On January 10, 2022 GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, reported a collaboration with Premier, Inc.’s PINC AI, an advanced technology and services platform that provides artificial intelligence-enabled clinical performance improvement technologies, to support patient access to Galleri, GRAIL’s groundbreaking multi-cancer early detection blood test (Press release, Grail, JAN 10, 2022, View Source [SID1234598540]).

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Under the partnership, Premier’s PINC AI will augment its AI-enabled clinical decision support technology to alert clinicians to patients who present an elevated risk of cancer and may benefit from early detection with the Galleri test. The alert will be evidence-based, integrated in the workflow and is expected to be compatible with existing electronic medical record systems. Indianapolis-based Community Health Network is expected to be the first health system to pilot candidate alerts.

"At GRAIL, we are steadfast in our mission to detect cancer early. We are committed to making Galleri available to healthcare providers and eligible patients as a complement to guideline recommended cancer screenings, because we know that most cancers are diagnosed too late, when outcomes are poor," said Dr. Joshua Ofman, president and chief medical officer at GRAIL. "The partnership with Premier’s PINC AI, a trusted leader in healthcare technology, will support a key pillar of new early cancer detection technology – the identification of eligible patients through healthcare providers’ existing workflows."

"PINC AI augments clinical intelligence and helps ensure patients receive evidence-based care," said Leigh Anderson, president of Premier’s PINC AI. "Our goal with the new candidate alerts is to ensure more patients who need a cancer screening get one. We believe that Galleri is a game-changing screening tool that has the potential to increase early detection and treatment that can save lives, improve quality and reduce unnecessary costs."

More than 600,000 people die from cancer each year in the U.S., according to the American Cancer Society. This is in large part because the majority of cancers are found in later stages when treatment options are limited. Recommended screening tests only cover five cancer types in the U.S.: breast, colon, cervical, prostate, and, in high-risk smokers, lung. More than 70 percent of cancer deaths are from cancers that lack recommended early detection screening.

In addition, studies have demonstrated that stage at diagnosis has the greatest impact on costs, with decreased costs for patients diagnosed early in the disease compared to those diagnosed at later stages.

"Galleri is a validated and transformational test that can detect more than 50 cancers with a single blood draw and predict the origin with a high degree of accuracy and a low rate of false positives," said Patrick McGill, M.D., executive vice president and chief transformation officer at Community Health Network. "With this collaboration between PINC AI and GRAIL, our clinicians will be alerted when patients meet certain criteria for the ordering of a Galleri test. We believe this will make Community Health Network much more effective in our efforts to detect cancers early, when treatments are more effective, giving our patients the best chances of a successful outcome. Thanks to Community Health Network’s Foundation sponsorship and funding, we are proud to be the first health system taking advantage of this collaboration."

Galleri is available in the U.S. by prescription only to complement existing single cancer screening tests.

About Galleri

The earlier that cancer is detected, the higher the chance of successful outcomes. The Galleri multi-cancer early detection test can detect more than 50 types of cancer, as defined by the American Joint Committee on Cancer Staging Manual, through a routine blood draw. When a cancer signal is detected, the Galleri test predicts the cancer signal origin, or where the cancer is located in the body, with high accuracy to help guide the next steps to diagnosis. The Galleri test requires a prescription from a licensed healthcare provider and should be used in addition to recommended cancer screenings such as mammography, colonoscopy, prostate-specific antigen (PSA) test, or cervical cancer screening. It is intended for use in people with an elevated risk of cancer, such as those aged 50 or older.

For more information about Galleri, visit www.galleri.com.

On January 10, 2022 GRAIL, LLC, a healthcare company whose mission is to detect cancer early, reported a collaboration with the Knight Cancer Institute at Oregon Health & Science University (OHSU) to offer Galleri, GRAIL’s multi-cancer early detection (MCED) blood test (Press release, Grail, JAN 10, 2022, View Source [SID1234598539]). OHSU will provide patients access to Galleri via a pilot program to help find signals of cancer in earlier stages and advance the delivery of cancer care.

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Beginning this month, the Galleri test will be offered to eligible patients through the OHSU Knight Cancer Institute. The OHSU Knight Cancer Institute is at the forefront of multi-cancer early detection, including serving as a founding member of the MCED consortium, a group of leading cancer-focused organizations evaluating technologies that have the potential to reduce cancer mortality through earlier detection and providing guidance for their clinical use.

"At GRAIL, we are focused on detecting cancer early, when treatments are more effective and there is potential for cure," said Dr. Josh Ofman, president and chief medical officer at GRAIL. "We are honored to work alongside the preeminent team of researchers and clinicians at the OHSU Knight Cancer Institute who share our vision and are committed to bringing their patients the benefits of earlier cancer detection."

More than 600,000 people die from cancer each year in the U.S., according to the American Cancer Society. This is in large part because the majority of cancers are found too late when outcomes are often poor. Recommended screening tests save lives, but only cover five cancer types in the U.S.: breast, colon, cervical, prostate, and, in high-risk smokers, lung. In fact, 71% of cancer deaths have no recommended early detection screening at all.

"Multi-cancer early detection is a true game-changing technology in how we detect and treat cancer," said Tom Beer, M.D., deputy director of the OHSU Knight Cancer Institute and chief medical officer of the Knight Cancer Institute’s Cancer Early Detection Advanced Research (CEDAR) Program. "After evaluating how the Galleri test worked in the clinical trial setting, we are now able to offer eligible patients access to the test."

In a clinical study, Galleri demonstrated the ability to detect more than 50 types of cancer, as defined by the American Joint Committee on Cancer Staging Manual, over 45 of which lack recommended screening tests today, with a low false positive rate of less than 1%. When cancer is detected, Galleri can determine the cancer signal origin with high accuracy.

OHSU is also a leading partner in the interventional PATHFINDER 2 study evaluating the implementation and performance of Galleri in a clinical care setting. Initial results from the first PATHFINDER study were presented by Dr. Beer at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting and demonstrated Galleri’s performance was consistent with findings from previous observational studies, underscoring the potential real-world ability of Galleri to find deadly cancers earlier.

About Galleri

The earlier that cancer is detected, the higher the chance of successful outcomes. The Galleri multi-cancer early detection test can detect more than 50 types of cancer, as defined by the American Joint Committee on Cancer Staging Manual, through a routine blood draw. When a cancer signal is detected, the Galleri test predicts the cancer signal origin, or where the cancer is located in the body, with high accuracy to help guide the next steps to diagnosis. The Galleri test requires a prescription from a licensed healthcare provider and should be used in addition to recommended cancer screenings such as mammography, colonoscopy, prostate-specific antigen (PSA) test, or cervical cancer screening. It is intended for use in people with an elevated risk of cancer, such as those aged 50 or older.

For more information about Galleri, visit www.galleri.com.

On January 10, 2022 Immune-Onc Therapeutics, Inc. ("Immune-Onc"), a clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting immunosuppressive myeloid checkpoints, reported the Company will present at the virtual 40th Annual J.P. Morgan Healthcare Conference on Tuesday, January 11, 2022, at 12:30 PM PST/3:30 PM EST, during the Private Companies Track 2 Immune-Onc Therapeutics, Inc. ("Immune-Onc"), a clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting immunosuppressive myeloid checkpoints, reported the Company will present at the virtual 40th Annual J.P. Morgan Healthcare Conference on Tuesday, January 11, 2022, at 12:30 PM PST/3:30 PM EST, during the Private Companies Track 2. Charlene Liao, Ph.D., chief executive officer of Immune-Onc, will provide a corporate overview, including recent clinical development progress and anticipated milestones for 2022 and beyond.. Charlene Liao, Ph.D., chief executive officer of Immune-Onc, will provide a corporate overview, including recent clinical development progress and anticipated milestones for 2022 and beyond.

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On January 10, 2022 Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) ("Aptorum Group" or "Aptorum"), a clinical-stage biopharmaceutical company, reported completion of the Phase I clinical trial for ALS-4 (a first in-class anti-virulence based small molecule drug targeting infections caused by Staphylococcus aureus, including, but not limited to Methicillin Resistant Staphylococcus Aureus ("MRSA")) and the Phase I clinical trial for assessing relative bioavailability and food effect of SACT-1 (a repurposed small molecule drug targeting Neuroblastoma and potentially other cancer types) (Press release, Aptorum, JAN 10, 2022, View Source [SID1234598537]).

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ALS-4’s first-in-human Phase I trial is a randomized, double-blinded, placebo-controlled, single and multiple ascending dose study designed to evaluate safety, tolerability, and pharmacokinetics of orally administered ALS-4 in healthy male and female adult volunteers. Dosing and clinical evaluations of the Single Ascending Dose studies ("SAD") and Multiple Ascending Dose studies ("MAD") have now been completed for a total of 72 healthy subjects and Aptorum is pleased to announce that no subjects were dropped from the studies. There were no Serious Adverse Events ("SAE") observed and no relevant clinical changes in respect of vital signs; ECG, clinical laboratory test results and physical examinations were observed compared to the relevant baseline in both SAD (25-200mg) and MAD (50-100mg). The safety data of the last SAD cohort (300mg) and MAD cohort (200mg twice a day for 14 days) are pending. With the encouraging safety data in our Phase 1 trial, we are on track to submit an IND application to the US FDA this year seeking to initiate a Phase 2 clinical study to assess the efficacy of ALS-4 in patients.

SACT-1’s first in-human clinical trial is a Phase 1, Open-label Randomized, Single Cross Over Bioavailability and Food Effect Study of SACT-1 in healthy adult volunteers. Aptorum is pleased to announce the successful completion of the trial, during which no SAE were observed. With the encouraging data in our trial so far, we are on track to submit an IND application to the US FDA this year seeking to initiate our planned Phase 1b/2a trial for SACT-1.

Dr. Clark Cheng, Chief Medical Officer and Executive Director of Aptorum Group, commented: "Further to our previous announcements, we are pleased to announce the completion of the above clinical trials for ALS-4 and SACT-1. This represents another key milestone for the company and one of the targeted strategic goals we had for 2021. This milestone supports the focus of Aptorum Group to embark on the exciting Phase II clinical trials for ALS-4 and planned Phase Ib/2a clinical trials for SACT-1, subject to IND clearance. The World Health Organization deems MRSA a high priority due to its significant mortality risks1. Neuroblastoma is a highly unmet solid tumor arising in the nervous system outside of the brain predominantly in pediatric patients. We believe that both ALS-4 and SACT-1 have the potential to effectively target these diseases, respectively and address the unmet needs in this area."

About ALS-4

As part of Aptorum Group’s Acticule infectious disease platform, ALS-4 is a novel first-in-class orally administered small molecule drug based on an anti-virulence approach targeting staphylococcus aureus including MRSA. ALS-4 targets the antimicrobial resistant properties of the bacteria and is believed to render the bacteria highly susceptible to the host’s immune clearance. ALS-4 is targeted for potential administration on a standalone or on a combination basis with other existing antibiotics such as vancomycin.

About SACT-1

SACT-1 is an orally administered repurposed small molecule drug to target neuroblastoma. SACT-1’s mechanism has been investigated in our preclinical studies to enhance tumor cell death and suppress MYCN expression (a common clinical diagnosis in high-risk or relapsed neuroblastoma patients where an amplification of MYCN is usually observed). SACT-1 is designed to be used especially in combination with standard-of-care chemotherapy.

On January 10, 2022 Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) ("Aptorum Group" or "Aptorum"), a clinical-stage biopharmaceutical company, reported the launch of its oncology and autoimmune discovery and development platform with an initial focus on indications including, but not limited to, non-small cell lung cancer ("NSCLC") and autoimmune diseases such as lupus, rheumatoid arthritis, inflammatory bowel diseases, etc (Press release, Aptorum, JAN 10, 2022, View Source [SID1234598536]).

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Under the platform, Aptorum has and will continue to conduct its screening process for novel first-in-class small molecule and PROTAC (Degrader) based drug candidates. On this basis, Aptorum is currently conducting optimisation for selected candidates as part of its small molecule library for major targets including, but not limited to EGFR, ALK, KRAS, p53 mutations. Aptorum has identified major unmet medical needs in third and fourth generation mutations, where applicable, for NSCLC for example and will be leveraging its existing drug discovery platform to deliver novel therapeutics for such targeted patient group.

Mr. Darren Lui, President and Executive Director, commented, "The exciting launch of our oncology and autoimmune platform, culminating with the discovery and development of small molecule and PROTAC based candidates, if achieved, will help address the significant unmet medical needs for patients suffering from NSCLC (and potentially other cancer types) and autoimmune diseases. For example, the current 5-year, average survival rate for NSCLC is 25%1, despite existing therapies available. Subject to further optimisation and development, we target to deliver these candidates to their respective clinical trial stage at the earliest for such unmet medical needs."

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