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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.

8-K – Current report

On April 14, 2015 Teva Pharmaceutical and Eagle Pharmaceuticals reported that the New Drug Application (NDA) for a liquid bendamustine hydrochloride (HCl) rapid infusion product has been accepted for filing by the U.S. Food and Drug Administration (FDA) (Filing, 8-K, Eagle Pharmaceuticals, APR 14, 2015, View Source [SID:1234502996]). The Prescription Drug User Fee Act (PDUFA) goal date for a decision on this NDA by the FDA is December 2015.

This NDA requests FDA approval of the rapid infusion bendamustine HCl product for the treatment of patients with chronic lymphocytic leukemia (CLL) and patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. This product candidate has received Orphan Drug Designations for both CLL and indolent B-cell NHL, and therefore may be eligible for seven years of exclusivity upon approval. The NDA is supported by data from a clinical trial completed in November 2014, which demonstrated that the rapid infusion bendamustine HCl product can be administered in ten minutes in a low-volume, 50 mL admixture.

"The rapid infusion bendamustine product, if approved, will be an important new treatment option for patients with CLL or indolent B-cell NHL that has progressed and their healthcare providers," said Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals. "We look forward to continuing to work closely with the FDA through the review process, and to their decision on the NDA in December of this year."

"We are very pleased the FDA has accepted the rapid infusion bendamustine NDA for review," stated Paul Rittman, Vice President and General Manager, Teva Oncology. "Teva looks forward to the opportunity to bring this product to market, if approved, and we believe it represents an important and improved benefit to both patients and healthcare providers."
In February 2015, Eagle and Teva Pharmaceutical Industries Ltd. entered into an exclusive license agreement for the rapid infusion bendamustine product. Teva will be responsible for all U.S. commercial activities for the product including promotion and distribution. Eagle has responsibility for obtaining all regulatory approvals, conducting post-approval clinical studies, if required, and initially supplying drug product to Teva.

8-K – Current report

On April 14, 2015 Argos Therapeutics and Lummy reported they have entered into a license agreement. Under the terms of the agreement, Lummy HK will license from Argos the rights to manufacture, develop and commercialize AGS-003, Argos’ investigational immunotherapy for the treatment of cancer, in China, Hong Kong, Taiwan and Macau (Filing, 8-K, Argos Therapeutics, APR 14, 2015, View Source [SID:1234502991]).

In connection with the license agreement, Tianyi Lummy International Holdings Group Ltd., an affiliate of Lummy HK ("Tianyi Lummy"), and the China BioPharma Capital I Fund ("China BioPharma Capital") have purchased an aggregate of one million shares of Argos’ common stock at a premium of 12.5% for a purchase price of approximately $10 million. Lummy HK has agreed to pay Argos a royalty on net sales of AGS-003 at a rate in the teens and up to an aggregate of $20 million for regulatory and commercial milestones. In addition, Tianyi Lummy and China BioPharma Capital have agreed to purchase an additional $10 million of Argos’ common stock following and subject to the interim data analysis from Argos’ pivotal phase 3 ADAPT trial of AGS-003 by the Independent Data Monitoring Committee expected in late 2015 that will occur at approximately 50% of events in the trial and certain other conditions. China BioPharma Capital recently announced its first closing and is focusing on investments in pharmaceutical life science innovation in Western companies with the objective to obtain licenses for development and commercialization in China.

"We are excited about the potential for Arcelis-based products to advance the treatment of cancer throughout Greater China and in markets around the world," said Jeff Abbey, president and CEO of Argos. "Our agreement with Lummy HK is another reflection of the strong clinical data that we have observed with AGS-003 and our ability to attract outstanding partners to support commercialization in the years ahead."

Argos’ proprietary Arcelis technology platform uses a patient’s own dendritic cells and tumor sample to create a fully personalized immunotherapy. AGS-003, Argos’ lead product candidate, is currently being tested in the pivotal phase 3 ADAPT clinical trial for the treatment of metastatic renal cell carcinoma (mRCC).

Under the license agreement, Lummy HK also acquires rights to develop Arcelis-based products for additional oncology indications, potentially including pancreatic, lung, liver, stomach, rectal, gastric, and esophageal cancers. Lummy HK will be responsible, at its expense, for all development costs that are necessary for regulatory approval in all markets covered in the license agreement.

"Our agreement with Argos to develop AGS-003 in China, Hong Kong, Taiwan and Macau is another example of our ongoing commitment to develop and market new therapies that can address serious unmet needs in the treatment of cancer in China and throughout Asia," said Mr. Qiu Yu, chairman of Lummy HK. "The Arcelis technology platform also holds great promise for automating the manufacturing and commercialization of a portfolio of fully personalized immunotherapies and we look forward to working with Argos to initiate our own development programs to bring products based on this innovative technology to the patients we serve."

About the Arcelis Technology Platform

Arcelis is a fully personalized immunotherapy technology that captures mutated and variant antigens that are specific to each patient’s disease. It is designed to overcome immunosuppression by producing a durable memory T-cell response without adjuvants that may be associated with toxicity. The technology is potentially applicable to a wide range of different cancers, and is designed to overcome many of the manufacturing and commercialization challenges that have impeded other personalized cancer immunotherapies. The Arcelis process uses only a small tumor or blood sample and the patient’s own dendritic cells, which are collected and optimized following a single leukapheresis procedure. The proprietary process uses RNA isolated from the patient’s disease sample to program dendritic cells to target disease specific antigens. The activated, antigen-loaded dendritic cells are then formulated into the patient’s plasma and administered via intradermal injection.

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

On April 13, 2015 Cancer Research Technology (CRT), Cancer Research UK’s commercialisation and development arm, and Medivir AB (Nasdaq Stockholm: MVIR) 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 Technology, APR 13, 2015, View Source [SID1234523206]).

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, which has been linked to tumour survival, cell invasion and metastasis.

Under the terms of the agreement Medivir receives an exclusive, global license to research, develop, manufacture and commercialize 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, located at Marburg University in Germany, in collaboration with Medivir. Prof. Bartsch previously worked at King’s College London 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 drugs for treating cancer. 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."

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

SignPath Pharma has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, SignPath Pharma, APR 9, 2015, View Source [SID1234502976]).