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Cantargia prepares intensified development strategy and capital raising

On September 20, 2016 Cantargia AB reported that the board has taken a decision on an enhanced development strategy for the company and its product candidate CAN04, and is initiating a project around a new antibody for the treatment of autoimmune and inflammatory diseases (Press release, Cantargia, SEP 20, 2016, View Source [SID:SID1234515265]). To accomplish this, the company plans to conduct a capital raising of approximately MSEK 80, in addition to the capitalization of up to MSEK 25 through the conversion of warrants in October 2016. The decision is planned to be taken at an extraordinary general meeting estimated to be held Q4 2016 / Q1 2017.

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Inclusion of combination therapies in the initial clinical study of CAN04

"Cantargia’s decision to increase the level of ambition in the CAN04 project is among the most important and the most intensified in the company’s history. This marks a major step to enhance the value of the CAN04 project and take greater advantage of the potential around the target IL1RAP (Interleukin 1 Receptor Associated Protein). I feel enthusiastic about the opportunities that open up with our intensified development strategy", says Göran Forsberg, CEO of Cantargia.

The decision has been taken in consultation with international key opinion leaders in the field of solid tumors, and it represents a significantly increased level of ambition in the initial stage of the clinical studies of Cantargia’s product candidate CAN04 against non-small cell lung cancer (NSCLC) and pancreatic cancer. By expanding the study to include combination therapies – where CAN04 is combined with existing standard treatment – Cantargia will receive significantly more data, which allows the company to accelerate the overall development of CAN04. This improves the conditions for a partnership of CAN04. Cancer treatment today is often some form of combination treatment, and in view of the good safety and unique mechanism, CAN04 can potentially be a good substance to combine with other treatments.

The clinical study protocol is still under development. It will be based on an adaptive design which means increased flexibility during the trial. The protocol will provide relevant data on combination therapy and significantly more information than initially planned. During 2017 Cantargia plans to start preclinical studies with different types of combination therapies to support the clinical development.

The clinical study of CAN04 is now planned to start during the first half of 2017, and a presentation of the phase I data is planned about a year after the start of the study. More data will be generated continuously, but based on the first data set, the foundation is laid for Cantargia’s ambition to find a partner who can take responsibility for the latter stages of clinical development. When phase I data are reported, in addition to the current study, the company also intends to finalize a protocol and start a clinical phase IIa trial for leukemia.

The next step in the production development of CAN04

In June 2016, Cantargia decided to invest in the further optimization of its production processes, which has resulted in a production process that can be used to produce material for initial clinical trials. Because of the company’s development strategy, the production process needs, however, to be carried out in a larger scale and at a higher cost than initially planned. Therefore, as part of the more aggressive clinical development of CAN04, Cantargia plans to invest in further process development of a production method that meets the requirements in subsequent clinical studies. Like other antibody production processes, substantial development activity and process optimization are needed between early and late clinical phase in order to increase yields and ensure a robust production. Through the investment in the production process, a better opportunity to take advantage of the time savings made in the overall clinical development is created.

Start of a new project against autoimmunity and inflammation

Cantargia intends to initiate the development of a new antibody against IL1RAP with properties optimized for the treatment of autoimmune and inflammatory diseases. IL1RAP mediates signals of both the cytokines IL-1 and IL-33, which have a role in several severe autoimmune and inflammatory diseases. The project is planned to start in 2017, and the goal is to select a clinical candidate that can enter development at the end of 2018 or the beginning of 2019.

By starting a new project against a disease segment that complements CAN04 in cancer treatment, the company gets a risk spreading that according to the board of directors is considered very attractive. In addition, the knowledge and tools developed within the CAN04 project gives a pronounced synergy between the two projects.

"The goal is that within our existing or new antibody libraries identify and optimize antibodies that inhibit both IL-1 and IL-33 activity to treat autoimmune and inflammatory diseases", says Göran Forsberg.

Planned future capitalization process

In order to carry out the activities presented above, Cantargia’s board assess that the company has an additional need of capital of about MSEK 80 until mid 2018, in addition to what has been previously announced. Further information on the planned capitalization is planned to be published in Q4 2016 or Q1 2017. In addition, the capitalization also includes the conversion of warrants of series TO 2 and TO 4 in October 2016. If fully exercised, these warrants add a total of about MSEK 25 before issue costs to Cantargia.

Cantargia’s board is expected to evaluate the opportunities and strategic options available for the company’s next development stage during mid 2018.

Certified Adviser: Sedermera Fondkommission

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 September 2016, at 8:00 am.

Abilita Bio, Inc. Awarded NCI Phase-I SBIR Grant to Develop Therapeutic Antibodies Targeting Metastatic Breast Cancer

On September 20, 2016 Abilita Bio, Inc. reported that it has been awarded a Phase I Small Business Innovation Research (SBIR) grant from the National Cancer Institute (NCI) to develop therapeutic antibodies targeting G Protein-Coupled Receptors (GPCRs) involved in the metastasis of breast cancer, including prostaglandin E2 receptor 2 (EP2), prostaglandin E2 receptor 4 (EP4), and C-C chemokine receptor 7 (CCR7) (Press release, Abilita Bio, SEP 20, 2016, View Source [SID:SID1234515259]). With an estimated 1.7 million new cases each year, breast cancer is the most common cancer among women worldwide. It is also the leading cause of cancer death among women, taking the lives of over 450,000 annually. In addition to the patients who are diagnosed with metastatic disease at initial diagnosis, nearly 30 percent of women diagnosed with early breast cancer will eventually develop metastatic disease.

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The chemokine receptor CCR7 is highly expressed in human breast cancer cells, malignant breast tumors and metastases, and overexpression correlates with larger primary tumors, deeper lymphatic invasion and poor prognosis. EP2 and EP4 receptors are positively correlated with increased breast cancer metastasis and have been implicated in suppression of the antitumor activity of natural killer cells. Given the body of evidence that implicates CCR7, EP2 and EP4 in cancer metastasis and immunosuppression, targeted inhibitory antibody therapeutics may address unmet needs in breast cancer therapy.

GPCRs have been proven to be challenging targets for antibody discovery due to low cell surface expression, lack of immunogenicity and marginal conformational stability when removed from the membrane. To address these limitations, Abilita Bio will leverage its directed evolution technology to rapidly generate enhanced GPCR antigens called EMPs (Enabled Membrane Proteins) that can be used for discovery and development of therapeutic antibodies targeting CCR7, EP2 and EP4 for the prevention or treatment of metastatic breast cancer.

"Antibody therapeutics against GPCRs have tremendous potential in treating cancer due to their exquisite specificity, high affinity and low toxicity relative to small molecules. However, despite intense efforts to develop them, only one GPCR targeted therapeutic antibody has gained approval in the world," said Mauro Mileni, Ph.D., Abilita Bio’s CEO and principal investigator on this grant. "We expect the use of EMPs as antigens to dramatically increase the probability of discovering new therapeutic antibodies to treat serious diseases, while reducing costs and development timelines."

About GPCRs
G Protein-Coupled Receptors (GPCRs) represent the largest class of membrane proteins in humans, and bind almost all of the known neurotransmitters and hormones that are released synaptically or secreted into the circulatory system. GPCRs are expressed in all tissue types and organs, and are associated with many diseases. The GPCR super-family includes approximately 400 medically relevant targets. To date more than 110 receptors have been exploited as drug targets, while most of the remaining receptors are orphan (130) or under-characterized.

Mirna Therapeutics Halts Phase 1 Clinical Study of MRX34

On September 20, 2016 Mirna Therapeutics, Inc. (Nasdaq:MIRN), a clinical stage biopharmaceutical company, reported its decision to close the ongoing Phase 1 study of MRX34, its investigational microRNA therapy for multiple cancers (Press release, Mirna Therapeutics, SEP 20, 2016, View Source [SID:SID1234515258]). The Company voluntarily halted enrollment and dosing in the clinical study following multiple immune-related severe adverse events (SAE) observed in patients dosed with MRX34 over the course of the trial.

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"Patient safety is the primary objective of our MRX34 Phase 1 clinical trial," said President and CEO Paul Lammers, M.D., M.Sc. "We made the difficult decision to close the study after a fifth, immune-related serious adverse event was recently reported by one of our clinical sites. This patient experienced severe (Grade 4) cytokine release syndrome and is undergoing treatment. We have notified the U.S. FDA and the Korean FDA of our decision and are in the process of closing the trial."

Mirna also announced that it will not be initiating a translational medicine study of MRX34 in melanoma patients, planned to begin later this year. The Company will be further analyzing its full preclinical and clinical data set, and will discuss with its advisors, as well as the FDA, possible future development of MRX34 and will provide updates when appropriate.

Puma Biotechnology Announces U.S. FDA Acceptance of New Drug Application for PB272 (Neratinib) for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer

On September 20, 2016 Puma Biotechnology, Inc. (NYSE: PBYI), a biopharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for its lead product candidate PB272 (neratinib) for the extended adjuvant treatment of patients with early stage HER2-overexpressed/amplified breast cancer who have received prior adjuvant trastuzumab (Herceptin)-based therapy (Press release, Puma Biotechnology, SEP 20, 2016, View Source [SID:SID1234515251]).

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"The FDA acceptance of our NDA is an important regulatory milestone," said Alan H. Auerbach, Chief Executive Officer and President of Puma. "Although the use of trastuzumab in the adjuvant setting has led to a reduction in disease recurrence in patients with early stage HER2-positive breast cancer, there remains an unmet clinical need to further reduce the risk of recurrence and improve outcome following trastuzumab therapy. We believe that neratinib may be able to provide this type of improvement to further help patients with this disease. We look forward to working with the FDA during their review of this submission."

The submission is supported by the results of the ExteNET Phase III study, in which treatment with neratinib resulted in a 33% reduction of risk of invasive disease recurrence or death versus placebo (hazard ratio = 0.67, p = 0.009). The 2-year invasive disease free survival (DFS) rate for the neratinib arm was 93.9% and the 2-year invasive DFS rate for the placebo arm was 91.6%. For the pre-defined subgroup of patients with hormone receptor positive disease, the results of the trial demonstrated that treatment with neratinib resulted in a 49% reduction of risk of invasive disease recurrence or death versus placebo (hazard ratio = 0.51, p = 0.001). For the patients with hormone receptor positive disease, the 2-year invasive DFS rate for the neratinib arm was 95.4% and the 2-year invasive DFS rate for the placebo arm was 91.2%.

Results of the study were published online in The Lancet Oncology on February 10, 2016.

The most frequently observed adverse event for the neratinib-treated patients was diarrhea, with approximately 39.9% of the neratinib-treated patients experiencing grade 3 or higher diarrhea (1 patient (0.1%) had grade 4 diarrhea). Patients who received neratinib in the ExteNET trial did not receive any prophylaxis with antidiarrheal agents to prevent the neratinib-related diarrhea. In patients with HER2-positive early stage breast cancer who have previously been treated with adjuvant trastuzumab and received anti-diarrheal prophylaxis with loperamide, interim results of a Phase II study of neratinib monotherapy demonstrated that treatment with prophylactic loperamide reduced the rate of grade 3 or higher diarrhea to between 13.0% and 18.5%.

About ExteNET

The ExteNET trial is a double-blind, placebo-controlled, Phase III trial of neratinib versus placebo after adjuvant treatment with trastuzumab (Herceptin) in women with early stage HER2-positive breast cancer. The trial randomized 2,840 patients in 41 countries with early-stage HER2-positive breast cancer who had undergone surgery and adjuvant treatment with trastuzumab. After completion of adjuvant treatment with trastuzumab, patients were randomized to receive extended adjuvant treatment with either neratinib or placebo for a period of one year. Patients were then followed for recurrent disease, ductal carcinoma in situ (DCIS), or death for a period of two years after randomization in the trial. The primary endpoint of the trial was invasive DFS.

Kite Pharma Announces Exclusive License with the National Institutes of Health for Multiple Neoantigen Directed T-Cell Receptor (TCR) Product Candidates to Treat Solid Tumors Expressing Mutated KRAS

On September 20, 2016 Kite Pharma, Inc. (Nasdaq:KITE), a clinical-stage biopharmaceutical company focused on developing engineered autologous T-cell therapy (eACT) products for the treatment of cancer, reported that the Company has entered into an exclusive, worldwide license with the National Institutes of Health (NIH) for intellectual property related to multiple T-cell receptor (TCR) based product candidates for the treatment of tumors expressing mutated KRAS antigens (Press release, Kite Pharma, SEP 20, 2016, View Source [SID:SID1234515250]).

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Kite expects the first of the licensed KRAS product candidates to enter clinical study in 2016 as part of the Company’s Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) under the direction of Steven A. Rosenberg, M.D., Ph.D., Chief of the Surgery Branch at the NCI.

KRAS is one of the most commonly mutated genes in all of human cancer and is involved in a broad range of solid tumors, such as pancreatic, colorectal, and lung cancer, for which there are significant unmet medical needs.

"Neoantigens are uniquely present in tumors but absent in healthy tissue which makes them attractive targets for using our TCR technology," stated Arie Belldegrun, M.D., FACS, Kite’s Chairman, President and Chief Executive Officer. "Kite has taken an important step toward building the first therapeutic franchise of its kind for cancers driven by KRAS mutations and has further expanded its efforts in building a TCR portfolio across key classes of antigens, including cancer testis and viral antigens."

Pursuant to the terms of the license agreement, NIH will receive from Kite an upfront payment and certain clinical, regulatory, and sales milestone payments, as well as royalties on net sales of products covered by the license.