On May 6, 2019 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported results of operations for the first quarter of 2019, meeting its outlook for net sales growth at constant exchange rates, or CER, and exceeding the outlook for adjusted earnings per share at CER while driving global expansion of its Sample to Insight portfolio of molecular testing solutions (Press release, Qiagen, MAY 6, 2019, View Source [SID1234535775]).

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"Our performance for the first quarter of 2019 was in line with our outlook for solid sales growth and continued improvements in profitability. QIAGEN is reaffirming the full-year outlook set for this year," said Peer M. Schatz, Chief Executive Officer of QIAGEN. "We have made significant progress in 2019 on advancing our portfolio of differentiated Sample to Insight solutions and are looking forward to delivering on its value."

"We are well positioned to achieve our goals for full-year sales growth, and to deliver faster growth particularly in the second half of 2019 given the success of our growth initiatives as well as the soon anticipated U.S. approval of the QIAstat-Dx system for multiplex syndromic testing. Our QuantiFERON latent TB test grew in line with the 2019 sales target range in the first quarter of 2019, and we announced additional automation options for this important contributor in the global fight against tuberculosis. We also expanded our portfolio of solutions for next-generation sequencing, which remains on track to achieve $190 million of sales in 2019 compared to $140 million in 2018, with the launch of new liquid biopsy and gene panels integrated with QIAGEN bioinformatics solutions. The launch of two new fully integrated molecular testing solutions – QIAstat-Dx and NeuMoDx for integrated molecular laboratory testing – are progressing well in Europe, are receiving a very positive acceptance and we are ready to capture share gains and growth opportunities in their very large target markets. Our teams are developing a broad range of tests to further expand the utility of these novel systems. In Precision Medicine, we are pleased by the breakthrough U.S. regulatory approval for a new therascreen companion diagnostic that tests for variants of the biomarker FGFR to help guide treatment decisions for patients with urothelial cancer. We are moving ahead with the transformation of QIAGEN and are continuing to execute on a strategy to maximize the value of this differentiated portfolio of molecular testing solutions along the continuum from Life Sciences research to Molecular Diagnostics."

On May 6, 2019 Physicians’ Education Resource (PER), a worldwide leading resource for continuing medical education, reported that it will host the 20th Annual International Lung Cancer Congress from July 25 to 27 at the Huntington Regency Huntington Beach in California (Press release, Physicians’ Education Resource, MAY 6, 2019, View Source [SID1234535774]). The program will be chaired by Dr. David R. Gandara, professor of medicine in the division of hematology/oncology at the University of California (UC) at Davis School of Medicine and the director of the thoracic oncology program and senior adviser to the director at UC Davis Comprehensive Cancer Center, and Dr. Roy S. Herbst, Ensign professor of medicine (medical oncology), professor of pharmacology, chief of medical oncology and associate director for translational research at Yale Cancer Center, Yale School of Medicine.

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"We are excited to celebrate 2 decades of educational excellence with this year’s upcoming International Lung Cancer Congress," said Phil Talamo, president of PER. "Now in its 20th year, the congress has become one of the most comprehensive and detailed educational lung cancer meetings in the world, with national and international faculty sharing perspectives on evolving data, discussing new patient management strategies, and reflecting on the evidence that drives the future treatment of lung cancer."

The 20th Annual International Lung Cancer Congress is a three-day program for surgical, medical and radiation oncologists interested in the treatment of patients with lung cancer. During this meeting, leading international and national experts will provide perspectives on how to incorporate the latest data on targeted agents, immunotherapy, surgery and radiation oncology in the clinic through a series of cutting-edge lectures, panel discussions, multidisciplinary tumor boards and interactive Q&A sessions. Attendees who participate will have the opportunity to engage with faculty as they share their perspectives and personal experiences on the clinical challenges and ongoing controversies in lung cancer management.

On May 6, 2019 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing targeted cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that advances have been completed in the manufacturing process for the clinical trial product that will be used in PharmaCyte’s planned clinical trial in locally advanced, inoperable pancreatic cancer (LAPC) (Press release, PharmaCyte Biotech, MAY 6, 2019, View Source [SID1234535773]).

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Since PharmaCyte’s last press release describing the manufacturing process for its clinical trial product and the testing of that product, the data from the manufacturing process has been reviewed, analyzed and discussed in great detail among PharmaCyte’s management team, including the leader of its clinical development program in pancreatic cancer and designated Principal Investigator (PI) for the LAPC trial, Prof. Manuel Hidalgo of the Harvard Medical School, Austrianova’s management team (the manufacturer of the clinical trial product), cGMP Validation (PharmaCyte’s cGMP expert consulting firm), Eurofins Lancaster Laboratories (who produced the cells for PharmaCyte’s Master Cell Bank) and several consulting cellular biologists.

The data obtained to date from the encapsulation parameters of the manufacturing process itself indicate that the encapsulation portion of the process is fault free and reproducible, which is a fundamental requirement of the FDA.

On the advice of PharmaCyte’s cGMP expert, the company plans to conduct two additional and staggered manufacturing runs in order to maximize the chances for a successful IND submission given the novelty and complexity of the entire process. In the time since the last manufacturing run, which we reported on in January of this year, those involved with the manufacturing process have been concentrating on changes that can be made to improve the process. We believe that these changes will improve the cGMP manufacturing process to the point that the entire process can be shown to be consistently reproducible and robust as required by the FDA, and to ensure that the end-products of these manufacturing runs will convert the cancer prodrug ifosfamide into its cancer-killing form as well as they should.

This intensive effort has involved several independent tests by Austrianova and Eurofins. The results of these tests strongly indicate that, after the suggested changes are implemented, positive results should be obtained. When the changes are made to the cGMP manufacturing process, they should significantly improve the growth of the cells obtained from the Master Cell Bank both before and after encapsulation takes place. PharmaCyte and Austrianova and its team of consultants are in the final stages of optimizing this aspect of the manufacturing process.

Meanwhile, PharmaCyte’s clinical development program in pancreatic cancer is progressing. As explained by Prof. Hidalgo, "PharmaCyte has a strong clinical trial program for pancreatic cancer. The trial design has been thoroughly vetted by a team of the best pancreatic cancer specialists in the country. I continue to lead PharmaCyte’s program in pancreatic cancer, and I am eager to get underway as its PI for the LAPC trial. Members of PharmaCyte’s team are working on various aspects of implementing the program. I remain excited about the potential that PharmaCyte’s technology can offer patients who are suffering from LAPC and am looking forward to what a successful trial may mean for the way some types of solid cancerous tumors are treated in the future."

On May 6, 2019 PIN Pharma, a company focused on modulating the immune system and having its first indication in oncology, reported the Company will be presenting a poster at the 55th Annual meeting of ASCO (Free ASCO Whitepaper) in Chicago on June 1 between 8:00 AM – 11:00 reporting the results of the first-in-human trial evaluating the immune activation and safety of PIN-2 administered to patients with advanced solid tumors (Press release, PIN Pharma, MAY 6, 2019, View Source [SID1234535772]).

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About PIN-2

PIN-2 is a novel immunomodulatory peptide with a unique mechanism of action in that it links the innate and adaptive immune systems, resulting in an enhanced immune response. In vitro and in vivo preclinical studies have shown that PIN-2 rapidly and preferentially penetrates monocytes, modifies the mRNAs involved in the induction of innate immune activation (with an attendant link to the adaptive immune system), and promotes endogenous cytotoxic T lymphocytes infiltration at the tumor site. PIN-2 acts upstream of other immune-based treatment modalities.

Given its unique, upstream immunomodulatory activity, its extensive preclinical body of evidence, and its first-in-human study results, PIN-2 holds the potential to be a new strategy in the fight against cancer and cancer-mediated immunosuppression. Further clinical research is warranted to evaluate the full potential of PIN-2 in cancer care.

On May 6, 2019 Shattuck Labs, Inc. ("Shattuck"), a biopharmaceutical company, reported that patients are being treated in its Phase 1 dose escalation and expansion clinical trial of its molecule SL-279252 (PD1/OX40L), a bi-functional fusion protein (View Source) (Press release, Shattuck Labs, MAY 6, 2019, View Source [SID1234535771]). Sarah Cannon Research Institute in Nashville, Tennessee and MD Anderson Cancer Center in Houston, Texas are the first enrolling sites in this multi-center, global trial. This first-in-human study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamic, and anti-tumor activity of SL-279252 in patients with advanced solid tumors or lymphomas. Takeda Pharmaceutical Company Limited currently holds an exclusive option to enter into a license to develop and commercialize SL-279252. Further information about this trial can be found on clinicaltrials.gov.

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"We are excited to have initiated clinical studies for SL-279252. While some patients with cancer enjoy long-term benefit from antibody-based PD-1 blockade, a majority of patients unfortunately do not," explained Lini Pandite, M.D., Chief Medical Officer of Shattuck. "Pre-clinical studies demonstrate that SL-279252 binds simultaneously and with high affinity to PD-L1 and OX40, and stimulates anti-tumor T cell activity. Pre-clinical studies further demonstrate improved pharmacologic and anti-tumor activity compared to antibody-based PD-1 blockade, either alone or in combination with antibody-based OX40 stimulation. We look forward to learning more about SL-279252 in the clinic and expect to gain insight into whether it can improve upon antibody-based PD-1 blockade as a standard of care in multiple tumor types."

SL-279252 is a novel therapeutic derived from Shattuck’s proprietary Agonist Redirected Checkpoint (ARC) platform and its first molecule to begin clinical trials. The dual-sided nature of SL-279252 is designed to simultaneously block the PD-L1 inhibitory signal and stimulate OX40 signaling. Preclinical studies have demonstrated that SL-279252 potently stimulates anti-tumor T cell activity.

"Shattuck’s ARC platform technology combines checkpoint blockade with immune stimulation representing an approach that is highly differentiated from antibody-based platforms," said Phil Rowlands, Ph.D., Head, Oncology Therapeutic Area Unit, Takeda. "It is a great example of our commitment to collaborating with world-class partners to pursue novel immuno-oncology targets and next-generation platforms, that may one day deliver transformational medicines to patients."