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Anri Okhanashvili, the Chair of the Georgian Parliament's Legal Affairs Committee, on Wednesday said domestic radical opposition groups that refused to participate in work for Georgia obtaining the European Union membership candidate status had been shown a red card from the European Unions highest tribune.

Okhanashvili was commenting after Josep Borrell, the EU High Representative for Foreign Affairs and Security Policy, said on Tuesday the process of joining the European Union must be based on the consensus of the whole nation and everyone should work together, not only the government but all political parties.

We have heard from the representatives of the European Union that the European perspective for Georgia is a great achievement within the framework of our close cooperation, Okhanashvili noted.

Also, we have heard assessments that both the Parliamentary majority and the entire opposition spectrum bear equal responsibility [in the implementation of EU conditions]. We have heard calls for everyone to be involved in this process, he added.

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Parliament Committee Chair: EU has shown red card to radical Georgian opposition refusing to join work on EU membership - Agenda.ge

First orphan drug designation granted for Nana-val by the European Commission; fifth globally

SAN DIEGO, Sept. 7, 2022 /PRNewswire/ -- ViractaTherapeutics, Inc. (Nasdaq: VIRX), a precision oncology company targeting virus-associated malignancies, today announced that the European Commission has granted an orphan drug designation (ODD) to nanatinostat and valganciclovir (Nana-val), the company's all-oral combination product candidate, for the treatment of peripheral T-cell lymphoma (PTCL). This represents Nana-val's first ODD in Europe and fifth globally. The U.S. Food and Drug Administration previously granted Nana-val ODD for the treatment of T-cell lymphoma, post-transplant lymphoproliferative disorder, plasmablastic lymphoma, and Epstein-Barr virus-positive (EBV+) diffuse large B-cell lymphoma, not otherwise specified.

"This orphan drug designation acknowledges the high unmet medical need of this patient population as well as the potential of the Nana-val o offer therapeutic benefit to patients with recurrent peripheral T-cell lymphoma," said Lisa Rojkjaer, M.D., Chief Medical Officer of Viracta. "Patients with peripheral T-cell lymphoma have few effective treatment options, particularly those with relapsed/refractory disease. Of note, Epstein-Barr virus is frequently associated with peripheral T-cell lymphoma, and reportedly confers a worse overall survival for patients. Following the conclusion of our Phase 1b/2 study, we are now continuing the evaluation of Nana-val in patients with relapsed/refractory Epstein-Barr virus-positive lymphoma in our global Phase 2 NAVAL-1 trial, which is actively enrolling at sites across Europe, North America and Southeast Asia."

ODD in the European Union (EU) is granted by the European Commission based on a positive opinion issued by the European Medicines Agency (EMA) Committee for Orphan Medical Products (COMP). To qualify for ODD from the European Commission, a product candidate must be intended to treat, prevent, or diagnose a life-threatening or chronically debilitating disease that does not affect more than 5 in 10,000 people across the EU. In addition, there must be sufficient clinical or non-clinical data to suggest the product candidate may produce clinically relevant outcomes, and grounds to indicate it can provide a significant benefit over any currently authorized products. Receiving an orphan drug designation from the European Commission provides companies with certain benefits and incentives including clinical protocol assistance, access to a centralized marketing authorization procedure valid in all EU member states, reduced regulatory fees, and ten years of market exclusivity upon receipt of marketing authorization in the EU. The availability of market exclusivity is intended to encourage the development of medicines for rare diseases by protecting them from competition from similar medicines with similar indications, which cannot be marketed during the exclusivity period.

About NAVAL-1

NAVAL-1 (Nanatinostat in Combination with Valganciclovir) is a global, multicenter, open-label Phase 2 basket trial. The trial, which will include patients with multiple subtypes of relapsed/refractory EBV-positive (EBV+) lymphoma, is designed to evaluate the anti-tumor activity of Nana-val and enroll approximately 140 patients. The primary endpoint of the trial is objective tumor response rate as assessed by an independent review committee. If successful, Viracta believes this trial could potentially support multiple new drug application filings across various EBV+ lymphoma subtypes. The study employs a Simon two-stage design where a limited number of patients are enrolled into each cohort in Stage 1 and, if a pre-specified activity threshold is reached, additional patients will be enrolled in Stage 2. During Stage 2, Viracta anticipates discussing the preliminary results with the FDA and may amend the protocol to include additional patients as necessary to enable registration.

About Nana-val (Nanatinostat and Valganciclovir)

Nanatinostat is an orally available histone deacetylase (HDAC) inhibitor being developed by Viracta. Nanatinostat is selective for specific isoforms of Class I HDACs, which is key to inducing viral genes that are epigenetically silenced in Epstein-Barr virus (EBV)-associated malignancies. Nanatinostat is currently being investigated in combination with the antiviral agent valganciclovir as an all-oral combination therapy, Nana-val, in various subtypes of EBV-associated malignancies.

About Viracta Therapeutics, Inc.

Viracta is a precision oncology company targeting virus-associated malignancies. Viracta's lead product candidate is an all-oral combination therapy of its proprietary investigational drug, nanatinostat, and the antiviral agent valganciclovir (collectively referred to as Nana-val). Nana-val is currently being evaluated in multiple ongoing clinical trials, including a pivotal, global, multicenter, open-label Phase 2 basket trial for the treatment of multiple subtypes of relapsed/refractory Epstein-Barr virus-positive (EBV+) lymphoma (NAVAL-1), as well as a multinational Phase 1b/2 trial for the treatment of EBV+ recurrent or metastatic nasopharyngeal carcinoma and other EBV+ solid tumors. Viracta is also pursuing the application of its inducible synthetic lethality approach in other virus-related cancers.

For additional information please visit http://www.viracta.com.

Forward-Looking Statements

This communication contains "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding: the details, timeline and expected progress for Viracta's ongoing trials and updates regarding the same; and other statements that are not historical facts. Risks and uncertainties related to Viracta that may cause actual results to differ materially from those expressed or implied in any forward-looking statement include, but are not limited to: Viracta's ability to successfully enroll patients in and complete its ongoing and planned clinical trials; Viracta's plans to globally develop and commercialize its product candidates, including all oral combinations of nanatinostat and valganciclovir; the timing of initiation of Viracta's planned clinical trials; the timing of the availability of data from Viracta's clinical trials; previous preclinical and clinical results may not be predictive of future clinical results; the timing of any planned investigational new drug application or new drug application; Viracta's plans to research, develop and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of Viracta's product candidates; Viracta's ability to manufacture or supplying nanatinostat, valganciclovir and pembrolizumab for clinical testing; Viracta's ability to identify additional products or product candidates with significant commercial potential; developments and projections relating to Viracta's competitors and its industry; the impact of government laws and regulations; Viracta's ability to protect its intellectual property position; and Viracta's estimates regarding future expenses, capital requirements and need for additional financing in the future.

These risks and uncertainties may be amplified by the COVID-19 pandemic, which has caused significant economic uncertainty. If any of these risks materialize or underlying assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption "Risk Factors" and elsewhere in Viracta's reports and other documents that Viracta has filed, or will file, with the SEC from time to time and available atwww.sec.gov.

The forward-looking statements included in this communication are made only as of the date hereof. Viracta assumes no obligation and does not intend to update these forward-looking statements, except as required by law or applicable regulation.

Investor Relations Contact:Ashleigh BarretoHead of Investor Relations & Corporate CommunicationsViracta Therapeutics, Inc.[emailprotected]

SOURCE Viracta Therapeutics, Inc.

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Viracta Therapeutics Announces Orphan Drug Designation Granted by the European Commission for Nana-val for the Treatment of Peripheral T-cell Lymphoma...

On Wednesday 7 September 2022, MEP Peter van Dalen (EPP Group, The Netherlands) hosted a conference with the title Human Rights & the Artsakh War 2020 in the European Parliament (EP). The conference was co-organized by the European Armenian Federation for Justice and Democracy (EAFJD).

The keynote speakers were the Human rights defender of the Nagorno-Karabakh/Artsakh Republic Gegham Stepanyan and the legal representative of the Armenian prisoners of war (POWs) before ECHR Siranush Sahakyan.

The conference was widely attended by Members of the European Parliament (MEP) from different political groups, EP advisers, politicians, diplomats, and representatives of civil society.

MEP Peter van Dalen reiterated his commitment to the cause:

I stand with the Armenian people. The life of the Armenian inhabitants of Nagorno-Karabakh/Artsakh, and their cultural heritage is under threat. We should not accept a status quo but ensure the Armenians from Nagorno-Karabakh have a future in their historic region.

In his opening remarks, the EAFJD President Kaspar Karampetian welcomed the participants and thanked MEP van Dalen for hosting the conference:

The second Artsakh war in 2020 launched by Azerbaijan was another attempt to carry out an ethnic cleansing of the native Armenian population of Artsakh. The native Armenian peoples right to live freely and independently in their homeland is a fundamental human right. The European Parliament condemned the state-level policy of Armenophobia by Azerbaijan by an urgent resolution, which is another acknowledgement that the native Armenian people cannot live under Azerbaijani rule, added the EAFJD President.

The keynote speakers addressed the gross violations of international human rights law and international humanitarian law by Azerbaijan during the Nagorno Karabakh/Artsakh war in 2020 and in its aftermath.

The Human rights defender of Nagorno-Karabakh/Artsakh, Gegham Stepanyan underlined:

Azerbaijans policyof ethnic cleansing, threats,use of force,psychological attacksare aimedaimedat disrupting normal lifeandcause uncertainty about the future among theArmenianpopulation of Artsakh. This uncertainty is aggravated especially due to the fact that the status of Nagorno-Karabakh is not clearly addressed in current negotiations, including through the mediationbythe European Union.

After giving an overview from the legal perspective, including the relevant judgements of international courts against Azerbaijan, Siranush Sahakyan, the legal representative of the Armenian POWs before ECHR elaborated:

Anti-Armenian xenophobia has become a defining feature of Azerbaijan, which manifests itself in forms of hate speech, maltreatment of prisoners of Armenian descent, glorification of ethnic violence against Armenians, ethnic cleansing, denial of history.

The interventions were followed by a question-and-answer session with the participants of the event, including Azerbaijanis.

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Human rights & Artsakh War discussed in the European Parliament Public Radio of Armenia - Public Radio of Armenia

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The following is attributable to Spokesperson Ned Price:

Secretary of State Antony J. Blinken spoke with European Union High Representative for Foreign Affairs and Security Policy and Vice President of the European Commission Josep Borrell today to reaffirm the importance of a successful Seventh Replenishment Conference for the Global Fund to Fight AIDS, Tuberculosis, and Malaria. President Biden will host the Replenishment Conference September 19, 2022, during the United Nations General Assembly in New York.

The United States is committed to helping the Global Fund reach its goal in order to get the world back on track toward ending HIV/AIDS, TB, and malaria and to building resilient and sustainable systems for health. President Biden has signaled that the United States will make a contribution of $2 billion and an intended pledge of $6 billion for the Seventh Replenishment period, demonstrating the United States readiness to match $1 for every $2 contributed by other donors.

Secretary Blinken and High Representative Borrell also discussed their shared commitment to support the Afghan people through Afghanistans ongoing economic and humanitarian crises as well as the importance of working with the broader international community, to support the education of Afghan girls.

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Secretary Blinken's Call with European Union High Representative for Foreign Affairs and Security Policy and Vice President of the European Commission...

On September 1, 2022, the European Union will officially open a new liaison office in Californias Silicon Valley. The new office coined the tech embassy follows the European Councils adoption of the Conclusions of EU Digital Diplomacy, which is a broad framework aimed to enhance the EUs regulatory capacity around the world. The office is aimed to liaise with Silicon Valley tech companies affected by the EUs two new technology regulations: the Digital Markets Act (DMA) and the Digital Services Act (DSA).

The DMA and DSA passed by the European Commission in March and April 2022 aim to create a safer digital space for internet users, and a more competitive digital marketplace for tech companies. Both pieces of legislation are set to go into effect this Fall, and are expected to have global implications on tech giants like Google, Apple, Meta, and Amazon.

Specifically, the DMA aims to restrict anti-competitive practices by large tech companies through new prohibitions and requirements for search engines, social networks, mobile apps, and online marketplaces. The DMA imposes, most notably, platform interoperability and data-portability requirements. For example, messaging apps from Apple, Google, and Meta platforms will be required to make end-to-end text messaging interoperable on request by competing services. The DMA also prohibits the use of non-public personal data for targeted advertising without user consent, and bars online marketplaces like Amazon from self-preferencing their own products and services over those of their competitors.

The DSA imposes new regulations on tech companies aimed to protect internet users. The DSA prohibits, among other things, advertising that targets children, and advertising that leverages sensitive personal data like race, religion, or sexual orientation. The DSA also requires online platforms to cooperate in the identification and removal of hate speech and illegal content. In addition, the act imposes heightened obligations for very large online platforms and search engines, defined to include those with more than 45 million active users in Europe. Under the DSA, the very large platforms and search engines must submit to independent audits, and facilitate access to their data and algorithms to authorities and vetted researchers. Both the DMA and DSA carry big fines for non-compliance up to 10% of worldwide sales for violating the DMA (20% for repeat offenders), and up to 6% for violating the DSA.

The DMA and DSA will transform the regulation of digital markets in the EU, and carry significant compliance risks in light of their global reach, broad scope, and the severe penalties for violations. The new legislation also raises significant data privacy and security concerns due to, most notably, the DMAs platform interoperability and data portability requirements.

Footnotes:

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The European Union Opens Tech Embassy in Silicon Valley Ahead of New Technology Regulations - JD Supra