On March 30, 2021 Novartis reported that it has obtained exclusive worldwide rights to develop and commercialize therapeutic applications for a library of Fibroblast Activation Protein (FAP) targeting agents including FAPI-46 and FAPI-74, through an assignment agreement with iTheranostics, Inc., an affiliate of SOFIE Biosciences, Inc (Press release, Novartis, MAR 30, 2021, View Source [SID1234577323]). The FAP assets were originally developed at the University of Heidelberg. The agreement also includes co-exclusive rights for Novartis to develop imaging applications for these assets.

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Fibroblast activation protein (FAP) is a cell-surface protein expressed at low levels in most normal adult tissues, but over-expressed in common cancers, particularly on cancer-associated fibroblasts that form the tumor stroma, which is essential for growth1,2,3,4. High FAP expression on cancer-associated fibroblasts is generally associated with worse prognosis in solid tumors due to promotion of tumorigenesis and progression4,5,6,7.

"We continue to invest in radioligand therapy as one of the four unique platforms of Novartis Oncology. We believe working across multiple approaches is the key to reimagining cancer care," said Susanne Schaffert, PhD, President, Novartis Oncology. "FAP is an exciting target and these agents are a great fit with our radioligand therapy pipeline, which we are actively investigating across multiple tumor types. We believe this technology has the potential to transform many patients’ lives."

Targeted radioligand therapy is a type of precision medicine combining two key elements: a targeting compound, or ligand, and a radioactive isotope, causing DNA damage that inhibits tumor growth and replication. These targeted drugs bind to markers or proteins over-expressed by certain tumors, or tumor-associated tissue, such as stroma. Due to the high-affinity of these agents for specific tumor cells or associated tumor tissue, surrounding healthy tissue is less affected.

On March 30, 2021 The Cancer Research Institute (CRI), a nonprofit organization dedicated to the discovery and development of powerful immunotherapies for all cancers and RevImmune, Inc., a privately held biotech company focused on T-cell technology and development, reported the dosing of the first patient in a new study designed to assess the therapeutic benefit of interleukin-7 (IL-7) in cancer patients with COVID-19 (Press release, Cancer Research Institute, MAR 30, 2021, View Source [SID1234577321]). This stems from a new understanding that patients with severe COVID-19 have low levels of T cells and exhausted T cells, and these patients benefit from therapies that focus on augmenting the cellular immune response, rather than solely therapies that dampen the immune system.

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The Phase 2 multi-center clinical trial called "ILIAD-7-US-O" will evaluate the clinical benefit of RevImmune’s product candidate CYT107 in approximately 48 patients living with cancer. CYT107 is a therapeutic form of the master growth factor for human T cells, IL-7, and this is the first study to test an IL-7 drug specifically in people with cancer who also have COVID-19. The clinical trial is funded by CRI’s Clinical Accelerator, a program that supports and coordinates early-phase clinical trials of promising immuno-oncology combination therapies.

"This partnership allows CRI to apply RevImmune’s promising IL-7 agent in a novel setting of patients with both cancer and COVID-19, potentially offering a way to strengthen the immune system’s ability to fend off the SARS-CoV-2 coronavirus, mitigate symptoms of COVID-19, and improve overall outcomes for people living with cancer and COVID," said Jay Campbell, managing director of CRI’s Venture Fund and Anna-Maria Kellen Clinical Accelerator.

Common cancer treatment regimens can compromise a patient’s immune system, including reductions in lymphocyte counts, such as T cells, a condition known as lymphopenia. Similarly, COVID-19 can lead to dysregulation of the adaptive immune system, which can also result in patients becoming lymphopenic. The profound and protracted lymphopenia experienced in COVID-19 patients has been correlated with increased secondary infections and death. Furthermore, surviving lymphocytes have severely impaired anti-viral function and are exhausted, ultimately resulting in immune system collapse.

IL-7 has been shown to provide a rapid and durable restoration of functional immune cells, predominantly CD4+ and CD8+ T cells, which are able to fight the primary viral infection and secondary infections. In previous clinical studies, CYT107 has demonstrated the ability to quickly restore immune function, such as increasing the number and diversity of T cells in patients, including those with low and exhausted T cell levels. CYT107 has been shown to be safe and well-tolerated and patients experienced durable long-lasting responses.

Researchers involved in the ILIAD-7 study hope CYT107 will provide the same benefit to cancer patients with COVID-19, with the aim of reducing risk of progressing to severe stages of COVID-19.

"The medical community has learned a great deal about COVID-19 as a disease this past year and has come to realize that patients who develop severe COVID-19 symptoms have impaired immune systems, including exhausted and depleted T-cells," said Michel Morre, D.V.M., M.Sc., chief scientific officer at RevImmune. "Therapies like IL-7 reinvigorate and expand the cellular immune response to the infection, and we are excited for the opportunity to continue to follow the science and evaluate a potential treatment option for those affected by both COVID-19 and cancer."

About the ILIAD-7-US-O Study
The ILIAD-7-US-O study tests RevImmune’s recombinant interleukin-7 product, CYT107, on patients with cancer and lymphopenic (with low lymphocyte counts) COVID-19. The trial aims to compare the effects of CYT107 versus placebo at producing immune reconstitution by restoring lymphocyte function and increasing lymphocyte proliferation in oncology patients, where their cancer is being or has been treated with standard of care therapies. The trial hopes to observe a possible clinical improvement as patients with restored lymphocyte counts should better eliminate invading pathogens such as SARS-CoV-2. Approximately 48 patients will be randomized 1:1 to receive either CYT107 or placebo at two trial sites: Memorial Sloan Kettering Cancer Center in New York City and The University of Texas MD Anderson Cancer Center in Houston, Texas, with Stephen Pastores, M.D., and Cristina Gutierrez, M.D., as Principal Investigators, respectively. The clinical trial is funded by the CRI Anna-Maria Kellen Clinical Accelerator, a program that supports and coordinates early-phase clinical trials of promising immuno-oncology combination therapies.

On March 30, 2021 Selvita (WSE: SLV), one of the largest preclinical contract research organizations in Europe, reported today EUR 31.8 million of consolidated revenues which constitutes a 35% increase compared to the values reported a year ago (Press release, Selvita, MAR 30, 2021, View Source;utm_medium=rss&utm_campaign=breakthrough-year-in-the-development-of-selvita-strategic-acquisition-strong-financial-results [SID1234577320]). The Company’s EBITDA result and net profit in 2020 amounted to, respectively, EUR 7.4 million and EUR 4.5 million, comparing to EUR 5.8 million and EUR 3.3 million for a corresponding period last year. The acquisition of Croatian contract research organization Fidelta from Galapagos which took place at the turn of 2020/2021 strengthens Selvita’s position as one of the largest preclinical contract research organizations in Europe.

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Strong financial results

Commercial revenues in the Services Segment increased in 2020 to EUR 25.5 million, showing a 35% increase, compared to EUR 19.6 million in the last year. The EBITDA result of the Services Segment amounted to EUR 6.3 million, which indicates a 23% profitability.

Selvita’s Bioinformatics segment – Ardigen S.A. – reported dynamic development as shown by a 69% y/y increase in commercial revenues up to EUR 4.0 million. The Company’s EBITDA result in 2020 amounted to EUR 1.1 million, an increase of 128% y/y, indicating a 23.6% margin.

In 2020 Selvita focused on expanding its international sales. Revenues from the services originated from the most significant market i.e. commissioned by the customers from the United States, increased by 133% y/y and already constitute nearly 30% of the entire Services Segment revenues. Simultaneously, revenues from the services commissioned by customers from the United Kingdom increased by 42% y/y. Increasing customer recognition related to the high quality of services offered and competent scientists, strengthens Selvita’s position on the largest global biotechnology markets and results in further contracts.

Year 2020 was the first full year where Selvita operated as an independent, purely Contract Research Organization, following the corporate split in October 2019, which was crucial for the Company’s further development. We maintained a high growth rate and achieved very good financial results. In spring, we announced a new development strategy and raised the capital from investors, thanks to which we continue our dynamic organic growth, as well as we initiated the development through acquisitions. The most significant event in our nearly 14-year history occurred at the turn of the year when Selvita acquired Fidelta, a Croatian CRO. This acquisition was a true milestone for our business scale and services portfolio. Our current achievements only motivate us to work further, we are not slowing down and we are looking into the future with optimism – comments Boguslaw Sieczkowski, Chief Executive Officer at Selvita.

Thanks to the teamwork, we consistently strengthen our position among customers. Our employees’ dedication and responsible attitude, allowed us to achieve such good results despite all turbulences caused by the COVID-19 pandemic. Every single person working at Selvita has a significant impact on the Company’s successes – adds Boguslaw Sieczkowski.

Towards further development

In 2020 Selvita consequently realized its strategic goals set up after the corporate split. In the first half of the year, the Company announced a new development strategy for 2020-2023 which assumed further organic growth supported with acquisitions. Selvita successfully raised EUR 20 million from the issue of C series shares and consistently increased its scale of business, hiring world-class specialists, expanding its services portfolio, and investing in technology and state-of-the-art equipment.

One of the key elements of the development strategy is securing own research space, through building Selvita Research Center, that will provide 4000 m2 of own research space necessary for further growth. The Company has already made the first step towards executing this goal and in August 2020 it has signed a contract to purchase a plot of land in the neighborhood of its current laboratories, as well as raised the funding for the investment which includes a EUR 9.3 million grant and a bank loan.

A breakthrough milestone in Selvita’s history – international acquisition

In the fourth quarter of 2020, Selvita announced the acquisition of a Croatian CRO company Fidelta. The transaction valued at EUR 31.2 million was finalized in January 2021. The scope of services provided by Fidelta will extend Selvita’s offer in the area of pharmacology in vivo and toxicology, as well as will increase its scale of operations within DMPK, medicinal chemistry, and in vitro pharmacology. Fidelta brings in also expertise in areas such as infectious diseases, inflammation, and fibrosis. As a result of the acquisition, Selvita gained over 150 highly experienced scientists with a track record of providing integrated drug discovery services to the largest global biotech and pharmaceutical companies, over many years. This historic step in Selvita’s development results in a significant expansion of its scope of services as well as revenue growth.

Last year had a strategic meaning in Selvita’s development, which managed to almost double in business scale thanks to organic growth and the acquisition. Simultaneously, Selvita’s stock price increased by 110%. The increase in Company’s valuation was also continued in Q1 2021. As a result of strengthening its position on the capital market, Selvita was promoted to the mWIG40 index, which gathers 40 leading mid-cap companies listed on the Warsaw Stock Exchange.

Moreover, in recognition of the Company’s performance, Selvita was named the Stock Company of the Year in the competition organized by "Puls Biznesu" – one of the largest business daily in Poland. Selvita also won in two other categories: "The Board Competencies" and "Development Perspectives."

* All % were calculated as compared to results denominated in Polish zloty

On March 30, 2021 Immunovia reported improved performance of its blood based IMMray PanCan-d biomarker signature together with CA 19-9, in a clinical retrospective study (Press release, Immunovia, MAR 30, 2021, View Source [SID1234577294]). The study was designed to evaluate detection of early stage pancreatic cancer in high risk patients with non-specific but concerning symptoms. The study data demonstrate that Immunovia’s test now detects pancreatic cancers (all stages) with 92% specificity and 81% sensitivity for this cohort, which is equivalent to results presented in the previous Commercial Test Model Study (link to PR). Importantly, early stage PDAC I/II were detected with specificity of 92% and sensitivity of 80%. The improved test performance was demonstrated in a combined samples cohort of newly collected samples and samples from the Clinical Verification study. In total 433 samples of which 202 were PDACs whereof 89 PDAC stage I/II and 231 symptomatic controls were analyzed. These samples have been freshly collected from 7 sites in the US and Europe: Beth Israel Deaconess Medical Center, University of Pittsburgh Medical Center, Pancreatic Cancer Center at NYU Langone’s Perlmutter Cancer Center in the US; University College London in the UK; Sahlgrenska University Hospital in Sweden; and University Hospital Erlangen in Germany; and Ramón y Cajal University Hospital, IRYCIS, CIBERONC in Spain.

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Linda Mellby, PhD, VP R&D Immunovia commented: "Detecting pancreatic cancer as early as possible in high risk symptomatic patients is a challenging but extremely important achievement that will support clinicians in providing accelerated and correct diagnosis to the patients. We are very excited to report 92% specificity and 80 % sensitivity for detecting early stage pancreatic cancer in this risk group of patients."

Patrik Dahlen, CEO, Immunovia added: " These results demonstrate great performance for detection of early stage pancreatic cancer in symptomatic cohorts, and they further confirm the commercialization strategy for this important risk group of patients. The market size for the symptomatic risk group is 1-2 million patients in USA and Europe. Our test is designed to help clinicians find the cancer at a treatable stage and thus help the patients live longer."

Webcasted teleconference

These results will be presented Tuesday March 30, 2021, in a webcasted teleconference at 16.30 (CET).

Presenters: Thomas King, MD, PhD, Linda Mellby, PhD, Patrik Dahlen CEO, Immunovia

The presentations will be followed by a Q&A session. The webcasted teleconference will be held in English.

On March 30, 2021 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported that a Phase 3 confirmatory trial of XOSPATA (gilteritinib) in patients with relapsed (disease that has returned) or refractory (resistant to treatment) FLT3 mutation-positive (FLT3mut+) acute myeloid leukemia (AML) met its primary endpoint of overall survival (OS) compared to chemotherapy at a planned interim analysis (Press release, Astellas, MAR 30, 2021, View Source [SID1234577280]).

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COMMODORE is an open-label, randomized study of gilteritinib versus salvage chemotherapy in adult patients who have relapsed or refractory AML in China and other countries. Astellas has stopped enrollment in the trial and patients in the chemotherapy arm will be offered the opportunity to receive gilteritinib.

Earlier this year, the China National Medical Products Administration (NMPA) granted conditional approval to gilteritinib for the treatment of adult patients who have relapsed or refractory AML with a FLT3 mutation detected by a fully validated test. Approval was granted under an expedited pathway, following NMPA’s acceptance of gilteritinib for priority review in July 20201 and its inclusion in the third batch of overseas new drugs urgently needed in clinical settings in November 2020.2

Astellas plans to submit results of COMMODORE to the NMPA in support of full approval. Detailed results will also be submitted to a peer-reviewed journal and/or scientific congress.

"In COMMODORE, patients receiving gilteritinib lived longer than those receiving salvage chemotherapy, confirming the overall survival benefit seen in the Phase 3 ADMIRAL trial," said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Global Therapeutic Area Head, Oncology Development. "For these patients, who have limited treatment options, the new findings provide additional evidence supporting gilteritinib as a treatment option."

AML is a cancer that impacts the blood and bone marrow,3 and its incidence increases with age.4 It is one of the most common types of leukemia in adults.5 Every year, it is estimated that more than 85,000 people in China are diagnosed with leukemia.6

In previous clinical trials, the safety of gilteritinib was evaluated in 319 patients with relapsed or refractory AML who had received at least one dose of 120 mg gilteritinib daily.7 The most frequent all-grade adverse reactions (frequency ≥ 10%) with gilteritinib were alanine aminotransferase (ALT) increased (25.4%), aspartate aminotransferase (AST) increased (24.5%), anemia (20.1%), thrombocytopenia (13.5%), febrile neutropenia (12.5%), platelet count decreased (12.2%), diarrhea (12.2%), nausea (11.3%), blood alkaline phosphatase increased (11%), fatigue (10.3%), white blood cell count decreased (10%), and blood creatine phosphokinase increased (10%). One fatal adverse reaction of differentiation syndrome occurred in patients receiving gilteritinib. The most frequent (frequency ≥3%) serious adverse reactions were febrile neutropenia (7.5%), ALT increased (3.4%), and AST increased (3.1%). Other clinically significant serious adverse reactions included electrocardiogram QT prolonged (0.9%) and posterior reversible encephalopathy syndrome (0.3%).