On July 9, 2015 Eli Lilly reported the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) met today to discuss the data supporting Eli Lilly and Company’s necitumumab in combination with gemcitabine and cisplatin for use in first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) (Press release, Eli Lilly, JUL 9, 2015, View Source [SID:1234506198]).

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Squamous NSCLC is a devastating and difficult-to-treat form of lung cancer. The five-year survival rate for patients with metastatic disease is less than five percent.[1] Necitumumab in combination with gemcitabine and cisplatin is the first regimen to show a significant improvement in overall survival over chemotherapy alone, specifically in the first-line setting.

"We are encouraged by the Committee’s constructive discussion on the benefit-risk profile of necitumumab as few advances have been made over the past two decades in the first-line treatment of advanced squamous NSCLC, leaving a significant unmet medical need," said Richard Gaynor, M.D., senior vice president, product development and medical affairs for Lilly Oncology. "We believe necitumumab with gemcitabine and cisplatin represents a meaningful advance in the search for a new first-line treatment option and look forward to working closely with the FDA as they continue their review."

The FDA is expected to make a decision on Lilly’s biologics license application for necitumumab later this year.

About Necitumumab
Necitumumab is a recombinant human IgG1 monoclonal antibody that is designed to block the ligand binding site of the human epidermal growth factor receptor 1 (EGFR). Activation of EGFR has been correlated with malignant progression, induction of angiogenesis and inhibition of apoptosis or cell death.

About Squamous Non-Small Cell Lung Cancer (NSCLC)
NSCLC is the most common type of lung cancer, and accounts for about 85 percent of all lung cancer cases.[2] Squamous NSCLC, which represents about 30 percent of all people affected by NSCLC,[3] is a devastating, difficult-to-treat form of the disease. Patients face an imposing disease and symptom burden with very poor prognosis; the five-year survival rate for patients with metastatic disease is less than five percent.[4] Little progress has been made over the last two decades, particularly in the first-line setting, leaving a significant unmet medical need. In order to address the unique and complex needs of individual patients with advanced squamous NSCLC, more first-line treatment options are needed.

On July 8, 2015 Xenetic Biosciences, Inc. ("Xenetic" or the "Company") (OTCQB:XBIO), a biopharmaceutical company focused on developing next-generation biologic drugs and novel orphan oncology therapeutics, reported that it has completed a $3,000,000 bridge note financing (Press release, Xenetic Biosciences, JUL 8, 2015, View Source [SID1234537814]). The financing was concluded with OJSC Pharmsynthez ("Pharmsynthez"), a collaborative partner of Xenetic and an affiliate of Xenetic’s largest shareholder SynBio LLC ("Synbio") and was arranged directly between the managements of Xenetic and Pharmsynthez on a commission free basis.

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The $3,000,000 was received from the sale of a ten percent (10%) senior secured collateralized convertible promissory note due July 1, 2016 (the "Note"). The Note is convertible, in whole or in part, into shares of Common Stock of the Company at the option of Pharmsynthez. In addition, in connection with the sale of the Note, Pharmsynthez received certain five year warrants to purchase shares of Common Stock of the Company. Please refer to SEC form 8-K filed on July 8, 2015 for further material information regarding the bridge note financing.

"We are very pleased to have completed this important bridge note financing with a company that has been associated with Xenetic for fifteen years," said Scott Maguire, Chief Executive Officer of Xenetic. "Pharmsynthez is an important collaborator with Xenetic. The partnership covers six drug candidates currently in development in Russia which include indications for cystic fibrosis and obesity with the intention that the Company will eventually seek approval of these drug candidates in the global markets."

"These funds will allow us to continue with our plan to seek a listing of the Company’s shares on a national U.S. securities exchange that offers greater liquidity and will allow Xenetic to trade alongside its peers, therefore allowing greater exposure to the life science investment community. We believe that this financing, which was concluded with an affiliate of our single largest shareholder, reflects a belief in the potential of the Company’s core technologies. Our primary focus remains to improve the human condition by developing and offering safer and more effective treatments via the development of our portfolio of proprietary products. We are looking forward to the future with great confidence."

Xenetic Biosciences, Inc. ("Xenetic" or the "Company") (OTCQB:XBIO), a biopharmaceutical company focused on developing next-generation biologic drugs and novel orphan oncology therapeutics, reported that it has completed a $3,000,000 bridge note financing. The financing was concluded with OJSC Pharmsynthez ("Pharmsynthez"), a collaborative partner of Xenetic and an affiliate of Xenetic’s largest shareholder SynBio LLC ("Synbio") and was arranged directly between the managements of Xenetic and Pharmsynthez on a commission free basis.

The $3,000,000 was received from the sale of a ten percent (10%) senior secured collateralized convertible promissory note due July 1, 2016 (the "Note"). The Note is convertible, in whole or in part, into shares of Common Stock of the Company at the option of Pharmsynthez. In addition, in connection with the sale of the Note, Pharmsynthez received certain five year warrants to purchase shares of Common Stock of the Company. Please refer to SEC form 8-K filed on July 8, 2015 for further material information regarding the bridge note financing.

"We are very pleased to have completed this important bridge note financing with a company that has been associated with Xenetic for fifteen years," said Scott Maguire, Chief Executive Officer of Xenetic. "Pharmsynthez is an important collaborator with Xenetic. The partnership covers six drug candidates currently in development in Russia which include indications for cystic fibrosis and obesity with the intention that the Company will eventually seek approval of these drug candidates in the global markets."

"These funds will allow us to continue with our plan to seek a listing of the Company’s shares on a national U.S. securities exchange that offers greater liquidity and will allow Xenetic to trade alongside its peers, therefore allowing greater exposure to the life science investment community. We believe that this financing, which was concluded with an affiliate of our single largest shareholder, reflects a belief in the potential of the Company’s core technologies. Our primary focus remains to improve the human condition by developing and offering safer and more effective treatments via the development of our portfolio of proprietary products. We are looking forward to the future with great confidence."

On June 8, 2015 CEL-SCI Corporation (NYSE MKT: CVM)("CEL SCI" or the "Company") reported that CEL-SCI is now cleared to start patient enrollment in Thailand in its ongoing Phase 3 trial with its investigational cancer immunotherapy Multikine* (Leukocyte Interleukin, Injection) in patients with advanced primary (not yet treated) head and neck cancer (Press release, Cel-Sci, JUL 8, 2015, View Source [SID:1234506548]). Thailand is the 24th country to authorize CEL-SCI’s Phase 3 trial for patient enrollment.

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"We have now completed enrollment of over 50% of the anticipated 880 patients in our Phase 3 trial and continue to expand the trial into more sites to increase the rate of enrollment. In the past month alone, we have added Spain and Italy as participating countries in our trial. We plan to have approximately 100 clinical centers around the world in about 25 countries screening and treating patients," stated CEL-SCI Chief Executive Officer Geert Kersten.

As of May 31, 2015, 463 patients had been enrolled in the global Phase 3 study.

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 (right after diagnosis, before surgery) 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, 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 July 8, 2015 Cellectis reported the achievement of a significant milestone under the Company’s collaboration agreement with Servier, in the preclinical development of two next-generation product candidates in solid tumors (Press release, Cellectis, JUL 8, 2015, View Source [SID:1234506188]).

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Under the terms of the Company’s collaboration agreement with Servier, Cellectis is eligible to an undisclosed payment.

The collaboration announced in February 2014, is focused on research, development, and potentially commercialization of five product candidates targeting leukemia and solid tumors.

"We are very pleased with the productivity of this alliance enabling us to accelerate our development in the field of solid tumors", commented Mathieu Simon, MD, EVP Chief Operating Officer of Cellectis.

"We believe that immunotherapy will dramatically change the management of metastatic cancers. Our goal at Servier is to make these new technologies available for the largest number of cancer patients", commented Jean-Pierre Abastado, MD, Director Oncology Innovation Therapeutic Pole of Servier.

On July 7, 2015 CureVac, a clinical-stage biopharmaceutical company pioneering the field of mRNA-based technology, reported that a Phase I/IIa study of the company’s mRNA cancer immunotherapy (CV9103) in advanced castration-resistant prostate cancer was published in the peer-reviewed Journal for ImmunoTherapy of Cancer ((Press release, CureVac, JUL 7, 2015, View Source [SID1234518778]). CV9103 is a self-adjuvanted, sequence-optimized, chemically unmodified mRNA immunotherapy targeting four antigens: prostate-specific antigen (PSA), prostate-specific membrane antigen (PSMA), prostate stem cell antigen (PSCA), and six- transmembrane epithelial antigen of the prostate 1 (STEAP1). The research article, titled "Self-adjuvanted mRNA vaccination in advanced prostate cancer patients: a first-in-man phase I/IIa study," describes CureVac’s clinical study of CV9103 in 44 patients with advanced castration-resistant prostate cancer. The related data signify the first Phase IIa clinical study in which an mRNA therapy has demonstrated antigen- specific immune responses in the majority of patients. Based on the favorable data, CureVac is currently conducting a randomized, placebo-controlled Phase IIb study in 197 prostate cancer patients with the follower vaccine CV9104 targeting six antigens. Ingmar Hoerr, CEO of CureVac, commented, "We are very pleased that the results of this Phase I/IIa clinical study of our RNActive technology were published in such an esteemed peer-reviewed journal as it validates our leadership position in mRNA therapeutics and highlights the continued advancement of our clinical pipeline. Prostate cancer remains our most advanced program, with the Phase IIb clinical trial progressing as planned, but CureVac also possesses a deep and diverse mRNA-driven pipeline spanning six clinical trials with more than 300 individuals treated so far and about 15 programs targeting multiple treatment opportunities and disease indications." As described in the article, the Phase I part of the study was designed to investigate the safety and recommended dosage of CV9103, with 12 patients up to five intradermal injections of 256 (n = 3), 640 (n = 3), or 1280 μg (n = 6) mRNA. In the Phase IIa part, 32 patients were enrolled to receive the recommended dose of 1280 μg mRNA defined in Phase I. The primary endpoint of the study was safety and tolerability, and the secondary endpoint was induction of antigen specific immune responses monitored at baseline and at weeks 5, 9 and 17. Data indicated that CV9103 was well tolerated, with the majority of related adverse events being of mild to moderate intensity. The most frequent treatment-related side effects were injection site erythema and injection site reaction in 27 (61%) and 21 (48%) patients, respectively. A quantitative analysis of ELISpot, ICS, and tetramer staining assays revealed that CV9103 was able to induce both CD4 and CD8 T cell responses. Of the 33 evaluable patients treated at 1280 μg, a cellular immune response could be detected in 25 (76%). Importantly immune responses against all four antigens could be induced indicating the versatility of the platform. Arnulf Stenzl, Medical Director of the Department of Urology, University of Tübingen Medical School, and senior author of the paper, stated, "The data generated by this Phase I/IIa clinical study demonstrate that CV9103 mRNA was well tolerated and immunogenic. Furthermore a trend towards longer survival time was also observed in immune responders that was strongest in patients responding to multiple antigens CV9103. Based on these results, it is evident that this mRNA technology warrants further clinical investigation." Just recently, CureVac published promising data of its RNArt technology platform in Molecular Therapy that demonstrated for the first time that sequence-optimized, chemically unmodified mRNAs raised relevant protein levels in non-human primates, indicating that mRNA achieves meaningful biological effects in large animals with body weight close to humans.

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