Approximately 1.5 million women in the United States will be monitored for disease recurrence in 2015. The long dormancy and spontaneous re-growth of cancer cells presents a major challenge for monitoring breast cancer survivors. Current imaging methods to detect disease recurrence are expensive, carry a risk of radiation exposure and have limited detection sensitivity for small masses and micro-metastases. Additionally, current tests do not provide personalized information about mutations that cause resistance to therapy. The test being developed by Kailos and HCI is intended to improve outcomes through a sensitive, accurate and affordable blood test that measures ctDNA to detect breast cancer tumors earlier than imaging, and provide information about therapy resistance mutations.
“When academic and commercial organizations collaborate, we are able to see exciting advances in research be practically applied within the consumer and clinical space,” said Troy Moore, chief scientific officer at Kailos Genetics.
“We hope that the work we do as a result of this grant accelerates the translation of research discoveries into useful tools that improve cancer care,” stated Katherine Varley, PhD, investigator at Huntsman Cancer Institute and assistant professor in the Department of Oncological Sciences at the University of Utah. “This research has the potential to make a big difference in the lives of breast cancer patients and oncologists in the coming years.”
The research and development of the test will be structured as a five-year multi-site study. It will occur at both HCI facilities and Kailos’ commercial next-generation sequencing CLIA-certified laboratory to ensure accuracy and reproducibility.
Sanyal Biotechnology announced Tuesday that it has signed a lease to move its corporate headquarters to Virginia Beach, where it will occupy a 1,500-square-foot facility in the VABeachBio Accelerator at the Regional Health Professions Center at Tidewater Community College.
The Virginia Beach Development Authority also has awarded Sanyal Biotechnology a $25,000 Economic Development Investment Program grant.
The move will take place July 1 and is especially appealing to Sanyal Biotechnology because it recently set up a partnership with Eastern Virginia Medical School in Norfolk to house its product — mice.
“There was just no vivarium space available in Richmond — with private companies or with universities — that we could lease or use to raise mice and run medical studies on the mice,” said Rebecca Caffrey, Sanyal’s CEO.
The company’s business model is based on a type of lab mouse developed through selective breeding by Dr. Arun Sanyal while doing research on non-alcoholic steatohepatitis, or NASH, with Virginia Commonwealth University.
The mice have livers that operate very similarly to those of humans — they contract diseases like non-alcoholic fatty liver disease and NASH in response to a high-fat, high-sugar diet.
According to a news release, by 2025 about 25 million Americans are expected to contract NASH.
By testing their drugs on Sanyal’s mice, pharmaceutical companies may be able to better understand how their drugs could do in human trials and quicken the process by which they are approved by the U.S. Food and Drug Administration.
To take over its new 1,500-square-foot Virginia Beach space, Sanyal Biotechnology will be leaving 8,600 square feet in Chesterfield.
But Caffrey pointed out that most of that is warehouse space in which the company had planned to build out a lab and vivarium, which is specially designed for animal studies.
“But we don’t need to now because we have the deal with (Eastern Virginia Medical School),” she explained.
Additionally, she said Sanyal Biotechnology will be saving about $5,000 a month between rent and bills by moving into the Virginia Beach facility.
Caffrey said Virginia Beach is working to develop a biotechnology research park, “with great forethought.”
She explained that Virginia Beach offers the total ecosystem that Sanyal Biotechnology, as a startup, needs to continue its growth — investors, a supportive government and a labor force.
The company’s relationship with Richmond will not be entirely severed. Sanyal, who also is the company’s president and chief medical officer, will continue to work with VCU.
“By moving all the company’s research out of Richmond and down to Virginia Beach and EVMS, that creates a nice, clear, bright line between (Sanyal’s) academic work and the company’s work,” Caffrey said.
Its move to Virginia Beach is already paying off. Sanyal Biotechnology has several pharmaceutical companies lined up to tour its new facility in July and August.
“That’s normally what large (pharmaceutical) companies do before engaging your services,” Caffrey said. “We’re preparing for those inspections and, after that, we’ll see business begin to take off with those billion-dollar companies.”
Sanyal Biotechnology also is stoking its outreach to international clients. With help from the Virginia Economic Development Partnership, the startup recently translated its website into four additional languages — Spanish, German, Japanese and Italian.
“We’re really preparing to expand overseas and expand our reach,” Caffrey said.
That’s the $11,000 question being asked by Greensboro’s newest life science company, SoBran Bioscience, in partnership with the Piedmont Triad Office of the North Carolina Biotechnology Center.
As announced in February 2016, SoBran, a 500-employee privately held contract research organization headquartered in Fairfax, Va., has opened a new animal care and research facility in partnership with North Carolina Agricultural and Technical State University.
As part of the opening celebration, SoBran and NCBiotech are co-sponsoring the Innovation for Impact Prize contest for researchers at North Carolina academic institutions and emerging companies – those with fewer than 50 employees and annual revenue under $10 million.
Entrants have until October 1, 2016 to submit brief confidential descriptions of their research, how it will impact the world, and how the prize can help them reach a decision faster.
Judges from SoBran and the North Carolina Biotechnology Center will select the finalists based on their level of innovation and the potential impact of the research.
“We are most proud to have been so warmly welcomed into the North Carolina life sciences community and be able to provide support for your researchers,” said Amos Otis, SoBran’s founder, president and CEO, in announcing the innovation challenge.
The grand prize is $1,000 in cash and a free preclinical research study from SoBran valued up to $10,000. Four runners-up will each get $500 cash prizes. Winners will be announced at the NCBiotech-sponsored Triad BioNight this fall. Triad BioNight is a gala held every other year to celebrate the region’s life science sector growth.
“We are honored that SoBran has chosen to locate this important facility here on the north campus of Gateway University Research Park,” said Nancy Johnston, executive director of the NCBiotech Piedmont Triad Office. “This prize contest gives us a great opportunity to celebrate not only this new partnership, but also to spotlight some of the most exciting life science breakthroughs coming out of the Piedmont Triad and across the state. This competition has the potential to help identify and advance this novel research, recognizing and encouraging the commercialization of technologies that can benefit from access to a preclinical study.”
The “Value of Bioscience Innovation in Growing Jobs and Improving Quality of Life 2016” Report examines metrics including the number of employees and companies in the field, wages, academic research and development expenditures, patents, and venture capital investments.
The Alabama biotech report found:
The report was released at the BIO International Convention in San Francisco this month. An Alabama delegation including state bioscience leaders and company executives attended the conference, which is the biotech industry’s largest trade and networking event.
“The biotechnology and life sciences industries have proven their value in generating important innovations that improve quality of life and creating high paying jobs in our state,” said Ted Clem, director of Business Recruitment and Retention Office at the Alabama Department of Commerce.
“We are encouraged to see our work in the bioscience industry validated in this report and remain focused on bringing more bioscience companies and jobs to the state,” added Clem, who attended the conference in San Francisco.
POWER OF DISCOVERY
BioAlabama, an organization representing the industry in the state, said bioscience growth in the state is being driven by three key sectors: drugs and pharmaceuticals; medical devices and equipment; and research, testing, and medical laboratories.
BioAlabama noted that the TEConomy/BIO report pointed to several metro areas that ranked highly on important performance measures.
“This report demonstrates the growing importance of biotechnology to our state economy,” said Carter Wells, a BioAlabama board member and vice president for economic development at the HudsonAlpha Institute for Biotechnology.
“We will continue to foster that growth and build biotech in Alabama through discoveries at our research leaders — UAB, Auburn, Southern Research, USA, and HudsonAlpha, among others,” he added. “Those discoveries lead to new industry and new jobs.”
“The FDA approval of GONITRO™ enhances the treatment options available to the more than 8 million U.S. patients suffering with stable angina due to coronary artery disease (CAD), the most common type of heart disease,” commented Quang Pham, Founder and CEO of Espero Pharmaceuticals. “GONITRO™ is a sublingual nitrate and as this class of drug therapy is a Class I recommendation according to the 2012 Stable Ischemic Heart Disease (SIHD) Guidelines, it should be prescribed to all patients with known SIHD.”
“Short-acting nitrates are the current standard of care for acute relief of an angina attack. The novel features of a sublingual powder in a portable single dose packet make GONITROTM attractive to angina patients who need fast relief and want to continue to live an active lifestyle,” said Dr. A. Allen Seals, Fellow of the American College of Cardiology (FACC).
GONITROTM was approved by the FDA via the 505(b) regulatory pathway. Each individual packet of GONITROTM contains 400 mcg of nitroglycerin. The clinical data indicate that the sublingual absorption of nitroglycerin is higher following the administration of GONITROTM compared to Nitrolingual® Pumpspray (nitroglycerin lingual spray) which was launched in 1997 and is currently marketed by Espero in the U.S.
Espero will promote and distribute GONITRO™ nitroglycerin sublingual powder in the U.S. market under an exclusive licensing agreement with G. Pohl-Boskamp GmbH & Co. KG, (Pohl Boskamp), an established global leader in the short-acting nitrate market. The United States Patent and Trademark Office awarded Pohl Boskamp Patent No. 9,101,592 B2 for stabilized granules containing glyceryl trinitrate (GTN or nitroglycerin) in August 2015.
“GONITROTM is the first new dosage form in the short-acting nitrate category in nearly 20 years and we intend to educate healthcare providers and patients about our exciting new product immediately,” remarked Jeff Cole, President & CFO of Espero Pharmaceuticals.
Espero expects GONITROTM to be available in the second half of 2016 and will promote by its specialty sales force at launch.
XLRP is an inherited condition that causes progressive vision loss, beginning with night blindness in young boys followed by progressive constriction of the field of vision. Affected men become legally blind at an average of about 45 years of age. The most common form of XLRP is caused by mutations in the RPGR gene. Preclinical data indicate that treatment with a gene therapy product slowed the loss of visual function in canines with XLRP caused by mutations in the RPGR gene. XLRP is one of two lead development programs within AGTC’s collaboration agreement with Biogen, announced in July 2015, along with X-linked retinoschisis.
“Receiving orphan medicinal product designation from the EC for our XLRP gene therapy candidate is an important milestone for AGTC, and a positive step forward in our ongoing efforts to develop effective treatments for rare inherited retinal diseases,” said Sue Washer, President and CEO of AGTC. “With many of our programs in or nearing clinical trials, this is an exciting time for the company and patients affected with ocular diseases with no currently available treatments.”
AGTC has already been granted orphan drug designation from the EC and the U.S. Food and Drug Administration (FDA) for its gene therapy product candidates for the treatment of X-linked retinoschisis and for the treatment of achromatopsia caused by mutations in the CNGA3 and CNGB3 genes.
Orphan medicinal product designation is granted by the European Commission, following a positive opinion from the Committee for Orphan Medicinal Products (COMP), to a medicinal product that is intended for the diagnosis, prevention or treatment of a life-threatening or a chronically debilitating condition affecting not more than five in 10,000 persons in the European Community when the application for designation is submitted. An orphan designation allows a company to benefit from incentives from the European Union to develop a medicine for a rare disease, such as reduced fees and protection from competition once the medicine is placed on the market.
The terms of the licensing agreement include $200,000 in near-term cash payments, the potential for up to $1.0 million to pay for advancing U.S. Food and Drug Administration approval for LuViva, funding to secure Chinese regulatory approval of LuViva and a royalty payable to Guided Therapeutics on disposables sold in the territories. Shenghuo also has the right to manufacture the LuViva and disposables under certain conditions.
“We are pleased to be continuing with Shenghuo to open up this valuable market to LuViva,” said Gene Cartwright, CEO and President of Guided therapeutics. “The agreement also opens up the possibility to bring efficiencies to our manufacturing processes and provides funding for Chinese regulatory approval.”
China is the second largest medical device market in the world, according to the U.S. Department of Commerce. Approximately 390 million Chinese women are between 25 and 64 years old, the prime age for cervical cancer screening. Prior to commercial sales, LuViva would need approval from the Chinese Food and Drug Administration. The Company currently anticipates interim device and disposable sales for clinical study and demonstration purposes. In Hong Kong, the Company believes the time to commercial sales is quicker, with device registration, rather than approval required.
Worldwide, the market for cervical cancer screening and diagnostics, as currently practiced using cytology (Pap test) for primary screening, is estimated at $6 billion and is projected to grow to almost $9 billion by 2020. There are about 2.6 billion women aged 15 years and older who are at risk of developing cervical cancer worldwide.
About LuViva® Advanced Cervical Scan
LuViva is a technologically advanced diagnostic device that scans the cervix with light and uses spectroscopy to measure how light interacts with the cervical tissue. Spectroscopy identifies chemical and structural indicators of precancer that may be below the surface of the cervix or misdiagnosed as benign. This technique is called biophotonics. Unlike Pap, HPV tests or biopsies, LuViva does not require laboratory analysis or a tissue sample, and is designed to provide results immediately, which may result in eliminating costly, painful and unnecessary additional testing. LuViva is intended for use with women who have undergone initial screening and are called back for follow up with a colposcopy examination, which in many cases, involves taking a biopsy of the cervix. It has also been used in clinical studies in Turkey and Nigeria as a means to screen women for cervical cancer where the availability of infrastructure necessary for Pap and HPV testing is restricted. The device is used in conjunction with the LuViva® Cervical Guide single-use patient interface and calibration disposable.
The disease in focus is polycystic kidney disease (PKD) and, in particular, the more common autosomal dominant genetic form of PKD (ADPKD). DBM is seeking to establish single cyst-derived primary cultures from each diseased kidney, among other types of cultures. DBM is also establishing primary human cell cultures from normal kidneys and its specific regions and nephron segments. These tissue samples would otherwise be discarded. DBM will select cultures based on their genotype with regard to the genes affected in ADPKD, ideal growth properties in 3D and 2D culture, and other metrics. DBM will then seek to immortalize them for expansion for larger initiatives such as therapeutics discovery. Various platforms, products and services are already emerging from this effort in DBM laboratories and that will enter the marketplace for academia and industry quickly. For example, DBM has a novel method and media for establishing 3D cultures of ADPKD and normal kidney cells. Stem cell biology is not part of this effort. Please visit our newly redesigned website, www.discoverybiomed.com, for frequent updates, news items, and blog posts on these efforts and methodology.
As with many of DBM’s R&D initiatives, the company is collaborating with academic experts. Dr. Peter Harris, Director of a PKD Genotyping Core within the Mayo Clinic PKD Center funded by a P30 grant from the NIDDK, and Dr. Darren Wallace, a pioneer and world authority in the establishment of primary human cell cultures from both ADPKD and normal kidneys, are involved in this program. Dr. Wallace operates Cores within the Kansas University Medical Center funded by a separate P30 grant from the NIDDK and another funded by the PKD Research Foundation. These collaborations are essential to the program, and an excellent example of how the biotechnology industry and academia can collaborate. “Dr. Wallace’s laboratory has established these cultures for decades but his laboratory approaches these methods differently than we do,” explained DBM’s Chief Scientific Officer, Dr. Schwiebert. “So, we are sharing experiences and establishing best practices. His laboratory will also perform some bioassays comparing immortal to primary cells that DBM is not equipped to perform. Darren and I have collaborated for decades.” Dr. Schwiebert also explained that “Dr. Harris’ laboratory is interested in genotyping single cyst-derived cultures, because there is a hypothesis that a second somatic mutation or ‘hit’ may occur in single cysts that worsen the disease in addition to the germline mutation that afflicts a family or kindred. Genotyping each cyst-derived cell culture can answer this hypothesis. We have observed one such example to date but it is early days.” The genotyping laboratory at the Mayo Clinic will also sequence the genome of normal human kidney cell cultures because Dr. Harris is also interested in the types of and frequency of polymorphisms (changes in gene sequence that may not cause disease) in the normal population. This effort gauges the susceptibility of the two ADPKD disease genes to mutation.
This program is another example of DBM’s novel approaches to “humanize” our niche in the life sciences and biotechnology industry through innovative Human Cell Culture and Engineering, Human Cell-based Bioassay Development and Implementation, and Humanized Drug Discovery, Drug Development and Lead Therapeutic Asset Profiling. Please see our newly redesigned DBM website,www.discoverybiomed.com, for more information about the company, its scientific strategies and methods, and its products and services offerings.
Incyte (NASADQ: INCY), a Wilmington, Delaware-based biotech firm, will fund three new Moffitt research programs over three years. Specific financial details were not disclosed in a press release announcing the deal.
It’s the latest of several industry alliances for Moffitt, said Jarett Rieger, senior director of Moffitt’s Office of Innovation and Industry Alliances, and associate general counsel. Over the last couple of years, research collaborations with a variety of organizations have provided an aggregate $35 million to Moffitt, and have been responsible for creating more than 30 new jobs for scientists at the Tampa-based institution.
Learning more about the biology of cancer accelerates drug development and gets potential life-saving medications to patients more quickly.
Moffitt has had a longstanding relationship with Incyte, running clinical studies for the company’s drug candidates, and now is expanding that relationship to laboratory studies. Incyte will provide its pipeline drugs, those that have not yet gone to market, to Moffitt to carry out lab studies and translational research, to determine clear clinical applications.
Incyte, like many pharmaceutical and biotech firms, uses a number of academic institutions for clinical studies, but “very few academic institutions have large research collaborations for laboratory studies,” Rieger said. “Incyte is a premier pharmaceutical company in the area of hematological malignancies, which are liquid tumors, and that’s an area of strength at Moffitt. We have a lot of scientists that specialized in this area so it’s a natural fit.”
The Incyte-backed studies will look at myeloproliferative neoplasms, or a group of diseases of the bone marrow in which excess cells are produced. The studies also will look at mantle cell lymphoma, which is a type of non-Hodgkin’s lymphoma; diffuse large B-cell lymphoma, or a cancer of the type of blood cells responsible for producing antibodies; and chronic myelomonocytic leukemia.
Incyte, with $754 million in revenue in 2015, is the company that developed Jakafi, a medication to treat certain bone marrow disorders.
Its IPO of 7.2 million shares at $7 each is less than half of what it originally sought. According to the Wall Street Journal, the company originally planned to sell 4 million shares between $14 and $16 a share.
The Alpharetta, Ga.-based late stage biopharmaceutical company announced in January it would go public.
Clearside develops drug therapies to treat blinding diseases of the eye using a microinjector to reach diseased tissue.