Floreo Inc. Wins BioHealth Capital Region 4th Annual Crab Trap Competition

By | News | No Comments

– Winning company focused on learning solutions for those with Autism.

Other finalists presented innovative technologies related to Multiple Sclerosis, Spine Alignment, TBI and Oncolytic Immunotherapeutics 

Competition sponsored by Wilson Sonsini Goodrich & Rosati held during 2019 BioHealth Capital Region Forum –

Floreo 2019 crab trap image

Judges of the 2019 Crab Trap competition present Floreo Inc. CEO and Co-Founder, Vijay Ravindran their award 

ROCKVILLE, MARYLAND, April 9, 2018 – Floreo Inc., an early stage startup founded in 2016 which is leveraging the power of virtual reality to deliver immersive, fun, and affordable lessons for children and adults with autism spectrum disorder (ASD), was chosen from five finalists as the firm with the most commercial potential at the 4th Annual Crab Trap Competition. This year’s judges included industry leaders John Rubin of JP Morgan Private Bank, Charles J. Andres of Wilson Sonsino Goodrich & Rosati’s, Raghav Bhargava of New Enterprise Associates (NEA), Ethel Rubin of NIH/BHI, John Trainer of AstraZeneca, and Norm Marcus, MD. Of Sanderling Ventures.

The Judges were impressed with Floreo’s CEO and Co-Founder, Vijay Ravindran, presentation of his company’s technology which was inspired by his autistic son’s reaction to virtual reality. Floreo’s library of lessions are currently used in schools, therapy, and homes while providing a supervising adult the opportunity to monitor and track the learner’s progress. Floreo joins previous Crab Trap winners Galen Robotics (2018), LifeSprout (2017) and Sonavex (2016).

In addition to Floreo, the judges and 2019 BioHealth Capital Forum audience viewed presentations by  four other finalists – BeCareLinkBRAINBox SolutionsSpine Align, and Unleash Immuno Oncolytics. “Every year the Crab Trap competition has brought some of the most exciting science and technology to the BioHealth Capital Region Forum. Most people know somebody who has been impacted by challenges of Autism. The technology that Floreo has developed and is continuing to improve makes them a very worthy award winner.” said Richard Bendis, BHI President & CEO.  “The congratulate all the companies and presenters on their progress to date and wish them great success in the future.  The judges made clear this was a particularly competitive group of finalists.”

Founded by BioHealth Innovation, Inc. (BHI) and MedImmune (now AstraZeneca) in 2016, the Crab Trap Competition focuses on companies in therapeutics, diagnostics, medical devices, healthcare services, e-health, mobile health, electronic medical records, health informatics, and biohealth cyber security. The grand prize this year is $10,000 plus $10,000 worth of legal consultive services provided by Crab Trap Sponsor Wilson Sonsini.

About the BioHealth Capital Region

The BioHealth Capital Region (BHCR) consisting of Maryland, Virginia, and Washington, DC is the prominent BioHealth cluster in the Mid-Atlantic. The BHCR encompasses more than 800 life sciences companies, over 70 federal labs and world-class academic and research institutions. According to Genetic Engineering News in 2018, the BHCR is ranked 4th in Top Biopharma Clusters in the country. The BHCR brand represents collaboration among leading stakeholders with a collective goal to make the BHCR a top 3 biohealth cluster by 2023. http://www.biohealthcapital.com/

###

Media contacts:
Richard Bendis
Phone: 301-637-6439, e-mail: rbendis@biohealthinnovation.org

Johnson & Johnson Innovation and Children’s National Health System* to Launch JLABS @ Washington, DC at the new Children’s National Research and Innovation Campus in 2020

By | News | No Comments

WASHINGTON, April 9, 2019 /PRNewswire/ — Johnson & Johnson Innovation LLC and Children’s National Health System (Children’s National) today announced a collaboration to launch JLABS @ Washington, DC, a 32,000-square foot facility to be located at the new Children’s National Research and Innovation Campus in Washington, DC. This Children’s National expansion is set on a nearly 12-acre portion of the former Walter Reed Army Medical Center campus in the nation’s capital. The co-location of the Research and Innovation Campus with key partners in the areas of public health research, innovation and incubator space is critical to accelerating the translation of potential breakthrough discoveries into new treatments and technologies. The JLABS @ Washington, DC site will be open to pharmaceutical, medical device, consumer and health technology companies that are aiming to advance the development of new drugs, medical devices, precision diagnostics and health technologies, including applications in pediatrics.

This collaboration marks the second time Johnson & Johnson and Children’s National have teamed up to emphasize the importance of investing in the health and well-being of babies and children around the world. Through either sponsorship or membership, both entities founded Safe Kids Worldwide, a nonprofit organization aiming to help families and communities keep kids safe from injuries.

“The vision we pursued for this campus required a global innovation partner with a strong commitment to pediatric health and a clear understanding of the next big areas of opportunity for improving human health. We believe the JLABS model is exactly what is needed to help us drive discoveries that are then rapidly translated into new treatments and technologies,” said Kurt Newman, M.D., President and Chief Executive Officer, Children’s National.

Click here to read the entire press release.

MaxCyte® Launches ExPERT™ Family of Instruments, Providing a Unifying Technology Platform from Concept to Commercialization for the Next Generation of Cellular Therapies

By | News | No Comments

Gaithersburg, Maryland – April 8, 2019: MaxCyte, the global clinical-stage cell-based medicines and life sciences company, announced today the launch of the new ExPERT™ technology platform. This family of instruments – the ATx, STx and GTx – represents the next generation of the industry’s leading, clinically validated Flow Electroporation® technology for complex cellular engineering. With these additions to the product portfolio, MaxCyte continues its uncompromising focus on high performance cellular editing, while delivering feature enhancements that will enable customers to use a single unifying technology, from concept to commercialization.

“The ExPERT instrument family is the result of extensive customer research into feature design, functionality and performance that are considered critical to enabling the next generation of cellular therapies,” said Brad Calvin, Executive Vice President of Global Commercial Operations for MaxCyte. “Creating cellular editing platforms standardized on a single, scalable, high performance technology can assist the industry in accelerating timelines, reducing costs and achieving milestones critical to the translation of this promising new generation of cellular therapies.”

The ExPERT ATx, STx and GTx build on the solid technology foundation that has been the core of MaxCyte’s historical instrument platforms, which are broadly used by leading companies across the biopharmaceutical industry who are developing increasingly sophisticated biological and cellular-based therapeutics.

Click here for the entire press release.

Immunomic Therapeutics Presents Late-Breaking Preclinical Data on DNA Vaccine ITI-7000 at AACR 2019

By | News | No Comments

ROCKVILLE, Md.–(BUSINESS WIRE)–Apr 2, 2019–Immunomic Therapeutics, Inc. will present late-breaking preclinical data which shows that its’ investigational nucleic acid platform, UNITE, may enhance antitumor immunity when used in connection with its investigational DNA vaccine, ITI-7000. In preclinical studies, ITI-7000, an investigational DNA vaccine targeting ErbB2/HER2, demonstrated robust activation of known anti-tumor CD4 and CD8 cells in vivo and promoted tumor infiltration with activated CD8 T cells. These data will be presented at the American Association for Cancer Research (AACR) 2019 meeting in Atlanta, Georgia.

“There’s no doubt that DNA vaccines are attractive immunotherapies to treat cancer and infectious diseases. However, research in this field has been met with many challenges, one of the most complex being low levels of immunogenicity and the inability to provoke an immune response and demonstrate favorable clinical outcomes,” said Teri Heiland, Ph.D., Senior Vice President of Research and Development at Immunomic Therapeutics. “These late-breaking data at AACR suggest that our proprietary UNITE platform has the potential to enhance the immunogenicity of DNA vaccines by activating T cell responses and increasing tumor infiltration. We are highly encouraged by this data and look forward to continuing to advance ITI-7000 toward the clinic.”

In addition to observing activation of known anti-tumor CD4 and CD8 cells in vivo, Immunomic scientists observed the overexpression of PDL1 in the tumor microenvironment. This pathway has shown clinical relevance as a cancer immunotherapy target of the tumor microenvironment. PDL1 overexpression upregulated by ITI-7000 suggests that a combination of ITI-7000 with an anti-PD1/PDL1 therapy may increase the therapeutic potential of either agent on its own. This data also supports the prevailing belief in the immunotherapy community that cancer vaccination could synergize with anti PD1 and PDL1 and other immunotherapies, as well as support the viability of the UNITE platform as a means to do so. In summary, these findings support the potential of ITI-7000 as a cancer vaccine and highlight that UNITE, Immunomic’s nucleic acid platform, may have the potential to enhance immunity of investigational cancer therapies.

Click here to read the entire release.

Emmes-Supported Study Results in the First Pediatric Drug Labeling Change for 2019

By | Uncategorized | No Comments

ROCKVILLE, Md.April 2, 2019 /PRNewswire/ — Emmes today announced that it provided the data management support for a study, funded by the National Institutes of Health (NIH) and approved by the Food and Drug Administration (FDA), to safely use Acyclovir to treat infants infected with the Herpes Simplex Virus. Acyclovir, known by the brand name Zovirax, now includes recommended usage and dosage for newborns and infants up to three months of age on its label.

The Best Pharmaceuticals for Children Act (BPCA) mandates that NIH prioritize therapeutic areas in critical need for pediatric labeling, sponsor pediatric clinical trials, and submit the data to the FDA for consideration for labeling changes. The clinical trials are sponsored by the National Institute of Child Health and Human Development (NICHD), with the labeling reviews and approvals administered by the FDA.

In the NIH news release, Dr. Perdita Taylor-Zapata, BPCA program lead at NICHD, stated: “With this label change, healthcare providers have clear guidance on how to use and prescribe this drug for their youngest patients.”

Newborns can become infected with the virus during pregnancy, labor and delivery, or shortly after birth if the mother develops genital herpes near the end of her pregnancy. The Herpes Simplex Virus in newborns can cause death or long-term problems such as blindness and damage to the brain and other organs.

Emmes has served as a data coordinating center for the BPCA contract since August 2009. This entails study design, data management, regulatory support, pharmacovigilance, site monitoring, and statistical analyses.

Dr. Anne Lindblad, president and chief executive officer of Emmes, said, “This is one of our  largest contracts and one that our Emmes team is extremely proud to support. Our role as a data coordinating center is a critical step in the process to study drugs and therapies used for infants and children and determine whether drug labeling updates are needed.”

Click here to read the entire release.

CNBC: Global pharma giant AstraZeneca strikes $6.9 billion deal to expand cancer portfolio

By | News | No Comments

Another day, another deal in the health care space.

AstraZeneca has agreed to a $6.9 billion collaboration with Japanese drugmaker Daiichi Sankyo to bolster its oncology franchise. Rather than a full acquisition, it’s agreed to pay for the shared rights for a new cancer drug called DS-8201.

AstraZeneca plans to raise up to $3.5 billion through a share placing to fund the transaction as well as pay down debt. Analysts generally see the deal as a logical strategic move but note the equity raise may disappoint some investors.

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines. Oncology is one of their key strategic focus areas.

This transaction is intended to build specifically on their heritage in breast cancer as well as expand their treatment offering for other mutant tumors.

This is the first big strategic deal since Jose Baselga joined the company in January as the executive vice president for oncology research and development. Prior to joining the U.K.-based pharma giant, Baselga served as physician-in-chief at Memorial Sloan Kettering Cancer Center which became the leader in early-stage clinical trials for cancer therapies and diagnostic genetic sequencing. So this partnership sits firmly in his wheelhouse.

AstraZeneca CEO Pascal Soriot confirmed the company sees very strong synergy potential and financial rationale for this transaction during a conference call with investors.

Click here to read more via CNBC

Interview: Viela Bio Eyes BLA for Lead Asset Only One Year After Launch

By | News | No Comments

One year after spinning out from AstraZeneca’s MedImmuneViela Bio is already anticipating filing a Biologics License Application with the U.S. Food and Drug Administration (FDA) for its lead asset, inebilizumab.

Chief Executive Officer Bing Yao told BioSpace that the company plans to file the BLA in the middle of 2019 based off results from its Phase IIb pivotal trial of inebilizumab in neuromyelitis optica spectrum disorder (NMOSD). In January, the company reported positive results from the Phase IIb trial that patients who received inebilizumab in the trial saw a 77 percent decrease in the risk of developing NMOSD attack in patients receiving inebilizumab monotherapy compared to placebo. Secondary analysis showed a decrease in worsening of disability in patients receiving the drug, the company said. Safety and tolerability were acceptable and consistent with previous data.

Viela’s inebilizumab is a humanized monoclonal antibody that binds with high affinity to CD19, a protein expressed on a broad range of B cells, which includes antibody-secreting plasmablasts and plasma cells. After binding to CD19, these cells are rapidly depleted from the circulation, the company said.

NMOSD is a rare condition that affects the optic nerve and spinal cord in approximately five in 100,000 people. About 80 percent of patients with NMOSD have autoantibodies to a water channel protein dubbed aquaporin-4. Following the Phase IIb results, Jorn Drapa, Viela’s chief medical officer and head of R&D, said the study supported the hypothesis that CD19 expressing B cells including plasmablasts and plasma cells play a key role in the pathogenesis of NMOSD.

Click here to read more via Biospace

Takeda and HemoShear Therapeutics Extend Exclusive Drug Discovery Partnership in Liver Diseases

By | News | No Comments

HemoShear Therapeutics, LLC, a privately held biotechnology company, today announced an extension of its partnership with Takeda Pharmaceutical Company Limited to discover and develop additional novel therapeutics for liver diseases, including nonalcoholic steatohepatitis (NASH).

“We are excited that Takeda recognizes our unique ability to identify novel therapeutic approaches for liver fibrosis and NASH,” said Jim Powers, HemoShear’s CEO.  “We have an incredibly strong and productive relationship with Takeda and are happy to see our science drive their decision to expand our partnership.”

Under the terms of the original agreement, HemoShear received upfront payments and R&D funding, and Takeda received exclusive access to HemoShear’s proprietary disease modeling platform to discover and develop best-in-class therapeutics for specific liver diseases.  HemoShear was eligible to receive milestone payments of potentially $470 million and royalties. Further additional financial terms related to the extension of the partnership were not disclosed.

HemoShear’s partnership with Takeda has already generated several early drug discovery therapeutic targets.  These targets were shown in the HemoShear REVEAL-Tx™ platform to inhibit biological processes associated with inflammation and fibrosis that can lead to nonalcoholic steatohepatitis (NASH), cirrhosis, and liver cancer.  Furthermore, analysis using REVEAL-Tx™ suggests that inhibition of these targets demonstrates disease responses that are superior to established mechanisms of fibrosis currently being targeted by other companies in clinical trials.

“Our partnership with HemoShear has already borne fruit and we are enthusiastic about expanding the relationship,” said Gareth Hicks, Ph.D., head of GI Drug Discovery at Takeda.  “We are planning to advance novel drug targets identified and validated by HemoShear into our discovery pipeline and look forward to bringing new therapies to the clinic.”

Click here to read the entire press release

We’re not doing enough for our kids | Kurt Newman | TEDxTysons – YouTube

By | News | No Comments

It all begins at birth. That’s the starting point for Kurt Newman as he shares his poignant journey as a pediatric surgeon. Newman offers a new perspective for approaching the most chronic and debilitating health conditions. Against a backdrop of personal challenges and patients who overcame impossible odds, we learn to appreciate the importance of treating every child with early customized care, and an eye for the future.

 

Join our Mailing List