On October 11, 2019 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that the National Institute for Health and Care Excellence (NICE) has recommended that women with relapsed ovarian cancer in England have access to rucaparib through the Cancer Drugs Fund (CDF) (Press release, Clovis Oncology, OCT 11, 2019, View Source [SID1234540965]).1 Rucaparib is available for use within the CDF as an option for the maintenance treatment of relapsed, platinum-sensitive high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer that has responded to platinum-based chemotherapy in adults, based on the conditions outlined in the managed access agreement.

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"Ovacome welcomes the availability of rucaparib via the CDF as an option for maintenance treatment of platinum-sensitive relapsed high grade serous epithelial ovarian cancer regardless of BRCA status or line of treatment in the relapsed maintenance setting," said Victoria Clare, CEO of Ovacome, a United Kingdom ovarian cancer charity focused on providing support to anyone affected by ovarian cancer. "It is vital that the expansion of available maintenance options continues as maintenance treatments extend the time between chemotherapies. Many women with relapsed ovarian cancer know that they are facing a future of managing their disease as a chronic illness."

"For too long ovarian cancer treatment options beyond chemotherapy or surgery have been limited, and today’s announcement means that women with ovarian cancer have more choice in their treatment than ever before," said Annwen Jones, Chief Executive of Target Ovarian Cancer, a United Kingdom ovarian cancer charity. "Target Ovarian Cancer has long campaigned for better treatment for women with ovarian cancer and we are delighted to see this latest development."

Approximately 6,400 women are diagnosed with ovarian cancer in the UK every year, which equates to roughly 17 every day.2 Despite advancements in treatment and care, more than 4,000 women still die each year from ovarian cancer in the UK.2 Of those treated with surgery and first line chemotherapy, approximately 70% of patients will relapse within the first three years.3

"Inclusion of rucaparib in the CDF as an option for maintenance treatment for patients with recurrent ovarian cancer responding to platinum-based therapy regardless of BRCA mutation status or line of treatment in the relapsed maintenance setting represents a much-needed treatment option for women with recurrent ovarian cancer," said Professor Jonathan Ledermann, MD, Professor of Medical Oncology, UCL Cancer Institute and UCL Hospitals, London, global Principal Investigator for non-US sites in the ARIEL3 study. "I am pleased that the CDF recommendation includes access for the broad patient population evaluated in the ARIEL3 trial which demonstrated rucaparib to be effective in eligible patients, regardless of their BRCA mutation status, providing a clinically-meaningful median progression-free survival of more than one year across the entire population studied by independent radiological review. This represents a significant step in the effective management of relapsed ovarian cancer in the NHS in England."

The European Union (EU) conditional marketing authorization is based on data from the pivotal Phase 3 ARIEL3 clinical trial. ARIEL3 successfully achieved its primary endpoint of extending investigator-assessed PFS versus placebo in all patients treated (intention-to-treat, or ITT), population, regardless of BRCA status (median 10.8 months vs 5.4 months).4,5 In addition, it successfully achieved the key secondary endpoint of extending PFS by independent radiological review versus placebo in all patients treated (ITT), regardless of BRCA status (median 13.7 months vs 5.4 months).5 The overall safety profile of rucaparib is based on data from 937 patients with ovarian cancer treated with rucaparib monotherapy in clinical trials.5

"We welcome NICE’s recommendation to make rucaparib available through the CDF to all eligible women in England who may potentially benefit from this important therapeutic option," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "For women with recurrent ovarian cancer, access to new treatments that successfully demonstrate prolonged progression-free survival is essential in the fight against this deadly disease and central to Clovis Oncology’s mission to provide the right drug, to the right patient at the right time."

About Rubraca (rucaparib)

Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 that is being developed in multiple tumor types, including ovarian and metastatic castration-resistant prostate cancer (mCRPC), as monotherapy, and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway.

Rubraca (rucaparib) European Union (EU) Conditional Marketing Authorization

Rubraca is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.

Rubraca is indicated as monotherapy treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with ≥ 2 prior lines of platinum-based chemotherapy, and who are unable to tolerate further platinum-based chemotherapy.

Summary Warnings, Precautions and Safety

Efficacy of Rubraca as treatment for relapsed or progressive EOC, FTC, or PPC has not been investigated in patients who have received prior treatment with a PARP inhibitor. Therefore, use in this patient population is not recommended.

The overall safety profile of rucaparib is based on data from 937 patients in clinical trials in ovarian cancer treated with rucaparib monotherapy. Adverse reactions occurring in ≥ 20% of patients receiving rucaparib were nausea, fatigue/asthenia, vomiting, anaemia, abdominal pain, dysgeusia, ALT elevations, AST elevations, decreased appetite, diarrhoea, thrombocytopenia and creatinine elevations. The majority of adverse reactions were mild to moderate (Grade 1 or 2).

The ≥ Grade 3 adverse reactions occurring in > 5% of patients were anaemia (23%), ALT elevations (10%), fatigue/asthenia (10%), neutropenia (8%), thrombocytopenia (6%), and nausea (5%). The only serious adverse reaction occurring in > 2% of patients was anaemia (5%).

Adverse reactions that most commonly led to dose reduction or interruption were anaemia (20%), fatigue/asthenia (18%), nausea (16%), thrombocytopenia (15%), and AST/ALT elevations (10%). Adverse reactions leading to permanent discontinuation occurred in 10% of patients, with thrombocytopenia, nausea, anaemia, and fatigue/asthenia being the most frequent adverse reactions leading to permanent discontinuation.

During treatment with rucaparib, events of myelosuppression (anaemia, neutropenia, thrombocytopenia) may be observed and are typically first observed after 8-10 weeks of treatment with rucaparib. These reactions are manageable with routine medical treatment and/or dose adjustment for more severe cases. Complete blood count testing prior to starting treatment with rucaparib and monthly thereafter, is advised. Patients should not start rucaparib until they have recovered from haematological toxicities caused by previous chemotherapy (≤ CTCAE Grade 1).

Myelodysplastic syndrome/acute myeloid leukaemia (MDS/AML), including cases with fatal outcome, have been reported in patients who received rucaparib. The duration of therapy with rucaparib in patients who developed MDS/AML varied from less than 1 month to approximately 28 months. If MDS/AML is suspected, the patient should be referred to a haematologist for further investigations, including bone marrow analysis and blood sampling for cytogenetics. If, following investigation for prolonged haematological toxicity, MDS/AML is confirmed, rucaparib should be discontinued.

Further information should be obtained from the Rucaparib Summary of Product Characteristics (SmPC) found here: View Source

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. Side effects should be reported. See View Source for how to report side effects.

On October 11, 2019 Vaccibody AS, a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, appoints Dr Siri Torhaug as Chief Medical Officer (Press release, Vaccibody, OCT 11, 2019, View Source [SID1234540958]).

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Siri Torhaug is a medical doctor and certified clinical specialist in oncology. She has broad experience in clinical development and translational research within immune oncology, and has led clinical trials from early phase as well as pivotal phase II and III studies during her ten years at Oslo university hospital and Radiumhospitalet, one of Europe`s premier oncology hospital and research centers.

Having spent more than six years in leading pharmaceutical companies, Siri Torhaug brings invaluable experience to the team. She held local and Nordic medical leadership roles during her four years at Novartisincluding the role of Nordic medical disease lead for melanoma, lung, pipeline and immunooncology covering all aspects of early clinical trials in the Nordic countries. In addition, she was instrumentalto medical affairs activities and the overall strategy for Novartis’ immune-oncology portfolio in the Nordics. In 2017, Siri Torhaug moved to Astrazeneca where she was part of the Nordic Medical Oncology Leadership team, responsible for medical execution. Siri Torhaug’s knowledge and extensive experience in scientific andmedical affairs covering all relevant tumor areas, R&D and general management of cancer drug development will be of great value to Vaccibody when the company continues to develop and expand its clinical trial portfolio in the coming years.

"I am very pleased to welcome Siri Torhaug as Chief Medical Officer of Vaccibody. Siri is a seasoned leader and has deep experience within the immuno-oncology field across technologies including T cell therapy. Her valuable experience covers multiple aspects of clinical development from both the side of the clinician to several years of medical responsibility in big pharma. The Management team and I look forward to workingwith Siri and to continue Vaccibody’s successful journey", said Michael Engsig, CEO of Vaccibody. Siri Torhaug continues, "Vaccibody has such a strong momentum and is leading within the field of neoantigen cancer vaccines. I am very excited to join Vaccibody and become a part of this great organization."

Siri Torhaug will initiate her employment on January 1st, 2020.

On October 11, 2019 Kangpu Biopharmaceuticals reported that it has successfully completed a first-in-human phase I single ascending dose (SAD) clinical study of KPG-818 conducted in the United States (Press release, Kangpu Biopharmaceuticals, OCT 11, 2019, View Source [SID1234540934]).

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This randomized, double-blind, placebo-controlled study evaluated the safety, tolerability and pharmacokinetics (PK) of KPG-818 in healthy male and female participants following oral administration. A total of 40 subjects were randomized to receive active drug or placebo in a double-blind fashion (8 subjects in each dose cohort, 6 subjects randomized to receive active drug and 2 subjects randomized to receive placebo). Five dose levels (2, 5, 10, 20 and 30 mg) were investigated.

In the completed phase I study, there were no safety or tolerability concerns. No serious adverse events (SAE) were reported at any dose level studied. No stopping criteria were met. KPG-818 was well tolerated at all tested dose levels. KPG-818 also demonstrated a favorable pharmacokinetic profile supporting once-daily oral dosing. The phase I results also revealed that dosing under fed conditions does not have significant influence on the exposure of KPG-818 as compared to fasted conditions.

The study results will assist Kangpu Biopharmaceuticals in identifying appropriate doses of KPG-818 that can be administered in subsequent clinical trials in patients with systemic lupus erythematosus (SLE) or hematological malignancies.

About KPG-818

KPG-818 is a novel small molecule modulator of the CRBN E3 ubiquitin ligase complex CRL4-CRBN. In preclinical studies, KPG-818 demonstrated outstanding in vitro anti-inflammatory and anti-proliferative properties as well as remarkable in vivo efficacy in myeloma and lymphoma animal models. KPG-818 is currently being developed by Kangpu Biopharmaceuticals for the treatment of SLE and hematological malignancies.

On October 17, 2019 Nordic Nanovector ASA (OSE: NANO) ("Nordic Nanovector" or the "Company"), a biopharmaceutical company dedicated to extending and improving the lives of patients with haematological cancers through the development and commercialisation of innovative targeted therapeutics, reported the launch of a private placement of new shares (the "Offer Shares") representing up to approximately 20% of the outstanding share capital of the Company at this date (the "Private Placement") (Press release, Nordic Nanovector, OCT 17, 2019, View Source [SID1234553443]). DNB Markets and Jefferies International Limited are acting as Joint Global Coordinators and joint bookrunners (the "Joint Global Coordinators"), and ABG Sundal Collier ASA is acting as joint bookrunner (together with the Joint Global Coordinators, the "Managers") in connection with the Private Placement .

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Nordic Nanovector intends to use the net proceeds from the Private Placement for the following purposes:

Continued clinical development, (including completion of enrolment of the PARADIGME study), and commercial preparation of Betalutin.
Manufacturing development activities for Biological License Application (BLA) readiness.
General corporate purposes.
The subscription price and the number of shares to be issued in the Private Placement will be determined through an accelerated bookbuilding process. The bookbuilding period and the application period for the Private Placement commence today at 16:30 hours CEST and will close at 08:00 hours (CEST) on 18 October 2019 (the "Application Period"). The Company and the Managers reserve the right to close or extend the Application Period at any time and for any reason. If the Application Period is shortened or extended, any other dates referred to herein may be amended accordingly.

The Company’s largest shareholder, HealthCap VI L.P., has informed the Company that it will participate in the Private Placement.

The minimum subscription and allocation amount in the Private Placement will be the NOK equivalent of EUR 100,000, provided that the Company may, at its sole discretion, allocate an amount below EUR 100,000 to the extent applicable exemptions from the prospectus requirement pursuant to applicable regulations, including the Norwegian Securities Trading Act and ancillary regulations, are available. Allocation of the Offer Shares will be determined at the end of the bookbuilding process, and the final allocation will be made by the Company’s Board of Directors (the "Board") at its sole discretion, following advice from the Managers.

The Offer Shares will be issued based on an authorisation granted to the Company’s Board at the Company’s annual general meeting on 25 April 2019 (the "Authorisation").

The Board has considered alternative structures for the raising of new equity. Following careful considerations, the Board is of the view that it will be in the common interest of the Company and its shareholders to raise equity through a private placement setting aside the pre-emptive rights of the shareholders. By structuring the transaction as a private placement, the Company will be in a position to raise capital in an efficient manner, with a lower discount to the current trading price and with significantly lower risks compared to a rights issue. In addition, the Private Placement is subject to marketing through a pre-sounding and a publicly announced bookbuilding process. By this, a market based subscription price will be achieved. The Company will also consider whether or not to commence a repair offering towards the existing shareholders who did not participate in the Private Placement.

The Private Placement will be directed towards Norwegian and international investors, in each case subject to and in compliance with applicable exemptions from relevant prospectus or registration requirements. Notification of allotment and payment instructions is expected to be issued to the applicants on or about 18 October 2019 through a notification to be issued by the Managers.

The Private Placement is divided into two tranches:

· A number of Offer Shares corresponding to approximately 10% of the Company’s share capital will be settled with existing and unencumbered shares in the Company that are already listed on the Oslo Stock Exchange, pursuant to a share lending agreement between DNB Markets (on behalf of the Managers), the Company and HealthCap VI L.P., in order to facilitate delivery of listed shares to investors on a delivery versus payment basis (the "Tranche 1 Offer Shares"). The Tranche 1 Offer Shares will be tradable from allocation. The Managers will settle the share loan with a corresponding number of new shares in the Company to be issued by the Board pursuant to the Authorisation, on or about 24 October 2019.

· The Managers are expected to pre-fund the subscription price for the rest of the Offer Shares (the "Tranche 2 Offer Shares") to facilitate a swift registration of the share capital increase in the Norwegian Register of Business Enterprises (the "NRBE"). The Tranche 2 Offer Shares will be tradable from registration of the share capital increase in the NBRE, expected to be on or about 22 October 2019. Delivery of the Tranche 2 Offer Shares will be on a delivery versus payment basis to the investors. The Tranche 2 Offer Shares will be issued by the Board pursuant to the Authorisation.

The Company has agreed with the Managers to a lock-up on future share issuances for a period of 180 days from the closing date, subject to customary exceptions. The Company’s Board and Executive Management have all agreed with the Managers to a lock-up on existing shareholdings for a period of 180 days from the closing date, subject to customary exceptions. In addition, the Company’s largest shareholder, HealthCap VI L.P. has agreed with the Managers to a lock-up for a period of 90 days from the closing date, subject to customary exceptions.

The Company will announce the final number of Offer Shares placed and the final subscription price in the Private Placement in a stock exchange announcement expected to be published before opening of trading on the Oslo Stock Exchange tomorrow, 18 October 2019. Completion of the Private Placement is subject to final approval by the Company’s Board.

Company update

The pivotal PARADIGME trial investigating Betalutin in relapsed/refractory non-Hodgkin’s lymphoma is now recruiting patients at 85 sites in 24 countries. Despite a slower than expected start, PARADIGME is now recruiting in line with the company’s expectations and in line with previous clinical trials in similar patient populations; with 32 patients enrolled to-date, the company aims to complete recruitment of the targeted 130 patients in H2 2020.

The company, working with the trial Contract Research Organisation (CRO), has initiated a suite of actions to meet this enrolment target. Specific actions include applying key learnings from high-recruiting sites, increased visits by senior management, other site engagement programmes and intensified efforts to raise the profile of PARADIGME and Betalutin with key opinion leaders, referrers and influencers.

Nordic Nanovector believes that these initiatives position PARADIGME strongly to reach its key enrolment milestone of 130 patients in H2 2020.

On October 10, 2019 Gilead Sciences, Inc. (Nasdaq: GILD) reported that its third quarter 2019 financial results will be released on Thursday, October 24, after the market closes (Press release, Gilead Sciences, OCT 10, 2019, View Source [SID1234540971]). At 4:30 p.m. Eastern Time, Gilead’s management will host a conference call to discuss the company’s financial results for the third quarter 2019 and provide a business update.

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The live webcast of the call can be accessed at the company’s Investors page at View Source Please connect to the company’s website at least 15 minutes prior to the start of the call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 877-359-9508 (U.S.) or 224-357-2393 (international) and dial the conference ID 6094972 to access the call. Telephone replay will be available approximately two hours after the call through 8:00 p.m. Eastern Time, October 26, 2019. To access the replay, please call 855-859-2056 (U.S.) or 404-537-3406 (international) and dial the conference ID 6094972. The webcast will be archived on www.gilead.com for one year.