Prima BioMed to Host Shareholder Briefing ($PBMD)

Prima BioMed Ltd (PRR.AX) (PBMD) is a globally active and listed (ASX, NASDAQ) biotechnology company focused on developing novel oncology therapies in the field of immunotherapy.  Prima BioMed has a clear strategy to develop and commercialize therapeutic vaccine CVac™ in ovarian cancer with an opportunity to expand to other indications. CVac™ has been tested successfully in two clinical studies and is currently in late stage clinical development in Australia, USA and Europe. Long term goal of Prima BioMed is the development of commercial cancer therapies on a worldwide scale. 

The company has advised that it will hold a shareholder briefing with the Company's CEO designate Matthew Lehman, current CEO Martin Rogers, Chairman Lucy Turnbull, and Deputy Chairman Albert Wong in Sydney, Australia, on Friday, 15 June 2012. 

The briefing will provide an opportunity for Mr. Lehman to meet shareholders and deliver an update on the Company's activities.

Mr. Lehman, who is currently Prima's Chief Operating Officer, will become the Company's CEO effective 1 September 2012 (see ASX announcement of 24 May).

Details of the shareholder briefing:

Date: 
Friday, 15 June 2012

Time: 
9:30am to 11:00am AEST (local time)

Venue: 
Radisson Blu Hotel Sydney 
27 O'Connell St Sydney (Marble Room 2 and 3)

Shareholders outside Sydney will be able to access the briefing via a webcast and dial-in facility. Webcast and dial-in details will be provided on the Prima BioMed and ASX websites prior to the meeting.

Shareholders, and other interested parties, are kindly requested to RSVP to  enquiries@primabiomed.com.au prior to the event to assist in planning the meeting. Shareholders are also encouraged to submit questions or comments via email prior to the meeting.

Prima has updated the Company Calendar section of its website to include this shareholder briefing and other relevant upcoming public presentations.

Read more at Yahoo Finance. 

Prima BioMed Announces Changes to the Board and Senior Management $PBMD

Prima BioMed Ltd ("Prima" or the "Company")(PRR.AX) $PBMD advises of the following changes to senior management and the board of directors.

The Company's Chief Executive Officer, Martin Rogers, will step down effective 31 August 2012. Mr. Rogers will remain on Prima's board as a non-executive director from 1 September 2012.

Matthew Lehman, the Company's Chief Operating Officer, will assume the CEO role effective 1 September 2012. Mr. Lehman will join the Prima board of directors effective immediately. Mr. Lehman will be the Acting CEO during the period of Mr. Rogers' nuptial leave until the end of July 2012.

These changes are intended to facilitate CVac's continued clinical and regulatory development, and position Prima for the Company's next stage of growth.

Prima Chairman Lucy Turnbull AO said: "On behalf of the Company, we would like to thank Martin Rogers for his tireless work in transforming Prima over the past 4 1/2 years. Under his leadership, Martin consolidated Prima's research activities to focus on development of CVac, he brought together a strong management team and board of directors, and he has overseen the globalization of Prima's development activities with key operations in the USA and Germany. As Martin transitions out of active management, he leaves the Company in a strong financial position with significant opportunity for growth. On behalf of everyone at Prima, we thank Martin for his service and wish him well in his future endeavors."

Mr. Rogers said: "It has been an honor to serve patients, the medical community, and our shareholders over the past 4 1/2 years. I have every confidence that the Prima team is in an excellent position to capitalize on the success the Company has achieved to date, in both the clinical programs for CVac™ and at the corporate level. Prima has a world class management team and it has been a privilege to work with such a talented group. I would like to acknowledge the outstanding support of the board and all the Prima team during my tenure as CEO."

Ms. Turnbull continued: "We are confident that Matthew Lehman's extensive experience in product development and clinical trial execution will serve Prima well in the next stages of the Company's growth. After successfully leading Prima's operations and clinical development for over 2 years, he is a natural choice for this role."

As Mr. Lehman transitions into the CEO role, he will relocate from Germany to the San Francisco Bay Area, where Prima plans to concentrate its longer-term operational expansion.

On his appointment as an executive director and being named CEO designate, Mr. Lehman said: "It gives me great pleasure to join Prima's board and to be named CEO designate after having worked closely with our directors for the past several years. I would like to thank Martin for his support, and the enthusiasm and passion he brought to Prima. As the Company's next CEO, I look forward to working with the Prima management team and the board to build upon the strong foundation set by Martin."

Mr. Lehman continued: "I also look forward to spending significant time in Australia meeting with shareholders, while maintaining a strong link to the major US and European markets. As a truly global organization, we will have a good geographic representation among our board and our senior management."

Also effective today, Dr. Neil Frazer has stepped down from his position as an executive director on the board. This move assures consistency with the Corporate Governance Principles and Recommendations of the Australian Securities Exchange such that the independent non-executive directors maintain a majority on the Company board. The board thanks Neil for his outstanding contributions as a board member and looks forward to a continued strong working relationship in his senior management role as Chief Medical Officer.

The Company advises of further updates to senior management. Dr. Sharron Gargosky has been promoted to Chief Technical Officer. Dr. Gargosky, based on the West Coast of the US, is charged with leading the scientific and technical development of CVac globally. Marc Voigt has been promoted to General Manager of the German subsidiary and Chief Business Officer of the Company. Mr. Voigt will be globally responsible for coordinating investor relations and driving business development.

About Matthew Lehman
Mr. Lehman joined Prima as Chief Operating Officer on 1 February 2010. He has since played a leading role in the clinical development of CVac as well as the executive management of the Company.

Prior to joining Prima, Mr. Lehman was the Chief Operating Officer for SPRI Clinical Trials, an international contract research organization servicing the biotechnology and pharmaceutical industries, where he led successful expansion of the business in the emerging Eastern European markets. Over the years, Mr. Lehman has held various positions of increasing responsibility in clinical development and biotechnology operations, with extensive experience managing large teams across the United States and Europe. He has been involved in hundreds of R&D programs in oncology and other therapeutic areas, including key development contributions to a number of now FDA- and EMA-approved products. Mr. Lehman is active in a number of industry organizations with a strong interest in optimizing clinical research and efficient deployment of R&D expenditures.

Mr. Lehman earned a BA from the University of Louisville and an MS from Columbia University.

About Prima BioMed
Prima BioMed is a global biotechnology company headquartered in Australia. As a leader in personalized bio-therapeutic products for cancer, Prima is dedicated to leveraging its current technology and expertise to develop innovative treatment options for patients and maximize value to shareholders. Prima's lead product is CVac™, an autologous dendritic cell product currently in clinical trials for ovarian cancer.

Contacts
Australia Investor/Media:
Mr. James Moses
Mandate Corporate
+61 (0) 420 991 574
Email Contact

USA Investor/Media:
Ms. Kathy Galante
Burns McClellan Inc.
+1 (212) 213-0006
Email Contact

Europe Investor/Media:
Mr. Axel Mühlhaus
edicto GmbH
+49 (0) 69 905505-52
Email Contact

Prima BioMed Ltd to Ring The NASDAQ Stock Market Opening Bell to Celebrate Listing on The NASDAQ Stock Market

Prima BioMed Ltd, a world leader in cancer immunotherapies, will visit the NASDAQ MarketSite in Times Square to celebrate its listing on The NASDAQ Stock Market. Prima BioMed Ltd. begins trading on NASDAQ today, April 16, 2012.

Prima's listing on NASDAQ comes at a significant point in the development timeline for CVac(TM) ovarian cancer vaccine. The timing should offer U.S, investors an opportunity to share in this growth phase of the Company.

In honor of the occasion, Martin Rogers, CEO will ring the Opening Bell.

Where:

NASDAQ MarketSite -- 4 Times Square -- 43^rd & Broadway -- Broadcast Studio

When:

Monday, April 16, 2012 -- 9:15 a.m. to 9:30 a.m. ET

Contact:

Ian Bangs
+61 9276 1250
Ian.bangs@primabiomed.com.au

NASDAQ MarketSite:

Jen Knapp
(212) 401-8916
Jennifer.knapp@nasdaqomx.com

Facebook and Twitter:

For multimedia features such as exclusive content, photo postings, status updates and video of bell ceremonies please visit our Facebook page at:
http://www.facebook.com/#!/NASDAQ.

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Webcast:

A live webcast of the NASDAQ Opening Bell will be available at:
http://www.nasdaq.com/about/marketsitetowervideo.asx.

Photos:

To obtain a hi-resolution photograph of the Market Open, please go to http://www.nasdaq.com/reference/marketsite_events.stm and click on the market open of your choice.

About Prima BioMed Ltd:

Prima BioMed is an ASX and NASDAQ listed Australian health care company. The Company is focused on technologies in the fields of cancer immunotherapy and immunology.

Prima's lead product is the CVac^TM ovarian cancer therapy treatment. It has completed two successful clinical trials and is progressing toward eventual commercialisation in the United States, Australia, Europe, and globally.

The Company's broader, long term goal is to develop commercial cancer treatment technologies and programs for global markets.

Biotech to come of age this year @ The Australian; Prima BioMed ($PRR)

Prima BioMed (ASX: PRR) is an Australian health care company focused on technologies in the fields of cancer immunotherapy and immunology. Prima’s lead product is the CVac (tm) ovarian cancer therapy treatment. It has completed two successful clinical trials and is progressing toward eventual commercialisation in the United States, Australia, Europe, and globally. The Company’s broader, long term goal is to develop commercial cancer treatment technologies and programs for global markets.

In The Australian, Prima BioMed CEO Martin Rogers wrote an article about current and past market conditions for public biotech companies and the strong opportunity for biotech companies to succeed. 

In describing the shifts that have poised biotech companies for success, he wrote,

"Major pharmaceutical companies are looking at tens of billions of dollars in loss in revenue as their drugs come off patent and become generic...[Big Pharma] companies are using their high levels of cash and looking at the biotech sector to acquire, instead of develop, the next raft of new blockbuster drugs.

This shift in thinking by big pharma cannot be underestimated.

Companies need new products to continue to grow and be profitable, but instead of creating these products themselves they are effectively outsourcing this job to the biotech sector, giving the entire sector a massive shot in the arm."

Recent success stories like Acrux and Mesoblast "should make market watchers and investors think twice about dismissing the biotech sector and consigning it to the too-hard basket."

He continued,

"Prima BioMed is one of the biotech companies that has been on the stock exchange for a decade. It completed a $41m capital raising in the middle of last year, to fund late-stage clinical studies. Successful results from the phase III study will see the company well placed to achieve commercialisation in important global markets...

It takes a lot of time and effort to become an overnight success, but the Australian biotech sector has never been better placed to become just that this year, and investors to be rewarded considerably."

Read more in The Australian. 

$ONTY: Oncothyreon initiates phase 1 trial of ONT-10

Oncothyreon ($ONTY) initiates phase 1 trial of ONT-10 ($4.80).

Oncothyreon is a biotechnology company dedicated to the development of oncology products that can improve the lives and outcomes of cancer patients. They are currently developing multiple therapeutic candidates designed to target cancer in specific and effective ways. The pipeline includes both synthetic vaccines and small molecules for a variety of cancer indications.

• The company announced that the first patient has been enrolled in a Phase 1 trial of ONT-10
• The Phase 1 trial is designed to evaluate the safety and immunogenicity of ONT-10 in patients with cancers which commonly express MUC1
• The Phase 1 trial of ONT-10 consists of two parts
• Part 1 will study a dose escalation schedule in up to 48 patients to determine the maximally tolerated and/or recommended dose of ONT-10 administered either once every other week or once every week over an 8 week period
• Part 2 will further investigate the safety of ONT-10 at the maximally tolerated or recommended dose in up to 15 additional patients at the weekly and/or biweekly schedule

The ability of ONT-10 to induce both a humoral and a cellular immune response will be investigated in both parts of the study.

Daily Dose Conclusion: This is an interesting data point in the wake of StimuVax delays which were not perceived well by the marketplace.

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Prima BioMed files for NASDAQ listing (ASX: PRR)

Just a quick heads up that Australian biotech company Prima BioMed (ASX: PRR) has filed for a NASDAQ listing of American Depositary Receipts (ADR). Once the listing is complete the company will have a dual listings of its securities on both the Australian Securities Exchange (ASX) and NASDAQ. Every one ADR will represent 30 common shares, so Prima at $0.17 cents would trade at $5.10 and a market cap of >$160 mln.

Prima’s proposed NASDAQ listing will be a Level II ADR compliance listing, and is being managed by Bank of New York Mellon and US broking houses Deutsche Bank AG, Noble Financial and Aegis. Prima did say that they are currently unable to say precisely when the shares will actually list and trade but we expect it will be soon.

Here the big question: Is this a blessing or a Curse ?

Prima is listing on the NASDAQ for better exposure and most importantly access to U.S. capital markets. The company is now beginning a Phase III trial in ovarian cancer using a dendritic cell based vaccine (in the U.S., Progenitor Cell Therapy (NeoStem-NBS) is doing the manufacturing, recall that PCT did the clinical work for Dendreon's Provenge and is also working for Coronado (CNDO) and Immunocellular (IMUC). If anyone can make sure that the "manufacturing goes off with-out a hitch” its PCT-NBS. 

So the next big question, is does it work ? Ovarian is a very tough indication and the life expectancy of Ovarian cancer varies a great deal. Prima's Phase II data was not double blinded cross-over so the results are not definitive. No way to say what the results of the current global PIII trial will be yet. We do know Prima will likely need to raise capital at some point ahead (thus the U.S. listing).

Perhaps the most important event that investors will watch will be not Prima at all, but Merck KG who is running the StimuVax trial which like Prima's product (C-Vac) targets the MUC-1 antigen (over-expressed in ovarian cancer).

If StimuVax works, Prima could rock, if not, it could flop as it validates one way or another the MUC-1 antigen as a target.

Let’s watch Prima and see how the company does as they work to build a U.S. institutional presence and present their data to the scrutiny of US investors.

Prima Biomed (ASX: PRR) enrolls first patient in Canvas CVac™ Trial

Prima BioMed (ASX: PRR) is an Australian health care company focused on technologies in the fields of cancer immunotherapy and immunology. Prima’s lead product is the CVac™ ovarian cancer therapy treatment. It has completed two successful clinical trials and is progressing toward eventual commercialisation in the United States, Australia, Europe, and globally. The Company’s broader, long term goal is to develop commercial cancer treatment technologies and programs for global markets. 

The company has announced that it has commenced patient enrollment in CANVAS (CANcer VAccine Study), a clinical trial for the CVac™ ovarian cancer therapy vaccine. Its first patient was recruited in the United States. CANVAS "is a multinational, multi-centre, randomised, double-blinded, placebo-controlled trial of CVac™ as a maintenance treatment for epithelial ovarian, primary peritoneal, or fallopian tube cancer in complete remission. The Study will enrol 800 women to assess those who are in complete remission after completing first-line treatment (surgery and chemotherapy) for ovarian cancer."

Prima BioMed Chief Executive Officer Martin Rogers commented,

“We are excited to have commenced patient enrollment for our major CVac™ trial. This represents a significant milestone in CVac™’s development timeline to date. The ability to embark on such a large scale study across multiple sites in different continents is a testament to the commitment and expertise of the Prima team, and also for the potential for CVac™ to provide a viable, commercially available treatment option for ovarian cancer patients globally.”

With its first patient now enrolled in the study, The Company expects to ramp-up enrollment through sites in Europe, Australasia and the US through 2012. 

Read the full press release at PrimaBioMed.com. 

Dendrion ($DNDN): Its Complex but Gold is Gone so is Platinium Ahead ?

A very significant event in the world of cell therapy occurred this week when news came that Mitch Gold, CEO of Dendreon (NASDAQ: DNDN) has left the company. Wall Street analysts reacted positively and the stock was up modestly on the news and has since settled back. Dendreon has been the shining example of what's possible in the cell therapy space until the company seemed to over-inflate expectations, and over-ramped manufacturing. When sales numbers failed to meet high expectations the stock corrected sharply (this past summer DNDN was >$40) and fell back to the $7 range. Savy investors who bought the over-sold stock at $7 have been rewarded as it bounced back to $14 (range). 

The key question now is what should we expect going forward ?

Dendreon remains a solid example of the utility a cell based immunological cancer therapy can have in the marketplace. We see Immunocellular (IMUC) as a very viable and cheaper play but granted earlier stage. PrimaBioMed (AUX: PRR) also falls into this space, chasing Ovarian cancer. Stay tuned for the results of Stimuvax, which would validate the MUC-1 antigen for Ovarian. As for Dendreon we believe a slow and steady climb back is likely as the company smooth’s out its commercialization and manufacturing ramp associated with Provenge.

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