On December 29, 2017 Mylan N.V. (NASDAQ, TASE: MYL) reported that Biosimilar Trastuzumab, co-developed by Biocon Ltd. (BSE code: 532523, NSE: BIOCON) and Mylan N.V. (NASDAQ, TASE: MYL), has been approved by ANVISA, the Brazilian regulatory agency, through their partner Libbs Farmaceutica (Libbs), a leading Brazilian pharmaceutical company (Press release, Mylan, DEC 28, 2017, View Source [SID1234522788]).

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Co-developed by Biocon and Mylan, this is the first biosimilar Trastuzumab to be approved in Brazil and is indicated for the treatment of overexpressing HER2-positive metastatic breast cancer, HER2-positive early stage breast cancer and HER2-positive advanced gastric cancer. Libbs will commercialize the product in Brazil under the brand name Zedora, which will provide affordable access to a cutting-edge biologics therapy for patients in Brazil.

Dr. Arun Chandavarkar, CEO and Joint Managing Director, Biocon, said: "This marks the first approval for a biosimilar Trastuzumab by Brazil’s ANVISA and demonstrates our commitment to provide access to high-quality and affordable biologics to patients across the globe. Cancer patients in India and some emerging markets have benefited with our Trastuzumab and the approval in Brazil will enable affordable access to this critical biologic therapy for the treatment of HER2-positive breast and gastric cancers in the country. We are committed to make global impact with our affordable antibodies against cancer."

Mylan CEO Heather Bresch commented: "The number of women diagnosed with breast cancer in Brazil is increasing. Sadly, many of the women with HER2-positive metastatic breast cancer in Brazil do not have access to Trastuzumab through the country’s public health system. The approval of Zedora, Brazil’s first Trastuzumab biosimilar, is an important step in our efforts to increase access to this critical product for patients with certain breast and gastric cancers and reduce the overall financial burden for health systems around the world."

Alcebíades de Mendonça Athayde Júnior, Libbs CEO, said: "The approval of Zedora will allow us to bring this first-of-its-kind biosimilar Trastuzumab to breast and gastric cancer patients in Brazil. Biosimilar Trastuzumab, co-developed by Biocon and Mylan, can help expand cancer­patient access to more affordable treatment and contribute to significant savings to Brazil’s healthcare system. Zedora will strengthen our current product portfolio as a new generation targeted therapy that can benefit cancer patients immensely."

Biocon and Mylan are responsible for the development of biosimilar Trastuzumab. While currently the trastuzumab will be manufactured by Biocon and supplied to Libbs for commercialization in Brazil; over a period of time the technology will be transferred to Libbs and the public partner Butantan through a Productive Development Partnership (PDP). Libbs have already built the biotechnological site to manufacture Zedora for the Brazilian market.

This is a significant approval as it sets the stage for the entry of our biosimilar Trastuzumab into Brazil, which is among the top three emerging markets globally for Trastuzumab. The pharmaceutical market in Brazil is predicted to grow to US$30 billion in 2021 from US$26 billion in 2016. (Source:GlobalData)

Breast cancer is the leading cause of cancer death in women in Brazil, where new cases are estimated to be over 57,000 annually, with an estimated incidence of 56 cases per 100,000 women. It is the second-most common type of cancer that affects women in Brazil, after non-melanoma skin cancer*. Trastuzumab is now included on the WHO list of essential medicines.

Earlier this month, Biocon and Mylan marked a major milestone with the U.S. Food and Drug Administration approval of their biosimilar Trastuzumab. Biocon and Mylan’s biosimilar Trastuzumab is also under review by regulatory authorities in Australia, Canada, Europe and several additional markets. It is already approved in several other countries around the world, including India, where it is providing increased access to this more affordable biologic for cancer patients.

About Biocon and Mylan Partnership
Mylan and Biocon are exclusive partners on a broad portfolio of biosimilar and insulin products. Our biosimilar Trastuzumab is one of the six biologic products co-developed by Mylan and Biocon for the global marketplace. Mylan has exclusive commercialization rights for the product in the U.S., Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries. Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world.

On December 28, 2017 Propanc Biopharma Inc. (OTCQB: PPCB) ("Propanc Biopharma" or "the Company"), a clinical stage biopharmaceutical company focusing on development of new and proprietary treatments for cancer patients suffering from solid tumors such as pancreatic, ovarian and colorectal cancers, reported that the Company’s Chief Executive Officer, Mr James Nathanielsz, reported that it will be presenting at the 10th Annual Biotech Showcase to be held on January 8 – 10, 2018, at the Hilton, Union Square, San Francisco, CA (Press release, Propanc, DEC 28, 2017, View Source [SID1234522786]). The Company’s presentation is scheduled for Wednesday, January 10, 2018, at 10:30 a.m., PST.

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Mr Nathanielsz will provide an overview of the Company and recent advancements of its lead product, PRP, during the live presentation and will be available to participate in one-on-one meetings with attendees who are registered to attend the conference.

Additionally, Mr Nathanielsz will be available to participate in investor and partnering meetings surrounding the 36th Annual J.P. Morgan Healthcare Conference to be held January 8-11, 2018 in San Francisco, CA. Investors are encouraged to contact [email protected] to request a meeting.

"I am looking forward to presenting at the upcoming conference and providing an update on the recent developments of PRP, as we prepare for filing our first clinical trial application in early 2018," said Mr Nathanielsz.

Currently progressing towards First-In-Human studies, PRP aims to prevent tumor recurrence and metastasis from solid tumors. Eighty percent of all cancers are solid tumors and metastasis is the main cause of patient death from cancer. According to the World Health Organization, 8.2 million people died from cancer in 2012. Consequently, a report by IMS Health states innovative therapies are driving the global oncology market to meet demand, which is expected to reach $150 billion by 2020. The Company’s initial target patient populations are pancreatic, ovarian and colorectal cancers, representing an estimated combined market segment of $14 billion in 2020, according to GBI Research.

To view Propanc Biopharma’s "Mechanism of Action" video on anti-cancer product candidate, PRP, please click on the following link: View Source

To be added to Propanc Biopharma’s email distribution list, please click on the following link: View Source and submit the online request form.

About Biotech Showcase:
Biotech Showcase is an investor and networking conference devoted to providing private and public biotechnology and life sciences companies with an opportunity to present to, and meet with, investors and pharmaceutical executives in one place during the course of one of the industry’s largest annual healthcare investor conferences. Investors and biopharmaceutical executives from around the world gather in San Francisco during this bellwether week which sets the tone for the coming year.

On December 28, 2017 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with a primary focus on myelodysplastic syndromes (MDS), reported that it will present at Biotech Showcase taking place January 8-10 in San Francisco (Press release, Onconova, DEC 28, 2017, View Source [SID1234522785]). The Company’s CEO and President, Dr. Ramesh Kumar, will present and management will be available for one-on-one meetings.

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Presentation Details:

Date: Tuesday, January 9th, 2018

Time: 2:00 pm PDT (5:00 pm EST)

Location: Franciscan Room B at the Hilton San Francisco Union Square, 333 O’Farrell Street – Ballroom Level

The presentation will be available on the Investors section of the Company’s website at: View Source

On December 28, 2017 Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a leading off-the-shelf T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, reported that it will host a live corporate update conference call and webcast on Friday, December 29, 2017, at 8:00 a.m. EST (Press release, Atara Biotherapeutics, DEC 28, 2017, http://investors.atarabio.com/news-releases/news-release-details/atara-biotherapeutics-host-corporate-update-conference-call [SID1234522784]).

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Analysts and investors can participate in the conference call by dialing (888) 540-6216 for domestic callers and (734) 385-2715 for international callers, using the conference ID 2395468. The live webcast can be accessed on the Events and Presentations page in the Investors and Media section of the Atara website, www.atarabio.com. A replay of the webcast will be available on the Company’s website for 90 days following the live conference call.

On December 27, 2017 Innovation Pharmaceuticals Inc., (OTCQB:IPIX) ("the Company"), a clinical stage biopharmaceutical company, reported highly encouraging preliminary data from the first patients treated in the Company’s Phase 2a clinical trial (see NCT03042702) of Kevetrin for ovarian cancer (Press release, Innovation Pharmaceuticals, DEC 27, 2017, View Source [SID1234522779]).

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Modulation of the p53 protein was observed in response to administration of Kevetrin. Pathways analyses also point to concomitant cell cycle modulation at the level of gene expression. Importantly, these data are the first to directly support, in ovarian cancer patient tumors, Kevetrin’s ability to affect p53 and associated molecular pathways—a central gene signaling network involved in regulating cell growth and the cell cycle, helping to prevent cancer.

In more detail, preliminary analyses used Western Blots to assess relative levels of key proteins extracted from tumor biopsies before and after a series of nine Kevetrin infusions administered over three weeks. The level of phospho-p53, the activated form of the protein, in addition to the noted p53 modulation, was also seen to change in response to Kevetrin administration. These findings confirm in patient tumors Kevetrin-induced anti-cancer effects similar to those demonstrated (pdf) preclinically in ovarian cancer cell-lines. These new data reinforce prior clinical data, from the earlier concluded Phase 1 study of Kevetrin in advanced solid tumors (see NCT01664000), in which observations of p21 expression in peripheral blood monocytes supported p53 involvement in Kevetrin’s mechanism of action.

Data from RNAseq analyses of expressed mRNAs and sRNAs in tumors, before and after treatment with Kevetrin, are being further analyzed to assess the nature and scope of molecular pathways modulations. The strongest signal so far detected concerns the cell cycle and a variety of transcription factors.

Running in parallel, the Company is making plans to develop Kevetrin as an oral agent (tablet or capsule) that could be dosed multiple times per day, leveraging its short half-life and pharmacokinetic profile. Bioavailability and other lab studies have been encouraging. Last, linked below is a blog post, published on the Company’s website, further elaborating on Kevetrin’s treatment potential as a novel, p53-modulating anti-cancer drug candidate.

"Kevetrin’s Effect on the p53 Signaling Pathway in a Broader Scientific Context"

Management Comments

"In a majority of cancers, p53 is mutated, preventing the body from performing its anti-tumor functions," said Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. "As a result, therapies targeting p53 have long been pursued, highly sought-after by Big Pharma, but have largely been met with limited success due to the inherent complexity of p53. So, to see Kevetrin modulate p53 in a clinical setting in tumor biopsies from patients is an exciting moment for the Company, positioning us at the forefront of developing a potentially transformative anti-cancer therapy."

"Our science team has been working on Kevetrin for over a decade now, studying its unique anti-cancer profile across multiple cancer types, from solid tumors to leukemias—a function of Kevetrin’s ability to induce apoptosis in both wild type p53 and mutant p53 tumors," said Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. "It’s rewarding to think—after so many years of research in the lab and in the clinical setting—that we now have more direct evidence of how Kevetrin’s multiple mechanisms of action modulate p53, helping to restore the body’s natural ability to fight cancer. Such mechanistic insights of the kind we’re observing will prove invaluable as we continue to advance Kevetrin into later-stage clinical development."

About Ovarian Cancer

Ovarian Cancer is a common type of cancer that commonly begins in women’s ovaries and associated tissues. Malignant ovarian tumor cells metastasize either directly through the organs of the pelvis region, or through the bloodstream, or the lymphatic system. The causes of ovarian cancer are still not known, though women over the age of 63 represent more than 50 percent of newly diagnosed cases, with the cancer more frequently found in white women than other ethnicities. Ovarian cancer ranks fifth in cancer deaths among women worldwide. It is estimated that in 2016, in the United States, over 22,000 women will be diagnosed with ovarian cancer, with approximately 14,000 women dying from the disease. A $1.6 billion market, current treatment is often limited to surgery and chemotherapy and there is no cure.

About Kevetrin and p53

Kevetrin is a small molecule that has demonstrated the potential of becoming a breakthrough cancer treatment by modulating p53, a protein frequently referred to as the "Guardian of the Genome" due to its critical role in controlling cell mutations. In the majority of cancers, and regardless of origin, type, and location, the p53 pathway is mutated, preventing the body from performing its natural anti-tumor functions. Conducted at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center, a Phase 1 clinical trial (see NCT01664000) of Kevetrin in treating advanced solid tumors has been successfully completed, with patients showing good toleration and encouraging signs of potential therapeutic response (see ASCO (Free ASCO Whitepaper) 2015, ASCO (Free ASCO Whitepaper) 2013). Additional pre-clinical work supporting Kevetrin’s anti-cancer activity has recently been presented at scientific conferences (see EHA (Free EHA Whitepaper) 2017, AACR (Free AACR Whitepaper) 2017). The Company has initiated a Phase 2a trial of Kevetrin (see NCT03042702) in late stage, platinum-resistant/refractory ovarian cancer. Patients will receive more frequent dosing (3 times per week) at higher levels and then receive standard of care treatment after trial conclusion. Efforts also are underway to develop Kevetrin as an oral anti-cancer agent that can be administered daily, potentially multiple times per day. The FDA has awarded Kevetrin Orphan Drug status for ovarian cancer, pancreatic cancer, and retinoblastoma, qualifying it for developmental incentives and a potential extra 7 years of market exclusivity upon drug approval. The FDA also has granted Kevetrin Rare Pediatric Disease designation for childhood retinoblastoma.