On February 24, 2023 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, reported that members of its management team will present at the following investor conferences (Press release, Natera, FEB 24, 2023, View Source [SID1234627691]).

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Raymond James 44th Annual Institutional Investors Conference on Tuesday, March 7 at 2:50 p.m. ET in Orlando, FL
Cowen 43rd Annual Health Care Conference on Wednesday, March 8 at 11:10 a.m. ET in Boston, MA
A live webcast and audio archive of each event may be accessed through the investor relations section of the Natera website at investor.natera.com. A replay of each event will be available shortly following the conferences.

On February 24, 2023 Quanterix Corporation (NASDAQ: QTRX), a company fueling scientific discovery through ultrasensitive biomarker detection, reported it will host a conference call on Monday, March 6, 2023, to discuss its fourth quarter earnings and full year 2022 financial results (Press release, Quanterix, FEB 24, 2023, View Source [SID1234627690]). The call will begin at 8:30 AM Eastern Time. It will be hosted by Masoud Toloue, the Company’s President and Chief Executive Officer, and Michael Doyle, the Company’s Chief Financial Officer.

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Quanterix will issue a press release regarding the fourth quarter 2022 earnings prior to the conference call. The press release will be posted on the Quanterix website at View Source

Click here to pre-register for the conference call and obtain your dial-in number and passcode. You can also visit this link to listen to the call via live webcast. You may also access the live webcast by visiting the News & Events page within the Investors section of the Quanterix website at www.quanterix.com. The webcast will be available on the Company’s website for one year following completion of the call.

On February 24, 2023 Servier, a global pharmaceutical company, reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting a marketing authorization for Tibsovo (ivosidenib tablets) – an inhibitor of the mutated isocitrate dehydrogenase-1 (IDH1) enzyme – for two indications (Press release, Servier, FEB 24, 2023, View Source [SID1234627689]).

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in combination with azacitidine, for the treatment of adult patients with newly diagnosed IDH1-mutated Acute Myeloid Leukemia and not eligible for standard induction chemotherapy,
in monotherapy, for the treatment of adult patients with locally advanced or metastatic IDH1-mutated Cholangiocarcinoma, previously treated by at least one prior line of systemic therapy.
Claude Bertrand, Executive Vice President R&D of Servier, said: "The positive CHMP opinion is a further step towards the availability, in the European Union, of Tibsovo which is the first IDH1 inhibitor to be recommended for approval in Europe for patients with Acute Myeloid Leukemia and Cholangiocarcinoma for whom therapeutic options are very limited. Tibsovo is an illustration of the Group’s transformation and commitment in oncology which focuses its research on hard-to-treat cancers with the development of targeted therapies being a promising path for patients."

The positive CHMP opinion is based on clinical data from the AGILE (AML) and ClarIDHy (CCA) studies.

The CHMP’s positive opinion on Tibsovo in IDH1 mutated AML and CCA patients will be referred to the European Commission (EC) which will deliver a final decision in the coming months. The decision will be applicable to all 27 EU member states plus Iceland, Norway, Northern Ireland and Liechtenstein.

On February 24, 2023 Hackensack Meridian Health and Neosoma, Inc., an innovative medical technology company focused on helping clinicians advance the treatment of brain cancers through the use of artificial intelligence (AI), reported a new strategic partnership to tackle some of the most difficult-to-treat tumors (Press release, Hackensack Meridian Health, FEB 24, 2023, View Source [SID1234627688]).

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The collaboration will include clinical data sharing, clinical research, and strategic investment from the health network to support the Massachusetts-based company’s innovative method of imaging, tracking and collecting data on numerous types of brain tumors including glioblastomas.

"We are committed to investing in research and innovative therapies to live our mission to transform healthcare and give our patients the best possible outcomes,” said Robert C. Garrett, FACHE, chief executive officer of Hackensack Meridian Health. "Partnering with Neosoma Inc. is a great way to continue to develop potential game changing therapies to treat these challenging cancers."

"We have a terrific partnership with Hackensack Meridian Health already," said Ken Kolodziej, the CEO and co-founder of Neosoma. "We’re very excited to expand the scope of our collaboration with the shared goal of improving treatment and outcomes for patients with brain cancer."

The partnership will include HMH physicians using Neosoma’s software in clinical practice, starting with Hackensack Meridian JFK University Medical Center; physician input and feedback for development of future software including neurosurgeons, neuro-oncologists, neuroradiologists, radiation oncologists, and other clinicians; and data sharing for product R&D efforts including collaboration with Anthology Diagnostics for genomics data and capabilities, among other benefits.

Neosoma recently received U.S. Food and Drug Administration (FDA) 510(k) clearance for its first AI-based neuro-oncology software device, Neosoma HGG (High-Grade Glioma). The technology produces precise and accurate brain tumor analysis on MRIs, providing physicians with critical insights to guide treatment decisions.

In clinical practice, the brain MRI is the physician’s best tool to evaluate the details and changes in a brain tumor. But even the most experienced physicians encounter considerable challenges in determining the extent and characteristics of the cancer, which can have a direct impact on clinical care.

The Neosoma technology will help physicians to better plan procedures, assess post-procedural results, guide chemo and immunotherapy treatments, track patients longitudinally, support an improved patient experience, and help lead to improved treatment, according to the company.

"Neosoma helps to avoid interruptions in care, unnecessary surgeries, and unnecessary changes in therapy," said Joseph Landolfi, D.O., a neuro-oncologist and also the chief medical officer at JFK University Medical Center. "The entire team benefits from centralized information, more efficient communication, and treatment protocols tailored to each specific patient."

"We are proud to support promising companies through the Bear’s Den, which accelerates innovation at key points in the pipeline," said Ihor Sawczuk, M.D., FACS, Hackensack Meridian Health’s president of Academics, Research and Innovation, founding chair of the Hackensack Meridian Health Research Institute, and also associate dean of Clinical Integration and professor and chair emeritus of Urology at the Hackensack Meridian School of Medicine. "This company’s expertise will also assist our physicians in some of the most difficult medical diagnoses. It’s a win-win."

Launched in 2017, the Bear’s Den features a panel of experts, including Hackensack Meridian Health CEO Garrett, leading physicians, key network executives, venture capitalists, patent attorneys, who gather regularly to vet proposals from entrepreneurs. The health network’s novel incubator has vetted many products and strategies to streamline care delivery, reduce infections, lower hospital readmissions and help patients partner in their care with physicians. The program has also invested in promising innovative companies.

On February 24, 2023 AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) reported that it has been approved in China as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens (Press release, AstraZeneca, FEB 24, 2023, View Source [SID1234627687]).

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Enhertu is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

The approval by China’s National Medical Products Administration (NMPA) is based on the results of the DESTINY-Breast03 Phase III trial, where Enhertu demonstrated a 72% reduction in the risk of disease progression or death compared to trastuzumab emtansine (T-DM1) (hazard ratio [HR] 0.28; 95% confidence interval [CI] 0.22-0.37; p<0.000001) in patients with HER2-positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane.

In China, breast cancer is the most common cancer in women, with more than 415,000 patients diagnosed in 2020.1 There were nearly 120,000 breast cancer deaths in China in 2020, representing approximately 18% of global breast cancer deaths.1 Approximately one in five cases of breast cancer are considered HER2-positive.2

Binghe Xu, MD, Professor and Director of the Department of Medical Oncology, Cancer Hospital and Institute Cancer Hospital, Chinese Academy of Medical Sciences, said: "This approval marks an important day for the breast cancer community in China as patients with HER2-positive metastatic breast cancer continue to need additional treatment options. Despite initial treatment, patients with HER2-positive metastatic breast cancer will often experience disease progression, demonstrating the importance of early systemic disease control and the potential for Enhertu to help eligible patients with metastatic breast cancer."

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: "This first approval of Enhertu in China represents a significant advance in the treatment of HER2-targetable tumours and provides the opportunity for patients with previously treated HER2-positive metastatic breast cancer to benefit from this important medicine as a second line therapy. The approval underscores our commitment to patients in China, where there has been an increased incidence rate of breast cancer, as we continue to explore the potential benefits of Enhertu earlier in the treatment of HER2-directed metastatic breast cancer and across HER2-targetable cancers."

Kiminori Nagao, Head of the Asia, South and Central America (ASCA) Business Unit, Daiichi Sankyo, said: "Enhertu is extending the time before disease progression or death and helping to redefine outcomes for patients with previously treated HER2-positive metastatic breast cancer, and now physicians in China will have this important medicine as an option for their patients. With this approval, Enhertu has the potential to become a new standard of care in China in the second-line setting for patients with HER2-positive metastatic breast cancer."

The safety profile of Enhertu in DESTINY-Breast03 was evaluated in 257 patients with unresectable or metastatic HER2-positive breast cancer and was consistent with previous clinical trials with no new safety concerns identified. The most common adverse reactions were nausea (75.9%), fatigue (49.4%), vomiting (49.0%), neutropenia (42.8%) and alopecia (37.0%).

This approval follows the Breakthrough Therapy Designation and Priority Review granted to Enhertu by China’s NMPA in this type of breast cancer in 2022.

Financial considerations
Sales of Enhertu in China are recognised by AstraZeneca and will be recorded as product sales on the profit and loss statement. Further details on the financial arrangements were set out in the March 2019 announcement of the collaboration.

Notes

Breast cancer and HER2 expression
Breast cancer is the most common cancer and one of the leading causes of cancer-related deaths worldwide.3 More than two million patients were diagnosed with breast cancer in 2020, with nearly 685,000 deaths globally.3 In China, breast cancer is the most common cancer in women, with more than 415,000 patients diagnosed in 2020.1 There were nearly 120,000 breast cancer deaths in China in 2020, representing approximately 18% of global breast cancer deaths.1 Approximately one in five cases of breast cancer are considered HER2-positive.2

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours including breast, gastric, lung and colorectal cancers.4 HER2 protein overexpression may occur as a result of HER2 gene amplification and is often associated with aggressive disease and poor prognosis in breast cancer.5

Despite initial treatment with trastuzumab and a taxane, patients with HER2-positive metastatic breast cancer will often experience disease progression.6,7

DESTINY-Breast03
DESTINY-Breast03 is a global, head-to-head, randomised, open-label, registrational Phase III trial evaluating the efficacy and safety of Enhertu (5.4mg/kg) versus T-DM1 in patients with HER2-positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane.

The primary efficacy endpoint of DESTINY-Breast03 is progression-free survival (PFS) based on blinded independent central review (BICR). Overall survival (OS) is a key secondary efficacy outcome measure. Other secondary efficacy endpoints include objective response rate (ORR), duration of response, PFS based on investigator assessment and safety. Primary results from DESTINY-Breast03 were published in The New England Journal of Medicine,8 with updated PFS and OS results published in The Lancet.9

DESTINY-Breast03 enrolled 524 patients at multiple sites in Asia, Europe, North America, Oceania and South America. For more information about the trial, visit ClinicalTrials.gov.