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Minomic enters into collaboration with GloriousMed Biomedical Group, Shanghai, to introduce MiCheck® Prostate into China

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."

Jazz Pharmaceuticals Announces Proposed Private Offering of Senior Secured Notes

On April 20, 2021 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) (the "Company") reported that its wholly owned subsidiary, Jazz Securities Designated Activity Company (the "Issuer"), is commencing a private offering (the "Offering") of senior secured notes (the "Notes") in a transaction exempt from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"), subject to market and other conditions (Press release, Jazz Pharmaceuticals, APR 20, 2021, View Source [SID1234578241]). The Notes will be guaranteed by the Company and certain of the Company’s subsidiaries.

If the Offering is consummated, the Company expects to use the net proceeds from the Notes and the acquisition date borrowings under new senior secured credit facilities (the "New Senior Secured Credit Facilities"), together with cash on hand to fund the cash consideration payable in connection with the previously announced proposed acquisition of GW Pharmaceuticals plc (the "Acquisition"), the refinancing of certain of the Company’s indebtedness (including the Company’s existing senior secured credit facility) and fees and expenses in connection with the foregoing. The Offering is not conditioned on the closing of the Acquisition. If (1) the Acquisition is consummated without the Company entering into the New Senior Secured Credit Facilities, (2) the Acquisition has not been consummated on or before August 3, 2021 (or such later date to which such date may be extended pursuant to the terms of the Transaction Agreement, dated February 3, 2021, among the Company, GW Pharmaceuticals plc and Jazz Pharmaceuticals UK Holdings Limited (the "Transaction Agreement") or (3) the Transaction Agreement is terminated in accordance with its terms, the Issuer will be required to redeem all of the Notes at a redemption price equal to 100% of their principal amount plus accrued and unpaid interest to, but excluding, the redemption date. There can be no assurance that either the issuance or sale of the Notes or the Acquisition will be consummated.

The Notes will be offered and sold only to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act that are located in the United States, Canada, France, Ireland, Luxembourg, the United Kingdom and Bermuda and to certain non-U.S. persons outside the United States pursuant to Regulation S under the Securities Act that are located in Canada, France, Ireland, Luxembourg, the United Kingdom and Bermuda. The Notes have not been registered under the Securities Act or any state securities law and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state laws.

This press release does not constitute an offer to sell or a solicitation of an offer to purchase the Notes or any other securities and does not constitute an offer, solicitation or sale in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful.

Epigenomics AG announces conversion result of the first conversion period of the mandatory convertible bond 2021/2024

On April 20, 2021 Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the "Company") reported that convertible bonds with a nominal value of EUR 4,357,606.00 have been converted into 3,961,460 new shares (ISIN DE000A3H2184) in the first conversion period of the mandatory convertible bond 2021/2024 (Press release, Epigenomics, APR 20, 2021, https://www.epigenomics.com/%E2%80%8B%E2%80%8B%E2%80%8B%E2%80%8B%E2%80%8B%E2%80%8B%E2%80%8Bepigenomics-ag-announces-conversion-result-of-the-first-conversion-period-of-the-mandatory-convertible-bond-2021-2024/ [SID1234578240]). Accordingly, the number of issued shares increased from 5,891,230 to 9,852,690 no par value registered shares of the Company. The Company’s share capital increases correspondingly by EUR 3,961,460.00 to EUR 9,852,690.00. The outstanding portion of the mandatory convertible bond 2021/2024 therefore has a nominal value of EUR 1,142,394.00.

The new shares, which carry full dividend rights as of January 1, 2021, were admitted to trading on the stock exchange on April 16, 2021. Delivery of the new shares to the custodian banks will be carried out promptly.

The first conversion period ran from April 1 to 14, 2021. The next opportunity to convert is offered to creditors of the convertible bond from July 1 to 14, 2021.

Tubulis appoints Günter Fingerle-Rowson as Chief Medical Officer to lead the clinical development of its new generation of ADCs

On April 20, 2021 Tubulis reported the appointment of Günter Fingerle-Rowson, MD, PhD, as Chief Medical Officer to complement the leadership team and to further build the company’s clinical expertise (Press release, Tubulis, APR 20, 2021, View Source [SID1234578239]). Dr. Fingerle-Rowson is an experienced hematologist and medical oncologist who brings to Tubulis more than two decades of academic, biotechnology and pharmaceutical industry experience. Moreover, he has a proven track record of advancing product candidates from early clinical phase through regulatory approval and into clinical practice. In this newly established role, he will use his extensive knowledge in the development of cancer therapeutics to oversee Tubulis’ clinical activities and advance the company’s Antibody Drug Conjugates (ADCs) towards clinical evaluation.

"Günter is an expert in developing successful clinical oncology programs that resulted in the regulatory approval of several monoclonal antibodies. His wealth of experience and his track record of execution will be a great asset to Tubulis as we transition towards becoming an established clinical-stage drug developer," said Dr. Dominik Schumacher, CEO and co-founder of Tubulis. "In addition, his background in translational research in immuno-oncology will further strengthen our team and our capabilities to rapidly deliver the benefits of our ADC approach to cancer patients."

Dr. Fingerle-Rowson commented: "I am thrilled to join Tubulis to be part of the team that brings ADC technology to a new level. The technological advancements that the company has made in a short period of time and the team’s clear vision to become a leader in the field of ADCs instantly drew my interest. I look forward to help shape the clinical development plan for Tubulis’ exciting technology platform and to bring its first candidate TUB-010 to patients in the near term. Tubulis´ proprietary ADC technology enables us to develop novel ADCs that have a better versability and an improved benefit/risk profile than current ADC options."

Prior to joining Tubulis, Dr. Fingerle-Rowson worked in Global Clinical Development at MorphoSys and F. Hoffmann-La Roche as well as in Medical Affairs at Janssen-Cilag, a J&J company. He has contributed to bring three drugs to patients with malignancies. In his latest role as VP, Global Product Head at MorphoSys, he steered the clinical development as well as the regulatory approval for Tafasitamab (MOR208, Monjuvi). From 2011-2018, he served as Associate Medical Group Director, Global Development Team Leader and Global Clinical Leader at F. Hoffmann-La Roche where he was responsible for the clinical development and regulatory approvals of Obinutuzumab (GA101, Gazyva). Dr. Fingerle-Rowson also worked as Medical Manager at Janssen-Cilag, and as academic physician in internal medicine, hemato-oncology at the University Hospitals in Cologne and Munich where he also led own research in the field of immuno-oncology. Dr. Fingerle-Rowson was a longstanding active member of the German CLL Study Group where he contributed to the approval of Rituximab. He is a board-certified hematologist/medical oncologist and holds an MD in Internal Medicine from Munich University, and a MD-PhD in Molecular Medicine from New York University.

Lineage Announces Worldwide License Agreement With Immunomic Therapeutics for an Allogeneic Cell-Based Cancer Immunotherapy Based on Its VAC Platform

On April 20, 2021 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell transplants for serious medical conditions, reported a worldwide license and development collaboration agreement with Immunomic Therapeutics, Inc., ("ITI"), a privately-held clinical-stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms (Press release, Lineage Cell Therapeutics, APR 20, 2021, View Source [SID1234578238]). The collaboration will generate a novel product candidate derived from Lineage’s VAC allogeneic 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 upfront payments totaling $2 million anticipated in the first year and up to $67 million in development and commercial milestones across multiple indications and territories. Lineage also will be eligible to receive royalties up to 10% on net sales of future products.

"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."

"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."

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.