On June 20, 2022 Novo Nordisk reported that initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Press release, Novo Nordisk, JUN 20, 2022, View Source [SID1234616121]). This programme is part of the overall share repurchase programme of up to DKK 24 billion to be executed during a 12-month period beginning 2 February 2022.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the programme initiated 3 May 2022, Novo Nordisk will repurchase B shares for an amount up to DKK 4.4 billion in the period from 4 May 2022 to 2 August 2022.

Since the announcement 13 June 2022, the following transactions have been made:

The details for each transaction made under the share repurchase programme are published on novonordisk.com.

With the transactions stated above, Novo Nordisk owns a total of 14,731,381 B shares of DKK 0.20 as treasury shares, corresponding to 0.6% of the share capital. The total amount of A and B shares in the company is 2,280,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 24 billion during a 12- month period beginning 2 February 2022. As of 17 June 2022, Novo Nordisk has since 2 February 2022 repurchased a total of 12,991,818 B shares at an average share price of DKK 757.73 per B share equal to a transaction value of DKK 9,844,234,990

Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 49,300 people in 80 countries and markets its products in around 170 countries. Novo Nordisk’s B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, and YouTube.

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 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]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (hereinafter referred to as "ImmuneOnco" and the company) reported that, on June 20, local time, an FDA-registered Phase I clinical trial of the first globally novel bi-specific antibody-receptor fusion protein targeting human CD47xHER2（IMM2902) completed the first patient in (FPI) (Press release, ImmuneOnco Biopharma, JUN 20, 2022, View Source [SID1234655662]). The first subject has been enrolled and dosed in the United States, and the infusion went well without any complications.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

IMM2902 is a CD47xHER2 bispecific fusion protein in the most cutting-edge of global research field for solid tumors. It was previously approved by the U.S. Food and Drug Administration (FDA) for clinical trials on August 21, 2021. It is the third CD47-based new drug projects in the clinical research stage of the company. On February 15, 2022, IMM2902 completed the first subject enrollment and dosing in China, and the clinical trial is progressing well. On June 16, the invention patent of the IMM2902 was authorized by the US Patent Office. The completion of the first patient enrollment and dosing of IMM2902 in the United States is another major milestone for the company!

Founder, Chairman and CEO of ImmuneOnco Dr. Tian, Wenzhi, said: "We are very pleased that our IMM2902 program has completed the first patient enrollment and dosing in clinical studies in the United States. IMM2902 is a bispecific molecule targeting CD47 and HER2 developed based on our mAb-Trap technology platform. The high affinity to HER2 enables the drug to bind to tumor cells preferentially without binding to human erythrocytes and avoiding the "antigen sink effect", thus greatly enhancing the specific synergistic effect against tumors. Although Her2-related ADC drugs have excellent clinical performance, the unavoidable serious toxic and side effects (such as the incidence of interstitial pneumonia as high as 9% and the fatality rate as high as 2.6%) also bring greater risks to patients. We believe that, on the premise of ensuring similar efficacy, IMM2902 will greatly improve clinical safety. We truly believe that IMM2902 has great value for further clinical development."