1stOncology™: Cancer Intelligence Service – Page 13418 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Transgene secures a €20 Million Revolving Credit Facility with Natixis

On March 18, 2019 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies against cancers and infectious diseases, reported that it has secured a €20 million revolving credit facility with Natixis, the French Corporate and Investment bank (Press release, Transgene, MAR 18, 2019, View Source [SID1234621822]).

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 credit facility will have a 30-month term and Transgene will be able to draw on and repay the facility at its discretion.

Transgene has used its shares in the Chinese biotech company Tasly Biopharmaceuticals as collateral for this loan. As a reminder, Transgene became a Tasly Biopharmaceuticals shareholder in July 2018 and holds 2.5% of its capital as the result of a series of agreements under which Transgene transferred to Tasly Biopharmaceuticals its Chinese rights to T601 and T101, two immunotherapies discovered by Transgene and which are currently being developed by Tasly Biopharmaceuticals in Greater China. Tasly Biopharmaceutials has announced its intention to list its shares on the Hong Kong Stock Exchange.

Jean-Philippe Del, Vice President, Finance, said: "I am glad that we have been able to monetize our shareholding in Tasly Biopharmaceutical to extend our cash runway. With this new loan facility, we now have the funds needed to support our clinical and pre-clinical activities until mid-2020."

Cytovation initiates clinical development programme with CyPep-1,a first-in-class lytic agent for tumor immunotherapy

On March 18, 2019 Cytovation AS, a privately held biotech company, reported that the first patients have been treated in a Phase I clinical study with CyPep-1, a novel therapeutic agent being developed as a new topical therapy for HPV-induced warts (Press release, Cytovation, MAR 18, 2019, View Source [SID1234561559]). The initiation of this clinical trial marks the start of the clinical development of CyPep-1 in dermatology and oncology applications, with a Phase I trial of CyPep-1 in malignant tumors planned to start in the second half of 2019.

First patients treated in a Phase I study with CyPep-1 as an investigational therapy for benign, HPV-induced cutaneous tumors (warts).
Novel targeted lytic mechanism offers broad application for multiple indications.
Further clinical trial in malignant tumors to start in 2H 2019.
CyPep-1 has been designed and developed by Cytovation. It is a first-in-class lytic agent with broad application across benign and malignant tumors as a result of its novel mechanism of action. CyPep- 1 selectively targets tumor cells, forming pores that destabilise and rupture the membrane to kill the cell and release neoantigens into the microenvironment and circulation, while leaving healthy cells intact. The release of neoantigens enables cytotoxic CD8 positive T-cells to mount a systemic immune response offering the possibility of long-lasting immunity against the tumor and, in the case of warts, HPV infection. For more information about the mode of action, click here.

Cytovation has formulated CyPep-1 as a cream for the topical treatment of HPV-induced warts, a large medical need for which there are currently no approved drug therapies. The Company has also developed CyPep-1 as a solution for intra-tumoral injection, as a single agent or in combination with checkpoint inhibitors.

Cytovation’s Chief Scientific Officer, Lars Prestegarden, said: "We are very pleased to achieve this first clinical milestone with CyPep-1 and to begin its formal clinical development. We have designed CyPep-1 to exploit key differences between healthy and tumor cells and have seen strong evidence of its efficacy in preclinical tumor models. We are excited to see if these results can be translated to humans both with this new trial in warts and the future trial in cancer. Both trials are expected to start during 2019 and we are looking forward to reporting first findings later in the year."

The clinical trial with CyPep-1 is a randomized, placebo-controlled, double-blind Phase I study. The study is being conducted at the Centre for Human Drug Research (Leiden, the Netherlands) and will enrol 58 patients with cutaneous warts. Results are expected in the late 2019. (ClinicalTrials.gov Identifier: NCT03846648).

Cellesce Announces License Agreement with Hubrecht Organoid Technology (HUB) for the Expansion of Breast Cancer Organoids at Scale

On March 18, 2019 Cellesce and Hubrecht Organoid Technology (HUB) have reported a licence agreement for the expansion of organoids using Cellesce’s own bioprocessing technology and HUB Organoid Technology for the scale up of breast organoids (Press release, Cellesce, MAR 18, 2019, View Source [SID1234553993]).

Cellesce and HUB have an ongoing agreement for the expansion of organoids using HUB Technology. In a new project, funded by Innovate UK, Cellesce will expand breast cancer organoids using a combination of HUB Organoid Technology and Cellesce’s own bioprocessing technology. The project aims to confirm that breast cancer organoids remain genetically and phenotypically stable and continue to faithfully recapitulate the characteristics of the tumours from which they were originally derived. The project will provide support for the scaling of organoid expansion to generate the quantities of organoids required by commercial and academic researchers in drug discovery programmes.

Cellesce Chief Executive, Dr Mark Treherne, commented: "By partnering with HUB Cellesce will be in a position to provide an integrated drug discovery solution. This will be a comprehensive package that supplies organoids at scale which will increase the impact that organoid models are having on the cancer research community."

"HUB Organoid Technology will benefit from Cellesce’s innovative technology to expand large quantities of organoids such as breast cancer organoids." added Dr Rob Vries, Managing Director of the HUB.

Mogrify Awarded $555,000 USD (£420,000 GBP) Innovate UK Funding to Accelerate Regenerative Cell Therapies

On March 18, 2019 Cell Mogrify Ltd (Mogrify), a UK company aiming to transform the future development of cell therapies, reported that it has been awarded $555,000 USD (£420,000 GBP) funding from Innovate UK, the UK’s innovation agency, through the investment accelerator for innovation in precision medicine (Press release, Mogrify, MAR 18, 2019, View Source [SID1234553931]). This funding will support the application of Mogrify’s bioinformatic approach to transition three cell therapy products to preclinical stage, with potential application in wound healing, and oncology immunotherapy.

Mogrify will utilize its patented systematic big-data approach (Rackham et al., Nature Genetics, 2016) to identify, from next-generation sequencing and gene-regulatory networks, the sets of highly influential and non-redundant transcription factors (in vitro) or small molecules (in vivo), needed to drive the direct conversion of one mature cell type (e.g. fibroblasts) into another (e.g. T cells). The reprogramed cells will then be subjected to a number of functional tests to demonstrate bioequivalence and potential as cell therapies, such as CAR-T for the treatment of cancers.

At present, cells used in cell therapies either need to be extracted and sorted from the patient themselves or a donor, or derived via experimental protocols that can take several years to develop, all of which can delay cell therapies reaching the clinic. Mogrify aims to accelerate this process by using its novel, bioinformatic platform to deliver an efficient, safe and scalable source of cells for the development of multiple personalized regenerative cell therapy products.

Dr. Darrin M. Disley, OBE, CEO, Mogrify, said: "Mogrify’s mission is to place ourselves, and as a result the UK, at the forefront of the next generation of cell therapy companies. By embracing systematic data science approaches built on large-scale transcriptomic, cell regulatory network and epigenetic data we believe better cell therapies can be developed at a lower cost across all therapeutic areas. The funding from Innovate UK will enable Mogrify to expand its portfolio of cell types and extend its reach into new therapeutics areas to address the global cell therapy opportunity, worth an estimated $30 billion USD."

Professor Julian Gough, PhD, Co-founder and CSO, Mogrify, said: "We have already used our bioinformatic-approach to produce chondrocytes and microvascular endothelial cells by transdifferentiation and speed up the protocols for acquiring astrocytes, neurons and chondrocytes from induced pluripotent stem cells. We are already engaging with companies that would like us to support development of autologous and allogeneic T-cell therapies, and are confident that our technology has the potential to provide a platform technology on which any cell for cell therapy can be developed."

Rackham OJL et al. A predictive computational framework for direct reprogramming between human cell types. Nature Genetics. 2016 Mar;48(3):331-5. doi: 10.1038/ng.3487. Epub 2016 Jan 18.

IMV and Centre de Recherche du CHU de Québec-Université Laval Collaboration Awarded a CQDM Grant to Develop First-in-Class Dual Target T Cell Therapy in Bladder Cancer Based on IMV’s DPX Technology

On March 18, 2019 IMV Inc. (IMV) (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology corporation, reported that Canadian bioresearch consortium CQDM has awarded a grant to a collaboration among IMV, Centre de recherche du CHU de Québec-Université Laval, and La Fondation du CHU de Québec (FCHUQc) (Press release, IMV, MAR 18, 2019, View Source [SID1234553817]).

Under the leadership of Yves Fradet, M.D., professor of surgery and researcher in cancer immunotherapy, and his team, in collaboration with IMV’s team , this project will receive a grant of up to CAN$1.2M from CQDM and CAN$300,000 from the FCHUQc, to develop a novel dual target T cell therapy for an initial clinical application in bladder cancer.

The work will target immunogenic peptides identified by Dr Fradet’s team from the MAGE protein family member A9 (MAGE-A9). This protein is frequently expressed in various human cancers including bladder, lung, and kidney.1 These peptides will be combined with selected immunogenic peptides from the survivin protein composing the DPX-Survivac T cell drug candidate.

The researchers believe that MAGE-A9 and survivin peptides presented on the surface of cancer cells can be used to program T cells to destroy tumors and may represent ideal targets for anti-cancer T cell immunotherapies. The collaborators will combine these peptides with IMV’s proprietary DPX technology to develop a first-in-class dual target T cell therapy (DPX-SurMAGE).

"We believe that DPX is a truly disruptive technology that enables us to program T cells in vivo in a novel way, and we are grateful that CQDM and its funding partner the Quebec Ministry of Economy and Innovation, along with the FCHUQc, are willing to support this highly innovative program," said Stéphan Fiset, Vice President, Clinical Research at IMV. "Our goal remains to expand the range of patients able to benefit from T cell immunotherapies. This program provides an opportunity for us to collaborate with Dr. Fradet’s team and other experts in the bladder cancer field to advance a potential new candidate for the many patients whose current treatment options are limited."

DPX-SurMAGE will be initially evaluated in preclinical studies. Upon successful completion of these preclinical evaluations, researchers are aiming to test the candidate in two clinical studies in patients with:

Muscle invasive bladder cancer combined with an anti-PD-1 and intermittent low-dose cyclophosphamide (CPA) prior to cystectomy
Low-grade highly recurrent non muscle invasive bladder cancer combined with CPA prior to transurethral resection
"Bladder cancer remains a significant unmet medical need and we believe that a novel T cell therapy directed against two cancer targets that are expressed in the majority of bladder tumors may improve outcomes, particularly for those who are at higher risk of recurrence and progression," said Dr. Fradet. "We are pleased to be working under the support of CQDM and the FCHUQc with our partner IMV, and its novel clinical development approach, to advance the options in this cancer, which has already shown promising response to immunotherapy. This project contributes to position the Centre de recherche du CHU de Québec-Université Laval as a leader in medical innovation."

The project is expected to span a three-year period and will be supported by IMV, CQDM and FCHUQc. As part of the collaboration agreement, IMV holds an exclusive option to in-license intellectual property related to the program.