Oncothyreon ($ONTY): Raising Capital as Rodman Re-itts the Buy Rating: "Down but not out - PX866 to drive value in 2012"

Oncothyreon ($ONTY) is a biotechnology company dedicated to the development of oncology products that can improve the lives and outcomes of cancer patients. The company is 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. 

Rodman & Renshaw has released a report on Oncothyreon, classifying it as "Outperform" with a "Speculative Risk." The report includes the following investment opinion:  

 

"We are reiterating our Market Outperform rating and 12-month price target of $10 per share for Oncothyreon. Our price target is based on a 2015 discounted revenues and earnings per share multiples analysis. Although the second interim analysis did not live up to investor’s expectations, we continue to believe in the Stimuvax story. The recent data highlights the therapeutic value of Stimuvax, and also serves to validate Oncothyreon’s MUC1 based vaccine technology platform. In addition to Stimuvax and ONT-10, Oncothyreon possesses a broad oncology pipeline, which includes PX-866 (an irreversible inhibitor of PI3K) and ONT-701 (a newly acquired pan Bcl-2 inhibitor)." 

Our Thoughts: Ovarian is a great indication, unmet medical need but tough to crack. Oncothyreon has postponed results but that may not be  bad thing, perhaps patients are living longer. We saw some news of a capital raise underwritten by Cowen and Stifel Nicolas.

Watch this name and the data as it rolls out, it will also impact dendritic cell company, Prima BioMed that chasing the same MUC-1 target.

Rodman Renshaw Report on ONTY

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ImmunoCellular Therapeutics ($IMUC) licenses EphA2 from University of Pittsburgh

ImmunoCellular Therapeutics (OTCBB: IMUC) has entered into an agreement with University of Pittsburgh under where Pitt has licensed intellectual property to the company surrounding EphA2, a tyrosine kinase receptor that is highly expressed by ovarian cancer and other advanced and metastatic malignancies.

This agreement grants a world-wide exclusive license to the Pitt intellectual property for ovarian and pancreatic cancers, and a world-wide non-exclusive license to the Pitt intellectual property for brain cancer.

Financial terms of the agreement were not disclosed. The company will employ the Pitt intellectual property in the development and commercialization of ICT-140, a multivalent, dendritic cell-based vaccine for the treatment of ovarian cancer.

Please see our other post(s) on IMUC, PrimaBioMed and Merck KG (StimuVax).

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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. 

ImmunoCellular Therapeutics ($IMUC) licenses mesothelin cancer antigen from Johns Hopkins

ImmunoCellular Therapeutics (OTCBB:IMUC) announced that they have entered into an agreement with Johns Hopkins University which sees the college grant an exclusive, worldwide license to intellectual property surrounding the tumor-associated antigen mesothelin.(The terms of the agreement were not disclosed).

Antigens are substances that cause the immune system to produce antibodies against it. Mesothelin is highly expressed in pancreatic cancer, ovarian cancer and mesothelioma.

The company will employ this intellectual property in the development and commercialization of ICT-140, a multivalent, dendritic cell-based vaccine for the treatment of ovarian cancer, one of multiple tumor types in which mesothelin is over-expressed.

ICT-140 is designed to target cancer stem cells as well as daughter cells in ovarian cancer by targeting multiple different antigens including mesothelin, Her-2/neu, IL-13Rα2 and several other undisclosed antigens.

ImmunoCellular president and CEO Manish Singh said: "As we continue the development of a novel, dendritic cell-based vaccine for the treatment of ovarian cancer, this licensing agreement for mesothelin technology will allow us to ensure that we have the critical components for a successful vaccine.

"We look forward to the ongoing support of Dr. Jaffee and her colleagues at Johns Hopkins as we develop the vaccine. We expect to file an Investigative New Drug application for the vaccine in the fourth quarter of this year."

IMUC recently started a phase II trial of its lead product candidate, ICT-107, a dendritic cell-based vaccine targeting multiple tumor associated antigens for glioblastoma. We do know that NeoStem's PCT is working with IMUC as the "contract maanufacturer".

Earlier this month the company received a "notice of allowance" from the U.S. Patent and Trademark office for its patent relating to the targeting of cancer stem cells in the treatment of patients with glioblastoma, an aggressive form of brain cancer.

The patent, called “Cancer Stem Cell Antigen Vaccines and Methods”, covers various methods of using dendritic cells combined with antigens derived from glioblastoma cancer stem cells.

Daily Dose Conclusion: The IMUC P1 Glioblastoma data is promising. The data set is smalla nd single center but if replicated in Phase II this could be the makings of the next Dendreon at a deep value. Also keep an eye on Prima BioMed working in ovarian cancer, also a dendritic cell approach.

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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.

Alliance for Regenerative Medicine, January 10, 2012, San Francisco

The Alliance for Regenerative Medicine Announces Presenting Companies and Second Annual State of the Industry Briefing and Regenerative Medicine Insight Track at Biotech Showcase

Event Takes Place on January 10, 2012 in San Francisco; Expanded Agenda Includes Panel Sessions on Major Regenerative Medicine Target Indications

PRESENTING COMPANIES: Aastrom Biosciences, Advanced BioHealing, Advanced Cell Technology, Aldagen, Allocure, Amorcyte, Athersys, Axogen, Coronado Biosciences, Cytori Therapeutics, Dendreon, Harvard Biosciences, Healthpoint, ImmunoCellular Therapeutics, InVivo Therapeutics, ISTO Technologies, Maxcyte, Mesoblast, MolMed, Neostem, Neuralstem, NexImmune, Organovo, Prima Biomed, Q Therapeutics, ReNeuron, SanBio, StemCells, Inc., Tengion, TiGenix, Tissue Genesis

The Alliance for Regenerative Medicine (ARM), the international organization representing the interests of the regenerative medicine community, today announced that the second annual State of the Industry Briefing will take place on January 10, 2012 in San Francisco. A full day of panels focused on several disease areas will follow the briefing as part of the Regenerative Medicine Insight track at the Biotech Showcase 2012. The panels will be moderated by key analysts in the sector.

The Regenerative Medicine State of the Industry Briefing will focus on recent developments and the future outlook for the cell therapy and regenerative medicine industries. Speakers will include Gil Van Bokkelen, CEO of Athersys; Silviu Itescu, CEO of Mesoblast; Tim Mayleben, CEO of Aaastrom; Gary Rabin, CEO of Advanced Cell Therapy; Dr. Robin Smith, CEO of NeoStem and senior executives from large pharmaceutical companies. The panels will cover the outlook for the industry, a review of pipelines and clinical trials, and a general discussion of critical success factors including technology advancements, regulatory issues and the financial outlook for the sector.

A series of analyst-led, therapeutic area focused panels will follow the briefing. The panels will discuss therapeutic categories where regenerative medicine holds great promise including cardiology and ischemic related disease, spinal injury, ophthalmology, metabolic disease, and central nervous system disorders as well as an exploration in cell based solutions in immunology and oncology. The panels will be moderated by analysts from Rodman & Renshaw, Piper Jaffray, JMP Securities, ROTH Capital Partners, and WBB Securities and feature participation from more than 25 companies including:

Aastrom, Advanced BioHealing/Shire, Advanced Cell Technology, Aldagen, Athersys, Cytori, Healthpoint, ISTO Technologies, Maxcyte, Mesoblast, Neostem, Organovo, ReNeuron, SanBio, StemCells, Inc., Tengion and Tigenix.

"We are excited to once again bring together many of the leading experts in the regenerative medicine field to report on the progress made during 2011 and provide an outlook for 2012 and beyond," said Gil Van Bokkelen, PhD, Chairman of ARM and CEO of Athersys. "Based on the significant response to the meeting last year, it's clear that recognition of the near-term therapeutic promise of regenerative medicine is growing, and this event represents a great opportunity for investors and others to hear from industry leaders and gain insight into the tremendous potential of the field."

This event was developed by the Alliance for Regenerative Medicine, and will be held as part of the Biotech Showcase 2012 conference taking place at the Park 55 Wyndham in San Francisco beginning at 8:00 a.m. To learn more and to register for the conference, please contact Rob Margolin at (646) 201-4192. Registration is complimentary for credentialed members of the media and the investment community. The State of the Industry briefing is open to the public, but attendance at the disease panels will require registration for individuals without press or investor credentials.

The Alliance for Regenerative Medicine (ARM) is a Washington, DC-based non-profit organization that promotes legislative, regulatory, reimbursement, and financing initiatives necessary to facilitate access to life-giving advances in regenerative medicine. ARM also works to increase public understanding of the field and its potential to transform human healthcare, and provides services to support the growth of its member companies and organizations. Prior to the formation of ARM, there was no advocacy organization operating in Washington, DC to specifically represent the interests of regenerative medicine companies, research institutions, investors, and patient groups supporting more rapid adoption of technologies in our field. To learn more about ARM or to become a member, visit www.alliancerm.org .

Media Contact:
      Michelle Linn
      Linnden Communications
      Phone: 508-362-3087

Oncothyreon (ONTY): Files IND for ONT-10 - Vaccine for Ovarian Cancer: Can you say PrimaBioMed ?

News on the tape today that Oncothyreon (ONTY) has filed an investigational new drug (IND) application for ONT-10. ONT-10, a therapeutic vaccine directed at cancers expressing MUC1. Upon completion of the FDA's review of the IND, Oncothyreon expects to initiate a Phase 1 trial of ONT-10. We recently wrote on this and discussed its implications for PrimaBioMed. Please see that note here.

Immunocellular ($IMUC) - Moving forward in Brain Cancer

IMUC is developing ICT-107, an autologous, dendritic cell-based vaccine (like Dendrion's Provenge) that works by activating a patient's immune system against specific tumor-associated antigens. This is accomplished by extracting dendritic cells from a patient, loading them with the antigens, and reintroducing them to the patient's body to trigger an immune response. It is still early days, but IMUC is targeting glioblastoma multiforme (aggressive brain cancer) with this product. Data from Phase 1 trials has been encouraging and the company is embarking on a P2 program. The company is also developing ICT-140: Dendritic cell-based vaccine for the treatment of ovarian cancer. This product will target multiple antigens present on cancer stem cells and daughter cells. Interesting because we have discussed Prima BioMed's dendritic approach in ovarian cancer too.

This is not new news, but its worthy of mention, according to a blurb we saw in Bio Century, IMUC announced in early December the company’s plans to raise capital in a follow-on offering with a goal to raise up to $13.8 million in cash (10 million at $1.40) with 1:1 share – warrant coverage.