On January 31, 2022 Semmelweis University and AstraZeneca it’s Hungarian subsidiary reported that they have signed a strategic cooperation agreement to further investigate the links between certain common diseases, such as diabetes, chronic kidney disease (CKD) and heart failure, to strengthen and expand joint research and development activities, and to implement joint programmes to help treat, educate and diagnose patients (Press release, Semmelweis University, JAN 31, 2022, View Source [SID1234607513]). A framework agreement for clinical trials was also signed at the event, which will allow for faster and more efficient trial start-ups.

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„Today, an agreement is being signed between AstraZeneca, one of the world’s leading biotechnology pharmaceutical companies, which also has a dominant market position in Hungary, and Semmelweis University, the leading medical and health sciences higher education institution of the Central European region. What we certainly have in common is a commitment to research and development and a dedication to providing patients with better and more innovative therapies," highlighted Dr. Béla Merkely, rector of Semmelweis University on signing the strategic partnership cooperation agreement. „This cooperation will allow us to increase our joint research and development activities in the fields of oncology, cardiology, diabetology, nephrology and other areas of internal medicine. As a first step, a complex program on chronic kidney disease (CKD) could be implemented in collaboration with our Department of Family Medicine," the rector explained, adding that CKD is an under-diagnosed condition which can increase the risk of cardiovascular damage many times over.

Semmelweis University and AstraZeneca also signed a framework agreement for clinical trials. „This will enable the contracting of individual clinical trials, and thus the launching of trials and the involvement of patients, to be faster and more efficient. Currently, Semmelweis University takes part in two-thirds of AstraZeneca’s Hungarian trials, but our aim is to increase this to over 80 percent," Dr. Béla Merkely emphasized. The rector also pointed out that one of the university’s strategic objectives is to increase clinical research activity by building strategic partnerships with the pharmaceutical industry. This allows patients to have access to the most innovative therapeutic options as soon as possible, and increases scientific performance as well, which contributes to moving up the rankings.

Kuuno Vaher, AstraZeneca’s Cluster Country Director of Central Europe reminded that the company’s main therapeutic areas are oncology, cardiovascular diseases, renal and metabolic diseases, respiratory diseases and immunology. "We know a lot more about these diseases by now, but the implementation of these new information is becoming more challenging – more and more aspects need to be taken into account in treatment," Kuuno Vaher said. „This is why an important part of the company’s partnerships in different countries, including now Hungary, is to look at how to improve the organisation of healthcare and how to use digitalisation, to enable doctors making better healthcare decisions based on all the available data. Basically, there are four pillars of collaboration: diagnostics, screening, education and analyzing the accumulated data, to see if what we are doing is really improving patients’ lives. For example, it is not enough to know how many people are utilizing a certain medicine; we also need to see if an innovation is having a real impact on patients’ outcome," Kuuno Vaher pointed out.

Dr. Mátyás Faluvégi, Managing Director of AstraZeneca’s Research Division, explained that the framework agreement on clinical trials is based on the fact that Semmelweis University has an optimal background for conducting such trials. In the last three years, a total of 855 clinical trials have been conducted in Hungary, out of which AstraZeneca owned 49 projects, and the university was involved in 31. „A large number of cardiovascular and pulmonary trials are already taking place at Semmelweis, so our aim is to launch more oncology trials in the coming years," the managing director said. „By signing the agreement, we would like to accelerate the start-up of trials in the short term, and our long-term goal is to strengthen AstraZeneca’s presence not only at the university, but throughout Hungary," he added.

Dr. Péter Ferdinandy, Vice-Rector for Science and Innovation of Semmelweis University, thanked the Clinical Research Coordination Center led by Dr. János Filakovszky for the work done in the preparation of the agreement. He then expressed hope that the cooperation will further increase the number of clinical trials, which could be a first step towards the joint development of new therapies, as well as the creation of shared intellectual property and a broader boost to scientific cooperation.

The strategic cooperation agreement and the framework agreement on clinical trials were signed by Rector Béla Merkely and Chancellor Lívia Pavlik on behalf of Semmelweis University, while the former document was signed by Cluster Director Kuuno Vaher on behalf of AstraZeneca and the latter by Managing Director Mátyás Faluvégi.

On January 31, 2022 Tollys, a biopharmaceutical company developing the first anti-cancer immunotherapy based on a synthetic Toll-Like Receptor 3 (TLR3) specific agonist, reported that it has renewed and extended its research collaboration started in 2020 with a global pharmaceutical company, a leader in immuno-oncology (Press release, Tollys, JAN 31, 2022, View Source [SID1234607500]). The company also announces the acceleration and expansion of its R&D platform in the fields of TLR3 agonist candidates for intravenous administration and Antibody-Drug-Conjugates (ADC, or AOC for Antibody-Oligonucleotide-Conjugates).

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Based on the strong preclinical data collected to date with locally administered TL-532, Tollys is also accelerating and expanding its internal and collaborative R&D activities on TLR3 agonist candidates designed for intravenous administration and antibody-drug-conjugates. Tollys is thus running several parallel preclinical programs using different vectorization and targeting methods for its TLR3 agonist candidate(s). According to Tollys, TL-532 is the first chemically conjugable specific TLR3 agonist usable as a payload with antibodies and other carriers.

This acceleration in the development of candidates for intravenous administration is in line with the recommendations of the international board of the European oncology innovation acceleration program MATWIN which awarded Tollys TLR3 agonist the status of ‘best-in-class innovation of the year’ in May 2021.

"Our renewed and extended pharma collaboration is further confirmation of the potential of specific TLR3 agonists. We are also very excited to advance our R&D programs for the selection of candidates for intravenous administration; we estimate that a lot more patients could benefit from treatment with TLR3 agonists, if administered intravenously rather than locally," said Vincent Charlon, CEO of Tollys.

About TL-532
TL-532 is the first synthetic specific TLR3 agonist with a proprietary defined double-stranded RNA sequence. As such, TL-532 has the potential to be the best-in-class and first-to-market TLR3 agonist. TL-532 was shown to have a triple mechanism of action inducing 1) death by apoptosis selective to cancer cells-not in normal cells, leading to the in-situ release of tumor specific antigens, 2) activation of the myeloid dendritic cells of the immune system to mount a specific T-cell response against the tumor antigens and 3) switch of the tumor microenvironment, by producing cytokines and chemokines which prevent tumor development. The result is the immunogenic cell death of tumor cells, together with an autovaccination preventing the recurrence of cancer.

On January 31, 2022 NEC reported that Consolidated Financial Results for the Nine-month Period Ended
December 31, 2021 (April 1, 2021 – December 31, 2021) (Press release, NEC, JAN 31, 2022, View Source [SID1234607499])

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1. Consolidated Financial Results for the Nine-month Period Ended December 31, 2021

(1) Consolidated Operating Results
(2) Consolidated Financial Position

2. Dividends

3. Consolidated Financial Results Forecast for the Year Ending March 31, 2022 (April 1, 2021 – March 31, 2022)

This consolidated financial results falls outside the scope of quarterly review procedures to be performed by certified public accountants or an audit firm.

*Explanation concerning the appropriate use of the financial results forecast and other special matters
(Adjusted profit (loss))
"Adjusted operating profit (loss)" is an indicator for measuring underlying profitability in order to clarify the contribution of acquired companies to the NEC Group’s overall earnings. It is measured by deducting amortization of intangible assets recognized as a result of M&A and expenses for acquisition of companies (financial advisory fees and other fees) from operating profit (loss). Also, "Adjusted net profit (loss) attributable to owners of the parent" is an indicator for measuring underlying profitability attributable to owners of the parent. It is measured by deducting adjustment items of operating profit (loss) and corresponding amounts of tax and non-controlling interests from net profit (loss) attributable to owners of the parent.

On January 31, 2022 Patrys reported its Quarterly Activities Report and 4C Quarterly Cash Flow Report (Press release, Patrys, JAN 31, 2022, View Source [SID1234607498]).

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Standout achievements for this Quarter have included:

PAT-DX3 manufacturing development program significantly ahead of schedule;
Non-clinical studies further define biological and pharmaceutical profile of PAT-DX3 deoxymab and potential use for expanded clinical applications;
Business development momentum;
Rodent, non-GLP toxicology studies confirm an acceptable safety and tolerability profile for PAT-DX1; and,
Balance sheet capacity with closing cash balance of $10.76M at 31 Dec 2021, with an additional $2M in short-term investments.

On January 30, 2022 Akeso, Inc. (9926.HK) reported that the first patient was dosed in a Phase III registrational clinical trial of the Company’s novel immuno-oncology drug, Ivonescimab (PD-1/VEGF bi-specific antibody, AK112), combined with chemotherapy versus placebo combined with chemotherapy for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (nsq-NSCLC) with EGFR mutation failed after EGFR-TKI treatment (Press release, Akeso Biopharma, JAN 30, 2022, View Source [SID1234607496]).

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This clinical trial is the world’s first bi-specific antibody for the Phase III clinical trial of EGFR-TKI resistant NSCLC, and is also an important development of Ivonescimab in the field of lung cancer.

This clinical trial is a randomized, double-blind, multi-center Phase III clinical study with approximately 320 Chinese subjects planned to be enrolled. The purpose of the study is to evaluate the efficacy and safety of Ivonescimab combined with pemetrexed + carboplatin and placebo combined with pemetrexed + carboplatin in the treatment of patients with advanced nsq-NSCLC resistant to EGFR-TKI. The primary endpoint of the study is progression-free survival (PFS) assessed by IRRC.

Lung cancer is a common malignant tumor with high incidence and high mortality in the world, with the number of new lung cancer cases in the world exceeding 2,200,000 in 2020, and the number of new cases in China exceeding 810,000. By type, NSCLC accounts for about 85% of lung cancer, of which about 75% is non-squamous cell NSCLC, and about 70% of NSCLC patients are diagnosed at an advanced stage (Phase IIIB/IV).

For patients with EGFR mutation or ALK fusion mutation-positive NSCLC, although targeted therapy is a first-line standard therapy, issue of drug resistance has become increasingly prominent, and if resistant to targeted therapy, platinum-based chemotherapy remains the most important treatment method, and the existing treatment options cannot effectively meet clinical needs.

”Immunotherapy + anti-angiogenesis” has proven its combined advantages in several worldrenowned studies. As anti-angiogenic therapy can normalize tumor blood vessels and make the tumor microenvironment more suitable for immunotherapy, Immunosuppressants combined with anti-angiogenic drugs has a synergistic anti-tumor effect. This combination is widely appreciated. Lung cancer treatment is the main exploration direction of the above combination therapy; The ”immune + anti-angiogenesis” combination therapy under development in the world for first-line and later-line treatment of NSCLC has shown promising anti-tumor activity and clinical application prospects.

Ivonescimab also has the effect of stimulating antitumor immune responses and inhibiting tumor angiogenesis. Because of the immunosuppressive effect of the overexpressed VEGF in the tumor microenvironment, if a bi-specific antibody can be used to block both PD-1 and VEGF, theoretically the synergistic anti-tumor effect of anti-PD-1 antibody and anti-VEGF antibody can be realized. As a result, Ivonescimab with chemotherapy for the treatment of EGFR-TKI resistant NSCLC is expected to achieve better clinical efficacy and safety than other therapies.

In a number of early clinical studies in Australia and China, Ivonescimab has demonstrated good safety and tolerability in the treatment of various types of lung cancer, including NSCLC and small cell lung cancer (SCLC), with excellent anti-tumor effects. In addition to this study, Ivonescimab’s Phase III clinical trial for the first-line treatment of PD-L1positive NSCLC and Ivonescimab’s Phase III clinical trial for the first-line treatment of extensive SCLC will commence soon. The Phase Ib/II clinical study of Cadonilimab (PD-1/ CTLA-4 bi-specific antibody, AK104) plus Ivonescimab and/or in combination with chemotherapy for the treatment of advanced non-small cell lung cancer (NSCLC) has also been carried out successively.