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VieCure and Labcorp Collaboration Will Improve Clinical Workflow, Increasing Patient Access to Genomic Testing

On January 25, 2023 VieCure reported a new collaboration with Labcorp to provide clinicians greater access to precision oncology decision support (Press release, VieCure, JAN 25, 2023, View Source [SID1234626562]). This strategic collaboration will support patient-specific treatment plans by integrating Labcorp’s precision medicine testing solutions with VieCure’s clinical decision support tool, helping community cancer care providers advance health equity and increase precision diagnostic test utilization for cancer patients, including those living in rural and remote areas who may lack access to larger oncology centers. Together, the two companies will be positioned to improve clinical outcomes for patients, creating a streamlined experience for biomarker-informed, personalized cancer care through an integrated clinic-genomic workflow of Labcorp’s precision medicine testing solutions.

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"We have an opportunity to help further democratize precision oncology and make it easier for community oncologists to offer the right care for the right patient every time."

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"Nearly 75% of cancer patients in the United States are treated in the community and private practice settings," said Dr. Fred Ashbury, chief scientific officer at VieCure. "We have an opportunity to help further democratize precision oncology and make it easier for community oncologists to offer the right care for the right patient every time."

Next-generation sequencing (NGS) has become foundational for precision oncology, with rapidly expanding diagnostic, prognostic, and therapeutic implications, but a there are a number of challenges for data standards and interoperability that make it difficult for clinicians to effectively manage and stay up-to-date on potential treatments. Labcorp’s comprehensive precision oncology test menu includes centralized solutions – including NGS-based tests spanning solid tumors, hematologic malignancies, and hereditary cancers – and kitted solutions (through the Feb. 2022 acquisition of Personal Genome Diagnostics Inc.), allowing institutions to internalize NGS and provide testing in house and integrate comprehensive molecular data into patient records.

"Labcorp’s leadership and scale in precision medicine diagnostic testing and drug development will accelerate access to personalized treatments for cancer patients treated in community oncology practices," said Prasanth Reddy, MD, MPH, FACP, senior vice president and global head of oncology at Labcorp. "Labcorp’s comprehensive portfolio of cancer diagnostic and next-generation sequencing products will be fully integrated into the VieCure platform, improving the clinical workflow experience for community oncologists to aid in precision medicine selection for oncology patients and drive better outcomes."

Latest Clinical Data of InnoCare’s Gunagratinib Presented at 2023 ASCO GI

On January 25, 2023 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the development of therapies for cancer and autoimmune diseases, reported that the latest clinical result of FGFR inhibitor gunagratinib (ICP-192) for the treatment of cholangiocarcinoma was presented at 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal (ASCO GI) Cancers Symposium (Press release, InnoCare Pharma, JAN 25, 2023, View Source [SID1234626561]).

The study was presented in a poster entitled "Gunagratinib, a highly selective irreversible FGFR inhibitor, in patients with previously treated locally advanced or metastatic cholangiocarcinoma harboring FGFR pathway alterations: A phase IIa dose-expansion study". Abstract number is 572.

As of September 5, 2022, 18 cholangiocarcinoma patients were treated orally with gunagratinib 20 mg QD. The median age of the patients was 52 with 44.4% male. Among 17 patients who have completed at least one tumor assessment, the overall response rate (ORR) was 52.9%, the disease control rate (DCR) was 94.1% and median progression free survival (mPFS) was 6.93 months (not reached at cutoff). Gunagratinib showed a well-tolerated safety profile.

Professor Ye Guo from Shanghai East Hospital of Tongji University said, "The study data demonstrated that gunagratinib is safe and well-tolerated in previously treated patients with locally advanced or metastatic cholangiocarcinoma harboring FGFR2 gene fusions or rearrangements. The response rate in such a patient group is high comparing to other approved FGFR inhibitors. Gunagratinib is a promising second-generation FGFR inhibitor with potential for the treatment of multiple indications with FGF/FGFR pathway abnormalities."

More information can be found at ASCO (Free ASCO Whitepaper) official website.

Hoth Therapeutics Announces Selection of First 3 Clinical Sites for its Phase 2 Clinical Trial to Treat Cancer Disorders Associated with Epidermal Growth Factor Receptor (EGFR) Inhibitor Therapy

On January 25, 2023 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company, reported that it has selected 3 of its clinical sites for its Phase 2a clinical trial for the treatment for rash and skin disorders associated with epidermal growth factor receptor (EGFR) inhibitor therapy (Press release, Hoth Therapeutics, JAN 25, 2023, View Source [SID1234626560]). EGFR inhibitors are critical therapeutic agents for the treatment of non-small cell lung cancer (NSCLC), pancreatic cancer, colorectal cancer, squamous-cell carcinoma of the head and neck, and breast cancer. The phase 2a dose ranging study as well as a proposed follow-up phase 2b safety and efficacy dose extension study; both studies will be conducted in cancer patients receiving EGFR inhibitor therapy.).

The initial 3 clinical sites for the Phase 2a are located across the United States in the following cities:
St Louis, MO
Miami, FL
Houston, TX

"We are pleased to have selected our initial clinical sites," said Robb Knie, the Company’s CEO. "The caliber of the clinics selected represents some of the best cancer treatment facilities in the country. This selection process represents a major milestone for Hoth and we look forward to initiating patient enrollment."

STORM Therapeutics Presents STC-15 Preclinical Data Supporting Treatment of Patients with AML at the AACR Acute Myeloid Leukemia and Myelodysplastic Syndrome Conference

On January 25, 2023 STORM Therapeutics Ltd. (STORM), the clinical stage biotechnology company discovering and developing novel small molecule therapies targeting RNA modifying enzymes (RMEs) for oncology and other diseases, reported new data on its lead candidate, the METTL3 inhibitor STC-15 (Press release, STORM Therapeutics, JAN 25, 2023, View Source [SID1234626558]). The new data in AML preclinical models was presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference: Acute Myeloid Leukemia and Myelodysplastic Syndrome, hosted in Austin, Texas on the 23-25 January.

The presentation entitled ‘STC-15, a novel METTL3 inhibitor, and its combination with venetoclax confer anti-tumour activity in AML models’ detailed the study of the pharmacological inhibition of METTL3 as monotherapy or in combination with venetoclax (FDA approved for AML treatment) in models of acute myeloid leukemia (AML) in vitro and in vivo.

Preclinical data demonstrated that:

STC-15 inhibited proliferation in some AML cell lines with sub- micromolar IC50 values
STC-15 inhibited the growth of 12 patient-derived AML samples in vitro with IC50 values reflecting a mean of approximately 1 micromolar
STC-15 reduced BCL2 protein levels in a dose-dependent manner in the majority of AML cell lines tested
STC-15 showed synergistic inhibition of tumor cell growth in vitro when combined with venetoclax
In an AML patient-derived in vivo model, STC-15 extended survival when compared to a vehicle-treated control group and a venatoclax-treated group of animals
In addition, STC-15 showed a decrease in circulating human CD45+ cells and decreased spleen weight when compared to vehicle treated animals
STORMS lead candidate STC-15 is advancing its ongoing Phase 1 study. The details of the study can be found on clinicaltrials.gov under the identifier NCT05584111.

Oliver Rausch, Chief Scientific Officer of STORM Therapeutics, said: "These studies provide evidence for the utility of METTL3 inhibitors as a new therapeutic approach to treat AML. We are delighted with the outcome of the data which further validates our previous publication that treatment with METTL3 inhibitors led to the downregulation of BCL2 protein levels in several AML cell lines and in vivo models and provides the rationale for conducting a clinical trial in AML with STC-15."

Jerry McMahon, Chief Executive Officer & President of STORM Therapeutics, said: "We are excited to present this new data with patient-derived tumor samples supporting the future clinical development of STC-15 in AML. Our ongoing Phase 1 multiple-ascending dose study in solid tumors is focused on establishing a potential dose and regimen of STC-15 to conduct future clinical studies in AML and solid tumors."

Details of the conference and presented poster are as follow:

Poster Presented Title: STC-15, a novel METTL3 inhibitor, and its combination with venetoclax confer anti-tumour activity in AML models

Presenting Authors: Lina Vasiliauskaitė1, Yaara Ofir-Rosenfeld1, Mark Albertella1, Coralie Hoareau-Aveilla2, Jerry McMahon1, Oliver Rausch1

Date and Time: Tuesday, 24 January, 07.15 – 21.30 ET

1Storm Therapeutics Ltd., Cambridge, UK

2Evotec SAS, Toulouse, FR

The Poster and Abstract are available on the STORM Therapeutics website: Publications.

STORM has developed potent and selective METTL3 inhibitors which include the first-in-class clinical candidate STC-15, an orally bioavailable, highly selective METTL3 inhibitor which commenced a clinical trial in cancer patients with solid tumors in November 2022.

Arrowhead Pharmaceuticals to Webcast Fiscal 2023 First Quarter Results

On January 25, 2023 Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) reported that it will host a webcast and conference call on February 6, 2023, at 4:30 p.m. ET to discuss its financial results for the fiscal 2023 first quarter ended December 31, 2022 (Press release, Arrowhead Pharmaceuticals, JAN 25, 2023, View Source [SID1234626557]).

Webcast and Conference Call and Details

Investors may access a live audio webcast on the Company’s website at View Source A replay of the webcast will be available approximately two hours after the conclusion of the call.

For analysts that wish to participate in the conference call, please register at https://register.vevent.com/register/BI9b2661110f7a4b0ebc648bf42d2a403f. Once registered, you will receive the dial-in number and a personalized PIN code that will be required to access the call.