Executive Officer Dr. Matt Coffey. Company management will also be participating in one-on-one investor meetings at the forum. To schedule a meeting, please submit a meeting request on the forum website, or email [email protected].

Exact Sciences and Pfizer Extend and Amend Cologuard® Promotion Agreement

On October 7, 2020 Exact Sciences Corp. (Nasdaq: EXAS) and Pfizer Inc. (NYSE: PFE) reported an extension and amendment of their agreement to promote Cologuard, the first and only FDA-approved non-invasive stool DNA screening test for colorectal cancer (Press release, Exact Sciences, OCT 7, 2020, View Source [SID1234568180]). Under terms of the nationwide agreement, Pfizer will continue to provide marketing and related support for Cologuard and join Exact Sciences’ efforts to educate patients, physicians, and health systems about Cologuard.

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The COVID-19 pandemic has highlighted the need for convenient, accurate cancer testing options. Outcomes can be dramatically improved if colorectal cancer is caught in early stages, and with more than an estimated one million screening colonoscopies missed this year, there is an urgent need to increase screening rates.1 Cologuard is an accurate, at-home colon cancer screening option and is uniquely positioned to support screening during this time and after the pandemic abates.

"We’re thrilled to continue working with Pfizer to increase screening rates with Cologuard, especially during this critical time," said Kevin Conroy, chairman and CEO of Exact Sciences. "Over the past two years, Pfizer has shown incredible commitment to Exact Sciences’ goal of eradicating colorectal cancer by helping detect the disease at its earliest, most treatable stages. The talented Exact Sciences team is excited to continue joining forces with Pfizer to help improve screening rates among the 46 million unscreened Americans."

In the two years since the partnership began, more than 3 million people were screened with Cologuard and more than 90,000 healthcare providers ordered Cologuard for the first time. The combined teams have also introduced several new direct-to-consumer marketing campaigns and worked with dozens of large health systems to improve colorectal cancer screening rates.

"Now more than ever, Pfizer’s purpose – breakthroughs that change patients’ lives – has taken on an even greater urgency. This partnership is a testament to that purpose, and Pfizer is incredibly proud of the work we have done with Exact Sciences to raise colorectal cancer screening rates," said Mike Gladstone, Global President of Internal Medicine at Pfizer.

Under the terms of the amended agreement, Pfizer will provide sales and marketing support through the end of 2022 and health system support through the end of 2021. Exact Sciences will compensate Pfizer based on the amount of services provided, along with additional fixed and performance-related fees set forth in the agreement. Exact Sciences will maintain responsibility for all aspects of manufacturing and laboratory operations of Cologuard.

More information about the agreement is available here, in a form 8-K that Exact Sciences has filed with the Securities and Exchange Commission.

About Cologuard
Cologuard was approved by the FDA in August 2014, and results from Exact Sciences’ prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. Cologuard is included in the American Cancer Society’s (2018) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2016) and National Comprehensive Cancer Network (2016). Cologuard is indicated to screen adults 45 years of age and older who are at average risk for colorectal cancer by detecting certain DNA markers and blood in the stool. Do not use Cologuard if you have had precancer, have inflammatory bowel disease and certain hereditary syndromes, or have a personal or family history of colorectal cancer. Cologuard is not a replacement for colonoscopy in high risk patients. Cologuard performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and older. Cologuard performance in repeat testing has not been evaluated.

The Cologuard test result should be interpreted with caution. A positive test result does not confirm the presence of cancer. Patients with a positive test result should be referred for diagnostic colonoscopy. A negative test result does not confirm the absence of cancer. Patients with a negative test result should discuss with their doctor when they need to be tested again.

Achilles Therapeutics appoints Professor Karl Peggs as Chief Medical Officer

On October 7, 2020 Achilles Therapeutics ("Achilles"), a clinical-stage oncology company developing personalised cell therapies targeting clonal neoantigens, a novel class of tumour target, reported the appointment of Professor Karl Peggs as Chief Medical Officer (CMO) with effect from 4th January 2021 (Press release, Achilles Therapeutics, OCT 7, 2020, View Source [SID1234568179]). Professor Peggs is an internationally recognised leader in the field of cancer immunology and a founder of the Company.

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"Karl is a pioneer in the field of cancer immunology and has an unparalleled reputation for execution of complex cellular therapy trials," said Dr Iraj Ali, CEO of Achilles Therapeutics. "He was instrumental in the formation of Achilles and we are delighted that he will be joining the Company on a permanent basis. We are at an exciting time in our growth as we continue to expand our studies in non-small cell lung cancer and melanoma, whilst broadening our pipeline into other solid tumour indications."

"Achilles’ innovative platform, which enables the development of personalised T cell therapies for solid tumours targeting clonal neoantigens, has produced a uniquely compelling pipeline with the potential to target a broad range of cancers not satisfactorily addressed by currently approved therapies," said Professor Karl Peggs, Chief Medical Officer of Achilles Therapeutics. "I am thrilled to be working with the dynamic team at Achilles to execute on our vision of fundamentally changing how certain cancers are treated."

Karl is currently a Professor of Transplant Science and Cancer Immunotherapy at UCL Cancer Institute, Scientific Director of the NIHR Blood and Transplant Research Unit for Stem Cells and Immunotherapies, and Clinical and Scientific Director of the Sir Naim Dangoor Centre for Cellular Immunotherapy at UCLH. Karl received his preclinical training and MA at Cambridge University, completing his clinical training at Oxford University Medical School. He completed his general medical training at Addenbrooke’s Hospital Cambridge, and specialist haematology training at the John Radcliffe Hospital, Oxford and subsequently UCLH, London. He spent over 2 years at Memorial Sloan Kettering Cancer Center NYC, USA in the laboratory of Professor James Allison studying murine models of regulatory checkpoint blockade and subsequently ran a joint Research Laboratory with Professor Sergio Quezada at the UCL Cancer Institute where his research interests included viral infections, adoptive cellular therapies, and regulatory checkpoint-directed immune-therapeutics and he and Sergio retain active links to the institute. More recently he has established the clinical translational side of the academic CAR T cell programme at UCLH.