On April 20, 2021 GloriousMed Biomedical Group Co., Ltd ("GloriousMed") and Minomic International Ltd ("Minomic") of Australia reported that officially executed the agreement, which formally launched the commercialization of MiCheck Prostate, a prostate cancer early diagnosis product, in mainland China (Press release, Minomic, APR 20, 2021, View Source [SID1234578242]). Finalizing this agreement completes an important step in commercializing MiCheck Prostate in one of the world’s largest healthcare markets. Under the agreement GloriousMed will make an initial investment in Minomic to fund a validation study of MiCheck Prostate using samples sourced from Chinese patients. The agreement also includes an option for GloriousMed to make a further investment of up to US$2.5 Million in Minomic.

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GloriousMed is a leading provider of total solutions for precision tumor management in China, and a market leader in precision urological tumor testing, committed to creating an integrated ecological loop for precision treatment of vertical tumor types. Minomic is an Australian medical diagnostic company specializing in the development of diagnostic technologies for solid tumors, including prostate, bladder and pancreatic cancers. MiCheck Prostate, a blood test developed by Minomic over six years, is a rapid, non-invasive, highly specific test with higher sensitivity and specificity than existing PSA screening technologies. The product helps urologists decide whether to subject patients to a puncture biopsy by assessing the risk of aggressive prostate cancer, effectively avoiding unnecessary biopsies.

With the aging of the population, the incidence of prostate cancer in China is increasing. GloriousMed is actively expanding its multi-omics technology platform and introducing the most cutting-edge international technologies and products to promote the development of precise diagnosis and treatment of prostate cancer in China and further assist in the early diagnosis and treatment of prostate cancer. Through the application of MiCheck Prostate in mainland China, it is expected to increase the early diagnosis rate of prostate cancer patients in China and improve their survival quality.

Dr Brad Walsh CEO Minomic, Mrs Jin Ge CEO GloriousMed, Prof Xue Wei, Shanghai Jiaotong University School of Medicine

Minomic’s CEO, Dr Brad Walsh, noted "being able to test MiCheck Prostate on a Chinese population has been an aim of the company for some time. We recognize that to be successful in the China market we must work with a partner with significant local expertise and experience to execute this and are very pleased to partner with one of the leading urology companies in China. Our thanks to the GloriousMed team for making this possible. We are very excited to be working with them as they continue to build their franchise in the urological testing space".

GloriousMed’ CEO, Mrs. Jin Ge, said "We are very pleased to reach this cooperation with Minomic. In the past five years, GloriousMed has devoted itself to the integration of urological tumor diagnosis and treatment. In both independent research and global introduction, we hope to establish the entire urological tumor treatment pathway and diagnostic sequence. With five years of hard work, GloriousMed has become a leader in precision treatment of urological tumors in China, and we also hope to build a more professional product system. MiCheck Prostate is a very competitive product that can bring real value to Chinese prostate cancer patients. GloriousMed has already started to communicate with many clinical experts in China and is ready for future clinical trials to achieve the translation of MiCheck in China as soon as possible.

Prostate cancer has now leaped to the top of malignant tumors of the male genitourinary system in China, said Professor Xue Wei of Renji Hospital, Shanghai Jiaotong University School of Medicine. Due to untimely screening and diagnosis, about half of the newly diagnosed prostate cancer patients in China are at advanced stages. It is evident that early screening, early diagnosis and early treatment of prostate cancer will be the key factor to improve the survival time and quality of life of patients. As we know, PSA test is one of the main tools for prostate cancer screening and diagnosis, but there are certain problems in the specificity of PSA test, leading some patients with elevated PSA to undergo unnecessary prostate puncture biopsy. Minomic has spent 6 years developing a rapid, non-invasive, highly specific blood test: MiCheck Prostate, which has higher sensitivity and specificity than existing PSA screening technologies. The introduction of this technology into China by GloriousMed is expected to improve the current situation of early diagnosis and treatment of prostate cancer in China, help clinicians accurately select patients who do need to undergo puncture biopsy, effectively avoid unnecessary biopsies and reduce patient trauma."

On April 20, 2021 Amgen reported that The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to bemarituzumab for first-line treatment of patients with fibroblast growth factor receptor 2b (FGFR2b) overexpressing and human epidermal growth factor receptor 2 (HER2)-negative metastatic and locally advanced gastric and gastroesophageal (GEJ) cancer (Press release, EVERSANA, APR 20, 2021, View Source [SID1234578243]).

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The designation was supported by the Phase II FIGHT trial, in which bemarituzumab treatment plus chemotherapy demonstrated clinically significant and substantial improvements in progression-free survival and overall survival in the patient population with at least 10% of tumor cells overexpressing FGFR2b.

"The FIGHT trial is the first study to evaluate targeting the overexpression of FGFR2b in cancer. Bemarituzumab demonstrated clinically meaningful outcomes in key endpoints for patients with advanced gastric or gastroesophageal cancer as a frontline therapy," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "Amgen looks forward to further investigating the role of FGFR2b and will continue to work with regulatory agencies on next steps to bring this potential first-in-class, frontline therapy to patients."

The designation makes bemarituzumab the second asset in Amgen’s oncology portfolio to receive Breakthrough Therapy Designation in the past six months – following sotorasib.

On April 20, 2021 Cerus Corporation (Nasdaq: CERS) reported that its first quarter 2021 financial results will be released on Tuesday, May 4, 2021, after the close of the stock market (Press release, Cerus, APR 20, 2021, View Source [SID1234578259]). The Company will host a conference call and webcast at 4:30 P.M. ET that afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook.

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To listen to the live webcast and view the presentation slides, please visit the Investor Relations page of the Cerus website at View Source Alternatively, you may access the live conference call by dialing (866) 235-9006 (U.S.) or (631) 291-4549 (international).

A replay will be available on Cerus’ website, or by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and entering conference ID number 8668508. The replay will be available approximately three hours after the call through May 18, 2021.

On April 20, 2021 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported a regulatory update for omburtamab, which is an investigational, monoclonal antibody that targets B7-H3 and has been radiolabeled before intraventricular central nervous system ("CNS") administration (Press release, Y-mAbs Therapeutics, APR 20, 2021, View Source [SID1234578244]). B7-H3 is an immune checkpoint molecule that is widely expressed in tumor cells of several cancer types.

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Y-mAbs recently concluded a Type B meeting with the U.S. Food and Drug Administration ("FDA") regarding omburtamab and received requests from the FDA for additional data concerning the granularity of data from our identified historical control groups. In order to agree on a statistical analysis plan ("SAP"), this additional granularity data is being collected and we anticipate submitting it to the FDA by the end of April. An additional Type B meeting has been scheduled for June 1, 2021 to discuss the SAP based on review of the additional data. We continue to be in close dialog with the FDA and maintain our aim of resubmitting the Biologics License Application ("BLA") for omburtamab late in the second quarter or in the third quarter of 2021.

"We believe omburtamab is on track to potentially become the first FDA approved targeted therapy for pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma, addressing an important unmet medical need, where no standard therapy is currently available," said Thomas Gad, founder, Chairman and President of Y-mAbs.

Dr. Claus Moller, the Company’s Chief Executive Officer, continued, "We believe omburtamab can potentially address a significant unmet medical need for children with CNS/leptomeningeal metastasis from neuroblastoma, and we continue to work closely with the FDA to resubmit the omburtamab BLA. In addition, we are targeting submission of a Marketing Authorization Application to the European Medicines Agency on April 30, 2021."

Researchers at Memorial Sloan Kettering Cancer Center ("MSK") developed omburtamab, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interest related to the compound and Y-mAbs.

On April 20, 2021 Immunomic Therapeutics, Inc., ("ITI"), a privately-held clinical stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, reported a worldwide license and development collaboration agreement with Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell transplants for serious medical conditions (Press release, Immunomic Therapeutics, APR 20, 2021, View Source [SID1234578260]). The collaboration will generate a novel product candidate derived from Lineage’s investigational allogeneic VAC cancer immunotherapy platform and targeting a proprietary Tumor Associated Antigen (TAA) construct provided by ITI, for the treatment of glioblastoma multiforme (GBM). Lineage and ITI will collaborate in the manufacturing and clinical development of a novel VAC product candidate. Following the full development and delivery of Current Good Manufacturing Practice (cGMP) VAC product material, ITI will assume full and independent clinical and commercial responsibility and further advancement of the program. Under the terms of the agreement, Lineage will be entitled to an upfront payment of $2 million paid in the first year and development and commercial milestones totaling $67 million across multiple indications. Lineage also will be eligible to receive royalties up to 10% on future product sales.

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"We’re very pleased to collaborate with Lineage, a well-recognized cell therapy company, to expand our pipeline with the development of a novel product candidate to treat GBM," commented Dr. William Hearl, CEO of ITI. "Over the last several years, ITI has invested significant capital and development resources to identifying multiple novel paths forward in GBM. By teaming up with Lineage, we are hoping to expand our efforts in this difficult to treat indication and look forward to the benefit that the VAC immunotherapy platform can bring to our antigen constructs."

"The VAC platform provides us with the opportunity to generate a broad pipeline of product candidates, each targeting a different type of cancer," stated Brian Culley, Lineage CEO. "This collaboration represents the first of many partnerships we hope to enter into with our platform and we believe it helps further validate VAC as a promising new therapeutic vaccine platform. Our objective is to leverage our technology to generate additional VAC-derived cell therapies for our pipeline, as well as in collaboration with partners, capitalizing on the strength of Lineage’s recent manufacturing and cell transplant success. These alliances also will diversify our oncology pipeline across more programs, providing new opportunities for success without the financial burden of independent development. We appreciate ITI selecting our antigen delivery platform for this collaboration and look forward to a productive partnership on this new VAC-derived product candidate. We also are eager to collaborate with additional partners on future versions of VAC."

About Glioblastoma multiforme (GBM)

Glioblastoma multiforme (GBM) (also called glioblastoma) is a fast-growing glioma that develops from star-shaped glial cells (astrocytes and oligodendrocytes) that support the health of the nerve cells within the brain. GBM is often referred to as a grade IV astrocytoma. These are the most invasive type of glial tumors, rapidly growing and commonly spreading into nearby brain tissue. GBMs can arise in the brain "de novo" or evolve from lower-grade astrocytomas or oligodendrogliomas. In adults, GBM occurs most often in the cerebral hemispheres, especially in the frontal and temporal lobes of the brain. GBM is a devastating brain cancer that typically results in death in the first 15 months after diagnosis, with only 25% of glioblastoma patients surviving more than one year, and only 5% of patients surviving more than five years.

About VAC2

VAC2 is an allogeneic, or non-patient specific "off-the-shelf," cancer vaccine product candidate designed to stimulate patient immune responses to an antigen commonly expressed in cancerous cells but not in normal adult cells. VAC2, which is produced from a pluripotent cell technology using a directed differentiation method, is comprised of a population of nonproliferating mature dendritic cells. As the most potent type of antigen presenting cell in the body, dendritic cells instruct the body’s immune system to attack and eliminate harmful pathogens and unwanted cells. Because the tumor antigen is loaded exogenously into the dendritic cells prior to administration, VAC2 is a platform technology that can be modified to carry selected antigens, including patient-specific tumor neo-antigens or viral antigens. VAC2 is currently being tested in a Phase 1 study in adult patients with non-small cell lung cancer (NSCLC) in the advanced and adjuvant settings (NCT03371485), conducted by Cancer Research UK.