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Cantargia to Present New Data from Preclinical Studies with CAN04 in Non-Small Cell Lung Cancer

On October 20, 2016 Cantargia AB ("Cantargia") reported that it will be presenting new data at the Protein & Antibody Engineering Summit ("PEGS (View Source)"), an international scientific conference to be held in Lisbon, Portugal, from October 31st to November 4th 2016 (Press release, Cantargia, OCT 20, 2016, View Source [SID1234515952]). The company will be presenting data from preclinical studies in non-small cell lung cancer, where the product candidate CAN04, a humanised antibody against the IL1RAP target molecule, has been investigated. The presentation will take place on October 31st 2016.

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With the ambition of developing a new cancer therapy, Cantargia has developed a fully humanised antibody, CAN04, which binds with high affinity to Interleukin-1 Receptor Associated Protein ("IL1RAP"). The antibody blocks signalling from the inflammatory cytokine IL-1, which in turn reduces signals that promote tumour growth and survival. Cantargia has previously shown that antibodies against IL1RAP can stimulate killing of tumour cells in various preclinical PDX-models of leukemia.

In the new study Cantargia shows that high levels of IL1RAP are expressed also in several different solid tumours, including non-small cell lung cancer. CAN04 treatment of various solid tumour cell lines with IL1RAP on the cell surface led to a reduced secretion of the inflammatory and tumorigenic cytokines IL-6 and IL-8. CAN04 also stimulated cells from the immune system to directly destroy these tumour cells. In a PDX model, mice were transplanted directly with tumour cells from a patient with non-small cell lung cancer. In this model a microenvironment is developed in the tumour that is not obtained in classical cell line-based models. A statistically significant treatment effect was obtained with CAN04 in the study.

"We are very pleased to present new data on CAN04 at an important scientific conference. In addition to the documented effect in various models of non-small cell lung cancer, including a very aggressive PDX model, these results constitute an important base for continued studies of CAN04 both as monotherapy and in combination with other drugs", Göran Forsberg, CEO, says.

The poster, The CAN04 antibody targets IL1RAP and inhibits tumor growth in a PDX model for NSCLC, will be available at www.cantargia.com after the presentation.

This constitutes information that Cantargia is required to publish under the EU’s Market Abuse Regulation. The information was submitted for publication through the above contact person on 20 October 2016, at 08.30.

New compound shows promise in treating multiple human cancers

On October 20 2016 Servier, headquartered in France, and Vernalis (R&D), a company based in the UK, reported that a new compound, discovered jointly by international pharmaceutical company has been shown by researchers at the Walter and Eliza Hall Institute and Servier to block a protein that is essential for the sustained growth of up to a quarter of all cancers (Press release, Servier, OCT 20, 2016, View Source [SID1234515950]).

The research presents a new way to efficiently kill these cancerous cells and holds promise for the treatment of blood cancers such as acute myeloid leukaemia, lymphoma and multiple myeloma, as well as solid cancers such as melanoma and cancers of the lung and breast. It is published online today in the journal Nature.

The Servier compound – S63845 – targets a protein of the BCL2 family, called MCL1, which is essential for the sustained survival of these cancer cells.

Institute scientist Associate Professor Guillaume Lessene, who led the Walter and Eliza Hall Institute’s research team in Melbourne, Australia, said the work provided the first clear preclinical evidence that inhibiting MCL1 was effective in targeting several cancer types.
"MCL1 is important for many cancers because it is a pro-survival protein that allows the cancerous cells to evade the process of programmed cell death that normally removes cancer cells from the body," Associate Professor Lessene said. "Extensive studies performed in a variety of cancer models have shown that S63845 potently targets cancer cells dependent on MCL1 for their survival."

The institute team of Associate Professor Lessene worked with haematologist Associate Professor Andrew Wei and Dr Donia Moujalled from The Alfred Hospital and Servier scientists, to demonstrate that not only was S63845 effective against several cancer types, but that it could also be delivered at doses that were well tolerated by normal cells.

Dr Olivier Geneste, Director of Oncology Research at Servier, said: "This preclinical research and the identification of drug candidates confirm the potential of MCL1 as a therapeutic target in cancers. S63845 was discovered through collaboration with the fragment and structure based discovery expertise at Vernalis. As part of the ongoing Servier / Novartis collaboration on this target class, clinical development of a MCL1 inhibitor should be launched in the near future."

Associate Professor Lessene said the research provided further evidence of the usefulness of a new class of anti-cancer drugs called BH3 mimetics. "BH3 mimetics inhibit a group of proteins known as the ‘pro-survival BCL-2 proteins’," he said. "MCL1 is a member of this protein family, and inhibiting it activates the process of programmed cell death. Walter and Eliza Hall Institute researchers revealed the role of BCL-2 in cancer more than 28 years ago and the essential role of MCL1 for the survival of malignant cells four years ago."

The research was supported through a research collaboration with Servier and through funding from the National Health and Medical Research Council of Australia, the Leukemia and Lymphoma Society (US), Cancer Council Victoria, the Kay Kendall Leukemia Fund, Victorian Cancer Agency, Australian Cancer Research Foundation, the Victorian Government Operational Infrastructure Scheme and the estate of Anthony Redstone.

The Walter and Eliza Hall Institute is the research powerhouse of the Victorian Comprehensive Cancer Centre, an alliance of leading Victorian hospitals and research centres committed to controlling cancer.

Transgenomic and Precipio Diagnostics Announce Planned Merger

On October 12, 2016 Transgenomic, Inc. (NASDAQ:TBIO), and privately-held Precipio Diagnostics, LLC reported entry into a merger agreement, pursuant to which Precipio will become a wholly owned subsidiary of Transgenomic, and Transgenomic will be renamed Precipio, Inc (Press release, Transgenomic, OCT 20, 2016, View Source [SID1234515937]). In connection with the merger, it is anticipated that the original Precipio security holders will receive between 62% and 80% of the outstanding shares of the combined company, depending on the relative amount of outstanding liabilities of the parties at closing and prior to the investment of new capital. The merger is expected to close in 2016, pending approval by Transgenomic shareholders and other closing conditions set forth in the merger agreement. Simultaneous to the merger, the combined company will receive an investment of up to $7 million from a syndicate led by BV Advisory Partners in a private placement of preferred convertible securities, and $3.0 million of outstanding debt of each company is expected to convert into this same class of preferred convertible securities. This comprehensive transaction will provide the Company with a clean balance sheet and sufficient capital to achieve its planned expansion.

Transgenomic has filed to complete a reverse stock split of between one-for-ten and one-for-thirty before the merger closes, and the company’s outstanding debt is expected to convert into common and preferred shares. The companies expect that shares of the combined company will be listed on the NASDAQ exchange and trade under the "PRPO" ticker (subject to filing and approval by NASDAQ). The merger agreement provides that, Ilan Danieli, Precipio founder and Chief Executive Officer, will serve as the Chief Executive Officer of the combined company. BV Advisory Partners is acting as advisor to the transaction.

Paul Kinnon, Transgenomic President and Chief Executive Officer, said "In recent years we have transitioned from a provider of conventional life science tools and diagnostic services into an innovative biotechnology enterprise focused on advancing precision medicine. We have done this through our revolutionary ICE COLD-PCR (ICP) technology, which enables accurate, non-invasive tumor profiling using circulating DNA in patient plasma. We have established a solid platform for commercialization of ICP, with leading global distributors and a solid pipeline of potential agreements with partners and customers. This is a good time to join forces with Precipio, which shares our commitment to accurate and timely advanced cancer diagnostics and has established an impressive infrastructure of academic experts and a growing customer base, validated by successful case studies. I look forward to working with my new colleagues to ensure a successful transition."

Ilan Danieli, Precipio founder and Chief Executive Officer, said "We are proud of Precipio’s progress in building a growing platform that provides unique services to cancer patients and their physicians by providing a demonstrated superior level of diagnostic accuracy, ensuring that patients receive the best possible treatment. Cancer misdiagnosis is an all too common and underappreciated problem, which frequently has a negative impact on patient treatment, and may cause needless loss of life. We provide both primary and second opinion screening, and our network of leading academic cancer researchers and advanced diagnostic technologies have proven to be an invaluable resource for patients and physicians. Our entire team is committed to ensuring that our services are made widely available. To that end we will continue building out our sales team to accelerate adoption and revenue growth. We believe Transgenomic’s ICP technology and commercial infrastructure fit well with our values and our business model, and look forward to this next stage of growth, as we work together to integrate our teams, technologies and services."

Keith Barksdale, Founder of BV Advisory Partners, commented, "Transgenomic and Precipio have complementary strengths with the potential to be a dynamic and strong competitor in the rapidly growing market for advanced cancer diagnostics. ICP is a revolutionary mutation detection technology that is now available through global distributors, and adoption by drug researchers and developers is ramping up. The technology is also available to help guide cancer diagnosis and treatment through Transgenomic’s CLIA laboratory. Precipio’s platform of leading academic cancer experts provides superior diagnostic accuracy level to oncologists and their patients; it represents a unique resource that can benefit from and leverage the power of ICE COLD-PCR. We look forward to working with the combined company going forward to help assure its growth and success."

Transgenomic’s ICE COLD-PCR offers major advantages over current sequencing technologies. It delivers at least a 100-fold improvement in sensitivity compared to standard methodologies, allowing detection of both known and previously unknown genetic alterations in any exon of any gene using a single assay. It is robust, easy to use and easily implemented, requiring minimal disruption to established sequencing workflows. It is available as ICEme Kits that deliver up to a 500-fold increase in mutation detection compared to most current methods, with levels of detection routinely achievable down to 0.01%. This ultra-high sensitivity enables detection of low level mutations and allows accurate patient monitoring as well as stratification of cancer sub-populations. ICEme Kits are compatible with most patient samples, including tissue, blood, plasma, urine and other biofluids. The kits are simple to use and work with most of the genomic analysis platforms available in laboratories today. They are easily customizable for use with single mutations or multiple mutations in combination. The current menu includes approximately 20 clinically relevant, actionable mutations that are associated with important cancers. The ICP range of mutation targets is being expanded on an ongoing basis.

ICE COLD-PCR was originally developed by the laboratory of Dr. Mike Makrigiorgos at the Dana-Farber Cancer Institute, which has exclusively licensed rights to the technology exclusively to Transgenomic.

Transgene Reports Third Quarter 2016 Financial Results

On October 20, 2016 Transgene (Euronext Paris:TNG), a company focused on discovering and developing targeted immunotherapies for the treatment of cancer and infectious diseases, reported its quarterly financial results as of September 30, 2016 (Press release, Transgene, OCT 20, 2016, View Source [SID1234515936]). The Company also announced today the launch of a share capital increase with shareholders’ preferential subscription rights for a total gross amount of c. €48.1 million.

Operating revenue:

The following table summarizes the third quarter operating revenue1 for 2016 compared to the same period in 2015:

Q3 First Nine Months
In million euros 2016 2015 2016 2015

Revenue from collaborative and licensing agreements 0.1 0.4 2.0 1.1
Government financing for research expenditures 1.4 1.9 4.4 6.4

Operating revenue 1.5 2.3 6.4 7.5

_______________

1 Excluding revenue from discontinued operations

During the third quarter of 2016, revenue from collaborative and licensing agreements was mainly composed of research services and royalties.

As of September 30, 2016, government financing for research expenditures mainly consisted of 75% of the research tax credit expected for 2016 (€4.4 million in the third quarter of 2016 versus €6.2 million over the same period in 2015). This decrease was due to lower eligible research and development expenses, explained by the restructuring of the Company.

Cash, cash equivalents, available-for-sale financial assets and other financial assets:

Cash, cash equivalents, available-for-sale financial assets and other financial assets stood at €25.4 million as of September 30, 2016, compared to €31.7 million as of December 31, 2015.

In the first nine months of 2016, Transgene’s cash burn was €16.3 million (excluding EIB loan), compared to €19.8 million for the same period in 2015. Cash burn was €8.2 million in the first half of 2016 and €8.1 million in the third quarter of 2016.

Net cash outflows linked to the restructuring plan amounted to €4.2 million over the period. Excluding the above disbursements, cash burn stood at €12.1 million in the first nine months of 2016, reflecting the positive effects of the reorganization plan.

Key achievements:

Since June 2016, Transgene continued rolling out its clinical development program, in line with the strategy aimed at combining Transgene’s immunotherapies with other immunotherapy treatment approaches, in particular immune checkpoint inhibitors (ICIs).

The development programs have progressed as follows:

Therapeutic vaccines:
TG4010: strategy focused on combination trials with ICIs in lung cancer. Two Phase 2 clinical trials are being prepared, in 1st and 2nd line of treatment of non-small cell lung cancer. The 2nd line clinical trial of TG4010 in combination with Opdivo (nivolumab), conducted by UC Davis Medical Center (USA), is expected to start in H2 2016.
TG4001: Transgene signed an agreement with Merck KGaA, Darmstadt, Germany, and Pfizer, to evaluate TG4001 and Avelumab in HPV-positive, advanced head and neck cancers. This Phase 1/2 trial is expected to start in H1 2017.
TG1050: the Phase 1/1b clinical trial is moving forward with the recruitment of the first patients that will receive multiple doses of TG1050, a therapeutic vaccine against chronic hepatitis B. This step follows the positive recommendation of the Safety Review Committee in July 2016.
Oncolytic viruses:
Pexa-Vec: ongoing recruitment and first patient in Europe expected at the very end of the year for this Phase 3 clinical trial in 1st line of hepatocellular carcinoma (HCC). Two Phase 2 clinical trials combining Pexa-Vec with ICIs are in preparation. Transgene confirms that a Phase 2 trial evaluating Pexa-Vec in combination with ipilimumab in solid tumors will start in H2 2016. The initiation of the Phase 2 trial of this oncolytic virus associated with nivolumab in advance primary liver cancer (HCC) is expected for H1 2017.
TG6002: preparation of the Phase 1 clinical trial in glioblastoma, expected to start in H1 2017.
Also, early October 2016, at the 10th International Meeting on Replicating Oncolytic Virus Therapeutics (Vancouver, Canada), Transgene presented a new generation of replicative oncolytic virus with improved cytotoxic activity in resistant tumor cell lines thanks to the vectorization of intrabodies. This original approach opens new possibilities for engineering the next generation of armed oncolytic viruses and confirms Transgene’s innovation capabilities and unique R&D know-how.

Outlook:

Transgene confirms that it expects 2016 cash burn to be around €35 million.

The Company announced today the launch of a share capital increase with shareholders’ preferential subscription rights. Institut Mérieux, Transgene’s reference shareholder via its affiliate TSGH, has committed to participate in this transaction and to subscribe up to 75% of the total number of the new shares, materializing its commitment, made at the beginning of the year, to bring additional funding to the Company.

Unum Therapeutics to Present on its Antibody-Coupled T-Cell Receptor (ACTR) Platform at the American Association for Cancer Research (AACR) Tumor Immunology and Immunotherapy 2016 Meeting

On October 20, 2016 Unum Therapeutics, a clinical stage biopharmaceutical company developing a universal cellular immunotherapy to treat multiple cancers, reported that the Company has been selected for two poster presentations on its Antibody-Coupled T-Cell Receptor (ACTR) platform at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Tumor Immunology and Immunotherapy 2016 Meeting (Press release, Unum Therapeutics, OCT 20, 2016, View Source [SID1234515935]). The conference will take place on October 20-23, 2016 at the Boston Marriott Copley Place in Boston, MA.

Presentation Details:
Presentation Title: Efficient targeting of HER‐2‐positive cancers by Antibody‐Coupled T cell Receptor (ACTR) engineered autologous T cells
Presenter: Casey B. Judge
Presentation Date: Friday, October 21, 2016
Presentation Time: 5:15 p.m.‐7:45 p.m.
Room: Back Bay Room
Abstract Number: A77

Presentation Title: High throughput triage of the ACTR platform demonstrates broad activity across multiple tumor targets
Presenter: Eugene Choi
Presentation Date: Saturday, October 22, 2016
Presentation Time: 6:00 p.m.‐8:45 p.m.
Room: Back Bay Room
Abstract Number: B60

The posters will be posted on Unum’s website following the presentations.

About Antibody-Coupled T-cell Receptor (ACTR) Technology and ACTR087

Unum’s proprietary ACTR is a chimeric protein that combines components from receptors normally found on two different human immune cell types – natural killer (NK) cells and T-cells – to create a novel cancer cell killing activity. T-cells bearing the ACTR receptor protein can be directed to attack a tumor by combining with a monoclonal antibody that binds antigens on the cancer cell surface.

In contrast to other T-cell therapy approaches for cancer that are limited to a single cancer cell surface target and, therefore, treat a narrow set of tumors, Unum’s approach is not restricted by a specific tumor cell antigen and, thus, may have applications for treating many different types of cancers when combined with the right antibody.

Unum is developing ACTR in combination with a range of tumor-targeting antibodies for use in both hematologic and solid tumor indications. ACTR087, Unum’s most advanced product candidate, combines Unum’s proprietary ACTR, with rituximab, an anti-CD20 antibody. The ACTR087 study will be the first clinical trial using a viral vector to permanently insert the ACTR gene into the genome of patient T-cells.