On March 2, 2020 Assistance Publique–Hôpitaux de Paris (AP-HP), the Europe’s leading hospital and university center (CHU) and Median Technologies (Paris:ALMDT) (ALMDT) reported that have signed a collaboration agreement aimed at carrying out studies that will be used for clinical validation of Median’s iBiopsy platform (Press release, MEDIAN Technologies, MAR 2, 2020, View Source [SID1234555090]). iBiopsy features advanced AI technologies for diagnostic and prognostic imaging biomarker qualification. A large panel of clinical indications may be considered within the frame of the agreement. The collaboration initially covers two clinical studies whose protocols have already been approved. Similar terms and conditions may apply to subsequent clinical studies carried out jointly by AP-HP and Median Technologies. This strategic collaboration with AP-HP will help advance clinical research intended to improve patient diagnosis and monitoring.

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The first study, PHELICAR, is led by Pr. Olivier Lucidarme and his team from the Pitié-Salpêtrière AP-HP hospital, in collaboration with teams from Beaujon and Paul-Brousse AP-HP hospitals. Using medical imaging, the study aims to identify the phenotypic heterogeneity of liver cancer and its impact on the diagnosis and prognosis of patients. The study will use retrospective data from a large patient cohort. The second study, LIVER IBIOPSY, is led by Pr. Maité Lewin and her team from Paul Brousse AP-HP hospital in collaboration with other teams from Paul Brousse and Bicêtre AP-HP hospitals. The study will use retrospective data from a smaller and more targeted patient cohort to identify phenotypes of high-risk liver tumor recurrence, in order to improve the treatment and follow-up of these high-risk patients.

Liver cancer is the fourth leading cause of death by cancer worldwide1, with a 5-year survival rate of 18%. Therapeutic strategies are difficult to implement for this type of cancer, mostly because liver tumors are highly heterogeneous. These two studies will address unmet medical needs in terms of early diagnosis, patient prognosis and dynamic monitoring of patients’ response to treatments. They will also aim clinical validation of iBiopsy as an innovative, reliable and non-invasive technology for phenotyping liver lesions. Both studies are part of the ongoing rise of predictive and personalized medicine.

For Median, the clinical expertise provided by the AP-HP hospitals involved in the two studies, as well as the large volume of data that will be made available to the company, will help optimize the AI algorithms developed within iBiopsy and, therefore, validate clinically the iBiopsy platform on large cohorts.

"We are delighted with this agreement between Median and AP-HP. With its 39 hospitals and 10 million patients a year, AP-HP is one of the largest health institutions in Europe and has gained world recognition for the quality of its care, research and medical training. AP-HP is also one of the world’s largest providers of high-quality medical data. This major collaboration, aimed to clinically validate our proprietary iBiopsy platform, makes good on our commitment to launch various clinical partnerships and collaborations in 2020. Our framework agreement with AP-HP opens up many prospects for future studies, including on other pathologies," said Fredrik Brag, Median’s co-founder and CEO.

"The possibilities offered by Median Technologies to best uncover the full potential of data embedded in CT-Scan images provided by the different departments of AP-HP, -those of La Pitié-Salpêtrière, Paul Brousse and Beaujon- with a focus on liver disease, should lead us to new and better understanding of data hidden in medical images. Combined with already existing partnerships we have with university research laboratories, this type of collaboration will enable us to advance research, specifically within the growing field at the nexus of Artificial Intelligence and medical imaging. As a company, Median is at the forefront of scientific analysis of medical images. We are eager to see the first results of this collaboration", said Pr. Olivier Lucidarme, Head of the Multipurpose Radiology and Oncology Department at the Pitié-Salpêtrière AP-HP Hospital.

On March 2, 2020 Vizient, Inc. reported that shared insights on chimeric antigen receptor T-cell (CAR-T) data and its implications for patients with cytokine release syndrome, large B-cell cancer, and pediatric and young adult patients with leukemia (Press release, Vizient, MAR 2, 2020, View Source [SID1234555089]). Analyses were derived using Vizient’s Clinical Data Base/Resource Manager (CDB/RM) and presented as posters at the 2020 Transplantation & Cellular Therapy Meeting of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Research (CIBMTR) held Feb. 19-23 in Orlando.

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The meeting included clinicians, administrators, clinical research professionals, laboratory technicians and pharmacists and focused on issues in hematopoietic cell transplantation and cellular therapy. Vizient‘s Alyssa Hartsell Harris, presented three posters at the event:

Real-World Quality and Cost Burden of Cytokine Release Syndrome (CRS) Requiring Tocilizumab or Steroids during CAR-T Infusion Encounter. The poster covered a retrospective cohort of 1,570 CAR-T infusion encounters for patients 18 years and older undergoing CAR-T procedures for diffuse large B-cell lymphoma from October 2017 to July 2019. It described the length of stay, costs and hospital mortality rates across patients who received tocilizumab and dexamethasone or prednisolone to treat CRS, a serious adverse event after CAR-T infusion.

Quality and Cost Outcomes in Chimeric Antigen Receptor T-Cell Immunotherapy in Adult Large B-Cell Cancer Patients from the Vizient Clinical Database. The poster covered a retrospective cohort of 1,570 patients 18 years and older undergoing CAR-T procedures from October 2017 to July 2019. It described unplanned readmission rates, adverse events due to the immunotherapy as well as provided a cost analysis.

Quality and Cost Outcomes in Chimeric Antigen Receptor T-cell Immunotherapy in Pediatric and Young Adult Patients with Acute Lymphoblastic Leukemia from the Vizient Clinical Database. The poster covered a retrospective cohort of 139 patients 25 years and under undergoing CAR-T procedures between October 2017 and October 2019. It described inpatient and outpatient mortality, length of stay, readmissions and provided a cost analysis.

"The collection of CAR-T data within our clinical data base continues to improve and is beginning to offer interesting insights into this new therapy," said Gladys J. Epting, Ph.D., associate vice president, analytics, at Vizient. "It is exciting to see how the data is demonstrating the clinical response by patients as well as cost and outcomes. These insights will help shape next steps for both clinicians and payers."

On March 2, 2020 Medivir AB (Nasdaq Stockholm: MVIR) reported that new data from the completed phase Ia study with MIV-818 will be presented at the R&D day hosted by the company today, from 2 pm – 4.30 pm (CET) (Press release, Medivir, MAR 2, 2020, View Source [SID1234555083]).

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The primary objective of the phase Ia study was to evaluate safety and tolerability of MIV-818 in liver cancer patients. A total of nine patients with advanced disease were included: six patients with metastatic liver cancer, two with hepatocellular carcinoma and one with intrahepatic cholangiocarcinoma.

The pharmacokinetic analysis showed that patients were exposed only to low levels of MIV-818 and troxacitabine outside of the liver, providing experimental support for MIV-818’s liver targeting. The adverse events were mainly mild and the more serious side effects observed were reversible.

Biomarker analysis of liver biopsies from patients showed a selective liver cancer effect of MIV-818: while tumor tissue had clear DNA damage, healthy liver tissue showed only minimal or no DNA damage. Based on an independent expert analysis of liver tumor growth, five of the nine patients were assessed to have stable liver disease after treatment.

– The analysis of data from the nine patients confirms our conclusion from the first six patients and provides strong support for the continued development of MIV-818 as a new and effective treatment for liver cancer. MIV-818 is our most important project and therefore it feels very good that our confidence in the possibilities of the compound is further strengthened by the new data presented today, says Medivir’s CEO, Dr. Uli Hacksell.

The R&D Day will be streamed via a link on the website: www.medivir.com.

Medivir AB is obliged to make this information public pursuant to the EU Market Abuse Regulation.

The information was submitted for publication, through the agency of the contact person set out above, at 08.30 CET on 2 March, 2020.

About MIV-818

MIV-818 is a pro-drug designed to selectively treat liver cancers and to minimize side effects. It has the potential to become the first liver-targeted, orally administered drug to benefit patients with HCC and other forms of liver cancer.

On March 2, 2020 Alligator Bioscience (Nasdaq Stockholm: ATORX), a biotechnology company developing antibody-based pharmaceuticals for tumor-directed immunotherapy, reported that the Swedish version of the Annual Report 2019 is available on the company website www.alligatorbioscience.com (Press release, Alligator Bioscience, MAR 2, 2020, View Source [SID1234555082]). An English version will follow shortly.

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The information was submitted for publication, through the agency of the contact person set out above, at 10:30 a.m. CET on 2 March 2020.

On March 2, 2020 Theravance Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma" and together with its subsidiaries, the "Company"), a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines, reported the closing of a private placement of $400 million of non-recourse Triple II 9.5% fixed rate term notes (Press release, Theravance, MAR 2, 2020, View Source [SID1234555081]). The notes are secured by a portion of the future payments the Company expects to receive related to royalties due on net sales of Trelegy Ellipta. The Company used a portion of the net proceeds from this transaction to repay in full the remaining outstanding balance of the $250 million Triple PhaRMASM 9.0% fixed rate term notes due 2033 and intends to use the remainder of the net proceeds to support continued execution of its key development programs.

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About the Financing

Triple Royalty Sub II LLC (the "Issuer"), a wholly-owned, indirect subsidiary of Theravance Biopharma, issued $400 million in aggregate principal amount of Triple II 9.5% fixed rate term notes due June 5, 2035. The notes are secured by all of the Issuer’s right, title and interest in certain membership interests (the "Issuer Class C Units") in Theravance Respiratory Company, LLC, a Delaware limited liability company ("TRC LLC"). TRC LLC holds the right to receive upward-tiering royalties ranging from 6.5% to 10% on worldwide net sales of Trelegy Ellipta, and the Company holds an 85% economic interest in TRC LLC. The Issuer Class C Units represent 75% of the Company’s 85% economic interest, which equates to 63.75% of the economic interests in TRC LLC.

The primary source of funds to make payments on the notes will be the Issuer’s 63.75% economic interest (evidenced by the Issuer Class C Units) in any future payments made by Glaxo Group Limited ("GSK") under the Collaboration Agreement, dated as of November 14, 2002, by and between Innoviva, Inc. and GSK, as amended from time to time (net of the amount of cash, if any, expected to be used in TRC LLC pursuant to the TRC LLC Agreement over the next four fiscal quarters) relating to the Trelegy Ellipta program. The notes are not convertible into Company equity and have no security interest in nor rights under any agreement with GSK.

The notes may be redeemed at any time after the second year and prior to maturity, in whole or in part, at specified redemption premiums.

The notes bear an annual interest rate of 9.5%, with interest and principal payable quarterly beginning June 5, 2020. Prior to and including the December 5, 2024 payment date, in the event that the distributions received by the Issuer from TRC LLC in a quarter is less than the interest accrued for that quarter, the principal amount of the notes will increase by the interest shortfall amount for that quarter. Because the principal and interest payments on the notes are ultimately based only on royalties from product sales, which will vary from quarter to quarter, the notes may be repaid prior to the final maturity date in 2035. Following the redemption or repayment of the notes, all Trelegy Ellipta-related pledged cash flows will revert back to the Company.

In order to comply with Regulation RR — Credit Risk Retention (17 C.F.R. Part 246), 5% of the notes were retained by Theravance Biopharma R&D, Inc., a wholly-owned subsidiary of Theravance Biopharma. Excluding the $20 million of retained notes and other fees related to the transaction, net proceeds of the offering were approximately $380 million. The notes have not been and will not be registered under the Securities Act of 1933, as amended (the "Securities Act"), and may not be offered or sold in the United States absent an applicable exemption from the registration requirements of the Securities Act. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any security.

Cowen and Company, LLC acted as sole placement agent for the notes.