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.

On February 24, 2023 Innovations in cancer treatment resulting from research conducted through the Florida Cancer Specialists & Research Institute, LLC (FCS) Phase 1 Drug Development Units and at FCS clinics throughout Florida were reported recently at two global gatherings sponsored by the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (Press release, Florida Cancer Specialists & Research Institute, FEB 24, 2023, View Source;research-institute-studies-offer-innovative-new-findings-in-the-diagnosis-and-treatment-of-gastrointestinal-and-genitourinary-cancers-at-global-symposium-301755620.html [SID1234627686]).

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Two FCS studies of advanced treatments for solid tumors experienced in bladder, hepatobiliary and similar cancers were featured at both the ASCO (Free ASCO Whitepaper) 2023 Gastrointestinal (GI) Cancers Symposium and the ASCO (Free ASCO Whitepaper) 2023 Genitourinary (GU) Cancers Symposium:

A Phase 2 study investigating a treatment for patients with malignant solid tumors, co-authored by FCS medical oncologist/hematologist Maen A. Hussein, MD.
A first in human Phase 1 study co-authored by FCS medical oncologist/hematologist Cesar Augusto Perez, MD, evaluating a next-generation treatment for patients with advanced bile duct cancer (cholangiocarcinoma), a rare disease that affects the network of tubes connecting the liver, gallbladder and small intestine.
Clinicians and researchers from around the globe came together at the two symposiums to share the latest science and approaches in GI and GU cancer treatment, research and care. Genitourinary cancers, including kidney and bladder cancers, occur in the urinary system of men and women and in the reproductive organs in men, such as prostate and testicular cancers. Gastrointestinal cancers affect the digestive tract organs, such as the stomach, large and small intestine, pancreas, colon, liver, rectum, anus and biliary system.

"Research conducted with participation from FCS continues to contribute to advancements in the study, diagnosis and treatment of all forms of cancer, including GI and GU malignancies that impact women and men around the globe," said Gustavo Fonseca, MD, FACP, Medical Director of the FCS Clinical Research Program.

"Increasingly, our studies are revealing new discoveries in the use of targeted immunotherapies and molecular-based treatments that effectively block or inhibit the growth of cancer cells," said FCS Director of Drug Development Manish R. Patel, MD, who oversees the statewide practice’s three early phase Drug Development Units in Sarasota, Lake Mary and Lake Nona.

FCS President & Managing Physician Lucio Gordan, MD added, "These findings are positively impacting patient outcomes – improving cure rates and extending lives for women and men around the world."

Also included among the FCS medical oncologists/hematologists sharing the outcomes of FCS research studies in presentations at the ASCO (Free ASCO Whitepaper) GI Symposium was FCS Associate Director of Drug Development Judy S. Wang, MD.

Trial in progress: A phase 1, first-in-human, open-label, multicenter, dose-escalation and dose-expansion study of ASP3082 in patients with previously treated advanced solid tumors and KRAS G12D mutations
Clinical and molecular presentation of KRAS G12D-mutated pancreatic ductal adenocarcinoma in real-world settings. Cesar Augusto Perez, MD was also a co-author.
The American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), Inc. (ASCO) (Free ASCO Whitepaper) represents nearly 45,000 oncology professionals who care for people living with cancer. Through research, education, and promotion of high quality and equitable patient care, ASCO (Free ASCO Whitepaper) works to conquer cancer.

On February 24, 2023 Aprea Therapeutics, Inc., a Delaware corporation (the "Company"), reported that it has entered into an underwriting agreement (the "Underwriting Agreement") with Maxim Group LLC as representative of the underwriters named therein (the "Underwriters") relating to the issuance and sale of 1,050,000 shares of the Company’s common stock, par value $0.001 per share (the "Offering") (Filing, 8-K, Aprea, FEB 24, 2023, View Source [SID1234627685]). The price to the public in the Offering is $5.25 per share, before underwriting discounts and commissions. Under the terms of the Underwriting Agreement, the Company has granted the Underwriters an option, exercisable for 30 days, to purchase up to an additional 157,500 shares of common stock. The net proceeds to the Company from the Offering are expected to be approximately $4.8 million, after deducting underwriting discounts and commissions and estimated Offering expenses payable by the Company, assuming no exercise by the Underwriters of their option to purchase additional shares of common stock. The transactions contemplated by the Underwriting Agreement are expected to close on February 27, 2023, subject to the satisfaction of customary closing conditions.

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The Offering is being made pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-250041) which became effective on November 30, 2020, as supplemented by a preliminary and final prospectus supplement thereunder, filed with the Securities and Exchange Commission pursuant to Rule 424(b) under the Securities Act of 1933, as amended (the "Securities Act").

The Underwriting Agreement contains customary representations, warranties and agreements by the Company, customary conditions to closing, indemnification obligations of the Company and the Underwriter, including for liabilities under the Securities Act, other obligations of the parties and termination provisions. A copy of the Underwriting Agreement is filed as Exhibit 1.1 to this Current Report and is incorporated herein by reference. The foregoing description of the terms of the Underwriting Agreement is qualified in its entirety by the Underwriting Agreement.

The legal opinion, including the related consent, of DLA Piper LLP (US) relating to the legality of the issuance and sale of the shares of the Company’s common stock in the Offering is filed as Exhibit 5.1 to this Current Report.

This Current Report contains forward-looking statements that involve risk and uncertainties, such as statements related to the anticipated closing of the Offering and the amount of net proceeds expected from the Offering. The risks and uncertainties involved include the Company’s ability to satisfy certain conditions to closing on a timely basis or at all, as well as other risks detailed from time to time in the Company’s Securities and Exchange Commission filings.

On February 24, 2023 Cytokinetics, Incorporated (Nasdaq: CYTK) reported three poster presentations at the American College of Cardiology 72nd Annual Scientific Session (ACC.23) taking place in New Orleans, LA from March 4, 2023 – March 6, 2023 (Press release, Cytokinetics, FEB 24, 2023, View Source [SID1234627684]).

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Title: 1560-153 – Aficamten in Patients with Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy (REDWOOD-HCM Cohort 4)
Presenter: Ahmad Masri, M.D. M.S., Director of the Hypertrophic Cardiomyopathy Center at Oregon Health & Science University
Session: 1560 – Heart Failure and Cardiomyopathies: Clinical Science 11
Date: March 5, 2023
Presentation Time: 12:45 PM-1:30 PM Central Time
Location: Poster Hall, Hall F

Title: 1042-07 – Long-Term Efficacy and Safety of Aficamten in Patients with Symptomatic Obstructive Hypertrophic Cardiomyopathy
Presenter: Sara Saberi, M.D., Associate Professor, Cardiovascular Medicine, Frankel Cardiovascular Center, University of Michigan Health
Session: 1042 – Bulking Up: New Research in Hypertrophic Cardiomyopathy
Date: March 5, 2023
Presentation Time: 9:45-9:55 AM Central Time
Location: Heart Failure and Cardiomyopathies Moderated Poster Theater 11, Hall F

Title: 1279-169 – Applicability of the GALACTIC-HF Trial and Omecamtiv Mecarbil to Patients Hospitalized for Heart Failure in the United States: From the GWTG-HF Registry
Presenter: Josephine Harrington, M.D., Fellow, Division of Cardiology, Duke Clinical Research Institute, Duke University School of Medicine
Session: 1279 – Heart Failure and Cardiomyopathies: Clinical Science 3
Date: March 4, 2023
Presentation Time: 11:45-12:30 PM Central Time
Location: Poster Hall, Hall F