PreciseDx Announces Publication in Breast Cancer Research; Validates Its AI-Enabled Platform that Predicts Early-Stage Breast Cancer Recurrence Better than Current Industry Standard

On January 19, 2023 PreciseDx, a leading innovator in AI-powered, patient-specific disease analysis, reported its recent publication in Breast Cancer Research, demonstrating the ability of its digital AI platform to enrich breast cancer grading and improve risk categorization (Press release, PreciseDx, JAN 19, 2023, View Source [SID1234626359]). The paper, entitled ‘Development and Validation of an AI-Enabled Digital Breast Cancer Assay to Predict Early-Stage Breast Cancer Recurrence Within 6 Years,’ illustrates an industry-changing advancement in cancer diagnosis and outcome predictions.

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Despite advances in breast cancer screening and diagnosis, there continues to be an opportunity to significantly improve accuracy in histologic characterization, grading and prognosis. Once breast cancer is detected, pathologists and oncologists are tasked to set a course for an effective treatment plan which is currently limited by the subjectivity of a visual interpretation of the invasive disease.

PreciseDx’s Platform, which leverages its Morphology Feature Array, has proven the ability to enhance pathology interpretation with objective, quantifiable, and highly accurate data. This provides more robust information regarding patient disease status, representing the next generation of pathology analysis.

"There still remains an inherent subjectiveness in the cancer classification, grading and prognosis," said PreciseDx CEO, Wayne Brinster. "Our platform was designed to set a new standard of information and accuracy without interrupting workflows. I am proud to lead an organization that is truly transforming the way cancer is staged and graded worldwide."

The population-based longitudinal clinical development and validation study examined more than 2,000 patients from Mount Sinai Hospital with infiltrating ductal carcinoma of the breast. Following patients retrospectively for a median of six years, the study determined the PreciseDx Platform improved risk stratification and prediction of disease recurrence over standard histologic grade and clinical features and, furthermore, demonstrated the ability to supplement molecular genomic tests.

"The recent publication in Breast Cancer Research on the clinical validation of our AI-enabled digital assay to predict early-stage breast cancer recurrence represents a key milestone in advancing our automated AI-driven platform to phenotype and grade invasive breast cancer with just an Hematoxylin and Eosin (H&E) image and readily available clinical data," said Michael Donovan, MD, PhD, Co-Founder and Chief Medical Officer at PreciseDx. "Additional extended validation studies are underway to enrich our current results and ultimately broaden access to this platform throughout the breast cancer community."

SELLAS Life Sciences to Host Key Opinion Leader Webinar on Galinpepimut-S Acute Myeloid Leukemia Program

On January 19, 2023 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported that it will host a virtual key opinion leader event to discuss the current treatment landscape for patients suffering from acute myeloid leukemia (AML) and the potential for galinpepimut-S (GPS) as a treatment solution (Press release, Sellas Life Sciences, JAN 19, 2023, View Source [SID1234626353]).

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The webinar event will feature Omer Jamy, MD who is principal investigator of the Phase 3 REGAL study at the University of Alabama at Birmingham (UAB), one of the highest enrolling REGAL sites. He is currently Assistant Professor of Medicine at UAB in the Division of Hematology and Oncology and Associate Scientist, Experimental Therapeutics at the O’Neal Comprehensive Cancer Center. Dr. Jamy is principal investigator on several clinical trials in addition to REGAL, focusing on AML, chronic myelogenous leukemia, and allogeneic stem cell transplantation. Dr. Jamy completed his internal medicine residency at the University of Tennessee in Memphis followed by fellowship training at UAB in hematology/oncology, bone marrow transplantation and cellular therapy.

The SELLAS management team will provide a corporate update on GPS, their lead pipeline candidate, which is currently being evaluated in a Phase 3 registrational clinical trial in AML patients who have achieved complete remission following second-line salvage therapy. GPS targets malignancies and tumors characterized by an overexpression of the WT1 antigen, one of the most widely expressed cancer antigens in multiple malignancies.

Seagen to Host Conference Call and Webcast Discussion of Fourth Quarter and Full Year 2022 Financial Results on February 15, 2023

On January 19, 2023 Seagen Inc. (Nasdaq: SGEN) reported that it will report its fourth quarter and full year 2022 financial results on Wednesday, February 15, 2023 after the close of U.S. financial markets (Press release, Seagen, JAN 19, 2023, View Source [SID1234626352]). Following the announcement, Company management will host a conference call and webcast at 4:30 p.m. Eastern Time to discuss the results and provide a business update.

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Conference call and webcast information:

Telephone 844-763-8274 (U.S.) or +1 412-717-9224 (international). Ask for the Seagen conference call.
Webcast with slides can be accessed at investor.seagen.com. A webcast replay will be archived on the Company’s website.

Bellicum Pharmaceuticals to Present Early Phase 1 Results for BPX-601 in Prostate Cancer at ASCO 2023 Genitourinary Cancers Symposium

On January 19, 2023 Bellicum Pharmaceuticals, Inc. (Nasdaq: BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, reported that an abstract on early results from a Phase 1 clinical trial for BPX-601, its lead GoCAR-T product candidate, has been accepted for poster presentation at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU) (Press release, Bellicum Pharmaceuticals, JAN 19, 2023, View Source [SID1234626351]). The meeting is being held February 16-18, 2023 in San Francisco and virtually. The ongoing trial is being conducted in patients with metastatic castration-resistant prostate cancer.

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Details of the poster presentation are as follows:

Title: Early Results from a Phase 1, Multicenter Trial of PSCA-Specific GoCAR-T Cells (BPX-601) in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Poster Board: E1, Abstract 140
Presenter: Mark N. Stein, M.D.
Time/Location: Thursday, February 16, 2023, 2:30 p.m. ET / 11:30 a.m. PT, Level 1, West Hall, Moscone Center

BRUKINSA® (zanubrutinib) Receives Marketing Authorization for Chronic Lymphocytic Leukemia (CLL) and Marginal Zone Lymphoma (MZL) in Great Britain by MHRA

On january 19, 2023 BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, reported that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorizations for BRUKINSA (zanubrutinib) in Great Britain for both the treatment of adult patients with chronic lymphocytic leukemia (CLL) and the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy (Press release, BeiGene, JAN 19, 2023, View Source [SID1234626350]).

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"BRUKINSA is a highly selective BTK inhibitor that has demonstrated clinically meaningful improvements over the first generation of BTK inhibitor in relapsed CLL," said Dr Renata Walewska, Department of Hematology, University Hospitals Dorset, Bournemouth, UK. "The authorization of BRUKINSA for MZL and CLL in Great Britain is a significant step forward for eligible patients and their physicians as there is no targeted treatment currently authorized for MZL patients other than chemoimmunotherapy, and it represents an alternative to current BTKi treatments for patients with CLL."

The MHRA authorization for CLL is based on two global Phase 3 clinical trials: SEQUOIA (NCT03336333)1, comparing BRUKINSA against bendamustine plus rituximab (BR) in patients with previously untreated CLL, and ALPINE (NCT03734016)2, comparing BRUKINSA against IMBRUVICA (ibrutinib) in patients with relapsed/refractory (R/R) CLL.

The MHRA authorization for MZL is based on results from the multicenter, global, single-arm, open-label, Phase 2 MAGNOLIA3 trial in patients with R/R MZL who received at least one anti-CD-20 based regimen.

"As a BTK inhibitor designed to maximize BTK occupancy and minimize off-target binding, we believe BRUKINSA presents a very promising treatment option for eligible patients with MZL and CLL," said Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene.

"As we strive for delivering cancer medicines more quickly to more patients around the world, we are pleased with the progress we’ve made in bringing BRUKINSA to more eligible patients with hematological malignancies in Great Britain following these authorizations," added Dr. Robert Mulrooney, General Manager, UK & Ireland at BeiGene.

Earlier this year, the National Institute for Health and Care Excellence (NICE), recommended BRUKINSA for the treatment of Waldenström’s macroglobulinemia (WM) in adults who have had at least one treatment, only if bendamustine plus rituximab is also suitable. BRUKINSA has also been recommended by the Scottish Medicines Consortium for the treatment of adult patients with WM who have received at least one prior therapy, or in first-line treatment for patients unsuitable for chemoimmunotherapy.

BRUKINSA is currently authorized in the European Union, and Northern Ireland, as per rulings set out in the Northern Ireland Protocol,for the treatment of adult patients with WM who have received at least one prior therapy or as the first-line treatment for patients unsuitable for chemoimmunotherapy; for the treatment of adult patients with CLL and for adult patients with MZL who have received at least one prior anti-CD20-based therapy.

About Chronic Lymphocytic Leukemia

A life-threatening cancer of adults, CLL is a type of mature B-cell malignancy in which abnormal leukemic B lymphocytes (a type of white blood cells) arise from the bone marrow and flood peripheral blood, bone marrow, and lymphoid tissues4,5. CLL is the most common type of leukemia in adults, accounting for about one-quarter of new cases of leukemia6. In Europe, the estimated incidence is 4.92/100,000 persons per year7,8.

About Marginal Zone Lymphoma

MZL is a group of ultra-rare, slow growing B-cell malignancies that begin in the marginal zones of lymph tissue9. Epidemiological data from Europe is limited, but the incidence rate of MZL is estimated to range between 20 and 30 persons per million per year10,11,12. There are three different subtypes of MZL: extranodal marginal zone B-cell lymphoma, or mucosa-associated lymphoid tissue (MALT), which is most common; nodal marginal zone B-cell lymphoma which develops in the lymph nodes and is rare; and splenic marginal zone B-cell lymphoma which develops in the spleen, bone marrow, or both, and is the rarest form of the disease13.

About BRUKINSA

BRUKINSA is a small-molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. BRUKINSA was specifically designed to deliver targeted and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease-relevant tissues.

BRUKINSA is supported by a broad clinical program which includes more than 4,700 subjects in 35 trials in more than 30 geographies. To date, BRUKINSA is approved in over 60 markets, including the United States, China, the European Union, Great Britain, Canada, Australia, South Korea, Iceland, Norway and Switzerland.