On June 14, 2016 Lytix Biopharma In collaboration with Adaptive Biotechnologies (Seattle, USA), reported that they have investigated changes in T cell clonality before and after treatment of murine B16 melanomas with LTX-315 (Press release, Lytix Biopharma, JUN 14, 2016, View Source [SID:1234514841]). At the World Preclinical Congress to be held in Boston this week, Sharon Benzeno from Adaptive Biotechnologies will present data showing that LTX-315 significantly enhances T cell infiltration and T cell clonality in B16 melanomas. The results indicate that LTX-315 has the potential to convert non-T cell inflamed tumors into T-cell inflamed tumors. Since immunotherapy normally is more effective in subsets of patients with a T cell inflamed tissue, LTX-315 may increase the number of patients responding to immunotherapy. In collaboration with Oncodesign (Dijon, France) Lytix has shown promising results by combining LTX-315 and the immune checkpoint blockade inhibitor anti-PD-L1. Phillippe Slos from Oncodesign will present data demonstrating that LTX-315 in combination anti-PD-L1 enhance the delay of tumor growth compared to each compound alone in the murine mammary carcinoma model EMT-6.

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World Preclinical Congress (WPC) is a key networking event for those involved in preclinical research and features conferences, training seminars and short courses that cover the very latest in preclinical strategies and technologies, to enable better and faster decisions in drug discovery.

On June 14, 2016 Sanofi reported the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR) in connection with Sanofi’s intent to acquire Medivation, Inc. (NASDAQ: MDVN) (Press release, Sanofi, JUN 14, 2016, View Source [SID:1234513297]). This milestone further supports Sanofi’s belief that the all cash acquisition proposal, which is not subject to any financing condition, would provide the highest level of transaction certainty to Medivation shareholders .

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As announced on April 28, 2016, Sanofi proposed to acquire Medivation for $52.50 per share, representing an all-cash transaction valued at approximately $9.4 billion.

On June 14, 2016 Transgenomic, Inc. (TBIO), (NASDAQ: TBIO), reported plans to expand its ICE COLD-PCR (ICP)-powered cancer assays ten-fold over the next 18 months, targeting a portfolio of more than 200 exons/mutations expected to be available to partners, cancer researchers, drug developers and clinicians by 2018 (Press release, Transgenomic, JUN 14, 2016, View Source [SID:1234513324]). Multiplexed ICP technology’s ultra-high sensitivity down to 0.01% makes it possible to run ICP assays using either tissue, blood or serum samples on any sequencing platform. Recently-released studies indicate high concordance between ICP detection tests and assays produced using conventional technology, with the added benefit that the ICP tests detected mutations in both plasma and tissue samples that were missed by conventional methods.

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The expanded ICP cancer test menu will be released over the course of the next 18 months, with about 10 new exons/mutations expected to be issued every 6-8 weeks. The new tests will available in several formats–for use by TBIO’s partners and licensees, through TBIO’s Biomarker Discovery Services group and Oncology CLIA laboratory, as well as through its ICEme kits, which customers can run on Sanger, NGS and other platforms in their own laboratories. The focus, as with TBIO’s current menu of detection tests and panels, will be on actionable mutations relevant to cancer treatment decisions, with priority given to mutations requested by customers along with those newly validated by cancer researchers. The company also intends to incorporate some of the added mutations into panels for use with specific cancers and tumor types.

TBIO President and CEO Paul Kinnon commented, "The rapidly growing use of genomic testing as an essential part of cancer treatment makes this a good time to build on the foundation we have created over the past year and to exponentially expand the menu of tumor exons/mutations that can be tested using our ICP technology. We have refined and industrialized the development of new tests, as we demonstrated with the recent rapid development and release of our EGFR C797S ICP assay. We therefore believe that our ambitious goal of offering more than 200 exons/mutations by 2018 is achievable. We are optimistic that the accuracy, versatility, ease of use and rapid turnaround of ICP cancer testing, along with its availability in multiple formats and on a variety of platforms, will generate strong demand as we expand the test menu. We look forward to working with a range of customers and diagnostic laboratory partners to apply the power of TBIO’s expanded ICP product line to accelerate cancer research and improve patient outcomes."

ICE COLD-PCR achieves its ultra-high sensitivity through selective amplification of mutant DNA. The result is up to a 500-fold increase in sensitivity in identifying mutations with the most precise sequence alteration detection rates available. ICP was originally developed by the laboratory of Dr. Mike Makrigiorgos at the Dana-Farber Cancer Institute, which has exclusively licensed rights to the technology to Transgenomic.

On June 13, 2016 MabVax Therapeutics Holdings, Inc. (OTCQB: MBVX), a clinical-stage oncology drug development company, reported the initiation of a second investigational Phase I site for MVT-5873 (HuMab-5B1) with Sarah Cannon Research Institute through its network of research sites (Press release, MabVax, JUN 13, 2016, View Source [SID:1234513257]). The product is for patients with locally advanced or metastatic adenocarcinoma of the pancreas (PDAC) or other CA19-9 positive malignancies. In addition to the Sarah Cannon Research Institute at Tennessee Oncology site in Nashville, Tenn., patient enrollment in the Phase I trial is underway within Sarah Cannon Research Institute at Florida Cancer Specialists in Sarasota, Fla.

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The Phase I trial is evaluating the safety, tolerability and pharmacokinetics of MVT-5873 as a single agent or in combination with the current standard-of-care chemotherapy regimen in patients with metastatic pancreatic cancer. The first group of patients are being enrolled in a traditional dose escalation regimen to assess safety and determine the optimal dose of the antibody. A second patient group will establish the safety and recommended dose of the antibody when administered with standard-of-care chemotherapy. Lead investigators at Sarah Cannon’s research sites are Todd M. Bauer, MD, associate director of drug development in Nashville, and Judy Wang, MD, associate director of drug development in Sarasota.

"We are very excited to engage with Sarah Cannon’s world-class clinical research organization and are highly encouraged by progress with patient enrollment to date," said David Hansen, MabVax President and CEO. "Pancreatic cancer is very difficult to treat and patients with advanced disease have few therapeutic options. We are delighted to be working with site staff at these research sites to evaluate MVT-5873 as a potential new therapeutic option for these patients."

About HuMab-5B1:

MabVax’s HuMab-5B1 antibody is fully human and was discovered from the immune response of cancer patients vaccinated with an antigen-specific vaccine during a Phase I trial at Memorial Sloan Kettering Cancer Center. In preclinical research, the 5B1 antibody has demonstrated high specificity and affinity, and has shown potent cancer cell killing capacity and efficacy in animal models of pancreatic, colon and small cell lung cancers. The antigen the antibody targets is expressed on more than 90% of pancreatic cancers making the antibody potentially broadly applicable to most patients suffering from this type of cancer.

On June 13, 2016 Perrigo Company plc (NYSE: PRGO; TASE) reported that it has filed Abbreviated New Drug Applications (ANDAs) with the U.S. Food and Drug Administration (FDA) for ingenol mebutate gel (0.015% and 0.05%), the generic versions of Picato gel (0.015% and 0.05%) (Press release, Perrigo Company, JUN 13, 2016, View Source [SID:1234514915]). Perrigo has notified Leo Pharma A/S and Leo Laboratories, Ltd., the owners of the New Drug Applications (NDAs) and patents listed in FDA’s Orange Book, of its filings.

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On June 10, 2016, Leo Pharma A/S, Leo Laboratories Limited and Leo Pharma, Inc. filed suit in the United States District Court for the District of Delaware alleging patent infringement. This action formally initiates the litigation process under the Hatch-Waxman Act. Perrigo believes that it is a first filer for this opportunity, making it eligible for 180 days of generic exclusivity.

Picato gel (ingenol mebutate gel) is a prescription medicine indicated for the topical treatment of actinic keratosis. Branded sales for the twelve months ending April 2016 were approximately $69 million.

Perrigo’s CEO John T. Hendrickson stated, "This filing illustrates Perrigo’s commitment to providing Quality Affordable Healthcare Products. The Rx team continues to invest in the development of important products that strengthen our extended topicals portfolio and drive savings for our customers and consumers."