On January 17, 2023 QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported the launch of EZ2 Connect MDx for use in diagnostic laboratories, making the IVD platform for automated sample processing available for widescale use 18 months after being made available for research (Press release, Qiagen, JAN 17, 2023, View Source [SID1234626301]).

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With a high degree of automation, the EZ2 Connect MDx enables labs to purify DNA and RNA from 24 samples in parallel in as little as 30 minutes1. The device now carries the EU’s CE-IVD compliance marking for in-vitro devices (IVD) for the European Union and other countries that accept this designation. It is also available in the United States, Canada and other countries.

"EZ2 Connect MDx puts standardized and efficient nucleic acid purification in reach of any clinical lab," said Jean-Pascal Viola, Senior Vice President, Head of the Molecular Diagnostics Business Area at QIAGEN. "It solves the challenges of many clinical diagnostics labs that have to provide diagnostics results quickly, that have to deal with fluctuating sample numbers as well as a large variety of sample types and quality."

EZ2 Connect MDx can extract nucleic acids from blood plasma, serum, stool and other sample types using magnetic-bead technology. High process safety is ensured with prefilled and sealed reagent cartridges, as well as load checking through integrated cameras. Other features include UV decontamination, onboard pipetting and heating as well as automated piercing of the sealed cartridge. The resulting analyte is compatible with a variety of downstream technologies such as real-time PCR, digital PCR and next-generation sequencing.

EZ2 Connect MDx complements QIAGEN’s leading offering of automated IVD nucleic extraction platforms, which includes QIAcube Connect MDx and QIAsymphony.

EZ2 Connect MDx is designed to handle a wide range of sample material thanks to QIAGEN’s elaborate kit portfolio and customizable protocols. It can be used in research mode with research kits (MBA) or in dedicated IVD mode with EZ1 DSP kits as well as protocols for diagnostic workflows. Another key feature is the ability to use the QIAsphere digital laboratory ecosystem, which enables full integration into the digital infrastructure of a lab that allows for remote instrument management.

The new platform builds on QIAGEN’s EZ1 family of devices, which set new standards in sample-prep automation and sample-data management. The EZ2 combines the ease of use, process safety and robustness of the EZ1 with improved throughput and digital features. More than 5,000 EZ1 and EZ2 instruments have been placed worldwide through the end of 2022.

On January 17, 2023 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported that it has scheduled its fourth quarter and year-end 2022 financial results conference call and webcast for 5:00 a.m. Pacific Time (8:00 a.m. Eastern Time) on February 6, 2023 (Press release, Neurocrine Biosciences, JAN 17, 2023, View Source [SID1234626299]).

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The schedule for the press release and conference call / webcast is as follows:

• Q4 & Year-End 2022 Press Release:

February 6, 2023 at 4:30 a.m. PT / 7:30 a.m. ET

• Q4 & Year-End 2022 Conference Call:

February 6, 2023 at 5:00 a.m. PT / 8:00 a.m. ET

• Domestic Dial-In Number:

866-952-8559

• International Dial-In Number:

785-424-1743

• Conference ID:

NBIX

The webcast can also be accessed on Neurocrine Biosciences’ website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.

On January 17, 2023 Ad hoc announcement pursuant to Art. 53 LR Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics, reported that the first patient has been treated in a Phase 1 first-in-human study evaluating the safety, tolerability, and efficacy of MP0533, the company’s candidate for acute myeloid leukemia (AML). MP0533 is designed to focus an immune attack against AML in a new way that preferentially spares healthy cells, which has been a historic challenge for CD3-targeting therapeutics (Press release, Molecular Partners, JAN 17, 2023, View Source [SID1234626298]).

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"AML is a notoriously difficult cancer to treat, largely due to the overlapping targets expressed on both healthy and leukemic cells. Our team has worked relentlessly over the past three years to develop a molecule intended to target these cancerous cells while avoiding healthy cells. MP0533’s mechanism represents a new level of precision targeting in complex cancers that may permit greater use of the cytotoxic power of engaging CD3," said Nicolas Leupin, M.D., Ph.D., Chief Medical Officer of Molecular Partners. "We are grateful to our team and our collaborators for reaching this milestone and look forward to learning more about the potential of MP0533 to help these patients."

MP0533 simultaneously targets three surface proteins, CD33, CD123, and CD70, that are vastly more likely to be expressed together on AML blast cells and leukemic stem cells over healthy cells. It also targets CD3 on cytotoxic T cells, which will preferentially activate when at least two of the surface proteins are bound. This novel mechanism is intended to greatly favor CD3 activation in leukemic stem cells rather than the systemic activation seen in previous CD3-based T cell engagers.

The Phase 1 open-label dose escalation study will enroll patients with relapsed/refractory AML and higher-risk myelodysplastic syndromes (MDS). It is designed to assess the safety, tolerability, and efficacy of MP0533 in addition to a range of secondary endpoints, such as the effect on LSCs, pharmacokinetics, T-cell activation, and cytokine release. Between 20-45 patients are expected to be enrolled across five sites in Switzerland and the Netherlands in collaboration with select sites within the HOVON cooperative group. Additional clinical sites are planned as well.

MP0533 preclinical data demonstrates it induces preferential T cell mediated killing of cells expressing two or three of the tumor associated antigens (TAAs) compared to cells expressing a single TAA. MP0533 also demonstrated an ability to induce T cell activation and killing of AML cells in samples from newly diagnosed and previously treated patients. The research also showed that MP0533 was able to directly target and kill LSCs while sparing a variety of healthy cells including hematopoietic stem cells, endothelial cells, and T cells.

About Molecular Partners’ Oncology Product Candidates

Molecular Partners is developing several candidates designed to activate the immune system to fight cancer while reducing damage to healthy cells. These candidates use multiple novel DARPin technologies potentially applicable against a wide range of tumor types, including DARPin candidates with the ability to restrict immune activation to the tumor microenvironment, the ability to target intracellular disease-associated proteins, and multiple novel control mechanisms for immune activation designed to direct immune attack to the right cells, at the right place, and at the right time. These capabilities can be combined during candidate design through the inherent modularity of the DARPin platform, to provide precise control over immune activation and potentially enable more effective cancer therapies.

On January 17, 2023 Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate"), a clinical-stage precision oncology company, reported the poster presentation of the design and rationale of a Phase 1 trial-in-progress (KN-4802, NCT05242822) evaluating the Company’s investigational pan-FGFR inhibitor, KIN-3248, at two upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)-related conferences (Press release, Kinnate Biopharma, JAN 17, 2023, View Source [SID1234626297]).

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KIN-3248 is an irreversible, small molecule pan-FGFR inhibitor designed to address primary FGFR2 and FGFR3 oncogenic alterations, and those predicted to drive acquired resistance to current FGFR-targeted therapies, including gatekeeper, molecular brake, and activation loop mutations observed in cancers such as intrahepatic cholangiocarcinoma (ICC) and urothelial carcinoma (UC). In preclinical studies, KIN-3248 demonstrated inhibitory activity across a wide range of clinically relevant mutations that drive primary disease and acquired resistance to other FGFR inhibitors.

The KN-4802 clinical trial (NCT05242822) is a multi-center, open-label, two-part study of approximately 120 patients to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of KIN-3248 in adults with advanced tumors harboring FGFR2 and/or FGFR3 gene alterations. Dose escalation (Part A) will determine the recommended dose and schedule of KIN-3248 for further evaluation in patients with FGFR2 and/or FGFR3 gene alteration-driven cancers. Dose expansion (Part B) will assess the safety and efficacy of KIN-3248 at the recommended dose and schedule in FGFR inhibitor naïve and FGFR inhibitor pretreated patients with cancers driven by FGFR2 and/or FGFR3 gene alterations, including ICC, UC, and other advanced or metastatic solid tumors in adults.

This trial is currently enrolling across multiple sites in the U.S. and Taiwan, with initial dose escalation data anticipated in the second half of 2023.

Poster Presentation Details

ASCO Gastrointestinal Cancers Symposium, January 19-21, 2023
San Francisco, Calif. and Online

Title: First-in-Human Phase 1/1b Study Evaluating KIN-3248, a Next-Generation, Irreversible Pan-FGFR Inhibitor, in Patients With Advanced Cholangiocarcinoma and Other Solid Tumors Harboring FGFR2 and/or FGFR3 Gene Alterations
Author: James Harding, MD
Abstract Number: TPS637
Poster Board: P6
Session Type and Track: Trials in Progress Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract
Session Date/Time: Friday, January 20, 2023 | 12:00 p.m. – 1:30 p.m. PT

ASCO Genitourinary Cancers Symposium, February 16-18, 2023
San Francisco, Calif. and Online

Title: First-in-Human Phase 1/1b Study Evaluating KIN-3248, a Next‑Generation, Irreversible Pan-FGFR Inhibitor, in Patients With Advanced Urothelial Carcinoma and Other Solid Tumors Harboring FGFR2 and/or FGFR3 Gene Alterations
Author: Benjamin Garmezy, MD
Abstract Number: TPS593
Poster Board: P16
Session Type and Track: Trials in Progress Poster Session, Urothelial Carcinoma
Session Date: February 17, 2023 |12:30 p.m. PT

For additional information, visit the ASCO (Free ASCO Whitepaper) Meeting webpage: View Source

On January 17, 2023 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, reported that the first patient has been dosed in its Phase 1 clinical trial evaluating IGM-7354, a targeted IL-15/IL-15R IgM antibody which could potentially be used for the treatment of patients with solid and hematologic malignancies (Press release, IGM Biosciences, JAN 17, 2023, View Source [SID1234626296]).

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The multicenter, open-label, dose escalation Phase 1 clinical trial will evaluate IGM-7354 intravenously administered as a monotherapy in patients with relapsed and/or refractory solid tumor cancers. The key objectives of this trial are to provide an initial assessment of pharmacokinetics, safety and immune cell proliferation. If IGM-7354 shows an encouraging safety profile and significant increases in T cells and natural killer (NK) cells in this clinical trial, the Company may begin combination studies of IGM-7354 with T cell engaging antibodies in 2024. The Company may also decide to pursue combination studies with CAR-T or CAR-NK cells with a partner.

"The initiation of this clinical trial is another significant milestone in IGM’s development, as it is the first clinical study of an IgM targeted immune cytokine," said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. "If IGM-7354 shows an encouraging safety profile and significant increases in T cells and NK cells, we believe it may have clinical application in treating cancer in combination with a broad range of oncology drugs that rely on those immune cells for efficacy."

About IGM-7354
IGM-7354 is a targeted IL-15/IL-15R IgM immune stimulating antibody for the treatment of patients with solid tumors and hematologic malignancies. The antibody binding domains of IGM-7354 target PD-L1 and are designed to concentrate the delivery of IL-15 in the area of cells with PD-L1 expression, including PD-L1-expressing tumors and tumor-draining lymph nodes. Through this targeting, IGM-7354 may be able to enhance the immune system’s activity in the tumor microenvironment, while potentially reducing systemic toxicities.