The Centers for Disease Control and Prevention estimates between 700,000 to 1.4 million people in the United States have chronic Hepatitis B virus infections, with an estimated 20,000 new infections every year.
The research collaboration will include the design, construction and characterization of multiple vaccine candidates by combining the preS VLP technology from Georgia State and GeoVax’s MVA-VLP vaccine platform. Unique VLP design and functional assays developed by Dr. Ming Luo, professor in the Department of Chemistry at Georgia State, and performed in collaboration with Peking University Shenzhen Graduate School, will provide key information on vaccine effectiveness.
“My team’s efforts continue to unveil the molecular mechanism of immune responses to HBV infection and we are excited to partner with GeoVax to further the development of a Hepatitis B therapeutic vaccine,” said Dr. Luo. “Globally, chronic Hepatitis B affects more than 240 million people and contributes to nearly 686,000 deaths worldwide each year. By joining forces with GeoVax, we will apply our highly complementary sets of expertise in an effort to address the problem.”
The vaccine will be based upon generating the preS VLP using the GeoVax’s novel MVA-VLP vector platform, which has been proven safe in multiple human clinical trials of the company’s preventive HIV vaccine. This platform is also being used to develop preventive vaccines against Zika virus and hemorrhagic fever viruses, such as Ebola, Sudan, Marburg and Lassa.
“We are fortunate to have the collaboration with nearby Georgia State University and Dr. Ming Luo,” said Farshad Guirakhoo, chief scientific officer at GeoVax. “The combined technologies and already defined functional assays will serve to rapidly test this innovative concept.”
Deals of the Year are awarded to one or more companies or institutions for the most significant financial or commercial transactions closed from November 1, 2015-October 31, 2016. The recipients will receive their awards at the Georgia Bio Annual Awards Dinner January 26, 6 pm to 9 pm, at the Westin Atlanta Perimeter North. Now in its 19th year, the Georgia Bio annual awards dinner brings together industry leaders to advance the growth of the life sciences industry and foster strategic partnerships that can create a healthier world. Other leading companies, executives, researchers and dedicated individuals will receive Georgia Bio Awards at the dinner. Learn more and register at www.gabio.org/awards.
The recipients are: Alimera Sciences, Inc.; Arbor Pharmaceuticals, LLC; Axion BioSystems, Inc.; Clearside Biomedical, Inc.; and CryoLife, Inc.
Arbor Pharmaceuticals, LLC
In May 2016, Arbor Pharmaceuticals, LLC (“Arbor”) announced that it had signed a definitive agreement under which the company acquired XenoPort for $7.03 per share in cash, or a total equity value of approximately $467 million. As part of this acquisition, Arbor gained the commercialization rights to Horizant (gabapentin enacarbil) and a pipeline of products in late-stage development. Horizant is also being studied as a potential treatment for patients with alcohol use disorder through a collaboration with the National Institute on Alcohol Abuse and Alcoholism (NIAAA). Arbor is currently focused on the cardiovascular, hospital, pediatric, and neuroscience markets as well as generics through its Wilshire division. The company has over 700 employees including sales professionals promoting its products to physicians, hospitals and pharmacists. Arbor currently sells over twenty FDA approved products with over thirty more in development. For more information, visit www.arborpharma.com.
Headquartered in suburban Atlanta, Georgia, CryoLife is a leader in the manufacturing, processing, and distribution of implantable living tissues and medical devices used in cardiac surgical procedures. CryoLife markets and sells products in more than 80 countries worldwide. CryoLife is being honored for its January 2016 acquisition of On-X Life Technologies Holdings, an Austin, Texas-based, privately held mechanical heart valve company. For additional information about CryoLife, visit www.cryolife.com.
Axion BioSystems, Inc.
Axion BioSystems, a life science company located in Atlanta, GA, has developed the industry’s first high-throughput microelectrode array (MEA) product line. MEAs are used for the in-vitro investigation of networks of electrically active cells (e.g. neurons, cardiac cells, muscle cells etc.) for screening compounds, chemicals, toxins etc. When combined with modern cell culture technologies, Axion’s platform allows scientists to model human heart-beats and brain activity in a dish. Axion’s products are used by pharmaceutical and biotech companies, governmental agencies, and universities for drug safety, drug discovery, and disease modeling assays. In May 2016, Axion Biosystems closed a $6 million equity financing round which included funds from the Georgia Research Alliance Venture Fund. Funds will be used to grow Axion’s core life science instrumentation product line. For more information, visit https://www.axionbiosystems.com/.
Initial Public Offering & Private Financing
Clearside Biomedical, Inc.
Clearside Biomedical, Inc., headquartered in Alpharetta, GA, is a publicly traded, ophthalmic biopharmaceutical company that envisions a world without blindness. Clearside relentlessly pursues transformative, elegant, precise solutions to restore and preserve vision. Clearside is developing advanced clinical and pre-clinical candidates using a proprietary treatment approach offering unprecedented access to the back of the eye through the suprachoroidal space (SCS™). This offers potentially meaningful treatment benefit to patients suffering from sight threatening diseases like uveitis, retinal vein occlusion, diabetic macular edema and wet age-related macular degeneration. Clearside is being honored for the December 2015 closing of a $20 million Series C financing and the June 2016 announcement of the pricing of its initial public offering of 7,200,000 shares of its common stock at a public offering price of $7.00 per share. For more information, visit http://clearsidebio.com/.
Alimera Sciences, Inc.
Alimera Sciences, a pharmaceutical company located in Atlanta, Georgia that focuses on diseases affecting the back of the eye, or retina, closed on an underwritten public offering of its common stock in August of 2016 for gross proceeds of $26.5 million. For more information, visit http://www.alimerasciences.com/.
For a list of past Georgia Bio award recipients, click here.
Georgia Bio (www.gabio.org) is the state’s life science industry association whose members include pharmaceutical, biotechnology and medical device companies, medical centers, universities and research institutes, government groups and other business organizations involved in the development of life sciences related products and services.
“We welcome the backing of Novartis Venture Fund, Lilly Ventures, and Enso,” said Andrew Krouse, President and CEO of Cavion. “They bring a superior track record of success stemming from their deep pharmaceutical industry experience and understanding of the biotech marketplace.”
Cavion’s neurology compounds selectively target Cav3, which mediates thalamocortical dysrhythmia, a common pathophysiology of neurological diseases such as Essential Tremor, Parkinson’s Disease, Neuropathic Pain, and Epilepsy as well as orphan neuro-developmental and genetic disorders such as Angelman Syndrome and Dravet Syndrome. Cavion will conduct a robust proof-of-concept Phase 2 study of its Cav3 inhibitor CX-8998 in Essential Tremor as a prototype thalamocortical dysrhythmia disease later this year. Essential Tremor is the most common movement disorder, with over 10 million patients in the United States alone, yet available therapeutic options have limited efficacy and significant tolerability issues.
“Cavion’s compelling science and its Cav3 modulators offer a unique opportunity to develop effective therapies for patients with medical needs unmet in the neurological field,” stated Dr. Sergei Petukhov, Partner at Enso Ventures.
“In addition to movement disorders such as Essential Tremor and Parkinson’s Disease, other neurological diseases share a common pathophysiology driven by Cav3, including Neuropathic Pain, Angelman Syndrome and other rare genetic diseases,” noted Steven Hall, Ph.D., General Partner at Lilly Ventures. “We are eager to study the impact of CX-8998 on multiple neurological diseases.”
Cavion is also developing additional new chemical entities that inhibit the Cav3 channel for application across multiple therapeutic areas.
In connection with the financing, Drs. Steven Hall, Henry Skinner and Sergei Petukhov have joined the Cavion Board of Directors. CEO Andrew Krouse and Mr. David E. Gibson will also be members of the Board.
Ms. Natalie McNamee will represent Tarnagulla on the Board of Directors at JOT.
“This is a great step for JOT to get Tarnagulla as an investor. They made a very thorough due-diligence and started to act as a partner very early in the investment process. We would be hard pressed to find a better lead investor,” stated JOT Chairman & CEO, Christer Rosén.
Natalie McNamee is a board member at Jupiter Orphan Therapeutics. Natalie attended and obtained her Masters of Bioengineering from the University of California San Diego (UCSD). During graduate school, Ms. McNamee worked at Tocagen Inc, a gene therapy company, in business development. She then went on to work as a bioengineer at the newly formed start up Quanticel Pharmaceuticals specializing in cancer stem cell drug development. In 2015, Celgene Corporation acquired Quanticel for $485M. Natalie currently serves as a Director of the healthcare investment firm, Tarnagulla Ventures.
About Jupiter Orphan Therapeutics
Jupiter Orphan Therapeutics, Inc. (JOT) is a clinical stage specialty pharmaceutical company developing therapies for rare diseases linked to single gene deficiencies. JOT, a Delaware Corporation with its principal office located in Jupiter, FL, USA, was founded in the summer of 2015. In its short period of operations, JOT has assembled a very strong management and scientific team as well as defined five pipeline products which of one is already in Phase II.
CDC Director Tom Frieden hopes the center will develop techniques to stop the spread of diseases like Zika.
“Zika continues to be a threat to pregnant women. States, territories, and communities need this CDC funding to fight Zika and protect the next generation of Americans,” Frieden said in a news release.
The infection swept the Western Hemisphere this year, affecting more than 1,200 people in Florida and more than 33,600 people in Puerto Rico. Zika can cause mild-flu like symptoms in some, but is associated with severe birth defects in babies who contract the disease in utero. Zika is the most recent mosquito-borne disease to sweep the state, but it is not the only one: chikungunya, yellow fever, and dengue virus have taken root as well. The state’s warm climate, urban density, and residents’ travel patterns make Florida especially vulnerable to mosquito-born diseases. But lead researcher Rhoel Dinglasan at the University of Florida says these factors also make the state a ‘real-world laboratory’.
“Florida really is ground zero. We are the gateway for vector-borne diseases into the United States. But we have the research capability to stop them,” Dinglasan said in a written statement.
The research center will also help train public health experts and local mosquito control managers, in order to combat a shortage of workers.
The deals will help Moffitt’s efforts to lead the way in providing cutting-edge immunotherapies to cancer patients in Florida and beyond, James Mulé, associate center director of translational science at Moffitt, said in a press release.
Lion is a clinical-stage biotechnology company focused on the development and commercialization of novel cancer immunotherapy products.
The company signed a licensing deal with Moffitt in 2014.
On Wednesday, Lion said it has a new three-year sponsored research agreement and a clinical grant agreement with Moffitt.
The grant agreement will support an ongoing clinical trial at Moffitt that uses Lion’s therapy to treat patients with metastatic melanoma. The research agreement will focus on tumor-infiltrating lymphocyte technology, a way of leveraging the body’s natural defense against cancer.
Financial terms were not disclosed.
Lion also leases 8,673-square-feet in the University of South Florida Research Park in Tampa.
“We are thrilled with the level of enthusiasm in this oversubscribed round of funding and grateful for the backing from our new and existing investors,” said Kathy Lee-Sepsick, Femasys President and CEO. “Their financial investment enables us to conduct and complete the FemBloc clinical plan, which will support our planned premarket approval application (PMA), and ultimately, our vision of improving the lives of women by providing access to an ideal permanent contraception solution that is safe and highly effective for women in the U.S. and worldwide.”
Femasys also announced that it has gained U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval to launch a prospective, multi-center, clinical trial to evaluate the safety of the FemBloc permanent contraceptive system while preventing pregnancy. The clinical trial, which will enroll women who desire permanent birth control by occlusion of the fallopian tubes, will be the Company’s first trial to evaluate the complete FemBloc contraceptive system for its intended use.
“FemBloc is designed to fill the unmet need of a safe, permanent contraceptive method that can be easily implemented since it does not require specialized surgical skills or investment in costly surgical equipment,” said Mimi Zieman, M.D., Vice President of Clinical Affairs at Femasys and a board certified Ob/Gyn specializing in Family Planning. “This contrasts with current female sterilization options that have the inconvenience and risks associated with surgery and anesthesia for tubal ligation; and for hysteroscopic procedures – the challenge of placing the devices correctly, and concerns with long-term use.”
The new building will be named for its location, 800 Hudson Way, and will be “similar in look, feel and layout to 601 Genome Way, the main campus building,” the institute said. It will be the fourth building on the growing biotech campus in Huntsville’s Cummings Research Park. The campus now employs more than 700 people.
“This building marks progress for retaining and creating new life sciences jobs in Alabama,” Carter Wells, an institute vice president, said in a news release. “We greatly appreciate the support of Gov. Bentley, the State of Alabama and our many partners for making this new addition possible.”
“It wasn’t that long ago that Lonnie McMillian and I had this dream of bringing researchers, educators and entrepreneurs under one roof,” HudsonAlpha co-founder Jim Hudson said in the statement. “It is wonderful to be breaking ground on another building so that our dream can continue to grow.”
Conversant Bio, a longtime HudsonAlpha associate company, will be one of the first companies to move to the new building.
“When we joined the HudsonAlpha campus, we knew Conversant Bio would be at the heart of life sciences research,” said Marshall Schreeder, co-founder and CEO of Conversant Bio. “Being here has allowed the company to continue to grow and stay on the cutting-edge of research and connected to the needs of scientists around the world on a daily basis.”
Conversant Bio supplies human tissue and cell samples to researchers working to develop new medicines and diagnostic tools.
The ground breaking will be Dec. 13 at 10:30 a.m.