On August 27, 2020 Vivoryon Therapeutics AG (Euronext Amsterdam: VVY), reported its financial results for the first six months of 2020 ending June 30 (Press release, Vivoryon Therapeutics, AUG 27, 2020, View Source [SID1234564086]). The full interim report is available on the company website: View Source

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KEY HIGHLIGHTS
Vivoryon Therapeutics and Nordic Bioscience enter research and development collaboration
Initiation of development program for Meprin protease inhibitors with potential therapeutic use in fibrosis, cancer and Alzheimer’s disease
Announcement of outcome on exclusive option deal with MorphoSys
Update on U.S. and EU Alzheimer’s clinical trial program with varoglutamstat (PQ912)

POST PERIOD HIGHLIGHTS
Vivoryon Therapeutics enrolled first patient in VIVIAD, European Phase 2b Alzheimer’s disease study with varoglutamstat (PQ912)
Vivoryon Therapeutics announced IND approval for varoglutamstat (PQ912)

Comment from Dr. Ulrich Dauer, Chief Executive Officer of Vivoryon Therapeutics:

"Notwithstanding the global crisis, the first six months of 2020 have yielded positive outcomes for Vivoryon that have resulted in the advancement of our clinical programs, the expansion of our drug development portfolio and the continued validation from regulatory bodies including the U.S. Food and Drug Administration (FDA) and World Health Organization.

In January, we entered a research and development collaboration with Nordic Bioscience, which will serve as our CRO (Clinical Research Organization) for the Phase 2b VIVIAD trial. We look forward to benefitting from Nordic Bioscience’s expertise in the development of blood-based biomarkers for the identification of specific patients that may benefit most from treatment with varoglutamstat (PQ912). The ability to select patients who have a greater chance of responding to varoglutamstat (PQ912) presents an opportunity for Vivoryon to transfer an already tested principle of precision medicine into Alzheimer’s disease.

Along with the update on our European Phase 2b clinical study in March, we announced the clinical trial’s name, ‘VIVIAD,’ derived from ‘advancing disease-modifying treatment and non-invasive diagnostics of Alzheimer’s disease.’ The study will test the efficacy and safety of various doses of varoglutamstat (PQ912) in 250 early-stage Alzheimer’s patients in a randomized, placebo-controlled study over the course of 48 to 96 weeks. Professor Dr. Scheltens, Director of the Alzheimer Center at the VU University Medical Center in Amsterdam, will act as the coordinating investigator of the study, which intends to use ten recruiting sites in Denmark, Germany and the Netherlands.

Our lead candidate, formerly known as PQ912, also received external recognition from the World Health Organization through its newly appointed and approved International Nonproprietary Name (INN), varoglutamstat (PQ912); we look forward to its development under this new name.

From a research and development perspective, during the first half of the year we extended our portfolio by acquiring patents from the Fraunhofer Institute for Cell Therapy and Immunology (IZI) for the further development of Meprin protease inhibitors which have the potential to not only target symptoms, but also treat a range of indications including acute and chronic kidney disease and multiple organ fibrosis. Together with the Fraunhofer Institute, we will collaborate to develop novel low-molecular Meprin inhibitors. As a company, it is our goal to identify opportunities that can leverage our expertise in translating basic research into marketable small molecule therapeutics and thereby strengthen our pipeline with the ultimate vision of delivering novel therapies to patients in need. On a similar note, although MorphoSys did not exercise the exclusive option to license our small molecule QPCTL inhibitors, we remain optimistic about collaborating with other leading oncology companies in order to leverage the strength and versatility of our small molecule therapeutics.

The second half of the year was marked with further positive developments for Vivoryon. In July, we announced the enrollment of the first patient in VIVIAD, the European Phase 2b Alzheimer’s disease study with varoglutamstat (PQ912). The data read-out of the VIVIAD study is expected to be available in 2023. Later in the month, the FDA cleared Vivoryon’s Investigational New Drug (IND) application for varoglutamstat (PQ912), which will enable the initiation of our U.S. Phase 2 clinical trial. The U.S. trial is projected to initiate mid-2021 with a final data readout in 2023.

Despite the past months being marked by the Covid-19 pandemic and strict lockdown regulations, we are proud to have kept our entire workforce employed during this crisis. In order to provide a safe working environment, we provided flexible solutions to employees including working from home and in-office shifts. Business travel, which usually serves as an opportunity to network with potential investors and/or partners, was largely replaced by integrating a video conference system. Although we cannot predict how the second half of the year will progress from a global standpoint, as a company we are well-positioned to continue moving the Alzheimer’s clinical trials forward while exploring the potential of our unique proprietary position in cancer and fibrosis and identifying additional opportunities within our small molecule therapeutics pipeline. I would therefore like to extend a big thank you to all employees for their continued dedication and commitment as well as our shareholders who continue to support Vivoryon during these unprecedented circumstances."

Details of the Financial Results (according to IFRS)

Net loss

The operating loss for first half of 2020 was increased by EUR 4,403k to EUR 7,480k (H1 2019: EUR 3,077k). This was mainly driven by higher research and development expenses of EUR 6,380k (H1 2019: EUR 1,862k). The general and administrative decreased slightly to EUR 1.138k (H1 2019: EUR 1,223k).

Consequently, net loss was increased to EUR 7,572k (H1 2019: EUR 3,091k).

Cash/Securities

Vivoryon Therapeutics held EUR 3,623k in cash and cash equivalents as of June 30, 2020 (Dec 31, 2019: EUR 41,524k).

The cash flows used in investing activities amount to EUR 31,501k mainly resulted from the purchase of other securities (EUR 19,999k) which can be liquidated at any time and from time deposits (EUR 10,929k) with a runtime of 6 months.

All results are in line with management expectations.

CONFERENCE CALL
Vivoryon Therapeutics will host a conference call and webcast open to the public today, August 27, 2020, at 3:00 pm CEST / 09:00 am EDT; the presentation will also be available on the company website. The conference will be held in English. A question and answer session will follow the presentation of the half year results.

To participate in the conference call, please call one of the following numbers ten minutes prior to commencement.

A live webcast and slides will be made available at: www.vivoryon.com/investors-news/financial-information/

Approximately one day after the call, a slide-synchronized audio replay of the conference will be available on: www.vivoryon.com/investors-news/financial-information/

FINANCIAL STATEMENTS
January to June 2020

Vivoryon Therapeutics has finalized its financial statements for the first six months of 2020 according to German GAAP ("HGB") and IFRS. The reports are available on the company website (View Source/).

Financial calendar 2020

September 30, 2020 Ordinary General Shareholder Meeting

November 26, 2020 Interim Management Statement Q3 2020

On August 27, 2020 Luminary Therapeutics (Luminary Tx) and Case Western Reserve University reported that have entered into a formal collaboration agreement that includes an option for Luminary to exclusively license a novel BAFF target for use in CAR-T (chimeric antigen receptor T cells) constructs (Press release, Case Western Reserve University, AUG 27, 2020, View Source [SID1234564083]).

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The BAFF target was discovered by Reshmi Parameswaran, an assistant professor at Case Western Reserve School of Medicine and a faculty member in the Division of Hematology and Oncology, Department of Medicine, and the Seidman Cancer Center at University Hospitals (UH) in Cleveland.

Luminary intends to conduct IND-enabling non-clinical studies to support two clinical trials with its novel and proprietary non-viral autologous BAFF CAR-T (LMY-920) to treat Mantle Cell Lymphoma and Sjogren’s Syndrome. This BAFF target is unique in that it binds to three distinct receptors (BAFF, BCMA, and TACI). Additionally, this BAFF target avoids early B-Cells while targeting more mature B-Cells that express one of three antigens.

"Our rationale for choosing to collaborate with Luminary Tx is due to their non-viral approach for clinical development with our BAFF target," said Michael Haag, Case Western Reserve’s executive director of Technology Management. "We believe that Luminary’s experience and flexibility can move this asset into the clinic faster than other therapeutic companies."

Luminary has an aggressive clinical development plan to initiate two Phase I clinical trials. Jeff Liter, Luminary Tx’s CEO, noted that, "Our development plan focuses on non-viral CAR-T platforms that can speed our time to the clinic well ahead of other virus-based approaches."

In addition to scientific expertise and intellectual property, Luminary is excited to work with CWRU and UH because of the expertise and infrastructure available in the Cellular Therapy Laboratory, an on-site state-of-the-art GMP cell manufacturing facility capable of generating CAR-T cells in an expedited fashion and at reduced cost. UH is also a home to several cell therapy clinical trials led by experienced oncologists at the UH Seidman Cancer Center, part of the NCI-designated Case Comprehensive Cancer Center and the region’s only freestanding cancer hospital.

On August 27, 2020 Nordic Nanovector ASA (OSE: NANO) reported its results for the second quarter and first half 2020 (Press release, Nordic Nanovector, AUG 27, 2020, View Source [SID1234564068]). A presentation by Nordic Nanovector’s management team will take place today in Oslo at 08.30 CET, see details below. A link to the webcast and the presentation is available from the company’s homepage (www.nordicnanovector.com) .

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Lars Nieba, interim CEO of Nordic Nanovector, said: "The management team together with the board have taken a range of actions during the last several months to increase focus, improve patient recruitment while at the same time conserve cash. These initiatives along with the positive PARADIGME interim analysis and on-going protocol amendments have put Nordic Nanovector in a significant improved position to deliver the three-month top line data from PARADIGME in H2’2021. "

Q2 and H1 2020 Highlights

Strategic review completed: clinical development strategy revised, and cost-saving initiatives implemented
Pivotal Phase 2b PARADIGME trial of Betalutin progressing in 3rd-line follicular lymphoma (3L FL)
COVID-19 continued to have a negative impact on PARADIGME patient recruitment during Q3
56 patients enrolled as of August 26th, 2020
Protocol amendments are being made to PARADIGME to enlarge the eligible patient population and increase the rate of enrolment into the study
Dr Lars Nieba appointed as interim Chief Executive Officer and Malene Brondberg as Chief Financial Officer
Planned restructuring completed
Corporate and personnel reorganisation implemented, headcount reduced by approximately 20%
Cost savings of approximately NOK 35 million per annum are expected from the restructuring
Betalutin granted Fast Track designation in the US and Orphan Drug Designation in the European Union for Marginal Zone Lymphoma (MZL)
Events after Q1 2020

Result of PARADIGME Interim Analysis: recommendation to focus on single arm investigating the "40/15" dosing regimen
Comprehensive review of data by Independent Review Committee
Both dosing regimens were well-tolerated and associated to a manageable safety profile
Both arms were active based on efficacy measures of Complete Response, Partial Response and Stable Disease
"40/15" arm demonstrated consistency across all sub-groups
"100/20" arm to be discontinued – dosed patients to be monitored for the remainder of the trial
Maintain target to recruit 130 patients
Although we see improvements in certain geographies, the negative impact due to COVID-19 continues to impact PARADIGME patient recruitment during Q3. The target patient population is a high-risk group for COVID-19
Target set to announce PARADIGME three-month top-line data in H2’2021
Dr Christine Wilkinson Blanc appointed Chief Medical Officer
Financial Highlights

(Figures in brackets = same period 2019 unless otherwise stated)

Revenues for the second quarter amounted to NOK 0.0 million (NOK 0.0 million)
Total operating expenses for the second quarter were NOK 113.4 million (NOK 111.0 million)
Comprehensive loss for the second quarter amounted to NOK 125.6 million (loss of NOK 110.4 million)
Revenues for the first half of 2020 amounted to NOK 0.0 million (NOK 0.0 million)
Total operating expenses for the first half of 2020 increased to NOK 239.3 million (NOK 200.9 million)
Comprehensive loss for the first half was NOK 217.2 (NOK 202.0 million)
Cash and cash equivalents amounted to NOK 246.2 million at the end of June 2020, compared to NOK 470.8 million at the end of December 2019
Outlook

The company is targeting the readout of three-month top line data from PARADIGME in H2’2021. This timeline assumes the efficient implementation of the protocol amendments and other initiatives to increase the rate of enrolment and the impact of the COVID pan-epidemic on patient recruitment to slowly subside over the next few months.

The steps the company has taken to conserve cash, including reducing headcount and pausing certain clinical trials, will extend the cash runway into 2021. The company expects to see the impact of these cost-saving initiatives emerge over the remainder of 2020.

Following a broad range of actions carried out by the management team during the course of 2020, the company now believes it is in a much-improved position to deliver the pivotal results from PARADIGME in a timely manner. This would be a key milestone for Nordic Nanovector as the company seeks to bring this exciting new targeted NHL treatment to patients and maximise the value of Betalutin.

Presentation and webcast – Q2 and H1 2020 results

A presentation by Nordic Nanovector’s management team will take place today at 8:30 am CET at Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo, Meeting Room: Vika Atrium

The presentation will be recorded as a webcast and will be available at www.nordicnanovector.com in the section: Investors & Media

The results report and the presentation is available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentation/Interim Reports/2020.

On August 27, 2020 BioInvent reported that Interim Report January 1 – June 30, 2020 (Press release, BioInvent, AUG 27, 2020, View Source;june-30-2020-301119462.html [SID1234564067])

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BioInvent is fully focused on moving our clinical projects forward. Our successful financing of SEK 625 million has strengthened our institutional investor base and is truly transformative for the company as it allows us to broaden and develop our exciting pipeline and creates a solid financial base going forward."

Martin Welschof, CEO BioInvent

Financial information

Second quarter 2020

Net sales SEK 15.6 (32.9) million.
Loss after tax SEK -39.3 (-32.8) million.
Loss after tax per share before and after dilution SEK -0.08 (-0.07).
Cash flow from operating activities and investment activities SEK -28.4 (-35.3) million.
January – June 2020

Net sales SEK 32.4 (50.3) million.
Loss after tax SEK -72.0 (-60.6) million.
Loss after tax per share before and after dilution SEK -0.14 (-0.15).
Cash flow from operating activities and investment activities SEK -63.9 (-75.8) million.
*Liquid funds as of June 30, 2020: SEK 182.3* (210.3) million.

*Liquid funds as of 30 June 2020 include SEK 95 million of the total net capital approx. SEK 589 million from the share issues. Remaining net capital SEK 494 million has been received in Q3 2020.

Events in the second quarter

BioInvent successfully completed a directed share issue of approximately SEK 487 million before transaction costs. Investors included new investors such as HBM Healthcare Investments Ltd., Swedbank Robur Medica and Invus Public Equities, L.P. as well as existing shareholders Van Herk Investments B.V., Omega Funds, The Fourth Swedish National Pension Fund and Handelsbanken Healthcare Fund. (R)
Promising progress was reported in the Phase I/lla trial of lead program BI-1206 in combination with rituximab. A complete response was observed in one follicular lymphoma patient and complete depletion of circulating tumoral cells in a mantle cell lymphoma patient. (R)
First patient enrolled in a Phase I/IIa clinical trial of BI-1206 in combination with anti-PD-1 therapy KEYTRUDA for patients with solid tumors.
BioInvent and Transgene presented preclinical data at AACR (Free AACR Whitepaper) Virtual Session II, demonstrating high cure rates in solid tumors of BT-001, an anti-CTLA4 antibody-encoding oncolytic virus. Phase I clinical trial expected to start before the end of 2020.
BioInvent presented new proof-of-concept data at AACR (Free AACR Whitepaper) Virtual Session II for BI-1808 and BI-1910, two different types of monoclonal antibodies targeting TNFR2. Both antibodies showed significant antitumor activity in several immunocompetent models.
A clinical trial application was submitted to begin a Phase I/IIa, first-in-human study of BI-1808 for the treatment of solid tumors or cutaneous T-cell lymphoma. The trial is expected to start before the end of 2020.
Manufacturing agreement signed with U.S. cell therapy company.
Events after the reporting period

In July 2020, BioInvent’s agreement with Pfizer Inc. was further extended until the end of 2020 to permit the companies to further identify and characterize new targets and antibodies binding to these targets.
The Extraordinary General Meeting on July 3 resolved to increase the Board of Directors with one member through new election of Dr. Thomas Hecht as a Board member. (R)
In July 2020, BioInvent’s Board of Directors resolved on a repair rights issue of a maximum of approximately SEK 139 million. It was completed in August and was heavily oversubscribed. (R)

(R)= Regulatory event
Comments from the CEO

BioInvent is continuing to make good progress toward our targets as we move into the second half of 2020. In particular, we successfully completed a directed share issue, followed by a repair rights issue which was heavily oversubscribed.

We were pleased to see such strong interest in these share issues and are grateful for the continued support and trust of all our investors. In total these share issues raised approximately SEK 625 million before transaction costs, which not only gives us the means to continue the development of BI-1206 in both hematological cancers and solid tumors, but also enables the development of a number of exciting new drug candidates. In short, these financings enable us to broaden and develop our pipeline and are truly transformative for the company.

Our lead drug candidate BI-1206 is progressing well in hematological cancer and solid tumors. The first patient has been enrolled in a Phase I/IIa trial of BI-1206 in combination with the anti-PD-1 therapy KEYTRUDA (pembrolizumab) in solid tumors. We believe BI-1206’s potential ability to increase and enhance the response rates to anti-PD1 targeting agents such as KEYTRUDA may be a powerful approach for the future treatment of a broad range of solid tumors and hematological cancer types. We are also progressing the Phase I/IIa trial of BI-1206 in combination with rituximab for the treatment of non-Hodgkin lymphoma (NHL) and are looking at the need to add additional sites to ensure good patient enrolment.

We hosted a successful virtual key opinion leader meeting in July with Alexander Eggermont, MD, PhD, Chief Scientific Officer at the Princess Máxima Center and renowned expert in immunotherapy. At this meeting, Prof. Eggermont discussed the clinical challenges associated with the use of checkpoint inhibitors in solid tumors and the potential for an enhanced response with immune-modulatory antibodies, specifically those targeting FcγRIIB, such as BI-1206. He concluded that BI-1206 has the potential to be effective against multiple tumor types, much like KEYTRUDA, which is approved in over 20 different cancers.

Our pipeline is becoming increasingly broad and robust, based on the productivity of our proprietary n-CoDeR/F.I.R.S.TTM platforms. In addition to BI-1206, we have a number of other candidates now progressing to clinical development.

Together with our partner Transgene, we presented preclinical data demonstrating high cure rates in solid tumors of BT-001 at AACR (Free AACR Whitepaper) Virtual Session II. BT-001 is a multifunctional oncolytic virus which was engineered to encode a Treg-depleting anti-CTLA4 antibody from n-CoDeR/F.I.R.S.TTM and we believe that the potential to combine anti-CTLA4, anti-PD-1/PD-L1 and oncolytic immunotherapy could change the treatment paradigm for multiple solid tumors. This sets the stage for starting a Phase I clinical trial with BT-001 before the end of 2020.

We have submitted a clinical trial application (CTA) to begin a Phase I/IIa, first-in-human study of BI-1808, a monoclonal antibody to tumor necrosis factor receptor 2 (TNFR2), as a single agent and in combination with KEYTRUDA for the treatment of solid tumors and cutaneous T-cell lymphoma (CTCL). This trial is expected to start before the end of 2020. Meanwhile, new proof-of-concept data on BI-1808 and BI-1910, presented at the AACR (Free AACR Whitepaper) Virtual Session II, showed that both these antibodies had significant antitumor activity in several immunocompetent models.

As well as all this, our work with Pfizer continues and we have extended our cancer immunotherapy research collaboration and license agreement until the end of 2020.

All this exciting progress is underpinned by our technology platform, which continues to produce new potential treatments ready for clinical development to address major unmet medical needs. With financing in place and the strong support of our investors, BioInvent is well positioned to continue to deliver on the promise of our pipeline.

We are now in a very strong position and I am confident we will be able to continue to add shareholder value going forward. We look forward to further updating you on all of our value adding projects next time and in the meantime, wish you all the best.

On August 27, 2020 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported interim safety data from its ongoing clinical Phase I study of the drug candidate ATOR-1017, its wholly owned 4-1BB antibody in development for the treatment of metastasized cancer (Press release, Alligator Bioscience, AUG 27, 2020, View Source [SID1234564066]).

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The data presented today displays an encouraging safety profile of ATOR-1017. Few drug related adverse events have been observed and all were mild or moderate (grade 1 or 2). The Data Review Committee that monitors the safety of the patients in the ATOR-1017 Phase I study, has cleared the 40 mg dose and approved to start dosing with the higher dose level of 100 mg, corresponding to approximately 1.6 mg/kg.

"Activation of the immune receptor 4-1BB holds enormous potential but has historically been associated with severe toxicity. ATOR-1017 demonstrates a very good tolerability profile this far, indicating that we have succeeded in generating a therapeutic antibody with potential for superior properties. I look forward to taking this drug candidate into clinical efficacy studies" commented Per Norlén, CEO at Alligator Bioscience.

Today at 2 p.m. CEST, Alligator hosts a public R&D update where CEO Per Norlén and COO Malin Carlsson will give an update on the latest development steps in the company’s clinical pipeline – focusing on the recent news on the drug candidate ATOR-1017. Guest speaker, Professor Ignacio Melero at University of Navarra, will give his view on the target 4-1BB. The clinical candidates ATOR-1015 and mitazalimab will be presented as well. The complete agenda is available below. View today’s presentations on the Alligator YouTube channel View Source

This information is such information as Alligator Bioscience AB (publ) is obliged to make 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 a.m. CEST on August 27, 2020.

Agenda for the virtual R&D update on August 27, 2020
Program (approximate times):

2:00 p.m. Company introduction and clinical development update ATOR-1015 and mitazalimab
Speaker: Per Norlén, CEO

2:15 p.m. ATOR-1017 – Concept and latest news
Speaker: Malin Carlsson, COO

2:30 p.m. 4-1BB – An attractive target for cancer immunotherapy
Speaker: Professor Ignacio Melero, University of Navarra, Pamplona, Spain

2:45 p.m. Q&A session

3:00 p.m. Conclusions

About ATOR-1017
ATOR-1017 activates 4-1BB receptors which increases the ability of the immune system to detect and kill tumor cells. ATOR-1017 has a unique profile related to the fact that its immune-stimulatory function is stronger in areas where immune cells are abundant, notably in tumors. This creates an opportunity for a strong immune activation that can increase efficacy and reduce side effects for the patient.

The ongoing Phase I study is a dose escalation study in patients with advanced cancer. The study is conducted at three different clinics in Sweden and is planned to include up to 50 patients. The primary objective of the study is to assess the safety and tolerability of ATOR-1017 and to determine the recommended dose for the subsequent Phase II studies.