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.

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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.

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]).

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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.

On March 18, 2019 Alligator Bioscience (Nasdaq Stockholm: ATORX), reported that they will present preclinical data for the drug candidate ATOR-1017 at the 4th Annual Immuno-oncology Summit Europe, to be held in London on March 18-22, 2019 (Press release, Alligator Bioscience, MAR 18, 2019, View Source [SID1234538668]).

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ATOR-1017 is a monoclonal antibody in development for the treatment of metastasizing cancer. It activates the costimulatory receptor 4-1BB and its immunostimulatory function is dependent on cross-linking to Fc-gamma receptors on immune cells.

The new data show that ATOR-1017, in an experimental model for colon cancer (MC38), displays potent anti-tumor effects. Furthermore, ATOR-1017 induces a dose-dependent effect on tumor growth inhibition and survival. Existing preclinical data have already shown that ATOR-1017 stimulates both NK (Natural Killer) and T cells, both of which contribute to an effective immune-mediated killing of tumor cells.

"ATOR-1017 is designed to have a superior safety and efficacy profile through its tumor-directed properties and these latest data support the positioning of ATOR-1017 as a best-in-class 4-1BB antibody with the potential to reduce side effects, but also to generate a potent and long-lasting immune response. This provide us with a strong preclinical package to move into the next phase of development. We expect to start clinical trials in cancer patients later this year," said Christina Furebring, SVP Preclinical Development, at Alligator Bioscience.

Dr Karin Enell Smith, Senior Scientist Immuno-oncology at Alligator, will hold an oral presentation with the title: "ATOR-1017 – A Tumor Directed Fcγ-Receptor Cross Linking Dependent 4-1BB Agonistic Antibody" on Monday, March 18, 5:45 p.m GMT (6:45 p.m. CET).

For further information, please contact:
Cecilia Hofvander, Director Investor Relations & Communications
Phone +46 46 540 82 06
E-mail: [email protected]

This information is such information as Alligator Bioscience AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 1:30 p.m. CET on March 18, 2019.

About ATOR-1017
ATOR-1017 is an immunostimulatory antibody (IgG4) that binds to the costimulatory receptor 4-1BB (also known as CD137) expressed on tumor-specific T cells and NK cells.
4-1BB has the capacity to support the immune cells involved in tumor control, making 4-1BB a particularly attractive target for cancer immunotherapy.

ATOR-1017 is differentiated from other 4-1BB antibodies, partly because of its unique binding profile, but also because its immunostimulatory function is dependent on cross-linking to Fc-gamma receptors on immune cells. The aim is to achieve effective tumor-targeted immune stimulation with minimum side effects. ATOR-1017 is planned to enter clinical studies 2019.

On March 18, 2019 Helix BioPharma Corp. (TSX: HBP) (FRANKFURT: HBP) ("Helix" or the "Company"), a clinical stage immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, reported its financial results for its fiscal second quarter ended January 31, 2019 (Press release, Helix BioPharma, MAR 18, 2019, View Source [SID1234536459]).

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FINANCIAL REVIEW

The Company recorded a net loss and total comprehensive loss of $1,908,000 ($0.02 loss per common share) and $2,564,000 ($0.03 loss per common share) for the three-month periods ended January 31, 2019 and 2018, respectively. For the six-month periods ended January 31, 2019 and 2018, respectively, the Company recorded a net loss and total comprehensive loss of $3,287,000 ($0.03 loss per common share) and $4,868,000 ($0.05 loss per common share).

Research and development

Research and development costs for the three and six-month periods ended January 31, 2019 totalled $1,330,000 and $2,344,000, respectively ($1,895,000 and $3,660,000 respectively for the three and six-month periods ended January 31, 2018).

The following table outlines research and development costs expensed and investment tax credits for the Company’s significant research and development projects for the following periods:

L-DOS47 research and development expenses for the three and six-month periods ended January 31, 2019 totalled $788,000 and $1,649,000, respectively ($1,472,000 and $3,010,000 respectively for the three and six-month periods ended January 31, 2018). L-DOS47 research and development expenditures relate primarily to the Company’s LDOS001 Phase I clinical study in the U.S., and preliminary expenditures related to the Company’s LDOS003 Phase II clinical study in Poland, Ukraine and Hungary.

The Company’s LDOS001 clinical study continues to face patient enrolment challenges. An accelerated dosing protocol has been approved to help accelerate the LDOS001 clinical study. The Company continues to be committed to the LDOS001 study and has re-allocated limited resources to improve patient enrollment. Enrolment in the Company’s LDOS002 clinical study was previously halted at the end of stage 1 of a two-stage phase II study as the intensified schedule did not result in improving patient benefits compared to that observed in the Phase I portion of the study. The Company recently advanced some funds to the CRO overseeing the LDOS003 study and most recently announced the dosing of the first patient. The Company is in the late stages of protocol development for a Phase I/II study with L-DOS47 given in combination with doxorubicin, for the treatment of metastatic pancreatic cancer. The Company expects to file an investigational new drug application with the U.S. Food and Drug Administration for a study protocol targeting advanced pancreatic cancer patients sometime in April/May 2019.

The Company’s Polish subsidiary continues to focus its activities on the V-DOS47 pre-clinical program. V-DOS47 research and development expenses for the three and six-month periods ended January 31, 2019 totalled $102,000 and $232,000, respectively ($94,000 and $177,000 respectively for the three and six-month periods ended January 31, 2018). For the three and six-month periods ended January 31, 2019 the Company’s Polish subsidiary received grant funding of $87,000 and $222,000, respectively ($87,000 and $200,000 respectively for the three and six-month periods ended January 31, 2018). Grant funding for the V-DOS4 program is the result of an agreement entered into with the Polish National Centre for Research and Development.

CAR-T research and development expenses for the three and six-month periods ended January 31, 2019 totalled $333,000 and $333,000 respectively ($125,000 and $125,000 respectively for the three and six-month periods ended January 31, 2018). The Company commenced development of novel CAR-T therapeutics and new antibody-based technologies for cell-based therapies. The Company’s CAR-T expenditures relate primarily to collaborative research activities with ProMab Biotechnologies Inc.

Trademark and patent related expenses for the three and six-month periods ended January 31, 2019 totalled $43,000 and $68,000, respectively ($139,000 and $238,000 respectively for the three and six-month periods ended January 31, 2019). The Company continues to ensure it adequately protects its intellectual property.

Operating, general and administration

Operating, general and administration expenses for the three and six-month periods ended January 31, 2019 and 2018 totalled $533,000 and $906,000, respectively ($644,000 and $1,170,000 respectively for the three and six-month periods ended January 31, 2018). The decrease in operating, general and administration expenses mainly reflects companywide cost cutting initiatives.

The Company recorded a net loss and total comprehensive loss of $1,908,000 ($0.02 loss per common share) and $2,564,000 ($0.03 loss per common share) for the three-month periods ended January 31, 2019 and 2018, respectively. For the six-month periods ended January 31, 2019 and 2018, respectively, the Company recorded a net loss and total comprehensive loss of $3,287,000 ($0.03 loss per common share) and $4,868,000 ($0.05 loss per common share), respectively.

As at January 31, 2019 the Company had a working capital deficiency of $1,998,000, shareholders’ deficiency of $1,686,000 and a deficit of $167,292,000. As at July 31, 2018 the Company had a working capital deficiency of $1,901,000, shareholders’ deficiency of $1,527,000 and a deficit of $164,005,000.

The Company continues to work with vendors to manage its cash position while ensuring vendors continue providing services while being paid, albeit over a longer period of time than previously agreed terms. Some vendors have placed the Company on hold (cash in advance) and is impacting the Company’s clinical development program. The Company has raised gross proceeds of approximately $8,518,000 from private placement financings during fiscal 2018 and an additional $3,878,400 during the six-month period ended January 31, 2019. In addition, the Company subsequent to the January 31, 2019 quarter end, announced the closing of a private placement on March 15, 2019 for gross proceeds of $609,450. Nevertheless, the Company’s cash reserves of $306,000 as at January 31, 2019 continue to be insufficient to meet anticipated cash needs for working capital and capital expenditures through the next twelve months, nor are they sufficient to see the current or any planned research and development initiatives through to completion. Though the funds raised have somewhat assisted the Company in dealing with its working capital deficiency and attempts to make vendors current, additional funds are required to advance the various clinical and preclinical programs, pay for the Company’s overhead costs and its past due vendors. To the extent that the Company does not believe it has sufficient liquidity to meet its current obligations, management considers securing additional funds, primarily through the issuance of equity securities of the Company, to be critical for its development needs.

Additional information can be found about the Company’s liquidity and capital resources in the Company’s Management Discussion and Analysis.

The Company’s condensed unaudited interim consolidated statement of net loss and comprehensive loss for the three and six-month periods ending January 31, 2019 and 2018 and the condensed unaudited interim consolidated statement of cash flows for the six-month periods ending January 31, 2019 and 2018 are summarized below:

The Company’s condensed unaudited interim consolidated financial statements and management’s discussion and analysis will be filed under the Company’s profile on SEDAR at www.sedar.com, as well as on the Company’s website.

On March 18, 2019 Personalis, Inc., a leader in advanced genomics for precision oncology, reported that they are scheduled to present at ICI-IO Combinations Summit 2019 in Boston on Wednesday, March 20, 2019 at 2:30 PM, EDT (Press release, Personalis, MAR 18, 2019, View Source [SID1234534801]).

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The presentation, entitled "Challenges and Solutions: Enabling multidimensional tumor immunogenomics for advancing biomarker discovery," will introduce Personalis’ new universal cancer immunogenomics platform, ImmunoID NeXT. In addition to an overview, the presentation will also highlight how this platform can be used to overcome the challenges facing immuno-oncology translational and clinical researchers. By deriving new insights through our industry leading NGS analysis platform, ImmunoID NeXT provides solutions to enable the development of safer, more effective precision oncology therapeutics and combinations.

ImmunoID NeXT is the first and only platform to provide comprehensive analysis of both a tumor and its microenvironment from a single sample. The platform can be used to investigate the key tumor- and immune-related areas of cancer biology; consolidating multiple oncology biomarker assays into one. This maximizes the biological information that can be generated from a precious tumor specimen.

The presentation will be delivered by Christelle Johnson, PhD, Senior Field Application Scientist, Cancer Genomics & Immuno-Oncology.