On November 22, 2018 CellProtect Nordic Pharmaceuticals AB reported that it has received a 1 MSEK grant from Vinnova, Sweden’s Innovation Agency (Press release, CellProtect Nordic Pharmaceuticals, NOV 22, 2018, View Source [SID1234533265]). The funds will be used to upscale the production of a novel drug candidate CellProtect, an advanced therapy medicinal product (ATMP), for the treatment of multiple myeloma. The project will be conducted in collaboration with Karolinska University Hospital.

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The grant has been provided to CellProtect Nordic Pharmaceuticals AB within the program "Competence Centers; Support for SMEs 2018″. Its aim is to stimulate active and sustainable participation of small and medium size enterprises facilitating growth of the Swedish biologics industry.

Moreover, CellProtect Nordic Pharmaceuticals AB and the Karolinska University Hospital, via the Karolinska Cell Therapy Center (KCC) and its production unit Vecura, are partners of the Vinnova Competence Centre for Advanced BioProduction by Continuous Processing (AdBIOPRO). This key competence centre, focusing on manufacturing of emerging potent therapeutic products, is coordinated by the Royal Institute of Technology in Stockholm, and includes a number of industrial partners.

"We are very grateful for the grant for this important work. Upscaling of the production is an imperative step in order to initiate confirmatory clinical trials with CellProtect in patients with multiple myeloma which is a primary indication for our drug candidate" says Karin Mellström, CEO of CellProtect Nordic Pharmaceuticals AB.

On November 22, 2018 Oasmia Pharmaceutical AB (NASDAQ: OASM) reported that the European Commission has granted an approval of Apealea for treatment of adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer in combination with Carboplatin (Press release, Oasmia, NOV 22, 2018, View Source [SID1234556568]). This approval marks the first approval for a systemic platinum-based paclitaxel combination therapy approved for first relapse of platinum-sensitive epithelial ovarian cancer.

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The European Commission has granted a centralized marketing authorization with unified labelling that is valid in 28 countries of the European Union (EU), as well as the European Economic Area members, Iceland, Lichtenstein and Norway.

Today’s milestone for Apealea is an important one for patients in Europe experiencing a relapse of their ovarian cancer disease since this treatment allows a platinum-based treatment option with a high dose paclitaxel free from Cremophor EL (CrEL).

About the OAS-07OVA study

The European Commission decision is based on clinical trials including the pivotal study OAS 07OVA conducted on patients with disease relapse. This study showed that the risks of disease progression or death after Apealea treatment in combination with carboplatin are similar as after comparator; CrEL-formulated paclitaxel in combination with carboplatin.

Median progression-free survival (PFS) was 10.3 months in the Apealea arm compared to 10.1 months in the comparator arm (HR:0.86; 95% CI: 0.72 – 1.03)
Median overall survival (OS) was 25.7 months in the Apealea arm compared to 24.8 months in the comparator arm (HR:0.95; 95% CI: 0.78 – 1.16)

About epithelial ovarian cancer

Ovarian cancer is the seventh most common cancer in women. Approximately 239,000 women are annually diagnosed with ovarian cancer globally and 152,000 dies from the disease. Epithelial ovarian cancer is the most common form and accounts for about 90% of ovarian cancers. The disease is often diagnosed at an advanced staged since it has no symptoms at early stages. The five-year survival rate (i.e. survival of patients with ovarian cancer compared to survival in the general population at the same age) for ovarian cancer has been estimated to 38% in Europe. During 2018, approximately 68,000 women will be diagnosed with ovarian cancer in Europe and 45,000 are predicted to die from the disease. Carboplatin and paclitaxel are common chemotherapy drugs for treatment of ovarian cancer, and are often used in combination.

About Apealea

Apealea is a Cremophor- and albumin-free formulation of the well-known cytostatic paclitaxel combined with Oasmia’s excipient technology XR17. Paclitaxel is one of the most widely used anticancer substances and is included in the standard treatment of a variety of cancers such as lung cancer, breast cancer and ovarian cancer. Apealea consists of a freeze-dried powder, which is dissolved in conventional solutions for infusion.

On November 22, 2018 Oncorena Holding AB reported that the company through a share issue has raised capital to build its organization and resources in preparation for clinical development with a patient study of a new treatment modality for advanced kidney (renal) cancer (Press release, Oncorena, NOV 22, 2018, View Source [SID1234531572]). The capital was raised from Oncorena’s largest shareholders P.U.L.S. AB and HealthCap, as well as other current shareholders. In addition, several new investors have made significant investments.

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The new capital will be used to build the company’s organization and resources, as well as all activities needed in preparation for the planned clinical study. In the phase I-IIa study to be conducted in patients with advanced kidney cancer on dialysis will be treated with Oncorena’s potential new drug orellanine. Orellanine is a substance that is taken up specifically by kidney cancer cells and kidney cells, pre-clinical experimental studies have shown very promising results.

"The new capital provides an important infusion to enable necessary steps in the development of orellanine into a novel treatment for patients with advanced renal cancer. The medical need is high for these patients since there is no effective treatment with good tolerability available today," says Lars Grundemar, CEO of Oncorena.

"It will be a strategically important step for Oncorena when the clinical patient study with this innovative compound can be started. I am therefore pleased to notice the great confidence in Oncorena amongst the existing shareholders as well as from new investors," says Bengt-Åke Bengtsson, chairman of Oncorena’s board.

For further information, please contact
Lars Grundemar, CEO, Oncorena Holding AB, [email protected],
phone +46 (0)76 209 5518
Bengt-Åke Bengtsson, Chairman of the Board, Oncorena Holding AB, [email protected], phone +46 (0)70 746 0000

About kidney cancer
Approximately 1 in 10,000 is afflicted with kidney cancer annually. 80% of the patients are between 40 and 69 years of age when they are diagnosed (median age 63 years). The disease can often be cured with surgery if detected in time, but unfortunately the diagnosis is often made when the tumor has already spread to other organs. The prognosis is then considerably less favorable and certain groups have a median survival of only approx. 1.5 years. Today the disease is treated with various types of drugs, often with severe side effects, and standard chemotherapy drugs have only limited effect. There is therefore a high need for new, effective and safe drugs.

On November 21, 2018 Amgen (NASDAQ: AMGN) reported that it will present at the Piper Jaffray Healthcare Conference at 8:30 a.m. ET on Tuesday, Nov. 27, 2018, in New York City and at the Evercore ISI Healthcare Conference at 11 a.m. ET on Wednesday, Nov. 28, 2018, in Boston (Press release, Amgen, NOV 21, 2018, View Source [SID1234531552]). Elliott M. Levy, M.D., senior vice president of Global Development at Amgen, will present at the conferences. Live audio of each presentation can be accessed from the Events Calendar on Amgen’s website, www.amgen.com, under Investors. A replay of each webcast will also be available on Amgen’s website for at least 90 days following the event.

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On November 21, 2018 Ascentage Pharma, a clinical-stage biopharmaceutical company dedicated to the development of small molecule therapies for the treatment of cancers, hepatitis B and aging-related diseases, reported that the Company will present clinical data of its novel BCR-ABL inhibitor HQP1351 in the upcoming 60th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) (Press release, Ascentage Pharma, NOV 21, 2018, View Source [SID1234531554]). The principal investigator of the study, Qian Jiang, MD, Deputy Director of Peking University People’s Hospital, Peking University Institute of Hematology, and Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, will give an oral report during the meeting. HQP1351 is a third-generation BCR-ABL inhibitor for the treatment of drug-resistant CML (Chronic Myeloid Leukemia).

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Oral Report
Topic: Safety and Efficacy of HQP1351, a Third-Generation Oral BCR-ABL Inhibitor in Patients with Tyrosine Kinase Inhibitor – Resistant Chronic Myelogenous Leukemia: Preliminary Results of Phase I Study
Number: 791
Speaker: Qian Jiang, MD
Time: Monday, December 3, 2018: 3:45 PM
Location: 6E (San Diego Convention Center)
Preview Link: View Source

About HQP1351
HQP1351 is a novel kinase inhibitor developed by Ascentage Pharma. It is an oral high-efficiency third-generation BCR-ABL inhibitor targeting a broad spectrum of BCR-ABL mutants, including those with the T315I mutation, to treat drug-resistant CML patients. Phase I clinical trials for patients with imatinib-resistant CML have been completed and Phase II clinical trials have been initiated.