Day: June 5, 2022

IRVINE, Calif. & AMSTERDAM–(BUSINESS WIRE)– Agendia, Inc., a commercial-stage company focused on improving outcomes for breast cancer patients worldwide by providing physicians and patients with next-generation diagnostic and information solutions to inform optimized treatment decision-making, today announced it will share findings in a poster discussion debuting initial data from its ImPrint test, a 53-gene signature in development, at the American Society of Clinical Oncology Annual Meeting (ASCO) 2022.

The poster discussion, titled The ImPrint immune signature identifies high risk early breast cancer patients who may benefit from PD1 checkpoint inhibition in I-SPY2 [Kuilman, M., et al.], draws from the neoadjuvant biomarker-rich I-SPY2 trial, which established a new benchmark for the efficacy of Phase 2 clinical trials and is widely regarded as the pioneer of the platform trial. In this study, whole transcriptome data collected by Agendia was assessed from patients who had high risk early breast cancer who received immunotherapy (IO). The goal was to migrate the I-SPY2 findings into a robust clinical-grade signature – a biomarker that had not previously existed in early stage breast cancer – to predict sensitivity to IO drugs that target PD-1/PDL-1, a cell pathway that, when overexpressed, allows many breast tumors to escape destruction by the immune system.

Importantly, results showed that in the development phase, the gene-expression biomarker ImPrint met this task and had the potential to predict pathologic complete response (pCR) to PD-1/PDL-1 checkpoint inhibitors with high sensitivity and specificity, especially in ER+ breast cancer which represents a large population of women who may benefit.

“We are incredibly encouraged by the data we are sharing with regard to the ImPrint Test, which is currently in development,” said Annuska Glas, Senior Vice President Research and Development and Innovation at Agendia. “ImPrint appears very effective in identifying a subset of HR+HER2- patients who could benefit from IO. We are also interested in the signature’s ability to identify tumors with an immune active phenotype denoted by the enrichment of several immune-related pathways. This kind of information is not currently available to a broad range of patients with breast cancer, and while we are in the research use only stage, we look forward to continuing validation to ensure ImPrint is in physicians’ hands as soon as possible.”

The effect of these findings on patients is potentially significant, ultimately having the potential to impact outcomes. The data shared at ASCO 2022 point to the RUO ImPrint Test’s ability to find those who will benefit from a PD-1/PDL-1 treatment as initial therapy, regardless of receptor subtype, providing the information needed to define more specific treatment planning soon after diagnosis.

“There has been a substantial increase of novel IO drugs in many types of diseases, which are astoundingly effective in some cases but not a panacea for all. This had led to the urgent need for biomarkers to identify which patients may benefit from them,” said Midas M. Kuilman, Research and Development, Agendia NV, Amsterdam and first author on the poster. “We see this signature as addressing an unmet need as various predictive biomarkers have been developed, but none have consistently predicted efficacy. Here, we see that ImPrint appears to predict with high sensitivity and specificity in both discovery and validation sets – it’s an incredibly promising set of data and we look forward to validating it in the I-SPY 2.2 trial.”

Redefining Breast Cancer Care in Post-Neoadjuvant Settings

Another poster, presented by Agendia in partnership with investigators from Cedars-Sinai Medical Center, Los Angeles, looks at matched tumors pre- and post-neoadjuvant chemotherapy analyzed by both MammaPrint® and BluePrint® to report differential gene expression and pathway analyses in the tumors that may help distinguish different responses. The poster, titled Identification of transcriptional changes with MammaPrint and BluePrint in early-stage breast cancer after neoadjuvant chemotherapy [Chung, A., et al.], found a more robust transcriptional change in tumors that remain MammaPrint High Risk between pre- and post-neoadjuvant chemotherapy. While these tumors remained High Risk, they also had many changes in gene expression pre- and post-neoadjuvant chemotherapy, unlocking clues to resistance and inspiring further research.

The study also found that tumors which changed from MammaPrint High Risk to MammaPrint Low Risk post-therapy had an activated immune response that may be a biomarker for therapy response and improved outcomes based on it.

Taken together, these posters represent Agendia’s continuous dedication to producing and evolving products that lead to insights across the breast cancer care continuum, from initial diagnosis to tailored treatment guidance.

In addition, Agendia will be presenting six posters and a second poster discussion centered on its revolutionary FLEX Trial, which is accelerating impactful data generation aimed at redefining cancer care. Its patient-centric design and national network of participating sites is backed by Agendia’s infrastructure, allowing its investigator-initiated sub-studies to produce important results that have the potential to drive science forward.

Agendia will be sharing updates throughout the conference on its Twitter, Facebook and LinkedIn pages.

About Agendia

Agendia is a mission-driven, commercial stage company focused on enabling optimized decision-making by providing physicians with next-generation diagnostic and information solutions that can be used to help improve outcomes for breast cancer patients worldwide. The company currently offers two commercially-available genomic profiling tests that help surgeons, oncologists and pathologists to personalize treatment for women at critical intervention points throughout their patient journey.

MammaPrint® is a 70-gene prognostic test that, along with other clinicopathologic factors, determines a specific patient’s breast cancer recurrence risk. BluePrint® is an 80-gene molecular subtyping test that identifies the underlying biology of an individual breast cancer to provide information about its behavior, long-term prognosis and potential response to systemic therapy. Together, MammaPrint® and BluePrint® provide a holistic view of the biology underlying an individual patient’s breast cancer, enabling physicians to objectively select the best treatment plan.

Source: Cyprus News Agency

Cyprus Interior Minister, Nicos Nouris, said on Saturday, after the meeting of the MED5 Interior Ministers, in Venice, that as an EU member state which faces for the fifth consecutive year the largest migration burden, Cyprus needs the solidarity of its European partners.

According to a press release issued by the Interior Ministry, Nouris noted that during the last years the members of the MED5, which constitute the frontline member states that face a number of problems due to illegal immigration, are working together and are joining forces.

He added that a series of initiatives have been taken, as in the case of evolving the European Asylum Service with a view to reach a Common European Pact on Migration and Asylum, adding that they will continue to work towards this direction and to be constructive.

“All efforts are founded on the need for solidarity”, he noted, adding that this is indispensable if they want to have an effective and sound European policy that will effectively address all the problems which Europe faces today. Moreover, he said that solidarity cannot be voluntarily expressed.

Nouris expressed the support of the Cyprus government to the initiative of the EU French Presidency for a sound basis of negotiations for a step by step process in an effort to get over the obstacles and proceed with the Pact. He thanked the French Minister of the Interior, Gerard Darmanin, for his devotion and his initiative, as well as the forthcoming EU Czech Presidency, which has assured that it will continue to work towards the same direction.

“As a member state that faces for the fifth consecutive year the largest migration burden, Cyprus needs the solidarity of its European partners. No state can manage the situation by itself, and Europe’s decisive support is required,” he underlined.

He noted that this solidarity must be expressed tangibly with the immediate relocation of immigrants from Cyprus, in order not to see soon dramatic demographic changes on the island.

Nouris said that at the same time the EU needs to proceed with bilateral agreements on returns with a number of third countries.

“If all these simple but pivotal issues are not part of the new European Pact on Asylum and Migration, unfortunately no agreement will be able to solve the problem, particularly taking into consideration that estimations refer to 150,000 new immigrants arriving at the frontline states just for this year.”

Nouris said that Cyprus will continue to participate in the constructive discussion with the prospect of establishing a new, sound and just asylum and migration system, based on an equal burden sharing.

“This is the only way to effectively manage migration pressures,” he concluded.

Source: Cyprus News Agency

Cyprus is promoting actions in excess of €1.3 billion for the protection of the environment, President of the Republic Nicos Anastasiades said in a post on Twitter on the occasion of World Environment Day.

“Environmental protection is at the heart of our policies. As Government we are investing in the green transition and environmental sustainability and through the Cyprus Tomorrow Plan and the Thalia Programme we are promoting actions in excess of €1.3 billion,” President Anastasiades noted.

Source: Cyprus News Agency

“Achieving a solution that will permanently rid Cyprus of Turkish occupation and reunite Cyprus is what we should all work for” said Presidential Commissioner Fotis Fotiou, while addressing the annual conference of the Federation of Cypriot American Organizations, held in New York.

He spoke of “a solution without foreign guarantees and guarantee rights” that will transform Cyprus into a “normal state that enjoys all the rights deriving from the international law.”

Fotiou, who represented the Cypriot government at the conference, referred to the efforts made to hold talks as Turkey pursues an uncompromising policy with the main goal of enforcing its control throughout the island.

“Whenever there is a question of resuming the negotiation process, Turkey and the puppet regime in the occupied territories demand that we recognize the so-called sovereign equality of the Turkish Cypriots and accept the solution of the two separate parts, that not only deviate from the UN parameters and the mandate of the General Secretary, but fall into the last category of ambitions to achieve the impossible, as President Anastasiades characteristically said ” Fotiou added.

The Commissioner also referred to Turkey’s mounting aggressive demands and said that Ankara is accusing Greece of an expansionist policy in the Aegean, trying to face international criticism against its own self-evident aspirations for a “Blue Homeland”.

In addition, he said, it threatens to invade Syrian territory beyond its expansionist ambitions for Libya and Iraq.

Fotiou recalled the letter that President Anastasiades recently sent to Turkish Cypriot leader Ersin Tatar in order to discuss confidence building measures, reduce tensions and resume negotiations for a solution to the Cyprus issue.

“In the context of our side’s efforts to find a way out of the impasse of the negative positions and approaches of the Turkish side, with this letter and the proposals of President Anastasiades, another attempt was made to repeat the negotiations in the interest of both communities, for peace and stability in the region” the Presidential Commissioner noted.

The Turkish side, through the Turkish occupation leader Ersin Tatar, rejected the initiative of President Anastasiades, reiterating once more the unacceptable positions of the Turkish side, he went on.

Fotiou referred to a teleconference, on May 9, attended by US Secretary of State Anthony Blinken, Foreign Minister of the Republic of Cyprus Ioannis Kasoulidis, Greek Foreign Minister Nikos Dendias and Israeli Foreign Minister Yair Lapid, where all four sides committed to promoting peace, stability and prosperity in the Eastern Mediterranean, as he pointed out. At the same time, he went on, they decided to intensify their cooperation in the fields of energy, economy, climate change, natural disasters and the fight against terrorism.

During his speech at the Conference, Fotiou made special reference to the issue of missing persons. “The families of the missing Cypriots continue, all these years, to carry on their shoulders the heavy cross of martyrdom for the disappearance of their loved ones” he said.

Unfortunately, he added “we are still facing the unacceptable behavior of Turkey, which not only does not cooperate as much as it should to determine the fate of all the missing, but, provocatively and unacceptably, continues to raise obstacles, essentially aiming at concealing its great guilt.

They refuse to provide information from Turkish army archives about mass graves of our people. They refuse to provide information about the other major war crimes committed, that of the relocation of remains from their original burial sites. Turkey’s responsibilities are enormous.”

Fotiou asked the International Community and the United Nations, the European Union, the United States and other countries, even after 48 years, to raise awareness and press Turkey to work together to resolve a humanitarian issue.

The Presidential Commissioner also addressed issues concerning Hellenism abroad, the prosperity of overseas communities and the promotion of their rights, as well as promoting the case for Cyprus.

As he underlined, the cooperation with the Greek government is valuable and Cypriot and Greek overseas organizations promote together actions. “Top priority of our strategy is the encouragement and active participation of expatriate youth which is the future of our diaspora. By investing in the new generation we are investing in the future of our diaspora. It is in this context that with concrete and innovative actions we try to keep young people closer, so that they know their culture, history, language, traditions and their roots” he concluded.

Source: Cyprus News Agency

Italian MP, Piero Fassino, the rapporteur of the subject “Call for return of Ammochostos to its lawful residents” in the Committee on Political Affairs and Democracy of the Parliamentary Assembly of the Council of Europe (PACE), is paying Cyprus a working visit during 5-8 June.

Fassino will be accompanied by the Secretary of the Committee, an announcement by the House of Representatives says.

During his visit to Cyprus, he will be received by House President, Annita Demetriou, and he is expected to meet with the heads or representatives of parliamentary parties, the President of the House Committee on Foreign and European Affairs, Harris Georgiades, the head and members of the Cypriot delegation to PACE, Nicos Tornaritis, Giorgos Loukaides and Christiana Erotocritou, as well as with Attorney General, Giorgos Savvides, the Minister of Foreign Affairs, Ioannis Kasoulides, and the Mayor and the Municipal Council of Ammochostos, in Deryneia.

Eventually, he will also attend meetings with the Special Representative of the UN in Cyprus, Colin Stewart, and the head of the European Commission in Cyprus, Myrto Zambartas, while a dinner with ambassadors of EU member-states is also in his schedule.

A PACE press release said that Fassino will also travel to the “northern part of the island” to meet in the Turkish-occupied areas with representatives of the Turkish Cypriot community and visit Varosha (part of Famagusta).

Cyprus has been divided since 1974, when Turkey invaded and occupied its northern third. Varosha, the fenced off section of the Turkish occupied town of Famagusta, is often described as a ‘ghost town’.

UN Security Council resolution 550 (1984) considers any attempts to settle any part of Varosha by people other than its inhabitants as inadmissible and calls for the transfer of this area to the administration of the UN. UN Security Council resolution 789 (1992) also urges that with a view to the implementation of resolution 550 (1984), the area at present under the control of the United Nations Peace-keeping Force in Cyprus be extended to include Varosha.

Turkish Cypriot leader, Ersin Tatar, announced in July 2021 a partial lifting of the military status in Varosha. On October 8, 2020, the Turkish side opened part of the fenced area of Varosha, following an announcement made in Ankara on October 6. Both the UN Secretary-General and the EU expressed concern, while the UN Security Council called for the reversal of this course of action. In his latest report to the Security Council, UN Secretary-General Guterres underlines the importance of adhering fully to UN resolutions, underscoring that the position of the United Nations on this matter “remains unchanged.”

On October 8, 2020, the Turkish side opened part of the fenced area of Varosha, following an announcement made in Ankara on October 6. Both the UN Secretary-General and the EU expressed concern, while the UN Security Council called for the reversal of this course of action.

Source: Cyprus News Agency

Cyprus is fully ready to handle cases of monkeypox, Minister of Health, Michalis Hadjipantela, said on Sunday, adding that tests will be conducted on the island if this is needed.

Asked if Cyprus is ready to face monkeypox cases, the Minister said that “we are all ready. Three to four days ago we had a suspected case that was handled in an excellent way in Nicosia General Hospital,” he added.

Replying to questions, Hadjipantela noted that there is an increase of monkeypox cases worldwide, but Cyprus is well prepared to address any such situation.

Moreover he said that if necessary, tests can be done in Cyprus and this happened with the suspected case for which a test was conducted at the Cyprus Institute of Neurology and Genetics.

Later on, the Health Ministry’s spokesperson, Constantinos Athanasiou, told CNA that the incident with a suspected rash, that was treated in Nicosia General Hospital, was a chickenpox case.

Athanasiou said that in the evening of June 1st a 31-year-old woman visited Larnaca General Hospital with a suspected rash.

He noted that all protocols were implemented and the suspected case was sent to Nicosia General Hospital, where it was treated. On Friday a sample was sent for tests and it was diagnosed as a chickenpox case, he added.

Meanwhile, asked about the health situation of the Minister of Labour, Zeta Emilianidou, who continues to be treated in a hospital in Athens, after suffering a cerebral aneurysm, the Health Minister said on Sunday that her condition remains critical.

Source: Cyprus News Agency

Environment Commissioner Klelia Vassiliou and Limassol Mayor, Nicos Nikolaides took part on Sunday in a clean-up campaign at Akti Olympion, in Cyprus’ southern coast, on the occasion of World Environment Day, underlining the need to protect the habitat.

Volunteers and personnel from the Office of the Commissioner and the Municipality, as well as young activists from eight different countries, brought together by “Youth for Climate” organisation, cleaned the stretch between Enaerios pier and Crowne Plaza hotel.

Young people fighting for climate change are fighting in fact for the preservation of humanity and the planet, Vassiliou said.

She pointed out that 300 thousand tons of garbage end up every year in the Mediterranean Sea, with a huge impact on marine life and people. The Environment Commissioner congratulated the Municipality of Limassol for being included recently in a program of 100 European cities, that will turn climate neutral by 2030.

Today we are making this symbolic gesture, as Limassol Municipality and as citizens, sending the message that the environment is a matter of concern for Cyprus and for Europe as a whole, Nicolaides said from his part.

Source: Cyprus News Agency

The Unfinished Famagusta Marathon 2022 took place on Sunday, with Cyprus Health Minister, Michalis Hadjipantela expressing the wish for the Turkish-occupied areas of Cyprus to be liberated.

The Marathon was organized by the Runners Department of the Famagusta Anorthosis Association and finished at Deryneia checkpoint.

“Today we sent the message that Famagusta has given us strength, during a hot day, to run for so many kilometers” the Health Minister said.

He called on everyone to get the message that “if we are united for a good cause we can achieve it, as we did today, managing to run for so many kilometers.”

On his part, Famagusta Mayor, Simos Ioannou, expressed hope that this will be the last Unfinished Marathon and the next one will finish at Famagusta stadium (GSE).

Cyprus has been divided since 1974, when Turkish troops invaded and occupied 37% of its territory.

Source: Cyprus News Agency