On June 20, 2022 AOP Health reported the final results on Ropeginterferon alfa-2b in patients with Polycythaemia Vera (PV) from its CONTINUATION-PV study in an oral presentation at the prestigious EHA (Free EHA Whitepaper) (European Hematology Association) 2022 Annual Meeting by Professor Heinz Gisslinger, Medical University of Vienna, Austria 1 (Press release, AOP Health, JUN 20, 2022, View Source;up-to-7.5-Years-Treatment-With-BESREMi%C2%AE-Ropeginterferon-alfa-2b-of-Polycythaemia-Vera-Patients—at-EHA-2022-Annual-Meeting [SID1234616105]).

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Link to abstract

Ropeginterferon alfa-2b is a long-acting, mono-pegylated proline interferon (ATC L03AB15). It is administered once every 2 weeks initially, or up to monthly after stabilization of hematological parameters.

AOP Health has been conducting a pivotal clinical development program, including the studies PEGINVERA, PROUD-PV and CONTINUATION-PV. The latter is an open-label, multicenter, phase IIIb study assessing the long-term efficacy and safety of Ropeginterferon alfa-2b versus hydroxyurea (HU) or best available treatment (BAT) in patients with PV who previously participated in the PROUD-PV study.

The clinical development program conducted by AOP Health in Europe since 2010, led to marketing authorizations of BESREMi for the treatment of PV, first granted by the European Commission in 2019, thereafter by Switzerland, Liechtenstein, Israel, Taiwan, Korea and most recently by the US FDA in November 2021.

The presentation during the EHA (Free EHA Whitepaper) 2022 Annual Meeting focused on patient-relevant outcomes after this long-term (up to 7.5 years) treatment:

Symptoms/Quality of Life: only a minority of patients (15.7%) treated with Ropeginterferon alfa-2b experienced disease related symptoms, and less than 2 out of 10 patients had to undergo phlebotomy to maintain hematocrit levels during their last year of treatment.

Disease modification: Besides that, treatment with Ropeginterferon alfa-2b led to reduction of the disease-causing mutated JAK2 allele burden below 1% in a sizeable proportion of patients (>20%). Most importantly, event-free survival, with events defined as death, thrombosis, or disease progression over the entire 7.5 years treatment period, was significantly better in the Ropeginterferon alfa-2b group with only 5 of 95 patients experiencing an event, whereas in the control group such an event was observed in 12 of 74 patients (p=0.04).

"The results of CONTI-PV after 7.5 years of treatment provide further evidence of the value of BESREMi for patients suffering from PV. We are very proud that our work not only delivered the first interferon with regulatory approval for any of the Myeloproliferative Neoplasms, but also contributed to a change of treatment paradigm in PV", says Dr. Christoph Klade, Chief Scientific Officer of AOP Health.

Professor Jean-Jacques Kiladjian from Paris, senior author of the paper adds: "Since its first approval in Europe in 2019, Ropeginterferon alfa-2b has become the first line therapy of choice for many PV patients. The striking JAK2 molecular response and the extremely low rate of disease progression and thrombosis suggest that Ropeginterferon alfa-2b might be the best available treatment option for disease modification, which may translate into improved survival and even the chance to stop treatment for some patients."

1 Ropeginterferon alpha-2b achieves patient-specific treatment goals in Polycythaemia Vera: final results from the PROUD-PV/CONTINUATION-PV studies. Heinz Gisslinger, Christoph Klade, Pencho Georgiev, Dorota Krochmalczyk, Liana Gercheva-Kyuchukova, Miklos Egyed, Petr Dulicek, Arpad Illes, Halyna Pylypenko, Lylia Sivcheva, Jiří Mayer, Vera Yablokova, Kurt Krejcy, Victoria Empson, Hans C. Hasselbalch, Robert Kralovics, and Jean-Jacques Kiladjian for the PROUD-PV Study Group, European Hematology Association (EHA) (Free EHA Whitepaper) EHA (Free EHA Whitepaper), 27th Annual Meeting June 2022

About BESREMi

BESREMi is a long-acting, mono-pegylated proline interferon (ATC L03AB15). Its unique pharmacokinetic properties offer a new level of tolerability. BESREMi is designed to be conveniently self-administered subcutaneously with a pen once every two weeks, or up to monthly after stabilization of hematological parameters. This treatment schedule is expected to lead to overall better safety, tolerability and adherence compared to conventional pegylated interferons.

For the EMA Summary of Product Characteristics please visit: BESREMi

Ropeginterferon alfa-2b was discovered by PharmaEssentia, a long-term partner of AOP Health. In 2009, AOP Health in-licensed the exclusive rights for clinical development and commercialization of Ropeginterferon alfa-2b in PV and other MPNs such as chronic myelogenous leukemia (CML) for European, Commonwealth of Independent States (CIS), and Middle Eastern markets.

About Polycythaemia Vera

Polycythaemia Vera (PV) is a rare cancer of the blood-building stem cells in the bone marrow resulting in a chronic increase of red blood cells, white blood cells and platelets. This condition increases the risk for circulatory disorders such as thrombosis and embolism, its symptoms lead to a reduced quality of life and on the long run may progress to myelofibrosis or transform to leukemia. While the molecular mechanism underlying PV is still subject of intense research, current results point to blood-building stem cells in the bone marrow with a set of acquired mutations, the most important being a mutant form of JAK2 that make up the malignant clone.

Important PV treatment goals are to achieve healthy blood counts (hematocrit below 45%), improve quality of life and to slow or delay the progression of disease.

On June 20, 2022 XOMA Corporation (Nasdaq: XOMA) ("XOMA" or the "Company") reported its Board of Directors has authorized the following cash dividends to holders of XOMA’s Series A and Series B Cumulative Preferred Stock (Press release, Xoma, JUN 20, 2022, View Source [SID1234616104]):

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Holders of the 8.625% Series A Cumulative Perpetual Preferred Stock (Nasdaq: XOMAP) shall receive a cash dividend equal to $0.53906 per share.

Holders of depositary shares, each representing 1/1000 of a share of XOMA’s 8.375% Series B Cumulative Perpetual Preferred Stock (Nasdaq: XOMAO), shall receive a cash dividend equal to $0.52344 per depositary share.

The preferred dividends will be paid on or about July 15, 2022, to respective holders of record at the close of business on July 1, 2022.

On June 20, 2022 XBiotech Inc. (NASDAQ: XBIT) reported it successfully completed the Phase I portion of its 1-BETTER study, a Phase I/II randomized, double-blind, placebo-controlled clinical study to evaluate its anti-cancer drug Natrunix in combination with chemotherapy for treating pancreatic cancer (Press release, XBiotech, JUN 20, 2022, View Source [SID1234616103]). Enrollment in the Phase II portion is commencing immediately.

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Thirty leading cancer centers across the United States are involved in the Phase I/II study. Pancreatic cancer is the 4th leading cause of cancer death in the United States and the incidence has been increasing steadily since 2000. In 2022 about 50,000 people will die from pancreatic cancer in the United States. The Natrunix antibody therapy represents a groundbreaking approach to therapy—with the aim to of reducing treatment related toxicity of chemotherapy while also blocking the tumor-associated signals that spurn growth and spread of tumors.

The key is Natrunix’s ability to specifically target the body’s response to injury. Chemotherapy and tumors both elicit an injury response from the body, and this response may counteract some of the beneficial effects of therapy while at the same time cause substantial morbidity. This injury response plays a crucial role in the growth, spread and morbidity of cancer. Natrunix targets this common pathway activated by cytotoxic therapy and paraneoplastic inflammation. Used in combination with chemotherapy, Natrunix is therefore being assessed for its ability to reduce the side effects of chemotherapy treatment and mediate anti-tumor effects.

The Phase I study enrolled patients in three groups, using escalating dose levels of Natrunix. Subjects received the maximum dosing of Natrunix without a single report of "possibly, probably, or definitely related dose limiting toxicity (DLT)" associated with the investigational agent. Subjects received two 14-day cycles of Natrunix in combination with the chemotherapy drugs Onivyde, 5-fluorouracil and leucovorin. At the discretion of the treating oncologist, after completing the two 14-day cycles, patients were allowed to continue to receive Natrunix if they were deemed to be potentially benefiting from the investigational agent. All patients in the highest dose group have continued to receive Natrunix; at this time a total of 14 additional cycles of therapy have been administered to the Phase I subjects.

Dr. David Park, Medical Director, Hematology, Medical Oncology, St Jude Crosson Cancer Institute, Providence OC Cancer Institute stated, "Natrunix has shown to be well-tolerated when administered concurrently with chemotherapy. We are seeing early encouraging signs that this investigational agent may have a salutary effect in patients via its action in the inflammatory pathway(s)."

The Phase II portion of the study is commencing immediately. Key endpoints in the Phase II portion will be progression-free survival, overall survival and time-to-treatment-failure. The Phase II portion is enrolling 60 subjects that will be randomized on a 1:1 basis to receive either Natrunix in combination with ONIVYDE+LV+5-FU (Arm 1), or placebo plus the chemotherapy combination. Subjects will receive the treatment for up to 12 cycles and will be allowed to continue to receive Natrunix if they were deemed to be potentially benefiting from the investigational agent.

About Natrunix
Natrunix is a True Human antibody that was discovered, developed and manufactured by XBiotech. True Human antibodies are derived—without modification—from individuals who possess natural immunity to certain diseases. In many individuals, the body naturally produces antibodies to block pathological inflammation associated with interleukin-1, one of the most extensively studied inflammatory pathways in medicine. Other marketed biological drugs attempt to treat diseases by blocking interleukin-1, however none specifically and exclusively target interleukin-1 alpha (IL-1a). There is also no other marketed monoclonal antibody therapy derived unaltered from a natural human immune response.

On June 20, 2022 Veracyte, Inc. (Nasdaq: VCYT) reported that findings from a new meta-analysis provide real-world evidence that the Afirma Genomic Sequencing Classifier (GSC) can accurately rule out thyroid cancer in patients with indeterminate thyroid nodules and that, when the test deems a nodule as suspicious, the patient’s risk of malignancy is consistent, and higher than that reported in the test’s original clinical validation (CV) study (Press release, Veracyte, JUN 20, 2022, View Source [SID1234616102]). The findings were presented for the first time at the ENDO 2022 Annual Conference (Poster LBSAT255).

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"The Afirma GSC’s clinical validation study provided high-quality evidence of our test’s ability to rule out malignancy in indeterminate thyroid nodules to help these patients avoid unnecessary surgery. Our new findings show that the real-world experience supports this data, further demonstrating that the likelihood of malignancy in Afirma GSC-suspicious nodules is even greater than what was reported in the validation study," said Joshua Klopper, M.D., Veracyte’s medical director for endocrinology and an author on the study.

In the new meta-analysis, researchers evaluated 13 independent studies and found that the Afirma GSC’s real-world ability to identify benign nodules with high sensitivity and high negative predictive value for thyroid cancer was similar to the CV study results (97 percent vs. 91 percent and 99 percent vs. 96 percent, respectively). Additionally, the meta-analysis data show that the Afirma test’s real-world performance surpasses that shown in the CV study when predicting the risk of malignancy in nodules labeled suspicious (65 percent positive predictive value vs. 47 percent).

Veracyte estimates that each year approximately 565,000 people undergo fine-needle aspiration (FNA) biopsy evaluation for potentially cancerous thyroid nodules and that more than 110,000 of these patients receive indeterminate results – meaning their nodules are not clearly benign or malignant based on traditional cytopathology evaluation. Historically, most of these patients were directed to diagnostic surgery, even though 70 percent to 80 percent of the time, the nodules proved to be benign. Current American Thyroid Association guidelines include molecular testing as a recommended option to achieve definitive diagnosis for nodules classified as indeterminate following FNA biopsy.

On June 20, 2022 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported that findings from a study interrogating the role of the IL-27 pathway in the development of hepatocellular carcinoma (HCC) have been published in the online edition of Cancer Discovery, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (Press release, Surface Oncology, JUN 20, 2022, View Source [SID1234616101]). The study was conducted by Cedars-Sinai Medical Center and Fox Chase Cancer Center in collaboration with Surface.

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Researchers found that IL-27 receptor signaling promoted HCC development in mice, and that IL-27 served as an immunological checkpoint that regulates natural killer (NK) cell and innate immune cell activation. The study also demonstrated that pharmacological neutralization of IL-27 using an antibody developed by Surface led to increased NK and innate immune cell activation and reduced HCC development. The study incorporated observations on the effect of IL-27 on several models of HCC development, including a model of non-alcoholic steatohepatitis (NASH), a known risk factor for the development of liver cancer, which is increasing in prevalence.

"The findings published in Cancer Discovery, combined with previously reported translational and early clinical data, support our hypothesis that IL-27 blockade is a promising immunotherapy for patients with cancer," said Vito Palombella, Ph.D., chief scientific officer at Surface. "HCC is the most common form of liver cancer and characterized by a poor survival rate and limited treatment options. These data bolster our belief that SRF388, a first-in-class IL-27 neutralizing antibody, holds the potential to become an important treatment option for patients confronting this devastating disease."

Surface’s lead IL-27 antibody, SRF388, is currently being evaluated in multiple clinical studies, including a randomized Phase 2 trial designed to evaluate its efficacy and safety in combination with atezolizumab plus bevacizumab in patients with first-line advanced or metastatic HCC. SRF388 was granted Orphan Drug designation and Fast Track designation for the treatment of HCC from the FDA.