On November 28, 2018 Advaxis, Inc. (NASDAQ: ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported that Kenneth A. Berlin, President and Chief Executive Officer of Advaxis, will present a corporate overview at the 11th Annual LD Micro Main Event on Tuesday, December 4, 2018 at 5:00 p.m. (Pacific) (Press release, Advaxis, NOV 28, 2018, View Source [SID1234531689]). The conference will be held on December 4-6, 2018 at the Luxe Sunset Bel-Air, California.

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Mr. Berlin’s presentation will be webcast live and available for replay in the Investors section of the Company’s website at www.ir.advaxis.com .

On November 28, 2018 The U.S. Food and Drug Administration reported that it approved Xospata (gilteritinib) tablets for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test (Press release, US FDA, NOV 28, 2018, View Source [SID1234531690]). The FDA also approved an expanded indication for a companion diagnostic, to include use with Xospata. The LeukoStrat CDx FLT3 Mutation Assay, developed by Invivoscribe Technologies, Inc., is used to detect the FLT3 mutation in patients with AML.

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"Approximately 25 to 30 percent of patients with AML have a mutation in the FLT3 gene. These mutations are associated with a particularly aggressive form of the disease and a higher risk of relapse," said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. "Xospata targets this gene and is the first drug to be approved that can be used alone in treating patients with AML having a FLT3 mutation who have relapsed or who don’t respond to initial treatment."

AML is a rapidly progressing cancer that crowds out normal cells in the bone marrow and bloodstream, resulting in low numbers of normal blood cells and a continuous need for transfusions. The National Cancer Institute estimates that approximately 19,520 people will be diagnosed with AML this year; approximately 10,670 patients with AML will die of the disease in 2018.

The efficiency of Xospata was studied in a clinical trial of 138 patients with relapsed or refractory AML having a confirmed FLT3 mutation. Twenty-one percent of patients achieved complete remission (no evidence of disease and full recovery of blood counts) or complete remission with partial hematologic recovery (no evidence of disease and partial recovery of blood counts) with treatment. Of the 106 patients who required red blood cell or platelet transfusions at the start of treatment with Xospata, 31 percent became transfusion-free for at least 56 days.

Common side effects reported by patients in clinical trials were muscle and joint pain (myalgia/arthralgia), fatigue and elevated liver enzymes (liver transaminase). Health care providers are advised to monitor patients for posterior reversible encephalopathy syndrome (a syndrome characterized by headache, confusion, seizures and visual loss), prolonged QT interval (a heart rhythm condition that can potentially cause fast, chaotic heartbeats) and pancreatitis (inflammation in the pancreas). Rare cases of differentiation syndrome (symptoms of which may include fever, cough, trouble breathing, fluid around the lungs or heart, rapid weight gain, swelling, and renal or hepatic dysfunction) have been seen in patients taking Xospata. Women who are pregnant or breastfeeding should not take Xospata because it may cause harm to a developing fetus or newborn baby.

The FDA granted this application Fast Track and Priority Review designation. Xospata also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.

The FDA granted the approval of Xospata to Astellas Pharma.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

On November 28, 2018 WuXi Biologics (2269.HK, WuXi Bio), a leading global open-access biologics technology platform company offering end-to-end solutions for biologics discovery, development and manufacturing, and ABL Bio Corporation (ABL Bio), a privately-held South Korean biotechnology company developing antibody therapeutics for immuno-oncology and neurodegenerative diseases, reported that the companies have entered into an exclusive development and clinical manufacturing partnership for up to 8 antibody therapeutics including ABL Bio’s biologics pipelines and collaboration programs between ABL Bio and I-Mab Biopharma (I-Mab) (Press release, WuXi Biologics, NOV 28, 2018, View Source [SID1234536985]). The agreement showcases the expansive biologics pipeline of ABL Bio and the world leading technical expertise and capabilities of WuXi Biologics in developing bispecific programs.

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"We are very pleased to enter into this partnership with WuXi Biologics. The partnership with WuXi Biologics is an important strategy for growing our internal and external programs of next-generation of biologics such as bispecific antibody. WuXi Biologics has enabled several preclinical and clinical manufacturing programs for ABL Bio as well as collaboration with I-Mab," said Dr. Sang Hoon Lee, Chief Executive Officer of ABL Bio. "I believe that the partnership with WuXi Biologics will bring a synergy effect for developing our bispecific antibody pipelines and help us step up to be a global top-tier biotechnology company for immuno-oncology and neurodegenerative disease treatment."

"We are excited about this exclusive partnership, our first in South Korea. WuXi Biologics has been well recognized as a global leader in the development and manufacturing of difficult biologics such as bispecific antibodies. This agreement continues to exemplify our technical strength and unparalleled capacity in global biologics development and manufacturing," said Dr. Chris Chen, Chief Executive Officer of WuXi Biologics. "We are able to initiate 60 IND-enabling programs and 3 BLA-enabling programs per year, enabled by one of the largest biologics development teams in the industry of approximately 2000 scientists. With globally recognized technical capabilities and unparalleled capacities, we are transforming how biologics are developed in the global setting."

On November 28, 2018 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a company focused on the development of novel immunotherapies based on proprietary chimeric antigen receptor engineered T cell ("CAR T") technology and gene therapies for rare diseases, reported that additional safety and efficacy Phase 1 data evaluating MB-102 (CD123 CAR) in relapsed or refractory acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN) have been selected for an oral presentation at the AACR (Free AACR Whitepaper) Special Conference on Tumor Immunology and Immunotherapy (Press release, Mustang Bio, NOV 28, 2018, View Source [SID1234531653]). The presentation will take place on November 30, 2018, in Miami Beach, Florida.

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Martina Sersch, M.D., Ph.D., Chief Medical Officer of Mustang, said, "We are excited about the additional data demonstrating MB-102’s (CD123 CAR T) potential to treat patients with AML and BPDCN. Initial safety and tolerability data as well as preliminary data on efficacy are very promising in a population with high unmet medical need. Based on the Phase 1 data, we expect to submit an IND filing for MB-102 and look forward to initiating a multicenter Phase 1/2 clinical trial in 2019 in patients with AML, BPDCN and high-risk myelodysplastic syndrome."

Lihua Elizabeth Budde, M.D., Ph.D., assistant professor in the Department of Hematology & Hematopoietic Cell Transplantation at City of Hope and principal investigator for the Phase 1 trial, said, "There is increased expression of CD123 on AML blasts, leukemic stem cells and BPDCN cells compared to normal hematopoietic stem cells, and it is therefore a promising target for cellular immunotherapy. We remain encouraged by interim data showing MB-102’s potential to treat BPDCN and AML and continue to evaluate MB-102’s clinical benefits in our ongoing Phase 1 clinical trial."

Details of the oral presentation are as follows:

Title: CD123CAR Displays Clinical Activity in Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) and Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN): Safety and Efficacy Results from a Phase 1 Study
Special Session: Novel Targets, Pathways and Tools
Date and Time: Friday, November 30, 2018; 8:00 AM – 9:30 AM ET
Location: Loews Miami Beach Hotel
Presenter: Elizabeth Lihua Budde, M.D., Ph.D., City of Hope, Duarte, CA

For more information, please visit: View Source;ItemID=733&DetailItemID=733.

Key Efficacy and Safety Findings
This single center, first-in-human Phase 1 dose-escalation clinical trial is evaluating the safety and activity of escalating doses of MB-102 in patients with relapsed or refractory AML (cohort 1) and BPDCN (cohort 2). Patients receive a single dose of MB-102 with an option for a second infusion if they continue to meet safety and eligibility criteria and still have CD123+ disease. To date, 18 patients have been enrolled and nine have been treated (seven with AML, two with BPDCN).

In the AML cohort, all seven patients had at least one prior allogeneic stem cell transplant and median of 4 (range: 4-10) prior lines of therapy. Two patients were treated at dose level 1 (50M CAR+ T). Trial investigators reported that one achieved a morphologic leukemic-free state (MLFS) that lasted 70 days. This patient received a second infusion three months later, with blast reduction from 77.9% to 0.9% (flow cytometry) after 35 days. Five patients received dose level 2 (200M CAR+ T). One patient achieved complete remission (CR) with incomplete count recovery at day 28, and one patient achieved MLFS that improved to CR at day 84. The remaining three patients had stable disease.

In the BPDCN cohort, two patients were treated with 100M CAR+ T and tolerated the treatment well, with no grade 3 or above treatment-related toxicities. One patient achieved CR with no evidence of disease in the bone marrow and skin at day 28.

Investigators found MB-102 infusions of up to 200M CAR T cells were safe. All toxicities observed to date were reversible and manageable. No patient developed grade 3 or above cytokine release syndrome or neurotoxicity. There were no treatment-related dose-limiting toxicities and no treatment-related cytopenias longer than 12 weeks. One patient with prior cutaneous graft-versus-host disease developed grade 1 rash five weeks after CAR T infusion, which resolved after clinical management. Peak of T cell expansion occurred within the first 14 days. Investigators did not observe any CD123-loss leukemic variants.

About Acute Myeloid Leukemia
Acute myeloid leukemia (AML) is a cancer of the myeloid line of blood cells characterized by rapid growth of abnormal white blood cells that accumulate in the bone marrow. Although AML is rare, there are approximately 20,000 new cases in the U.S. each year and 10,000 deaths. Current treatment of relapsed or refractory AML with chemotherapy or hematopoietic stem cell transplantation is associated with low rates of complete response and considerable complications.

CD123 is overexpressed on AML blasts and leukemic stem cell-enriched cell subpopulations compared to normal hematopoietic stem cells and myeloid progenitors, making CD123 an attractive target for T cell-based adoptive immunotherapy.

About Blastic Plasmacytoid Dendritic Cell Neoplasm
Blastic plasmacytoid dendritic cell neoplasm (BPDCN) is a rare and incurable blood cancer with a median survival of less than 18 months and no standard of care. High levels of CD123 expression is one of the diagnostic hallmarks of BPDCN, making CD123 an attractive target for T cell-based adoptive immunotherapy.

About MB-102 (CD123 CAR T)
MB-102 (CD123 CAR T) is a CAR T cell therapy that is produced by engineering patient T cells to recognize and eliminate CD123-expressing tumors. CD123 is widely expressed on bone marrow cells of patients with MDS, as well as in hematologic malignancies including AML, B cell acute lymphoblastic leukemia, hairy cell leukemia, BPDCN, chronic myeloid leukemia and Hodgkin’s lymphoma.

In the first-in-human clinical trial at City of Hope (NCT02159495), MB-102 has demonstrated complete responses at low doses in AML and BPDCN without dose-limiting toxicities, as reported at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December 2017. Dose escalation continues at City of Hope in both indications.

On November 28, 2018 Varian (NYSE: VAR) reported its Halcyon system has been approved by the China National Medical Product Administration (NMPA), which allows the company to market this new cancer treatment system in China (Press release, Varian Medical Systems, NOV 28, 2018, View Source [SID1234531710]). This approval further expands the global availability of Halcyon and access to high-quality, cost-effective cancer treatments.

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As an advanced cancer treatment system with a human-centered and user-friendly design, Halcyon is engineered to revolutionize clinical workflow, accelerate installation timeframes, expedite commissioning, simplify training, and automate treatment. The system is well suited to treat cancer patients with radiotherapy, offering advanced treatments for lung, prostate, breast, head & neck, and many other forms of cancer.

"We are very excited to further expand the Halcyon system’s global availability," said Chris Toth, president Varian Oncology Systems. "With the most recent announcement by the Chinese government for expanding Category B licenses and enabling County hospital oncology services availability, Halcyon is a perfect fit."

Halcyon has already received FDA 510(k) clearance in the US, CE mark in Europe, Shonin approval in Japan, ANVISA registration in Brazil, Atomic Energy Regulatory Board (AERB) Certificate for Import and Supply as well as Type Approval in India and TFDA approval in Taiwan since its launch in May 2017.