The announcement comes days after the Biden administration reached a deal to buy 3.2 million doses.

Image: Novavax has received emergency use authorization from the Food and Drug Administration for its two-dose Covid vaccine. MATTHEW FELDMAN

· Glioblastoma multiforme is one of the most complex, deadly and treatment-resistant cancer with a 5-year survival rate of 6.8% and an average length of survival of only 8 months *

· FDA ODD designation bolsters NeoImmuneTech's determination to accelerate the clinical development of NT-I7 as a potential new therapy for this difficult-to-treat cancer

ROCKVILLE, Md, July 13, 2022 /PRNewswire/ -- NeoImmuneTech, Inc. (NIT), a T cell-focused therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has granted NT-I7 (efineptakin alfa) (rhIL-7-hyFc) Orphan Drug Designation for the treatment of Glioblastoma Multiforme.

Despite decades of research, GBM remains one of the deadliest and hardest-to-treat cancers. More than 13,000 Americans are expected to be diagnosed with GBM in 2022.1 Standard treatments using surgery, radiation, TMZ and TTFs have failed to date to greatly improve survival, and there is no standard treatment for recurrence, which is inevitable. Also, among the multiple factors impacting the survival of GBM patients, the current treatment options expose patients to a severe and prolonged systemic lymphopenic state known as "treatment-related lymphopenia" (TRL). TRL is associated with shorter survival both in GBM and other solid tumors. With its potential to restore lymphocyte levels and subsequently reverse systemic lymphopenia, NT-I7 may offer promising ways to effectively treat GBM, if confirmed by its development program.

Jul 11, 2022

Agreement will provide the first protein-based vaccine option in the U.S., pending FDA Emergency Use Authorization and CDC recommendation GAITHERSBURG, Md., July 11, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced an agreement with the U.S. Department of Health and Human Services (HHS), in collaboration with the Department of Defense, to secure an initial 3.2 million doses of Novavax' COVID-19 vaccine (NVX-CoV2373) should it receive U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) and a recommendation from the Centers for Disease Control and Prevention (CDC). Novavax' protein-based vaccine will be made available for free to states, jurisdictions, federal pharmacy partners, and federally qualified health centers.

"We are pleased to come one step closer to potentially offering our vaccine to physicians, healthcare organizations, and consumers who have been awaiting a protein-based vaccine option," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "We are grateful for the U.S. government's ongoing support and partnership to bring Novavax' COVID-19 vaccine to the U.S., and we look forward to the FDA's decision on an emergency use authorization."

LG Chem to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform to accelerate the development of its T-cell therapy candidates for solid tumors

GAITHERSBURG, Md., July 12, 2022 (GLOBE NEWSWIRE) -- MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT), a leading commercial cell-engineering company focused on providing enabling platform technologies to advance innovative cell-based research as well as next-generation cell therapeutic discovery, development and commercialization, today announces the signing of a strategic platform license (SPL) with LG Chem Ltd., a globally diversified chemical company established in petrochemical, advanced materials and bio-technology, aiming to create new value for its customers based on science.

AmerisourceBergen, one of the top pharmaceutical distributors, is investing $150 million in a corporate venture fund focused on healthcare startups.

The wholesale giant's new VC fund, called AB Health Ventures, will initially look to invest in early to midstage health-related startups both in the U.S. and abroad. The fund will prioritize investments in startups focused on innovation in pharmacy and distribution, clinical development and commercialization of pharmaceuticals, practice solutions for healthcare providers and animal health, executives said in a press release.

WASHINGTON  –  To advance quantum network capabilities and leadership, the U.S. Naval Research Laboratory (NRL) announced work with five other U.S. Government agencies on May 18 to establish the Washington Metropolitan Quantum Network Research Consortium (DC-QNet) to create, demonstrate and operate a quantum network as a regional testbed.

Quantum networks, an emerging research frontier, will one day offer the ability to distribute and share quantum information securely among quantum computers, clusters of quantum sensors and related devices at regional and national distances. They can also be used to distribute ultra-precise time signals, and offer the potential to enable the creation of new applications not yet imagined.

Image: https://www.nrl.navy.mil/

A state's competitiveness in the innovation economy stems from the extent of its involvement in the global economy, its capacity for innovation, and its cultivation of a knowledge-based workforce. Massachusetts, California, Ontario, Maryland, and Washington rank highest among North American states in ITIF's index scoring subnational innovation competitiveness. Canadian provinces overrepresent among North America's most competitive states in the innovation economy. Ontario ranks third, British Columbia fourth, and Quebec nineth. Mexico's industrially intensive states are among its most innovative: Nuevo Leon, Baja California, Chihuahua, and Tamaulipas are some of the highest-ranking Mexican states. Cross-border innovation clusters are taking shape in the Pacific Northwest's life-sciences industry and in the next-generation automobile and semiconductor industries near the U.S.-Mexico border. Canadian, U.S., and Mexican states should leverage each other's comparative advantages in different phases of innovation in order to build North American global value chains that are cost-competitive with Asia.

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With the support of its homegrown Johns Hopkins Technology Ventures (JHTV), Baltimore’s oldest private university has helped many of its own students and faculty bring their technological innovations to market — and with wildly successful results. Now, JHTV has a new guide to make the process even easier for those within and beyond its namesake school’s community to understand.

Image:  Inside a Johns Hopkins Technology Ventures FastForward innovation hub. (Courtesy photo)

Kubanda Cryotherapy cofounder Bailey Surtees was building the foundation for her company as an undergraduate at Johns Hopkins University (JHU) before she knew it. In 2016, she was researching how to make breast cancer treatment more affordable and accessible for low- and middle-income countries. Surtees surmised that cryotherapy was the ideal solution because it doesn’t require a sterile operating room or anesthesia. Thus, she began developing a probe that could be used for this treatment.

Image:  The team behind TEDCO's Maryland Innovation Initiative. (Courtesy photo)

A $1.6 million grant has been awarded to the state of Maryland from the Economic Development Administration's American Rescue Plan.

The federal funding will go towards the Maryland Economic Adjustment Fund (MEAF), administered by the Maryland Department of Commerce, and will be used to assist underserved small businesses across the state.

The MEAF revolving loan fund will serve businesses that do not qualify for traditional financing or lending sources. According to the EDA, this investment could help create 250 new jobs and generate a private investment of $210,000 in Maryland.

GAITHERSBURG, Md. and MIAMI, July 07, 2022 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) announced today that it has entered into an agreement with Ridgeback Biotherapeutics (“Ridgeback Bio”), a biotechnology company focused on emerging infectious diseases, intended to create a collaboration to expand the availability of Ebanga™ (Ansuvimab-zykl). Under the terms of the contemplated collaboration, Emergent will be responsible for the manufacturing, sale, and distribution of Ebanga™ in the United States and Canada, and Ridgeback Bio will serve as the global access partner for Ebanga™, ensuring it remains available to patients in endemic countries free of charge through Ridgeback Bio’s compassionate use program. Ebanga™ was approved by the U.S. Food and Drug Administration (FDA) in December 2020 for the treatment of Ebola.

AMPEL BioSolutions' Precision Medicine Breakthrough AMPEL BioSolutions' Precision Medicine Breakthrough Predicts Drug Options with RNA Analytics & Machine Learning CHARLOTTESVILLE, Va., July 6, 2022 -- AMPEL BioSolutions today announces a breakthrough in precision and personalized medicine that could modernize the way doctors treat patients across a wide variety of diseases including autoimmunity, infectious disease and cancer.  Revealed at the Precision Medicine World Conference in Silicon Valley California, the first-in-class platform technology utilizes RNA analytics and machine learning to characterize an individual’s gene expression and provide clinical decision support to physicians for treatment options for their patients.  The technology, only a concept for the last few years, is being utilized to launch a portfolio of 10+ clinical tests over the next five years to provide decision support for diseases that affect more than 50 million Americans.

Currently reporting to the Vice President of Economic Development, the Senior Life Sciences BusinessCurrently reporting to the Vice President of Economic Development, the Senior Life Sciences BusinessStrategist evaluates the commercial potential of emerging technologies and provides recommendations ongo-to-market strategies.

This is a customer facing role with a focus on supporting clients in the development of commercial analysesand federal grant proposals.

The Senior Life Sciences Business Strategist also supervises junior Life Sciences Business Strategists andmanages consultants, as needed.

Click here for more information.

The recent BIO International Convention not only brought showcasing opportunities for the state and its unparalleled life sciences assets, but also several exciting announcements from Maryland-based companies.

Horizon Therapeutics, a global biotech business focused on addressing autoimmune and inflammatory diseases, is working on quadrupling its space in Montgomery County. The company currently has a new state-of-the-art lab under construction with completion planned for 2024. Horizon anticipates doubling its employees in Maryland, with room in the new facility for more than 200 scientists.

The Maryland Technology Development Corp. is searching for a firm to assess Maryland’s current economic development strategy and make recommendations to help shape the creation of a possible $500 million fund.

TEDCO issued a request for proposal (RFP) for firms to conduct the study earlier this week. The research will be used by TEDCO to help create draft legislation for the Maryland Equitech Growth Fund, which has a recommended minimum of $500 million worth of public investment over a 10-year period. The study is being done at the behest of the Maryland legislature, which called on TEDCO to create the report.

Image: TEDCO, led by CEO Troy LeMaile-Stovall, is searching for a firm to assess Maryland's current economic development strategy. TEDCO

The TABA Needs Assessment Report provides a third party, unbiased assessment of a Phase I project’s progress in technical and business areas that are critical to success in the competitive healthcare marketplace. There is no cost for this report and the time commitment for participation is minimal.

The Needs Assessment Report helps companies strategize for the project’s next steps. It analyzes the current state of your Phase I project and identifies strengths and weaknesses across four categories.

A new international partnership has formed between the state of Maryland and the Republic of Ireland.

As a result of Governor Hogan’s trade mission to France and Ireland, Maryland and the Guinness Enterprise Centre are teaming up to provide business assistance and expansion opportunities to companies at home and abroad. The partnership will also focus on academics and networking opportunities between the regions, by connecting local talent at universities to work directly with innovative start-ups.

Crab Trap 2022 applications are being accepted through August 31st! Entrepreneurs with innovative diagnostics, medical devices, therapeutics, or other transformative health solutions are invited to apply to the 7th annual BioHealth Capital Region Crab Trap pitch competition. Finalists for the 2022 Crab Trap competition will pitch IN PERSON on September 21st as part of the BioHealth Capital Region Investor Conference. The winning teams will receive cash prizes from our sponsors.

Applications are due by 5pm on Wednesday, August 31st. Crab Trap finalists will be notified the week of 9/5/22. Mandatory virtual pitch coaching for all finalists will take place the week of 9/12/22.

At his State of the Union speech in March, President Joe Biden urged Congress to fund a new federal agency that would “supercharge” breakthrough medical research and “end cancer as we know it.”

Congress responded two weeks later by approving $1 billion for the Advanced Research Projects Agency for Health, or ARPA-H, which will tackle projects that are seen as too costly, risky or time-intensive for the private sector and traditional public research.

In Maryland, research institutions, labs, pharmaceutical companies and biotech startups have long had a close, symbiotic relationship with the numerous federal health agencies already located here, but federal leaders and lawmakers think it might be time now for some distance.

Image: President Joe Biden speaks with researchers and patients about ARPA-H, a new health research agency that seeks to accelerate progress on curing cancer and other health innovations, on March 18 in the South Court Auditorium on the White House campus in Washington. (Patrick Semansky/AP)

GAITHERSBURG, Md., May 16, 2022 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (: EBS) announced today that it has entered into a definitive agreement with Chimerix, Inc. ( CMRX), to acquire Chimerix’s exclusive worldwide rights to TEMBEXA® (brincidofovir), the first antiviral approved by the U.S. Food and Drug Administration (FDA) for all age groups for the treatment of smallpox. TEMBEXA was approved in June 2021 and is indicated for the treatment of human smallpox disease in adult and pediatric patients, including neonates.

“The addition of TEMBEXA to Emergent’s portfolio of medical countermeasures builds upon our core capabilities and leverages our long and successful history partnering with the U.S. government to address dangerous public health threats,” said Robert G. Kramer, president and CEO of Emergent. “It exemplifies our thoughtful M&A strategy as part of our 2024 growth plan and positions us better to deliver value for our shareholders.”

GAITHERSBURG, Md., June 24, 2022 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) announced today that the U.S. Food and Drug Administration (FDA) accepted for review the Biologics License Application (BLA) for AV7909 (Anthrax Vaccine Adsorbed, Adjuvanted). AV7909 is the company’s new anthrax vaccine candidate evaluated for post-exposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis in persons 18 through 65 years of age when administered in conjunction with recommended antibacterial drugs. The Prescription Drug User Fee Act goal date for a decision by the FDA is in April 2023.

“Over the last 20 years, Emergent has partnered with the U.S. government to lead this program from early- to advanced-stage development,” said Kelly Warfield, senior vice president research and development at Emergent BioSolutions. “As we progress toward licensure of AV7909, which is designed to follow a two-dose immunization schedule and to elicit a faster immune response, we redouble our efforts to support the government’s overall preparedness and response strategy for large-scale emergencies involving anthrax and other threats to public health.”

The National Institutes of Health (NIH) is the world's largest public funder of biomedical research, investing more than $30 billion in taxpayer dollars. However, what is little known about the agency is that its technologies are available for licensing and collaboration, according to Michael Salgaller, PhD, supervisor of the technology analysis and marketing unit at the National Cancer Institute's (NCI) Technology Transfer Center.

The North American innovation ecosystem is increasingly diverse. In collaboration with Macdonald-Laurier Institute, Fundación IDEA, and the Bay Area Economic Council Institute, ITIF compiled this index to identify economic differences among states and provinces and highlight regions needing more federal attention, identify cross-national innovation performance, and track the continent’s overall competitiveness in the innovation-driven global economy.

NEW YORK, June 22, 2022 /PRNewswire/ -- Alexandria Real Estate Equities, Inc. (NYSE: ARE), an urban office REIT and the first, longest-tenured and pioneering owner, operator and developer uniquely focused on collaborative life science, agtech and technology campuses in AAA innovation cluster locations, today celebrates the grand opening of Alexandria LaunchLabs® at Columbia, which was created in a strategic collaboration with Columbia University. As the company's second LaunchLabs site in New York City, Alexandria LaunchLabs at Columbia builds upon the success of the flagship LaunchLabs site at the Alexandria Center® for Life Science – New York City, which reached its fifth anniversary this month. The grand opening event marks an important milestone for the unique and leading life science startup platform purpose-built to accelerate innovation and growth for promising early-stage companies. With over 10,000 diseases known to humankind and less than 10% currently addressable with therapies, Alexandria LaunchLabs at Columbia is playing an essential role in catalyzing the translation of scientific research emerging from Columbia University and other leading NYC academic and medical research institutions into treatments and cures to help meet humanity's massive unmet medical need and alleviate patient suffering.

Image: Alexandria LaunchLabs® at Columbia, located on the Columbia University Irving Medical Center campus. Courtesy of Alexandria Real Estate Equities, Inc.

Vaccitech’s VTP-300 induced sustained reductions of surface antigen in patients with chronic hepatitis B both as a monotherapy and in combination with a single low dose of anti-PD-1

VTP-300 as a monotherapy and in combination with a single administration of low-dose nivolumab was administered, with no treatment-related serious adverse events and infrequent transient transaminitis.

Meaningful, durable reductions of Hepatitis B surface antigen (HBsAg) were seen in some patients who received VTP-300 as either a monotherapy or in combination with a single low dose of nivolumab at the booster dose. Declines were most prominent in patients with lower baseline HBsAg.

All patients who received VTP-300 monotherapy or in combination with low-dose nivolumab and who had a HBsAg decline greater than 0.5 log[10] had durable reductions of HBsAg until the last measurement (up to eight months after last dose).

BETHESDA, Md., June 06, 2022 (GLOBE NEWSWIRE) -- Today, Aledade announced it has closed a $123 million Series E funding round to support investments in value-based care for more seniors covered by Medicare Advantage (MA) and innovation that improves patient care and increases medical cost savings, including expanded offerings through its new health services subsidiary, Aledade Care Solutions (ACS). Returning investor OMERS Growth Equity led the round, which also included Fidelity Management & Research Company and other current investors.

GAITHERSBURG, Md., June 21, 2022 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) announced today that two-year persistence data from its phase 2 clinical study evaluating the safety and immunogenicity of the company’s investigational chikungunya virus virus-like particle (CHIKV VLP) vaccine candidate were published in The Lancet Infectious Diseases. The article, Safety and immunogenicity of PXVX0317, an aluminum hydroxide-adjuvanted chikungunya virus-like particle vaccine: a randomised, double-blind, parallel-group, phase 2 trial, is available online.

“Emergent is pleased that results from our CHIKV VLP phase 2 study have been published and shared with the scientific community in The Lancet Infectious Diseases, a highly esteemed peer-reviewed journal,” said Chris Cabell, M.D., chief medical officer and SVP clinical development at Emergent BioSolutions. “Publication of this body of work highlights the importance of developing ways to address Chikungunya disease, a public health threat for which no vaccine or treatment exists.”

Summary of published results This randomized, double-blind, parallel-group, phase 2 study was conducted at three U.S. sites with 415 participants. Eligible participants were healthy CHIKV-naïve adults aged 18–45 years. The primary endpoint was the geometric mean titer of anti-CHIKV neutralizing antibody on day 57 (28 days after the last vaccination). Safety was also assessed.

Partnership to Support Emmes' Next Phase of Tech-Enabled Growth NEW YORK and ROCKVILLE, Md., June 21, 2022 /PRNewswire/ -- New Mountain Capital, a leading growth-oriented investment firm with more than $37 billion in assets under management and Emmes, a global, tech-enabled full-service clinical research organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that they have formed a partnership to support and accelerate Emmes' next phase of growth. Affiliates of New Mountain will acquire the ownership interest of Behrman Capital, the majority investor in Emmes since March 2019, and the ownership interests of Emmes' other investors. The transaction is expected to close in early July and terms were not disclosed. 

Emmes is a leading CRO that provides its clients with expertise in biostatistics, technologies and dedicated service required to manage clinical research studies with the highest standards of quality. The company sits at the intersection of the public and private healthcare sectors with clients including biopharmaceutical companies, government agencies, foundations, academic institutions and other non-profit organizations. Emmes is proud to support the research efforts of agencies such as the National Institutes of Health (NIH), Food and Drug Administration (FDA), Department of Defense (DOD), Department of Health and Human Services (HHS) and the Biomedical Advanced Research and Development Authority (BARDA). Emmes' five acquisitions since December 2020 have complemented the company's core operations in the greater Washington, D.C. area, Canada and India, while expanding its international presence throughout Europe.

The University System of Maryland this week approved a new pilot program to fund early-stage startups.

The measure, which was approved by the USM Board of Regents on Friday, will allocate $200,000 per year to the Early Capital Pilot fund over three years.

The program will be funded with money currently allocated for the Maryland Momentum Fund, a USM-run venture capital fund that began with $25 million in 2016. The Board of Regents recently authorized an additional $6 million over three years for the program.

Image: The University System of Maryland (USM) approved a new pilot program investing $200,000 a year in early stage startups. Jessica Iannetta/BBJ

These free 1:1 virtual sessions are an opportunity to discuss your company with experts in diagnostics, therapeutics, digital health and medical devices. If you’re a growth-stage biohealth company looking for unbiased advice on your pitch deck, commercialization strategy, evidence development or entrepreneurial challenges, our EIRs can help.

To sign-up for any of the EIR dates in 2022, please follow this link.

Treatment of Precursor Lesions Was Found to Significantly Reduce the Risk of Progression to Anal Cancer, with Study Result Highlighted in the New England Journal of Medicine

ROCKVILLE, Md., June 16, 2022 /PRNewswire/ -- Emmes, a global, full-service clinical research organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that a team of its researchers contributed to a successful AIDS Malignancy Consortium (AMC) study. Results of the study, which demonstrated that treating and removing anal cancer precursor lesions reduced the cancer risk for HIV-infected men and women, were published in the New England Journal of Medicine. The Phase 3 trial results included 4,446 participants at 21 clinical sites across the U.S. and Puerto Rico.

The study enrolled people living with HIV aged 35 years and older who had at least one precursor lesion for anal cancer, called high-grade squamous intraepithelial lesions (HSIL). Participants were randomized into two groups: those who received treatment for the lesion(s) and those who were actively monitored but did not receive treatment. Participants were re-evaluated every three to six months. Rates of progression to anal cancer were compared between the two groups. The findings showed that treating HSIL resulted in a nearly 60 percent reduction in anal cancer progression among people living with HIV.

WASHINGTON, D.C. – The Senate Health, Education, Labor and Pensions Committee today passed S. 4348, the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act. The legislation is the Senate's version of user fees reauthorization, including the Medical Device User Fee Amendments agreement (MDUFA V) between the medical technology industry and the FDA. The Senate committee action follows full House of Representatives passage of its version of the legislation last week. Scott Whitaker, president and CEO of AdvaMed, the world's largest trade association representing medical technology companies, made the following comment on the Senate committee work.

"A well-functioning user fee system is essential to help ensure FDA's timely review of innovative medical technology for patients. AdvaMed appreciates the timely work of each chamber of Congress to reauthorize this critical system with improvements to make the process better. MDUFA V has historic firsts, including provisions for greater accountability, predictability, consistency, and communication to increase patient access to safe, effective medical innovations.

Antimicrobial resistance (AMR) is named one of the top 10 global health threats facing humanity by the World Health Organization and was associated with nearly 5 million deaths in 2019. With a challenge of this magnitude, it’s critical to have visibility in the supply chain for antimicrobials—medicines used to prevent and treat infections that include antibiotics (also known as antibacterials), antifungals, antivirals and antiparasitics.