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 PDC*line Pharma reported that grants exclusive license in South Korea and exclusive option in other Asian countries to LG Chem Life Sciences Company, for the development and commercialization of PDC*lung cancer vaccine for lung cancer (Press release, PDC Line Pharma, MAR 20, 2019, View Source [SID1234554037]).

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The total deal value is 108M€ (123M$) plus significant tiered royalties on net sales in Asia.
Under the terms of the agreements, PDC*line Pharma will co-operate with LG Chem, who will have the full rights in South Korea and an exclusive option for other Asian countries, to develop and commercialize the company’s drug candidate, PDC*lung, in lung cancer. PDC*lung is constituted of a PDC*line loaded with HLA-A2 restricted peptides derived from six shared tumor antigens.
Under the terms of the agreement, PDC*line Pharma will continue developing its PDC*lung candidate in the EU, US and global markets outside of Asia, and LG Chem will be responsible for future development and commercialization in its territories.

On March 20, 2019 Oncorus, Inc., an oncolytic virus therapeutics company focused on driving innovation to transform outcomes for cancer patients, reported that four abstracts have been accepted for presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019, which will be held from March 29 through April 3, 2019 at the Georgia World Congress Center in Atlanta, GA (Press release, Oncorus, MAR 20, 2019, View Source [SID1234534509]).

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Oncorus will give an oral presentation highlighting preclinical data supporting the advancement of its lead pipeline candidate, ONCR-177, a locally administered oncolytic virus therapy armed with five immunomodulatory payloads for the treatment of multiple solid tumor indications. ONCR-177 is built on Oncorus’ proprietary, next-generation oncolytic herpes simplex virus (oHSV) platform. The company’s three poster presentations will detail proprietary innovations in potency and safety engineered by Oncorus into both its oHSV platform as well as its novel synthetic oncolytic virus platform that enable best-in-class potential for the company’s portfolio programs and the opportunity to pursue multiple tumor indications

"Our research team under the leadership of our CSO, Dr. Christophe Quéva, continues to make rapid progress advancing both our oncolytic herpes simplex virus and synthetic oncolytic virus platforms to enable intratumoral and intravenous administration of oncolytic virus therapies, respectively, that have the potential to address a spectrum of critical, unmet cancer treatment needs," said Ted Ashburn, M.D., Ph.D., President and Chief Executive Officer of Oncorus. "We look forward to sharing our proprietary innovations on both platforms at this year’s AACR (Free AACR Whitepaper) Annual Meeting, in particular preclinical data supporting the clinical advancement of our lead candidate ONCR-177."

The schedule and details for Oncorus’ oral and poster presentations are as follows:

Oral Presentation

Abstract #: 940
Title: Development of ONCR-177, a miR-attenuated oncolytic HSV-1 designed to potently activate systemic antitumor immunity
Session: MS.IM02.03 – Cancer Vaccines and Intratumoral Immunomodulation
Date and Time: Sunday, March 31, 2019 / 3:05 – 3:20 pm EDT
Location: Georgia Ballroom 3 – Building C
Abstract Link: View Source!/6812/presentation/2236

Poster Presentations

Abstract #: 1455
Title: Design of ONCR-177 base vector, a next generation oncolytic herpes simplex virus type-1, optimized for robust oncolysis, transgene expression and tumor-selective replication
Session: PO.IM02.08 — Cancer Vaccines and Intratumoral Immunomodulation
Date and Time: Monday, April 1, 2019 / 8:00 am – 12:00 pm EDT
Location: Poster Section 22
Abstract Link: View Source!/6812/presentation/2749

Abstract #: 1452
Title: Development of ONCR-148, a miR-attenuated oncolytic HSV-1 designed to potently activate antitumor T cell response
Session: PO.IM02.08 — Cancer Vaccines and Intratumoral Immunomodulation
Date and Time: Monday, April 1, 2019 / 8:00 am – 12:00 pm EDT
Location: Poster Section 22
Abstract Link: View Source!/6812/presentation/2746

Abstract #: 4773
Title: Development of ONCR-NEP, a lipid nanoparticle delivered oncolytic virus capable of robust in situ amplification resulting in tumor lysis and regression
Session: PO.ET08.01 — Gene- and Vector-based Therapy
Date and Time: Wednesday, April 3, 2019 / 8:00 am – 12:00 pm EDT
Location: Poster Section 12
Abstract Link: View Source!/6812/presentation/1354

On March 20, 2019 Genzada Pharmaceuticals USA Inc. (Genzada), a subsidiary of Ionics Life Sciences Limited, reported that the first patient enrolled in its Phase 1 clinical trial for the oral therapeutic GZ17-6.02 received the first dose this week at HonorHealth Research Institute in Scottsdale, Ariz (Press release, Genzada Pharmaceuticals, MAR 20, 2019, View Source [SID1234534510]). Genzada’s GZ17-6.02 will be administered to patients with advanced solid cancers and lymphoma.

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The drug is derived in part from the black calla lily (arum palaestinum), a native plant found in several regions of the Middle East. Traditional Middle Eastern medicine has used the lily for more than 1,000 years as an herbal remedy for multiple maladies, including inflammation, viral infection and cancer.

"We’re excited to have reached the clinical stage of development of GZ17-6.02. Through the rigorous preclinical developmental path, we have discovered a unique mechanism of action via super-enhancer inhibition. We’re confident that this agent will be both safe and effective in cancer patients and are thrilled to bring this into the clinic," said Genzada Chief Operating Officer Cameron West, MD. "Additionally, as GZ17-6.02 is composed of three active pharmaceutical ingredients—originally derived from medicinal plants—we’re hopeful that 6.02 will tackle various malignancies on multiple fronts."

Genzada chose TD2, a contract research organization (CRO), to manage the operational aspects of the trial, including trial design, project management, data management, monitoring, clinical site management, safety and statistics.

"Reaching the clinical stage is a huge milestone for the companies we work with, as it takes a lot of hard work and preparation to get to this point," said Stephen Gately, president and CEO of TD2. "This particular drug is quite interesting in its composition, and we’re honored to be part of this trial that could potentially improve the lives of cancer patients."

With enrollment for the study projected to reach 30-40 patients nationally, Genzada expects continued treatments among trial patients throughout the remainder of 2019. Currently, patients enrolled in this clinical trial will receive the GZ17-6.02 (6.02), an investigational compound, at HonorHealth Research Institute in Scottsdale. In the future, additional trial sites may be included as the study progresses.

"GZ17-6.02 is truly a novel therapy with the potential to transform cancer care. With the support of Genzada and TD2, we are pleased to make this treatment available at HonorHealth Research Institute," said Frank Tsai, MD, medical oncologist, principal investigator at HonorHealth Research Institute.

In November 2018, the project’s Investigational New Drug (IND) application received clearance from the U.S. Food and Drug Administration (FDA) to proceed with the Phase 1 human trial of 6.02 in patients with advanced solid cancers and lymphoma.

The 6.02 compound acts as an inhibitor to super-enhancers, the areas of the genome bound by transcription factors that are uniquely susceptible to repair signal disruption. It previously showed success in many therapeutic settings, including patients with pancreatic cancer and those with head and neck squamous cell carcinoma.

On March 20, 2019 Dynavax Technologies Corporation (NASDAQ: DVAX), a fully-integrated biopharmaceutical company focused on discovering and developing novel vaccines and immuno-oncology therapeutics, reported it will present safety and biomarker data for DV281, its inhaled TLR9 agonist, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019, being held March 29 – April 3, in Atlanta, Georgia (Press release, Dynavax Technologies, MAR 20, 2019, View Source [SID1234534546]).

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Abstract Number and Title: #8304, "Phase Ib/II, open label, multicenter study of inhaled DV281, a Toll-like receptor 9 agonist, in combination with nivolumab in patients with advanced or metastatic non-small cell lung cancer (NSCLC)"

Poster Session Title: Phase I-III Trials in Progress: Part 3

Session Date and Time:Tuesday, April 2, 2019, 1 – 5 p.m. ET

Session Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 17, Poster Board Number: #18

Permanent Abstract Number: CT224

About DV281
DV281 is Dynavax’s proprietary investigational TLR9 agonist designed specifically for focused delivery to primary lung tumors and lung metastases. DV281 is similar in biological activity and mechanism of action to Dynavax’s Phase 2 immunotherapy candidate, SD-101, but has been optimized for administration as an inhaled therapy. Both SD-101 and DV281 activate plasmacytoid dendritic cells which then stimulate T cells specific for antigens released from dying tumor cells. TLR9 agonists such as DV281 and SD-101 have been shown to stimulate potent Type 1 interferon induction along with maturation of dendritic cells to effective antigen-presenting cells; both activities are important for the induction of effective anti-tumor immunity.