On October 2, 2015 Laboratory Corporation of America Holdings (LabCorp) (NYSE: LH) reported the nationwide availability of a new FDA-approved companion diagnostic, the PD-L1 IHC 22C3 pharmDx assay by Dako, an Agilent Technologies company, to assess the eligibility of non-small cell lung cancer (NSCLC) patients for treatment with pembrolizumab (Keytruda) (Press release, LabCorp, OCT 2, 2015, View Source;p=RssLanding&cat=news&id=2092774 [SID:1234507639]).

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"This significant launch powerfully demonstrates the importance of the LabCorp-Covance combination," said David P. King, Chairman and Chief Executive Officer. "Our central laboratory was exclusively responsible for testing specimens for PD-L1 expression in the KEYNOTE-001 registration trial, and LabCorp is one of the first laboratory providers of the PD-L1 IHC 22C3 pharmDx test. We continue to focus on our three strategic priorities: bringing innovative medicines to patients, using information to change the way care is delivered, and providing world-class diagnostic results."

"Importantly, LabCorp’s involvement with the KEYNOTE-001 registration trial gives us experience that no other lab has in performing and interpreting the results of this assay in a standardized manner," stated Dr. Steve Anderson, Chief Scientific Officer of Covance Drug Development. "The availability of this test reflects how our combined capabilities will support improved patient outcomes and reduced healthcare costs by delivering world class diagnostics and bringing innovative new medicines to patients."

"LabCorp’s best-in-class companion diagnostic capabilities supported the approval of Keytruda and its companion diagnostic," stated Dr. Marcia Eisenberg, LabCorp Diagnostics’ Chief Scientific Officer. "The PD-L1 IHC 22C3 pharmDx assay is an important advance in personalized medicine that enables clinicians to determine whether a patient with metastatic NSCLC is a candidate for this new immuno-oncology therapy. The launch of this innovative test is another example of our unique ability to support development and commercialization of new companion diagnostics, helping to advance treatment options for cancer and other diseases."

"We are very pleased with LabCorp’s efforts to bring this important new test to patients with metastatic non-small cell lung cancer. As the central testing laboratory for the registration trial, LabCorp supported the development of the therapeutic and companion diagnostic applications for Keytruda, and will now make this approved test for the PD-L1 biomarker available to physicians and patients across the country," said Dr. Eric Rubin, vice president, Merck Research Laboratories.

According to the American Cancer Society, lung cancer is the leading cause of cancer death in the U.S. and is the second most commonly diagnosed cancer with an estimated 221,200 new cases diagnosed in 2015. The vast majority of patients exhibit the non-small cell subtype, representing 80-85% of patients, and over half of these patients are diagnosed with metastatic or advanced disease at initial presentation. Data from the KEYNOTE trial recently presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting and published in the New England Journal of Medicine demonstrated that PD-L1 expression in at least 50% of non-small cell lung tumor cells correlated with improved response rates and progression free survival in patients treated with Keytruda.

For more information on the PD-L1 pharmDx test, contact the Integrated Oncology customer service line at (800) 447-5816.

On October 2, 2015 Recipharm and XSpray Microparticles reported that XSpray Microparticles will receive 18 million SEK from a consortium led by The Foundation for Baltic and East European Studies (Östersjöstiftelsen) and Recipharm Venture Fund.

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The 18 million SEK investment will be used to finance the clinical development of XSpray’s lead compound, XS004, developed with XSpray’s proprietary HyNap drug formulation technology. XS004 is based on a well-known protein kinase inhibitor (PKI) compound.

It is anticipated that these funds will finance XS004 through the Phase 1 clinical trial, results of which are expected in Q2 2016.

Recipharm as a CDMO will be engaged as a development and potential future manufacturing partner to Xspray for its XS004 and XS005 product projects.

CEO of XSpray, Dr. Per Andersson said that "This marks the beginning of an exciting phase for XSpray, securing the necessary funding for the Phase 1 study with our lead compound, XS004. Also the new ownership structure will give us access to a strong mix of experience and capacities that are needed to commercialize the HyNap technology in the market of small molecule PKIs. This market segment currently comprises about 30 PKI products that command about 20% of the total cancer market value in the US. A market share that is expected to grow to 25% by 2020. Our proprietary HyNap technology applied to this important class of anti-cancer compounds has the potential to improve both present and upcoming PKI product profiles with respect to safety and enhanced quality of life.

Carl-Johan Spak, EVP at Recipharm, said "XSpray is a very interesting company with a unique technology for improvement of drug delivery. We are glad to assist XSpray with pharmaceutical drug development services and we are looking forward to opportunities to serve the company with commercial manufacturing."

"We are very pleased with this investment in XSpray Microparticles," said Mattias Klintemar, Director of Investments for Östersjöstiftelsen "XSpray’s technology has shown significant potential in the development of new PKI therapies as well as generating early access generic PKIs and improved versions of existing PKI products. This is an important market and XSpray has a unique solution."

About Recipharm
Recipharm is a leading CDMO (Contract Development and Manufacturing Organisation) in the pharmaceutical industry employing some 2,200 employees. Recipharm offers manufacturing services of pharmaceuticals in various dosage forms, production of clinical trial material including API and pharmaceutical product development. Recipharm manufactures more than 400 different products to customers ranging from Big Pharma to smaller research- and development companies. Recipharm’s turnover is approximately SEK 3.3 billion and the Company operates development and manufacturing facilities in Sweden, France, the UK, Germany, Spain, Italy and Portugal and is headquartered in Jordbro, Sweden. The Recipharm B-share (RECI B) is listed on NASDAQ Stockholm.
For more information on Recipharm and our services, please visit www.recipharm.com

About XSpray Microparticles AB
XSpray Microparticles AB is a drug delivery company with a proprietary HyNap technology that it uses to develop new protein kinase inhibitors (PKIs) therapies, as well as bioequivalent and improved versions of commercially available PKIs. XSpray’s HyNap technology enables optimization of cost, time and risk during development while enabling a reduction of the significant problems associated with variable bioavailability. These problems affect many NCEs as well as existing PKIs due to pH dependent absorption, food interaction and poor solubility. These traits often lead to complicated dosing regimens for patients and even ‘black box’ warnings.
XSpray formulates compounds as HyNap – hybrid nanoparticles. The technology is used both to improve the product profiles of currently marketed drugs and to speed up the development of new drugs.
XSpray has its headquarters and development laboratories in Stockholm, Sweden, and offers GMP material from a state-of-the-art facility.

On October 01, 2015 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, as well as autoimmune disorders and infectious diseases, reported that interim results of an ongoing Phase 1 dose escalation study of MGA271 will be presented by the Company in the late-breaking abstract session at the 2015 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in National Harbor, MD (Press release, MacroGenics, OCT 1, 2015, View Source [SID:1234507629]). The 30th Anniversary Annual Meeting is being held November 4-8, 2015 at the Gaylord National Hotel & Convention Center. Presentation details include:

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Title: Interim Results of an Ongoing Phase 1, Dose Escalation Study of MGA271 (Fc-optimized Humanized Anti-B7-H3 Monoclonal Antibody) in Patients with Refractory B7-H3-Expressing Neoplasms or Neoplasms Whose Vasculature Expresses B7-H3

Session: Late-Breaking Abstract Session

Time: Saturday, November 7, 2015, from 12:00 pm – 12:15 pm ET

Presented by: MacroGenics, Inc.

Background on MGA271

MGA271 is a humanized, Fc-optimized monoclonal antibody that targets B7-H3, a member of the B7 family of molecules that are involved in immune regulation. B7-H3 is over-expressed by a wide variety of solid tumor cells as well as cancer stem-like cells and the supporting tumor vasculature. MGA271 is currently undergoing Phase 1 testing both as monotherapy and in combination with checkpoint inhibitors including ipilimumab and pembrolizumab across a wide range of solid tumors.

On October 1, 2015 CEL-SCI Corporation (NYSE MKT: CVM) ("CEL SCI" or the "Company") reported that in the month of September it has enrolled 30 patients in its ongoing Phase 3 trial of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) in patients with advanced primary head and neck cancer (Press release, Cel-Sci, OCT 1, 2015, View Source [SID:1234507626]). Total patient enrollment is now 570 as of September 30, 2015 in the world’s largest Phase 3 study in head and neck cancer.

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A total of 880 patients are expected to be enrolled in over 20 countries.

About the Multikine Phase 3 Study

The Multikine Phase 3 study is enrolling patients with advanced primary squamous cell carcinoma of the head and neck. The objective of the study is to demonstrate a statistically significant improvement in the overall survival of enrolled patients who are treated with the Multikine treatment regimen plus standard of care ("SOC") vs. subjects who are treated with SOC only.

About Multikine

Multikine (Leukocyte Interleukin, Injection) is an investigational immunotherapeutic agent that is being tested in an open-label, randomized, controlled, global pivotal Phase 3 clinical trial as a potential first-line treatment for advanced primary squamous cell carcinoma of the head and neck. Multikine is designed to be a different type of therapy in the fight against cancer: one that appears to have the potential to work with the body’s natural immune system in the fight against tumors.

Multikine is also being tested in a Phase 1 study under a Cooperative Research and Development Agreement ("CRADA") with the U.S. Naval Medical Center, San Diego, and at University of California, San Francisco (UCSF), as a potential treatment for peri-anal warts in HIV/HPV co-infected men and women. CEL-SCI has also entered into two co-development agreements with Ergomed Clinical Research Limited to further the development of Multikine for cervical dysplasia/neoplasia in women who are co-infected with HIV and HPV and for peri-anal warts in men and women who are co-infected with HIV and HPV.

On October 1, 2015 Kancera reported ithat in the ROR project, follow-up studies of the pharmaceutical properties of KAN0439834 show that they probably are better than previously assumed with respect to uptake and penetration of the substance to the cancer (Press release, Kancera, OCT 1, 2015, View Source;releaseID=1055733 [SID:1234507628]). The new studies indicate that dosing 2-3 times a day at 65-300 mg gives a concentration in the body that may be sufficient to exert an effect on solid tumors. However, the effect of KAN0439834 on solid tumors cannot be demonstrated in mice since the substance is metabolized too quickly in that species. Therefore, KAN0439834 and related substances will be tested against human solid tumors in an established zebra fish model for tumor growth and metastasis. This will allow effect studies of the ROR inhibitors at concentrations that are expected to be achievable in humans.

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Further, the effects of KAN0439834 and three new drugs have been evaluated in tumor cells isolated from blood, lymph and bone marrow from nine patients. The background to this study is that new drugs such as Ibrutinib and Idelalisib give effect in 70-80% of patients with chronic lymphocytic leukemia (CLL). However, a so-called complete remission (the disappearance of symptoms) has only been reached in limited number of these patients. The lack of effect is particularly evident in the bone marrow. Since complete remission in cancer is generally linked to a longer survival, there is a need for drugs that work in a new way. Kancera has previously shown that the candidate drug KAN0439834 effectively kills patient CLL cells from blood and lymph in the laboratory and also in animal studies of the human disease. The present study, conducted by Prof. Håkan Mellstedt’s team at the Karolinska Institute, shows that Kancera’s ROR inhibitors are also effective in killing CLL cells from bone marrow which is a capacity wanted as a complement to the currently registered drugs against CLL.

In the Fractalkine project, Kancera has now established the network of leading cancer and pain scientists that in a collaborative project will evaluate the drug candidate KAN0440567 (AZD8797) in an advanced animal model closely resembling the human form of pancreatic cancer. Further, Kancera has synthesized and quality controlled the salt form of the drug candidate that will be used in the collaborative project and conducted a dosing study in mice. The results from this study support that an effective dose of the drug candidate can be achieved in mice via oral administration.

About the ROR project
ROR is a family of receptors, ROR1 and ROR2. The ROR receptors mediate signals for growth and survival. Originally ROR was linked to fetal development, but it is now known that they also contribute to cancer cell development and proliferation. Professor Håkan Mellstedt, Kancera´s co-founder and professor at the Karolinska Institute, and his colleagues have shown that Kancera´s ROR inhibitors have the ability to kill cells from tumors in pancreas, and leukemia cells. Professor Mellstedt and his colleagues as well as independent researchers have shown that ROR is also active as a target in prostate, breast, skin and lung cancer.

Because ROR primarily generates a survival and growth signal to tumor cells but is inactive in healthy cells in adults, there are good prospects that a drug directed against ROR hit the tumor much harder than the surrounding healthy cells. Kancera and Professor Mellstedt have shown that inhibition of ROR leads to that cancer cells eliminate themselves by cellular suicide. Against this background, there are reasons to anticipate that a ROR-targeted drug is both safer and more effective than several chemotherapies currently used to treat cancer.