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.

On November 23, 2021 Aadi Bioscience, Inc. ("Aadi") (Nasdaq: AADI), a biopharmaceutical company focusing on precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, reported that the U.S. Food and Drug Administration (FDA) has approved FYARRO (sirolimus protein-bound particles for injectable suspension) (albumin-bound) for intravenous use for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa) (Press release, Aadi Bioscience, NOV 23, 2021, View Source [SID1234595966]). FYARRO is the first and only FDA-approved treatment for advanced malignant PEComa in adults.

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Neil Desai, Ph.D., Founder, Chief Executive Officer and President of Aadi, stated, "We are thrilled to have received full FDA-approval of FYARRO. The approval of FYARRO is a momentous event not just for Aadi but, importantly for advanced malignant PEComa patients. We reiterate that all of us at Aadi are incredibly grateful to all of the people with advanced malignant PEComa, their families and caregivers, as well as the healthcare professionals who made the FYARRO clinical studies possible."

"The approval of FYARRO, the first approved drug for advanced malignant PEComa, an aggressive sarcoma with a poor prognosis and few treatment options, will provide physicians with a new weapon for treating patients with this rare disease," added Andrew Wagner, M.D., Ph.D., a senior oncologist at Dana-Farber Cancer Institute and the Principal Investigator in the pivotal AMPECT registrational trial. "In our AMPECT trial, FYARRO demonstrated durable responses in mTOR inhibitor-naïve patients with locally advanced unresectable or metastatic PEComa, with an acceptable and manageable safety profile. This is a drug that will be welcomed by the physician community as the only approved therapeutic option for patients with advanced malignant PEComa."

In the Phase 2 registrational AMPECT trial the overall response rate as assessed by independent review was 39% (12/31) with 2 patients achieving a Complete Response after prolonged follow up. The median duration of response has not been reached with a median follow-up of 36 months, and a range of 5.6 to 55.5+ months and ongoing. Among responders, 92% had a response lasting greater than or equal to 6 months; 67% had a response lasting greater than or equal to 12 months; and 58% had a response lasting greater than or equal to 2 years. As is the case with other therapeutics of the mTOR class, the FYARRO prescribing information includes warnings and precautions related to stomatitis, myelosuppression, infections, hypokalemia, hyperglycemia, interstitial lung disease, hemorrhage, and hypersensitivity reactions. Grade 3 non-hematologic events occurring in more than 10% of patients included stomatitis, rash, fatigue and infections. Grade 3 laboratory abnormalities occurring in more than 10% of patients that worsened from baseline included lymphocytopenia, increased glucose, and decreased potassium. For detailed important safety information, please see below.

Brendan Delaney, Chief Operating Officer of Aadi, added, "We have built a strong commercial team and devised a thoughtful strategy in preparation for FYARRO’s launch. With FYARRO’s demonstrated clinical profile we believe it will become a standard of care for advanced malignant PEComa. We look forward to engaging with physicians to educate the market about this new treatment."

Robert G. Maki, M.D., Ph.D., Clinical Director of the Sarcoma Program, and Professor of Medicine at the University of Pennsylvania, added, "Patients living with locally advanced or metastatic PEComa are in urgent need of new treatment options. The approval of FYARRO is a significant advancement for treating patients with this disease. Treating sarcoma patients in my practice, I have seen the need for a therapy that addresses the specific molecular alterations of advanced malignant PEComa. I am encouraged that FYARRO provided a clinically meaningful benefit in overall response rate, with some patients responding for up to several years. I am pleased to have FYARRO as a new therapeutic option to offer my advanced malignant PEComa patients."

Aadi will hold a conference call and webcast to discuss today’s announcement, Tuesday, November 23, 2021 at 8:30 a.m. ET.

Investor conference call information:

A listen-in only webcast of the conference call with corresponding slides can be accessed via Aadi’s website, within the Investors & News/Events & Presentations section. A replay of the webcast can also be accessed at this link.

Dial-in only information:

Investors, U.S.: 877-407-9716
Investors, non-U.S.: 201-493-6779
Conference ID: 13725222

About Malignant PEComa

Advanced malignant PEComa, defined by the World Health Organization as ‘mesenchymal tumors composed of distinctive cells that show a focal association with blood-vessel walls and usually express both melanocytic and smooth muscle markers,’ are a rare subset of soft-tissue sarcomas, with an undefined cell of origin. While there is no formal epidemiology for malignant PEComa, it is estimated that there are about 100-300 new patients per year in the United States. Malignant PEComas may arise in almost any body site (typically the uterus, retroperitoneum, lung, kidney, liver, genitourinary, and gastrointestinal tract with a female predominance) and can have an aggressive clinical course including distant metastases and ultimately death. The estimated prognosis based on retrospective reports is 12-16 months. Cytotoxic chemotherapies typically used for sarcoma show minimal benefit and there are currently no drugs approved for this disease. Malignant PEComas have been shown to frequently harbor mutations in the TSC1 and/or TSC2 genes that result in the activation of mTOR pathway making it a rational therapeutic target for this disease.

About FYARRO

FYARRO is an mTOR inhibitor indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).

Important Safety Information

Contraindication

FYARRO is contraindicated in patients with a history of severe hypersensitivity to sirolimus, other rapamycin derivatives, or albumin.

Warnings and Precautions

Stomatitis

Stomatitis, including mouth ulcers and oral mucositis, occurred in 79% of patients treated with FYARRO, including 18% Grade 3. Stomatitis was most often first reported within 8 weeks of treatment. Based on the severity of the adverse reaction, withhold, resume at reduced dose, or permanently discontinue FYARRO.

Myelosuppression

FYARRO can cause myelosuppression including anemia, thrombocytopenia and neutropenia. Anemia occurred in 68% of patients; 6% were Grade 3. Thrombocytopenia and neutropenia occurred in 35% of patients each. Obtain blood counts at baseline and every 2 months for the first year of treatment and every 3 months thereafter, or more frequently if clinically indicated. Based on the severity of the adverse reaction, withhold, resume at reduced dose, or permanently discontinue FYARRO.

Infections

FYARRO can cause infections. Infections such as urinary tract infections (UTI), upper respiratory tract infections and sinusitis occurred in 59% of patients. Grade 3 infections occurred in 12% of patients, including a single case each of a UTI, pneumonia, skin, and abdominal infections. Monitor patients for infections, including opportunistic infections. Based on the severity of the adverse reaction, withhold, resume at reduced dose, or permanently discontinue FYARRO.

Hypokalemia

FYARRO can cause hypokalemia. Hypokalemia occurred in 44% of patients including 12% Grade 3 events. Monitor potassium levels prior to starting FYARRO and implement potassium supplementation as medically indicated. Based on the severity of the adverse reaction, withhold, resume at reduced dose, or permanently discontinue FYARRO.

Hyperglycemia

FYARRO can cause hyperglycemia. Hyperglycemia occurred in 12% of patients treated with FYARRO, all of which were Grade 3 events. Monitor fasting serum glucose prior to starting FYARRO. During treatment, monitor serum glucose every 3 months in non-diabetic patients, or as clinically indicated. Monitor serum glucose more frequently in diabetic patients. Based on the severity of the adverse reaction, withhold, resume at reduced dose, or permanently discontinue FYARRO.

Interstitial Lung Disease / Non-Infectious Pneumonitis

FYARRO can cause interstitial lung disease (ILD) / non-infectious pneumonitis. ILD / non-infectious pneumonitis occurred in 18% of patients treated with FYARRO, of which all were Grades 1 and 2. Based on the severity of the adverse reaction, withhold, reduce the dose, or permanently discontinue FYARRO.

Hemorrhage

FYARRO can cause serious and sometimes fatal hemorrhage. Hemorrhage occurred in 24% of patients treated with FYARRO, including Grade 3 and Grade 5 events in 2.9% of patients each. Monitor patients for signs and symptoms of hemorrhage. Based on the severity of adverse reaction, withhold, resume at reduced dose, or permanently discontinue FYARRO.

Hypersensitivity Reactions

FYARRO can cause hypersensitivity reactions. Hypersensitivity reactions, including anaphylaxis, angioedema, exfoliative dermatitis, and hypersensitivity vasculitis have been observed with administration of the oral formulation of sirolimus. Hypersensitivity reactions including anaphylaxis have been observed with human albumin administration. Monitor patients closely for signs and symptoms of infusion reactions during and following each FYARRO infusion in a setting where cardiopulmonary resuscitation medication and equipment are available. Monitor patients for at least 2 hours after the first infusion and as clinically needed for each subsequent infusion. Reduce the rate, interrupt infusion, or permanently discontinue FYARRO based on severity and institute appropriate medical management as needed.

Embryo-Fetal Toxicity

Based on animal studies and the mechanism of action, FYARRO can cause fetal harm when administered to a pregnant woman. In animal studies, mTOR inhibitors caused embryo-fetal toxicity when administered during the period of organogenesis at maternal exposures that were equal to or less than human exposures at the recommended lowest starting dose. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to avoid becoming pregnant and to use effective contraception while using FYARRO and for 12 weeks after the last dose.

Male Infertility

Azoospermia or oligospermia may be observed in patients treated with FYARRO. FYARRO is an anti-proliferative drug and affects rapidly dividing cells such as germ cells.

Immunizations and Risks Associated with Live Vaccines

No studies in conjunction with immunization have been conducted with FYARRO. Immunization during FYARRO treatment may be ineffective. Update immunizations according to immunization guidelines prior to initiating FYARRO, if possible. Immunization with live vaccines is not recommended during treatment and avoid close contact with those who have received live vaccines while on FYARRO. The interval between live vaccinations and initiation of FYARRO should be in accordance with current vaccination guidelines for patients on immunosuppressive therapies.

Risk of Transmission of Infectious Agents with Human Albumin

FYARRO contains human albumin, a derivative of human blood. Human albumin carries only a remote risk of transmission of viral diseases because of effective donor screening and product manufacturing processes. A theoretical risk for transmission of Creutzfeldt-Jakob Disease (CJD) also is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been associated with albumin.

Adverse Reactions

Adverse Reactions in PEComa

The most common adverse reactions (≥30%) were stomatitis in 27 (79%) patients; fatigue and rash in 23 (68%) patients each; infection in 20 (59%) patients; nausea and edema in 17 (50%) patients each; diarrhea, musculoskeletal pain and decreased weight in 16 (47%) patients each; decreased appetite in 15 (44%) patients; cough in 12 (35%) patients; and vomiting and dysgeusia in 11 (32%) patients each.

Laboratory Abnormalities in PEComa

The most common Grade 3 to 4 laboratory abnormalities (≥6%) were decreased lymphocytes in 7 (21%) patients; increased glucose and decreased potassium in 4 (12%) patients each; decreased phosphate in 3 (9%) patients; and decreased hemoglobin and increased lipase in 2 (6%) patients each.

Dosage interruptions

Dose interruptions of FYARRO due to an adverse reaction occurred in 22 (65%) patients. Adverse reactions which required dosage interruption in >5% of patients included stomatitis in 6 (18%) patients, pneumonitis in 5 (15%) patients, anemia in 3 (9%) patients, and dehydration, dermatitis acneiform, and thrombocytopenia in 2 (6%) patients each.

Dose reduction

Dose reductions of FYARRO due to an adverse reaction occurred in 12 (35%) patients. Adverse reactions which required dose reductions in >5% of patients included stomatitis and pneumonitis in 3 (9%) patients each.

Drug Interactions

Reduce the dosage of FYARRO to 56 mg/m2 when used concomitantly with a moderate or weak cytochrome P-450 3A4 (CYP3A4) inhibitor. Avoid concomitant use with drugs that are strong CYP3A4 and/or P-glycoprotein (P-gp) inhibitors and inducers and with grapefruit and grapefruit juice.

Use in Specific Populations

Pregnancy

Based on the mechanism of action and findings in animals, FYARRO can cause fetal harm when administered to a pregnant woman. Advise females of the potential risk to a fetus and to avoid becoming pregnant while receiving FYARRO.

Lactation

Sirolimus is present in the milk of lactating rats. There is potential for serious adverse effects from sirolimus in breastfed infants based on mechanism of action. Because of the potential for serious adverse reactions in breastfed infants from FYARRO, advise women not to breastfeed during treatment with FYARRO and for 2 weeks after the last dose.

Females and Males of Reproductive Potential

FYARRO can cause fetal harm when administered to a pregnant woman. Verify the pregnancy status of females of reproductive potential prior to starting treatment with FYARRO. Advise females of reproductive potential to use effective contraception and avoid becoming pregnant during treatment with and for at least twelve weeks after the last dose of FYARRO. Advise males with female partners of reproductive potential to use effective contraception and avoid fathering a child during treatment with FYARRO and for at least twelve weeks after the last dose of FYARRO. Although there are no data on the impact of FYARRO on fertility, based on available clinical findings with oral formulation of sirolimus and findings in animals, male and female fertility may be compromised by the treatment with FYARRO.

Pediatric

The safety and effectiveness of FYARRO in pediatric patients have not been established.

Geriatric Use

Of the 34 patients treated with FYARRO, 44% were 65 years of age and older, and 6% were 75 years of age and older. Clinical studies of FYARRO did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.

Hepatic Impairment

FYARRO is not recommended for use in patients with severe hepatic impairment. Reduce FYARRO dosage in patients with mild or moderate hepatic impairment.

On November 23, 2021 Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, reported that it will participate in the Evercore ISI 4th Annual HealthCONx Conference on November 30, 2021 (Press release, Myovant Sciences, NOV 23, 2021, https://investors.myovant.com/news-releases/news-release-details/myovant-sciences-participate-evercore-isi-4th-annual-healthconx [SID1234595965]). David Marek, Chief Executive Officer of Myovant Sciences, Inc. will participate in a fireside chat at 11:45 a.m. Eastern Time.

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Investors and the general public are invited to listen to the Evercore fireside chat, which will be accessible on the Events page under the Investors & Media section of the Myovant website at www.myovant.com.

On November 23, 2021 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported that members of its senior management team are scheduled to participate in the following virtual investor conferences in December (Press release, CRISPR Therapeutics, NOV 23, 2021, View Source [SID1234595964]):

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4th Annual Evercore ISI HealthCONx Conference
Date: Wednesday, December 1, 2021
Time: 12:35 p.m. ET

Piper Sandler 33rd Annual Healthcare Conference
Date: Thursday, December 2, 2021
Time: 1:00 p.m. ET

A live webcast of the events will be available on the "Events & Presentations" page in the Investors section of the Company’s website at View Source A replay of the webcasts will be archived on the Company’s website for 14 days following each presentation.