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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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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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.

On January 17, 2023 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported that new data from its portfolio of blood tests will be presented at the ASCO (Free ASCO Whitepaper) 2023 Gastrointestinal Cancers Symposium, January 19-21 in San Francisco (Press release, Guardant Health, JAN 17, 2023, View Source [SID1234626295]).

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The 10 poster presentations highlight the use of the Guardant360 and Guardant RevealTM blood tests and the GuardantINFORMTM real-world evidence dataset to identify critical biomarkers and acquired co-mutations, track associated treatment patterns and clinical outcomes, and predict disease recurrence from minimal residual disease (MRD) detection.

"We look forward to sharing new data at the ASCO (Free ASCO Whitepaper) GI Symposium demonstrating the utility of our blood tests and real-world data to increase the understanding of potential biomarker targets for therapy, as well as predictive markers for treatment resistance and disease recurrence in patients with gastrointestinal cancers," said Helmy Eltoukhy, Guardant Health co-CEO. "The presentations will show how data from circulating tumor DNA tests provide critical insights that can contribute to the development of more effective therapies and better-informed patient care."

Full List of Guardant Health Presentations

Guardant360

ctDNA-based fusion detection for advanced colorectal cancer with a partner-agnostic assay (abstract 186)
FGFR2-amplified gastroesophageal adenocarcinoma is a distinct genomic class: Lessons learned from a liquid biopsy platform (abstract 429)
A plasma-based analysis and genomic landscape of patients with high tumor mutational burden (TMB-H), microsatellite stable (MSS) colorectal cancer (CRC) (abstract 249)
Frequency and outcomes of BRAF alterations identified by liquid biopsy in metastatic non-colorectal gastrointestinal cancers (abstract 808)
The identification of reversion mutations in patients with advanced pancreatic cancer and germline or somatic BRCA or PALB2 variants who were treated with maintenance rucaparib (abstract 734)
Circulating tumor DNA-based genomic landscape of KRAS wild-type pancreatic adenocarcinoma (abstract 747)
Effect of EGFR and ERBB2 amplifications and activating alterations on efficacy of lenvatinib in hepatocellular carcinoma (abstract 600)
GuardantINFORM

Use of circulating tumor DNA (ctDNA) for early assessment of treatment response in patients with advanced colorectal cancer (aCRC): A real-world (RW) analysis (abstract 246)
Guardant Reveal

Optimising longitudinal plasma-only circulating tumour DNA (ctDNA) for minimal residual disease (MRD) detection with combined genomic/methylation signals to predict recurrence in patients (pts) with resected stage I-III colorectal cancer (CRC) in the UK multicentre prospective study TRACC (abstract 169) (Merit Award recipient)
Plasma-only multiomic minimal residual disease (MRD) testing in 2,000 consecutive patients with colorectal cancer (CRC) (abstract 28)
The full abstracts are available on the officialASCO 2023 GI Cancers Symposiumwebsite.