On December 17, 2018 AOP Orphan Pharmaceuticals AG (AOP Orphan) reported that EMA´s CHMP adopted a positive opinion for approval of Ropeginterferon alfa-2b/BESREMi indicated as monotherapy in adults for the treatment of Polycythaemia vera without symptomatic splenomegaly (Press release, AOP Orphan Pharmaceuticals, DEC 17, 2018, View Source [SID1234533574]).

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Ropeginterferon alfa-2b/BESREMi is a novel, long-acting interferon, which is administered once every two weeks, or 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.

AOP Orphan has been running the BESREMi clinical development in PV since 2010. The latest phase III data, three years treatment, and phase II data, up to seven years treatment, were presented at ASH (Free ASH Whitepaper) 2018. In summary, BESREMi showed high hematologic and clinical response rates with good tolerability.


In addition, BESREMi showed high molecular response rates, associated with the ability to reduce allelic burden of both mutant JAK2 and importantly also non-JAK2 mutations, which are believed to have a role in disease progression.

Andreas Steiner, Chief Executive Officer of AOP Orphan commented: "Although interferons are a treatment modality widely used throughout the myeloproliferative neoplasms including CML, BESREMi will be the first licensed interferon in any of these indications. Physicians experienced in the management of the disease and administration of BESREMi during the clinical studies expect many advantages for the patients with PV."

About Ropeginterferon alfa-2b/BESREMi
Ropeginterferon alfa-2b/BESREMi is a novel, long-acting, mono-pegylated proline interferon (ATC L03AB15) with improved pharmacokinetic properties offering improved tolerability and adherence to treatment. It is administered once every two weeks, or monthly during long-term maintenance, and is expected to be the first interferon approved for PV worldwide.

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

About Polycythemia Vera
Polycythemia Vera (PV) is a cancer of the blood-building cells in the bone marrow resulting in a chronic increase of red blood cells, white blood cells and platelets. This condition may result in circulatory disorders such as thrombosis and embolism, as well as malignant transformation to myelofibrosis or leukemia. While the molecular mechanism underlying PV is still subject of intense research, current results point to a set of acquired mutations, the most important being a mutant form of JAK2 that make the malignant clone.

On December 17, 2018 Bristol-Myers Squibb Company (NYSE:BMY), and Boston Medical Center, a private, not-for-profit, academic medical center, reported a multi-year joint research study to identify and analyze potential sensitivity and resistance markers in patients treated with standard-of-care checkpoint inhibitors (Press release, Bristol-Myers Squibb, DEC 17, 2018, View Source [SID1234532098]). The comprehensive, multi-dimensional study will place an emphasis on uncovering mechanisms associated with lack of response to Immuno-Oncology (I-O) therapies, with the ultimate goal of identifying prognostic and potentially predictive I-O biomarkers in a variety of cancers.

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"Our newly opened R&D site in Kendall Square is focused on better understanding, and ultimately overcoming, the challenge of I-O resistance. We are thrilled to establish our first partnership since the site opened with our new neighbor, Boston Medical Center, with the goal of uncovering new insights into the biology of cancer and how it evolves with exposure to I-O intervention," said Saurabh Saha, M.D., Ph.D., senior vice president and global head of translational medicine, Bristol-Myers Squibb. "The information we glean from this collaboration will ultimately inform the development of novel therapeutic strategies to improve response rates and outcomes for patients."

Through the study, researchers will explore the role of tissue and circulating biomarkers on treatment sensitivity and resistance. In addition, scientists will investigate the role of the microbiome as a potential predictive biomarker in patients receiving treatment with immune checkpoint inhibitors.

"Boston Medical Center serves a diverse patient population, with 70 percent of our patients coming from underserved communities," said Matthew Kulke, M.D., chief of hematology/oncology at Boston Medical Center. "These patients are sorely underrepresented in current research studies. We look forward to partnering with Bristol-Myers Squibb on this study to identify and assess biomarkers across a diverse patient population, providing us with a deeper and more comprehensive understanding of I-O resistance."

The two organizations will jointly conduct the research throughout the duration of the study, after which Bristol-Myers Squibb and Boston Medical Center may collaborate to publish results.

Bristol-Myers Squibb opened its Cambridge R&D site, located in Kendall Square, on November 26, 2018.

On December 17, 2018 Abbott (NYSE: ABT) reported that it will announce its fourth-quarter 2018 financial results on Wednesday, Jan. 23, 2019, before the market opens (Press release, Abbott, DEC 17, 2018, View Source [SID1234532099]).

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The announcement will be followed by a live webcast of the earnings conference call at 8 a.m. Central time (9 a.m. Eastern), and will be accessible through Abbott’s Investor Relations website at www.abbottinvestor.com. An archived edition of the call will be available later that day.

On December 17, 2018 RhoVac AB ("RhoVac") reported that the first prostate cancer patient included in the clinical phase I / II study with RhoVac’s drug candidate RV001 has completed it’s 12-month follow-up and thus the entire clinical phase I / II- study (Press release, RhoVac, DEC 17, 2018, https://www.rhovac.com/rhovac-announces-that-the-first-patient-completed-the-follow-up-phase-of-the-clinical-phase-i-ii-study/ [SID1234532083]).

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Prior to the clinical phase I / II study, conducted between 2017 and 2018, 22 patients with diagnosed prostate cancer and prostatectomized. Blood samples were taken before, during and after the study to analyse the product mediated immune response to treatments. The results, reported earlier this year, showed a significant immune response in 86% of the patients. Patients have also participated in a 3-, 6-, 9- and 12-month follow-up phase of the study, to assess the duration of the immune response.

RhoVac announces that the first patient has completed his 12-month follow-up and thus also completed his participation in RhoVac’s phase I / II clinical study. The samples for immunological analysis have been sent to the University of Tübingen. The interim report on the duration of the immunological responses, from all participating patients’ 3- and 6-month follow-up will be published in January 2019.

The last patient is expected to complete his 12-month follow-up in March 2019. The final report on the duration of the immunological responses is expected in the second quarter of 2019.

The company’s drug candidate RV001 activates T cells of the immune system to identify and eliminate cancer cells expressing the protein RhoC. As RhoC is generally overexpressed in metastatic cancer cells, RV001 can potentially be used in the treatment of several different cancer indications. It is the company’s ambition that the product being developed shall be used as a preventive treatment against metastases, thus preventing, or limiting the spread and recurrence of cancer

On December 17, 2018 Kineta Immuno-Oncology, LLC (KIO), a subsidiary of Kineta, Inc., reported that it has entered into a strategic research collaboration with Pfizer Inc. (NYSE: PFE) to develop RIG-I agonist immunotherapies for the treatment of cancer (Press release, Kineta, DEC 17, 2018, View Source [SID1234532100]). The research collaboration and license agreement grants to Pfizer the exclusive rights to KIO’s RIG-I screening platform and related compounds and technologies. The companies will collaborate to develop and test small molecule agonists that target RIG-I, an innate immunostimulatory pathway that can elicit immunogenic cell death (ICD) in tumors, providing both direct tumor cell killing and enhanced anti-tumor immune responses.

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In preclinical models, Kineta’s RIG-I agonists have demonstrated complete tumor regression and an increase in tumor-specific T cells when given as a monotherapy. Additionally, the compounds have demonstrated synergistic effects when used in combination with other immunotherapies like checkpoint inhibitors. Kineta’s proprietary approach is part of an internally developed discovery program focused on innate immune drug targets in cancer. The lead program is focused on the RIG-I pathway, which is differentiated from other innate immune-targeted immunotherapies as its compounds are small molecule drugs with the potential for oral and systemic administration.

"This alliance will enable Kineta and Pfizer to leverage each company’s expertise to accelerate the development of our RIG-I immuno-oncology program," said Kineta CEO, Shawn Iadonato. "Pfizer is an excellent partner for Kineta’s technology, with a strong commitment to oncology and outstanding development capabilities. We are very enthusiastic about this new cancer immunotherapy collaboration, which represents the second major partnering transaction for Kineta this year."

Dr. Robert Abraham, Senior Vice President and Group Head of Pfizer’s Oncology Research & Development Group said: "Therapies that trigger activation of the innate immune response in tumors have significant potential to expand the number of patients who will benefit from cancer immunotherapy, especially if they can be administered systemically. Kineta has taken a promising, differentiated approach to the discovery of RIG-I agonists, and we are looking forward to collaborating with Kineta and jointly developing these RIG-I-targeted agents into medicines with potentially unique immune-stimulating properties."

Under the terms of the agreement, KIO will receive a $15 million upfront payment and will be eligible to receive up to $505 million in potential research, development and sales milestone payments. Additionally, KIO is eligible to receive tiered royalties on net sales. Pfizer will fund RIG-I target-related research conducted by Kineta for an initial period of three years, after which Pfizer will be responsible for further development and commercialization of product candidates.

Torreya acted as exclusive financial advisor to Kineta on this transaction.