On November 23, 2021 GlycoMimetics, Inc. (Nasdaq: GLYC) reported that Apollomics has dosed the first patient in China in a Phase 3 clinical trial of APL-106 (uproleselan injection) for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) (Press release, GlycoMimetics, NOV 23, 2021, View Source [SID1234595972]). Apollomics’ Phase 3 trial with APL-106 is part of the overall development program for Apollomics in China that also includes an ongoing Phase 1 pharmacokinetics (PK) and tolerability study. The Phase 3 clinical trial is part of a randomized, double-blind, placebo controlled, bridging study program that will evaluate the efficacy of uproleselan in combination with chemotherapy, compared to chemotherapy alone, for treating relapsed/refractory AML, in Chinese patients. The trial will enroll approximately 140 adult patients with primary refractory AML or relapsed AML (first or second untreated relapse) and eligible to receive induction chemotherapy.

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"Dosing of the first patient in this Phase 3 clinical trial in Greater China is a significant accomplishment for Apollomics and comes quickly on the heels of our recent completion of enrollment in our own pivotal Phase 3 trial evaluating uproleselan in addition to a standard chemotherapy regimen in patients with relapsed/refractory AML," commented Harout Semerjian, GlycoMimetics Chief Executive Officer.

The primary endpoint for the Apollomics Phase 3 trial is overall survival. Secondary outcome measures include the rate and duration of remission, and whether uproleselan could reduce the rate of oral mucositis, a chemotherapy-related side effect. Apollomics expects to conduct this study at approximately 20 blood cancer clinical research centers across China. Additional information on the Phase 3 trial can be found on clinicaltrials.gov (NCT05054543)

On November 23, 2021 Isofol Medical AB (View Source) (publ) (Nasdaq Stockholm: ISOFOL), reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for the development of the Company’s lead drug candidate arfolitixorin, the stabilized and biologically active pure form of folate ([6R]-MTHF), for treatment of patients with metastatic colorectal cancer (mCRC) (Press release, Isofol Medical, NOV 23, 2021, View Source [SID1234595971]). The FDA’s decision is based on the potential for arfolitixorin to address a large unmet medical need for new and more effective treatments of mCRC, the second deadliest and third most common form of cancer. Fast Track Designation facilitates frequent communication with the FDA and can result in expedited review timelines and a potential earlier market authorization and approval to ensure that new treatments can be made available quicker for patients with serious diseases.

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– We are thrilled that the FDA has granted Fast Track Designation to our lead candidate arfolitixorin. This serves as a strong external validation of arfolitixorin’s potential to benefit patients with this devastating disease. Our next clinical milestone is reaching 300 progression-free survival events in the Phase III AGENT study which means that data can be deblinded so that we can analyze and present top-line results in the first half of 2022. The Fast Track Designation will enable us to engage more frequently with the FDA to optimally plan for the continued development of arfolitixorin and potentially make it the first novel drug to improve the standard of care in mCRC in over 40 years, said Ulf Jungnelius, CEO of Isofol.

As defined by the FDA, Fast Track Designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions, thereby meeting an unmet medical need. The designation allows for such options as eligibility for priority review, if relevant criteria are met, more frequent meetings with FDA, and rolling review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed. The NDA review otherwise usually does not begin until the drug company has submitted the entire application to the FDA. More information about the Fast Track Designation can be found here.

As the first and only pure form of the folate ([6R]-MTHF) that increases 5FU-cytotoxicity, arfolitixorin is currently being evaluated in the global pivotal Phase III AGENT study. The AGENT study is fully recruited and approximately 90 clinics in the United States, Canada, Europe, Australia and Japan have been involved in the study. Isofol’s ambition is to conclude the AGENT study in 2022 and thereafter apply for market approval with the FDA and EMA, which could result in a potential commercialization of arfolitixorin as early as 2023.

This is information that Isofol Medical AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 18:45 CET on November 23, 2021.

About arfolitixorin
Arfolitixorin is Isofol’s proprietary drug candidate being developed to increase the efficacy of standard of care chemotherapy for advanced colorectal cancer. The drug candidate is currently being studied in a global pivotal Phase III study, AGENT. As the key active metabolite of the widely used folate-based drugs, arfolitixorin can potentially benefit all patients with advanced colorectal cancer, as it does not require complicated metabolic activation to become effective.

About the AGENT study
The Phase III AGENT study is a randomized, controlled, multi-centre study assessing the efficacy and safety of arfolitixorin, [6R]-5,10-methylene-THF acid (MTHF), compared to leucovorin, both used in combination with 5-FU, oxaliplatin, and bevacizumab, in first line metastatic colorectal cancer patients. Patients are randomized in a 1:1 ratio and the primary endpoint is overall response rate (ORR). The key secondary endpoints are progression free survival (PFS) and duration of response (DOR). Other secondary endpoints include overall survival (OS), number of curative metastasis resections, safety, and patient reported outcomes such as quality of life (QoL). Exploratory endpoints include pharmacokinetic (PK) measurements and level of gene expression of folate relevant genes in tumour cells. The study is designed to show superiority for arfolitixorin over leucovorin.

The study has involved approximately 90 clinics in the U.S., Canada, Europe, Australia and Japan. In December 2020, the last of the AGENT study’s 440 patients were recruited, which is the basis in the statistical analysis plan. Isofol is now focusing on completing the ongoing AGENT study where the patients receive first-line standard treatment with either leucovorin or arfolitixorin for metastatic colorectal cancer (mCRC). The company expects that top-line results of the AGENT study will be available during H1 2022. Further information about the study, including patient eligibility requirements, is available at www.clinicaltrials.gov id:NCT03750786.

On November 23, 2021 Nykode Therapeutics (formerly Vaccibody*)) (Euronext Growth (Oslo): VACC (ticker will soon be changed)), a clinical-stage biopharmaceutical company dedicated to the discovery and development of vaccines and novel immunotherapies, reported that the Company is changing its name to reflect its exciting development and mark a milestone in our journey of growth and transformation (Press release, Vaccibody, NOV 23, 2021, View Source [SID1234595970]). It acts as a visible symbol of a new phase of opportunity based on collaborations, internationalization, and future ambitions. And it conveys how we are truly starting to realize our vision of being a leading immunotherapy platform company, breaking down the boundaries of conventional drug design to unlock the future of medicine.

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The Company’s new name is inspired by its Norwegian roots and links to our platform’s modularity. Nykode translates as ‘new code’, playing on the potential of our technology to generate novel codes and create innovative patient therapies. Michael Engsig, CEO of Nykode Therapeutics: "Over the last few years, the Company has made significant steps forward. We have reported promising clinical data, continued to grow our pipeline and forged significant partnerships."

Michael Engsig added, "We continue our exciting transformation from a two-asset focused company to a fully-fledged platform biotech company. During the past year, we have increased the number of talented colleagues, made important additions to our senior management team, invested strategically, and expanded internationally. This positive evolution, combined with our future ambitions, inspired the need to revisit our brand."

Agnete B. Fredriksen, Chief Innovation & Strategy Officer of Nykode Therapeutics, continued, "The challenge of changing our name was to consolidate everything we have achieved to date with our future plans to expand, and combine this into a powerful new brand." Agnete B. Fredriksen added, "We have shown that we can generate novel molecules by combining multiple different genes or codes to generate new medicines with unique properties. We will build further on this know-how, driven by our guiding purpose to push the boundaries of human advancement by rethinking conventional drug design. We want to express how our platform’s intelligent modular design and tailored hyper targeting may deliver game-changing medicines for patients. This vision aims to create innovative therapies and continues to broaden our reach into multiple therapeutic areas, both with and without our partners. In essence, we believe that our new name, Nykode, uniquely captures our progress and possibilities."

Read more about the journey and inspiration regarding our new name, logo, and visual identity on our new website, nykode.com. *)

Vaccibody AS, which is changing its company name to Nykode Therapeutics AS, has called for an EGM on November 30, 2021, to vote for the approval of the change of its company name from Vaccibody AS to Nykode Therapeutics AS.

On November 23, 2021 AI medical technology company Artrya Limited reported its partnership with leading global commercial services provider EVERSANA Life Sciences LLC ("EVERSANA") as its launch and commercialisation partner to access the UK market (Press release, EVERSANA, NOV 23, 2021, View Source [SID1234595969]).

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The announcement follows Artrya’s recent appointment onto the United Kingdom National Health Service Shared Business Services (NHS SBS) Framework as a supplier of artificial intelligence software and platforms, following a successful tender bid.

Artrya’s core software is the novel technology Salix – a fast and effective AI-based solution which analyses cardiac CT scans. Salix supports clinicians in their diagnosis of coronary artery disease by detecting key disease biomarkers, including location and severity, on a 3D heart image. The comprehensive patient report is produced in approximately 15 minutes, assisting ‘first-time-right’ treatment.

EVERSANA’s CEO Jim Lang commented: "We are delighted to partner with Artrya to initiate the company’s UK commercialisation plan. Around the world we have seen first-hand how digital innovations such as Salix have the ability to change lives and improve care, but these technologies require commercialisation strategies that reach beyond traditional life science tactics."

"There’s an opportunity for hospitals to substantially benefit from the efficiencies AI can offer, especially with high patient demand and staff shortages," said Mr. Lang.

Artrya’s Managing Director and Co-founder John Barrington said the partnership with EVERSANA is a significant step in making coronary heart disease diagnosis more efficient and accurate in the UK.

"Hospitals will soon have the opportunity to access cutting edge technology which can detect vulnerable plaque in a patient’s arteries. Vulnerable plaques are the major cause of most fatal and non-fatal heart attacks in individuals.

"There is a growing need for better diagnostics around the international problem of coronary artery disease which is responsible for one in three deaths globally. The cost to the United Kingdom economy alone annually is £7.6 billion," said Mr. Barrington.

Under the NHS SBS framework agreement Artrya is listed among a select, preferred, and pre-qualified shortlist of approved suppliers from which various public organisations, including 1,250 NHS hospitals, can commission services.

Market pilots of Salix are presently underway in Perth and Sydney, with an unrestricted launch planned across Australia in early 2022.

Artrya anticipates the ability to sell into the UK in mid-2022.

On November 23, 2021 Exact Sciences Corp. (NASDAQ: EXAS), a global leader in cancer diagnostics, reported the publication of results underscoring the importance of adverse pathology as a reliable and critical endpoint for risk-assessment in clinically low-risk prostate cancer patients (Press release, Exact Sciences, NOV 23, 2021, View Source [SID1234595967]).1 Published in Urologic Oncology: Seminars and Original Investigations and led by study collaborators at the Cleveland Clinic, the findings showed that men who were discovered to have adverse pathology, following a radical prostatectomy, were 10 times more likely to develop metastatic disease and eight times more likely to die from their prostate cancer than those with favorable pathology, up to a 20-year follow up.1 The findings strongly support the clinical use of the Oncotype DX Genomic Prostate Score (GPS) test, the only commercial genomic test that was specifically developed to improve assessment of a patient’s risk of adverse pathology, beyond clinical factors alone, and optimized to perform in biopsy samples. 2,3

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New data in clinically low-risk prostate cancer patients supports the use of the Oncotype DX(R) GPS (TM) test.
"The critical clinical question urologists ask when treating their low-risk prostate cancer patients is whether active surveillance may be appropriate or if they may be harboring more aggressive disease that needs to be treated immediately," said Eric Klein, MD, chairman of the Glickman Urological and Kidney Institute at Cleveland Clinic. "These findings are important as they establish adverse pathology at radical prostatectomy as a strong prognostic factor for long-term prostate cancer outcomes and demonstrate the value of AP for assessing risk in this low-risk population, ultimately providing confidence when deciding between active surveillance or other immediate treatment strategies."

In the study, analyses were performed on a sample of 428 patients, largely clinically low and intermediate risk (10% being clinically high risk), treated with radical prostatectomy (RP) between 1987 and 2004. Adverse pathology was defined as either high-grade or high-stage disease (Gleason Grade 3 or above and/or non-organ confined disease, pT3 or higher). Patients with no AP at surgery had a nearly zero risk of metastasis and death even at 20 years, while metastatic and death events rose immediately and sharply in the group of patients who had adverse pathology.

"We developed the GPS test to fundamentally change how risk assessment at the time of biopsy for prostate cancer patients could be improved with genomics, and we chose adverse pathology as the actionable endpoint in all of our validation studies," said Rick Baehner, MD, chief medical officer of Precision Oncology at Exact Sciences. "These study results show that the combined risk of adverse pathology is strongly associated with worse long-term outcomes, supporting the clinical utility of the Oncotype DX GPS test and the many patients who have put their trust in the GPS test to confidently manage their treatment decisions."

The Oncotype DX GPS test is backed by a robust body of clinical evidence in more than 9,000 men4 and Exact Sciences is committed to further strengthening the data supporting the expanded clinical utility of the test. Recently, the company has redesigned its patient test reports to reflect new clinical evidence and to answer the different clinical needs in low- and high-risk patients. With two tailored reports, the Oncotype DX GPS assay provides critical information for when active surveillance may be an appropriate decision in lower-risk patients and provides risk estimates to help inform treatment decisions for higher risk patients.4 The patient-friendly resources help facilitate discussions between patients and their healthcare practitioners by consolidating key prostate cancer characteristics in a single document for ease of reference during treatment management conversations. The new high-risk reports are currently available, and the new low-risk reports will launch December 2021.

For more information about Exact Sciences’ Oncotype DX Genomic Prostate Score test and to view samples of the new patient test reports, visit www.oncotypeiq.com.

About the Oncotype DX Genomic Prostate Score Test
The Oncotype DX Genomic Prostate Score (GPS) test is a genomic assay designed for men with clinically low- and high-risk localized prostate cancer to help guide treatment decisions at the time of diagnosis. Developed, clinically validated, and studied collectively in over 9,000 patients, the Oncotype DX GPS test analyzes prostate cancer gene activity to predict disease aggressiveness to help refine risk assessment, as well as provides clinically meaningful endpoints.4 With two tailored patient reports, the GPS assay provides useful information for when active surveillance may be an appropriate decision, as well as risk estimates to help inform treatment decisions for higher risk patients. To learn more about the Oncotype DX GPS test, visit www.OncotypeIQ.com or www.MyProstateCancerTreatment.org.