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.

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!

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 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.

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!

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.

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]).

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!

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.

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.

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!

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 C4X Discovery Holdings plc (AIM: C4XD), a pioneering drug discovery company,reported its full year results for the year ended 31 July 2018 (Press release, C4X Discovery, NOV 21, 2018, View Source [SID1234533246]).

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!

Financial highlights
Revenue increased to £7,064,000 (2017: £143,000), driven entirely by the Indivior licensing agreement.
R&D expenses increased 15% to £6,992,000 (2017: £6,100,000), reflecting the Company’s investment in drug discovery activity and its continued development of lead drug candidates.
Total loss after tax was £1,135,000 or 2.44 pence per share (2017: £6,782,000 or 16.88 pence per share).
Post period end, C4XD completed a £10.1 million fundraise (before expenses) in October 2018 through the placing and open offer of 11,210,674 new ordinary shares in the capital of the Company (Ordinary Shares) at a price of 90 pence (GBX) per Ordinary Share.
Operational highlights
Business model validated

Licensing deal with Indivior in March 2018 for our Orexin-1 antagonist programme; $10 million upfront with up to $284 million in milestone payments.
Discovery Engine progress

C4XD’s proprietary drug asset portfolio has grown from three programmes in 2014 to nine active programmes spread across multiple therapeutic areas.
Disease areas of focus are inflammation, neurodegeneration, immune-oncology/oncology and additional opportunistic areas (e.g., addiction and diabetes).
To date, the Taxonomy3 platform has identified 285 novel, genetically-validated and disease-linked genes that will generate target insights for future discovery programmes in inflammation and neurodegeneration.
Launched Stage 1 of virtual reality-based molecular visualisation tool, 4Sight with the aim of increasing the throughput of the Company’s pre-clinical portfolio by accelerating hit generation and lead optimisation timeframes.
Partnerships

Continued to enhance core, state-of-the-art target identification and drug design capabilities through synergistic strategic partnerships:
o Joint research collaboration with e-Therapeutics plc (AIM:ETX) to identify novel mechanistic insights in Parkinson’s Disease was announced in May 2018.
Senior appointments

Eva-Lotta Allan, Non-Executive Chairman, and Natalie Walter, Non-Executive Director, were appointed to the Board of Directors in July 2018.
Dr Clive Dix, CEO of C4X Discovery, said: "C4X Discovery has had a transformational year in 2018, underlined by the successful completion of our pre-clinical licensing deal with Indivior in March. This pivotal milestone validated our business model. Our pipeline continues to progress, with NRF-2 entering a formal partnering process and excellent in vivo data on IL-17 moving this programme towards partnering. This maturing pipeline, combined with our enhanced commercial capabilities and our innovative collaborations with multiple partners, positions us well to carry out our strategy of becoming the world’s most productive drug discovery engine and delivering returns to our shareholders."

A copy of the final results presentation given by Clive Dix (Chief Executive Officer) will be released later this morning on the Group’s website at www.c4xdiscovery.com.

Analyst conference call today

Dr Clive Dix, Chief Executive Officer, will present the results at 11:30am GMT on 21 November 2018 during a live conference call. A copy of the results presentation will be released later this morning on the Company website at www.c4xdiscovery.com.