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Phase II Bisantrene trial data to be presented at ASH 2020

On November 5, 2020 Race Oncology Limited (ASX: RAC) reported that the clinical data from the investigator initiated Phase II clinical trial of Bisantrene in relapsed and refractory Acute Myeloid Leukaemia (R/R AML), conducted at Israel’s Sheba Medical Centre has been accepted for presentation at the American Society for Haematology 2020 Conference (ASH 2020) (Press release, Race Oncology, NOV 5, 2020, View Source [SID1234570036]).

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This open label, single agent trial, led by Professor Arnon Nagler, studied patients (n=10) with relapsed or refractory Acute Myeloid Leukaemia (R/R AML) who on average had failed three prior lines of treatment. Bisantrene was found to be well tolerated, and after only a single course of treatment, had an overall clinical response rate of 40% (ASX Announcement: June 16 2020).

The ASH (Free ASH Whitepaper) Annual Meeting is the premier international clinical conference for malignant and non-malignant haematology and attracts over 30,000 attendees across four days. The annual meeting presentations are chosen by peer-review and cover the latest developments in scientific and clinical research in the field of haematology.

The presentation, entitled "A Phase II Study of Bisantrene in Patients with Relapsed/ Refractory Acute Myeloid Leukemia" will be presented on 5 December 2020. The abstract for this presentation is available via:

Alligator Bioscience presents the CD40 antibody mitazalimab at the World Immunotherapy Congress 2020

On November 5, 2020 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that its CD40 targeting antibody mitazalimab will be presented at the World Immunotherapy Congress, November 2-6, 2020. The presentation will include new benchmark data demonstrating that mitazalimab has the potential to be best-in-class in the CD40 field.

The new preclinical data include analyses of mitazalimab compared with analogues of the CD40 antibodies of key competitors. The comparison demonstrates the potent immune-activating properties and anti-tumor effects of mitazalimab.

Mitazalimab’s mode of action is clearly dependent on Fc-gamma-receptor engagement, resulting in a more tumor-selective immune-activation. This differentiation may translate into a superior risk-benefit profile in patients.

The presentation will also summarize previously released clinical data from the Phase I study performed by Janssen Biotech Inc. Mitazalimab shows a manageable safety profile both with and without corticosteroid premedication. A partial response was observed in one patient with renal cell cancer and 10 patients with different advanced cancers showed stable disease lasting ≥ 6 months. In addition, clinical biomarker data confirm proof of mechanism in patients.

"The solid clinical package from Phase I and the new favorable benchmark data to our key competitors further strengthen our belief in mitazalimab as a potent immunotherapy agent. Mitazalimab has demonstrated strong activity and superior tolerability, which probably reflects the fact that the antibody has been optimized for more tumor-selective effects", said Per Norlén, CEO at Alligator Bioscience. "We are now completing the clinical file for the submission of the CTA for the upcoming Phase Ib/II efficacy study in pancreatic cancer", he added.

Dr Peter Ellmark, VP Discovery, Alligator Bioscience will give an oral presentation with the title "Mitazalimab – a CD40 agonist to unleash CD40 in immuno-oncology" on November 5, 2020, at 12:50 p.m CET. For further information, please see View Source

Targovax ASA: third quarter 2020 results

On November 5, 2020 Targovax ASA (OSE: TRVX), a clinical stage biotechnology company developing immune activators to target hard-to-treat solid tumors, reported its third quarter 2020 results (Press release, Targovax, NOV 5, 2020, View Source [SID1234570034]).

An online presentation by Targovax’s management to investors, analysts and the press will take place at 10:00 CET today (details below).

RECENT HIGHLIGHTS
Announced that the ONCOS-102 and Imfinzi (durvalumab) trial successfully completed part 1 in colorectal cancer. The pre-defined disease control efficacy threshold in the colorectal cancer cohort was met and the part 2 has opened for recruitment of 14 additional patients.
Announced that an abstract on the mesothelioma trial has been accepted and will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 35th Anniversary Annual Meeting, 9 -14 November 2020. The abstract presents the 12-month analysis of biomarkers and clinical outcome from the phase I/II trial in malignant pleural mesothelioma where ONCOS-102 is added to standard of care chemotherapy (pemetrexed / cisplatin). This analysis supports the data previously presented in June.
Completed a private placement, raising gross proceeds of approximately NOK 75 million (USD 8 million). The Private Placement attracted strong interest from existing shareholders and new institutional investors, both in the Nordics and internationally, and the transaction was oversubscribed multiple times.
Announced grant of European Patent no 3293201 by the European Patent Office. The patent covers the use of ONCOS-102 in combination with checkpoint inhibitors until 2036.
Formed a new Scientific Advisory Board (SAB), consisting of a group of world-renowned experts in immuno-oncology research and drug development carefully selected to act as advisors to guide the Targovax R&D strategy.
Øystein Soug, CEO commented:

"As the end of 2020 is approaching, we are entering a period of intensive data analysis and reporting from our ongoing ONCOS-102 clinical program. Important efficacy and immune marker readouts from our two Targovax-sponsored ONCOS-102 trials in mesothelioma and melanoma are due late in the year. In October we reported that the pre-defined threshold for clinical benefit was met in the colorectal cancer cohort of the ONCOS-102 and Imfinzi collaboration trial. The second part of this trial has now been opened for recruitment, and results are expected in about a year’s time. As we wrap up these phase I/II clinical trials, we are in parallel planning the next steps for ONCOS-102 development and expanding our pre-clinical pipeline to shape our future R&D programs."

Presentation
As a consequence of the Corona situation, there will not be a physical presentation of the results. Instead, we invite to a live webcast today at 10.00 CET. You can join the webcast here. It will be possible to ask questions during the presentation.

Sysmex Announces Financial Forecast for the Fiscal Year Ending March 31, 2021(PDF?83KB)

On November 5, 2020 Sysmex’s reported that financial forecast for the fiscal year ending March 31, 2021 was undetermined as of May 12, 2020, when the Company released its "Summary of Consolidated Financial Results for the Fiscal Year Ended March 31, 2020 (Press release, Sysmex, NOV 5, 2020, View Source [SID1234570033])." This forecast is now available, as outlined below.

1. Forecast of Consolidated Financial Results for the Fiscal Year Ending March 31, 2021 (April 1, 2020 to March 31, 2021)
2. Reasons for Announcement

Previously, Sysmex’s financial forecast for the fiscal year ending March 31, 2021 was undetermined, as it was difficult to rationally calculate the impact the COVID-19 pandemic might have on the Company’s performance. However, we have now calculated and are disclosing our financial forecast, based on performance for the first six months of the fiscal year and taking into account the information and forecasts currently available.

In the first quarter, COVID-19 led to lower market demand for testing. As a result, performance in the first six months was down year on year, including net sales and all levels of profit. Nevertheless, testing demand began to recover in the second quarter (July through September) largely, and we expect operating performance to gradually rebound going forward.

For the fiscal year ending March 31, 2021, we expect net sales to increase year on year. Although the global outlook remains uncertain due to concerns about further waves of COVID-19 and ongoing trade friction between the United States and China, we expect sales to recover owing to solid resurgent testing demand and efforts to put healthcare systems in place. On the profit front, however, we expect year-on-year decreases in operating profit, Profit before tax and Profit attributable to owners of the parent as the result of decrease in reagent sales (stemming from lost testing demand in the first half) and proactive R&D expenses as we continuingly invest toward future growth.

These forecasts are calculated on the basis of currently available information. Actual results may differ for a variety of reasons.

The foreign exchange assumptions used for calculating financial forecasts from the third quarter onward are USD1.00 = JPY106, EUR1.00 = JPY122 and CNY1.00 = JPY15.3

Boston Scientific Announces November 2020 Conference Schedule

On November 5, 2020 Boston Scientific Corporation (NYSE: BSX) reported that it will participate in two upcoming virtual investor conferences (Press release, Boston Scientific, NOV 5, 2020, View Source [SID1234570031]).

On November 12, 2020, Meghan Scanlon, senior vice president and president, Urology and Pelvic Health, and Susie Lisa, vice president, Investor Relations, will participate in a 40-minute question-and-answer session with the host analyst at the 29th Annual Credit Suisse Virtual Healthcare Conference. The session will begin at approximately 8:00 a.m. EST.

On November 18, 2020, Dan Brennan, executive vice president and chief financial officer, and Susie Lisa will participate in a 30-minute question-and-answer session with the host analyst at the Stifel 2020 Virtual Healthcare Conference. The session will begin at approximately 8:40 a.m. EST.

A live webcast and replay of the webcast for each event will be accessible at investors.bostonscientific.comView Source The replay will be available beginning approximately one hour following the completion of each event.