Optimistic For OncoMed's Future

Optimistic for OncoMed's Future

By: Meital Gabay Ph.D., Alan Leung, Andy Chang, and Mei-Hsin Cheng

OncoMed Pharmaceuticals (OMED) is a development stage biotech company that focuses on discovering and developing monoclonal antibody therapeutics that target cancer stem cells (CSCs). OncoMed recently had its IPO on July 18th in which it sold 4.8 million shares at $17 each [1]. OncoMed currently has five products in Phase 1 Clinical Trials [2]. Though many of OncoMed's products are still in development, they already have two partnerships with GSK and Bayer [3].

OncoMed is well positioned. Monoclonal antibodies are more likely to receive FDA approval. In a study from Tufts University, large molecules of which monoclonal antibodies made up the largest group at 47%, had an average approval rate of 32%, while small molecules had a much lower approval rate of 13% [4,5]. OncoMed's management team also includes Jakob Dupont who was the Global Medical Director for Avastin (bevacizumab) at Genentech [6].

Targeting cancer stem cells directly is an emerging field in biotechnology. Currently, OncoMed's two main competitors in the cancer stem cell industry are Stemline Therapeutics Inc and Verastem Inc. Verastem develops small molecule drugs that target cancer stem cells. To find their drug targets, Verastem uses high-throughput screening of compound libraries in cancer stem cells. One of the drawbacks of screening in CSCs is that CSCs are not stable in culture.

Stemline targets both CSCs and tumor bulk, to identify their targets Stemline has two of their own platform technologies: StemScreen-1 and StemScreen-2. They use StemScreen-1 to identify targets based on gene expression analyses on CSCs isolated from primary tumor tissue and cell lines. StemScreen-2 is a high-throughput platform that tests live, labeled CSCs in their native environment.

Clinical Trial Status of Most Advanced Product

Phase 1b for lung cancer in combination with other chemotherapy drugs. Starting Phase 1b/2 trials in ovarian and pancreatic cancers. Some adverse cardiovascular effects.

In Phase 1 dose trial in combination with paclitaxel. 1 out of 6 patients had a complete response. Phase Ib ongoing.

SL-401* (IL-3 linked to diphtheria toxin) and SL-701 (vaccine against IL-13R and EphA2)

Both Phase 1 and 2. SL-401: 1 cycle has improved median overall survival by more than three fold.

SL-701: 19/22 patients had tumor reductions or disease stabilization.

*SL-401 is being developed for orphan indication

Information from table [6].

Wnt Pathway Drugs: OMP-18R5 and OMP-54F28

OncoMed currently has two product candidates that target the Wnt pathway: OMP-18R5 (Anti-Fzd7, vantictumab) and OMP-54F28 (Fzd8-Fc). OMP-18R5 and OMP-54F28 have both entered Phase I clinical trials to determine safety, pharmacokinetics, immunogenicity and preliminary efficacy of the drugs.

OMP-18R5 is a fully human monoclonal antibody that binds a conserved epitope that is on five Frizzled receptors and inhibits Wnt signaling. In a first-in-human trial, OMP-18R5 has been tolerable with limited side effects. The most common treatment-related side effects were fatigue, nausea, altered taste, vomiting, increased alkaline phosphatase, constipation, decreased appetite, increased blood pressure, hypercalcemia and peripheral edema [2,6,7]. OMP-18R5 has single-agent activity in patients with neuroendocrine tumors. It is expected to enter three Phase Ib combination trials this year. It binds to key Fzd receptors and prevents the activation of the Wnt signaling pathway. In mouse xenograft studies, OMP-18R5 inhibits the growth of a range of tumor types and exhibits synergistic activity with standard-of-care chemotherapeutic agents [8].

OMP-54F28 is a proprietary fusion protein based on a truncated form of the Frizzled8 receptor (Fzd8). For OMP-54F28 , no clinical data has been reported yet. OMP-54F28 acts as a "decoy receptor" and functions by sequestering Wnts so that they are unable to bind to Frizzled receptors. OMP-54F28 has shown evidence of anti-tumor activity and reduction of CSC frequency in multiple preclinical models either as a single agent or when combined with chemotherapy [9].

OncoMed is still actively recruiting patients for both OMP-18R5 and OMP-54F28. Specifically, they are recruiting patients with histologically confirmed malignancies that have no standard curative therapy with a demonstrated survival benefit. OncoMed is also planning to report data for Phase I this year and to initiate three Phase Ib clinical trials in late 2013 or early 2014 in distinct tumor types in combination with standard-of-care therapies.

Four drugs targeting Wnt signaling have reached clinical trials. Two of these compounds are biologics developed by OncoMed (OMP-18R5 and OMP-54F28). The other two small-molecules are developed by Prism Pharma and Novartis (see table 1). It is not surprising that there are several drugs in development targeting the Wnt pathway because the Wnt pathway is known to be inappropriately activated through frizzled receptors in many major tumor types, including colon, breast, liver, lung and pancreatic cancers, and is critical for the function of cancer stem cells (CSCs). High-throughput screens have been used extensively to identify small-molecule targeted inhibitors of different Wnt pathway components. This work was proven useful in cell-based assays, but translation into the clinic has remained difficult due to the potential off-target effects.

OncoMed has chosen to target Wnt pathway with biologics. OMP-18R5 and OMP-54F28 block Wnt ligand recognition. Preclinical evidence has been encouraging so far. Since Wnt pathway is so important in the maintenance of tumor-initiating cells, inhibition could ultimately target cells that are resistant to traditional chemotherapy.

OMP-18R5 and OMP-54F28 are both being developed by OncoMed with a partnership with Bayer. OncoMed and Bayer are developing three biologics and two small molecules that target the wnt pathway. Bayer gave OncoMed $40 million in cash payment in exchange for the rights to exercise an option for an exclusive license to develop and commercialize biologics they discover Phase I trials [3]. OncoMed has the potential to recieve #387.5 million for each biologic therapeutic upon reaching milestones. The royalty percentages for OncoMed range from the high single digits to the high teens depending on the drug.

Table 1 - Wnt-Targeting Compounds in Development (Adapted from Emma Hitt, OncLive, January 7, 2013)

OMP-18R5

(OncoMed Pharmaceuticals/Bayer)

Monoclonal antibody targets the Frizzled receptors to block association with Wnt ligands.

OMP-54F28

(OncoMed Pharmaceuticals/Bayer)

Fusion protein of the Frizzled8 ligand-binding domain with the Fc region of a human immunoglobulin. It binds and sequesters soluble Wnt ligand, impairing its recognition by receptors on tissues.

PRI-724

(Prism Pharma Co, Ltd/Eisai)

Small-molecule inhibitor of the interaction between ß-catenin and CBP. Disrupting the interaction prevents activated transcription by aberrant Wnt signaling at many levels.

LGK974

(Novartis Pharmaceuticals)

Small molecule that inhibits acyltransferase porcupine. Inhibiting porcupine can be a small-molecule-based method for inhibiting Wnt ligand-mediated activation.

Anti-Notch 2/3: OMP-59R5

OMP-59R5 (Anti-Notch2/3) is a fully human monoclonal antibody that targets the Notch2 and Notch3 receptors. A single-agent Phase I trial in advanced solid tumor patients has been completed. Phase Ib/II trials for pancreatic cancer and small cell lung cancer are ongoing.

Data from Phase I in advanced solid tumor patients is encouraging. Intravenous administration of OMP-59R5 to patients with advanced solid tumors was well tolerated and maximum tolerated doses were established. The most frequently reported drug-related adverse events were: mild to moderate diarrhea, fatigue, nausea, vomiting, decreased appetite, and constipation. Diarrhea was dose related and appeared less pronounced with every-other-week dosing [10]. Data for the Phase I trial were presented at the ASCO Annual Meeting in Chicago, June 2012, as well as at the 24th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Dublin, Ireland, in November 2012.

OMP-59R5 is currently enrolled in two Phase Ib/II trials. One was initiated for pancreatic cancer patients in July 2012. The trial is still recruiting patients with stage IV ductal adenocarcinoma of the pancreas. They are looking for the highest dose of OMP59R5 that can be given safely with the standard chemotherapy for advanced pancreatic cancer (gemcitabine and Nab-Paclitaxel).

The second Phase Ib/II trial is in small cell lung cancer and was initiated earlier this year (May 2013). This trial is still recruiting patients with histologically or cytologically documented extensive stage small cell lung cancer. The purpose of the study is to find the highest dose of OMP59R5 that can be given safely with the standard chemotherapy for extensive stage small cell lung cancer (Etoposide and Cisplatin). Both trials also test potential predictive biomarkers to identify patients that may derive the greatest benefit from OMP-59R5.

OMP-59R5 is a fully human IgG2 monoclonal antibody. The antibody binds to a conserved epitope on Notch2 and Notch3 and inhibits the signaling of both receptors. The Notch pathway plays a central role in embryonic development, the regulation of stem and progenitor cells, and is implicated centrally in many human cancers.

Based on preclinical experiments, it seems that OMP-59R5 could be a novel anti-cancer agent that inhibits tumor growth. OMP-59R5 is being developed by OncoMed with a partnership with GSK. OncoMed can receive $344.5 million for OMP-59R5 for reaching milestones and a royalty percentage in the low to high teens. GSK has the option to obtain an exclusive license to develop and commercialize OMP-59R5 through proof-of-concept completion.

Demcizumab:OMP-21M18

Demcizumab (OMP-21M18) is a humanized antibody against the delta-like ligand 4 (DLL4), a ligand in the Notch signaling pathway. Targeting DLL4 attacks cancer via multiple mechanisms. DLL4 inhibits CSC growth and promotes cell differentiation, while disrupting angiogenesis (which provides blood vessels to allow for tumor growt.h)

Anti-DLL4 antibodies have shown great promise for treating cancer, with results published in several big impact papers [11,12]. These papers showed that anti-DLL4 therapy inhibited the growth of multiple tumor models, including ones resistant to anti-VEGF therapy, a strategy used by clinically approved antiangiogenic drugs such as Avastin. While these animal studies are very promising, it is well known that animal models do not always correspond to actual human disease, so it is important to see how this drug behaves in the clinic.

In addition to demcizumab, OncoMed is developing an anti-DLL4/anti-VEGF bispecific antibody, and preclinical studies have shown that it can potentially be more efficacious than anti-DLL4 or anti-VEGF alone. This molecule is expected to move into the clinic in 2014.

OncoMed completed a single-agent Phase Ia trial with demcizumab in advanced solid tumor patients in 2011. Two Phase Ib combination trials with demcizumab are currently being conducted to treat pancreatic cancer and non-small-cell lung cancer (NSCLC). In addition, a Phase Ib/II trial focused on ovarian cancer is planned for the second half of 2013, and a Phase Ib trial targeting colorectal cancer that was initiated in 2010 was closed based on prioritization of resources. These trials pair demcizumab with standard-of-care treatments including gemcitabine and Abraxane® for pancreatic cancer, carboplatin and pemetrexed (Alimta®) for NSCLC, and paclitaxel for ovarian cancer.

Side effects seen in Phase Ia included hypertension (high blood pressure) and cardiovascular events (pulmonary hypertension or heart failure) for dosing longer than 100-150 days [6]. Others included fatigue, anemia, diarrhea, headache, nausea, hypoalbuminemia, blood pressure increase, dizziness, and dyspnea. In Phase Ib when combined with chemotherapy, side effect included fatigue, nausea, vomiting, hypertension, neutropenia, decreased appetite, increased BNP levels, pulmonary hypertension, thrombocytopenia, diarrhea, peripheral edema, anemia, dyspnea, constipation, increased alanine aminotransferase, and rash.

There are currently two other anti-DLL4 drugs in the clinic: enoticumab from Regeneron and Sanofi and MEDI0639 from MedImmune, which are also monoclonal antibodies against DLL4. Both of these molecules lag behind OncoMed's demcizumab and are only in single agent Phase I studies. OncoMed projects spending approximately $18.0 to $25.0 million from its IPO proceeds for clinical expenditures to advance demcizumab through Phase II clinical trials.

References:

1. Timmerman, L. "OncoMed Pharmaceuticals Soars in IPO Debut." Xconomy. July 18, 2013.

2. Oncomed.com/pipeline.html

3. Wei, T and Deepak, S. "OncoMed Initiating Coverage." Equity Research Americas. Aug 12, 2013.

4. Becker, M. "Monoclonal Antibody Companies Command Premiums." Seeking Alpha. Jul 12, 2010.

5. DiMasi, J, et al. "Trend in Risks Associated with New Drug Development: Success Rates for Investigational Drugs." Clinical Pharmacology and Therapeutics. Feb 3 2010.

6. OncoMed SEC Filing.

7. clinicaltrials.gov

8. Gurney, A. et al. "Wnt pathway inhibition via the targeting of Frizzled receptors results in decreased growth and tumorigenicity of human tumors", Procof Natl Acad Sci, Jul 17, 2012; 109(29):11717-22

9. OncoMed press release, July 12, 2012; Zach Hartman, AACR conference report, April 11, 2013.

10. OncoMed press release, ASCO, June 6, 2012

11. I. Noguera-Troise et al. "Blockade of Dll4 inhibits tumour growth by promoting non-productive angiogenesis." Nature, 444 (2006), pp. 1032-1037.

12. J. Ridgway et al. "Inhibition of Dll4 signalling inhibits tumour growth by deregulating angiogenesis." Nature, 444 (2006), pp. 1083-1087.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article. (More...)

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Are social enterprises fit for the future of public services?

Spin outs need investment to compete for contracts against organisations with more financial muscle. Photograph: Johannes Eisele/AFP/Getty Images

Social enterprises are playing a growing role in the health and social care sectors in the UK. Major growth is coming from spin-outs – organisations leaving the NHS to become independent social enterprises. Primarily as a result of the previous government's Right to Request programme and its successors, by the end of 2011 spin-outs were delivering £886m worth of health services and that figure is growing.

Social Enterprise UK (SEUK)'s 2013 State of Social Enterprise survey, The People's Business, reported both an increase in the percentage of social enterprises that have the public sector (in general) as their main source of income (23% compared to 18% in 2011) and that 15% of social enterprises trading for three years or less are operating in healthcare compared to 5% of older social enterprises.

Discussions at SEUK's Fit For the Future conference on social enterprise in health and social care in June illustrated there are at least two groups of social enterprises currently operating in health and social care.

One is spin-outs, many of whom are competing for large contracts worth tens or in some cases, hundreds of millions of pounds. Another is those social enterprises whose starting point is similar to traditional voluntary sector organisations and who are looking to win relatively small locally-based contracts.

Both groups face new challenges and opportunities as result of changes to the NHS following the implementation of the Health and Social Act 2012. Speaking at Fit for the Future, Andrew Burnell, chief executive of Hull-based spin out City Healthcare Partnership CIC noted that: "We've worked really hard to demonstrate our differentiation from the SERCOs. How are others in the sector doing that? We are, in part, open to being picked off."

Burnell's comments illustrate two of the key challenges currently facing spin-outs: to demonstrate why they're different and better to alternative providers from both private and public sectors and to ensure they can both keep existing contracts and win new ones in an increasingly competitive market place. Both of these points are partially addressed in Spin-Out, Step Out, a new SEUK report that looks at the challenges faced by spin outs in raising finance to develop and grow.

The report, which is based on a survey of 27 existing health spin-outs, said: "the respondents were not very strong in articulating their social impact. Some of the organisations surveyed are known to have produced relatively robust social impact reports but this did not come through in the survey for the spin-outs as a whole."

There is clearly a need for spin-outs to get better at explaining what it is they offer that's demonstrably better than what their competitors can provide, however the primary focus of Spin-Out, Step Out is on how spin outs can find the investment that will enable them to compete for contracts against organisations with more financial muscle.

The report quotes one spin out leader talking about the difficulty of bidding against private sector competitors: "I saw how they worked. There is absolutely no way my organisation can compete with them… They were prepared to invest to make sure they won the contract…We can compete with Serco [on delivery] but we just don't have the [bidding] resources."

It would be easier for spin-outs to compete with private sector, if they could attract investment for social investors. Unfortunately, despite spin-outs being relatively large businesses by social enterprises standards – with a median turnover of £2.9m compared, more than 15 times the median UK social enterprise turnover of £187,000 - only 1 of 27 spin-outs surveyed had done so.

The report claims this is partly because social investors are wary of investing in spin-out, based on the fact that: "these businesses are sometimes perceived negatively to have a limited track record as new entities, just one or two contracts, a lack of assets, to be operating in a highly unpredictable market environment with highly aggressive, professional and well capitalised competitors."

A video made at Fit for the Future conference by Pioneers Post suggests that social investors concerns may be based more on myth than reality.

Unfortunately, even if social investors were prepared to put their money into spin-outs, there is still a problem that the money they provide is too expensive and many spin outs have been surprised that the fact they deliver positive social outcomes, doesn't mean investors will offer them a better financial deal: "where social return is taken into account it does not necessarily influence the investment terms in a way that makes them any more generous than finance provided by purely financially motivated commercial investors. Yet the spin-outs, like many other social enterprises, interpret the rhetoric around social return and social investment to suggest that there could be a good generous offer on the table."

Beyond the world of large scale spin-outs and direct competition with SERCO, Virgin Care and others, smaller local social enterprises are trying to work out how to navigate the NHS landscape.

Earlier in the year SEUK and IVAR produced The Power of Partnerships, a resource to promote better working between new local health structures - Clinical Commissioning Groups (CCGs) and Health and Wellbeing Boards (HWBs) – and local charities and social enterprises based on work in four local areas in England.

At Fit for the Future, commissioners and social enterprise leaders involved in the project discussed ways that social enterprises can build relationships with commissioners in CCGs in local authorities.

A key message for social enterprises looking to engage with new NHS structures is that its important to find out what is going on in your area because every area will be different. As Dr Johnny Marshall, Policy Director at the NHS Confederation, told the conference: "There's already an old adage: when you've met one CCG, you've met one CCG."

David Floyd is managing director of Social Spider CIC. He writes the blog Beanbags and Bullsh!t.

This content is brought to you by Guardian Professional. To join the social enterprise network, click here.

View the original article here

Are social enterprises fit for the future of public services?

Spin outs need investment to compete for contracts against organisations with more financial muscle. Photograph: Johannes Eisele/AFP/Getty Images

Social enterprises are playing a growing role in the health and social care sectors in the UK. Major growth is coming from spin-outs – organisations leaving the NHS to become independent social enterprises. Primarily as a result of the previous government's Right to Request programme and its successors, by the end of 2011 spin-outs were delivering £886m worth of health services and that figure is growing.

Social Enterprise UK (SEUK)'s 2013 State of Social Enterprise survey, The People's Business, reported both an increase in the percentage of social enterprises that have the public sector (in general) as their main source of income (23% compared to 18% in 2011) and that 15% of social enterprises trading for three years or less are operating in healthcare compared to 5% of older social enterprises.

Discussions at SEUK's Fit For the Future conference on social enterprise in health and social care in June illustrated there are at least two groups of social enterprises currently operating in health and social care.

One is spin-outs, many of whom are competing for large contracts worth tens or in some cases, hundreds of millions of pounds. Another is those social enterprises whose starting point is similar to traditional voluntary sector organisations and who are looking to win relatively small locally-based contracts.

Both groups face new challenges and opportunities as result of changes to the NHS following the implementation of the Health and Social Act 2012. Speaking at Fit for the Future, Andrew Burnell, chief executive of Hull-based spin out City Healthcare Partnership CIC noted that: "We've worked really hard to demonstrate our differentiation from the SERCOs. How are others in the sector doing that? We are, in part, open to being picked off."

Burnell's comments illustrate two of the key challenges currently facing spin-outs: to demonstrate why they're different and better to alternative providers from both private and public sectors and to ensure they can both keep existing contracts and win new ones in an increasingly competitive market place. Both of these points are partially addressed in Spin-Out, Step Out, a new SEUK report that looks at the challenges faced by spin outs in raising finance to develop and grow.

The report, which is based on a survey of 27 existing health spin-outs, said: "the respondents were not very strong in articulating their social impact. Some of the organisations surveyed are known to have produced relatively robust social impact reports but this did not come through in the survey for the spin-outs as a whole."

There is clearly a need for spin-outs to get better at explaining what it is they offer that's demonstrably better than what their competitors can provide, however the primary focus of Spin-Out, Step Out is on how spin outs can find the investment that will enable them to compete for contracts against organisations with more financial muscle.

The report quotes one spin out leader talking about the difficulty of bidding against private sector competitors: "I saw how they worked. There is absolutely no way my organisation can compete with them… They were prepared to invest to make sure they won the contract…We can compete with Serco [on delivery] but we just don't have the [bidding] resources."

It would be easier for spin-outs to compete with private sector, if they could attract investment for social investors. Unfortunately, despite spin-outs being relatively large businesses by social enterprises standards – with a median turnover of £2.9m compared, more than 15 times the median UK social enterprise turnover of £187,000 - only 1 of 27 spin-outs surveyed had done so.

The report claims this is partly because social investors are wary of investing in spin-out, based on the fact that: "these businesses are sometimes perceived negatively to have a limited track record as new entities, just one or two contracts, a lack of assets, to be operating in a highly unpredictable market environment with highly aggressive, professional and well capitalised competitors."

A video made at Fit for the Future conference by Pioneers Post suggests that social investors concerns may be based more on myth than reality.

Unfortunately, even if social investors were prepared to put their money into spin-outs, there is still a problem that the money they provide is too expensive and many spin outs have been surprised that the fact they deliver positive social outcomes, doesn't mean investors will offer them a better financial deal: "where social return is taken into account it does not necessarily influence the investment terms in a way that makes them any more generous than finance provided by purely financially motivated commercial investors. Yet the spin-outs, like many other social enterprises, interpret the rhetoric around social return and social investment to suggest that there could be a good generous offer on the table."

Beyond the world of large scale spin-outs and direct competition with SERCO, Virgin Care and others, smaller local social enterprises are trying to work out how to navigate the NHS landscape.

Earlier in the year SEUK and IVAR produced The Power of Partnerships, a resource to promote better working between new local health structures - Clinical Commissioning Groups (CCGs) and Health and Wellbeing Boards (HWBs) – and local charities and social enterprises based on work in four local areas in England.

At Fit for the Future, commissioners and social enterprise leaders involved in the project discussed ways that social enterprises can build relationships with commissioners in CCGs in local authorities.

A key message for social enterprises looking to engage with new NHS structures is that its important to find out what is going on in your area because every area will be different. As Dr Johnny Marshall, Policy Director at the NHS Confederation, told the conference: "There's already an old adage: when you've met one CCG, you've met one CCG."

David Floyd is managing director of Social Spider CIC. He writes the blog Beanbags and Bullsh!t.

This content is brought to you by Guardian Professional. To join the social enterprise network, click here.

View the original article here

Are social enterprises fit for the future of public services?

Spin outs need investment to compete for contracts against organisations with more financial muscle. Photograph: Johannes Eisele/AFP/Getty Images

Social enterprises are playing a growing role in the health and social care sectors in the UK. Major growth is coming from spin-outs – organisations leaving the NHS to become independent social enterprises. Primarily as a result of the previous government's Right to Request programme and its successors, by the end of 2011 spin-outs were delivering £886m worth of health services and that figure is growing.

Social Enterprise UK (SEUK)'s 2013 State of Social Enterprise survey, The People's Business, reported both an increase in the percentage of social enterprises that have the public sector (in general) as their main source of income (23% compared to 18% in 2011) and that 15% of social enterprises trading for three years or less are operating in healthcare compared to 5% of older social enterprises.

Discussions at SEUK's Fit For the Future conference on social enterprise in health and social care in June illustrated there are at least two groups of social enterprises currently operating in health and social care.

One is spin-outs, many of whom are competing for large contracts worth tens or in some cases, hundreds of millions of pounds. Another is those social enterprises whose starting point is similar to traditional voluntary sector organisations and who are looking to win relatively small locally-based contracts.

Both groups face new challenges and opportunities as result of changes to the NHS following the implementation of the Health and Social Act 2012. Speaking at Fit for the Future, Andrew Burnell, chief executive of Hull-based spin out City Healthcare Partnership CIC noted that: "We've worked really hard to demonstrate our differentiation from the SERCOs. How are others in the sector doing that? We are, in part, open to being picked off."

Burnell's comments illustrate two of the key challenges currently facing spin-outs: to demonstrate why they're different and better to alternative providers from both private and public sectors and to ensure they can both keep existing contracts and win new ones in an increasingly competitive market place. Both of these points are partially addressed in Spin-Out, Step Out, a new SEUK report that looks at the challenges faced by spin outs in raising finance to develop and grow.

The report, which is based on a survey of 27 existing health spin-outs, said: "the respondents were not very strong in articulating their social impact. Some of the organisations surveyed are known to have produced relatively robust social impact reports but this did not come through in the survey for the spin-outs as a whole."

There is clearly a need for spin-outs to get better at explaining what it is they offer that's demonstrably better than what their competitors can provide, however the primary focus of Spin-Out, Step Out is on how spin outs can find the investment that will enable them to compete for contracts against organisations with more financial muscle.

The report quotes one spin out leader talking about the difficulty of bidding against private sector competitors: "I saw how they worked. There is absolutely no way my organisation can compete with them… They were prepared to invest to make sure they won the contract…We can compete with Serco [on delivery] but we just don't have the [bidding] resources."

It would be easier for spin-outs to compete with private sector, if they could attract investment for social investors. Unfortunately, despite spin-outs being relatively large businesses by social enterprises standards – with a median turnover of £2.9m compared, more than 15 times the median UK social enterprise turnover of £187,000 - only 1 of 27 spin-outs surveyed had done so.

The report claims this is partly because social investors are wary of investing in spin-out, based on the fact that: "these businesses are sometimes perceived negatively to have a limited track record as new entities, just one or two contracts, a lack of assets, to be operating in a highly unpredictable market environment with highly aggressive, professional and well capitalised competitors."

A video made at Fit for the Future conference by Pioneers Post suggests that social investors concerns may be based more on myth than reality.

Unfortunately, even if social investors were prepared to put their money into spin-outs, there is still a problem that the money they provide is too expensive and many spin outs have been surprised that the fact they deliver positive social outcomes, doesn't mean investors will offer them a better financial deal: "where social return is taken into account it does not necessarily influence the investment terms in a way that makes them any more generous than finance provided by purely financially motivated commercial investors. Yet the spin-outs, like many other social enterprises, interpret the rhetoric around social return and social investment to suggest that there could be a good generous offer on the table."

Beyond the world of large scale spin-outs and direct competition with SERCO, Virgin Care and others, smaller local social enterprises are trying to work out how to navigate the NHS landscape.

Earlier in the year SEUK and IVAR produced The Power of Partnerships, a resource to promote better working between new local health structures - Clinical Commissioning Groups (CCGs) and Health and Wellbeing Boards (HWBs) – and local charities and social enterprises based on work in four local areas in England.

At Fit for the Future, commissioners and social enterprise leaders involved in the project discussed ways that social enterprises can build relationships with commissioners in CCGs in local authorities.

A key message for social enterprises looking to engage with new NHS structures is that its important to find out what is going on in your area because every area will be different. As Dr Johnny Marshall, Policy Director at the NHS Confederation, told the conference: "There's already an old adage: when you've met one CCG, you've met one CCG."

David Floyd is managing director of Social Spider CIC. He writes the blog Beanbags and Bullsh!t.

This content is brought to you by Guardian Professional. To join the social enterprise network, click here.

View the original article here

Siemens introduces the future of molecular imaging

Main Category: Radiology / Nuclear Medicine
Also Included In: Medical Devices / Diagnostics
Article Date: 16 Aug 2013 - 2:00 PDT Current ratings for:
Siemens introduces the future of molecular imaging

Siemens Healthcare has launched a new platform with the potential to change how molecular imaging is performed. The Symbia Intevo™ is the world's first xSPECT system. It combines the high sensitivity of single-photon emission computed tomography (SPECT) with the high specificity of CT, completely integrating the data from the two modalities, to generate high resolution and, for the first time, quantitative images[1]. The system demonstrates Siemens' innovation and competitiveness, key components of the Healthcare Sector's Agenda 2013 two-year initiative.

The new Symbia Intevo xSPECT system reconstructs both the SPECT and CT portions of an image into a much higher frame of reference than other systems for precise, accurate alignment facilitating the extraction and deep integration of medically relevant information. This ability is the basis for differentiating between tissue boundaries in bone imaging. With xSPECT Bone clinicians can potentially provide additional support for detection and distinguishing between cancerous lesions and degenerative disorders. The Symbia Intevo's precise alignment of SPECT and CT provides clinicians with essential volumetric information from the CT scan, enabling accurate and consistent quantitative assessment meaning the clinician can apply quantitative information to assess whether a patient's condition has regressed, stabilised or progressed.

SPECT and CT integrated.

The Symbia Intevo uses more CT data than ever before, but Siemens is still able to limit patient dose by offering Combined Applications to Reduce Exposure (CARE). The system uses AUTOFORM collimator, capturing up to 26 more counts, helping boost image acquisition time and patient throughput.

"Siemens Healthcare anticipates the new Symbia Intevo technology will improve the quality of care, while helping to reduce costs," states Lawrence Foulsham, Molecular Imaging Product Manager at Siemens Healthcare. "Siemens recognises that these two elements must go hand-in-hand, and with our new molecular imaging solutions, we can demonstrate our commitment to true innovation leadership by overcoming the limitations of conventional SPECT systems to help provide answers to the toughest clinical questions in the safest and most efficient way possible."

Article adapted by Medical News Today from original press release. Source:

1. Pending 510(k) clearance,

Siemens

Visit our radiology / nuclear medicine section for the latest news on this subject.

1. Pending 510(k) clearance,

Siemens

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Cardiovascular researchers examine habits that can lead to obesity, future heart risk

Main Category: Obesity / Weight Loss / Fitness
Also Included In: Pediatrics / Children's Health;  Heart Disease
Article Date: 14 Aug 2013 - 0:00 PDT Current ratings for:
Cardiovascular researchers examine habits that can lead to obesity, future heart risk

Among middle-school children, the behaviors most often linked with obesity are school lunch consumption and two hours or more of daily TV viewing, according to a new look at the dramatic increase in childhood obesity.

The findings by the University of Michigan Frankel Cardiovascular Center will be published in the September issue of Pediatrics.

While some habits were the same for all overweight and obese children, the study found some gender differences in the habits influencing body weight.

Data from 1,714 sixth grade students enrolled in Project Healthy Schools showed girls who drank two servings of milk each day were less likely to be obese, and boys who played on a sports team were also at a healthier weight.

"Additional work is needed to help us understand the beneficial impact of improving school lunches and decreasing screen time," says cardiologist and senior study author Elizabeth Jackson, M.D., M.P.H., assistant professor of internal medicine at the University of Michigan Medical School. "Presumably playing video games, or watching TV replaces physical activity."

Students enrolled in sixth grade at 20 schools in the southeastern Michigan communinities of Detroit, Ann Arbor, Ypsilanti and Owosso were eligible for participation in this study. The median age was 11.

Obese boys and girls had poor cardiovascular profiles with lower HDL-cholesterol, higher triglycerides, higher blood pressure and higher heart rate recovery - indicating a lower level of fitness - compared to normal weight kids.

"Cardiovascular disease doesn't just start in adulthood, and there may be factors that could help us identify during youth or adolescence who might be at increased risk for developing health problems later on," Jackson says.

Other studies have linked eating school lunch with obesity, but a major issue with such studies, Jackson says, is the influence of socioeconomic status. Poor children eligible for free or reduced school lunch may already be overweight, considering the link between obesity and lower socioeconomic status.

"Although we were not able to examine the specific nutritional content of school lunches, previous research suggests school lunches include nutrient-poor and calorie-rich foods," Jackson says.

The University of Michigan study adds a new element in the fight to reduce childhood obesity by providing a real-world view of the gender differences in obesity risk factors.

Milk consumption seemed to protect girls from obesity, but made no difference for boys. A possible explanation would be a reduction in sugary drinks, which girls replaced with milk.

In the study, 61 percent of obese boys and 63 percent of obese girls reported watching television for two or more hours a day. The assumption is watching television mediates physical activity, but there were gender differences in how children spent their so-called "screen time."

When asked, obese girls were more likely than any other group to use a computer. Obese boys reported playing video games more often than normal weight boys, although the association was not as strong as in other studies.

"We did not find a significant association between time spent playing video games and obesity among boys, which has been observed in other studies," says study lead author Morgen Govindan, an investigator with the Michigan Cardiovascular Research and Reporting Program at the U-M. "Although we saw a similar trend, the association was not as strong perhaps due to our smaller sample size."

She adds: "Exploring such gender-related differences in a larger group may help in refining the interventions to promote weight loss and prevent obesity among middle school children."

The Project Healthy Schools program is designed to teach sixth graders heart-healthy lifestyles including eating more fruits and vegetables, making better beverage choices, engaging in 150 minutes of exercise per week, eating less fast food and less fatty foods, plus reducing time spent in front of computer and video game screens.

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our obesity / weight loss / fitness section for the latest news on this subject.

Funding: Project Healthy Schools’ wellness efforts have been generously supported by a number of health systems, foundations, and individuals, including the University of Michigan Health System, the Thompson Foundation, the Hewlett Foundation, the Mardigian Foundation, the Memorial Healthcare Foundation, the William Beaumont Health System Foundation, the Robert C. Atkins Foundation, the Ann Arbor Area Community Foundation, the Allen Foundation, AstraZeneca HealthCare Foundation, Borders, Inc. and the Robert Beard Foundation.

Gender Differences in Physiologic Markers and Health Behaviors Associated With Childhood Obesity

Additional University of Michigan authors: Morgen Govindan; Roopa Gurm; Sathish Mohan; Eva Kline-Rogers, RN; Nicole Corriveau; Caren Goldberg, M.D.; Jean DuRussel-Weston, RN, M.P.H. and Kim A. Eagle, M.D. Pediatrics, Volume 132, Number 3, September 2013. Published online August 12, 2013. (doi: 10.1542/peds.2012-2994)

University of Michigan Health System

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CombiMatrix - Can We Predict A Bright Future?

CombiMatrix - Can We Predict A Bright Future? - Seeking Alpha (function(_,e,rr,s){_errs=[s];var c=_.onerror;_.onerror=function(){var a=arguments;_errs.push(a); c&&c.apply(this,a)};var b=function(){var c=e.createElement(rr),b=e.getElementsByTagName(rr)[0]; c.src="//beacon.errorception.com/"+s+".js";c.async=!0;b.parentNode.insertBefore(c,b)}; _.addEventListener?_.addEventListener("load",b,!1):_.attachEvent("onload",b)}) (window,document,"script","4ffae9d6f05d1da630000008"); if (SA.Data && SA.Data.Cache) { var adata = SA.Data.Cache.get('campaign_content'); } var ms_slug = ''; var article_dashboards = '@investing-ideas@sectors@'; var article_sectors_themes = '@long-ideas@small-cap-insight@us@biotechnology@healthcare@article@'; var ratings_hash={}; var ARTICLE_ID = 1568252; var ARTICLE_TYPE = "standard"; var ARTICLE_LOCK = ""; var author_slug = "spencer-osborne"; var pticker_for_ads = "cbmx"; var lock_comments = false; var machine_cookie = readCookie('machine_cookie'); var middle_version = ABTest.identity%10; try { window.sessionStorage.setItem("/article/"+ARTICLE_ID, '1'); } catch (error) {}var mone_article_tags = "{arna,cbmx};;;{healthcare};;;{long-ideas,small-cap-insight,us,biotechnology,sa-exclusive};;;{spencer-osborne}"var ord = Math.floor(Math.random()*1000000000);Seeking Alpha Seeking Alpha Portfolio App for iPad Finance (1) var ipadData; SeekingAlpha.Initializer.AddAfterLoad(function(){ if (SA.Utils.Env.isIPad && !/3/.test(SA.Data.Cookies.get("user_devices"))){ Mone.event("ipad_promotion_top","top_ipad_banner_large","ipad_promotion_displayed"); ipadData = new SA.Data.iPad(); ipadData.instanceName = "ipadData"; var responseHandler = new Object(); responseHandler.handleResponse = function(data){ if (!data.averageUserRating) return; var stars = data.averageUserRating Home | Portfolio | Market Currents | Investing Ideas | Dividends & Income | ETFs | Macro View | ALERTS | PRO   This article was sent to 573 people who get email alerts on  . Which cover: new articles | breaking news | earnings results | dividend announcements Get email alerts on   » This article was sent to 319,665 people who get the Investing Ideas newsletter. Get the Investing Ideas newsletter » Comments () This article has  comments. To read them or add your own, click here. Download the Free Seeking Alpha Portfolio App Now! The #1 Portfolio App is Now on iPad! Get instant notifications & never miss a critical update on your stocks! Which Seeking Alpha App is best for you? Seeking Alpha Portfolio Tech Investor ETF investor Energy Investor Email me a link to open from my phone: Continue CombiMatrix - Can We Predict A Bright Future? Jul 24 2013, 13:59 by: Spencer Osborne |  about: CBMX (CombiMatrix Corporation), includes: ARNA

(Editors' Note: This article discusses a micro-cap stock. Please be aware of the risks associated with these stocks.)

Taking a small test and having your future health outlined for you may seem like science fiction, but the ability to assess human health and potential for disease is getting to that point, if not already there. For some the concept may not seem comforting, but for others, knowing that a potential exists will enable fast and early treatment, thus avoiding a terrible fate that might have come.

CombiMatrix (CBMX) is a company that conducts DNA-based genomic testing services in the areas of Prenatal and Pediatric developmental disorders and Oncology. The company carries a $12 million dollar market cap and has a 52 week high of an impressive $14.14 with a 52 week low of $1.40. CombiMatrix currently trades at $3.33. At the moment this stock is highly speculative, highly volatile, and full of potential. The trick is gauging whether or not that potential can turn into something much bigger.

The Potential

In order to gauge the potential of this company we must first understand exactly what it does. We must then determine if there is a market for it, and lastly what the size of that market could be. We want to see if growth is possible, where finances stand, and how the company can derive revenue.

CombiMatrix turns discoveries in human genetics into diagnostic, prognostic and predictive tests that inform physicians, patients and families about specific diseases and clinical manifestations that previously went undetected by older technologies. The theory here is that a predisposition to certain conditions or diseases can be determined on a much more scientific level now. This offers a degree of accuracy that until now was based more on supposition and a look into "family history". In the past you might hear statements such as, "grandpa had high cholesterol, dad had high cholesterol, so I think I will have high cholesterol." Sometime a patient would act on that information and try to maintain a healthy lifestyle and diet that would better his chances of avoiding high cholesterol. However, and perhaps more often, people might take the stance that "it wont happen to me" only to realize too late that they now have high cholesterol and need medicine to deal with the issue. The concept here is predicting for the purpose of treating before the fact.

CombiMatrix is an industry leader in microarray-based clinical testing. The company employs a core team of array CGH-pioneering physicians, scientists and technicians to maintain and evolve that leadership role. CombiMarix is a growing company, That presents a world of opportunity, but also inherent challenges. Keeping this core team in tact will be an important factor in the success of this company. By example, CombiMatrix recently received the recommendation of the American College of Medical Genetics (ACMG) which positioned its DNAarray™ testing as a first line option for the detection and clarification of prevalent developmental disorders such as Autism. Autism is seeing the number of incidents rise substantially over the last decade. While there is still a lot of debate about the reasons for a rise in Autism, there is also a need to be able to diagnose early so that families can work on preparation and proper treatment options. The value of diagnosis and detection is massive.

Over the past six years the predictive testing in oncology has been a critical path item for CombiMatrix. The company has established itself as a sector leader in the implementation of clinical genomic profiling services for hematological malignancies and solid tumors. Certainly no one want to hear that they have cancer. However, if diagnostic testing can give a patient and physician a better understanding of the odds of cancer, that patient and doctor can make the necessary changes to perhaps create changes that do not allow the odds to increase. For patients already diagnosed, the DNAArray tests can give a better understanding of treatment options.

In theory the diagnostic technologies can have even broader capabilities as time passes. As healthcare shifts from a reactionary stance to a more proactive approach, testing early can become beneficial to patient, doctor, as well as insurer. While there are certainly privacy issues that may concern people, there still exists the tried and true doctor/patient confidentiality as a foundation for how medical care will continue.

What Is Happening Now

By all appearances CombiMatrix looks to be a company that is making moves to grow and expand. The company does have challenges. It has fallen below some Nasdaq listing requirements, and at the moment must supply the necessary documentation by August 20th to correct that matter. Other concerns I have are convertible Series C stock and warrants. There are 2,400 shares of Series C Stock outstanding, which are convertible into an aggregate of 839,870 shares of Common Stock at a conversion price of $2.85759. There is a set of warrants to purchase 491,803 shares of Common Stock at the current exercise price of $3.55 and other warrants outstanding to purchase 491,803 shares of Common Stock at an exercise price of $3.77. Convertibles and warrants are sometimes necessary to obtain financing and liquidity, but they can be dilutive later on, especially if they are in the money. With just over 3 million shares currently outstanding, you can imagine the impact of an additional 1.8 million shares in the float.

With that being said, part of this story is potential and business moves that are accretive to the company. In the last month CombiMatrix has been quite busy:

The company has seen substantial growth in prenatal testing subsequent to a study that the company partnered in which was published in the New England Journal of Medicine.CombiMatrix was selected by Pathology, Inc., as the exclusive source for POC testing used in assessing potential and reasons for miscarriages. The state of New York has also approved the Combimatrix tests. This is a fast growing, revenue generating segment of the CombiMatrix business. It appears that this will be one of the core revenue generators for the company.The company inked an impressive deal with Blue Sheild of California for a wide range of testing. Blue shield covers 3 million lives, bringing the total insurance deals to over 60 million lives. This represents about 20% of the population, which leaves a lot of room for growth. A key element of success for CombiMatrix is in insurance, The more insurance companies that come on board, the more the services of CombiMatrix will be utilized by patients and physicians.

Perhaps the most important move that CombiMatrix has made in the past month is appoiting Robert Hoffman to its Board of Directors. Hoffman is a seasoned professional in the biotech space and is currently the Chief Financial Officer at Arena Pharmaceuticals (ARNA). Arena recently launched an anti-obesity called Belviq with marketing partner Eisai. The experience that Hoffman can bring to the table is second to none. Hoffman was an integral part of a company that developed a technology, secured financing, developed a product from that technology, secured a partner to market the product, and essentially was an architect in the inner workings of taking Arena from a concept to a company with a $2 billion dollar market cap and one of only two anti-obesity drugs to gain FDA approval in the last decade. Essentially, the path that Hoffman just navigated down is the path that CombiMatrix want to follow. Hoffman will bring insight to CombiMatrix at a critical juncture in its corporate story.

While there are still substantial risks with an investment in CombiMatrix, there is also substantial potential. The company will have several hurdles to navigate, but with good management and an experienced Board of Directors, the company is making some good moves early in the process. In my opinion this is an equity that saw a run, saw a correction, and has settled to a great starting point. At $3.33 it is worth some serious consideration.

Source: CombiMatrix - Can We Predict A Bright Future?

Disclosure: I am long ARNA. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. (More...)

Additional disclosure: I have no position in CombiMatrix

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