On November 27, 2017 Medigene AG (FSE: MDG1, Prime Standard, TecDAX) reported that all planned patients have been enrolled in the Company’s ongoing Phase I/II study with dendritic cell (DC) vaccines in acute myeloid leukaemia (AML) (Press release, MediGene, NOV 27, 2017, https://www.medigene.com/investors-media/press-releases/detail/article/patient-recruitment-completed-for-phase-iii-dc-vaccine-trial-in-aml/ [SID1234522264]). The completion of the study, as previously announced, is expected in 2019 after a treatment period of two years for all patients.

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Medigene’s Phase I/II trial (NCT02405338) includes 20 AML patients who show complete remission after standard chemotherapy, but who are not eligible for stem cell transplantation that would reduce the risk of a relapse. All patients will be vaccinated with Medigene’s DC vaccines for two years. The primary objective is to assess safety and feasibility of the active immunotherapy with Medigene’s dendritic cells. Secondary objectives of the study are induction of immune responses, overall survival (OS), progression free survival (PFS), control of minimal residual disease (MRD) and time to progression (TTP).

Dr. Kai Pinkernell, SVP Clinical Affairs and Chief Medical Officer of Medigene AG, comments: "With this study we aim to improve the outcome of the patients and show that vaccination with dendritic cells can help to control AML, a leukemia with normally high relapse rates. We are glad to announce the complete enrollment of our phase I/II trial as projected, which puts us on track for a study end in 2019. We intend to provide preliminary data on certain aspects of the trial at scientific conferences once a large part of the patients has been treated for more than a year."

About Medigene’s DC vaccines: The platform for the development of antigen-tailored DC vaccines is the most advanced of Medigene’s highly innovative and complementary immunotherapy platforms. Currently Medigene evaluates its DC vaccines in a company-sponsored Phase I/II clinical trial in acute myeloid leukaemia (AML).

Dendritic cells (DCs) are the most potent antigen-presenting cells of our immune system. Their task is to take up, process and present antigens on their cell surface, which enables them to activate antigen-specific T cells for maturation and proliferation. This way T cells can recognize and eliminate antigen-bearing tumor cells. Dendritic cells can also induce natural killer cells (NK cells) to attack tumor cells. The team of Medigene Immunotherapies scientists has developed new, fast and effective methods for generating dendritic cells ex-vivo, which are able to activate both T cells and NK cells. The DC vaccines are developed from autologous (patient-derived) precursor cells, isolated from the patient’s blood, and can be loaded with tumor-specific antigens to treat different types of cancer. Medigene’s DC vaccines are in development for the treatment of minimal residual disease or for use in combination therapies.

About acute myeloid leukaemia (AML): Acute myeloid leukaemia is a malignant disease of the hematopoietic system, affecting mainly adults above 60 years of age. In Germany, about 3,600 incidences are registered annually.
AML is caused by uncontrolled growth of dysfunctional hematopoietic precursor cells in the bone marrow. These cells prevent the generation of normal blood cells, causing a drop in erythrocytes and platelets, for example. Typical symptoms of AML include anemia, fever, increased risk of infection, and blood coagulation disorder. AML progresses rapidly and may be fatal within a few weeks if untreated.
AML is treated initially with intensive chemotherapy. Another treatment option is allogeneic hematopoietic stem cell transplantation. Unfortunately, the majority of patients suffer a relapse. Only about 15 – 20% of the patients show long-term remission after conventional chemotherapy. Allogeneic hematopoietic stem cell transplantation is the only treatment option that offers a more positive prognosis.

Genprex has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Genprex, 2018, NOV 27, 2017, View Source [SID1234527530]).

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On November 24, 2017 Alligator presented at Redeye Life Science Seminar Film (Presentation, Alligator Bioscience, NOV 24, 2017, View Source [SID1234538702]).

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On November 24, 2017 LIDDS reported that it has started four internal projects that focus on assessing the feasibility of using the NanoZolid drug delivery technology for local or intratumoral immunotherapy (Press release, Lidds, NOV 24, 2017, View Source [SID1234555922]).

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These feasibility studies will investigate if four different immunomodulatory agents can be formulated with the NanoZolid drug delivery technology. The studies include biophysical and pharmacological characterization as well as studies in relevant disease models. The objective is to demonstrate that the NanoZolid drug delivery technology can be leveraged to develop novel immunotherapies that can act locally or intratumorally. A locally delivered immunotherapy has the potential to act either as a monotherapy or in combination with systemic immunotherapies e.g. checkpoint inhibitors. A successful combination treatment could significantly increase the response rates and efficacy rates of current immunotherapies.

Results from these preclinical feasibility studies are expected in the first and second quarter of 2018.

Immunotherapy for the treatment of cancer aims to activate and utilize the body’s own immune system to recognize and attack tumors and cancer cells and is today the fastest growing and most promising area of cancer research.

On November 23, 2017 Biocon Ltd (BSE code: 532523, NSE: BIOCON), Asia’s premier biopharmaceuticals company, reported that it has launched KRABEVA, a biosimilar Bevacizumab for the treatment of patients with metastatic colorectal cancer and other types of lung, kidney, cervical, ovarian and brain cancers, in India (Press release, Biocon, NOV 23, 2017, View Source [SID1234594759]).

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KRABEVA, a monoclonal antibody (mAb) developed by Biocon, will help expand access to a world class, high quality biosimilar Bevacizumab for cancer patients in India. It is the world´s first and only Bevacizumab with a unique ´Qual­Check´ mechanism, which will ensure that patients get a quality-ascertained product right upto infusion.

Bevacizumab is indicated as a first-line treatment of patients with metastatic colorectal cancer (mCRC), and is accepted as a standard treatment option in combination with chemotherapy for patients with non-small-cell lung cancer (NSLC), metastatic renal cell carcinoma and recurrent ovarian cancer.

Dr Arun Chandavarkar, CEO & Joint Managing Director, Biocon said: "With KRABEVA we intend to provide a high quality, world-class biosimilar Bevacizumab as an affordable therapy option for patients of various types of cancer. We believe KRABEVA will be an important addition to our Oncology portfolio of novel biologics as well as biosimilars, which are making a significant impact in the realm of cancer care in India."

KRABEVA is the second key oncologic biosimilar product from Biocon´s global biosimilars portfolio to be launched in India, in order to address the unmet patient need for affordable biological therapies. It is being offered to patients at an MRP of Rs 24,000 for 100 mg / 4 ml vials and Rs 39,990 for 400 mg / 16 ml vials, making it a high quality affordable alternative to the innovator brand.

KRABEVA is being launched post successful completion of Phase III clinical trials and approval of Biocon´s Marketing Authorization Application by the Drug Controller General of India (DCGI).

Most biologic products require a specific storage condition to maintain the safety, purity and potency of the drug. An efficient and seamless cold chain prevents denaturation of antibodies due to heat.KRABEVA is being introduced with an innovative temperature-sensitive packaging that includes thermo-chromic stickers, which change colour irreversibly if the cold chain temperature is not maintained. This first-of-its-kind ´Qual Check´ feature ensures quality check of the product up to the point of administration to the patient. This will provide greater confidence to pharmacists, nurses and caregivers about the quality of the product they are dispensing and will enable better patient safety.

Clinical Development

Biocon´s biosimilar Bevacizumab has been developed for global markets with a clear focus to meet strict quality and regulatory requirements and provide access to a high quality biosimilar to patients.

The Phase III clinical study involving 146 patients of mCRC, has been conducted after obtaining regulatory approvals in India. The extrapolation to other indications has been approved by the DCGI.

The global Phase III trial in non-small-cell lung cancer (NSLC) patients is being conducted at more than 100 sites across multiple countries using an EU and US sourced reference product. Prior to this, a three-way Phase I PK study in healthy volunteers was conducted in Europe.

MoA of Bevacizumab – Antiangiogenesis Targeted Therapy

Bevacizumab is a monoclonal antibody (mAb) targeting Vascular Endothelial Growth Factor- A (VEGF-A), a cell protein that induces growth of blood vessels that feed tumors. By blocking this protein, Bevacizumab cuts the supply of food and oxygen to the tumor, thus starving it. Bevacizumab is prescribed in the treatment of several cancers including metastatic colorectal cancer, ovarian cancer, advanced non-small-cell lung cancer, recurrent glioblastoma, cervical cancer and renal cancer.

Addressing the Cancer Challenge

The launch of KRABEVA, biosimilar Bevacizumab, comes at a time when the incidence of cancer is projected to reach alarming numbers, with over 17.3 lakh new cases of cancer and over 8.8 lakh cancer deaths projected in India by 2020 as per the Indian Council of Medical Research (ICMR).

An estimated 64,000 cases of colorectal cancer were diagnosed and 49,000 deaths recorded due to the disease in India, according to GLOBOCAN´s 2012 estimates of the worldwide incidence and mortality from cancers.

There were an estimated 1.14 lakh new lung cancer cases in India in 2016 and the number is projected to grow to 1.40 lakh by 2020, according to ICMR. Similarly, new cervical cancer cases are expected to rise from an estimated 1 lakh in 2016 to about 1.04 lakh by 2020.

Global sales of the innovator product in 2016 were pegged at USD 6.9 billion. The market size for Bevacizumab, both innovator product and biosimilars, in India is estimated at Rs 177 Crore (USD 27 million), according to IPSOS June MAT 2017 data.