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568 posts categorized "Biobiz news"

June 29, 2016

Mayo Clinic tech doesn't fare well in Celyad/Cardio3 study

Sometimes lost opportunities are actually positive things. 
The City of Rochester really wanted rock star Belgium biotech Celyad/ Cardio3 to build a manufacturing facility here to handle the Mayo Clinic-created C-Cure stem cell cardiac treatment.
CelyadThat fell apart, when Celyad/Cardio3 pulled out of its plan to take over the fifth floor of the Minnesota Buiobusiness Center.
However, this week that looks like a good thing. Rochester make have ducked being stuck with a half built facility after the results of the latest study of C-Cure.
A Chart 1 Phase 3 study found that no difference between patients treated with the C-Cure and those given a placebo.
Here's how an article on the Seeking Alpha investment news site described the situation:

The failure of a pivotal trial of its heart failure cell therapy C-Cure, erased 38% from the Belgian company’s valuation this afternoon, an outcome that will make its search for a partner considerably harder.

Indeed, without a partner the project is effectively dead, as Celyad confirmed today that it would not conduct further clinical work alone.


The Chart-1 phase III study failed to show this: it recruited 271 patients with chronic advanced symptomatic heart failure, and compared C-Cure against sham treatment. The primary endpoint was a composite of mortality, morbidity, quality of life, six-minute-walk test and left ventricular structure and function at 39 weeks, and on this measure C-Cure patients failed to show any difference versus placebo.

That must be pretty disappointing after nine years of promising results.
 Celyad/Cardio3 licensed stem-cell research by Mayo Clinic's Dr. Andre Terzic and Dr. Atta Behfar in 2007. It was called Cardio3 Biosciences back then. They have collaborated for years on the cardiopoiesis technology the company uses to repair patients' hearts by re-programming their own stem cells to regenerate cardiac tissue. Mayo Clinic owned 2.69 percent of Celyad as of March 3, 2015.
However, Celayd bought an NKR-T cell platform from Celdara Medical in 2015. It appeared that the company very quickly turned away from C-Cure to focus on the new area. That is looking like the saving grace for Celyad today.

 All of which would have been disastrous if not for the presence of its fledgling immuno-oncology pipeline, which no doubt prevented an even bigger share price collapse.


Further data updates are expected in the coming months, and indeed this afternoon Celyad’s chief executive, Christian Homsy, ended a conference call discussing the C-Cure results by flagging approaching good news in oncology. Given the relatively small amount paid to access this technology and the huge hopes for the adoptive T-cell space, investors could indeed soon forget the C-Cure failure.

June 27, 2016

Mayo Clinic announces Transplant Genomics deal

It looks like Mayo Clinic is joining forces with a Pleasanton, Calif.-based (previously of Massachusetts) firm to bolster its genetic testing to predict the success of organ transplants.

Logo-2-ret1Here's the vague description of the deal announced in a general press release this morning:


Transplant Genomics Inc. is collaborating with the Mayo Clinic Center for Individualized Medicine to develop, validate and commercialize diagnostic tests enabling personalized immunosuppression for solid organ transplant recipients. This multiyear collaboration includes an assessment of TGI's TruGraf test for renal transplant monitoring, a Mayo Clinic investment in TGI, and the co-development of new tests and technologies for additional targets, including exploratory studies in heart and liver transplantation.

This seems like this could be an interesting project. I wonder how long Mayo Clinic has been working with Transplant Genomics. 

It also would be fascinating to know how much Mayo Clinic is investing in TGI as well as how long this "multiyear" deal is slated to last.




June 07, 2016

For $300,000 upfront fee, Mayo Clinic licences cancer vaccine technology

May 31, 2016

A look at Mayo Clinic's NIH funding

It was announced last week that the National Institutes of Health awarded Mayo Clinic $142 million, spread out over five years, to a new federal Precision Medicine Initiative Cohort Program biobank.

NIH_Master_Logo_Vertical_2ColorThat made me think of a couple things. First, I remembered writing about the formation of Mayo Clinic Bioservices in 2014. It looks like that program is probably the core of this new project.

Next I wondered how $28.4 million a year or $142 million over five years measures up against Mayo Clinic's typical annual funding grants from NIH. Mayo Clinic has lots of money coming in from government contracts and grants from a variety of sources ranging from NIH to the Dept. of Defense.

Looking at just the NIH funding, this new grant is significant, but not not huge, in comparison to recent years.

Before this latest grant, NIH has already given Mayo Clinic $85.8 million in funding through 176 awards for 2016. The $28.4 million for this year will ramp it up to $114.2 million for 2016, which puts Mayo possibly on track for a record year. Here's the breakdown of Mayo's NIH grants in recent years.

• 2015 - 395 awards - $207.6 million

• 2014 - 401 awards - $201.2 million

• 2013 - 376 awards - $192.2 million

• 2012 - 380 awards - $205.2 million

• 2011 - 362 awards - $193.9 million

2016 - 176 awards - $85,878,422


May 20, 2016

Mayo Clinic Ventures looks to Israel for collaborations

Looking to help boost a variety of medical start-up businesses, Mayo Clinic Ventures is targeting collaborations and investments in Israel with a new program.

The goal of the Mayo Clinic Israeli Startup Initiative is to work with companies either through sponsored research grants or co-development.  

Flags"Co-development can include licensing of Mayo Clinic know-how or an investment," explained Timmeko Love, of Mayo Clinic Ventures. "It's about matching the right opportunities with Mayo Clinic know-how for collaboration. It's all about finding the right strategic fit."

Candidates for the Israeli Startup Initiative can include very early stage companies to ones that are much further along in development. They can work in any area of health care. 

"We're not limiting our options," Love said.

The project announced this week actually is a new phase of an existing Mayo Clinic initiative.

It has been active in Israel for about a year, partnering with the philanthropic Merage Institute. The California-based Merage Institute awards up to $150,000 in annual research grants for Israeli companies working with Mayo Clinic. The most recent recipient was EyeYon Medical, which makes a noninvasive medical device to treat corneal edema.

Mayo Clinic Ventures recently took on the Israel initiative and that has put co-development on the table. That new approach is being launched next week in Tel Aviv at IATI-Biomed, Israel’s largest life sciences and technology conference. Mayo teams will meet start-ups to study their technology, and then consider making investments or collaborations.

This is first time Mayo Clinic Ventures has focused on one whole country for business opportunities, despite its long history of international projects. Many might not be aware of it, but Israel is a logical candidate for a such a relationship.

"It's a natural next step for us," Love said.

Israel is considered to be the worldwide leader in innovation in medical devices, biopharma, software and other types of health-care businesses. The U.S imported $600 million of Israeli medical devices in 2011. In 2015, Israel housed 725 medical-devices businesses with an overall total of 1,380 life-sciences companies.

While California's Silicon Valley is known as the hottest spot in the world for business start-ups, Israel is recognized as a close second. A 2009 book, "Start-up Nation," documents how Israel, with a population of 7.1 million, generates more tech businesses than many much larger countries.

"It's kind of a national sport in Israel," said Guy David, a professor of health-care management at University of Pennsylvania’s Wharton School. He was born and raised in Israel and tracks its medical businesses closely.

David said Israel's required military service coupled with an environment that encourages questioning and taking risks is a big factor.

"Israel is hugely innovative. The innovative spirit starts at a very young age," he said.

While launching technology companies is a big focus in the country, the entrepreneurs all know the market for their products or services is elsewhere.

"There is no market in Israel. Israel is tiny," said David. "If they invent something, they know it has to be a global product."

Does that mean businesses partnering with Mayo Clinic could open offices or build facilities in Rochester?

"That certainly could be a possibility. We do look at an economic development when considering companies," said Love. "But it has to make sense for that company. There would need to be a business reason for it."


May 17, 2016

Mayo Clinic to take over Biobusiness Center floor as Celyad pulls out

Mayo Clinic is returning to the fifth floor of Rochester's Minnesota BioBusiness Center, after a Belgium-based biotech firm left it empty for more than a year. 

In March 2015, the Rochester City Council approved a five-year lease for Mayo Clinic-linked Celyad to take over the fifth floor to create a prototype manufacturing facility that would add 33 jobs to Rochester.

CelyadCelyad's lease meant displacing all the Mayo Clinic workers based on that floor. Mayo Clinic moved its employees out at the start of 2015.

However, the project didn't go as planned. Celyad, formerly known as Cardio3, was unhappy when development costs came in much higher than the estimate provided by the city. 

051509biobusinesscenteratnight"The budgets we got far exceeded initial assumptions on which the project was decided," said Celyad CEO Dr. Christian Homsy in an email from Belgium in November. "Including the city support, the fit-out cost now exceeds the cost to do the same work in other locations where there is no city or state support."

Celyad halted the project before any construction work was done, so the 14,963 square feet of space remained just as Mayo Clinic left it. However, the biotech company did uphold its end of the lease and has been paying rent of $22,444.50 per month, or $269,334 per year. City officials say the company has made all of the required payments.

Since the end of 2015, the city has been looking for a new tenant to take over the fifth floor. Now, the city has approved a new lease with an old tenant.

The new deal adds the fifth floor to Mayo Clinic's lease, which already includes four floors of the seven-year-old building. 

"The lease amendment would provide for a rental rate of $17 per square foot for the 'premises,' which consists of the entire fifth floor. That rate would be in effect for a term consistent with the present term for the other four floors through April 1, 2029," according to the agreement approved by the Rochester City Council on Monday. 

Mayo-clinic-logoThat's $1 less per square foot than the $18 per square foot Celyad has been paying.

Before approving the new Mayo Clinic lease, the city council OKed the termination of the Celyad agreement. It called for Celyad to continue paying its regular rent through Sept. 30, plus "a lease termination fee" of $111,549.18. 

That fee will cover costs for the space from October to Jan. 1. Mayo Clinic will be building out the space starting in October and it will began paying rent in January. Mayo Clinic plans on using the floor to help teams that need more room.

"Planned occupancy will include relocating certain research support teams in need of additional office type space," stated Kelley Luckstein, of Mayo Clinic Media Relation, in an email.

Celyad's relationship with Rochester began in 2007, when it licensed stem-cell research by Mayo Clinic's Dr. Andre Terzic and Dr. Atta Behfar. It was called Cardio3 Biosciences back then. They have collaborated for years on the cardiopoiesis technology the company uses to repair patients' hearts by re-programming their own stem cells to regenerate cardiac tissue. Mayo Clinic owned 2.69 percent of Celyad as of March 3, 2015.

Beyond the fifth floor prototype manufacturing facility, the Celyad deal was designed to clear the way for the biobusiness to possibly build a 100,000-square-foot manufacturing facility with 350 employees in Rochester. That's what the company anticipates it will need if the Federal Drug Administration gives it a green light to take its stem-cell treatment to market.

Celyad's Homsy says Rochester now is out of the running for that.

"Celyad has assessed that a manufacturing plant in Rochester at this point of time cannot be justified.  We have opened an office in Boston from where our U.S. management is based, but we have delayed the decision on a manufacturing plant in the U.S. as we are able to manufacture all clinical lots out of our Belgian facility. As we approach commercial launch in the U.S., this situation may be revisited," he responded from Belgium by email.

Though the relationship between Rochester and Celyad has diminished dramatically in recent months, Homsy said it is not completely over.

"We continue to collaborate with Mayo Clinic, as well as with Andre Terzic, in the context of the evaluation of our CHART-1 data that should be disclosed by end of June 2016. If the data is positive, further development in the U.S. in the form of CHART-2, and, potentially, commercialization would follow," he stated.

December 16, 2015

New Stewartville firm to collaborate with Mayo Clinic

A new medical device company launched by well-known local experts is joining forces with the top health care name in the region - Mayo Clinic.

Minnesota Medical Technologies, recently started by Jim and Philip Conway, announced this week that it will collaborate with Mayo Clinic in the development of new fecal incontinence products. As part of the deal, Mayo Clinic will have some ownership of Minnesota Medical Technologies.

5627967a5e7bd.imageThe Conways have experience working with Mayo Clinic at their former company, Rochester Medical, which made catheters and urinary incontinence products.

"We are pretty expert in fabricating and designing devices, but we can't pretend to experts in the medical field. That's why working with Mayo Clinic makes sense," said Jim Conway. "It's very likely when we get our first patents, a Mayo Clinic name will also be on it."

The Conway brothers, along with partners Lonnie Boe and Sarah Grinde, are building a 6,500-square-foot pilot manufacturing facility in Stewartville's Schumann Business Park. Jim Conway says the goal is to start using the building sometime in April with early prototype production starting soon after.

"We're shooting to get FDA approval by the end of 2016," he said.

Minnesota Medical is already working on the early groundwork to develop a dual U.S.-European market for these new products. Like when they entered the catheter field in 1989, the Conways see a lot of opportunity to develop better products in area where there is a lot of need.

Fecal incontinence affects an estimated 1 percent to 2 percent of the general population and 40 percent to 50 percent people living in long term care facilities. U.S. sales of fecal incontinence products is predicted to hit $1.9 billion by 2018. Minnesota Medical is targeting 10 percent of U.S. and international sales, a goal they hit with Rochester Medical and urinary incontinence.

Rochester Medical grew into a major international manufacturer with hundreds of local employees and more than $60 million in annual sales. In 2013, the Conways sold it to rival C.R. Baird for $262 million. They signed a five-year, non-compete agreement not to make urinary incontinence products.

December 09, 2015

Is Medisun's interest in Rochester cooling?

Of the three most expensive real estate listings for houses for sale in Rochester, two are owned by a Hong Kong billionaire who has not ever lived in them.

Danny Wong is the CEO of Medisun International Holdings Ltd., which is collaborating with Mayo Clinic to bring more Chinese patients to Rochester. Medisun also is a major investor in Celyad, formerly Cardio3, which is leasing an empty floor of the Minnesota Biobusiness Center in downtown Rochester.

734c36a08cc30596-4066082Wong purchased large Rochester residences at 615 10th Ave. SW and 2515 Crest Lane SW in the fall of 2014. He paid $1.3 million and $1.4 million, respectively. At the start of this year, Medisun announced a deal with Mayo Clinic.

"The medical service will be provided by Mayo, and everything else will be provided by Medisun," said then-Medisun spokesman Dr. Jason Zhang in January.

While in Rochester this summer, Wong had his photo taken at Mayo Clinic with local leaders, including developer Gus Chafoulias and Mayo's Lisa Clarke, who leads the Destination Medical Center initiative.

However, Medisun's interest in Rochester seems to have cooled a bit since then.

By summer, Medisun halted construction of a $1 million office on the west corner of Titan Development's H3 Plaza. The offices were slated to span part of the second and third floors of the building at 300 Broadway.

00e2d817d5550daa56a1d0ade5d78548l-m0oMayo Clinic commented at the time that Wong planned to use one of his two Rochester estates as a guest house for the Chinese patient venture. Construction to an indoor pool at 2515 Crest Lane SW began around that time.

That guest house project seems unlikely now, because Wong has listed both of his Rochester estates for sale. The 2515 Crest Lane SW house is priced at $1.7 million, and the 615 10th Ave. SW is listed at $1.4 million. If they sell at the list price, Wong will make $400,000 on his short-term investment.

Only one Rochester property currently is listed at a higher price — $2 million — than Wong's estates, according to the MLS listings. A total of 10 residences in Rochester currently are priced at more than $1 million.

Does the sale of these estates signal any changes in Medisun's relationship with Mayo Clinic? No one from Medisun was available for comment, but Mayo Clinic said nothing has changed.

"… We continue to work with the MediSun on specific engagements," stated Mayo Clinic spokeswoman Duska Anastasijevic by email Tuesday.

While those "engagements" continue to develop, there are two nice Rochester estates available for local home buyers.

October 01, 2015

A Mayo Clinic linked firm working with DMC planner to develop new Madison biosciences hub

A firm with deep ties to Mayo Clinic is making a move to anchor a downtown Madison, Wis., biosciences hub with help from the development manager of Rochester's Destination Medical Center initiative.

Exact Sciences Corp. licensed technology from Mayo Clinic in 2009 and 2012 for Cologuard, a stool-based DNA test for colorectal cancer. The test is based on research by Mayo Clinic's Dr. David A. Ahlquist and his laboratory.

LogoOriginally based in Boston, city officials at one point hoped Exact would move to Rochester. However, Madison gave the company $1 million to move its headquarters there in 2009.

Since then, the company has flourished, and now it's planning to build a new $200 million, 250,000-square-foot headquarters in downtown Madison with $46.7 million in financial aid from the city.The Madison City Council recently OKed the deal, which requires that Exact will have 400 employees in the building by 2019.

The developer of the project is JDS Development LLC, which is a joint venture between Hammes Co. and Majestic Realty. Hammes is the Wisconsin consultant that is in charge of DMC. It also is working directly with Mayo Clinic on the Discovery Square portion of the DMC project. Hammes also has been hired by the Rochester Convention and Visitors Bureau to do a feasibility study for the proposed hockey arena to house a possible US Hockey League team here.

Hammesco_blue_logoHammes' Exact development will include a 250 room hotel, a food court, health and wellness facility, conference and media centers and lots of room for retail and restaurants.

Exact CEO Kevin Conroy told the Madison City Council that, "We hope that by having a life science company headquarters in downtown Madison, it will spur economic development throughout the region and have a positive impact on downtown."

September 01, 2015

Celyad, Medisun collaborating on new China deal

Two international firms with deep Mayo Clinic and Rochester ties are joining forces for a new $22.4 million collaboration. 

Belgium-based Celyad, formerly called Cardio3, announced Monday it's entering into a new venture and distribution deal with its partner, Medisun International Limited, for its C-Cure cardiac treatment. C-Cure is based on stem-cell technology called cardiopoiesis licensed from Mayo Clinic.

CelyadBoth Celyad and the Hong Kong-based Medisun continue to collaborate with Mayo Clinic and both are in the process of creating facilities in Rochester.

This new 15-year agreement between Celyad and Medisun guarantees Celyad will "conduct all clinical development and undertake any regulatory steps necessary for market approval in China, Hong-Kong, Taiwan and Macau (collectively 'Greater China')," according to a news release about the venture.

Medisun will fund that push with a minimum of 20 million Euros, or $22.4 million. In addition to the funding cash, Celyad will collect royalties and profit sharing. The royalty rates, based on the total revenues from C-Cure, are expected to range from 10 percent to 30 percent. Profit-sharing amounts will be based on total revenues after royalties are taken out. The profit sharing is expected to range from 20 to 25 percent.

"We are pleased to have this new license agreement in place with our local partner Medisun, which give us full control over clinical developments in these territories, fully funded by our local partner. Pending receipt of necessary approvals, we look forward to giving access to this technology to patients in Greater China," stated Celyad CEO Christian Homsy in the release.

6a00d83451cc8269e201b8d0c98293970c-120wiCelyad is paying rent on the entire fifth floor, or 14,963 square feet, in the city of Rochester's Minnesota Biobusiness Center. The city signed a lease with Celyad earlier this year for it to develop a prototype manufacturing facility in the downtown building. Construction has been underway for months, but is not yet completed. The five-year lease calls for Celyad to pay a rent of $18 per square foot, or $22,444.50 per month. The city agreed in the lease to pay for $600,000 in equipment and improvements to the space.

Local officials hope to convince Celyad to build a 100,000-square-foot manufacturing facility with 350 employees in Rochester, according to officials at Rochester Area Economic Development Inc.  Celyad also has plans to build a U.S. headquarters in Boston.

The company recently reported a $17.04 million loss for the first half of 2015. It lost $18.1 million for the whole year in 2014, up from $15.9 million in losses in 2013. Dr. Homsy told Reuters last week the company has enough cash to make it through the end of 2017.

The company did an initial public stock offering in 2014, which yielded about $500,000 worth of shares for Mayo Clinic.

Medisun also is collaborating with Mayo Clinic on a project to bring more patients from China to Rochester for treatment. While Medisun began building a $1 million office in the H3 Plaza building in downtown Rochester earlier this year, it recently put an end to that project.

Mayo Clinic, however, has confirmed it still is working with Medisun. Mayo Clinic spokeswoman Duska Anastasijevic said she didn't believe "the scope and nature of the relationship has been impacted or altered, just the planned location of their offices has changed." 

She added that Mayo staff working with Medisun said the company will be using one of its Rochester homes as "a guest house" and headquarters for the project. Medisun CEO Danny Wong personally owns two houses in Rochester. He bought a house at 2515 Crest Lane SW for $1.4 million as well as one at 615 10th Ave. SW for $1.31 million. It is not known which property will serve as the guest house.