On November 27, 2017 AstraZeneca reported a strategic joint venture with the Chinese Future Industry Investment Fund (FIIF) to form an equally-owned, stand-alone company in China to discover, develop and commercialise potential new medicines to help meet unmet needs globally, and to bring innovative new medicines to patients in China faster (Press release, AstraZeneca, NOV 27, 2017, View Source [SID1234537458]). FIIF is managed by the SDIC Fund Management Company (SDIC Fund), a private equity management company.

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The new company, Dizal Pharmaceutical, incorporates all scientific and technical capabilities of AstraZeneca’s Innovation Center China (ICC), and holds exclusive rights to develop and commercialise three potential medicines currently in pre-clinical development from AstraZeneca’s pipeline in its main therapy areas of oncology, cardiovascular and metabolic diseases, and respiratory. It is also expected to initiate novel clinical programmes. The FIIF will contribute funding and expertise in establishing strategic partnerships in China.

Dr. Xiaolin Zhang, previously Head of AstraZeneca’s ICC, has been named as Chief Executive Officer of the new company. All staff employed by the ICC have been invited to join the new company.

Pascal Soriot, Chief Executive Officer of AstraZeneca, said: "AstraZeneca has a long-standing and strong commitment to China, which we are reinforcing today with this ground-breaking joint venture. By joining forces with the FIIF, we aim to accelerate the local discovery and development of innovative, affordable medicines for patients in China and around the world."

Guohua Gao, Chairman of SDIC Fund, said: "FIIF is delighted to be collaborating with AstraZeneca to promote the development of innovative medicines. AstraZeneca’s Innovation Center China has an excellent track record of drug discovery, and the synergy created by combining AstraZeneca’s scientific talent and assets with FIIF’s China expertise and funding will help further promote innovation in medical science."

The remit of the FIIF in the pharmaceutical industry is to promote the development and manufacturing of innovative medicines in China through strategic partnerships. The joint venture supports AstraZeneca’s commitment to enhancing China’s research and development capabilities through diversified external partnerships that deliver value to patients in China.

On November 27, 2017 STORM Therapeutics, the leading drug discovery company focused on the discovery of small molecule therapies modulating RNA epigenetics, reported the publication of data in the internationally renowned scientific journal Nature linking an essential RNA-modifying enzyme to acute myeloid leukaemia (AML) (Press release, STORM Therapeutics, NOV 27, 2017, View Source [SID1234561048]).

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The study has found an unexpected new drug target for acute myeloid leukaemia (AML) that could open new avenues to develop effective treatments against this potentially lethal disease. Data show that inhibiting the METTL3 gene destroys human and mouse AML cells without harming nonleukaemic blood cells. The paper, entitled "Promoter-bound METTL3 maintains myeloid leukaemia via m6A-dependent translation control’, goes on to reveal why METTL3 is required for AML cell survival, by deciphering the new mechanism it uses to regulate several other leukaemia genes.

Professor Tony Kouzarides, Founder of STORM Therapeutics and joint project leader from the Gurdon Institute, University of Cambridge, commented: "This is an important milestone in the understanding of RNA epigenetics and its links to disease. These findings highlight the importance of RNA modifying enzymes in cancer, and in particular in leukaemia. New treatments for AML are desperately needed and we have been looking for novel genes that would be good drug targets. We identified the methyl transferase enzyme METTL3 as a highly viable target against AML. Our study will inspire pharmaceutical efforts to find drugs that specifically inhibit METTL3 to treat AML."

STORM has established a pipeline of drug discovery programmes to develop novel, first-in-class drugs for the treatment of specific cancers and other diseases with high unmet medical need. It is focusing on two classes of RNA modifying enzymes, RNA methyltransferases and terminal uridyltransferases (TUTases), and has already advanced two undisclosed targets in drug discovery.

Keith Blundy, CEO of STORM Therapeutics, said: "STORM leads the field of harnessing the power of RNA epigenetics as a new area of important biology. Our ambition is to become a world leading therapeutics company tackling diseases through modulating RNA modifying enzymes. Publication of these data, in such a prestigious journal as Nature, is validation of the world class science on which the Company was founded."

This publication represents results obtained from research conducted in collaboration by: Wellcome Trust Sanger Institute, The Gurdon Institute and Department of Pathology at the University of Cambridge, Cold Spring Harbor Laboratory and STORM Therapeutics.

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 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 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.