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Median Technologies Receives a Disbursement of €15 Million, Corresponding to the First Tranche of the Loan Granted by the European Investment Bank

On April 20, 2020 Median Technologies (Paris:ALMDT), The Imaging Phenomics Company reported that it had received the disbursement of €15 million, corresponding to the first tranche of the loan granted by the European Investment Bank (EIB) (Press release, MEDIAN Technologies, APR 20, 2020, View Source [SID1234556436]). The loan agreement was signed on December 18, 2019.

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The loan agreement allows the Company to borrow up to €35 million. The second and third tranches, in the amount of €10 million each, may be drawn at the discretion of Median Technologies, subject to the achievement of a set of operational and financial performance criteria agreed upon with the EIB.

The objective of this financing, granted by the EIB together with the European Commission, under the guarantee of the European Fund for Strategic Investment (so called "Juncker Plan), is to support research and innovation projects developed by companies with substantial growth potential. Median Technologies meets these criteria as its iBiopsy technology has the potential to impact the lives of hundreds of thousands of patients worldwide.

iBiopsy fundamentals

Median develops imaging tests based on the most advanced AI technologies. Using imaging biomarkers, iBiopsy will identify in an innovative manner the specific signatures of certain diseases for their early detection, the quantification of their severity and their monitoring. The non-invasive imaging tests that the company is developing will help pharmaceutical companies develop new treatment for cancer and NASH patients. They will also provide key information to help patients receive treatment that is adapted to their specific conditions.

Outlook and main elements of the iBiopsy investment program for 2020

The funding granted by the EIB will cover the iBiopsy investment program over several years. For 2020, the iBiopsy roadmap focuses on several priorities: clinical development plan, product roadmap, key clinical and technological partnerships supported by a strategic intellectual property policy.

Clinical development and product roadmap: the clinical development plan will help channel the product deployment strategy in various areas of high clinical utility, such as:

A test for the non-invasive assessment of hepatic fibrosis (NASH), a disease whose prevalence is significantly increasing worldwide, as well as tests to assess treatment response in patients,
A test to identify potential responding patients to immuno-oncology treatment to enable biopharmaceutical companies better target the efficacy of their treatment during the phases of clinical tests and match the right treatment with the right patients in clinical routine,
A test for the detection, characterization and prognosis of HCC.
An assessment of commercial strategies for the reimbursement of tests and regulatory strategies in particular with the Food and Drug Administration (FDA) will also be carried out.

Strategic partnerships: like the collaboration agreement with AP-HP announced on March 2, 2020, Median Technologies will continue its partnership strategy with healthcare institutions and biopharmaceutical companies on a global scale, to ensure access to the best clinical expertise and high-quality imaging data. These partnerships, some of which are already being discussed, will be announced upon their signature. The partnership strategy will also cover agreements with technology companies, to enable the roll out of the iBiopsy platform by targeted sectors: healthcare institutions for clinical routine and biopharmaceutical companies for clinical research and development.

Intellectual property protection strategy: Median continues to develop its differentiating assets with the implementation at the end of 2019 of a strategy to pursue several patent submissions on iBiopsy. The innovations developed in 2019 are already the subject of several patents pending in Europe, the United States, China and Japan.

"This first disbursement of the loan granted to Median in December 2019, before the coronavirus crisis, proves the continuous support of the European Investment Bank to the Medtech sector and the health system in general", said Ambroise Fayolle, Vice-President of the EIB. "To cope with the health crisis that hits all Europe, EIB has decided to increase the financing of the health sector to €5 billion which will enable innovative companies like Median – pioneer in AI and health – to become a leading European company"

"This initial €15 million disbursement from the EIB allows us to strengthen our financial visibility and considerably step up our investment plan for iBiopsy", said Fredrik Brag, CEO and co-founder of Median Technologies. "Our current effort to solidify the clinical development plan will drive the iBiopsy product roadmap right through to regulatory filing which we expect to take place in 2021", he added.

As of the date on which this first loan disbursement is received from the EIB, Median Technologies intends to provide quarterly updates on iBiopsy, to ensure regularly updated information on its development to the Company’s various audiences.

TUKYSA (tucatinib), FDA Approved for Treatment of Advanced Unresectable or Metastatic HER2-Positive Breast Cancer, Available at Biologics by McKesson

On April 20, 2020 McKesson, an independent specialty pharmacy for oncology and other rare and complex therapeutic areas, reported that it has been selected by Seattle Genetics as a specialty pharmacy provider for TUKYSATM (tucatinib) for the treatment of HER2-positive breast cancer (Press release, McKesson, APR 20, 2020, View Source [SID1234556435]).

TUKYSA, approved by the FDA on April 17, 2020, is an orally bioavailable, small molecule tyrosine kinase inhibitor (TKI) that is highly selective for HER2, a growth factor receptor that is over-expressed in multiple cancers. This drug is indicated in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting. On October 21, 2019, Seattle Genetics announced positive topline results from the HER2CLIMB trial evaluating tucatinib. The trial compared this therapy used in combination with trastuzumab and capecitabine to trastuzumab and capecitabine alone in patients who have locally advanced unresectable or metastatic HER2-positive breast cancer.

"We’re proud that Seattle Genetics has entrusted us to dispense this important therapy option for patients with metastatic HER2-positive breast cancer," said Brandon Tom, vice president of Commercial Services at Biologics. "The addition of TUKYSA enables us to support providers across the various treatment options that exist for these patients."

Biologics specialty pharmacy is committed to and recognized for its high level of customer service as well as its innovative, high-touch and multidisciplinary patient-centric approach. Each team includes a pharmacist with in-depth knowledge of therapies, an experienced nurse, and a financial counselor who is familiar with various financial assistance programs and organizations that help patients. This highly-skilled care team works together to develop individualized care plans that address each patient’s unique clinical, financial and emotional needs and streamlines communication back to the treating provider, enabling high-quality care and differentiated outcomes. In addition, the Biologics team works closely with payers to ensure patients can access the specialty medications they need.

Physicians may submit prescriptions to Biologics via phone (800.850.4306), fax (800.823.4506) or eScribe. For electronic prescribing systems, physicians may search for Biologics within their EMR system.

Genetron Health Announces Forthcoming Unveiling of Its Cancer Research Papers at the AACR Annual Meeting

On April 20, 2020 Genetron Holdings Limited ("Genetron Health"), a China-based precision oncology company that covers full-cycle cancer care, reported that 14 cancer research papers will be presented as posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2020 Annual Meeting, which will take place virtually on April 27-28 and June 22-24 (Press release, Genetron Health Technologies, APR 20, 2020, https://www.businesswire.com/news/home/20200420005389/en/Genetron-Health-Announces-Forthcoming-Unveiling-Cancer-Research [SID1234556434]).

In collaboration with over 10 notable cancer research centers and clinical hospitals in China, including the Chinese PLA General Hospital (301 Hospital), Cancer Hospital of Chinese Academy of Medical Sciences, Beijing Tiantan Hospital of Capital Medical University, Genetron Health’s presentation will cover a broad spectrum of precision oncology topics such as molecular and immunological diagnostics, bio-informatics analysis in multiple cancer types including lung cancer, gastric cancer, central nervous system tumors and urinary system tumors.

Scientists at Genetron Health with a multi-disciplinary background have devoted significant resources to continuously optimize key diagnostics technologies including liquid biopsy, fusion detection, and algorithms for bioinformatics. They focus on improving the quality and efficiency of sample testing, as well as the comprehensiveness and stability of bioinformatics analysis. Genetron Health has accumulated clinically valuable data in the fields of diagnostics, neoadjuvant chemotherapy prognosis and efficacy evaluation, immunotherapy, and drug resistance to facilitate translation into clinical applications.

Genetron Health actively collaborates with clinicians to drive cancer genomics research. The Company has published over 20 papers in Nature Genetics, Cancer Cell, Nature Communications, PNAS, and other internationally recognized academic journals, accelerating the clinical translation and commercialization of scientific research and continously improving the reliability and accessibility of its products and technology. Genetron Health is committed to making available advanced and reliable precision medicine technology to the community.

About the AACR (Free AACR Whitepaper)

Founded in 1907, the American Association for Cancer Research (AACR) (Free AACR Whitepaper) is the first and largest cancer research organization dedicated to accelerating the conquest of cancer. It has grown from its earliest 11 members to over 47,000 members in 127 countries and territories. The mission of AACR (Free AACR Whitepaper) is to prevent and cure cancer through research, education, communication and collaboration. Through its programs and services, the AACR (Free AACR Whitepaper) fosters research in cancer and related biomedical science; accelerates the dissemination of new research findings among scientists and others dedicated to the conquest of cancer; promotes science education and training; and advances the understanding of cancer etiology, prevention, diagnosis, and treatment throughout the world.The AACR (Free AACR Whitepaper) Annual Meeting is one of the largest cancer research conferences in the world, attracting nearly 20,000 professionals from across the globe each year.

Vertex to Announce First-Quarter 2020 Financial Results on April 29

On April 20, 2020 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) reported that it will report its first-quarter 2020 financial results on Wednesday, April 29, 2020 after the financial markets close (Press release, Vertex Pharmaceuticals, APR 20, 2020, View Source [SID1234556433]). The company will host a conference call and webcast at 5:00 p.m. ET. To access the call, please dial (866) 501-1537 (U.S.) or +1 (720) 545-0001 (International).

The conference call will be webcast live and a link to the webcast can be accessed through Vertex’s website at www.vrtx.com in the "Investors" section. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast. An archived webcast will be available on the company’s website.

PRECIGEN ANNOUNCES CLEARANCE OF IND TO INITIATE PHASE I/II STUDY FOR FIRST-IN-CLASS PRGN-2009 ADENOVERSE™ IMMUNOTHERAPY TO TREAT HPV-POSITIVE (HPV+) SOLID TUMORS

On April 20, 2020 Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, reported that the US Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application to initiate a Phase I/II trial for Precigen’s PRGN-2009, a first-in-class, off-the-shelf (OTS) investigational immunotherapy utilizing the AdenoVerse platform designed to activate the immune system to recognize and target HPV+ solid tumors(Press release, Precigen, APR 20, 2020, View Source [SID1234556432]). HPV+ cancers represent a significant health burden in indications such as head and neck, cervical, vaginal and anal cancer.

The Phase I portion of the study will follow 3+3 dose escalation to evaluate the safety of PRGN-2009 administered as a monotherapy and to determine the recommended Phase II dose (R2PD) followed by an evaluation of the safety of the combination of PRGN-2009 at the R2PD and an investigational bifunctional fusion protein in patients with recurrent or metastatic HPV-associated cancers. The Phase II portion of the study will evaluate PRGN-2009 as a monotherapy or in combination with the bifunctional fusion protein in patients with newly-diagnosed stage II/III HPV16-positive oropharyngeal cancer.

PRGN-2009 leverages Precigen’s UltraVector and AdenoVerse platforms to optimize HPV antigen design in combination with its gorilla adenovector with a large payload capacity and the ability for repeat administration due to very low to non-existent seroprevalence in the human population.

PRGN-2009 is under development through a Cooperative Research and Development Agreement, or CRADA, within the laboratory of Dr. Jeffrey Schlom, Chief of the Laboratory of Tumor Immunology and Biology (LTIB), Center for Cancer Research (CCR), National Cancer Institute (NCI). This CRADA has allowed Precigen to rapidly and cost-effectively advance PRGN-2009 to the clinic. The Phase I/II clinical trial of PRGN-2009 will be conducted at the NIH Clinical Center and will be led by Dr. Julius Strauss, Co-Director of the LTIB’s Clinical Trials Group, and Dr. James Gulley, Chief of the Genitourinary Malignancies Branch, CCR, NCI.

"Globally, high-risk HPVs cause nearly 5% of all cancers, with about 570,000 women and 60,000 men diagnosed with HPV-related cancers each year," said Helen Sabzevari, PhD, President and CEO of Precigen. "We are incredibly proud of our continued relationship with NCI and the tremendous progress in bringing forward this novel asset class in such a short period of time. Advancements are critically needed to better target HPV+ tumors across multiple patient groups, and we have been encouraged by the promising preclinical data for PRGN-2009 in potentially targeting this patient population."

About HPV+ Cancers
HPV infects the squamous cells that line the inner surfaces of certain organs and, consequently, most HPV-related cancers are a type of cancer called squamous cell carcinoma. Some cervical cancers come from HPV infection of gland cells in the cervix and are referred to as adenocarcinomas.1 HPV-related cancers include cervical, oropharyngeal, anal, penile, vaginal, and vulvar.1 Nearly 44,000 HPV-associated cancers occur in the United States each year. Of these, approximately 25,000 occur in women and 19,000 occur in men.2 HPV is considered responsible for more than 90% of anal and cervical cancers, about 70% of vaginal and vulvar cancers, and more than 60% of penile cancers.2 Recent studies indicate that about 70% of cancers of the oropharynx also may be related to HPV.2