On December 6, 2021 Helio Health ("Helio") and its commercial partner, Fulgent Genetics, Inc. (NASDAQ: FLGT) ("Fulgent"), reported the commercial launch of HelioLiver, a multi-analyte blood test that incorporates cell free DNA (cfDNA) methylation patterns and serum protein markers for the detection of hepatocellular carcinoma (HCC) – the most common form of liver cancer (Press release, Fulgent Genetics, DEC 6, 2021, View Source [SID1234596511]). HelioLiver can detect HCC at its earliest stages when lesions are still very small, an area where traditional standard-of-care imaging tools often fall short, with the potential to enable more curative treatment options known to increase five-year survival rates by up to 13 times compared to when cancer has metastasized.1,2

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Recent data presented at The Liver Meeting 2021 outlined HelioLiver’s superior sensitivity over currently available blood-based tests. With a specificity of 91%, HelioLiver demonstrated 76% sensitivity in detecting early-stage HCC, significantly outperforming other detection tools such as AFP (57%), GALAD (65%), and ultrasound (47%).3,4

"We are excited to offer patients at high risk of developing liver cancer a convenient and sensitive serial testing option to catch cancer early when it counts the most," said Justin Chen Li, U.S. Chief Executive Officer, Helio Health. "We are proud to partner with Fulgent to launch this innovative, simple, and reliable test that has the potential to redefine the future of cancer testing and foster better patient outcomes."

HelioLiver offers a simplified process for patients with a blood draw that can be conducted during a routine check-up, providing a quick and accurate way to receive regular surveillance for people at risk of developing liver cancer. While the American Association for the Study of Liver Diseases (AASLD) guidelines recommend ultrasound screening every six months for patients who are at risk, studies have shown that as few as 20% of patients actually receive regular surveillance due to the inconvenience of accessing testing via ultrasound.5 Helio believes this number can dramatically increase with this new, blood-based test.

"Through our partnership with Helio, our joint priority is to bring HelioLiver to providers and patients in a seamless manner," said Brandon Perthuis, Chief Commercial Officer, Fulgent Genetics. "Leveraging our extensive commercial infrastructure, we are well-positioned to deliver an easy ordering experience for providers with our representatives at the ready to provide the best-in-class white glove service throughout the entire experience."

Providers can place orders online at HelioLiver.com/how-to-order, via phone (+1 626-350-0537) or email at [email protected] to get connected with a representative.

For more information about HelioLiver and its clinical performance, please visit www.HelioLiver.com.

On December 6, 2021 AIM ImmunoTech Inc. (NYSE American: AIM) reported that Thomas Equels, Chief Executive Officer of AIM, will be participating in two upcoming investor conferences (Press release, AIM ImmunoTech, DEC 6, 2021, View Source [SID1234596532]).

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BioFlorida Conference
Mr. Equels will be participating in the "COVID-19: What’s Next in Prevention, Treatment & Diagnostics" panel taking place on Thursday, December 9, 2021 at 1:45 PM EST during the BioFlorida Conference. He will also be participating in the CEO Forum at 5:30 PM EST.

The BioFlorida conference will consist of a series of roundtable panel discussions that will be moderated by Maulik Shah, MD, PhD, from Applied Ingenuity Diagnostics.

For more information on the BioFlorida Conference, please visit BioFlorida.com or contact [email protected].

Benzinga All-Access Event
Mr. Equels is scheduled to participate on December 16, 2021 at 11:20 AM EST during the Benzinga All Access event. The event will be broadcast live and can be viewed here. An archived recording of the presentation will be available on the investor relations section of the AIM website at View Source

The Benzinga All Access Show is a 2-hour talk-show event where a select number of companies are chosen to give a 20-minute interview to discuss their companies. Benzinga All Access is a first-of-its-kind show: part interview, part investor presentation. On All Access, Benzinga partners with companies to bring you in-depth one-on-one conversations with executives across a wide range of industries and asset classes.

On December 6, 2021 GlycoMimetics, Inc. (Nasdaq: GLYC), a clinical-stage biotechnology company, reported that the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), and the Alliance for Clinical Trials in Oncology, have completed enrollment of 267 patients in the Phase 2 portion of the adaptive Phase 2/3 trial evaluating whether uproleselan improves overall survival in newly diagnosed patients 60 years or older with acute myeloid leukemia (AML) (Press release, GlycoMimetics, DEC 6, 2021, View Source [SID1234596480]). The randomized, controlled trial is evaluating the addition of uproleselan, GlycoMimetics’ investigational, first-in-class, targeted antagonist of E-selectin, to a standard cytarabine/daunorubicin regimen (7&3) in older adults with previously untreated AML who are suitable for intensive chemotherapy. Completion of enrollment now sets the stage for a planned evaluation of the Phase 2 portion of the trial to determine whether the prespecified threshold for continuing to Phase 3 has been met based on event-free survival (EFS). Geoffrey Uy, M.D., Professor of Medicine, Washington University School of Medicine in St. Louis, is the trial’s Principal Investigator. GlycoMimetics and NCI are collaborating on the development of uproleselan under a Cooperative Research and Development Agreement.

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This press release features multimedia. View the full release here: View Source

"I would like to thank the Alliance for completing the enrollment of the Phase 2 portion despite all of the logistical challenges associated with the pandemic. If the EFS analysis meets the preplanned metric, the data will be transferred confidentially to GlycoMimetics to support regulatory filings for uproleselan in AML, and enrollment will continue in the Phase 3 portion of the trial," said Harout Semerjian, GlycoMimetics Chief Executive Officer. "Together, the GlycoMimetics- and NCI-sponsored programs will constitute a large dataset of 650 patients with AML. We would anticipate filing with regulatory agencies for approval for treatment of patients in both the frontline and relapsed/refractory AML settings should both trials achieve positive readouts."

About Uproleselan

Discovered and developed by GlycoMimetics, uproleselan is an investigational, first-in-class, targeted antagonist of E-selectin. Uproleselan (yoo’ pro le’ sel an), currently in a comprehensive Phase 3 development program in AML, has received Breakthrough Therapy designation from the U.S. Food and Drug Administration and the Chinese Health authority for the treatment of adult patients with AML who have relapsed or refractory disease. Uproleselan is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance.

On December 6, 2021 Merus N.V. (Nasdaq: MRUS) ("Merus", "the Company", "we", or "our"), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported that clinical data on MCLA-145 from the phase 1 trial in patients with solid tumors at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2021 being held virtually (Press release, Merus, DEC 6, 2021, View Source [SID1234596496]).

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"We are encouraged by the progress we are making with MCLA-145," said Dr. Andrew Joe, Chief Medical Officer. "Patients have been treated at 8 dose levels with preliminary evidence of antitumor activity observed, as we continue to explore MCLA-145 as monotherapy."

MCLA-145

The reported data are from the phase 1 open-label, multicenter dose escalation study, of bispecific antibody MCLA-145 in patients with solid tumors. The primary objective is to evaluate the safety, tolerability, and dose-limiting toxicity (DLT) of MCLA-145 and to determine maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE).

Observations in the presentation include:

As of the data cutoff date of July 14, 2021, 34 patients with advanced or metastatic solid tumors with median age of 60.5 (range 27-81) years have been treated at 8 dose levels ranging from 0.4-75mg Q2W
Median (range) duration of treatment with MCLA 145 was approximately 6 (1–74) weeks
Reported adverse events (AEs) have been managed with drug interruption and/or administration of steroids in some patients
Treatment-emergent AEs (TEAEs) occurred in 33 patients (97.1%); treatment-related TEAEs occurred in 23 patients (67.6%), most commonly fatigue (n=6, 17.6%) and decreased neutrophil count (n=6, 17.6%)
DLTs defined as within 28 days from the first infusion occurred in 4 patients (11.8%)
Laboratory alanine transaminase/aspartate transaminase (ALT/AST) elevations of any grade were observed in 15 patients (44.1%), with grade ≥3 ALT/AST elevations in 6 patients (17.6%)
Preliminary evidence of antitumor activity has been observed at doses ≥25 mg biweekly
Peripheral blood shows robust T-cell activation, including activation of cytotoxic CD8+ cells and cytokines, across the 10 to 75 mg biweekly dosing range
Further evaluation of optimal dose and efficacy in PD-L1+ tumors is planned.
The phase 1 clinical trial of MCLA-145 consists of a dose escalation phase, followed by a planned dose expansion phase. MCLA-145 is the first drug candidate co-developed under Merus’ global collaboration and license agreement with Incyte, which permits the development and commercialization of up to 11 bispecific and monospecific antibodies from the Merus Biclonics platform. Merus retains full rights to develop and commercialize MCLA-145, if approved, in the United States; and Incyte holds full rights to develop and commercialize MCLA-145 outside the United States.

On December 6, 2021 Paige, the global leader in AI-based diagnostic software in pathology, reported it will present new data demonstrating the performance of Paige Breast "Beta" in detecting various forms of breast cancer and highlight the accuracy of a new AI-based system that detects invasive lobular carcinoma (ILC), the most frequent subtype of breast cancer (Press release, Paige AI, DEC 6, 2021, View Source [SID1234596512]). The data will be featured during a Spotlight Poster Discussion at the upcoming 2021 San Antonio Breast Cancer Symposium (SABCS 2021), taking place virtually and in-person at the Henry B. Gonzalez Convention Center in San Antonio, Texas from December 7-10, 2021.

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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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An artificial intelligence-based predictor of CDH1 biallelic mutations and lobular carcinoma
Authors: Jorge S. Reis-Filho, et al.
Session: Spotlight Poster Discussion 11 – The future is now: Innovation in pathology and radiology
Poster #: PD11-01
Date and Time: Thursday, December 9, 2021; 5:00 p.m. – 6:30 p.m. CST
Location: Stars at Night Ballroom 3&4
Subtyping invasive carcinomas and high-risk lesions for Machine-Learning-Based Breast Pathology
Authors: Matthew G. Hanna, et al.
Session: Spotlight Poster Discussion 11 – The future is now: Innovation in pathology and radiology
Poster #: PD11-02
Date and Time: Thursday, December 9, 2021; 5:00 p.m. – 6:30 p.m. CST
Location: Stars at Night Ballroom 3&4
Additionally, Thomas J. Fuchs, Dr.Sc., Chief Scientist and Founder of Paige, will discuss the implications of AI technology in pathology during an educational session titled "Artificial Intelligence: Beyond the Soundbites," moderated by Jorge S. Reis-Filho, M.D., Ph.D., Principal of Biomarker Development at Paige and Chief of Experimental Pathology Service at Memorial Sloan Kettering Cancer Center. Details are below:

Artificial intelligence: Guiding the pathologists’ eyes
Presenter: Thomas J. Fuchs
Session: Educational Sessions
Date and Time: Tuesday, December 7, 2021; 5:00 p.m. – 7:00 p.m. CST
Location: Stars at Night Ballroom 3&4
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