On February 5, 2018 Yuhan Corporation (KRX:000100.KS) (Yuhan) and Sorrento Therapeutics, Inc. (Nasdaq:SRNE) (Sorrento) reported that the South Korean Ministry of Food and Drug Safety (MFDS) has approved ImmuneOncia Therapeutics’ (51% Yuhan/49% Sorrento joint venture formed in March 2016) IND for the initiation of clinical trials for Sorrento-discovered anti-PD-L1 monoclonal antibody STI-A1015 (IMC-001), which is exclusively licensed to ImmuneOncia for select regional markets by Sorrento (Press release, ImmuneOncia Therapeutics, FEB 5, 2018, View Source [SID1234531898]).

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Yuhan had initially contributed more than $10M to the formation of ImmuneOncia and towards the development of IMC-001, with a commitment of additional funding for clinical development of IMC-001. Sorrento contributed its antibody STI-A1015 (IMC-001) and two other antibodies, as well as cGMP manufacturing and regulatory expertise support for the data submission package for the IND.

The clinical Phase 1 studies will enroll patients suffering from solid tumors at two clinical sites in South Korea, namely, Seoul National University Hospital (SNUH) and Samsung Medical Center (SMC).

"We are proud to announce the acceptance of the IND by MFDS for our anti-PD-L1 antibody IMC-001. Throughout the IND-enabling activities, our team has worked collaboratively with our Sorrento colleagues to generate a high-quality submission package that was very well received by MFDS", said Dr. Kwang Ho Cheong, CEO of ImmuneOncia Therapeutics.

"Yuhan is proud of this outstanding achievement by Dr. Cheong and the ImmuneOncia team. Together with our friends and partners from Sorrento, we created ImmuneOncia to develop important immunotherapies for cancer patients in South Korea and worldwide. Through our investment in ImmuneOncia, Yuhan has become a true biopharmaceutical company. We look forward to the future success of IMC-001 and the other antibody programs in ImmuneOncia’s pipeline", said Mr. Jung Hee Lee, CEO and President of Yuhan Corporation.

"We are very pleased with the progress made by our joint venture in the past year. We believe this is additional validation of our antibody technology as well as our in-house cGMP antibody manufacturing and development capabilities. Notably, Sorrento has retained the rights for STI-A1015 (IMC-001) in many major markets, including the EU, Japan and the US, and we intend to leverage ImmuneOncia’s clinical work to support our clinical development in these territories where we retain rights to STI-A1015 (IMC-001). We also think the success of ImmuneOncia further highlights our ability to create shareholder value through productive strategic partnerships," added Dr. Henry Ji, Chairman and CEO of Sorrento Therapeutics.

ImmuneOncia is exploring being publicly-listed on the South Korea Stock Exchange (KSEX) in 2019, which could result in additional sources of non-dilutive capital for Sorrento.

About IMC-001 (PD-L1 monoclonal antibody)

IMC-001 is a fully human anti-PD-L1 monoclonal antibody (mAb) immune checkpoint inhibitor. The mAb blocks the interaction of PD-L1 protein with its receptor PD-1, then suppressing the inhibition of PD-1/PDL1 signal to T cells and enhancing the killing effect of T cells on tumors. This antibody also kills cancer cells through traditional antibody-dependent cell-mediated cytotoxicity (ADCC) recruiting Natural Killer (NK) cells and other effector cells against the tumor potentially further strengthening the anti-tumor effect of the antibody

On February 5, 2018 OncBioMune Pharmaceuticals, Inc. (OTCQB:OBMP) ("OncBioMune" or the "Company"), a clinical-stage biopharmaceutical company engaged in the development of a proprietary immunotherapy cancer vaccine technology and targeted cancer therapies, is pleased to announce the signing of a Letter of Intent with Urology Clinics of North Texas (UCNT) for the purpose of initiating a Phase 2 Clinical Trial of ProscaVax in advanced prostate cancer patients (Press release, Oncbiomune, FEB 5, 2018, View Source [SID1234524043]). ProscaVax is OncBioMune’s novel immunotherapeutic cancer vaccine consisting of a combination of prostate cancer associated prostate specific antigen (PSA) with the biological adjuvants interleukin-2 (IL-2) and granulocyte-macrophage colony-stimulating factor (GM-CSF).

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Dr. James S. Cochran, M.D., D.A.B.U., F.A.C.S., UCNT Medical Director, has agreed to serve as the trial’s Principal Investigator. Dr. Cochran has over 30 years of clinical practice experience and has participated in and provided oversight in more than 300 clinical trials.

"Ever since I learned of ProscaVax, I have been highly interested in its potential benefit to the thousands of prostate cancer patients with late-stage disease that face a bleak prognosis with negligible therapeutic options," commented Dr. Cochran. "Now that I have reviewed the data from the Phase 1 Clinical Trial, I believe this immunotherapy has the potential to be a game-changer in urology. I am extremely eager to move this trial forward expeditiously to address an area of great unmet medical need."

UCNT is an award-winning organization servicing the Dallas Metroplex area, the fifth most populous area in North America with approximately 6.5 million people in 13 counties. The organization is comprised of 16 private urology practices and over 40 providers with approximately half a million patients in their database.

"We could not be more pleased that Dr. Cochran and the esteemed prostate cancer experts at UCNT have such a strong desire to be a part of the clinical development of ProscaVax; it truly speaks highly of the vaccine’s potential," said Dr. Jonathan Head, Chief Executive Officer at OncBioMune. "Given their decades of experience and robust patient population, we expect the mid-stage study to go very smoothly, with no enrollment competition whatsoever, which should allow the trial to progress quickly. The study will be a great complement to our planned study at a major Northeast university in early-stage prostate cancer patients, for which we anticipate reporting news on commencing that trial as well in the near term."

OncBioMune will release more details on the trial in collaboration with UCNT as they become available in the coming weeks.

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On February 5, 2018 Varian (NYSE: VAR) reported it has acquired privately-held Mobius Medical Systems, a leader in radiation oncology Quality Assurance (QA) software (Press release, Varian Medical Systems, FEB 5, 2018, View Source [SID1234523897]). This acquisition expands Varian’s leadership in radiation medicine, by increasing its portfolio of patient treatment plan QA and machine QA technologies, and enables the company to potentially impact more patients around the globe with software solutions designed to assure the quality of treatments.

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The acquisition of Mobius is consistent with Varian’s long-term growth and value creation strategy and broadens its cancer care portfolio. The integration of additional QA tools into the Varian ecosystem will allow advanced QA processes to be more seamlessly combined into treatment workflows. Additionally, Varian also can ensure that QA methods advance at the same time as Varian introduces new treatment techniques.

"Varian has a long history of providing high-quality QA for its products and the treatments they deliver," said Kolleen Kennedy, president of Varian’s Oncology Systems business. "Varian places high value on the market-leading Mobius QA products, including Mobius3D and DoseLab, and is dedicated to expanding their global reach. The two companies have similar cultures with deep commitments to enabling quality cancer care for patients around the globe."

The Mobius QA software is in use at over 1000 sites worldwide to ensure patients receive high-quality care. Mobius3D is a 3D dose verification and IMRT/VMAT treatment delivery QA system. Mobius3D performs 3D dose verification for patient plans, supports verification checks throughout the entire clinical process for IMRT and VMAT, and includes modular staged testing to reinforce the confidence of the medical physicist in the patient plan and treatment delivery. DoseLab is fast, simple and powerful software for quality assurance of medical linear accelerators.

For more information about the Mobius products that are now part of the Varian cancer care portfolio, visit www.varian.com/mobius.

On February 5, 2018 Nymox Pharmaceutical Corporation (NASDAQ:NYMX) reported that the Company will submit a New Drug Application (NDA) for Fexapotide Triflutate for the treatment of BPH in the US (Press release, Nymox, FEB 5, 2018, View Source [SID1234523738]). The Company has recently had a pre-NDA meeting with FDA. The NDA will be submitted by the Company later this year.‎ The Company further states again that there can be no assurances about the timelines or outcomes of any submission and that no forward looking statements will be made.

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The full results of the Company’s Phase 3 US trials were recently published in World Journal of Urology. World Journal of Urology is the Official Journal of the Urological Research Society and is also the Official Journal of the International Society of Urology. The article’s lead author was Dr. Neal Shore, along with 16 co-authors consisting of prominent clinical trial urologist-investigators from across the US. The peer review article is entitled "Fexapotide Triflutate: Results of Long-Term Safety and Efficacy Trials of a Novel Injectable Therapy for Symptomatic Prostate Enlargement". The article is available at View Source

For more information please contact [email protected] or 800-936-9669.

On February 5, 2018 BeiGene, Ltd. (NASDAQ:BGNE), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly targeted and immuno-oncology drugs for the treatment of cancer, reported the commercial availability of VIDAZA (azacitidine for injection) in China (Press release, BeiGene, FEB 5, 2018, View Source;p=RssLanding&cat=news&id=2330400 [SID1234523732]). VIDAZA is a nucleoside metabolic inhibitor and was approved in China for patients with Intermediate-2 / High-risk myelodysplastic syndrome (MDS), acute myeloid leukemia (AML) with 20-30% bone marrow blasts and chronic myelomonocyte leukemia (CMML). It is marketed in China by BeiGene under an exclusive license from Celgene Corporation.

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"VIDAZA is the only approved hypomethylating agent shown to prolong survival for patients with MDS, and the first new treatment for MDS patients approved in China since 2009. It is the third approved therapy in our commercial portfolio in China, which we plan to further expand in the coming years. We are excited to announce that the first prescription was made in January 2018. From now on, Chinese patients can benefit from VIDAZA in hospitals around China," commented John V. Oyler, Founder, Chief Executive Officer, and Chairman of BeiGene.

VIDAZA is recommended by National Comprehensive Cancer Network (NCCN) Guidelines in the U.S. as a front-line treatment. In a global Phase 3 trial (AZA-001) involving Intermediate-2 and High risk MDS patients, VIDAZA significantly prolonged the median overall survival to 24.5 months compared with 15 months for the conventional care regimens (CCR- best supportive care, low-dose cytarabine and intensive chemotherapy) group. In the VIDAZA group, 45% of patients who were dependent on red blood cell transfusions at baseline became transfusion independent compared with 11% in the CCR group. There was a higher objective response rate among patients treated with VIDAZA (49%) as compared to the CCR arm (29%). VIDAZA also delayed the onset of AML for these patients (17.8 months vs.11.5 months). The most common grade 3–4 events were peripheral blood cytopenias for all treatments.

About Myelodysplastic Syndrome, Acute Myeloid Leukemia and Chronic Myelomonocyte Leukemia

MDS is a heterogeneous group of diseases characterized by bone marrow failure and one or more myelodysplasia. In about one-third of patients with MDS, the disease can progress to a rapidly growing cancer of bone marrow cells called AML.i CMML is a type of cancer that starts in blood-forming cells of the bone marrow and invades the blood; it affects mainly older adults. CMML has features of both MDS and myeloproliferative disorder and is considered the most common disease among myelodysplastic/myeloproliferative diseases.ii

About VIDAZA (Azacytidine for Injection)

VIDAZA is a nucleoside metabolic inhibitor indicated in China for the treatment of patients with intermediate-2 / high-risk MDS, AML with 20-30% bone marrow blasts and CMML. It is marketed in China by BeiGene under an exclusive license from Celgene Corporation.

In the U.S. VIDAZA is indicated for the treatment of patients with the following FAB MDS subtypes: refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and CMML.

Important Safety Information

VIDAZA is contraindicated in patients with a known hypersensitivity to azacitidine or mannitol and in patients with advanced malignant hepatic tumors.

In Study 1 (a randomized, open-label, controlled trial carried out in 53 U.S. sites compared the safety and efficacy of subcutaneous VIDAZA plus supportive care with supportive care alone ("observation") in patients with any of the five FAB subtypes of myelodysplastic syndromes (MDS)) and Study 2 (a multi-center, open-label, single-arm study of 72 patients with RAEB, RAEB-T, CMMoL, or AML), the most commonly occurring adverse reactions by SC route were nausea (70.5%), anemia (69.5%), thrombocytopenia (65.5%), vomiting (54.1%), pyrexia (51.8%), leukopenia (48.2%), diarrhea (36.4%), injection site erythema (35.0%), constipation (33.6%), neutropenia (32.3%), and ecchymosis (30.5%). Other adverse reactions included dizziness (18.6%), chest pain (16.4%), febrile neutropenia (16.4%), myalgia (15.9%), injection site reaction (13.6%), and malaise (10.9%). In Study 3, the most common adverse reactions by IV route also included petechiae (45.8%), weakness (35.4%), rigors (35.4%), and hypokalemia (31.3%).

In Study 4 (the AZA-001 survival trial), the most commonly occurring adverse reactions were thrombocytopenia (69.7%), neutropenia (65.7%), anemia (51.4%), constipation (50.3%), nausea (48.0%), injection site erythema (42.9%), and pyrexia (30.3%). The most commonly occurring Grade 3/4 adverse reactions were neutropenia (61.1%), thrombocytopenia (58.3%), leukopenia (14.9%), anemia (13.7%), and febrile neutropenia (12.6%).

Because treatment with VIDAZA is associated with anemia, neutropenia and thrombocytopenia, complete blood counts should be performed as needed to monitor response and toxicity, but at a minimum, prior to each dosing cycle.

Because azacitidine is potentially hepatotoxic in patients with severe preexisting hepatic impairment, caution is needed in patients with liver disease. In addition, azacitidine and its metabolites are substantially excreted by the kidneys and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, it may be useful to monitor renal function.

VIDAZA may cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be apprised of the potential hazard to the fetus. Men should be advised not to father a child while receiving VIDAZA.

Nursing mothers discontinue nursing or the drug, taking into consideration the importance of the drug to the mother.