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European Commission Approves Pelmeg▼® (pegfilgrastim) as a Biosimilar Treatment to Reduce the Duration of Neutropenia and Incidence of Febrile Neutropenia in Adults Treated with Chemotherapy

On November 23, 2018 The Mundipharma network of independent associated companies reported that the European Commission (EC) has granted approval for the use of Pelmeg (pegfilgrastim) as a treatment for reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).1 (Press release, Mundipharma, NOV 23, 2018, View Source [SID1234531587])

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The EC’s decision follows a recommendation from the Committee for Medicinal Products for Human Use (CHMP) that was based on a robust regulatory submission of key biosimilarity data from analytical, biofunctional and clinical study comparisons for Pelmeg.2 In all cases it demonstrated comparable pharmacodynamics, pharmacokinetics, and immunogenicity to its reference product Neulasta.3,4,5 The information submitted, and conclusions reached, were comprehensive enough to extrapolate the indication for Neulasta across to Pelmeg.2 As such, it is indicated in the exact same way as subcutaneous (pre-filled syringe) Neulasta.

"We hope this approval will significantly improve the lives of people who are affected by chemotherapy induced neutropenia and febrile neutropenia. The availability of this biosimilar represents an important opportunity to reduce healthcare costs while increasing access to an effective treatment option," said Philippe Bastide, Head of Biosimilars, Mundipharma International.

Pelmeg is the fourth biosimilar medicine to be commercialised by the Mundipharma network. It was developed by Cinfa Biotech which was acquired by the Mundipharma network and announced in October 2018. The acquisition of Cinfa Biotech provides Mundipharma with global reach and expanded development capabilities.

▼ This medicinal product is subject to additional monitoring.

Notes to editors

About the clinical data

A comprehensive analytical, biofunctional, preclinical and clinical comparability programme has demonstrated a high degree of similarity between Pelmeg and Neulasta. Its biosimilarity has been studied in healthy volunteers who have no comorbidities, require no co-medication and are immunocompetent.3,4,5

The Pelmeg data:

Confirmed biosimilarity to Neulasta in sensitive clinical study settings
Demonstrated pharmacokinetic comparability to Neulasta at the clinical dose of 6 mg
Demonstrated pharmacodynamic comparability to Neulasta at the clinical dose of 6 mg and at the reduced dose of 3 mg
Did not show any clinically meaningful differences in the safety and immunogenicity profile compared to Neulasta
About Pelmeg

Pelmeg is a pegfilgrastim biosimilar.6 Pegfilgrastim is a pegylated version of granulocyte-colony stimulating factor (G-CSF) that works by stimulating the bone marrow to produce more neutrophils, thereby reducing the incidence of febrile neutropenia. It is administered as a subcutaneous injection once per chemotherapy cycle, at least 24 hours after cytotoxic chemotherapy.6

About neutropenia and febrile neutropenia

People taking chemotherapy for cancer are at risk of dangerously low levels of a type of white blood cell called a neutrophil. Neutrophils play an important role in the immune system guarding against infection. Febrile neutropenia is a low level of neutrophils in the blood accompanied by a fever.7

Oasmia Pharmaceutical Receives Approval from European Commission for Apealea® (paclitaxel micellar) in the European Union

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.

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.

CellProtect Nordic Pharmaceuticals AB receives funding from Vinnova

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.

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.

BerGenBio appoints cancer drug development specialist Alan Barge MD as interim Chief Medical Officer

On November 22, 2018 BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, oral, selective AXL kinase inhibitors for multiple cancer indications, is reported the appointment of Alan Barge MD as Interim Chief Medical Officer and member of the leadership team (Press release, BerGenBio, NOV 22, 2018, View Source [SID1234531625]). The Company also announces further senior organisational changes and a strengthening of its clinical operations as it prepares for the intended advancement of its lead candidate bemcentinib into the next stages of clinical development.

Dr Barge is a board-certified oncologist and haematologist, with more than 25 years of experience in cancer drug development, spent primarily at AstraZeneca and Amgen. He spent over 12 years at AstraZeneca, where he was VP and Head Oncology and Infection, during which time he was responsible for the development of Iressa (gefitinib) for non-small cell lung cancer (NSCLC) and the translational research that resulted in the successful personalised medicine strategy for AZ. Prior to AZ, Dr Barge was European and Global Medical Director at Amgen, at which he was responsible for European approval and label extensions for several of Amgen’s cancer therapies. More recently, Dr Barge has been actively involved in the biotech sector in both CMO and non-executive positions, including CMO of Carrick Therapeutics (UK and Ireland) and SVP Oncology at ASLAN Pharmaceuticals (Singapore).

Dr Barge will work as part of BerGenBio’s leadership team on an interim basis until a permanent CMO is appointed.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "We are delighted to welcome Alan to the team. His vast experience from developing successful cancer drugs with AstraZeneca and Amgen will be most valuable in forming and executing the Company’s clinical and regulatory strategy for bemcentinib as we enter the next phase of development. We anticipate further results from our phase II proof-of-concept studies of bemcentinib in NSCLC and AML in the coming months, and aim to start a randomised phase 2 trial programme in these indications in 2019."

In addition, BerGenBio announces the promotion of Dr Anthony Brown to Chief Scientific Officer from Director of Research, succeeding BerGenBio co-founder Professor James Lorens, who becomes a Senior Scientific Advisor to the Company. Murray Yule, BerGenBio’s Clinical Development Officer, will leave the Company with effect from 30 November 2018. Further, as noted during the Company’s 03 2018 results presentation, Dr Tone Bjaaland has recently been appointed as Director of Clinical Operations (>25 years’ experience in clinical research) and further strengthens the team.

Vineti™ to Partner With Tessa Therapeutics™ to Advance and Scale Cancer Immunotherapies World-Wide

On November 22, 2018 Vineti, Inc., the leading digital "platform of record" for personalized therapies, reported a new partnership with Tessa Therapeutics to advance and scale personalized cell therapies for solid tumors in Asia and world-wide (Press release, Tessa Therapeutics, NOV 22, 2018, View Source [SID1234531574]).

Tessa Therapeutics (Tessa), an international clinical stage biopharmaceutical company focusing on cellular immunotherapy treatments for cancer, is a leading developer of personalized T cell therapies for solid tumors, including head and neck cancers and cervical cancer. Vineti provides the leading digital software platform to align and manage the complex personalized cell therapy process, safely and efficiently.

The goal of the partnership is to scale Tessa’s therapies world-wide in a safe and efficient manner, supporting both late clinical stage therapies approaching commercialization and early-phase therapies progressing through various clinical stages. Tessa, headquartered in Singapore, brings international expertise through both its Asia operations and its global treatment network.

Tessa’s Virus-Specific T cell (VST) technology is showing compelling results and an excellent safety profile in the treatment of cancer. The company is currently conducting a multi-center Phase III trial targeting nasopharyngeal cancer, and a Phase I trial targeting cervical cancer and oropharyngeal cancer, set to move into Phase II in 2019. In addition, Tessa is developing a broad pipeline of pre-clinical therapies targeting major cancers such as liver and lung using its VST platform.

"As a team of industry experts who care deeply about patient care, Tessa understands the current challenges in cell therapy and is addressing them proactively by partnering with Vineti," said Tessa Chief Business Officer Jennifer Butler. "By running our therapies on the Vineti platform, we are taking an important step towards global commercial readiness."

Vineti’s platform will support Tessa as it builds its pipeline of therapies and prepares for commercialization, with a focus on providing a digital orchestration platform to track, trace, align, and simplify the complex journey that underlies each therapy’s personalized operations and logistics chain. Vineti is now supporting patients and clinicians in more than 65 leading medical centers, and is rapidly expanding to Asia-Pacific and Europe.

"Vineti is honored to support Tessa in its work to develop transformative, critically-needed therapies," said Vineti CEO Amy DuRoss. "The Vineti platform is designed to support innovative therapies as they evolve and scale. Therapeutic advances against solid tumors will make a real difference for even more patients, and we are very excited to help Tessa scale their treatments globally."

Vineti is the first cloud-based software platform to safely and efficiently move patient-based personalized therapies into mainstream medicine at scale. The Vineti platform – configurable, cloud-based, secure and scalable – brings the best of enterprise software to next-generation pharmaceutical science. Vineti’s solution aligns, manages, integrates and simplifies all the major steps and stakeholders in the inherently complex cell and gene therapy process, helping everyone from health care providers to biopharma and manufacturers exert efficiency and control to optimize the patient’s therapy journey.

This announcement follows Tessa’s recent research collaboration with St. Jude, and Vineti’s strategic teaming agreement with Deloitte.