Ventria Bioscience

Nature Magazine: FDA grants first approval for plant-made pharmaceutical; Ventria Bioscience weighs in on significance for PMP industry.

jpmoran — Tue, 08 May 2012 20:53:09 +0000

Last week, the FDA gave its first-ever regulatory clearance for a plant-made pharmaceutical (PMP) product. As discussed in today’s article in Nature, this is an important development for the PMP industry not only because it opens a pathway for FDA approval, but also because it signals biotherapeutics developers that they should consider plants as an alternative, lower cost manufacturing system. Ventria Bioscience’s CEO is quoted in the article, and our lead therapeutic candidate VEN100 is shown in a chart showing plant-made pharmaceuticals in the pipeline.

>> Read the full article in Nature

Phase 2 Clinical Trial Results: VEN100 Reduces Antibiotic-Associated Diarrhea by 50% in High-Risk Patients

jpmoran — Wed, 04 Apr 2012 09:00:31 +0000

FORT COLLINS, Colo. – April 4, 2012 – Ventria Bioscience has announced the successful completion of a phase 2 clinical trial of its lead therapeutic candidate, VEN100. The study was conducted by a team of investigators from the Department of Epidemiology, Division of Infectious Diseases, and Division of Geriatric Medicine at Johns Hopkins University (Baltimore, Md.). The randomized, double-blind, placebo-controlled study tested the safety and tolerability of VEN100 and its ability to reduce the incidence of antibiotic-associated diarrhea (AAD) in high-risk patients. The results showed a 52 percent relative risk reduction (RRR) and a 47.9 percent absolute risk reduction (ARR) in the incidence of diarrhea in the placebo versus VEN100 treatment groups (92.3 vs. 44.4 percent, respectively; P = 0.023). Thus, patients treated with VEN100 concurrently with antibiotic treatment were at a significantly reduced risk of experiencing diarrhea compared to the participants in the control group (the odds ratio was 0.07 [95% CI, 0.001–0.97]). VEN100 was also found to be safe and well tolerated, with no observed adverse events in the study.

“The development of AAD presents serious health risks, especially for the 14 million patients currently taking antibiotics in U.S. hospitals and skilled nursing facilities,” said William B. Greenough III M.D., professor in the Division of Geriatric Medicine at Johns Hopkins University and the senior author on the study. “AAD is a significant cause of morbidity and death in this population, and we are currently without preventive options. A safe, new prophylaxis and treatment for AAD – especially one like VEN100, which is orally delivered and based on naturally occurring proteins – could have an important positive impact on patient care.”

AAD is a common adverse effect of broad-spectrum antibiotics, occurring in as many as 25 percent of patients taking these drugs. AAD can be mild in otherwise healthy adults but can become severe and life threatening in high-risk patients including elderly, immune-compromised, or otherwise vulnerable patient groups. While Clostridium difficile is a known etiologic agent for diarrhea, C difficile infection explains less than half of all AAD cases.

“Current medical strategies for treating AAD and C difficile involve administration of additional antibiotics,” said study author Michele Bellantoni, M.D., clinical director, Division of Geriatric Medicine and Gerontology at Johns Hopkins University. “These are not always effective and may contribute to the increase in antibiotic-resistant pathogens in health care settings. The results of our study suggest that VEN100, which contains recombinant human lactoferrin, may represent an interesting alternative approach to preventing and, perhaps, treating AAD.”

VEN100 is a product under development to reduce risk of AAD in high-risk patients taking antibiotics. Its active ingredient is recombinant human lactoferrin, an iron-binding glycoprotein first identified in human breast milk as a protein product of mammary epithelial cells. Endogenous lactoferrin is believed to promote healthy establishment of the infant gastrointestinal system and has multiple anti-inflammatory and antimicrobial properties believed to contribute to this effect. The recombinant form, VEN100, is produced by Ventria using its proprietary ExpressTec biomanufacturing platform. In a previous study, Ventria’s recombinant human lactoferrin was shown to reduce the duration of diarrhea in children when combined with another breast milk protein.

“The completion of this trial, along with the results of prior early-stage clinical efficacy and preclinical safety studies, paves the way for us to begin our pivotal phase 3 trial,” said Scott Deeter, chief executive officer at Ventria Bioscience. “These trials also provide important validation of our method for producing highly pure, therapeutically active recombinant proteins in a cost-effective manner, with high production yields that can reduce the current economic barriers to their routine use.”

The results of the phase 2 study were published in the Journal of Health, Population and Nutrition.* Thirty patients were enrolled in the randomized, double-blind, placebo-controlled study, testing eight weeks of human recombinant lactoferrin compared to the placebo for the prevention of AAD in long-term care patients.
*Complete reference: Laffan AM, McKenzie R, Forti J, Conklin D, Marcinko R, Shrestha R, Bellantoni M, Greenough WB. Lactoferrin for the prevention of post-antibiotic diarrhoea. J Health Popul Nutr. 2011;29(6):547-551.

About Ventria Bioscience
Ventria Bioscience develops, manufactures and markets biotherapeutics and products used in bioprocessing, regenerative medicine, cell culture media, and research and development. Ventria’s patented ExpressTec biomanufacturing technology enables the development of new and cost-effective biologic products.

# # #

Ventria Bioscience and EMD Millipore Announce Exclusive Global Supply and Marketing Agreement

jpmoran — Wed, 21 Mar 2012 15:35:30 +0000

Ventria to use ExpressTec to manufacture and supply animal component-free recombinant protein products

FORT COLLINS, Colo. – March 21, 2012 – Ventria Bioscience today announced an exclusive collaboration with EMD Millipore, the Life Science division of Merck KGaA of Germany, in which Ventria will manufacture and supply a recombinant protein to EMD Millipore. EMD Millipore will exclusively market and distribute this product, manufactured using Ventria’s ExpressTec system, to its customers on a global basis.

“Ventria’s ExpressTec biomanufacturing system provides a highly efficient source of non-animal origin recombinant products derived from plants,” said Morgan Norris, Head of Biopharm Materials and Technologies, EMD Millipore. “These products offer EMD Millipore the opportunity to expand its CellPrime™ line of non-animal origin products and provide customers with a wide range of solutions for biomanufacturing.”

ExpressTec enables large-scale, cost-effective production of high-quality recombinant protein and peptide products used as biotherapeutics, vaccines and as part of the biomanufacturing process. The recombinant material will be completely free of animal- or human-derived components, and meet EMD Millipore’s requirements for use in cGMP biomanufacturing.

“This collaboration with EMD Millipore, an industry leader in biomanufacturing, aligns Ventria’s recombinant protein manufacturing technology with EMD Millipore’s technical applications expertise and customer relationships in research, development and bioproduction,” said Randy Semadeni, Vice President Business Development for Ventria Bioscience. “We look forward to working with EMD Millipore on this and future endeavors to expand our offering of high quality animal component-free recombinant proteins.”

About Ventria Bioscience

Ventria Bioscience develops, manufactures and markets biotherapeutics, vaccines and products used in bioprocessing, regenerative medicine, cell culture media, and research and development. Ventria’s patented ExpressTec biomanufacturing technology enables the development of new and cost-effective biologic products. For more information visit www.Ventria.com.

About EMD Millipore

EMD Millipore is the Life Science division of Merck KGaA of Germany and offers a broad range of innovative, performance products, services and business relationships that enable our customers’ success in research, development and production of biotech and pharmaceutical drug therapies. Through dedicated collaboration on new scientific and engineering insights, and as one of the top three R&D investors in the Life Science Tools industry, EMD Millipore serves as a strategic partner to customers and helps advance the promise of life science.

Headquartered in Billerica, Massachusetts, the division has around 10,000 employees, operations in 67 countries and 2010 revenues of $2.2 billion. EMD Millipore is known as Merck Millipore outside of the U.S. and Canada.

###

Note: Merck KGaA or Merck shall mean Merck KGaA, Darmstadt, Germany.

Ventria Announces Presentation of Two Preclinical Safety Studies at 2012 Society of Toxicology

jpmoran — Wed, 14 Mar 2012 15:37:51 +0000

Results support IND submission and initiation of Phase 3 pivotal clinical trial for VEN100

FORT COLLINS, Colo. – March 14, 2012 – Ventria Bioscience has announced the results of two preclinical safety studies of its orally administered therapeutic candidate, VEN100 (recombinant human lactoferrin). The results were presented Wednesday, March 14th at the 2012 Society of Toxicology meeting in San Francisco, Calif.

The first study, conducted in a standard rat model of subchronic toxicity, showed no observed adverse affects at any dose level tested, after 4 weeks of oral administration. Based on the lack of toxicological findings, the authors concluded that the No Observed Effect Level (NOEL) of VEN100 was 2000 mg/kg/day, the highest dose level tested, and the limit dose for this species. The second study, conducted in a standard canine model, showed similar results, with a NOEL at the limit dose, 1000 mg/kg/day.

“The results of these two toxicology studies confirm previous work showing that VEN100 is safe and well tolerated,” said Dale E. Johnson, PharmD, PhD, DABT, an author on both studies. “They support the initiation of two pivotal Phase 3 clinical studies of VEN100, which investigate its ability to reduce incidence of antibiotic-associated diarrhea in hospitalized patients.”

Human lactoferrin is an iron-binding glycoprotein first identified in human breast milk as a protein product of mammary epithelial cells. Endogenous lactoferrin is believed to promote healthy establishment of the infant gastrointestinal system and has multiple functions responsible for this effect. The recombinant form, VEN100, is produced by Ventria using ExpressTec and is currently being tested for its ability to protect adult patients from the severe diarrhea that can accompany the use of broad-spectrum antibiotics.

About Ventria Bioscience

Ventria Bioscience develops, manufactures, and markets biotherapeutics and products used in bioprocessing, regenerative medicine, cell culture media, and research and development. Ventria’s patented ExpressTec biomanufacturing technology enables the development of new and cost-effective biologic products.

###

Ventria Bioscience Named as 2011’s “Rising Star” at Colorado Bioscience Association’s 9th Annual Industry Awards Dinner

jpmoran — Fri, 09 Dec 2011 21:06:57 +0000

FORT COLLINS, Colo. – December 9, 2011 – Ventria Bioscience announced today that it was honored as one of Colorado’s outstanding bioscience companies during an annual awards dinner hosted last night by the Colorado BioScience Association (CBSA). The CBSA’s annual awards program, which was held at the Downtown Denver Embassy Suites, showcases the significant achievements coming out of the state’s bioscience industry throughout the year.

“Our awards program recognizes and honors those individuals and companies making a significant difference to Colorado’s bioscience industry during the past year,” said Holli Reibel, CBSA President and CEO. “Each honoree joins a list of highly respected alums. We are very proud to announce this year’s winners and celebrate the successes of our industry.”

According to Reibel, Ventria Bioscience was selected for the Rising Star award in recognition of its work in commercializing recombinant proteins produced from a plant-based manufacturing system.

“We are deeply honored to be recognized by CBSA this year for the hard work and dedication of our team toward improving the availability and accessibility of life-saving recombinant medicines,” said Scott Deeter, CEO at Ventria. “We view the CBSA’s award as a challenge, and we have every intention of living up to that call.”

The 2010 Rising Star Award was given to Sharklet Technologies (Aurora, Colo.). Other honorees recognized at the 2011 event were:
• Lifetime Achievement Award: Brian, Greg and Jeff Baldwin, Baxa Corporation
• Company of the Year: LABS Inc.
• Volunteer of the Year: Timothy Rodell, M.D., President and CEO, GlobeImmune
• Educator of the Year: Melissa Reynolds, Ph.D., Assistant Professor of Chemistry, Colorado State University
• Business Partner of the Year: Ernst & Young
• Legislator of the Year: State Representative Cheri Gerou
• Chairman’s Award: Johnson & Johnson
• Chairman’s Award: U.S. Senator Michael Bennet

About Ventria Bioscience
Ventria Bioscience develops, manufactures and markets biotherapeutics and products used in bioprocessing, regenerative medicine, cell culture media, and research and development. Ventria’s patented ExpressTec biomanufacturing technology enables the development of new and cost-effective biologic products.

About the Colorado BioScience Association
The CBSA is a not-for-profit corporation providing services and support for Colorado’s growing biosciences industry. With more than 350 members, CBSA actively works to promote the growth of the industry by working for a better business environment, grow the state’s biotech workforce, fight for policies that support a strong bioscience industry in the state, and speak with a single voice on behalf of the industry. For more information, visit www.cobioscience.com.

# # #

Ventria Bioscience Receives Fast-Track SBIR Grant to Study VEN100 in Antibiotic Associated Diarrhea

jpmoran — Mon, 22 Aug 2011 21:15:26 +0000

$1.38 million, 3-year research grant will foster commercial development of preventive treatment for AAD

FORT COLLINS, Colo. – August 22, 2011 – Ventria Bioscience today announced that the Small Business Innovation Research Program (SBIR), Department of Health and Human Services, National Institutes of Health, National Institute on Aging has funded part of the company’s research program “Lactoferrin for the prevention of antibiotic-associated diarrhea (AAD) in adults.” The 3-year project was designed to refine protocols for production of the company’s lead therapeutic candidate, VEN100, and test its safety and efficacy in human clinical trials.

The current award signifies the successful completion of year 1 of the research project, the specific aim of which was to produce the recombinant protein, formulate it as VEN100 for use in a phase 3 clinical trial, and obtain Institutional Review Board approval for that trial. A phase 2 clinical trial testing VEN100’s safety and efficacy for the prevention of AAD has completed enrollment; results are expected to be published in 2012. The phase 2 clinical trial was conducted in partnership with researchers at Johns Hopkins University (Baltimore, Md.).

Patients treated with antibiotics frequently develop AAD. Because elderly adults are at higher risk for death from diarrhea than younger segments of the population, there is currently an urgent need for preventative treatments. VEN100’s active ingredient, recombinant human lactoferrin, is produced by Ventria using its proprietary ExpressTec biomanufacturing platform and has been previously shown to reduce the duration of diarrhea in children when combined with another breast milk protein.

“Based on prior results, our hope is that clinical trials will confirm that VEN100 can dramatically reduce the absolute incidence of AAD and shorten its duration in patients who do experience this condition,” said Ning Huang, Ph.D., Vice President of Research at Ventria Bioscience and the principal investigator on the grant.

Under the terms of the SBIR grant, Ventria Bioscience received approximately $540,000 for project year 1 (2010-2011). The new award will provide an additional $413,000 in funds for project year 2 (2011-2012). The award letter also recommended that Ventria be awarded $429,000 for project year 3 (2012-2013), subject to the availability of funds and satisfactory progress of the project.

“The outcomes of this project will not only provide the commercial foundation to launch VEN100 but will also lead to numerous societal benefits,” said Scott Deeter, CEO at Ventria Bioscience. “The availability of a new preventative treatment for AAD will significantly improve patient health, relieve the burden on caregivers, reduce the significant health care costs associated with managing AAD, and foster local economic development related to Ventria’s growth.”

# # #

Ventria Bioscience to Attend Annual BIO Conference

Ventria — Fri, 08 Jul 2011 23:00:24 +0000

Ventria will present ExpressTec at the Kansas Pavilion in the Exhibit Hall and will participate in BIO’s One-on-One Partnering Sessions.

June 23, 2011 – Ventria announced that Company representatives will attend the Annual BIO Convention in Washington DC, June 27^th-30^th, 2011. This is the largest international event for the biotechnology industry with over 15,000 attendees from 60 countries.

Ventria will be exhibiting as part of the Kansas Pavilion at booth number 4637 and will be participating in BIO’s One-on-One partnering sessions.

“Ventria is excited to be joining the biotech industry in Washington, DC. The innovative spirit of the biotech industry thrives when we collaborate and create win-win relationships that deliver better healthcare outcomes for patients around the world,” said Scott Deeter, President and CEO, Ventria Bioscience.

###

Ventria Bioscience Invited to Present ExpressTec at the 4th International Plant-Based Vaccines & Antibodies Conference

Ventria — Fri, 08 Jul 2011 22:57:53 +0000

ExpressTec is a plant-based manufacturing technology that enables safe, affordable, and sustainable production of biologics.

June 2, 2011 – Ventria Bioscience will showcase its ExpressTec^TM biomanufacturing technology at the 4^th International Plant-Based Vaccines & Antibodies (PBVA) Conference. Scott Deeter, President and CEO, will present “High Yielding and Scalable Plant-based Recombinant Protein Production in Monocots,” as part of the Facilities and Production plenary session on Friday, June 10^th, 2011. The PBVA conference provides an international forum for the medical, veterinary, and plant biotechnology research communities to discuss the current state-of-the art in plant-based biologics technology and research and development related to new product development.

At the conference, Ventria Bioscience will discuss its experience scaling up a plant-based cGMP manufacturing system to commercial scale exceeding 1,000 kilograms of recombinant protein. To accomplish this scale, Ventria employs its proprietary recombinant protein manufacturing technology called ExpressTec^TM. ExpressTec^TM provides a safe, affordable, and sustainable manufacturing platform that produces target protein yields more than ten times higher than alternative systems.

“Ventria is the first company to commercialize recombinant proteins derived from a plant-based manufacturing system and has proven this technology at large scale,” said Scott Deeter, President and CEO for Ventria Bioscience. “ExpressTec^TM achieves protein yields, cost-effectiveness and safety advantages that are the foundation of a portfolio of products that were previously not available to a global customer base.”

###

2010 – Protein Expr Purif

Ventria — Mon, 02 May 2011 18:27:36 +0000

Protein Expr Purif. 2010 Nov;74(1):69-79. Epub 2010 May 4.

Expression, purification, and characterization of recombinant human transferrin from rice.

Zhang D., Nandi S, Bryan P, Pettit S, Nguyen D, Santos MA, Huang N.

Transferrin is an essential ingredient used in cell culture media due to its crucial role in regulating cellular iron uptake, transport, and utilization. It is also a promising drug carrier used to increase a drug’s therapeutic index via the unique transferrin receptor-mediated endocytosis pathway. Due to the high risk of contamination with blood-borne pathogens from the use of human or animal plasma-derived transferrin, recombinant transferrin is preferred for use as a replacement for native transferrin. We expressed recombinant human transferrin in rice (Oryza sativa L.) at a high level of 1% seed dry weight (10 g/kg). The recombinant human transferrin was able to be extracted with saline buffers and then purified by a one step anion exchange chromatographic process to greater than 95% purity. The rice-derived recombinant human transferrin was shown to be not only structurally similar to the native human transferrin, but also functionally the same as native transferrin in terms of reversible iron binding and promoting cell growth and productivity. These results indicate that rice-derived recombinant human transferrin should be a safe and low cost alternative to human or animal plasma-derived transferrin for use in cell culture-based biopharmaceutical production of protein therapeutics and vaccines.

PubMed Link – Click Here

2010 – Protein Expression & Purification

Ventria — Sat, 12 Mar 2011 18:37:51 +0000

Protein Expr Purif. 2010 Nov;74(1):69-79. Epub 2010 May 4.

Expression, purification, and characterization of recombinant human transferrin from rice (Oryza sativa L.).

Zhang D, Nandi S, Bryan P, Pettit S, Nguyen D, Santos MA, Huang N.

PubMed Link – Click Here