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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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.

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.

On September 6, 2022Takara Bio Europe (TBE) reported a partnership with the German company BioeXsen GmbH for the distribution of in vitro diagnostic solutions for the qPCR detection of common pathogens found in respiratory tract infections (Press release, Takara Bio, SEP 6, 2022, View Source [SID1234619033]).

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Respiratory tract infections are associated with high morbidity and mortality worldwide, and their symptoms may not point to a single diagnosis. In such cases, a rapid and accurate pathogen diagnosis is essential for appropriate treatment.

BioeXsen has been one of the leading suppliers of RT-qPCR kits during the Covid-19 pandemic. The reliability of their products, evidenced by their inclusion in the WHO emergency use list, has further improved with the addition of Takara Bio’s enzymes. Combining Takara Bio’s renowned expertise in molecular biology with BioeXsen GmbH’s state-of-the-art clinical solutions, the in vitro diagnostic medical devices detect more than 20 pathogens.

Ranging from the detection of the novel coronavirus (SARS-CoV-2) to multiplexed detection of 24 pathogens in a syndromic panel, these CE-IVD kits’ simple yet efficient protocols have been tested and validated on commonly used instruments and can accommodate a wide range of samples, with an optimized turnaround time of 29 to 60 minutes. These efficient and significant solutions have already been used for more than 200 million tests worldwide, proving their versatility and suitability for all laboratories.

"At Takara Bio, we strongly believe that high-performing technologies are the keystone to accurate diagnosis" says Pierre Lacaze, Managing Director at TBE. "Since the beginning of the Covid-19 pandemic, we have been committed to supplying robust enzymes and supporting our customers to develop and optimize their diagnostic solutions. We are proud to take another step forward in our partnership with BioeXsen GmbH to distribute a broad portfolio of vital in vitro diagnostic medical devices for infectious diseases."

Klaus Skripalle, Managing Director of BioeXsen GmbH, added, "The synergistic combination of Takara Bio’s reliable enzymes and the cutting-edge technology here at BioeXsen GmbH will result in both higher specificity and increased sensitivity. This alliance provides us with enzymes of better calibre to our previous existing products, allowing us to increase our strength further, which is particularly pertinent at this critical time. As we have all learned during the pandemic, early diagnosis reduces the risk of hospitalization, decreases drug use, and minimizes the risk of death."

With the distribution of these kits, Takara Bio Europe is proud to continue providing essential tools in the fight against COVID-19 and related diseases.

On September 6, 2022 Triumvira Immunologics ("Triumvira"), a clinical-stage company developing novel, targeted autologous and allogeneic T cell therapeutics that co-opt the natural biology of T cells to treat patients with solid tumors, reported that it will present interim clinical data from its ongoing TACTIC-2 clinical trial (NCT04727151) for TAC01-HER2 in a poster presentation at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, being held Sept. 9-13, 2022 in Paris, France (Press release, Triumvira Immunologics, SEP 6, 2022, View Source [SID1234619028]). TAC01-HER2 is a novel cell therapy that consists of genetically engineered autologous T cells expressing T-cell Antigen Coupler (TAC) that recognizes human epidermal growth factor receptor 2 (HER2).

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Details of presentation:

Title: A Phase I/II Trial Investigating Safety and Efficacy of Autologous TAC T Cells Targeting HER2 in Relapsed or Refractory Solid Tumors
Presenter: Benjamin L. Schlechter, M.D., GI-Medical Oncology at Dana-Farber Cancer Institute
Abstract #: 778TiP
Date: Monday, Sept. 12, 2022
Time: 11:00 a.m. – 12:00 p.m. CEST
Location: Paris Expo Porte de Versailles, Hall 4