On December 29, 2017 SELLAS Life Sciences Group, Inc. (Nasdaq:SLS) (SELLAS Inc.) reported that the proposed merger of the businesses of SELLAS Life Sciences Group Ltd. (SELLAS Ltd.) and Galena Biopharma, Inc. (Galena) has closed effective December 29, 2017, following approval by Galena’s stockholders (Press release, Sellas Life Sciences, DEC 29, 2017, View Source [SID1234526857]). Upon completion of the merger, Galena was renamed "SELLAS Life Sciences Group, Inc." and now features a late-stage pipeline led by novel immunotherapies targeting a broad range of indications in hematologic and solid malignancies. SELLAS Inc. is expected to commence trading on the Nasdaq Capital Market on January 2, 2018, under the ticker symbol "SLS".

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"This public listing provides us with the opportunity to further develop our novel immunotherapies for a wide range of cancers with unmet medical needs as a public company," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS Inc. "Over the past year, we have advanced the development of galinpepimut-S (GPS), our Wilms Tumor 1-targeting immunotherapy, through collaborations with Merck & Co., among others, as well as our ongoing Phase 2 trials of GPS in patients with multiple myeloma, as a monotherapy, and with ovarian cancer, in combination with Bristol-Myers Squibb’s nivolumab. We also had successful End-of-Phase 2 meetings with the FDA pertaining to our planned Phase 3 studies in acute myeloid leukemia and malignant pleural mesothelioma. We are excited by the potential of GPS, both as a monotherapy and in combination with other agents to serve as a promising therapy for patients with a broad array of cancers."

"I am delighted to be working with Angelos and the rest of the SELLAS Inc. team, who have been responsible for building the company and progressing its novel, high potential pipeline to address the unmet needs of patients battling various types of cancer. The transition to being a publicly traded company marks a significant milestone, providing the opportunity for greater financial resources and enhanced corporate structure to better advance the company’s clinical programs," noted Jane Wasman, newly-appointed Chair of SELLAS Inc.’s Board of Directors.

Following completion of the merger, the combined company will relocate its headquarters to New York City, NY, and operate under the management team of SELLAS Ltd.: Dr. Angelos M. Stergiou (Chief Executive Officer), Aleksey N. Krylov (Interim Chief Financial Officer), Dr. Nicolas J. Sarlis (Chief Medical Officer), and Dr. Gregory M. Torre (Chief Regulatory Officer). The Board of Directors now is led by Jane Wasman (Chair), along with Stephen F. Ghiglieri, Fabio Lopez, Dr. David A. Scheinberg, Dr. Angelos M. Stergiou, Robert L. Van Nostrand and John Varian.

Guggenheim Securities acted as SELLAS Ltd.’s financial advisor for the transaction, and Cooley LLP and Conyers Dill & Pearman acted as SELLAS Ltd.’s legal counsel. Canaccord Genuity Inc. acted as Galena’s financial advisor for the transaction and Paul Hastings LLP and BeesMont Law Limited acted as Galena’s legal counsel.

About the Transaction

In connection with and prior to the closing of the merger, Galena effected a 1-for-30 reverse stock split of its common stock. As a result of the reverse stock split, every 30 shares of Galena common stock issued and outstanding or held by Galena in treasury immediately prior to the effective time of the reverse stock split was automatically reclassified into one fully paid and nonassessable share of Galena common stock. Pursuant to the merger, the holders of SELLAS Ltd. shares outstanding immediately prior to the merger received 43.9972 shares of Galena common stock in exchange for each SELLAS Ltd. share in the merger. Post-merger and post-reverse split, SELLAS Inc. now has approximately 5,766,891 shares of common stock issued and outstanding, with prior SELLAS Ltd. securityholders collectively owning approximately 67.5% of the combined company, and prior Galena securityholders collectively owning approximately 32.5% of the combined company, in each case on a fully diluted basis, without taking into account certain out-of-the-money Galena warrants.

About SELLAS Inc.’s Pipeline

The combined company features a late-stage pipeline led by novel immunotherapies targeting a broad range of indications in hematologic and solid tumor malignancies. SELLAS Inc. plans to initiate a Phase 3 trial of GPS for the treatment of acute myeloid leukemia (AML) in 2018, pending funding availability, and has also successfully completed a Phase 2 study of GPS in malignant pleural mesothelioma (MPM). End-of-Phase 2 meetings have been completed with the U.S. Food and Drug Administration (FDA) for GPS in both indications.

In addition, SELLAS Inc. is currently conducting two Phase 2 trials of GPS, in multiple myeloma as a monotherapy, as well as in a combination trial in ovarian cancer with nivolumab (OPDIVO; Bristol-Myers Squibb). SELLAS Inc. is currently preparing for an open label, 5-arm ‘basket’ type combination trial of GPS in combination with the anti-PD-1 therapy pembrolizumab (KEYTRUDA; Merck & Co.). SELLAS Inc. also assumes Galena’s Phase 2 investigator-sponsored nelipepimut-S clinical trials in breast cancer and a controlled release version of anagrelide for potential internal development or strategic partnership.

On December 29, 2017 CEL-SCI Corporation (NYSE American: CVM) reported financial results today for the fiscal year ended September 30, 2017 (Press release, Cel-Sci, DEC 29, 2017, View Source [SID1234522862]). The Company also reported key clinical and corporate developments achieved during and subsequent to fiscal 2017.

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Clinical and Corporate Developments included:

Full enrollment was achieved in CEL-SCI’s pivotal Phase 3 head and neck cancer study. The study’s Independent Data Monitoring Committee (IDMC) completed its most recent review of the data from all 928 patients enrolled in the study and recommended continuing the study as constituted, as there was no evidence of any significant safety questions.
CEL-SCI’s LEAPS vaccine for the treatment of rheumatoid arthritis received a $1.5 million grant from the U.S. National Institutes of Health (NIH). The grant provides funding for CEL-SCI to advance its first LEAPS product candidate, CEL-4000, towards an Investigational New Drug (IND) application. Preclinical data on CEL-4000 were presented at several scientific conferences and published in a scientific journal during fiscal 2017.
In the $50 million arbitration suit brought by CEL-SCI against its former clinical research organization (CRO), the testimony phase of the arbitration has concluded, and all that remains at the trial level are closing statements and post-trial submissions.
CEL-SCI raised approximately $14.7 million gross proceeds during fiscal 2017.
"While we went through a challenging period during fiscal 2017, we are pleased to move forward with the achievement of our biggest milestone to date, completion of enrollment and treatment of all 928 patients in the world’s largest head and neck cancer study," stated CEL-SCI CEO, Geert Kersten. "The study is now fully enrolled. Per the recommendation of the study’s IDMC to continue the study, in accordance with the study protocol, the enrolled patients are being followed for survival outcome. After 298 patient deaths have occurred in the two comparator arms of the study the company will be able to determine if the study’s endpoint is achieved."

CEL-SCI reported a net loss of ($14.36) million in fiscal year 2017 versus a net loss of ($11.51) million in fiscal 2016.

The Company’s audited financial statements contained an audit opinion from its independent registered public accounting firm that included an explanatory paragraph related to the Company’s ability to continue as a going concern.

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 Odonate Therapeutics, Inc. (NASDAQ: ODT), a pharmaceutical company dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer, reported that it has initiated CONTESSA, a multinational, multicenter, randomized, Phase 3 study of tesetaxel in patients with locally advanced or metastatic breast cancer (MBC) (Press release, Odonate Therapeutics, DEC 28, 2017, View Source [SID1234522794]).

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Tesetaxel is an investigational, orally administered chemotherapy agent that belongs to a class of drugs known as taxanes, which are widely used in the treatment of cancer. Currently available taxanes must be delivered intravenously, typically at an infusion center. Tesetaxel has several potential therapeutic advantages over currently available taxanes, including oral administration with a low pill burden and a patient-friendly dosing regimen and a formulation that does not contain solubilizing agents that are known to cause hypersensitivity (allergic) reactions. More than 500 patients have been treated with tesetaxel across 22 clinical studies. In patients with MBC, tesetaxel was shown to have robust single-agent antitumor activity in two, multicenter, Phase 2 studies.

CONTESSA will compare tesetaxel dosed orally at 27 mg/m2 on the first day of a 21-day cycle plus a reduced dose of capecitabine (1,650 mg/m2/day dosed orally on days 1-14 of a 21-day cycle) to the approved dose of capecitabine alone (2,500 mg/m2/day dosed orally on days 1-14 of a 21-day cycle) in approximately 600 patients randomized 1:1 with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in MBC. Where indicated, patients must have received an anthracycline and/or endocrine therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor. The primary endpoint is progression-free survival (PFS) assessed by an Independent Radiologic Review Committee (IRC). CONTESSA’s secondary efficacy endpoints are overall survival, objective response rate (ORR) assessed by IRC, disease control rate (ORR + prolonged (≥ 24 weeks) stable disease) assessed by IRC and patient-reported outcomes.

"Despite recent advances in the treatment of advanced breast cancer, there remains a significant need for new therapies that allow patients to maintain a better quality of life," said Kevin Tang, Chairman and Chief Executive Officer of Odonate. "CONTESSA is designed to evaluate the potential benefit of an all-oral regimen that combines tesetaxel with a reduced dose of capecitabine as compared to the approved dose of capecitabine alone, with the goal of establishing a new, all-oral treatment option with an improved benefit-risk profile."

About Breast Cancer and Its Treatment

Breast cancer is the second most common cancer worldwide, with an estimated 1.8 million new cases diagnosed per year.1 In Europe, an estimated 494,000 new cases are diagnosed and approximately 143,000 women will die of the disease each year, making it the leading cause of cancer death in women.1 In the U.S., an estimated 255,000 new cases are diagnosed and approximately 41,000 women will die of the disease each year, making it the second-leading cause of cancer death in women.2 The 5-year survival rate for patients with metastatic breast cancer is approximately 22%.2

Breast cancer is a heterogeneous disease comprised of several molecular subtypes, which are commonly grouped into clinical subtypes based on receptor status. Human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive disease, which represents the majority of all MBC cases, remains an area of high unmet medical need. Over the past two decades, only modest survival benefits have been achieved in this patient population; hence, treatment goals emphasize controlling disease-related symptoms, minimizing toxicity and maximizing quality of life.

Patients with HER2 negative, HR positive MBC are typically treated with endocrine therapy (with or without targeted agents such as a cyclin-dependent kinase ("CDK") 4/6 inhibitor), chemotherapy, or both. The recently approved CDK 4/6 inhibitor palbociclib, an orally administered therapy, has significantly improved outcomes for patients with MBC when used in combination with endocrine agents. However, virtually all MBC patients on endocrine therapy will eventually progress and require subsequent treatment with chemotherapy. Chemotherapy agents currently available for the treatment of HER2 negative, HR positive MBC, including the oral agent, capecitabine, and the approved taxanes, generally are limited by their toxicity and impact on quality of life.

About Taxanes

Taxanes are an established class of anticancer agents that are broadly used in various cancers, including breast cancer. While paclitaxel and docetaxel, the first two taxanes approved for the treatment of breast cancer, possess robust antitumor activity, they have low oral bioavailability and low solubility. Therefore, these pharmaceutical agents must be delivered intravenously, typically at an infusion center, and also are formulated with solubilizing agents that are known to cause hypersensitivity reactions. Nab-paclitaxel, a different formulation of paclitaxel that also is approved for the treatment of breast cancer, has a greatly reduced risk of hypersensitivity reactions, but must still be delivered intravenously. Therapies given intravenously at an infusion center often are associated with: fear of needles and complications associated with venous access; anxiety, including institutional-triggered side effects such as nausea and vomiting; heightened awareness of life-threatening disease presence; and disruption of daily activities.3,4

About Tesetaxel

Tesetaxel is an investigational, orally administered chemotherapy agent that belongs to a class of drugs known as taxanes, which are widely used in the treatment of cancer. Tesetaxel has several potential therapeutic advantages over currently available taxanes, including oral administration with a low pill burden and a patient-friendly dosing regimen and a formulation that does not contain solubilizing agents that are known to cause hypersensitivity (allergic) reactions. More than 500 patients have been treated with tesetaxel across 22 clinical studies. In patients with locally advanced or metastatic breast cancer (MBC), tesetaxel was shown to have robust single-agent antitumor activity in two, multicenter, Phase 2 studies.

About CONTESSA

Odonate recently initiated CONTESSA, a multinational, multicenter, randomized, Phase 3 study of tesetaxel, an investigational, orally administered taxane, in patients with locally advanced or metastatic breast cancer (MBC). CONTESSA will compare tesetaxel dosed orally at 27 mg/m2 on the first day of a 21-day cycle plus a reduced dose of capecitabine (1,650 mg/m2/day dosed orally on days 1-14 of a 21-day cycle) to the approved dose of capecitabine alone (2,500 mg/m2/day dosed orally on days 1-14 of a 21-day cycle) in approximately 600 patients randomized 1:1 with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in MBC. Where indicated, patients must have received an anthracycline and/or endocrine therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor. The primary endpoint is progression-free survival (PFS) assessed by an Independent Radiologic Review Committee (IRC). CONTESSA’s secondary efficacy endpoints are overall survival, objective response rate (ORR) assessed by IRC, disease control rate (ORR + prolonged (≥ 24 weeks) stable disease) assessed by IRC and patient-reported outcomes. To learn more, please visit www.contessastudy.com.

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.