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10-Q – Quarterly report [Sections 13 or 15(d)]

MultiCell Technologies has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, MultiCell Technologies, APR 14, 2015, View Source [SID1234503000]).

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ThromboGenics and VIB launch New Oncology Company Oncurious NV to develop TB-403 for Pediatric Brain Tumors

On April 14, 2015 ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, reported the foundation of Oncurious NV, a new oncology company that will develop TB-403 for the treatment of pediatric brain tumors. VIB, a leading life sciences institute in Flanders (Belgium), will become a shareholder alongside ThromboGenics in this new oncology venture (Press release, Oncurious, APR 14, 2015, View Source [SID:1234508611]). ThromboGenics will be the majority shareholder.

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TB-403 is a humanized monoclonal antibody against placental growth factor (PlGF). PlGF is expressed in several types of cancer, including medulloblastoma. High expression of the PlGF receptor neuropilin 1 has been shown to correlate with poor overall survival. Medulloblastoma is a rare, life-threatening brain tumor that mainly affects children.

Treatment with TB-403 in relevant animal models for medulloblastoma has demonstrated beneficial effects on tumor growth and survival. The antibody can potentially be used in other pediatric cancer indications, including neuroblastoma.

In February 2013, a paper in Cell (Cell, 152, 1065-76, 2013) highlighted for the first time that PlGF plays a vital role in the brain and that its expression is required for the growth and spread of medulloblastoma. The paper was based on pre-clinical research conducted by Prof Rakesh Jain from the Massachusetts General Hospital at Harvard (Boston) and the team of Prof Peter Carmeliet from VIB/ KU Leuven.

Oncurious now plans to start a Phase I/IIa program with TB-403 in medulloblastoma patients. Enrollment of the first patient is expected for the end of 2015.

The favorable safety profile of TB-403 has already been demonstrated in clinical trials in patients with other diseases.

Cancer Cell publishes data highlighting the potential of BioInvent’s BI-1206 to help overcome antibody drug resistance in cancer therapy

On April 14, 2015 BioInvent International (OMXS: BINV), a biotech company developing novel antibody therapeutics for treatment of cancer, and the University of Southampton reported that the April 13, 2015 online issue of the highly prestigious cancer research journal Cancer Cell features groundbreaking findings that resistance to many types of antibody drugs can be overcome by preventing cancer cells from ‘hiding’ from immune cells (Press release, BioInvent, APR 14, 2015, http://www.bioinvent.com/media-centre/press-releases/release/?ReleaseID=07F3EB5C52AA8F90 [SID:1234506611]). The research was carried out by BioInvent and by scientists at the University of Southampton.

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The research, which was partly funded by Leukaemia & Lymphoma Research and Cancer Research UK, have shown that some cancer cells are able to draw monoclonal antibodies inside themselves, making them invisible to immune cells. However, the researchers showed that a new antibody developed by BioInvent, called BI-1206, can effectively prevent this drug destruction process and enhance cancer killing by binding to a molecule called FcgRIIB. BI-1206 showed success in mice in overcoming resistance to monoclonal antibodies like rituximab, currently used to treat different types of lymphoma and leukaemia. BI-1206 is currently in preclinical development and scheduled to enter Phase I/II clinical testing later this year.

"With more monoclonal antibody treatments being developed, there is an urgent need to understand how tumours become resistant to them and develop ways to overcome it. Not only does BI-1206 appear to be able to reverse resistance to a range of monoclonal antibodies, it is also effective at directly killing cancer cells itself", said Mark Cragg, Professor at SOTON and co-senior author on the paper.

The collaboration was initiated at a Keystone conference in 2009, and has since been led by Dr Björn Frendéus and Dr Ingrid Teige at BioInvent and Professor Mark Cragg and Dr Ali Roghanian at the University of Southampton.

"The collaboration has been extremely rewarding and important for BioInvent’s transition towards becoming an important player in the immuno-oncology space and in development of antibody based cancer immunotherapies. BI-1206 binds very specifically to the inhibitory Fc gamma receptor IIB (CD32B), a receptor that acts as a brake to dampen critical anti-cancer immune cell’s (macrophages) function and to eliminate therapeutic antibodies from the targeted tumour cell surface, both processes reducing efficacy and promoting drug resistance. We are hopeful that the strong preclinical data can be translated into clinically meaningful responses, and look forward to entering clinical testing later this year", said Björn Frendéus, Ph.D., Chief Scientific Officer of BioInvent and co-senior author on the paper.

Michael Oredsson, CEO of BioInvent, said, "BI-1206 is one of several immune modulatory antibodies that BioInvent is developing for treatment of cancer. The first in man study is a signal-seeking study designed to demonstrate the safety of BI-1206, when used alone or in combination with rituximab, and to explore its potential efficacy in treatment of B cell malignancy. I am very pleased with the strong translational collaboration with the University of Southampton, led by Professors Martin Glennie and Mark Cragg and their distinguished clinical colleagues Professor Peter Johnson and Dr Andrew Davies".

Cancer Research Technology and Medivir collaborate to develop new class of cancer drugs

On April 14, 2015 Cancer Research Technology (CRT) and Medivir reported a partnership to develop a new class of drugs that has shown promise for treating a range of different cancers, especially breast and pancreatic cancer (Press release, Cancer Research UK, APR 14, 2015, View Source [SID:1234503012]).

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As part of the collaboration, CRT and Medivir will conduct a two-year research programme to optimize and develop small molecules targeting the cell surface protein ADAM8 (link is external), which has been linked to tumour survival, cell invasion and metastasis.

"Medivir’s significant expertise in protease inhibitor design coupled with CRT’s proven track record in drug development will hopefully pave the way for an exciting new class of cancer drugs." – Dr Keith Blundy, CRT

Under the terms of the agreement Medivir receives an exclusive, global license to research, develop, manufacture and commercialise ADAM8 inhibitor drugs resulting from development. CRT receives an upfront payment and future success milestones as well as royalties on sales which are shared with the academic collaborators.

Blocking ADAM8 in mice with pancreatic cancer prevented the spread of the disease, shrunk tumours and significantly extended lifespan. This is thought to be due to its involvement in cell adhesion, cell migration, inflammation and the growth of blood vessels – key processes that many cancers rely on for growth and development. High levels of the protein have been linked with more aggressive tumours including those in pancreatic, brain, prostate, lung, head and neck, and kidney cancers.

This research will be led by Professor Jörg Bartsch as head of the TransMIT-Project Division for Research in Neuro-Oncology at TransMIT GmbH (link is external), located at Marburg University in Germany, in collaboration with Medivir. Prof. Bartsch previously worked at King’s College London (link is external)where the initial patent application was filed by King’s College IP and Licensing team. Further proof of concept studies were funded by Cancer Research UK at King’s College.

Professor Bartsch said: "We are very glad and excited to see this collaboration come to life. The synergy of expertise between Medivir and our Laboratory forms an excellent platform for successful exploration of this first-in-class approach to targeted therapy against ADAM8. This really is ‘bench-to bedside’ research at its best."

Niklas Prager, Medivir’s CEO, said: "This collaboration is a demonstration of our commitment to advance oncology drug discovery at Medivir and we are pleased to partner with such a renowned institution such as Cancer Research UK, and with Professor Bartsch, a leading researcher in the field."

Dr Keith Blundy, Cancer Research Technology’s chief executive officer, said: "Medivir’s significant expertise in protease inhibitor design coupled with CRT’s proven track record in drug development will hopefully pave the way for an exciting new class of cancer drugs. Exploratory studies indicate that ADAM8 is an attractive target across many types of cancer, and potentially other diseases driven by inflammation, and we look forward to further exploring that promise through this innovative collaboration.

8-K – Current report

On April 14, 2015 Puma Biotechnology reported that it has expanded the second cohort from its Phase II clinical trial of its lead drug candidate PB272 (neratinib) as a single agent in patients with solid tumors who have an activating HER2 mutation (basket trial) (Filing, 8-K, Puma Biotechnology, APR 14, 2015, View Source [SID:1234502999]). The cohort that has been expanded is the cohort that includes patients with metastatic non-small cell lung cancer and whose tumors have a HER2 mutation.

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The Phase II basket trial, which was initiated in October 2013, is an open-label, multicenter, multinational study to evaluate the safety and efficacy of PB272 administered daily to patients who have solid tumors with activating (driver) ERBB mutations, including epidermal growth factor receptor (EGFR), HER2 and HER3. The cohorts (baskets) included in the study are (1) bladder/urinary tract cancer; (2) breast cancer; (3) colorectal cancer; (4) endometrial cancer; (5) gastric/esophageal cancer; (6) ovarian cancer; (7) all other solid tumors with a HER2 mutation; (8) EGFR mutated and/or amplified primary brain cancer; and (9) solid tumors with a HER3 mutation. The non-small cell lung cancer (NSCLC) patients initially entered the study in the "other solid tumors with a HER2 mutation" basket and due to the preliminary activity seen in the trial the Company has expanded the basket, as per the protocol for the trial. The expanded HER2 mutant NSCLC basket will now enroll a total of 18 patients.

Last year at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2014 Congress, Puma presented initial data from the Phase II clinical trial of PB272 (neratinib) for the treatment of patients with NSCLC with somatic HER2 mutations. The efficacy results from the trial showed that for the 13 patients in the trial who received neratinib monotherapy, no patient experienced a partial response, 7 (54%) patients achieved stable disease and 4 (31%) patients achieved clinical benefit (defined as a partial response or stable disease for 12 or more weeks). In addition, the median progression free survival of the neratinib monotherapy arm was 2.9 months. In that study, the majority of the patients had the YVMA exon 20 mutation and there was less representation from other HER2 mutations. In the patients with NSCLC who have been treated in the basket study thus far, a much more diverse and a broader representation of HER2 mutations has been seen. The Company believes that although it is early and difficult to draw definitive conclusions, it appears that neratinib may be more selectively active in some HER2 mutated NSCLC tumors compared to others, which may account for the difference in activity being seen in the HER2 mutated NSCLC patients treated in the basket trial compared to those treated in the prior trial. The Company will continue to monitor this activity as the trial progresses.

"We are pleased to expand the second cohort in the basket trial. Although it is early, we are pleased with the initial activity that we are seeing in the patients with HER2 mutated non-small cell lung cancer in the trial," said Alan H. Auerbach, Chief Executive Officer and President of Puma. "We look forward to continuing enrollment into this initially expanded cohort and we look forward to expanding additional cohorts from the basket trial, which we anticipate being able to do later this year."

About Puma Biotechnology

Puma Biotechnology, Inc. is a development stage biopharmaceutical company that acquires and develops innovative products for the treatment of various forms of cancer. The Company focuses on in-licensing drug candidates that are undergoing or have already completed initial clinical testing for the treatment of cancer and then seeks to further develop those drug candidates for commercial use. The Company is initially focused on the development of PB272 (oral neratinib), a potent irreversible tyrosine kinase inhibitor, for the treatment of patients with HER2-positive breast cancer and patients with non-small cell lung cancer, breast cancer and other solid tumors that have a HER2 mutation.