News About Spherium

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  • 29 MAY 2017

    Spherium to scout for partners at BIO San Diego 2017

    From 19 to 22 June, the Spherium Biomed team will be at the BIO International Convention 2017 in San Diego, the largest biotechnology convention in the world that brought together 16,000 executives and decision makers from 76 countries...

  • 6 MARCH 2017

    An Astronaut’s guide…. to biotech Project Management

    It was about three years ago when I was coming back from BioTrinity in London. It had been a good event and we had had a lot of one-to-one meetings where we had tried to explain to a number of universities and hospitals why it could be...

  • 9 DECEMBER 2016

    Let’s keep it simple

    Most of us make a living on biotech thanks to the April 1953 Nature paper, A Structure for Deoxyribose Nucleic Acid” recognized as the landmark starter of modern biology. The paper is a one pager: Watson and Crick used just 985 words distributed...

29 MAY 2017

Spherium to scout for partners at BIO San Diego 2017

From 19 to 22 June, the Spherium Biomed team will be at the BIO International Convention 2017 in San Diego, the largest biotechnology convention in the world that brought together 16,000 executives and decision makers from 76 countries for more than 35,000 business meetings last year. This year, Spherium will be part of the Biocat delegation along with other innovative companies and organisations from the healthcare and life sciences sector in Barcelona.

For four intense days, “We will scout for international partners to license our clinical and pre-clinical projects and we will continue our systematic work to assess and acquire portfolios from universities and research centres around the world,” explains Maribel Bergés, managing partner and CBDO of the company.

The Spherium product pipeline includes innovative drugs in clinical stage like SP13004, with a unique disease-modifying mechanism of action to prevent and treat mucositis caused by cancer therapy (phase IIa results in 2018); SP14019, to treat atopic dermatitis and psoriasis with an innovative, proprietary Cyclosporine topical formulation (clinical PoC results by the end of 2017); and SP12006, used to treat mild to moderate muscular pain associated with sport or temporomandibular joint disorder (clinical PoC results in 2017).

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6 MARCH 2017

An Astronaut’s guide…. to biotech Project Management

It was about three years ago when I was coming back from BioTrinity in London. It had been a good event and we had had a lot of one-to-one meetings where we had tried to explain to a number of universities and hospitals why it could be a good idea for them to license out their projects to Spherium Biomed and how we could help them to test their inventions and eventually increase their value.

Having taken the Gatwick express too early, I was now just wandering around the airport and waiting for my flight. I realized I still had 20 pounds in my pocket, and I was trying to invest them in something worth to before my return to the Euro space, when I entered the newspapers shop and saw this paperback edition with an astronaut picture on the front page. It came to me like an old dream from some years ago, when I was young, I had this idea of becoming an astronaut myself, an idea that had to be abandoned for a more down-to-earth professional plan when I learned about the extremely demanding vision requirements. So I bought the book. An astronaut’s guide to life on earth by Canadian astronaut Chris Hadfield and I started to discover the secrets of this profession that most of us will never get to really know, and learn about the lights and shadows that are so surprisingly close to our own.

As commander Hadfield describes his profession, it takes years to become an astronaut, since they need to keep always learning about the prospects of out of earth missions and getting their minds to think like astronauts: “No matter how competent or how seasoned, every astronaut is essentially a perpetual student forever cramming for the next test”. It takes hours of simulations, debriefing, courses, reading, and homework for an astronaut to be ready to take a mission, and yet we only know about them when a new record is achieved or something epic or sometimes even disastrous happened in their last mission. Another important advice from Hadfield is to prepare previously to each mission, even a single recognition flight, to check every potential problem that may come up and be ready for the unexpected events, as he puts it, you need to “sweat the small stuff” so you know ahead of a situation all the potential trouble you may find.

It turns out that it is very similar when you come to biotech Project Management. We will never have the thrill of actually leaving the ground to come higher than the 50 miles that it takes to be an astronaut, but a Project Manager is also a lifetime student that invests an incredible amount of time learning about the very specifics of a new mechanism of action, the properties or a complex biological system, or the clinical needs in a particular indication. Before starting a new experiment, may it be a murine model or a clinical trial, there are a number of small decisions to be taken in order to learn the most from the experience: how to administer the product, how many doses, how often, which are the readouts that are going to be collected and reported, and then we need to debrief to understand what happened, what went right and what went wrong, and start to plan for our next experiment again.

So what makes us good as Project Managers and, in a word, why should anyone want to partner with us? It is not so much about how good or exceptional are our successes, but it is about how long our hours have been in this field and how deep and extended is our experience. It is about how many experiments we have seen, how many right or wrong decisions we have made, how many projects we started and how many failed and how our team has learned from all that to bring it to any new development we start.

Since we incorporated Spherium Biomed, we have reviewed in depth more than 500 projects, we have started almost 70 new preclinical developments after closing as many licenses, and we are now conducting three phase II clinical trials. This is the real value that we can bring to an academic research organization: the experience and time it has taken to our team to be developing projects continuously for the last eight years. Or to say it in the words of Michael Jordan: “I've missed more than 9000 shots in my career. I've lost almost 300 games. 26 times, I've been trusted to take the game winning shot and missed. I've failed over and over and over again in my life. And that is why I succeed”.

In the next months we will learn the results of our first three clinical trials, we may succeed or we may fail, but no matter what we will debrief and learn to bring the best of our experience to our technological partners (worldwide universities and hospitals) and to the patients that deserve the best of our efforts to develop biomedical innovations for the improvement of their health.

Now the countdown is ready for our first results, in a way, our first lift-off. 5…4...3…2…1…

Maribel Berges, Managing Partner and CBDO of Spherium Biomed

9 DECEMBER 2016

Let’s keep it simple

Most of us make a living on biotech thanks to the April 1953 Nature paper, A Structure for Deoxyribose Nucleic Acid” recognized as the landmark starter of modern biology. The paper is a one pager: Watson and Crick used just 985 words distributed in less than 6.000 characters and one drawing to describe the double helix of DNA and to suggest how its information could be copied and transmitted from one generation to the following.

“Distrust the idea that does not fit in a sentence”, says Jorge Wagensberg in his marvelous short aphorism book If Nature is the answer, what was the question? Simplicity is a key to understanding problems and to make others understanding the problems, also a key to propose solutions to problems. Simplicity helps in any kind of communication. However, sensible simplification is probably the most challenging effort for anyone with communication responsibilities, from the community manager in the Linkedin page to the CFO talking to investors; from the bench scientist telling the CEO how important the new program is for the company, to the University Professor explaining the tech transfer guys her last discovery (which by the way could be the next Watson & Crick thing…).

Ever heard of the elevator pitch concept?

Counter-example: I remember one honest and hard-working man going all over Spain explaining a full range of public financing options for science projects. He had 30 slides and his concept of adaptability was this: if he had 30 minutes, his presentation was OK, normal pace. If he had 45 minutes, then he explained his 30 slides at a slower, mindfulness-style rhythm. If he had only 10 minutes, then he was really fast, still showing the 30 slides.

We started Spherium Biomed in 2009. Our name was Janus at the time, after the bi-faced Roman divinity taking care of the transitions (January…), looking at the same time to the past and to the future. We thought of Janus because we wanted to look at the academic research and the unmet needs in the biomedical market and bridge the gap (our first catchy motto). Simultaneously we defined our mission as to turn biomedical knowledge into social and economic value. We spent infinite hours trying to find a sentence to define our company, a simple, easy-to-remember and true statement fitting in a short sentence that even my mum could understand.

During our first four years we tried several adaptations of known concepts: hands-on biomedical incubator; accelerator, a company specialized in maturing projects originated in academia; or cost-efficient de-risk incubator of biomedical technologies. All that time we spoke a lot with different local journalists who were interested in the evolution of the company. A symptom of us not communicating well was that one of them systematically defined us as a consulting firm giving strategic advice to research institutions, no matter how nice our pipeline started to look or how many licensing-in deals we had closed with academia.

Seven years have gone-by already, and we are still looking for that sexy and informative short sentence that defines as better. As of today we are a clinical stage biopharmaceutical company that sources its pipeline from academic research. Perhaps it is a good definition. For sure we will have another one in a couple of years.

Yes, I’ve checked already. The post has 566 words including this sentence. 3414 characters including spaces. No drawings.

It may work.

Dr. Luis Ruiz-Ávila, CEO of Spherium Biomed

  • 14 FEBRUARY 2017

    Advances in Spherium's clinical portfolio

    Spherium Biomed's portfolio is steadily advancing to reach the preclinical and clinical value inflection points. From the clinical portfolio, all three ongoing trials reached recently important milestones as a result of the commitment and...

  • 12 FEBRUARY 2017

    Mucomel® at the 6th International Conference on Innovative Approaches in Head & Neck Oncology

    Spherium Biomed will attend to the 6th International Conference on Innovative Approaches in Head & Neck Oncology (ICHNO) from 16th to 18th March 2017 in Barcelona to share with the medical experts in this field both the preclinical background...

  • 16 NOVEMBER 2016

    Dr Pawel Zajdel receives recognition under the auspice of prestigious Prix Galien

    Dr Pawel Zajdel, a specialist in medicinal and organic chemistry from Jagiellonian University (Kraków), has been awarded a fellowship from the French Embassy under the auspices of the Prix Galien Poland for his innovation in academic research.

14 FEBRUARY 2017

Advances in Spherium's clinical portfolio

Spherium Biomed's portfolio is steadily advancing to reach the preclinical and clinical value inflection points. From the clinical portfolio, all three ongoing trials reached recently important milestones as a result of the commitment and hard work of the internal and external collaborators involved in these projects.

Most relevant goal was reached by SP12006, the program in Temporo-Mandibular Joint Disease (TMJD). In this project, the phase II clinical trial successfully completed the recruitment of 96 patients in 4 different centers: the Universitary Dental Clinic (UIC), the Hospital Odontológico of the University of Barcelona, the Universitary Hospital Rey Juan Carlos I in Madrid and the University Hospital de la Fe in Valencia. This exploratory trial is a randomized, double blind, placebo controlled study designed to evaluate safety and efficacy of a triple combination (ibuprofen, magnesium and vitamin C) for the treatment of acute pain in TMDJ. Another relevant milestone was reached by SP14019, the program in Atopic Dermatitis (AD). In this case, the phase II clinical trial successfully completed the recruitment of the adult cohorts, which allows Spherium Biomed to start the recruitment of children under 18 years. AD is a major unmet need in the children, so testing in this population is a critical objective of the project.

Finally, the program in Oral Mucositis (OM) SP13004 also has shown important advances: phase Ib-II clinical trial (reached the recruitment of 2/3 of the target patient population, and is actively recruiting at a steady pace.

'In summary we had a very busy clinical year, but we expect 2017 to be even busier.
Next milestone ahead: top line results of our clinical TMJD program, expected in the coming weeks' explain Dr. Benjamín Santos,and Dr. Wilmar Castillo Ávila, Project Managers at Spherium Biomed.

12 FEBRUARY 2017

Mucomel® at the 6th International Conference on Innovative Approaches in Head & Neck Oncology

Spherium Biomed will attend to the 6th International Conference on Innovative Approaches in Head & Neck Oncology (ICHNO) from 16th to 18th March 2017 in Barcelona to share with the medical experts in this field both the preclinical background and the design of the ongoing trial Mucomel®.

In the phase IB-II clinical trial, Spherium Biomed investigates the safety and efficacy of a proprietary oral gel for the prevention and treatment of severe oral mucositis in 84 patients with head and neck cancer undergoing radio/chemo therapy. At present, the trial is actively recruiting patients in seven leading hospitals in Spain (ICO L’Hospitalet, Vall d’Hebron University Hospital and Hospital Sant Pau in Barcelona, ICO GironaICO BadalonaMiguel Servet University Hospital in Zaragoza and La Paz University Hospital in Madrid). Recruitment pace forecasts that last patient will be included by June 2017.

Severe oral mucositis is a major adverse event of the oncologic treatment with a large incidence: 95% of head and neck cancer patients, 78% of haematological cancer patients, 40% of patients with solid tumors, among others. It is recognized by experts as one of the major unmet medical needs in cancer supportive care, since at present only partial symptomatic treatments are available (anesthesic washes, hygiene procedures and anti-inflammatories) and consequences of the disease can led to breaks in oncologic treatment, parenteral feeding and oral chronic toxicities. Mucomel® represents a unique opportunity to improve the quality of life for these patients.

During the 6th ICHNO, five posters related to melatonin, mucositis and cancer will be presented. The design of Spherium Biomed's clinical study will be summarized in the poster entitled Melatonin oral gel for the prevention of oral mucositis H&N cancer undergoing chemo/bio radiation, presented by the principal investigator Dra. Alicia Lozano. The preclinical in vivo results of the use of melatonin in prevention of oral mucositis will be summarized in two posters, Effects of melatonin oral gel to prevent radiation-induced mucositis model in rat and A melatonin gel protects the mitochondria from radiation damage preventing radiotherapy-induced mucositis, that will be presented by the originator of the Mucomel® technology, Dra. Germaine Escames. She will also present two posters summarizing her ongoing research work on melatonin at the University of Granada: Oncostatic effect of Melatonin in H&N cancer: role of mitochondrial function and Melatonin enhances the toxicity of Radio- and Chemotherapy in H&N cancer cells.

Meet Spherium Biomed at the 6th ICHNO! Please contact in advance our representatives Dr. Cristina Tarragó and Dr. Pedro Grima in order to arrange a meeting during the conference.

16 NOVEMBER 2016

Dr Pawel Zajdel receives recognition under the auspice of prestigious Prix Galien

Dr Pawel Zajdel, a specialist in medicinal and organic chemistry from Jagiellonian University (Kraków), has been awarded a fellowship from the French Embassy under the auspices of the Prix Galien Poland for his innovation in academic research. Specifically, the award acknowledges the merit of the Polish-French initiative that has led to the discovery of preclinical candidate SP14040, a first-in-class small molecule for cognitive impairment in patients with Alzheimer or schizophrenia licensed by Spherium Biomed. Dr Zajdel is one of the owners of the patent on this compound, licensed to Spherium.

The awards ceremony took place at the Hilton Warsaw Hotel in Poland on 16 November 2016.

Considered the Nobel Prize of the pharmaceutical industry, Prix Galien was created in France in 1970 by a pharmacist named Roland Mehl with the aim of recognising and promoting significant advances in pharmaceutical research that improve the human condition by developing novel, high-value medicines. The Prix Galien are the only independent awards of their kind across the global industry and winners are chosen by eminent healthcare leaders and specialists. Nowadays, it is a global brand with fifteen national awards in Belgium-Luxemburg, Canada, Germany, Greece, Israël, Italy, Morocco, Poland, Portugal, Russia, Spain, Switzerland, The Netherlands, USA and United Kingdom.

  • 15 JANUARY 2017

    BIO-Europe Spring 2017: Getting collaborations at home

    Spherium Biomed will participate on next BIO-Europe Spring 2017. This year, winter is over and spring is coming to Barcelona. From 20th to 22nd March, Spherium Biomed team will join company presentations and partnering meetings with other...

  • 6 NOVEMBER 2016

    Spherium’s key patent achievements in 2016

    2016 has been a productive and positive year for the patent portfolio behind Spherium Biomed’s active projects. Strategic intellectual property (IP) management is a key element for any company focused on drug development. 'We are no exception,'...

  • 2 OCTOBER 2016

    Spherium expands its pipeline with new preclinical program for autoimmune diseases

    Spherium Biomed has added PeMTADiV (SP15008) to its pipeline. This patented preclinical candidate for autoimmune diseases was discovered by Professor David Naor, a renowned immunologist from Israel. The aim is to reach the clinical phase...

15 JANUARY 2017

BIO-Europe Spring 2017: Getting collaborations at home

Spherium Biomed will participate on next BIO-Europe Spring 2017. This year, winter is over and spring is coming to Barcelona. From 20th to 22nd March, Spherium Biomed team will join company presentations and partnering meetings with other participants in our city.

As part of its regular business, Spherium Biomed is seeking in-licensing opportunities from academic sources, preferably therapeutically oriented projects with solid preclinical POC and repurposing (repositioning) opportunities of molecules that have reached the market or discontinued during development because of lack of efficacy.

On the other side, the company will look for out-licensing ongoing projects in clinical proof-of-concept stage (mucositis, psoriasis and atopic dermatitis, muscular soreness and acute kidney injury) and also in non-clinical stage (a local intramuscular treatment for muscle injury, a safe biomolecule that is a modulator of the immune response with proof-of-concept in lupus nephritis and rheumatoid arthritis and a preclinical candidate for cognitive deficit and negative symptoms in schyzophrenia).

See you soon in Barcelona!

6 NOVEMBER 2016

Spherium’s key patent achievements in 2016

2016 has been a productive and positive year for the patent portfolio behind Spherium Biomed’s active projects. Strategic intellectual property (IP) management is a key element for any company focused on drug development. 'We are no exception,' says Maribel Berges, Managing Partner and CBDO of Spherium Biomed.

Spherium Biomed sources most of its projects from academic institutions, which are usually public. The company takes full responsibility not only for regular, reactive maintenance and defence of the IP licensed from universities, “but also for prospective, proactive generation of data to support the evaluation process. And sometimes, we produce experimental results that allow us to generate new IP, always in coordination with the original inventors,' explains Berges.

So, it’s time to look at what happened on the IP front in 2016:

* For the patent that protects MUCOMEL (SP 13004), a product to treat mucositis, Spherium Biomed has received notice of allowance from China, Japan, Mexico, Russia and Australia, a nice collection to add to the patents already issued in the US and Spain.

* In January, Spherium Biomed filed a composition of matter application for CYCLATOP (SP14019), a topical Cyclosporine solution for atopic dermatitis and psoriasis. The product is also covered by an umbrella patent granted for the US, Japan and Australia in 2016.

* Concerning COMBOPROFEN (SP12006), a product to treat mild muscle pain, Spherium received a very positive written opinion from the EPO and the company will push this application forward to then widen protection on a national and regional level in July 2017.

* One of the patents covering SP15016, a product to prevent iatrogenic acute kidney injury, was granted in the US and two more applications were filed based on exciting new data to broaden the IP protection and the project scope.

* Cognition deficit product SP14040, whose inventor has just been given an award under the auspices of the Prix Galien Poland, has seen its 2014 application proceeding to the national/regional phase with very good prospects, confirming the high scientific level of the research and the quality standards of the tech-transfer team at Jagiellonian University in Poland.

* Part of the broad patent application covering SP12008, a preclinical biological candidate for autoimmune diseases, received a notice to grant from Europe in 2016. Spherium Biomed expects to file new patents in the near future, to comprehesively cover the IP space for this breakthrough product.

* PeMTADiV (SP15008), for rheumatoid arthritis and other autoimmune diseases, licensed from Yissum, the tech-transfer company of the Hebrew University of Jerusalem. The technology is covered by patent applications from 2014 and by an additional one filed in July of this year on the basis of the molecule’s unexpected therapeutic attributes discovered in preclinical models.

So, 2016 has been a very good year. However, none of these achievements would have been possible without a strong foundation. Spherium Biomed works very closely with more than 50 research and tech-transfer teams all over the world, having closed deals with several Universities and Research Centers in Spain, France, Poland and Israel.

Such commitment translates into an ever-growing investment from our side as the IP portfolio reaches maturity: in 2016 Spherium invested €250,000 in patent management (up 60% from the previous year). 'That shows the continuous commitment to protect and increase the value of our licensors’ inventions,' concludes Maribel Berges.

2 OCTOBER 2016

Spherium expands its pipeline with new preclinical program for autoimmune diseases

Spherium Biomed has added PeMTADiV (SP15008) to its pipeline. This patented preclinical candidate for autoimmune diseases was discovered by Professor David Naor, a renowned immunologist from Israel. The aim is to reach the clinical phase within two years.

This drug is a 5-mer peptide (MTADV) derived from a CD44 variant expressed only in the inflammatory cells of the joints of rheumatoid arthritis patients. It inhibites substantially joint inflammation in a RA-CIA mouse model, as well as strongly inhibiting limb paralysis in a multiple sclerosis mouse model. The peptide has a novel, targeted mechanism of action directed at key pathways of the immune response and inflammatory cascade.

Yissum, tech transfer from Hebrew University of Jerusalem

The technology is covered by patent applications from 2014 and 2016. Spherium Biomed acquired an exclusive option to license PeMTADiV from Yissum, the technology transfer company of the Hebrew University of Jerusalem. Ranked among the top tech transfer companies, Yissum has registered over 9,300 patents, out-licensed 800 technologies and spun off 110 companies. Products that are based on Hebrew University technologies and commercialised by Yissum now generate over $2 billion in sales each year.

Spherium Biomed is closing out 2016 with a pipeline consisting of ten active projects in the field of human and animal health (four in the preclinical phase and six in the clinical phase). Furthermore, Spherium is a partner in one of them (veterinary vaccines for respiratory diseases) with the company Aquilon Cyl.

  • 27 SEPTEMBER 2016

    Developing new drugs: from pull (problem-driven) to push (technology-driven)

    Biomedicine is the most unpredictable of all sciences. Take thousand engineers and close them down in a quiet Pacific Island. Give them ten billion dollars and specific instructions to deliver a new plane in 10 years. They most probably...

  • 27 SEPTEMBER 2016

    Cyclatop study for atopic dermatitis starts patient recruitment

    Spherium Biomed has opened the first of eight clinical sites in Spain participating in Cyclatop study, to evaluate the safety and efficacy of a proprietary cutaneous spray of Cyclosporine A (coded SP14019-F1) for the treatment of mild to...

  • 27 SEPTEMBER 2016

    Spherium Biomed at BIO-Europe 2016

    After attending Biospain, Spherium Biomed will participate at BIO-Europe 2016, the  Europe's largest partnering conference for the global biotechnology industry that take place from 7th to 9th November in Cologne (Germany).

    BIO-Europe attracts...

27 SEPTEMBER 2016

Developing new drugs: from pull (problem-driven) to push (technology-driven)

Biomedicine is the most unpredictable of all sciences. Take thousand engineers and close them down in a quiet Pacific Island. Give them ten billion dollars and specific instructions to deliver a new plane in 10 years. They most probably will deliver the new plane according to specifications. Take thousand biomedical scientists and do the same asking them to deliver an HIV vaccine, and they most probably won’t get it.

Applied biomedical research, particularly new drug development, is a pay per view business and the quintessence of the scientific method: no matter how good is your science, the only way to know if your hypothesis is right is to test it experimentally in the right model. And, in biomedicine, key experiments are outrageously expensive (the right model is a human and the experiments are called clinical trials) and surprises (unexpected results) are more the norm than the exception. Anybody in applied biomedical research has to learn to cope with technical failure. Actually, the real challenge of an R&D executive in the biopharma industry is to be able to minimize the cost of failures while performing sufficient number of attempts to get at least one drug to the patients once in a while, without being fired along the way because of incompetence or budgetary restrictions. 

 

There are two basic approaches to deliver a new drug: pull and push. The pull approach follows a very institutionalized path in the biopharma industry: define a medical unmet need, find a new therapeutic target, discover a molecule that acts on the target, show it works in preclinical models of the predefined unmet need, make the molecule industrial and regulatory compliant, define the clinical and market access strategy, take a deep breath and start formal development. It is a problem-driven approach. The key element is to find the right technology to solve a predefined problem. The driver of the process is the dedicated industry, that expends enormous amount of resources in understanding and predicting unmet medical needs, payer trends and, sometimes, even defining new diseases or disease sub-classifications. 

The push, by contrast, is technology-driven. One team of scientists makes a seminal discovery, then the key is to find the right problem where the new discovery can be used. Mechanistic research often leads to great discoveries sitting there waiting for somebody to find a way to use them. By far, most of the new knowledge is generated because of the mechanistic motivations of scientists exploring new explanations to understand better the basis of life. In fact, in general scientists do not care too much about market access and the likes. However, mechanistic research is probably the only effective path to real breakthroughs, something that was recognized in 1945 in Science, the endless frontier, a document that lead to the creation of the National Science Foundation, the National Institutes of Health  and the Defense Advanced Research Projects Agency  in the US. The idea-force behind this landmark document was the following (quoted literally): “To discover is to obtain for the first time sight or knowledge of some fact or principle hitherto unknown. Discovery cannot be achieved by directive. New products and new processes do not appear full-grown. They are founded on new principles and new conceptions, which in turn are painstakingly developed by research in the purest realms of science.”  

 

While the pull approach has been the main driver of the biopharma industry over the last fifty years, its perceived increasing lack of productivity combined with the massive amount of mechanistic knowledge that is permanently being generated in academic institutions are the basis of a very clear trend that permeates modern pharma. Big or small, almost everybody in the industry is trying to fish in the open innovation space, adding the push strategy to their business models with more or less fortune.

 

When we started Spherium Biomed we decided to stay in the push side. Our key assumption was that academic research was mechanistically driven, and that even when the results were presented as a consequence of a problem-solving process, in the great majority of cases the problem itself was badly defined and that just the right definition of the problem to solve lead to a significant improvement (or refutation) of the potential value of the research from the applied point of view.

 

Defining the right problem (in our process, the right Target Product Profile, TPP) is the very first step in our company when we start the evaluation of an academic technology. If we are able to define the TPP we have the most important thing that any new project can have: a defined goal (in engineering language, the specifications of the product). Then we can start thinking in a development plan (basically a development plan should aim to fill the gaps between the technology at time zero and the technology at TPP stage). If we can deliver a development plan, that means that have identified all the required providers and collaborators, so we have budgets and calendars. If those fit our budgetary and time constrains, then we have a project and we try to negotiate a license to be able to develop and commercialize the technology. If not, we don’t go for it. As simple and as complex as that.  

 

 

27 SEPTEMBER 2016

Cyclatop study for atopic dermatitis starts patient recruitment

Spherium Biomed has opened the first of eight clinical sites in Spain participating in Cyclatop study, to evaluate the safety and efficacy of a proprietary cutaneous spray of Cyclosporine A (coded SP14019-F1) for the treatment of mild to moderate atopic dermatitis (AD) across all group ages, including pediatric population. It will include 36 patients (with a blinded left-right design so that each patient is its own control) from ages 2 to 75 segmented in three cohorts (pediatric, juveniles and adults).

Systemic Cyclosporine A is an efficacious and well established treatment for moderate to severe atopic dermatitis. Its use is limited to short term because of the risk of adverse events, in particular nephrotoxicity. The topical formulation is expected to have a much better safety profile since it reduces dramatically the systemic exposure. “In our view it represents a unique opportunity to extend the well-established benefits of cyclosporine in the indication, both in time (allowing for longer treatment periods) and in patient base (broadening the scope of treatment to milder cases and pediatric populations)” explains Dr. Benjamín Santos, Senior Project Leader of Spherium Biomed.

20% of Spanish children suffer from atopic dermatitis

Atopic dermatitis , also called atopic eczema, is a chronic and relapsing inflammatory skin disease affecting up to 20% of children and up to 3% of adults depending on the country. Its prevalence is still on the rise. The disease is characterized by itchy skin lesions and rashes. It is primarily managed in primary healthcare settings and often is considered a minor condition, but it has a significant impact in quality of life and in costs for the health-care systems and families. When its first manifestations appear early in life it often precedes other allergic diseases such as asthma or allergic rhinitis.

The global market is in the 4 billion dollar range worldwide, with an estimated target population of 54 million people for the next decade. The long lasting nature of AD and the multiple etiologies underlying the disease are the basis for the existence of many therapeutic options and, simultaneously, of an intense research activity focused in niche unmet needs in severe, refractory cases, and in expanding the current armamentarium, especially topical alternatives for infants.

Presentation at the 25th EADV Congress

Spherium Biomed high-load formulation of Cyclosporine A is compatible with cutaneous spray administration. “We have already shown that the formulation delivers appropriate amounts of Cyclosporine to the target layers in the skin, with a parallel, dose dependent efficacy in preclinical models of atopic dermatitis,” says Dr Santos. The key aspect of SP14019 development has been solving the pharmaceutical challenge of obtaining a high-load, skin penetrating, scalable, stable and regulatory compliant formulation of CsA, a technical milestone that we couldn’t have achieved without the close collaboration with Bionanoplus, a Navarra University spin-off from which we licensed the technology in exclusive for this project. Dr. Benjamin Santos will present the project at an oral poster (Stable, high-load topical formulation of Ciclosporin for the treatment of Psoriasis and Atopic Dermatitis) at the 25th EADV Congress in Vienna  on 1st October .

This is the third project of Spherium Biomed's portfolio that reaches clinical efficacy stage over the last year. Exciting times ahead, since the three of them are expected to deliver top line results before the end of 2017. Keep you posted! 

 

27 SEPTEMBER 2016

Spherium Biomed at BIO-Europe 2016

After attending Biospain, Spherium Biomed will participate at BIO-Europe 2016, the  Europe's largest partnering conference for the global biotechnology industry that take place from 7th to 9th November in Cologne (Germany).

BIO-Europe attracts more than 3,500 dealmakers from biotech, pharma and finance.

Morever, in 2015 the re were 4,358 licensing opportunities posted. BIO-Europe is

specially interesting for Spherium, a company that develops biomedical

innovations from academic sources to accelerate their transition to the value chain

 and to the market. See the portfolio here and request a meeting with our

executive team!

  • 27 SEPTEMBER 2016

    FROM OUR NEWSLETTER Spherium Biomed at Biospain 2016

    The executive team of Spherium Biomed is attending Biospain 2016,  the 8th International Biotechnology Meeting, organised by the Spanish Bioindustry Association (Asebio) and the Basque Business Development Agency from 28th to 30th September...

  • 13 JANUARY 2016

    Spherium Biomed iniciates an efficacy trial for SP12006 for the treatment of acute pain in patients with Temporomandibular Joint Disorders (TMJD).

     Barcelona, January 21th, 2016.- Spherium Biomed announced today it has completed the enrollment of the first 10 patients in a randomized, double blind, placebo controlled exploratory  efficacy trial of SP12006 for the treatment of acute...

  • 17 NOVEMBER 2015

    First patient in for SP13004 efficacy trial in oral mucositis

    The Phase IB-II clinical trial is designed to investigate the safety, tolerability, pharmacokinetics and efficacy of SP13004 for the prevention and treatment of oral mucositis in patients with head and neck cancer undergoing chemoradiation.

27 SEPTEMBER 2016

FROM OUR NEWSLETTER Spherium Biomed at Biospain 2016

The executive team of Spherium Biomed is attending Biospain 2016,  the 8th International Biotechnology Meeting, organised by the Spanish Bioindustry Association (Asebio) and the Basque Business Development Agency from 28th to 30th September in Bilbao. The fair is one of the most important in the world, due to the number of one-to-one meetings (more than 3,000 in each edition), as well as the number of companies participating (over 850). Thirty-four percent of the delegates come from outside Spain. US is the country invited.

 Spherium is a company that develops biomedical innovations from academic sources to accelerate their transition to the value chain and to the market. See the pipeline here and meet us at the partnering area!

13 JANUARY 2016

Spherium Biomed iniciates an efficacy trial for SP12006 for the treatment of acute pain in patients with Temporomandibular Joint Disorders (TMJD).

 Barcelona, January 21th, 2016.- Spherium Biomed announced today it has completed the enrollment of the first 10 patients in a randomized, double blind, placebo controlled exploratory  efficacy trial of SP12006 for the treatment of acute pain of patients with temporomandibular joint disorder (TMJD). Luis Ruiz-Avila, Spherium Biomed’s CEO, shared that “SP12006 represents a unique opportunity to improve the quality of life for these patients, since the currently available tools for the management of the disease are not satisfactory. Actually there is no drug or combination accepted as standard of care for the indication”.

 The temporomandibular joint disorders include many clinical problems impairing the chewing muscles, temporomandibular joint and associated structures or both. TMJD are very common in population, studies show that 50% of the population shows one or more TMJD signal. For many, symptoms of TMJD resolve on their own without significant medical intervention; however, 5% to 10% of adults suffering from TMJMD symptoms require professional treatment. About 5.3 million people seek treatment for TMJD within 6 to 12 months after onset of symptoms, with direct costs of treatment alone conservatively estimated at $2 billion annually in the US.

 

SP12006 is based on seminal clinical observations from Dr. Pablo Llorens, in Chile. Dr. Llorens discovered a key synergistic effect between the anti-inflammatory and pain protective roles of common AINEs and the muscle relaxation properties of magnesium, with a significant and surprising contribution of a third component of the combination which significantly improved the pain relief and also the muscle discomfort of TMJD patients compared with the individual components. The combination have strong potential in muscle pain and discomfort related to other conditions, such as delayed onset muscular soreness derived from heavy sportive practice or muscular effort.

 Spherium Biomed aims to complete the clinical trial and to deliver top line results by the first half of 2016. 

17 NOVEMBER 2015

First patient in for SP13004 efficacy trial in oral mucositis

The Phase IB-II clinical trial is designed to investigate the safety, tolerability, pharmacokinetics and efficacy of SP13004 for the prevention and treatment of oral mucositis in patients with head and neck cancer undergoing chemoradiation. SP13004 is a proprietary, high density gel containing melatonin (HD Melatonin©) to be used in mouth washes several times a day. In preclinical animal models it has shown promising results based on a novel,protective effect on the mucosa at local level.

BARCELONA, Spain - Nov. 17, 2015 - PRLog -- Spherium Biomed announced today the enrollment of the first patient in a double-blind, placebo controlled efficacy trial of SP13004 for the prevention of mucositis in patients with head and neck cancer undergoing chemoradiation. The clinical trial initially involves clinical sites at four leading hospitals in Spain, and will include up to 84 patients. Luis Ruiz-Avila, Spherium Biomed’s CEO, shared that “SP13004 represents a unique opportunity to improve the quality of life for these patients, since most of them will develop oral mucositis as a side effect of their treatment.”

Mucositis is a painful inflammation/ulceration of the mucous membranes lining the digestive tract. Mucositis can occur anywhere along the gastrointestinal (GI) tract, but oral mucositis (OM) refers to the particular inflammation and ulceration that occurs in the mouth. Mucositis can also occur in the larynx, pharynx, esophagus, and even in the GI tract. Severe OM is associated with significant morbidities (Grade III reduces oral intake, increases the use of pain medication, and Grade IV can result in radio and/or chemotherapy dose reduction, hospitalization and parenteral nutrition) and impact on health economics.

More than 600,000 people/year are affected by the condition in Europe and in the United States; with 95% of head and neck cancer receiving radiotherapy and 78% of patients with hematological cancers receiving bone marrow or stem cell transplantation (HSCT) likely to develop oral mucositis. Patients are currently treated with local anesthetic washes, hygiene procedures, anti-inflammatories or opioids; nevertheless mucositis is still recognized by oncologists and radiologists as a significant unmet medical need.

SP13004 is based on a seminal observation from Dr. Germaine Escame’s research at the University of Granada. Dr. Escames discovered a key protective role of melatonin at the local level in the mucosa. Melatonin, known for its hormone-like, sleep-regulating properties, also exerts a potent antioxidant and anti-inflammatory effect in the mucosal cells. The concentration of melatonin in these cells is more than 100 fold higher than in the pineal gland and blood. There is a natural, endogenous melatonin system that protects the mucosal tissue from external insults. This system is affected by the chemo-radiation protocols used to treat head and neck cancer, thus leading to mucositis. SP13004 is a proprietary, dense, adherent gel formulation of melatonin (HD-Melatonin©) which restores the natural levels of melatonin in the mucosa after topical exposure. This effect cannot be achieved from systemic exposure through the blood or by using mouth washes with regular solutions or gels. Spherium Biomed aims to complete the clinical trial and to deliver top line results by the first half of 2017.

  • 19 OCTOBER 2015

    INNPACTO project "Apta4" in its final stretch

    A clinical study that is being carried out in various hospitals of the Community of Madrid, makes Apta4 project to enter in its final stage. The project began in 2011 as a public-private partnership, under the INNPACTO 2011 program of the...

  • 6 OCTOBER 2015

    BIO-Europe® 2015

    The 21st annual BIO-Europe is Europe's largest partnering conference serving the global biotechnology industry.

    Delegates from all parts of the biotechnology value chain come to BIO-Europe to quickly identify, engage and enter into strategic...

  • 14 APRIL 2015

    Meet us at BIO 2015 (booth #2301)

    The coming edition of BIO will take place in Philadelphia (United States) from 15 to 18 June 2015. This metropolitan area is home to more than 1,200 companies, ranging from large multinational corporations from the biopharmaceutical industry...

19 OCTOBER 2015

INNPACTO project "Apta4" in its final stretch

A clinical study that is being carried out in various hospitals of the Community of Madrid, makes Apta4 project to enter in its final stage. The project began in 2011 as a public-private partnership, under the INNPACTO 2011 program of the Ministry of Economy and Competitiveness, and has as main objective to develop a kit capable of measuring the intestinal malabsorption. Two research institutions (University of Barcelona and Hospital Ramon y Cajal in Madrid ) and four companies (Spherium, Biosystems, and Igen Aptus Biotech) are involved in the consortium.

6 OCTOBER 2015

BIO-Europe® 2015

The 21st annual BIO-Europe is Europe's largest partnering conference serving the global biotechnology industry.

Delegates from all parts of the biotechnology value chain come to BIO-Europe to quickly identify, engage and enter into strategic relationships that drive their businesses successfully forward. Investment and collaboration opportunities developed in prior BIO-Europe conferences have produced many highly successful business partnerships. This year´s BIO-Europe partnering event will again draw over 3,000 industry attendees from nearly 60 countries, representing more than 1,800 companies for three days of high level networking.

14 APRIL 2015

Meet us at BIO 2015 (booth #2301)

The coming edition of BIO will take place in Philadelphia (United States) from 15 to 18 June 2015. This metropolitan area is home to more than 1,200 companies, ranging from large multinational corporations from the biopharmaceutical industry to national companies with great projection and high growth. So, exhibitors at BIO have the chance to reach top executives and decision-makers attending the convention in order to discover new stakeholders in the industry, forge collaborations and assess emerging technology.

  • 14 APRIL 2015

    Spherium at BioForum 2015

    Since its beginnings in 2000, BioForum has become a centre of  innovative biobusiness that integrates entrepreneurs related to the fields of biotechnology, pharmacy and veterinary, as well as scientific research teams. Because of the fact...

  • 14 APRIL 2015

    Spherium at BioTrinity 2015

    BioTrinity is the leading European Biopartnering and Investment Conference.  It provides the best opportunity to meet investors, senior licensing executives from global pharma organisations and senior management of innovative drug development...

  • 14 OCTOBER 2014

    Aquilon wins prize Cinco Dias

    Aquilón Cyl SL has been chosen as most innovative company by Cinco Dias awards for business innovation in the 2014 edition. This prestigious award recognizes the innovative business model of the company, based on the transformation in products...

14 APRIL 2015

Spherium at BioForum 2015

Since its beginnings in 2000, BioForum has become a centre of  innovative biobusiness that integrates entrepreneurs related to the fields of biotechnology, pharmacy and veterinary, as well as scientific research teams. Because of the fact, that partnership in CEE is speeding up, makes this region attractive for investors and companies from other parts of the world. At the very beginning, BioForum was a meeting platform for both scientists and entrepreneurs. Each year, it was growing up and gathering more and more participants – only from Poland at the beginning.

14 APRIL 2015

Spherium at BioTrinity 2015

BioTrinity is the leading European Biopartnering and Investment Conference.  It provides the best opportunity to meet investors, senior licensing executives from global pharma organisations and senior management of innovative drug development and platform technology companies, many of whom present in the company showcase tracks.

14 OCTOBER 2014

Aquilon wins prize Cinco Dias

Aquilón Cyl SL has been chosen as most innovative company by Cinco Dias awards for business innovation in the 2014 edition. This prestigious award recognizes the innovative business model of the company, based on the transformation in products of the fertile academic knowledge in animal health generated by the Spanish universities. Aquilón was conceived and promoted by Spherium (when the name of the company was Janus Developments) in 2012 to channel the development of a group of technologies aimed at improving animal productivity that we had acquired or detected at different Spanish universities. The Aquilón story is a good example of the strenghs of the business model of Spherium Biomed. Spherium currently runs the company and participates in its capital. Aquilón has so far managed to mobilize EUR 1,7 million of private capital to complete the development of three innovative products with high potential impact on improving productivity in the swine industry.

http://cincodias.com/cincodias/2014/10/10/sentidos/1412971029_355536.html

  • 1 JANUARY 2014

    Spherium’s new facilities

    Spherium starts operations at its brand new facilities in Esplugues de Llobregat, in the metropolitan area of Barcelona (Spain) and nearby El Prat-BCN airport. Our offices are reached easily by public transportation from the city center.

  • 27 NOVEMBER 2013

    Janus and Ferrer create Spherium

    Janus create a strategic alliance with Ferrer to implement a new R&D model within Spanish Pharma Industry.
    With the creation of Spherium, Janus Developments validates its business model and Ferrer diversifies R&D approaches in order to efficienly...

1 JANUARY 2014

Spherium’s new facilities

Spherium starts operations at its brand new facilities in Esplugues de Llobregat, in the metropolitan area of Barcelona (Spain) and nearby El Prat-BCN airport. Our offices are reached easily by public transportation from the city center. Please check our Contact section for further info.

27 NOVEMBER 2013

Janus and Ferrer create Spherium

Janus create a strategic alliance with Ferrer to implement a new R&D model within Spanish Pharma Industry.
With the creation of Spherium, Janus Developments validates its business model and Ferrer diversifies R&D approaches in order to efficienly adapt to present market needs.