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  • Phase 1/2 clinical trial of COVID-19-Influenza combination vaccine candidate indicates vaccine is well-tolerated and immunogenic
  • Data from this combination trial will inform planned Phase 2 dose confirmation trial, scheduled to begin by the end of 2022
  • Immune response confirmed in stand-alone influenza vaccine and combination vaccine with potential path forward for both

GAITHERSBURG, Md., April 21, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced initial results from the Phase 1/2 clinical trial of its COVID-Influenza Combination Vaccine (CIC). The CIC combines Novavax' COVID-19 vaccine, NVX-CoV2373, and its quadrivalent influenza vaccine candidate. The CIC trial demonstrated that formulating the combination vaccine is feasible, well-tolerated and immunogenic.

"We continue to evaluate the dynamic public health landscape and believe there may be a need for recurrent boosters to fight both COVID-19 and seasonal influenza," said Gregory M. Glenn, M.D., President of Research and Development, Novavax. "We're encouraged by these data and the potential path forward for a combination COVID-19-influenza vaccine as well as stand-alone vaccines for influenza and COVID-19."

The safety and tolerability profile of the combination vaccine was consistent with the stand-alone NVX-CoV2373 and quadrivalent nanoparticle influenza vaccine reference formulations in the trial. The combination vaccine was found to be generally well tolerated. Serious adverse were rare and none were assessed as being related to the vaccine.

Open Mic Pitch Night  Event Cover  Final 2  2

Join ETC and Squadra Ventures on May 18, 2022 from 5:00 pm - 7:00 pm at Monument City Brewing for the second Open Mic Pitch Night!  This is an opportunity for the Baltimore community to embrace new technology and foster connections. This is where entrepreneurs can practice pitching their startup or idea to an audience and receive feedback from a group of like-minded peers, investors, and tech leaders in a safe space.

Pitches will be casual - no presentations - simply get up on stage and spend 2 minutes telling the audience about your company or idea. During the networking hour, audience members will have the opportunity to ask companies questions.

To apply to pitch; please fill out this form by Tuesday, May 17th, 2022 at 11:59 PM. After completing the form you will receive an email with instructions on what to expect, your pitch timeslot, and any other information you may need. If you have any questions, please contact Breonna Massey at This email address is being protected from spambots. You need JavaScript enabled to view it..

Happy hour drinks and light appetizers will be provided.

Click here to register.

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The Life Sciences Advisory Board added three new members, Ellington West of Sonavi Labs, Michael Weingarten of the National Cancer Institute, and GlaxoSmithKline’s KaShauna G. Rohlehr.

Ellington West West was tapped to serve as chief executive officer of Sonavi Labs in 2018. Along with Ian McLane, she is the co-founder of the Johns Hopkins startup digital stethoscope technology company. West was the founder of West Labs Research Group at Johns Hopkins where the company’s core Feelix technology was developed.

Image: https://biobuzz.io

Aurinia Pharma New

– Company seeks proposals to create and sustain community-focused programs to support underserved populations with these conditions –  

VICTORIA, British Columbia & ROCKVILLE, Md.--(BUSINESS WIRE)--Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) today, affirmed its commitment to individuals living with the systemic lupus erythematosus (SLE) and lupus nephritis (LN) through the sponsorship of charitable grants to establish or expand community-focused patient navigator programs. This is the second year of this unique program aimed at eliminating barriers to care for individuals living with SLE/LN. LN is a serious manifestation of SLE that can cause irreversible kidney damage and kidney failure and significantly affects more Black, Asian, and Hispanic individuals than non-Hispanic White individuals. Selected applicants may receive up to $50,000 over a one-year period.  

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April 19, 2022 12:00 UTC   -- Kite’s Global CAR T-Cell Therapy Manufacturing Network Increasing Capacity by 50% to Meet Patient Demand for New Cancer Therapies -- Scalable and Adaptable Facility Provides Flexibility for Current and Future Cell Therapy Innovation   SANTA MONICA, Calif.--(BUSINESS WIRE)-- Kite Pharma, a Gilead Company (Nasdaq: GILD), today announced the U.S. Food and Drug Administration (FDA) has approved commercial production at the company's new CAR T-cell therapy manufacturing facility in Frederick, Maryland. The site will produce Kite’s FDA approved CAR T-cell therapy used to treat blood cancer.  

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The new ARPA-H, an agency designed to fund moonshot health research, will fall under the umbrella of the National Institutes of Health.

Cities and states jockeying for position in the race for biotech dollars and talent have their sights set on a whale that comes along once in a generation.

When President Joe Biden announced last year that the federal government is launching a new outfit, the Advanced Research Projects Agency for Health, dedicated to funding moonshot tech research, he kicked off a new, high-stakes battle among municipalities that are eager to land the headquarters of a federal agency dedicated to advancing and funding cutting-edge research.

Image: Creative Commons The new ARPA-H, an agency designed to fund moonshot health research, will fall under the umbrella of the National Institutes of Health.

 

Join BLUE KNIGHT™ this June Accelerating preparedness together

Did you hear? Our second BLUE KNIGHT™ Symposium will take place June 9, 2022, and we’re excited to present your first chance to register! Tune in virtually from wherever you are around the world for a day of live programming. This year’s theme, The Power of Partnering to Accelerate Preparedness, aims to answer the questions startups have around accelerating innovations and earning a seat at the global preparedness table.

We echo that theme in today’s exclusive Q&A with Dr. David Boucher of ASPR and Dr. Karen Martins of BARDA, on the power of collaboration to build global resiliency toward health security threats. These experts share advice for early-stage companies and explore their experiences partnering to move "faster and better". Read more here.

 

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LEIDEN, The Netherlands, April 14, 2022 - MIMETAS, a global leader in organ-on-chip-based disease models, is a partner in the Oncode-PACT initiative that has been granted today an amount of €325 million by the Dutch National Growth Fund.

Oncode Institute will lead the Oncode-PACT consortium and its operations. With this investment, the consortium will develop cancer drug candidates faster and bring them to patients sooner. As a partner in Oncode-PACT, MIMETAS will develop the next generation of patient-specific cancer organoid models that include immune cells, blood vessels, and other essential cell types to drive novel cancer drug discovery and developm ent. Using these models, MIMETAS will screen compounds and targets using fully integrated, automatic phenotypic screening lines with AI data interpretation, bringing early validation and de-risking to the cancer drug development pipeline.

Image: https://www.mimetas.com

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Please join the inaugural webcast “Tell Me Something I Don’t Know,” hosted by Children’s National Hospital (CNH) Innovation Ventures and the National Capital Consortium for Pediatric Device Innovation (NCC-PDI). In this episode, we learn about the process of selecting novel technologies for implementation at CNH. Jennifer Yin, MSN, RN, CVAHP, hospital’s Value Analysis Clinical Program Manager, will engage in a fireside chat with Francesca Joseph, MD, FAAP, Pediatrician at CNH and co-Investigator of NCC-PDI. Jennifer and Francesca will provide a general understanding of the Value Analysis process and highlight topics most relevant to medical device innovators.

 

Maryland is Open for Business Make Your Move

A new 500,000 square-foot life science campus is being planned for Frederick County.

With two 100,000 square-foot research and development labs; two additional 145,000 square-foot production buildings; co-working space; conference rooms; and more, The Labs at Jefferson Tech Park will provide in demand, state-of-the-art space for life science companies looking to locate along the I-270 corridor.

The campus – which aims to be the “premier biodiscovery campus” in the county – is also expected to host numerous fitness and walking trails, outdoor green space, a cafe, and plenty of parking.

 

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Individuals from diverse backgrounds can provide unique and valuable contributions in the research and development of life science innovations that prevent disease, prolong life, and promote health. However, certain groups, such as women and individuals from racial/ethnic minoritized groups, remain underrepresented in the U.S. biomedical sciences and in life science entrepreneurship.

 

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Today, I am pleased to introduce the inaugural cohort of the NIH 21st Century Scholars Program—a new COSWD-sponsored initiative to promote awareness of the science of scientific workforce diversity. Six mentors and 13 cohort engagement participants from the NIH extramural scientific workforce were selected; together, they will build a vibrant, self-reinforcing culture of mentoring and support with a focus on diversity at the NIH.

 

Cursor and Home Office of Governor Larry Hogan

ANNAPOLIS, MD—Governor Larry Hogan today announced a new Maryland Cancer Moonshot Initiative to expand and accelerate cancer detection, screening, prevention, treatment, and research in the state. The state is committing $216 million in investments as a down payment to jumpstart this far-reaching initiative to save lives, including the first ever comprehensive cancer center in Prince George’s County.

Image: https://governor.maryland.gov/

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A Brisbane-based company that has targeted the premium end of the COVID home diagnosis boom has officially opened its 20,000-square-metre facility in the US, but its founder is now nervous about a potential flu pandemic as "vaccine weariness" sets in.

Ellume founder and CEO Sean Parsons tells Business News Australia the opening of the facility in Frederick, Maryland moves "moves us into pretty rarefied air" of companies that have massive capability for manufacturing tests for COVID and other viruses, at around 500,000 per day.

Cursor and Sector Report FINAL pdf

One of the most impactful moments I’ve witnessed working in the life sciences sector happened on the campus of Edwards Lifesciences last year.

Just months after having surgery, a patient met face to face with the team behind her heart valve replacement. She got to thank the people who built and inspected the very device now helping her heart function properly. They hugged, they clapped. For many of the Edwards team, it was the first time they were able to meet a patient whose life they changed.

It’s not often we see these moments up close – the ones where it’s so clear why we do what we do in the life sciences. This is what we do—deliver innovative solutions for healthier lives.

The Top European Biotech Investments in February 2022

Companies developing lab automation, ophthalmological treatments, and novel foods received Europe’s top biotech investments in February 2022.

European and Israeli biotech investments in February 2022 narrowly beat January’s performance. Life sciences companies in these regions bagged 52 private investments and initial public offerings (IPOs), worth €664M in total. Meanwhile, January’s tally was 41 deals totaling €660M. Neither month matched the biotech investment highs of December 2021.

Image: https://www.labiotech.eu

Ellume manufacturing rapid at home COVID 19 test kits in Maryland

FREDERICK, Md. — The first company to make rapid take-home COVID-19 tests is now making them in Maryland.

A few months ago, it was nearly impossible to find an at-home COVID-19 test in stores across Maryland. Now, store shelves are stocked with boxes of test kits from different brands.

But it's not just about COVID-19 at Ellume's manufacturing plant In Frederick. The large manufacturing facility was built to support the federal government's response to the current pandemic and future ones.

Hailed as a medical breakthrough a year ago, Ellume's COVID-19 at-home test kits are rolling off a state-of-the-art assembly line in Frederick, which held its grand opening Thursday.

Image: https://www-wbaltv-com.cdn.ampproject.org

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Life Sciences Business Strategist

BioHealth Innovation (BHI) is an innovation intermediary that facilitates the commercialization of emerging technologies in the BioHealth Capital Region (Maryland, DC and Virginia).  We are seeking a Life Sciences Business Strategist to join our team remotely.

The right candidate will be an energetic and continuous learner who is passionate about accelerating the adoption of new technologies to improve lives. The position is geared toward an early-career scientist (generally in their first 5-7 years after receiving their PhD) who wants to engage with the biohealth industry in new ways.  

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WASHINGTON, DC and ROCKVILLE, Md., March 28, 2022 – The Federal Laboratory Consortium (FLC) has entered into a strategic partnership with Rockville Economic Development, Inc. (REDI), based in Rockville, MD as part of an ongoing campaign to help local businesses and entrepreneurs with innovative technologies succeed through collaborations with federal laboratories.

The Rockville Economic Development, Inc. (REDI) was formed in 1997 as a public-private partnership (formerly known as the Greater Rockville Partnership) by the City of Rockville, Maryland, to build the city’s economic base through entrepreneurship, expansion, retention, and recruitment programs. REDI and the FLC signed a Memorandum of Understanding on March 22, 2022.

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The U.S. Senate confirmed Laurie Locascio, a former bioengineering professor at the University of Maryland, to helm the National Institute of Standards and Technology on Thursday.

Following Locascio’s nomination by President Joe Biden back in 2021, the Senate voted in her favor during an April 8 voice vote. Her nomination was first approved by the Senate Committee on Commerce, Science and Transportation before being sent to the floor for a final vote.

Image: J. STOUGHTON/NIST

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For months, some American and European leaders have foretold that the coronavirus pandemic would soon become endemic. Covid-19 would resolve into a disease that we learn to live with. According to several governors, it nearly has.

But we are still in the acute phase of the pandemic, and what endemic Covid might look like remains a mystery. Endemic diseases can take many forms, and we do not know yet where this two-year-old disease will fall among them.

Image: https://www.nytimes.com

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Modern Healthcare last week released its annual list of the "Top 25 Innovators," recognizing leaders who initiate and lead change in the health care industry.

Methodology For the list, Modern Healthcare accepted nominations from Nov. 22, 2021 to Jan. 31, 2022.

To be eligible, nominees had to be at the director level or higher within a provider organization—including a hospital, health system, clinic, or physician group—or an insurer. 

 

AmerisourceBergen United in our responsibility to create healthier futures

CONSHOHOCKEN, Pa.--(BUSINESS WIRE)--AmerisourceBergen, a global healthcare solutions company, today announced the establishment of AB Health Ventures, a dedicated corporate venture capital fund that will invest in and partner with emerging healthcare startup companies working to transform healthcare for people and animals globally. AB Health Ventures will build on AmerisourceBergen’s ongoing commitment to delivering innovation for its customers.

 

(L to R) Fearless' design director Jordan Watts; Exelon's principal product designer Chris-Anne Correa; Mindgrub's research and experience design director Shannon Hosmer; Christine Jackson, director of digital Strategy for the National Aquarium; and Solomon Scott, engineering lead, for The Washington Post, speak on a panel during the third annual Digital Transformation Summit.

The impacts of various ongoing developments, from the metaverse’s increasing prominence to the forthcoming gubernatorial shift, on Maryland’s tech economy were on the minds of attendees and panelists alike at last Thursday’s Digital Transformation Summit.

The Maryland Tech Council hosted its third iteration of the annual convention, in which the economic development group looks at the Maryland tech economy’s future, at the Maryland Jockey Club in Laurel.

Image: (L to R) Fearless' design director Jordan Watts; Exelon's principal product designer Chris-Anne Correa; Mindgrub's research and experience design director Shannon Hosmer; Christine Jackson, director of digital Strategy for the National Aquarium; and Solomon Scott, engineering lead, for The Washington Post, speak on a panel during the third annual Digital Transformation Summit. - https://technical.ly

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GERMANTOWN, Md., April 6, 2022 /PRNewswire/ — BiOneCure Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the IND for BIO-106, an antibody-drug conjugate (ADC) designed to target TROP-2 to treat a broad range of advanced solid tumors.

 The clinical study cleared by the FDA, known as StarBridge-1, is a Phase I/II, multicenter, open-label study to evaluate the safety, pharmacokinetics and preliminary anti-tumor activity of BIO-106 as monotherapy and in combination with pembrolizumab in patients with advanced cancers.

 

John Newby

John Newby is CEO of Virginia Bio, the nonprofit statewide trade association that serves and promotes the life sciences industry in the Commonwealth. VEDP Interim President and CEO Jason El Koubi spoke with Newby about recent life sciences success stories in the Commonwealth and Virginia Bio’s efforts to grow the industry, including the recently announced industry hub, Virginia Bio-Connect.

 

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TUSCON, AZ / ACCESSWIRE / April 5, 2022 / AURP, the leading nonprofit representing research parks, innovation districts and regional technology clusters, today announced a realignment of its executive team to optimize AURP’s continued success and global development strategies.

Vickie Palmer, current Director of Operations, has been appointed AURP CEO. Palmer assumes this executive leadership role following her 15 years of experience significantly expanding AURP’s membership and sponsorship community, plus overseeing AURP’s roster of events and programs. During her time with AURP, Palmer has led the organization’s membership, event management and overall operations while working closely with the organization’s CEO, Board of Directors and membership community.

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OLATHE, Kan., April 06, 2022--(BUSINESS WIRE)--Innara Health, the industry leader in feeding development for newborns and infants born prematurely is collaborating with Cardinal Health on the redesign of the NTrainer System. The next generation NTrainer will be smaller, more intuitive, and easier to integrate into NICU feeding protocols.

"We are thrilled to have a globally recognized organization like Cardinal Health support Innara and the NTrainer. Not only is this collaboration validating for our clients and our team, but it is also a clear indication of Cardinal Health’s commitment to improving clinical outcomes through innovation. We look forward to seeing their contributions toward providing preterm infants with their best opportunity to develop, grow, and thrive," stated Innara Health CEO Chris Mathia.

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Adaptive Phage Therapeutics, Inc., a Gaithersburg, MD-based clinical-stage biotechnology company dedicated to providing therapies to treat infectious diseases, raised $20m in further funding.

The AMR Action Fund has joined an existing $41m Series B round as a co-investor. The round was initiated in May 2021 and led by Deerfield Management Company, with participation from a second institutional investor and Mayo Clinic. Martin Heidecker, PhD, Chief Investment Officer of the AMR Action Fund, will join APT’s Board of Directors.

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Akan Biosciences

Three portfolio companies have graduated from the Germantown Innovation Center (GIC), Montgomery County's business incubator program. The County's incubator program started in 1999 to foster the growth and development of young technology companies. Akan Biosciences, Intelligent Fusion Technology and Seraxis are the three County-based companies graduating from the program this spring.

"Montgomery County continues to be the epicenter of bio health and information technology in the region," said County Executive Marc Elrich. "Congratulations to Akan Bio, Intelligent Fusion Technology, and Seraxis on their graduation from our incubator. We are excited for their continued growth in the County. Montgomery County is committed to having an economic development environment that fosters growth and entrepreneurship, and these graduates are just the most recent example of the great work happening in our incubators and throughout the County."

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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.

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GAITHERSBURG, Md., April 01, 2022 (GLOBE NEWSWIRE) -- Altimmune, Inc.,  (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that it has enrolled the first subject in the 48-week Phase 2 MOMENTUM trial evaluating the safety and efficacy of pemvidutide1 in subjects with obesity or overweight. Pemvidutide is a novel, investigational GLP-1/glucagon dual receptor agonist under development for the treatment of obesity and non-alcoholic steatohepatitis (NASH). The Company also today announced the completion of enrollment in its 12-week Phase 1b clinical trial of pemvidutide in subjects with non-alcoholic fatty liver disease (NAFLD).

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GAITHERSBURG, Md.--(BUSINESS WIRE)--Adaptive Phage Therapeutics, Inc. (“APT”), a clinical-stage biotechnology company dedicated to providing therapies to treat infectious diseases, today announced that the AMR Action Fund has joined an existing $41 million Series B round as a co-investor. The round was initiated in May 2021 and led by Deerfield Management Company, with participation from a second institutional investor and Mayo Clinic. Proceeds of the AMR Action Fund’s investment are primarily intended to support APT’s clinical trials to address substantial unmet patient needs in Prosthetic Joint Infection (PJI) and Diabetic Foot Osteomyelitis (DFO).

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Brian Coblitz, executive director of GW Technology Commercialization Office. (Maansi Srivastava/GW Today)

The Office of the Provost has appointed Brian Coblitz to be the new executive director of George Washington University’s Technology Commercialization Office (TCO).

TCO promotes and facilitates the transfer of technology developed at GW for the benefit of the university community and the public while leveraging GW resources by partnering with industry experts and entrepreneurs. Coblitz, who was previously interim director of the office and managed licensing for GW's life science technologies for nine years, has been with TCO since 2012.

Image: Brian Coblitz, executive director of GW Technology Commercialization Office. (Maansi Srivastava/GW Today) - https://gwtoday.gwu.edu