On October 4, 2021 Freenome, a privately held biotech company, reported that presented at the American Association of Family Practitioners (AAFP) Family Medicine Experience virtual meeting last week (Press release, Freenome, OCT 4, 2021, View Source [SID1234590780]). The poster1 describes the development of Freenome’s multiomics blood test for the detection of early-stage colorectal cancer (CRC) and its validation study. The study, called PREEMPT CRC, is the largest registrational study to date for a noninvasive test for CRC screening in an average-risk population.

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PREEMPT CRC, builds on the results from a study at last year’s American Society of Clinical Oncologists (ASCO) (Free ASCO Whitepaper) Gastroenterology annual meeting, that demonstrated Freenome’s blood test detected early-stage (I/II) CRC with a sensitivity of 94% and specificity of 94%.

Freenome’s multiomics approach combines tumor and non-tumor signals from DNA and protein and uses machine learning to detect CRC and advanced adenomas. The registrational study, PREEMPT CRC, is a large, multi-center study of average-risk participants that uses both traditional and virtual recruitment to ensure a diverse and representative clinical trial population.

"Regular screenings can help detect colorectal cancer early, providing a better chance of survival," said Theodore R. Levin, M.D., clinical lead for colorectal cancer screening for the Permanente Medical Group, research scientist at the Kaiser Permanente Division of Research, principal investigator of PREEMPT CRC and co-author of the study. "Continued research will help us develop a test that makes it easier for patients to be screened, ultimately saving more lives."

Currently, only 67% of average-risk individuals over the age of 50 are up to date on CRC screening,2 which is likely to decrease even more with new guideline changes recommending lowering the age to initiate CRC screening from 50 to 45.3

"This presentation demonstrates how our multiomics platform works in detecting early-stage colorectal cancer," said Mike Nolan, chief executive officer of Freenome. "We want to make CRC screening easy and accessible, so as we near the completion of PREEMPT CRC, we’re driven to accomplish that goal."

On October 4, 2021 Boston Scientific Corporation (NYSE: BSX) reported that it will webcast its conference call discussing financial results and business highlights for the third quarter ended September 30, 2021 on Wednesday, October 27, 2021 at 8:00 a.m. EDT (Press release, Boston Scientific, OCT 4, 2021, View Source [SID1234590778]). The call will be hosted by Mike Mahoney, chairman and chief executive officer, and Dan Brennan, executive vice president and chief financial officer. The company will issue a news release announcing financial results for the third quarter on October 27 prior to the conference call.

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A live webcast and replay of the webcast will be accessible at investors.bostonscientific.com. The replay will be available beginning approximately one hour following the completion of each event.

On October 4, 2021 Himalaya Therapeutics ("Himalaya"), a clinical-stage biopharmaceutical company focused on development and commercialization in Greater China, of a novel class of investigational antibody therapeutics for the treatment of solid tumor cancer, which are based on the Conditionally Active Biologics ("CAB") technology platform, reported that it has submitted four investigational new drug (IND) applications to the Center for Drug Evaluation (CDE) of the China National Medical Products Association (NMPA) (Press release, Himalaya Therapeutics, OCT 4, 2021, View Source [SID1234590776]).

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Himalaya submitted one IND for HTBA3011, its CAB-antibody drug conjugate (ADC) targeting AXL, a protein expressed on many tumor cells, for soft tissue and bone sarcomas, one for HTBA3011 for non-small cell lung cancer (NSCLC), one for HTBA3021, its CAB-ADC targeting ROR2, another protein expressed on many tumor cells, for melanoma, and one for HTBA3021 for NSCLC. AXL and ROR2 are both well-validated targets, where high expression has been correlated with aggressive disease in multiple cancer types and have both also been shown to be a common escape mechanism following PD-1, PD-L1, ALK and EGFR treatment.

"Although our Taiwan and Hong Kong sites are already part of the ongoing registrational global trials for these product candidates, adding Mainland China to our global trials as well will be a key milestone in our goal of providing treatment to patients in China for these deadly cancers for which availability of effective, novel treatments has been limited" said Brian Zhang, Himalaya’s CEO.

"This IND submission reflects our ability to operate quickly and efficiently in China by working closely with the regulatory authorities to advance its clinical candidates here" said Howe Li, Himalaya’s CMO. "This is an affirmation of the hard work, support and close coordination among not only our team members, but also our local and global partners, and BioAtla, our collaboration partner."

On October 4, 2021 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported new clinical and preclinical research will be presented at the 2021 AACR (Free AACR Whitepaper)-NCI-EORTC Virtual 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), taking place October 7 – 10, 2021 (Press release, Mirati, OCT 4, 2021, View Source [SID1234590773]).

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The Company will present preclinical data evaluating MRTX1719, the selected clinical candidate from our MTA-cooperative PRMT5 inhibitor program, in MTAP-deleted cancer models.

In addition, the Company will present a summary of the discovery and characterization of initial formulations of MRTX1133, a KRASG12D inhibitor, including in pancreatic cancer models. The presentation will also include preliminary new clinical data from a cohort of the KRYSTAL-1 study evaluating adagrasib in previously-treated patients with KRASG12C-mutated pancreatic cancer.

Learn more about Mirati’s development of therapies that target the genetic and immunological drivers of cancers at Mirati.com/science.

Mirati studies at the 2021 AACR (Free AACR Whitepaper)-NCI-EORTC International Conference include:
All times noted are U.S. Eastern Time (ET)

Presentation Title: MRTX1719: A First-in-class MTA-cooperative PRMT5 Inhibitor that Selectively Elicits Antitumor Activity in MTAP/CDKN2A Deleted Cancer Models
Author: Peter Olson, Ph.D., Mirati Therapeutics, Inc.
Session: Poster
Session Date/Time: Thursday, October 7, 9:00 a.m. and on-demand throughout conference

Presentation Title: Discovery and Characterization of MRTX1133, a Selective Non-Covalent Inhibitor of KRASG12D*
Author: James G. Christensen, Ph.D., Mirati Therapeutics, Inc.
Session: Plenary Session 5: Drugging Difficult Targets
Session Date/Time: Saturday, October 9, 12:05 – 1:55 p.m.

*Presentation to include preliminary clinical data from a cohort of the KRYSTAL-1 trial evaluating adagrasib in previously treated patients with KRASG12C-mutated pancreatic cancer.

About Adagrasib (MRTX849)
Adagrasib is an investigational, highly selective, and potent oral small-molecule inhibitor of KRASG12C that is optimized to sustain target inhibition, an attribute that could be important to treat KRASG12C-mutated cancers, as the KRASG12C protein regenerates every 24−48 hours. Adagrasib is a being evaluated as monotherapy and in combination with other anti-cancer therapies in patients with advanced KRASG12C-mutated solid tumors, including non-small cell lung cancer (NSCLC), colorectal cancer and pancreatic cancer. For more information visit Mirati.com/science.

About MRTX1133
MRTX1133 is an investigational, highly selective and potent small molecule inhibitor of KRASG12D. In preclinical studies, MRTX1133 exhibited a long half-life, an ability to bind the KRASG12D protein in both active and inactive states, and selective inhibition of KRAS G12D mutant cancer cells. In G12D mutant tumor models, MRTX1133 showed dose-dependent selective inhibition of the KRAS pathway and tumor regression. Increased activity was also shown when combined with rational combination therapies. MRTX1133 is in Investigational New Drug-enabling studies and has the potential to be a first-in-class therapeutic. For more information visit Mirati.com/science.

About MRTX1719
Mirati is developing MRTX1719, an internally discovered, synthetic lethal PRMT5 inhibitor for the treatment of methylthioadenosine phosphoylase (MTAP)-deleted cancers. PRMT5 is an enzyme critical to the survival of both healthy and cancer cells and is partially inhibited by methylthioadenosine (MTA), which accumulates in MTAP-deleted cancers. MRTX1719 has shown in preclinical models to selectively target the PRMT5/MTA complex in MTAP-deleted cancer cells while sparing healthy cells. MTAP gene deletion occurs in approximately 9% of all cancers including pancreatic, lung, and bladder cancers, as well as other patient populations that have limited treatment options. MRTX1719 is in Investigational New Drug-enabling studies and has the potential to be a first-in-class therapeutic.

On October 4, 2021 Exicure, Inc. (NASDAQ: XCUR), a pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) technology, reported a presentation at the Chardan Virtual 5th Annual Genetic Medicines Conference on Tuesday, October 5, 2021 (Press release, Exicure, OCT 4, 2021, View Source [SID1234590770]).

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Date: Tuesday, October 5, 2021
Time: 11:00 – 11:25 AM Eastern Time
Location: Virtual Webcast

The presentation will be available for live streaming via View Source

Replays of the webcast will be available on Exicure’s website for 30 days following the webcast.