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.

On January 17, 2023 Glycotope GmbH, a biotechnology company with a proprietary platform technology for developing antibodies against proteins carrying tumor-specific carbohydrate structures, repoerted that it will present its glyco-engineered cell lines at GlycoBioTec 2023 – 3rd International GlycoBioTec Symposium, being held in Berlin, Germany, on 17 and 18 January 2023 (Press release, Glycotope, JAN 17, 2023, View Source [SID1234626294]).

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Patrik Kehler, Chief Scientific Officer of Glycotope GmbH commented: "Our glyco-engineered cell lines provide the basis for the generation of therapeutic antibodies with increased tumor specificity and safety for highly potent therapeutic approaches like ADCs, CARs and radiotherapeutics. It represents a versatile tool for target validation and screening of glycosylation-dependent protein binding antibodies. It is great, that our scientists have the opportunity to present their work at GlycoBioTec 2023 and to discuss with other glycobiotechnology experts."

Poster details are as follows:

Abstract: Download here

Title: Using glyco-engineered cells with flexible expression of tumor-associated carbohydrates for the generation of highly tumor-specific antibodies

Poster Presentation: 17 January 2023, 6:00am – 7:00pm CET

Contact Information:

Glycotope GmbH

Dr. Patrik Kehler (CSO)

Phone: +49 30 9489 2600

Email: [email protected]

On January 17, 2023 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported the presentation of research across various types of gastrointestinal cancers during the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (#GI23), which is taking place in-person in San Francisco, California and virtually from January 19-21 (Press release, Eisai, JAN 17, 2023, View Source [SID1234626293]).

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Notable data include an update from the dose-escalation part of a Phase 1 Study evaluating E7386*1, a CREB-binding protein (CBP) / β-catenin interaction inhibitor, in patients with advanced solid tumors including colorectal cancer (NCT03833700(New Window); Abstract: #106). Based on these additional analyses, further investigation of safety, preliminary efficacy, pharmacokinetics and biomarker analyses of E7386 is ongoing using two dose levels in the expansion part.

Research from the LEAP (LEnvatinib And Pembrolizumab) clinical program includes a poster presentation featuring a health-related quality of life analysis from the Phase 3 LEAP-002 trial investigating the lenvatinib (LENVIMA) plus pembrolizumab (KEYTRUDA*2) combination versus lenvatinib plus placebo as a first-line treatment for patients with unresectable hepatocellular carcinoma (NCT03713593(New Window); Abstract: #506). Additional presentations on Eisai’s oncology pipeline showcase Eisai’s investigational compound, E7389-LF, a new liposomal formulation of eribulin, in combination with nivolumab in patients with solid tumors. Efficacy and safety were evaluated in expansion cohorts, including an esophageal cancer cohort (NCT04078295(New Window); Abstract: #337) and a gastric cancer cohort (NCT04078295(New Window); Abstract: #339).

"We are eager to share new data at the annual symposium where specialists in gastrointestinal cancers gather from all over the world, including findings from a Phase 1 study evaluating the novel investigational anticancer agent, E7386, in advanced solid tumors including colorectal cancer," said Dr. Takashi Owa, Chief Scientific Officer, Senior Vice President, Eisai Co., Ltd. "Our findings across colorectal, esophageal, gastric and liver cancer illustrate Eisai’s commitment to further oncology research for people living with gastrointestinal cancers, who account for over one quarter of the global cancer incidence1."

In March 2018, Eisai and Merck (known as MSD outside the United States and Canada), through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib, both as monotherapy and in combination with Merck’s anti-PD-1 therapy pembrolizumab. To date, more than 10 trials have been initiated under the LEAP clinical program, which is evaluating the combination across multiple tumor types.

This release discusses investigational compounds and investigational uses for FDA-approved products. It is not intended to convey conclusions about efficacy and safety. There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.

The full list of Eisai presentations is included below. The majority of abstracts are currently available on the ASCO (Free ASCO Whitepaper) website. The late-breaking abstracts will be released at the time of presentation during the symposium.

Cancer Type Study/ Compound Abstract Title Abstract Type & Details (Pacific Standard Time)
Pipeline
Solid Tumors

E7386

A phase 1 study of E7386, a CREB-binding protein (CBP)/β-catenin interaction inhibitor, in patients (pts) with advanced solid tumors including colorectal cancer: updated dose-escalation part
Poster Presentation
Abstract #106
January 21, 2023

6:30-7:55 AM
E7389-LF

Gastric cancer (GC) cohort of a phase 2 trial of E7389-LF (liposomal formulation of eribulin) in combination with nivolumab
Poster Presentation
Abstract #339
January 19, 2023

12:00-1:30 PM
E7389-LF

The esophageal cancer cohort of a phase 2 trial of E7389‐LF (liposomal formulation of eribulin) + nivolumab
Poster Presentation
Abstract #337
January 19, 2023

12:00-1:30 PM
LEAP clinical program
Gastrointestinal Cancers LEAP-015 First-line lenvatinib plus pembrolizumab plus chemotherapy versus chemotherapy in advanced/metastatic gastroesophageal adenocarcinoma: (LEAP-015): Safety run-in results (Encore presentation)
Poster Presentation
Abstract #411
January 19, 2023

12:00-1:30 PM
LEAP-002 Health-related quality of life (HRQoL) impact of lenvatinib (len) plus pembrolizumab (pembro) versus len plus placebo (pbo) as first-line (1L) therapy for advanced hepatocellular carcinoma (aHCC): Phase 3 LEAP-002 study
Poster Presentation
Abstract #506
January 20, 2023

12:00-1:30 PM
Real World Evidence
Gastrointestinal Cancer Real-world data Prevalence of historical medical conditions or comorbidities with potential role in clinical decision making related to suitability of immuno-oncologic plus IV antiangiogenic therapy in newly diagnosed first-line unresectable hepatocellular carcinoma in the United States
Poster Presentation
Presentation #511
January 20, 2023

12:00-1:30 PM