More News

CEOs from two Maryland biotech heavyweights will be among the speakers headlining the sixth annual Mid-Atlantic Bio Conference, which kicks off with a reception Wednesday evening in North Bethesda.

H. Thomas Watkins of Rockville's Human Genome Sciences and Martine Rothblatt of United Therapeutics in Silver Spring are slated to speak in a plenary session Thursday moderated by Frederick Frank, vice chairman of investment banking advisers Peter J. Solomon Co. of New York. Frank is a member of the company's mergers and acquisitions group and co-leads its global pharmaceutical and life sciences practice.

The conference, which runs through Friday afternoon, is hosted by the Mid-Atlantic Venture Association, the Tech Council of Maryland/MdBio and the Virginia Biotechnology Association.

Although all industries have "taken a hit," the state's $2 billion bioscience industry has seen some improvement from a year ago in terms of public and private investment and is "emerging on the right side of the downturn," said Renée Winsky, executive director of the tech council.

The array of companies — including 15 from Maryland — that are scheduled to make pitches to potential investors reflects the industry's diversity in the region, she said.

The conference is an opportunity "for investors to see the latest and greatest coming from biotechs," Winsky said. It showcases the region to the national and global bioscience communities and provides local leaders some exposure, "right here in our backyard."

Besides Watkins and Rothblatt, other Maryland biotech CEOs featured at the conference include Rachel King of GlycoMimetics, Eric Richman of PharmAthene and Peter Keiner of Zyngenia, who will participate in a panel discussion titled, appropriately enough, "CEO War Stories: A Roundtable."

Participants in other panel talks include national industry leaders such as John Castellani, president and CEO of the Pharmaceutical Research and Manufacturers of America, and James C. Greenwood, president and CEO of the Biotechnology Industry Organization.

Organizers say they expect more than 800 national and international industry leaders, government representatives, executives, researchers, investors and entrepreneurs to attend this year's conference, which returns to Maryland for the first time since 2007. It again will be at the Montgomery County Conference Center, 5701 Marinelli Road. Information: midatlanticbio.org.

In other Maryland bioscience industry news:

MacroGenics of Rockville and its partner, Eli Lilly of Indianapolis, reported disappointing news Wednesday: A phase 3 clinical trial of its teplizumab treatment for recent-onset type 1 diabetes failed to meet its primary efficacy endpoint.

The Protege Data Monitoring Committee, comprising independent experts in the fields of diabetes and biostatistics, delivered the news after an analysis of one-year safety and efficacy data. The panel said the treatment didn't result in a significant reduction in daily insulin use.

"We will comply with the [committee's] recommendations," said Scott Koenig, MacroGenics CEO, in a statement. "We remain committed to discovering and developing novel biologics for the treatment of autoimmune disorders like type 1 diabetes."

The companies are suspending enrollment and dosing of patients in two other ongoing clinical trials of teplizumab in type 1 diabetes: another phase 3 trial and a phase 1b trial studying subcutaneous administration.

"The failure to meet the primary endpoint is obviously disappointing for the millions of people who live with and treat type 1 diabetes," said Gwen Krivi, vice president, product development, Lilly Diabetes, in the statement. "Lilly and MacroGenics will be considering all options for teplizumab in type 1 diabetes, as well as the impact of the [committee's] recommendations on other potential indications."

In type 1 diabetes, the body's immune system attacks and destroys the insulin-producing beta cells of the pancreas. Up to 3 million of the nearly 24 million Americans who have diabetes have type 1, according to company information.

rrand@gazette.net

Sucampo Pharmaceuticals of Bethesda and Abbott of Abbott Park, Ill., have applied to Japanese regulators for approval to market Amitiza to treat chronic idiopathic constipation.

Abbott Japan holds commercialization rights to the product in Japan. Under the companies' 2009 agreement, the new regulatory submission triggers a $5 million milestone payment from Abbott Japan to Sucampo.

The application includes the results of a phase 3 efficacy trial that involved 124 patients. The submission will be amended early next year with complete results from the trial, the companies said in a statement.

"We are pleased to have submitted the Japanese regulatory application for Amitiza, a first in class therapeutic. We will work diligently to achieve licensure in order to bring this potentially important new therapeutic tool to Japanese patients," Sucampo CEO Ryuji Ueno said in the statement.

Bethesda biotech Micromet reported the FDA has accepted its investigational new drug application for an antibody treatment for gastrointestinal cancer and its licensee, MedImmune of Gaithersburg, plans to begin a phase 1 clinical trial in the first half of next year.

Micromet is developing antibody treatments, including MT111, designed to direct a patient's T cells to target cancer cells that express carcinoembryonic antigen, a protein found on the surface of colorectal, esophageal and gastric cancers.

Under a 2003 contract, MedImmune is leading the development and commercialization of the treatment in the U.S. and outside of Europe, while Micromet is leading those efforts in Europe.

MedImmune's submission of the FDA application triggered a milestone payment to Micromet, the Bethesda company said in a statement.

"We are very pleased with the progress achieved under our collaboration with MedImmune and are excited to see the third BiTE antibody enter the clinic," said Micromet CEO Christian Itin in a statement.

Emergent BioSolutions of Rockville is one of three companies to win new federal grants to develop biodefense vaccines.

The National Institute of Allergy and Infectious Diseases is granting up to $68 million, depending on the products' developmental success, to help fund programs to prevent anthrax and dengue fever.

Emergent is working on a product that combines its currently licensed anthrax vaccine, BioThrax, with an adjuvant to improve its efficiency. The vaccine already has been tested in a phase 1 clinical trial. The new grant will help fund manufacturing, stability studies, assay validation and clinical trial preparation, after which phase 2 testing may begin.

Emergent has received an initial award of $9.1 million, with the total reaching $28.7 million during the next four years if clinical milestones are met.

The other recipient working on an anthrax vaccine is PaxVax of San Diego.

Meanwhile, Emergent reported the FDA has granted fast-track designation to its monoclonal antibody development program investigating AVP-21D9 for treating inhalational anthrax.

Emergent recently initiated a phase 1 clinical trial of the candidate, designed for post-exposure treatment. The trial, which involves 50 healthy volunteers, is studying the product's safety and pharmacokinetics.

Emergent also reported launching development and manufacturing operations in Singapore in a joint venture with Temasek Life Sciences Ventures called Epic Bio.

The facility will focus on developing, manufacturing and commercializing pandemic flu vaccines and treatments.

"... By broadening the scope of Emergent's Singapore operations, not only will it continue to make our present and future biodefense products available, but it will also provide support to the company's ongoing tuberculosis program, as well as explore manufacturing and business development opportunities in the region," Emergent CEO Fuad El-Hibri said in a statement.

Epic Bio plans to begin clinical manufacturing of a broad-spectrum flu vaccine candidate next year and to begin a clinical trial in 2012.

In other Emergent news, the company reported to the Securities and Exchange Commission it has settled two class-action lawsuits filed by stockholders of Trubion Pharmaceuticals, the Seattle biotech it agreed to acquire in August, for up to $135.5 million.

The suits, against Emergent, Trubion and Trubion's directors, claimed the directors "breached their fiduciary duties by conducting an unfair sale process and agreeing to an unfair price," abetted by management and Emergent.

The stockholders claimed the companies omitted certain material information from the proxy statement/prospectus concerning the deal. The companies reported settling the suits by making additional disclosures and agreeing to pay the plaintiffs' legal fees and costs up to $475,000.

Trubion stockholders are scheduled to vote on the acquisition on Thursday.

Paragon Bioservices, a contract research and manufacturing organization in Baltimore, reported winning a $5.0 million contract to help the Army Medical Research Institute for Infectious Diseases develop virus-like-particle vaccines against Ebola Zaire, Ebola Sudan and Marburg viruses.

Paragon is to develop a large-scale process suitable for future manufacturing, according to company information.

There are no vaccines or therapies for Ebola and Marburg viruses, which are potential biological warfare agents.

20/20 GeneSystems reported receiving two Small Business Innovation Research grants from the National Cancer Institute totaling almost $3 million to develop tests designed to help oncologists predict the effectiveness of targeted cancer therapies.

According to the Rockville company, more than 20 targeted therapies have been approved during the past 10 years but they usually help only some patients who receive them, wasting hundreds of millions of dollars.

20/20 received a $2.75 million phase 2 award to help develop a companion diagnostic called PredicTOR to predict tumor response to drugs that target, or are affected by, activation of the mTOR pathway. Among such drugs are Pfizer's Torisel and Novartis' Afinitor, both of which have been approved to treat kidney cancer.

The grant calls for matching funds from outside investors and non-federal organizations, which the company received from several private investors, plus $200,000 from the Maryland Biotechnology Center. "We congratulate 20/20 on winning the Bridge Award for their groundbreaking proposal in breast and kidney cancer diagnostics," Judith Britz, director of the biotech center, in a statement. "The [center] is proud to participate in the match for this award since it demonstrates the power of leveraging funds from both public and private sources."

20/20 also won a $200,000 phase 1 award to help develop a test to predict kidney tumor response to drugs, such as Pfizer's Sutent.

Both tests use 20/20's patented technology that allows for simultaneous detection of multiple biomarkers in a single tissue section. Last month 20/20 began offering the technology to industry and academic researchers under service contracts.

BioElectronics of Frederick is ramping up its marketing and distribution efforts in the U.K. for its new Allay menstrual pain therapy device.

The drug-free device delivers low-level energy pulses designed to reduce menstrual cramps, bloating and discomfort, and can be worn under clothing, according to company information. The launch of Allay in the U.K. will be supported by 60- and 90-second television commercials over four weeks, with the potential of reaching 95 percent of all U.K. households.

The FDA has awarded a total of $2.9 million to help fund six research projects for diagnosing, treating and preventing tuberculosis. The projects were selected from 30 applications.

Among the projects is one conducted by Michael Brennan of the nonprofit Aeras Global TB Vaccine Foundation in Rockville. Brennan is studying biological and immunological biomarkers for TB vaccines.

VIRxSYS of Gaithersburg reported two out of five monkeys immunized with its HIV vaccine candidate could "functionally cure," or fully control and suppress viral replication after they were exposed to a highly pathogenic simian immunodeficiency virus.

The vaccine was safely and repeatedly administered and was highly immunogenic with sustained immune responses, according to a company statement.

"We and HIV key opinion leaders are very optimistic about these long-term results showing viral suppression, protection of the immune system and survival in this prophylactic study," said Gary J. McGarrity, executive vice president of scientific and clinical affairs, in a statement.

A&G Pharmaceutical, which is developing personalized cancer treatments, has received a $1.2 million phase 2 Small Business Innovation Research grant from the National Cancer Institute to help fund its breast cancer program, the Columbia company reported.

"This grant will be enormously helpful as we continue to pursue development of a novel targeted breast cancer therapy based on this important cancer biomarker," CEO Ginette Serrero said in a statement. "This award recognizes the achievements we've made in advancing the development of a GP88 therapeutic antibody and the great potential it has demonstrated in preclinical studies to inhibit tumor growth in breast and lung cancers."

A&G also is developing companion diagnostic products that measure GP88 levels in patients' tissue and blood specimens. In ongoing prospective trials for the GP88 blood test, breast cancer patients have been found to have elevated levels of GP88.

GlycoMimetics of Gaithersburg reported the journal Blood has published preclinical data on the company's lead compound, GMI-1070, in a mouse model of sickle cell disease.

The article presents the data supporting testing of GMI-1070 in clinical trials to treat patients with vaso-occlusive crisis of sickle cell disease.

The paper "provides key support for the Company's clinical program in sickle cell disease, which is targeting treatment of vaso-occlusive crisis — the disease's main clinical feature," John Magnani, the company's chief scientific officer, said in a statement. "Currently, there are no mechanism-based therapies for treatment of vaso-occlusive crisis, which is a significant clinical problem."

A phase 2 clinical trial of GMI-1070 in sickle cell disease was launched in June.

Vaso-occlusive crisis often results in significant patient complications, and sometimes death, according to GlycoMimetics information. There are more than 75,000 hospitalizations annually per year associated with vaso-occlusive crisis in the U.S.

Akonni Biosystems of Frederick has won a $500,000 phase 3 grant from the National Institute of Justice to help develop its DNA system that could help law enforcement officials nab criminal suspects.

This new application, called human characteristic identification, is designed to deduce an unknown individual's physical appearance from trace or degraded DNA samples, such as blood, saliva, semen, bone, body oils or body parts. The physical traits revealed include eye, hair and skin color, plus more complex characteristics such as height, hair type and facial features.

"The implications of our system in the field of forensics [are] far reaching — it has the potential to provide law enforcement, crime scene investigators and homeland security officers with a new tool to more accurately and rapidly apprehend perpetrators, identify victims and reduce the backlog of cold cases," Phil Belgrader, vice president of research and development, said in the statement.

The FDA has indicated that, based on preclinical studies, Celsion has met regulatory requirements to submit its new drug application for ThermoDox to treat primary liver cancer, the Columbia company said in a statement.

The FDA previously granted fast-track designation for Celsion's 600-patient phase 3 clinical trial for ThermoDox, in combination with radiofrequency ablation.

"We are very pleased with the FDA's continued willingness to work closely with the Company to identify the most expeditious regulatory pathway forward for ThermoDox," CEO Michael H. Tardugno said in a statement.

ThermoDox is a heat-activated delivery method for doxorubicin, an approved and frequently used cancer drug. It allows high concentrations of doxorubicin to be deposited preferentially at the targeted tumor.

Spherix of Bethesda, which is developing its tagatose sweetener as a treatment for diabetes and to reduce triglycerides, closed on previously reported agreements to sell $5.25 million in stock and warrants in a registered offering to institutional investors.

Spherix also reported "statistically significant" results in a phase 3 study of tagatose in type 2 diabetes.

The data show the treatment was more effective in the U.S. population than in the Indian population.

"These are promising results and we are pleased with the significant drop in HbA1c levels among patients treated with D-tagatose," CEO Claire Kruger said in a statement. "We believe that further development in the Type 2 diabetes indication is merited, and we look forward to engaging a partner to continue this work."

Profectus BioSciences of Baltimore reported it has received $6.25 million grants and contracts from the National Institute of Allergy and Infectious Disease, including three Small Business Innovation grants totaling $2.9 million.

Profectus focuses on using the body's immune system to treat and prevent viral diseases and cancers through proprietary prime/boost vaccines.

The funding also includes $2.75 million in continued contracts from the Division of AIDS to develop the company's recombinant Vesicular Stomatitis Virus platform as an HIV vaccine.

Previously this month, the company reported receiving $4.4 million in grants to develop an HIV prophylactic vaccine, including a $3.1 million SBIR grant from the Division of AIDS.

EntreMed said it has received notice from the Nasdaq exchange that it now complies with its listing requirements.

The Rockville biotech, which develops cancer treatments, regained compliance with the exchange's requirement that it have a $35 million market value of listed securities.

Meanwhile, PharmAthene said that NYSE Amex officials have determined that the Annapolis biodefense company has "made a reasonable demonstration of its ability to regain compliance" with the exchange's listing requirements and granted an extension until Jan. 26, 2012, to demonstrate compliance.

In July, PharmAthene was warned that it failed to comply with minimum stockholder equity and/or operating result requirements. It submitted a compliance plan in August.

"We are extremely pleased by this decision and optimistic in our ability to satisfy the continued listing standards of the NYSE Amex by the end of the extension period," PharmAthene CEO Eric I. Richman said in a statement.

Qiagen and Abbott have agreed to work together on developing their automated molecular tests for HIV, human papillomavirus and hepatitis C.

The U.S. market for tests for HIV and hepatitis C ranges upward of $180 million annually, according to a statement from Qiagen, a Dutch biotech whose North American headquarters are in Germantown.

"The agreement is a good strategic fit," Qiagen CEO Peer Schatz said in a statement. "It has the potential to significantly accelerate our dissemination strategy for the QIAsymphony RGQ by expanding our molecular diagnostic menu offering in the United States with important testing options."

Regulators have given Neuralstem the green light to continue its study of using spinal cord stem cells to treat patients with amyotrophic lateral disease in a phase 1 trial at Emory University in Atlanta.

After the trial's safety monitoring board reviewed safety data from the first six nonambulatory patients in the study, it unanimously approved treating the next phase of ALS patients, all of whom will be ambulatory.

"We are pleased with the progress of the trial to date, and look forward to moving directly into more recently-diagnosed patients," said Eva Feldman, principal investigator of the trial and a consultant to the Rockville company, in a statement. Feldman is director of the A. Alfred Taubman Medical Research Institute and director of research of the ALS Clinic at the University of Michigan Health System.

"We are encouraged by the Board's approval to advance the trial to patients who have an earlier stage of the disease," company CEO Richard Garr said in the statement. "While the primary endpoint of the trial is safety, we also hope to see some secondary endpoints showing efficacy. We are grateful to the patients, and their families, for participating in this trial."

The trial, which started in January, is the first approved by the U.S. Food and Drug Administration for stem cells in ALS patients. It is to eventually involve up to 18 patients.

Sequella has agreed with Ludwig-Maximilians-University of Munich, Germany, to coordinate a European Union grant for phase 2 clinical trials of the Rockville biotech's SQ109 in adult pulmonary tuberculosis in seven sites in South Africa, Tanzania, Gabon and Zambia.

The multi-year trials, designed to support international regulatory submissions, will be performed by the Pan African Consortium for Evaluation of Antituberculosis Antibiotics. The studies will be funded by a $16.5 million grant by the European and Developing Countries Clinical Trials Partnership and a $4.1 million commitment by Sequella for in-kind and corporate funding.

"TB is a global health problem that will only be solved by international cooperation and focus on improvement in patient care," CEO Carol A. Nacy said in a statement.

Medifocus of Columbia has won two international patents, one to treat and prevent breast cancer and one to treat deep-seated tumors.

The first patent, previously granted in the U.S., is from Japan. This and other Medifocus patents are the foundation for the company's clinical breast cancer treatment system, which has received regulatory approval for a phase 3 trial in the U.S. and Canada.

The second patent, from the European Patent Office, also has been granted in the U.S. This patent will let the company develop more focused heat treatment systems for deep-seated lung, liver, ovarian, prostate and other tumors.

Medifocus' system targets and concentrates microwave energy to destroy cancer tumors without damaging healthy tissue when used alone or in conjunction with chemotherapy or radiation, according to company information.

The company also reported the University of Oklahoma Health Sciences Center's Institutional Review Board has granted final approval to conduct the phase 3 breast cancer treatment study at the university's Breast Institute in Oklahoma City.

The trial is designed to assess the safety and efficacy of the microwave technology, when used with chemotherapy, as measured by tumor shrinkage. The study is to involve 238 patients at six medical institutions in the U.S. and Canada. Medifocus expects similar approvals for the other five sites soon, with the study to begin by mid-2011.

STB Lifesaving Technologies of Rockville reported it has completed a successful pre-investigational new drug submission to the FDA for its lead product, the Fibrin Adhesive Stat.

The company has conducted successful animal studies for the dressing with both military and commercial partners and also is supported by published data from the American Red Cross, showing that the dressing is "functionally superior in significantly reducing blood loss," according to STB information.

"The FDA provided us with some very helpful and substantive comments," CEO Richard Moscarello said in a statement. "We have incorporated them and now are finalizing our development plan and partner relationships, so we can go forward with our ... filing as soon as possible."

Cytomedix of Gaithersburg reported securing about $13 million in current and future funding commitments from investors, led by agreements with Lincoln Park Capital Fund of Chicago.

"We are pleased by the commitment from Lincoln Park, a fundamentally oriented investor," CEO Martin P. Rosendale said in a statement. "We are under no obligation to utilize the facility, but plan to use any proceeds to support and accelerate the development of our regenerative therapies and to expand our marketing efforts."

Cytomedix develops regenerative therapies for wound care, inflammation and angiogenesis, the growth of new blood vessels.

Rexahn Pharmaceuticals of Rockville has published new preclinical data on the development of 3-aryl-1-isoquinolinamines in the European Journal & Medicinal Chemistry, showing they have "excellent cytotoxicity against eight different human cancer cells": breast, prostate, colon, ovary, kidney, pancreas, glioblastoma and melanoma.

"In this second published study, we further establish that isoquinolinamine derivatives, such as our anti-cancer compound RX-8243 — a new chemical entity — are potent anti-cancer compounds that have the potential to be developed into chemotherapeutic agents," said Rick Soni, president of Rexahn, in a statement.

BioServe of Beltsville has enlisted the Maine Medical Center of Portland to provide its tissue bank for the BioServe's biorepository.

The Maryland Stem Cell Research Commission is seeking requests for applications for funding through the Maryland Stem Cell Research Fund, which has an operational budget of $10.4 million for fiscal 2011.

The grants will fund basic and translational research with human stem cells of all types.

Projects leading to advances in regenerative medicine will receive highest priority, the commission said in a statement. A one-page letter of intent must be submitted by Nov.15, with applications due Jan. 13. Funding decisions are to be announced in April.

Information: mscrfinfo@marylandtedco.org.