FREENOME LAUNCHES ITS FIRST STUDY FOR THE DETECTION OF MULTIPLE CANCERS THAT PAIRS MULTIOMICS WITH REAL-WORLD DATA

On September 6, 2022 Freenome, a privately held biotech company, reported the launch of the Sanderson Study, the company’s latest study of its multiomics platform, in combination with real-world data to detect multiple cancers (Press release, Freenome, SEP 6, 2022, View Source [SID1234619039]).

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The study will encompass both traditional and real-world data to generate evidence of clinical validation for certain high- and elevated-risk populations while also refining the platform’s cancer classification and risk prediction models. In addition, the Sanderson Study will build the necessary infrastructure to bridge the gap between clinical research and day-to-day clinical impact.

Freenome is developing a tailored multi-cancer screening approach that assesses a patient’s individual risk and identifies cancer signals to provide patients with a clear path forward. Freenome uses a multiomics platform, combining tumor and non-tumor signals with machine learning to detect cancer in its earliest stages using a standard blood draw.

The Sanderson Study will enroll approximately 8,000 patients through Freenome’s clinical study partner network and numerous regional health systems across the United States. The study will focus on those cancers with significant unmet needs such as pancreatic and lung cancer.

"We’re incorporating real-world data with a precision health mindset on clinical actionability," said Lance Baldo, M.D., chief medical officer at Freenome. "Our goal is to identify the right patient for the right screening tests at the right time, with clear next steps. We believe this approach will ultimately save more lives."

Key collaborators include Oracle Cerner and its Learning Health Network (LHN), a group founded in 2020 of more than 90 diverse health systems across the U.S. that are working together to advance research and increase equitable access to clinical trials by contributing de-identified data to the LHN. In addition, Elligo Health Research will collaborate with LHN members using existing health data to identify and enroll patients significantly faster than traditional recruitment models.

Trial participation will help LHN members bring innovative cancer prevention testing to the communities they serve.

"Early cancer detection with more convenient screening will expand available treatments with better outcomes for patients," said Christy Dueck, vice president of Cerner Enviza, an Oracle company. "Oracle Cerner is thrilled to be working with Freenome to help expedite the study process, from hospital and health system readiness to patient participation and identification. The Learning Health Network acts as an accelerant by addressing the current challenge of the scarcity in sites in the traditional clinical-trial model by creating an abundance of patients who are already actively engaged in healthcare."

"Achieving earlier detection of cancer is critical to improving health outcomes and we’re honored to bring this groundbreaking research to our community," said Ruth Colby, president and chief executive officer of Silver Cross Hospital, a Learning Health Network member in the Chicago area. "This opportunity enables us to expand clinical research opportunities for patients and further our mission to care for members of our community."

Freenome’s clinical studies are named for employees’ loved ones who battled cancer. This study honors Tim Sanderson, the father of a Freenome engineer.

Athenex to Participate in the H.C. Wainwright 24th Annual Global Investment Conference

On September 6, 2022 thenex (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported that management will present at the H.C. Wainwright 24th Annual Global Investment Conference, taking place September 12-14, 2022, in New York, NY and virtually (Press release, Athenex, SEP 6, 2022, View Source [SID1234619038]). Company management will also be available for one-on-one investor meetings during the event. Please find additional details about the presentation below.

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A replay of the presentation will be available in the "Events and Presentations" section of the Athenex website for the following 90 days. Please contact your representative at H.C. Wainwright to schedule a virtual one-on-one meeting with Athenex during the conference. For information about the H.C. Wainwright Global Investment Conference, please refer to the event’s website.

Genmab to Present at Morgan Stanley 20th Annual Global Healthcare Conference

On September 6, 2022 Genmab A/S (Nasdaq: GMAB) reported that its Chief Executive Officer Jan van de Winkel, Ph.D. and Chief Financial Officer Anthony Pagano will participate in a fireside chat at the Morgan Stanley 20th Annual Global Healthcare Conference at 8:00 AM EDT / 2:00 PM CEST on September 13, 2022 (Press release, Genmab, SEP 6, 2022, View Source [SID1234619037]). A webcast of the event, which will include brief opening remarks followed by a question-and-answer session, will be available on Genmab’s website at View Source

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Fresenius Kabi receives U.S. FDA approval for biosimilar Stimufend®* (pegfilgrastim)

On September 6, 2022 Fresenius Kabi reported The U.S. Food and Drug Administration (FDA) has approved it’s pegfilgrastim biosimilar, Stimufend, for use in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia (Press release, Fresenius, SEP 6, 2022, View Source [SID1234619035]).

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The company expects to launch the product in a prefilled syringe next year and additionally in an on-body injector following FDA approval.
This is another important achievement in the development of Fresenius Kabi’s biosimilar pipeline, representing Fresenius Kabi’s first U.S. approved therapy in its biosimilar portfolio.

Orum Therapeutics to Participate at Investor Conferences in September

On September 6, 2022 Orum Therapeutics, a private clinical stage biotechnology company pioneering the development of tumor-directed targeted protein degraders (TPDs), reported that the Company’s leadership will participate in the following investor conferences (Press release, Orum Therapeutics, SEP 6, 2022, View Source [SID1234619034]):

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Morgan Stanley 20th Annual Global Healthcare Conference

Forum: 1×1 In-Person Meetings

Dates: Monday, September 12th to Wednesday, September 14, 2022Location: New York, NY

Baird’s Global Healthcare Conference 2022

Forum: Presentation and 1×1 In-Person Meetings

Dates: Tuesday, September 13th to Wednesday, September 14, 2022

Location: New York, NYThe presentation will take place at 4:20 pm ET on September 13th.

UBS Virtual Biotechnology Private Company Symposium

Forum: 1×1 Virtual Meetings

Date: Wednesday, September 21 to Thursday, September 22, 2022

About Orum’s GSPT1 Platform Using the TPD²Approach

Orum’s GSPT1 platform uses the Company’s unique Dual-Precision Targeted Protein Degradation (TPD²) approach to build novel targeted protein degraders (TPD) combined with the precise tumor cell delivery mechanisms of antibodies to generate innovative, first-in-class, cell-specific TPD for the treatment of cancer. The company has developed new molecular glue degrader payloads to specifically degrade an intracellular target protein within cancer cells via the E3 ubiquitin ligase pathway. Conjugated to antibodies, the payloads are designed to be delivered specifically to cancer cells and degrade the intracellular target protein GSPT1 and cause tumor cell death.