On March 20, 2019 4SC AG (4SC, FSE Prime Standard: VSC) reported the financial results for the financial year ended 31 December 2018, presenting all material reporting period developments and provides an outlook for 2019. The full report is available at 4SC’s website (Press release, 4SC, MAR 20, 2019, View Source [SID1234534507]).

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Key highlights of 2018 and 2019 YTD

4SC continued to make solid progress on clinical development of both resminostat and domatinostat (4SC-202)
More than two thirds of patients recruited for pivotal RESMAIN study of resminostat in advanced-stage cutaneous T-cell lymphoma (CTCL); positive safety outcomes to date
Phase II study of resminostat plus S-1 chemotherapy versus S-1 chemotherapy plus placebo as second-line treatment in Japanese patients with biliary tract cancer initiated by Yakult Honsha Co., Ltd. (Yakult Honsha), 4SC’s development partner for resminostat in Japan
Completed second dose cohort of Phase Ib/II study SENSITIZE of domatinostat in combination with pembrolizumab in advanced-stage melanoma; positive safety outcomes to date; third dose cohort started
Initiated investigator-initiated Phase II study EMERGE of domatinostat in combination with avelumab in microsatellite-stable gastrointestinal tumors
Published preclinical data on combination of domatinostat with either chemotherapy or several immunotherapeutic agents leading to evaluation of further clinical combination trials
Strengthened patent protection for Hedgehog/GLI signaling inhibitor 4SC-208 in the U.S., China, Japan, Singapore, Australia and New Zealand.
Received milestone payments from several partnered programs.
Jason Loveridge, Ph.D., CEO of 4SC, said: "4SC continues to make excellent progress with the development of our portfolio of drug candidates.

We expect that the two ongoing clinical trials of domatinostat will provide clinical evidence to further support the efficacy of domatinostat in patients that do not benefit from immunotherapeutic treatment with checkpoint inhibitors (SENSITIZE study, melanoma) or in a historically checkpoint inhibitor non-responsive indication (EMERGE study, microsatellite-stable gastrointestinal cancer). Taken together, we expect these studies to drive initiation of a pivotal clinical study of domatinostat in the aggressive rare skin cancer Merkel-cell carcinoma.

For resminostat, we expect to enroll sufficient patients in the pivotal RESMAIN study in 2019 to observe the required 125 events to unblind the study. Should the trial prove positive, we plan to submit applications for marketing approval of resminostat in CTCL in Europe, and potentially the U.S., and Yakult Honsha will submit in Japan. If approved, resminostat would be the first histone deacetylase inhibitor approved for CTCL in Europe and the first and only drug approved for maintenance therapy in this indication in either Europe, Japan or the U.S.

The main goal of all our activities is to create significant benefit for patients and value for our shareholders by bringing resminostat and domatinostat to market as soon as possible."

Business outlook

Top-line data of the pivotal RESMAIN study expected in H1 2020.
Results of Yakult Honsha’s Phase II study of resminostat in biliary tract cancer to be available by mid-2020.
SENSITIZE study expected to complete in H1 2019.
Safety data of EMERGE expected in Q2 2019 and early efficacy data in H2 2019
Expand clinical development for domatinostat and initiate potentially pivotal study in Merkel-cell carcinoma
Cash balance development in full year 2018 and financial forecast

As of 31 December 2018, 4SC holds cash balance/funds of €25.0 million, as compared to €41.3 million as of 31 December 2017. The average monthly use of cash from operations in 2018 was €1.357 million (2017: €0.723 million), which is within the €1.3 million to €1.5 million forecast in the previous Q3 announcement. The increase of the monthly use of cash and the decrease in cash balance/funds in 2018 was mainly driven by investments in the ongoing clinical studies RESMAIN and SENSITIZE.

Taking into account the current financial planning and the intended operating activities, the Management Board estimates that current funds should be sufficient to finance 4SC for the next twelve months. For 2019, 4SC is expecting an average monthly use of cash from operations of between €1.4 million and €1.6 million. For 2019, 4SC expects the net loss to be similar to 2018. 4SC is expecting to report similar annual net losses, with almost identical functional cost allocations in the short to medium term future as well.

Conference call

Investors, financial analysts, and journalists interested in participating in the conference call on the annual results 2018 can access via the telephone numbers stated below. Please join the event conference 5-10 minutes prior to the start time. You will be asked to provide your name, company and location as well as the access code.

Date: 20 March 2019
Time: 3 pm CET (10 am ET)
Phone Numbers: +49 (0)32 22109 8334 (Germany)
+44 (0)20 3936 2999 (United Kingdom)
+1 845 709 8568 (USA)
Joining by web (free of charge): www.incommuk.com/customers/online
Access Code: 802724

A presentation document supporting the conference call will be available earlier on the same day at 4SC’s website. After the event, a replay can be accessed from there as well.

On March 20, 2019 Actinium Pharmaceuticals, Inc. (NYSE American: ATNM), reported that preclinical data from the novel combination of its CD33 ARC or Antibody Radiation-Conjugate Actimab-A (lintzumab-Ac-225) with venetoclax has been accepted for poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper), or AACR (Free AACR Whitepaper), Annual Meeting 2019 (Press release, Actinium Pharmaceuticals, MAR 20, 2019, View Source [SID1234534505]). The data to be presented builds on research by Actinium that demonstrated a synergy between Actimab-A and venetoclax, which resulted in greater cancer cell killing. This research supported the initiation of a Phase 1/2 doublet clinical trial studying Actimab-A and venetoclax and a planned Phase 1/2 triplet combination trial of Actimab-A and venetoclax with a hypomethylating agent, both for patients with relapsed or refractory AML or Acute Myeloid Leukemia. Actinium is conducting these trials with the goal of improving outcomes for patients with the addition of Actimab-A to address patients who do not respond, have suboptimal responses, no longer respond and patients who relapse after treatment with venetoclax.

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Venetoclax is a BCL-2 or B-Cell Lymphoma 2 inhibitor jointly developed and marketed by AbbVie and Genentech. BCL-2 is one of several proteins encoded by the BCL2 gene that regulates apoptosis or programmed cell death. MCL-1 is another protein encoded by the BCL2 gene that has been found to be overexpressed in relapsed or refractory AML patients, that prevents apoptosis and promotes resistance to venetoclax which does not bind to MCL-1. It has been observed that MCL-1 levels can be depleted with radiation, but only external radiation was used in these studies. Actinium believes that the targeted internalized radiation from Actimab-A can more effectively deplete MCL-1 levels thereby removing the AML cells’ resistance mechanism and rendering them more susceptible to venetoclax. Actinium has filed a patent on the combination of a targeted alpha-emitting therapeutic such as Actimab-A together with a BCL-2 inhibitor, which includes venetoclax, as a method to treat cancer. The details on Actinium’s poster are as follows:

Title: 225Ac-CD33 Radioimmunotherapy potently increases the sensitivity of resistant acute myeloid leukemia lines to the Bcl-2 inhibitor venetoclax by mediating a reduction in cellular Mcl-1 levels

Session Category: Experimental and Molecular Therapeutics
Session Title: Drug Resistance 5
Session Date and Time: Tuesday Apr 2, 2019 1:00 PM – 5:00 PM
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 10
Poster Board Number: 13
Abstract Number: 3808

Dr. Dale Ludwig, Actinium’s Chief Scientific Officer said, "We are excited to present new data from this Actimab-A ARC and venetoclax combination to further support our recently initiated clinical study and prior work. We have high confidence in the mechanistic rationale of the Actimab-A and venetoclax combination and are encouraged by the results we have seen thus far. With radiation being used in the treatment of up to 60% of cancer patients and a growing body of literature supporting the synergies of radiation therapy with other modalities, we are motivated to capitalize on numerous opportunities that can leverage our AWE or Antibody Warhead Enabling technology platform to exploit radiation’s synergistic effects. Indeed, our AWE technology platform is a tool for innovation that has the potential to expand our pipeline and facilitate collaborations and partnerships."

Actimab-A delivers the potent alpha-particle emitting radioisotope Ac-225 or Actinium-225 to cells with the CD33 antigen, which is expressed in the vast majority of patients with AML, MDS or Myelodysplastic Syndrome, and 25-35% of patients with Multiple Myeloma, or MM. Venetoclax is a BCL-2 or B-Cell Lymphoma 2 inhibitor that is jointly developed and marketed by AbbVie and Genentech that is approved for patients with AML, Chronic Lymphocytic Leukemia, and Small Lymphocytic Leukemia. Actinium has initiated a Phase 1/2 trial that is studying Actimab-A in combination with venetoclax for patients with relapsed or refractory AML and is planning a Phase 1/2 trial that is expected to study Actimab-A and venetoclax with a hypomethylating agent also for patients with relapsed or refractory AML.

Dr. Mark Berger, Actinium’s Chief Medical Officer said, "Our Actimab-A venetoclax combination trials are a strategic priority within our CD33 program that demonstrate our ability to rapidly translate research from our AWE technology platform to our clinical pipeline. Our preclinical data demonstrating a synergy between targeted radiation from Actimab-A and venetoclax, together with Actimab-A’s single agent activity and minimal extramedullary toxicities was well received by investigators, allowing us to develop two distinct clinical trials with this novel combination. As a result, we have created multiple opportunities to advance the treatment of patients with unmet needs with our ARC approach."

On March 20, 2019 RhoVac AB (publ) ("RhoVac") reported that FDA (US Food and Drug Administration) has accepted RhoVac’s application for a pre-IND meeting, which is focused on the clinical development program with the drug candidate RV001 (Press release, RhoVac, MAR 20, 2019, View Source [SID1234534503]).

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RhoVac’s next step in the clinical development of the drug candidate RV001 is expected to start in mid-2019. Clinical development is going to be run primarily in Europe, but part of the company’s strategy is to run some of the clinical development in the US.

Therefore, RhoVac has submitted an application for a pre-IND meeting with the FDA to get answers and recommendations on specific issues related to the continued clinical development. A pre-IND meeting with the FDA is very similar to EMA’s Scientific Advice procedure, which was conducted by RhoVac in spring of 2018.

FDA has now confirmed RhoVac’s application following which the company has submitted the required Briefing Package. The evaluation of the FDA will be based on this package. RhoVac is expected to receive FDA’s comments on RV001 project by end of April 2019.

CEO Anders Ljungqvist comments
-It is very exciting that we now have the opportunity to receive FDA’s feedback and comments on RV001 project. The company’s drug candidate, RV001, is aimed at treating metastatic cancer in an earlier phase of prostate cancer development than existing treatments currently do. Therefore, it is important that both FDA and RhoVac have a common understanding of the concept of the treatment under development.

For more information, please contact:
Anders Ljungqvist – CEO, RhoVac AB
Phone: +45 4083 2365
E-mail: [email protected]

On March 20, 2019 Diffusion Pharmaceuticals Inc. (Nasdaq: DFFN), a cutting-edge biotechnology company developing new treatments for life-threatening medical conditions by improving the body’s ability to bring oxygen to the areas where it is needed most, reported financial results for the year ended December 31, 2018 and provided a business update (Press release, Diffusion Pharmaceuticals, MAR 20, 2019, View Source [SID1234534500]).

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2018 was marked by significant developments related to the Company’s lead drug candidate, trans sodium crocetinate (TSC), for the treatment of stroke and cancer. During the third quarter Diffusion received approval from the U.S. Food and Drug Administration (FDA) to enroll patients in an ambulance-based Phase 2 clinical trial testing TSC for the treatment of acute stroke, while the in-ambulance trial design was presented at several important medical conferences. The trial, named PHAST-TSC (Pre-Hospital Administration of Stroke Therapy-TSC), will involve 23 hospitals across urban, suburban and rural areas in Los Angeles County and Central Virginia, working closely with approximately 150 emergency medical transport groups. PHAST-TSC will be led by researchers at the University of California Los Angeles (UCLA) and the University of Virginia (UVA). Diffusion is working to engage local ambulance companies and expects the first patients to be treated in the coming months. Results for the trial will potentially be available in just under two years, subject to Diffusion receiving the necessary funding.

The Company continues to screen and enroll patients in its Phase 3 INTACT (INvestigation of TSC Against Cancerous Tumors) program, using TSC to treat inoperable glioblastoma multiforme (GBM) brain cancer. In Phase 2 testing TSC demonstrated a nearly four-fold improvement in overall survival at two years for the subset of inoperable GBM patients compared with the control group of GBM patients.

Commenting on 2018 and plans for 2019, David Kalergis, chairman and chief executive officer of Diffusion, said, "In the coming weeks we expect to complete enrollment in the initial dose-escalation cohort of the INTACT trial. In addition, we expect to begin enrollment in PHAST-TSC during the second quarter of 2019. We continue to be excited about the potential for TSC to bring new hope to patients with life-threatening unmet medical needs and making TSC a commercial success.

Several patents were allowed and issued during the course of 2018, strengthening the Company’s intellectual property portfolio around broad uses of TSC in hypoxic conditions such as stroke, and as a treatment for solid cancerous tumors in conjunction with radiation and chemotherapy. Of note, a U.S. patent was issued for TSC in conjunction with tissue plasminogen activator (tPA) for the treatment of stroke. tPA is the only FDA-approved therapeutic for this indication. At the end of 2018, the company had 56 issued patents in the U.S. and abroad.

2018 Financial Results

Diffusion had cash and cash equivalents of $8.0 million as of December 31, 2018. The Company believes its cash and cash equivalents are sufficient to fund operations into July 2019.

Diffusion recognized $5.8 million in research and development expenses during 2018, compared with $5.1 million during 2017. This increase was primarily attributable to a $1.7 million increase in Phase 3 GBM trial expenses and to a $0.2 million increase in salary and wages expenses, partially offset by a $1.2 million decrease in manufacturing and other costs.

General and administrative expenses were $6.2 million during 2018, which were flat compared with 2017. Salaries and wages expense increased by $0.6 million, which was offset by a $0.6 million decrease in professional fees.

The Company recognized a non-cash goodwill impairment charge of $6.9 million during the year ended December 31, 2018 as a result of a sustained decrease in our market capitalization during the second half of 2018. There was no such charge in 2017.

Net cash used in operating activities for 2018 was $10.8 million, compared with $12.3 million during 2017

On March 20, 2019 Abbott (NYSE: ABT) reported that it will announce its first-quarter 2019 financial results on Wednesday, April 17, 2019, before the market opens (Press release, Abbott, MAR 20, 2019, View Source [SID1234534498]).

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The announcement will be followed by a live webcast of the earnings conference call at 8 a.m. Central time (9 a.m. Eastern), and will be accessible through Abbott’s Investor Relations website at www.abbottinvestor.com. An archived edition of the call will be available later that day.

About Abbott:
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

Connect with us at www.abbott.com, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

SOURCE Abbott

For further information: Abbott Media: Elissa Maurer, (224) 668-3309; Abbott Financial: Scott Leinenweber, (224) 668-0791
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