On March 23, 2020 SpagoPix reported that Data from the first dose group in the phase I study show that SN132D is well tolerated and provides valuable information for optimizing MR images in the next step (Press release, Spago Nanomedical, MAR 23, 2020, View Source [SID1234555755]). As the study thus continues to the next dose level, Spago has taken steps to increase patient recruitment, including by engaging in another breast cancer center.

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The internal safety committee of the SPAGOPIX-01 clinical trial, after analyzing data from the first six patients, has determined that the initial dose of SN132D is safe. The Committee also notes that the dose should be increased to optimize contrast enhancement in the tumors. The study thus continues with the next group of six patients, after which a new interim analysis will be done.

The fact that the first dose group was completed and proved to be safe is expected to facilitate continued patient recruitment. To further increase the recruitment rate, Spago Nanomedical has decided to extend the study to another breast cancer center, Sahlgrenska Hospital, to increase the patient base.

"The results are fully in line with our expectations and we are now looking forward to the results from the next dose level. We also intend to expand with another center to create even better conditions for including patients and being able to run the study at a higher rate, "says CEO Mats Hansen.

The dose that patients have received in the study so far has a very broad safety margin to the levels that have resulted in preclinical studies. The initial dose was intended to document initial safety and provide a basis for optimizing the possibilities of showing effect on subsequent dose levels.

SpagoPix (SN132D) is a contrast agent with the potential to significantly improve cancer diagnostics with magnetic resonance imaging (MRI). Initially, Spago Nanomedical has chosen to focus on breast cancer, a disease that affects approximately 2.1 million people annually, where MRI is already routinely used today for screening, diagnostics, or follow-up in 15-30 percent of all patients and the need for better precision in diagnoses. is big.

The primary goal of the SPAGOPIX-01 study is to document safety at different dose levels, but another important goal is to initially investigate the MR contrast effect in clinical use in patients with confirmed breast cancer. Study details and updates are published at www.clinicaltrials.gov .

On March 23, 2020 Nordic Nanovector ASA (OSE: NANO) reported that Dr Dominic Smethurst has been appointed Interim Chief Medical Officer with immediate effect (Press release, Nordic Nanovector, MAR 23, 2020, View Source [SID1234555771]). Dr Smethurst replaces Dr Lisa Rojkjaer, MD, who after a handover period will leave Nordic Nanovector to pursue other career opportunities.

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Dr Smethurst is an experienced drug development physician having led complex global clinical trials within oncology. Previously, Dr Smethurst was the Group Medical Director of Tusk Therapeutics, where he played a key role in the development of this private immuno-oncology company focused on therapeutic antibodies. Tusk Therapeutics was acquired by Roche for potentially €655 million in September 2018.

Prior to Tusk, Dr Smethurst has held senior roles at Icon, a global Contract Research Organisation (CRO), where he was VP Oncology Global Therapeutic Area Lead and at Adaptimmune/Immunocore, where he was CMO. Dr Smethurst has also worked for Amgen and AstraZeneca in medical roles of increasing seniority.

Dr Smethurst gained his medical qualifications, at the Addenbrooke’s Clinical School (Cambridge, UK). He is member of both the Royal College of Physicians (UK) and the Faculty of Pharmaceutical Medicine (UK).

Dr Lars Nieba, Interim CEO of Nordic Nanovector, commented: "I am pleased that we have been able to appoint Dominic as our new Interim CMO. He is a very experienced and commercially focused medical physician with significant clinical development skills, and I am sure his input will be of great value as we work together to complete the PARADIGME study and to prepare for the planned filing for Betalutin in the US. I would like to take this opportunity to thank Lisa for her contribution in advancing the clinical development of Betalutin."

Dr Dominic Smethurst, Interim CMO of Nordic Nanovector, said: "I am looking forward to joining at this critical time for Nordic Nanovector as it seeks to complete the pivotal trial PARADIGME with Betalutin in a timely manner. I believe it is important that we can bring Betalutin to patients with advanced follicular lymphoma given the very promising efficacy data that has been generated alongside a favourable safety profile and convenient once-only dosing regimen."

On March 23, 2020 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory, cancer, and other diseases, reported an update on its strategic immuno-oncology collaboration with Servier, originally established in 2017 (Press release, Pieris Pharmaceuticals, MAR 23, 2020, View Source [SID1234555756]). After conducting an extensive portfolio review, Servier has decided to focus on continued and accelerated development of the two most advanced programs, including PRS-344/S095012, and to discontinue development of the two earlier-stage programs in the collaboration.

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Pieris and Servier will continue the development of PRS-344/S095012, a 4-1BB/PD-L1 bispecific and the lead program in the collaboration. Pieris holds exclusive commercialization rights for PRS-344/S095012 in the United States and will receive royalties on ex-U.S. sales for this program. The companies will also prioritize the development of PRS-352, a preclinical-stage program addressing undisclosed targets, and for which Servier has worldwide rights. Pieris is working to complete the non-GLP preclinical work for that program and expects to hand it over to Servier this year for IND-enabling activities. Pieris will retain all rights to the discontinued programs and will consider development and strategic options with regard to those programs upon reviewing the data generated as part of the collaboration.

"We are very pleased with the collaboration with Pieris. Over the past three years, significant progress has been made in the research programs of two drug candidates," said Patrick Therasse, Head of Servier Research and Development Oncology. "We believe that focusing our joint efforts on the later-stage bispecific programs will drive the greatest value in the collaboration, and we are enthusiastic about the prospect of bringing PRS-344/S095012, the most advanced of these two programs, into the clinic soon. Immuno-oncology is one of the two major axes of Servier’s oncology research in order to develop promising innovative and effective treatments for cancer patients."

"Our collaboration with Servier remains a highly productive and valuable one, and we believe that concentrating our efforts towards the development of the more advanced programs will allow us to focus our immuno-oncology pipeline with the added benefit of using our capital more efficiently," said Stephen S. Yoder, President and Chief Executive Office of Pieris. "Additionally, we have generated promising clinical data in our proprietary 4-1BB-based program, PRS-343, in parallel, and we look forward to leveraging that know-how in the development of PRS-344/S095012 and PRS-352 with Servier."

On March 23, 2020 Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported that the global Phase Ib/II clinical study of APG-2575, a Bcl-2 selective inhibitor, as a single agent or in combination for the treatment of relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (r/r CLL/SLL), has dosed its first patient in the United States (Press release, Ascentage Pharma, MAR 23, 2020, View Source [SID1234555773]).

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This global multicenter, open-label, Phase Ib/II dose-escalation and dose-expansion study is designed to evaluate the safety, tolerability, and anticancer activity of APG-2575 as a single agent or in combination with rituximab or acalabrutinib in patients with r/r CLL/SLL.

APG-2575 is a novel, orally administered Bcl-2‒selective inhibitor being developed by Ascentage Pharma. APG-2575 is designed to treat several hematologic malignancies by selectively blocking Bcl-2 to restore the normal apoptosis process in cancer cells. Ascentage Pharma has previously commenced a Phase I study of APG-2575 as a single agent in the United States, Australia, and China. Ascentage Pharma recently received clearances in China and the United States for three Phase Ib/II clinical studies of APG-2575, continuing clinical development of APG-2575 in multiple disease conditions globally.

"APG-2575 is a key drug candidate in our development pipeline targeting apoptosis. Upon receiving clearance from the US FDA, we promptly initiated the trial and achieved dosing of its first patient," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "We look forward to effectively advancing this critical clinical development program, which hopefully will soon benefit patients with r/r CLL/SLL."

On March 23, 2020 DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for kidney diseases and neurological disorders, reported its financial results for the year ended December 31, 2019 (Press release, DiaMedica, MAR 23, 2020, View Source [SID1234555757]).

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"DiaMedica set out and achieved some ambitious goals for 2019. We completed a Phase Ib pharmacokinetic study in subjects with chronic kidney disease, which was required to prepare for Phase II work. We assembled a world-class advisory board to guide our chronic kidney disease (CKD) clinical program, and collectively identified several rare forms of CKD to study. We planned and initiated our Phase II work in chronic kidney disease. We accomplished all of this while completing enrollment in our enlarged REMEDY study in acute ischemic stroke. We expect to build upon these accomplishments in 2020 as we work toward advancing DM199, which holds the potential to have significant impact on patients suffering from chronic kidney disease and acute ischemic stroke," stated Rick Pauls, DiaMedica’s President and CEO. "We are excited and cautiously optimistic as we look forward to the Phase II clinical results during 2020 as part of continuing to execute on our clinical development plans during 2020 and we look forward to sharing results as they become available."

Clinical Developments

DM199 for the Treatment of Chronic Kidney Disease

Phase II REDUX Clinical Study in CKD Caused by IgA Nephropathy and African Americans with Hypertension

In October 2019, the FDA accepted the Company’s Phase II clinical trial protocol for the treatment of CKD caused by rare or significant unmet diseases. The trial named REDUX, Latin for restore, is a multi-center, open-label investigation of approximately 60 participants with CKD, who are being enrolled in two cohorts (30 participants per cohort). The study is being conducted in the United States at 12 sites and is focused on participants with two specific causes of CKD. Cohort I is focused on non-diabetic, hypertensive African Americans with Stage II or III CKD. African Americans are at greater risk for CKD than Caucasians, and those who have the APOL1 gene mutation, are at an even higher risk. The study is designed to capture the APOL1 gene mutation as an exploratory biomarker in this cohort. Cohort II is focused on participants with IgA Nephropathy (IgAN). The study will evaluate two dose levels of DM199 within each cohort. Study participants will receive DM199 by subcutaneous injection twice weekly for 95 days. The primary study endpoints include safety, tolerability, blood pressure, albuminuria and kidney function, which will be evaluated by changes from baseline in eGFR and albuminuria, as measured by the UACR. Participant enrollment and dosing for this study commenced in December 2019.

Subject enrollment has been slower than expected, primarily in the African American cohort. Enrollment in the African American cohort has been hindered by a higher level of screen failures related to finding individuals with Stage II or III CKD that are not diabetic. The Company has taken several measures to increase/complete enrollment including increasing the number of clinical study sites to 12. In addition, the current COVID-19 outbreak in the United States, and measures being taken to mitigate the spread of this virus, appear to be adversely affecting the ability of sites to recruit subjects. The REDUX study design provides for registered nurses to make home visits for the majority of subject treatments, a practice consistent with the principle of social distancing recommended by governmental authorities; therefore, the Company does not currently anticipate any treatment disruptions to patients already enrolled. The Company continues to evaluate the impact of COVID-19 on enrollment and is taking steps to mitigate any impact. The Company will provide additional information on when preliminary top-line information will be available as conditions allow.

"We are focused on working with our study sites and home nursing services to ensure that protocols are in place to maximize the safety of study participants and clinical personnel," commented Dr. Harry Alcorn, DiaMedica’s Chief Medical Officer. "We are taking steps to revise our protocol to maximize the subject interactions occurring at home to minimize the impact of social isolation steps on study participation."

DM199 for the Treatment of Acute Ischemic Stroke

DM199 Acute Ischemic Stroke Phase II "REMEDY" Trial Update – Enrollment Completed

As previously announced, DiaMedica completed enrollment in the REMEDY trial, the Company’s Phase II study assessing the safety, tolerability and markers of therapeutic efficacy of DM199 in participants suffering from acute ischemic stroke (AIS). Final enrollment was 92 participants. The markers of therapeutic efficacy will include multiple plasma-based biomarkers (e.g. C-reactive protein), the Modified Rankin Scale, National Institutes of Health Stroke Scale and the Barthel Index. These markers are assessed at multiple points throughout the study, including 90 days post-stroke. The last subject follow-up visit was completed in late January 2020 and the Company is in the process of verifying the completeness and accuracy of the information collected in the clinical database and analyzing the results. The Company expects to release preliminary top-line results in the next few weeks. Full results from REMEDY were expected to be reported at the European Stoke Conference in Vienna, Austria. However, since the conference has been postponed until November 7-9, 2020, the Company is evaluating alternatives for releasing full study results.

Recent Public Offering

On February 11, 2020, DiaMedica completed an offering of its common shares selling an aggregate of 2,125,000 common shares in a public, underwritten offering at a public offering price of $4.00 per share, raising gross proceeds of $8.5 million and net proceeds of $7.7 million, after deducting the underwriting discount and offering expenses. This offering was completed with biotech investment funds. The additional capital should allow DiaMedica to complete its current Phase II clinical studies and fund its operations through 2021.

Financial Results

Research and development (R&D) expenses were $7.9 million for the year ended December 31, 2019 compared to $4.5 million for the year ended December 31, 2018, an increase of $3.4 million. The increase was due to costs of approximately $1.4 million incurred for a new production run of the DM199 drug substance, as well as costs incurred in conjunction with the Phase Ib and Phase II clinical studies in CKD patients and related non-clinical testing. Increased non-cash share-based compensation costs also contributed to the increase. These increases were partially offset by a reduction in costs incurred in conjunction with the REMEDY Phase II clinical study in AIS patients for which we completed enrollment in October 2019.

General and administrative (G&A) expenses were $3.7 million and $2.7 million for the years ended December 31, 2019 and 2018, respectively. This $1.0 million increase was primarily due to costs associated with the Company’s status as a Nasdaq-listed U.S. public reporting company, which commenced in December 2018, including increased professional service, compliance and non-cash share-based compensation costs. Increased personnel costs also contributed to the increase. This increase was partially offset by one-time costs of approximately $360,000 incurred in 2018, associated with the Nasdaq listing process and related legal and accounting fees.

Total other income, net, was $1.0 million for the year ended December 31, 2019 compared to $1.1 million for 2018. This decrease is primarily related to the initial recognition of R&D incentives, from the Australian Government, paid for qualifying research work performed by DiaMedica Australia Pty Ltd. during 2018, which included research work performed in 2017 and 2018. The decrease was partially offset by increased interest income earned on marketable securities during 2019.

Balance Sheet and Cash Flow

The Company had cash, cash equivalents and marketable securities of $7.9 million, or $15.6 million on a pro forma basis, including the $7.7 million in net proceeds from its February 2020 public offering, current liabilities of $1.3 million and working capital of $7.5 million as of December 31, 2019, compared to $16.8 million in cash, cash equivalents and marketable securities, $1.3 million in current liabilities and $16.7 million in working capital as of December 31, 2018. The decreases in cash, cash equivalents and marketable securities and working capital are mainly due to the use of cash to fund operating activities during 2019.

Net cash used in operating activities for the year ended December 31, 2019 was $9.1 million compared to $5.7 million for the year ended December 31, 2018. This increase relates primarily to an increase in the net loss, partially offset by non-cash expenses and the effects of the changes in operating assets and liabilities.

Conference Call Information

DiaMedica management will host a conference call to discuss these results on Tuesday, March 24, 2020, at 7:00 a.m. Central Time:

Date:

Tuesday, March 24, 2020

Time:

7:00 AM CT / 8:00 AM ET

Web access:

View Source

Dial In:

(844) 557-8483 (domestic)

(825) 312-2381 (international)

Conference ID:

9270458

Interested parties may access the conference call by dialing in or listening to the simultaneous webcast. Listeners should log on to the website or dial in 15 minutes prior to the call. The webcast will remain available for play back on our website, under investor events and presentations, following the earnings call and for 12 months thereafter. A telephonic replay of the conference call will be available until March 31, 2020, by dialing (800) 585-8367 (US Toll Free), (416) 621-4642 (International), replay passcode 9270458.

About DM199

DM199 is a recombinant (synthetic) form of the human serine protease, KLK1. The KLK1 protein plays an important role in the regulation of diverse physiological processes including blood flow, inflammation, fibrosis, oxidative stress and neurogenesis via a molecular mechanism that increases production of nitric oxide and prostaglandin. KLK1 deficiency may play a role in multiple vascular and fibrotic diseases such as chronic kidney disease, retinopathy, stroke, vascular dementia and resistant hypertension where current treatment options are limited or ineffective. DiaMedica is the first company to have developed a recombinant form of the KLK1 protein. The KLK1 protein, produced from porcine pancreas and human urine, has been used to treat patients in Japan, China and Korea for decades. DM199 is currently being studied in patients with chronic kidney disease and patients with acute ischemic stroke.