Changes to the Leadership of Boehringer Ingelheim

On September 10, 2018 Boehringer Ingelheim reported that Dr Christopher Corsico, Senior Vice President, Corporate Division Medicine and Chief Medical Officer, will be leaving Boehringer Ingelheim to pursue his career outside of the company effective 31 December 2018 (Press release, Boehringer Ingelheim, SEP 10, 2018, View Source [SID1234529413]). Dr Thor Voigt, currently Medical Director Germany, has agreed to assume the leadership of the Corporate Division Medicine and to become Chief Medical Officer, effective October 1, 2018.

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Dr. Thor Voigt
Allan Hillgrove, Member of the Board of Managing Directors with responsibility for the Human Pharma Business Unit said: "We are grateful to Dr Corsico for his valuable contributions during many years of service for Boehringer Ingelheim. He has been instrumental for Boehringer Ingelheim’s drive for medical and patient focus. On behalf of the Board of Managing Directors I wish him all the best for the future." Allan Hillgrove further commented: "We are pleased to appoint Thor Voigt as Chief Medical Officer and Head of our Corporate Division Medicine. Dr Voigt is a highly respected and trusted leader who has taken multiple roles within Boehringer Ingelheim’s medical division in recent years."

Dr. Christopher Corsico
Christopher Corsico joined Boehringer Ingelheim in April 1998 as a Pharmacovigilance Physician, followed by the positions of US Pharmacovigilance Head, US Regulatory Head, and Regional Medical Director for North America. In 2012, he became Head of Corporate Division Quality, Regulatory, Pharmacovigilance and Epidemiology (QRPE) and Medicine, before he took over his current role in 2016.

Thor Voigt joined Boehringer Ingelheim in 1992 and was appointed to his current role in 2015. Prior to his current role, Thor was Medical Director in the Netherlands and the USA and Global Head of Clinical Operations. Thor holds a medical degree from University of Mainz, Germany.

Boehringer Ingelheim

Improving the health and quality of life of patients is the goal of the research-driven pharmaceutical company Boehringer Ingelheim. The focus in doing so is on diseases for which no satisfactory treatment option exists to date. The company therefore concentrates on developing innovative therapies that can extend patients’ lives. In animal health, Boehringer Ingelheim stands for advanced prevention.

Family-owned since it was established in 1885, Boehringer Ingelheim is one of the pharmaceutical industry’s top 20 companies. Some 50,000 employees create value through innovation daily for the three business areas human pharmaceuticals, animal health and biopharmaceuticals. In 2017, Boehringer Ingelheim achieved net sales of nearly 18.1 billion euros. R&D expenditure, exceeding three billion euros, corresponded to 17.0 per cent of net sales.

As a family-owned company, Boehringer Ingelheim plans in generations and focuses on long-term success. The company therefore aims at organic growth from its own resources with simultaneous openness to partnerships and strategic alliances in research. In everything it does, Boehringer Ingelheim naturally adopts responsibility towards mankind and the environment.

Innovent’s Anti-CD47 Antibody IBI188 Receives IND Approval in China

On September 9, 2018 Innovent Biologics (Innovent), a world-class China-based biopharmaceutical company that develops and commercializes high quality drugs, reported that its IND application for IBI188, a fully human anti-CD47 monoclonal antibody (mAb) drug candidate, has been approved by the National Medical Products Administration (NMPA, formerly known as CFDA) for clinical trials (Press release, Innovent Biologics, SEP 9, 2018, View Source [SID1234529358]). Innovent will launch several clinical trials based on this mAb drug to assess its safety and efficacy for multiple tumor types, including non-Hodgkin’s lymphoma and ovarian cancer. This is the fourth IND approval the company has received this year, including anti-CTLA-4 mAb, anti-RANKL mAb, anti-OX40 mAb and anti-CD47 mAb.

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As one of the key targets in the field of anti-tumor immunotherapy, CD47 is regarded by many experts to have the possibility of becoming the next "star" in the field of immuno-oncology following the ground-breaking success of PD1 / PD-L1 antibodies. The IND approval signals that Innovent’s discovery and development on CD47 has advanced IBI188 as a leading player for this target to enter into clinical development stage.

"Innovent, with a relentless focus on innovation and quality, has developed programs that are advancing into cutting edge drug development frontiers. We hope that through our efforts, we can advance the field of cancer treatment, provide better treatment options to increase patients’ survival rate and improve their quality of life," said Michael Yu, Founder, Chief Executive Officer and Chairman.

"Emerging data suggests that CD47 antibody in combination with other treatments, including anti-PD-1 monoclonal antibodies, could result in higher levels of anti-tumor efficacy. Innovent’s current rich pipeline will allow multiple drug combinations with IBI188 creating many opportunities to achieve breakthroughs in cancer treatment to meet more unmet patient needs in the future," said Dr. Kerry Blanchard, Chief Scientific Officer of Innovent.

CD47 is one of the most important targets in the field of immuno-oncology. The development of anti-CD47 monoclonal antibody has recently attracted much attention. Innovent will be among one of a few companies pursuing the development of an anti-CD47 antibody in the early clinical stage.

About IBI188

IBI188 is an anti-CD47 IgG4 monoclonal antibody developed by Innovent with independent intellectual property rights. Both in vitro and in vivo experiments showed that IBI188 can bind to the CD47 antigen on the surface of tumor cells, block the CD47-SIRPα signaling pathway, inhibit the "Don’t Eat Me" signal, and promote the phagocytosis of tumor cells by macrophages, thereby exerting an anti-tumor effect. It has stronger receptor blocking ability than similar drugs. Innovent will launch several clinical trials to assess its safety and efficacy for multiple tumor types, including non-Hodgkin’s lymphoma and ovarian cancer.

Xspray Pharma announces positive clinical data for its lead product candidate HyNap-Dasa

On September 9, 2018. Xspray Pharma reported positive data from a clinical bioequivalence study with the company’s lead product candidate HyNap-Dasa (Press release, Xspray, SEP 9, 2018, View Source [SID1234649534]). The study results confirmed its primary aim to show bioequivalence of an optimized formulation of HyNap-Dasa compared to Sprycel. The data will be instrumental in the design of the planned registration study for an ANDA application.
The completed clinical Phase I study examined HyNap-Dasa’s bioavailability compared to the dasatinib cancer drug, currently marketed as Sprycel for the treatment of chronic myeloid leukemia (CML). In the study, bioavailability of two different tablet formulations of HyNap-Dasa was tested in comparison with Sprycel tablets in 16 healthy subjects. The results are very positive and confirm the validity of Xspray’s patented formulation technology. The planned studies required to take HyNap-Dasa to final registration studies will now be performed as planned. The results also strengthen the potential for additional product candidates in the pipeline being developed with the same technology to reach the market.

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"I am happy to see that the data so strongly confirm our technology. The outcome of this study represents an important milestone for Xspray Pharma as it means that we now can initiate the preparation of the pivotal phase of the clinical program, taking us closer to a commercial launch of HyNap-Dasa. Furthermore, the results pave the way also for additional product candidates in our pipeline. It signifies a new and important step in our development as a company" said Per Andersson, CEO of Xspray Pharma.

The clinical results in summary:

The study compared the pharmacokinetic parameters Cmax and AUC for the originator product Sprycel and two different HyNap tablet formulations of dasatinib. Sixteen healthy volunteers received single doses of each product in a cross-over design. Although this study was not powered to demonstrate formal bioequivalence, an analysis of preliminary data indicate that bioequivalence with Sprycel was achieved for one of the HyNap formulations. The results demonstrate a high likelihood that formal bioequivalence will be achieved in an adequately powered study.

Sprycel is a registered trademark of Bristol-Myers Squibb.

Adaptimmune Therapeutics plc Announces Closing of Registered Direct Offering of American Depositary Shares

On September 7, 2018 Adaptimmune Therapeutics plc ("Adaptimmune") (Nasdaq: ADAP), a leader in T-cell therapy to treat cancer, reported the closing of its previously announced registered direct offering of its American Depositary Shares ("ADSs") (Press release, Adaptimmune, SEP 7, 2018, View Source;p=RssLanding&cat=news&id=2366583 [SID1234529380]). Adaptimmune sold 10,000,000 ADSs at a price of $10.00 per ADS.

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Net proceeds of the offering are approximately $100.0 million. Adaptimmune intends to use the net proceeds from this offering to advance the company’s wholly-owned pipeline of SPEAR T-cell candidates through clinical trials as well as for other general corporate purposes.

A shelf registration statement on Form S-3 relating to the public offering of the ADSs described above was filed with the Securities and Exchange Commission ("SEC") and became effective on July 12, 2018. The offering was made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. The prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC’s website at View Source, or may be obtained, when available, by contacting Adaptimmune Therapeutics plc, Attn: Investor Relations, 351 Rouse Boulevard, Philadelphia, PA 19112, or by telephone at: (215) 825-9310.

This press release shall not constitute an offer to sell nor the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

For readers in the European Economic Area

In any EEA Member State that has implemented the Prospectus Directive, this communication is only addressed to and directed at qualified investors in that Member State within the meaning of the Prospectus Directive. The term "Prospectus Directive" means Directive 2003/71/EC (and amendments thereto, including Directive 2010/73/EU, to the extent implemented in each relevant Member State), together with any relevant implementing measure in the relevant Member State.

For readers in the United Kingdom

This communication, in so far as it constitutes an invitation or inducement to enter into investment activity (within the meaning of s21 Financial Services and Markets Act 2000 as amended) in connection with the securities which are the subject of the offering described in this press release or otherwise, is being directed only at (i) persons who are outside the United Kingdom or (ii) persons who have professional experience in matters relating to investments who fall within Article 19(5) ("Investment professionals") of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the "Order") or (iii) certain high value persons and entities who fall within Article 49(2)(a) to (d) ("High net worth companies, unincorporated associations etc") of the Order; or (iv) any other person to whom it may lawfully be communicated (all such persons in (i) to (iv) together being referred to as "relevant persons"). The ADSs are only available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such ADSs will be engaged in only with, relevant persons. Any person who is not a relevant person should not act or rely on this document or any of its contents.

Corporate Presentation

On September 7, 2018, Propanc Biopharma, Inc. (the "Company")reported that it has released a corporate presentation (the "Corporate Presentation") which it utilized at the 25th Annual NewsMakers in the Biotech Industry Conference held on September 7, 2018 at the Millennium Broadway Hotel and Conference Center in New York City (Presentation, Propanc, SEP 7, 2018, View Source [SID1234529355]).

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