Aeras, Glaxo launching massive TB vaccine trial -- Gazette.Net


Aeras is taking its collaboration with GlaxoSmithKline on a new tuberculosis vaccine to the next level.

The Rockville nonprofit, which has worked with the British pharma giant for several years on the candidate, plans to launch a phase 2b proof-of-concept clinical trial in Kenya, India and South Africa next year, pending regulatory approval.

“This partnership signals our commitment to building innovative collaborations to develop and deliver new TB vaccines,” Aeras CEO James Connolly said in a statement. “We will never reverse the spread of the global TB epidemic without new vaccines as part of the solution.”

The new clinical trial, involving healthy adults ages 18 to 50, will be funded by both Aeras and Glaxo, according to Aeras spokeswoman Jamie Rosen.

It will test a vaccine candidate that contains Glaxo's proprietary M72 antigen and AS01E adjuvant. Early-stage trials showed the candidate has an acceptable safety and reactogenicity profile and demonstrated an immune response, according to Aeras' statement.

The trial will involve 7,000 subjects, a large number. Most clinical trials involve hundreds, not thousands of subjects. Why so many?

“Even though TB is a very prevalent disease, the incidence in any healthy study population is relatively low," Tom Evans, Aeras' chief scientific officer, said through Rosen. "Since we have no clear correlate of immunity, we have to vaccinate and wait for actual cases of TB to occur, which may range from 1 in 100 to 1 in 1,000 participants. This drives the large trial size."

Connolly said Glaxo's participation in the study is crucial.

“When considering the massive public health impact and costs to society of neglected diseases including tuberculosis, global financing for [research and development] remains critically low in this area,” Connolly said. “Working in partnership with GSK — sharing resources, capabilities and know-how — affords us the opportunity to conduct this pivotal, multicountry proof-of-concept trial, getting us that much closer to potentially one day having a TB vaccine that could protect adolescents and adults from one of the world’s deadliest infectious diseases.”

Worldwide, the lung disease kills 1.4 million people annually. The currently available vaccine protects against some forms of tuberculosis in babies, but not pulmonary TB, which causes most of the infections and deaths among teenagers and adults.

In other Maryland bioscience industry news:

MedImmune is teaming up with two cancer institutes to research immunotherapy in cancer, focusing on treatment combinations involving three monoclonal antibodies that the Gaithersburg biotech is developing.

Along with the Cancer Research Institute and the Ludwig Institute for Cancer Research, MedImmune will research a burgeoning field in cancer therapy: using the body's own immune system to recognize and attack cancer cells.

“We are just beginning to scratch the surface of the immune system’s potential as a new tool in cancer treatment,” Jonathan Skipper, executive director of technology development at the Ludwig Institute, said in a joint statement. “By identifying and evaluating new combinations of treatments, we aim to facilitate the development of a more powerful generation of smarter immunotherapy drugs to manage cancer patients’ disease over the long term.”

MedImmune will provide its experimental antibodies to the New York organizations, which will conduct trials involving them and other compounds. The MedImmune antibodies modify regulatory checkpoints of the immune system, and can increase the body’s immune response to cancer, according to the company. MedImmune — the biologics division of AstraZeneca — also will continue its original development plan for the three agents, now being studied in pre-clinical and clinical studies.

“This collaboration is an innovative way to advance immunologic therapies and uncover optimal treatments for patients with cancer,” Edward Bradley, senior vice president and head of MedImmune’s oncology innovative medicines unit, said in the statement. “By joining forces in the early stages of clinical development, MedImmune can leverage the extensive experience and synergy of these premier cancer research institutions to expand its portfolio of clinical-stage immune-active molecules.”

Novavax has started enrolling women in a phase 2 clinical trial of its respiratory syncytial virus vaccine candidate.

The Rockville biotech is collaborating with the global nonprofit Program for Appropriate Technology in Health, known as PATH, which is providing about $2 million to support the trial.

The trial will involve 330 women of childbearing age to study the protein nanoparticle candidate's vaccine and immunogenicity. The idea is to administer the vaccine to women, who would develop immunity against the childhood respiratory ailment and then pass it on to their fetuses.

"This study will be crucial for both the determination of the optimal dosing regimen for future studies and the potential adjuvant effect of aluminum phosphate, an adjuvant used in U.S. licensed products," Gregory Glenn, senior vice president and chief medical officer of Novavax, said in a statement. "Previous clinical and preclinical findings have suggested that immunization with our nanoparticle vaccine produces functional neutralizing antibodies to multiple sites on the F protein. We expect to report top-line results from this trial, through Day 56 observations, in the first quarter of 2013."

The disease causes about 160,000 deaths and 3.4 million hospital admissions annually, according to Novavax.

Gliknik has raised $4.83 million of a series B $15 million equity offering, according to the privately held Baltimore biotech's filing with the Securities and Exchange Commission.

The company, which develops treatments for cancer and immune-inflammatory disorders, said in a statement that it plans to use the cash to support development of its lead compound, GL-2045, which it is studying as a therapy for Myasthenia gravis, a neuromuscular disorder, and other neurological indications. Clinical studies are expected to start in about a year.

The 24 investors in this round were led by Baxter Ventures, an initiative created in 2011 by Baxter International.

"Baxter is the leader in immunoglobulin therapy and has a detailed understanding of [Gliknik's lead compound] and the potential benefits of ultimately having a recombinant version," Gliknik CEO David S. Block said in the statement. "With such a deep knowledge base, Baxter Ventures' investment in Gliknik is a real vote of confidence in our scientific approach."

In its filing, Gliknik listed revenues of up to $1 million.

DSM Nutritional Products of Columbia is teaming up with a French company to develop animal health vaccines using DSM's proprietary algal expression system.

Using microbial algae as a growth platform could produce vaccines faster and more efficiently, according to a DSM statement.

Under their agreement, Merial of Lyon, will provide research and development funding to DSM, which is also eligible for milestone payments, license fees and sales royalties.

"We are pleased to join with Merial on this important project that we expect will validate the algal expression system as a viable alternative to egg or cell culture-based vaccines, which would offer important benefits for animal vaccine production," Peter Nitze, president of DSM's nutritional lipids division, said in the statement.

If the collaboration is successful, the companies will, before commercialization, either sign a commercial supply agreement for production of the vaccine antigen or DSM will receive a technology transfer fee to convey the manufacturing rights to Merial, according to the statement.

Emergent BioSolutions has won a federal contract option to continue developing its next-generation anthrax vaccine candidate.

The Biomedical Advanced Research Development Authority exercised the option, part of its 2010 contract with Emergent, the Rockville biotech said in a statement.

“Emergent is pleased that PreviThrax ... has met all of the key milestones necessary for [the authority] to exercise the contract option,” Adam Havey, executive vice president, said in the statement.

Under the contract, Emergent said it has boosted the candidate's manufacturing yield by over fourfold; transferred the manufacturing process to its Baltimore plant; and showed the vaccine's stability for both liquid and dry formulations and at higher temperatures.

Arcion Therapeutics, Baltimore incubator company that develops topical pain treatments, reported raising $1.5 million from three investors in a mixed, indefinite offering, according to a regulatory filing.

The company focuses on therapies for chronic neuropathic pain.