Enrollment has begun in an early-stage clinical trial evaluating bacteriophage therapy in adults with cystic fibrosis (CF) who carry Pseudomonas aeruginosa (P. aeruginosa) in their lungs. The trial is evaluating whether the bacteriophage, or “phage,” therapy is safe and able to reduce the amount of bacteria in the lungs of volunteers. The trial is being conducted by the Antibacterial Resistance Leadership Group (ARLG), funded by the National Institute of Allergy and Infectious Diseases. Investigators aim to enroll up to 72 adults at 16 CF centers across the United States.

AMPEL Biosolutions (AMPEL), located in Charlottesville, Virginia is a leading personalized precision medicine company developing tools that can help autoimmune and inflammatory disease patients improve their quality of life. AMPEL is one of the exciting companies that have emerged from the Charlottesville (CVille) biohub clustered around the University of Virginia (UVA).

Image: https://biobuzz.io

An Annapolis company that hopes to create a non-drug treatment for migraine and mood disorders has raised $4 million of a $7 million series A round.

The funding round will help Mi-Helper conduct clinical studies to get U.S. Food and Drug Administration clearance for its eponymous device. Mi-Helper has already gone through clinical studies at the Mayo Clinic, Michigan State University and Atrium Health and CEO Steve Schaefer plans for the device to hit the market in 2024. The company is planning to conduct a large at-home study to see if patients will be able to use the device at home instead of at a doctor’s office.

Image: CEO Steve Schaefer hopes Mi-Helper can provide a drug free treatment for migraines. Courtesy of Steve Schaefer

A throng of entrepreneurs, academics, developers and prominent life sciences players milled about two construction vehicles parked on a vacant, grass-covered lot at West Fayette Street and Martin Luther King Jr. Boulevard in West Baltimore Friday afternoon.

The crowd came to celebrate the start of construction on 4MLK, a project that has been in the works for nearly a decade and will eventually provide the local life sciences sector with badly needed wet lab space.

COLUMBIA, Md. (October 18, 2022)—TEDCO, Maryland’s economic engine for technology companies, announced today its Seed Funds invested $200,000 in CoolTech, LLC, a Maryland-based medical device start-up. TEDCO’s Seed Funds invest in early-stage, technology and life sciences companies and includes gap financing.

“CoolTech is leveraging its patented platform to develop novel therapies such as transnasal evaporative cooling for temperature management and thermodynamic neuromodulation for migraine and other pain disorders.  Without using drugs or chemicals, we drive results, with lower cost and virtually no side effects,” said CoolTech CEO, Steven Schaefer. “Thanks to TEDCO, we are tackling some of the most debilitating clinical conditions in the world.”

Without much fanfare, Congress recently passed legislation reauthorizing the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs and President Biden quickly signed it into law. The reauthorization of this critical program builds off of important pieces of recent economic legislation like the Inflation Reduction Act, the Bipartisan Infrastructure Law, and the American Rescue Plan. While many Americans, including small business owners and entrepreneurs, may not be aware of either of these U.S. Small Business Administration (SBA) efforts, their reauthorization is a big deal for innovation.

Image: 1982: President Ronald Reagan, surrounded by Rep. John LaFalce, D-N.Y., and Sen. Warren Rudman, R-N.H., after signing the Small Business Innovation Development Act into law in the Rose Garden. - BETTMANN ARCHIVE

FOSTER CITY, Calif. & ROCKVILLE, Md.--(BUSINESS WIRE)--Gilead Sciences, Inc. (NASDAQ: GILD) and MacroGenics (NASDAQ: MGNX) today announced an exclusive option and collaboration agreement to develop MGD024, an investigational, bispecific antibody that binds CD123 and CD3 using MacroGenics’ DART® platform, and two additional bispecific research programs. The collaboration agreement grants Gilead the option to license MGD024, a potential treatment for certain blood cancers, including acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).

A leader in the bispecific antibody space, MacroGenics has extensive experience applying its proprietary DART platform to develop novel therapeutics. MGD024 is a next-generation, bispecific that incorporates a CD3 component that is designed to minimize cytokine-release syndrome (CRS), a potentially life-threatening toxicity, while increasing the magnitude of antitumor activity with a longer half-life to permit intermittent dosing.

Neuroene Therapeutics Co-Founder and CEO Sherine Chan, Ph.D., joins Rich Bendis on BioTalk to discuss winning the 7th Annual BioHealth Capital Region Crab Trap, their drug discovery platform and being located at JLABS @ Washington, DC.

Listen now via Google bit.ly/3D5tm9O, apple.co/3eGzXy7, or Spotify spoti.fi/3D6lgOx.

Baltimore's Vita Therapeutics announced the completion of a $31 million series B funding round on Wednesday, propelling the cell therapy company toward a clinical trial and the development of new treatments for rare diseases.

Image: Vita Therapeutics, led by CEO Douglas Falk, recently completed a $31 million series B funding round. - Douglas Falk

“The 2022 venture capital market” is nearly a misnomer, as each quarter that passes seems to bring with it a new normal for startup investment. The pace of quarterly change in how venture investors are disbursing capital is making full-year numbers almost misleading.

The change inside of 2022, in other words, may at times mask just how much things have been evolving more recently; January and February feel like years ago in startup time, not merely a few quarters back.

Image: https://techcrunch.com/

We are so thankful for our Entrepreneurs-in-Residence (EIRs), who provide free business development guidance and counsel to assist #SmallBiz awardees with progress toward #commercialization objectives and ensuring success in the market. Each EIR brings unique expertise and experience from the field. Learn more and connect with an EIR today: https://bit.ly/3Ov55gH #Entrepreneur

Venture-capital firms are jumping into the stock market, buying up battered shares in publicly traded tech companies at a time when they are investing less in the startups that have long been their focus.

Some major venture firms including Accel and Lightspeed Venture Partners have purchased more stocks of companies they first backed as startups this year, defying the industry norm of selling those shares soon after public listings.

Image: One of Amplitude’s largest shareholders when the data-analytics firm went public was Sequoia Capital. PHOTO: ANDREW KELLY/ASSOCIATED PRESS

Oct 10 (Reuters) - California-based diagnostics company Bio-Rad Laboratories (BIO.N) is in talks to merge with Qiagen NV (QIA.DE), the Wall Street Journal reported on Monday, citing people familiar with the matter.

Talks between the two companies have been going on for a while but an agreement is unlikely for another few weeks, the report said.

U.S-listed shares of Qiagen rose 8% while Bio-Rad fell nearly 10% after the report.

Biotech and life sciences companies can benefit from partnering with the federal government in many ways, from funding to increased access to resources and manufacturing. But lesser-known than its counterparts at the National Institute of Health and National Cancer Institute is the Biomedical Advanced Research and Development Authority, or BARDA.

Image: https://biobuzz.io/

What does the Zulu word “ubuntu” have to do with a successful science and tech fund at Maryland’s TEDCO? To start, it’s been a guiding force for that fund’s leader.

The Maryland Technology Development Corporation (TEDCO) has an important mission in Maryland: “enhance economic empowerment by fostering an inclusive and entrepreneurial innovation ecosystem. Identify, invest in, and help grow technology companies in Maryland.”

Image: https://www.tedcomd.com/about-tedco/staff/arti-santhanam-phd

Oct 12, 2022

• Homologous boosting with the prototype Novavax COVID-19 vaccine induced robust antibody titers for Omicron BA.1, BA.2, and BA.5
• Study 307 (Lot Consistency) achieved its primary endpoint, showing that three vaccine lots induced a comparable immune response thereby demonstrating the consistency of the manufacturing process
• A durable immunogenicity response was observed following primary vaccination as well as boosting which matched the levels previously associated with protection

GAITHERSBURG, Md., Oct. 12, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today presented data from the Phase 3 PREVENT-19 trial and Study 307 (Lot Consistency) at the World Vaccine Congress Europe 2022. PREVENT-19 data in both adults aged 18 and older and adolescents aged 12 through 17 showed the prototype Novavax COVID-19 vaccine (NVX-CoV2373) achieved its pre-specified immunologic endpoint. Study 307 (Lot Consistency) met its primary endpoint, showing that three lots of the Novavax COVID-19 vaccine tested as a heterologous booster induced consistent immune responses in previously vaccinated adults aged 18 to 49.

WASHINGTON--(BUSINESS WIRE)--The Biotechnology Innovation Organization (BIO) – the world’s largest science and public advocacy organization, representing 1,000 members — announced today that Rachel King, co-founder and former CEO of GlycoMimetics, Inc., has agreed to serve as interim President and CEO. King’s appointment follows Dr. Michelle McMurry-Heath stepping down as President and CEO to serve as an Advisor to the Executive Committee of the BIO Board of Directors. The organization is searching for a full-time successor.

Neuroene and Polaris Genomics benefit from increased prizes

Did you miss the 7th Annual BioHealth Capital Region Crab Trap Competition? Below we are
sharing a review of the event, participants, judges, and video replays.

Thank you to all the Sponsors and Partners of the event and region this year.

(Winner) Neuroene Therapeutics (watch presentation)
(Montgomery County Winner) , Polaris Genomics (watch presentation)
(Finalist) Kubanda Cryotherapy (watch presentation)
(Finalist) Perfusion Medical (watch presentation)
(Finalist) VPIX Medical (watch presentation)

Click here to read more.

Doubling the University of Maryland BioPark’s lab space, the two-phase 4MLK development project will represent more than $320 million in total capital investment

BALTIMORE, Maryland, September 22, 2022 — University of Maryland, Baltimore (UMB) and Wexford Science & Technology, LLC, announced today that 4MLK, the newest development project in the University of Maryland BioPark, is slated to move forward, with groundbreaking this fall (2022) and delivering in summer 2024. The 8-story, 250,000-square-foot building, Phase I of a two-phase project representing a $320 million total capital investment, will provide critical wet laboratory space in downtown Baltimore for researchers and companies, flexible lab and office/support space for start-ups, and Class A office space, along with areas for convening and a conference center.

GAITHERSBURG, Md--(BUSINESS WIRE)--Adaptive Phage Therapeutics, Inc. (“APT”), a clinical-stage biotechnology company advancing the world’s largest therapeutic phage initiative for treatment of bacterial infectious diseases, today announced that the Defense Health Agency (DHA) has awarded an additional $5 million to support clinical development of APT’s adaptive bacteriophage (“phage”) therapy in treatment of diabetic foot osteomyelitis (DFO). APT is evaluating safety and efficacy of its precision phage-based therapy in the ongoing Phase 1/2 DANCE™ (DFO Adaptive Novel Care Evaluation) clinical trial.

Image: https://www.businesswire.com

The collaboration will explore EBV and HTLV-1 antigen-specific immune responses in immunological diseases

GAITHERSBURG, Md., Oct. 06, 2022 (GLOBE NEWSWIRE) -- NexImmune, Inc. (Nasdaq: NEXI), a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells, today announced a collaboration with the National Institute of Neurological Disorders and Stroke (NINDS), a division of the U.S. National Institutes of Health (NIH). The collaboration will focus on enriching and expanding virus-specific T cell populations and determining their activity against infected human cell lines. The goal of this collaboration is to develop adoptive cell therapies that may benefit patients afflicted with immunological disorders related to these viral infections. Initially, we will focus our efforts on studying Epstein-Barr virus (EBV) and Human T-cell Leukemia Virus, type 1 (HTLV-1).

WASHINGTON – Administrator Isabella Casillas Guzman, head of the U.S. Small Business Administration and voice for America’s 33 million small businesses in President Biden’s Cabinet, released the following statement today after the House voted to reauthorize funding for the Small Business Innovation Research (SBIR) program:

It’s no secret that a recession could hit the United States before the year ends. No one knows for sure yet, and many economists believe that the current record high inflation and capital markets distress are symptoms of what could be a substantial economic downturn,

Possible effects have already hit the biotech and life sciences. To discuss how the Biohealth Capital Region would fare out in a potential recession, and whether it can actually avoid one, the I-270 Innovation Labs brought together an outstanding group of regional experts from across key sectors connected to both industries.

Image: https://biobuzz.io

Today, the U.S. Economic Development Administration awarded 51 “Build to Scale” grants – totaling $47 million – to organizations that support technology entrepreneurs, catalyze innovation and fuel economic growth. [Read full press release here]

EDA’s “Build to Scale” program provides annual grants that aim to accelerate technology entrepreneurship by increasing inclusive access to support and startup capital. The 2022 awardees will leverage an additional $48 million in matching funds from a variety of private and public sector sources. These EDA investments support advanced manufacturing, bioscience, clean energy and blue economy clusters in regions throughout the United States.

Image: https://content.govdelivery.com/

The Richmond area is planning a major pharmaceutical manufacturing initiative to build drugs here, restore the nation’s stockpile of essential medicines and to make them more affordably.

The sprawling enterprise has major players, including Virginia Commonwealth University, the cities of Richmond and Petersburg and drug manufacturers Civica, Phlow and AMPAC Fine Chemicals.

Now it has a new pivotal piece: the money.

The initiative, named the Alliance for Building Better Medicine, has received $53 million from the federal government’s Build Back Better Regional Challenge. Those funds come in addition to $14 million in local donations and $45 million from the state.

The money will help build labs in downtown Richmond and Chesterfield County and manufacturing facilities in Petersburg. Not only will the alliance bring jobs to the area, it will boost national security, said Sen. Mark Warner, D-Va., who came to Richmond on Tuesday to celebrate the budding development.

Click here to read more.

BELTSVILLE, Md., Oct. 04, 2022 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases, today announced the initiation of a Phase 1b/2 clinical trial to evaluate NC410 in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with immune checkpoint refractory or immune checkpoint naïve solid tumors. In addition, NextCure announced it has entered into a supply agreement for KEYTRUDA with Merck (known as MSD outside the United States and Canada).

NC410 is a first-in-class immunomedicine designed to block immune suppression mediated by LAIR-1, an immunomodulatory receptor expressed on T cells and dendritic cells. Under the terms of the agreement, NextCure will sponsor the study and Merck will supply KEYTRUDA. The Phase 1b/2 trial will evaluate NC410 in combination with KEYTRUDA in patients with immune checkpoint refractory colorectal, esophageal, endometrial and head and neck cancers or immune checkpoint naïve patients with colorectal and ovarian cancers. The company expects to report initial Phase 1b data in mid-2023 followed by the initiation of the Phase 2 component of the study.

Is there a recession on the horizon?

Some economists say yes — and predict it’s going to be bad — while others say the United States will avoid one altogether. Still others forecast that one will linger for a while, but be relatively shallow.

But even if the country can’t dodge what many fear will follow record levels of inflation, a panel of experts in the life sciences field said on Tuesday they’re optimistic that the Frederick County biohealth sector may be spared from the worst effects of an economic downturn.

Image: Staff photo by Angela Roberts

BioHealth Innovation, Inc. (BHI) has partnered with Montgomery County, Maryland to support entrepreneurs seeking to commercialize life sciences, digital health, and medical device technologies. The new BHI-County agreement will fund one or more Executives in Residence, dedicated to cultivating the local life sciences ecosystem within Montgomery County.

Background

Over a decade ago, BHI was founded in Rockville, Maryland to coordinate and amplify the county’s existing innovation assets. Since then, our work has expanded to the BioHealth Capital Region (any beyond) by connecting life sciences, biotech and healthcare stakeholders, developing entrepreneurial talent, identifying commercially relevant federal and university technology, and attracting funding for growth-stage companies. BHI’s original goal of raising the BioHealth Capital Region’s life sciences cluster ranking to one of the “Top 3 by 2023” is within reach.

Click here to read more.

Partnership combines miRecule’s unique RNA therapeutic discovery and conjugation platforms with Sanofi’s NANOBODY® technology to create a groundbreaking treatment for FSHD miRecule will receive an upfront payment with potential future milestone payments of nearly $400 million, in addition to tiered royalties Collaboration marks the first licensing transaction leveraging miRecule’s proprietary DREAmiR™ discovery platform, validating foundational science, and bolstering commitment to further expansion of the company’s RNA therapeutic pipeline October 04, 2022 07:00 AM Eastern Daylight Time GAITHERSBURG, Md.--(BUSINESS WIRE)--miRecule, Inc., an innovator of next-generation RNA therapeutics, today announced a strategic collaboration and exclusive license agreement with Sanofi to develop and commercialize a best-in-class antibody-RNA conjugate (ARC) for the treatment of facioscapulohumeral muscular dystrophy (FSHD). The collaboration marks miRecule’s first licensing transaction leveraging its proprietary DREAmiR platform.

October 04, 2022 08:29 AM Eastern Daylight Time

GAITHERSBURG, Md--(BUSINESS WIRE)--Adaptive Phage Therapeutics, Inc. (“APT”), a clinical-stage biotechnology company advancing the world’s largest therapeutic phage initiative for treatment of bacterial infectious diseases, today announced that the Defense Health Agency (DHA) has awarded an additional $5 million to support clinical development of APT’s adaptive bacteriophage (“phage”) therapy in treatment of diabetic foot osteomyelitis (DFO). APT is evaluating safety and efficacy of its precision phage-based therapy in the ongoing Phase 1/2 DANCE™ (DFO Adaptive Novel Care Evaluation) clinical trial.

Johns Hopkins University is teaming with two D.C.-area institutions, Howard University and the National Institutes of Health, to create a new accelerator to help companies and research scientists focused on treating neurological conditions.

The nonprofit biotechnology accelerator, NeuroTech Harbor, is funded by an NIH investment of $5 million a year over five years, which could go up to $20 million annually. The NeuroTech Harbor plans to launch 45 new neurological companies over the next five years.

Image: NeuroTech Harbor Executive Director Sri Sarma views the project as a catalyst to turn Baltimore into a the Silicon Valley of neurological technology. COURTESY OF SRI SARMA

The BioHealth Capital Region has made a name for itself in the last few years, currently holding tight to its #4 ranking on the Genetic & Engineering News (GEN) Top 10 Biopharma Clusters list. As more life science companies flock to the region, though, a new challenge arises – how do we create a strong pipeline of local talent to support their needs? This pipeline not only includes the high concentration of experienced talent the BHCR is known for but entry-level employees and people without four-year degrees who can be trained on-the-job.

Did you miss the 8^th Annual BioHealth Capital Region Forum? Below we are sharing many of the panels, fireside chats, and keynotes from this event hosted on September 20^th, 2022, from USP in Rockville, Maryland.

The year’s theme was “Imagine the Future Together,” with discussions on Healthcare Innovation, Change, Diversity, Equity, and Inclusion.

Thank you to all the Sponsors and Partners of the event and region this year.

Quantum World Congress is where global trailblazers, game-changers, innovators, and visionaries come together to accelerate a quantum-ready future

Quantum World Congress is the first-of-its-kind global conference, exposition, and networking event that brings a quantum-ready future into focus. Cross-sector, multi-disciplinary leaders and participants from around the world will gather for three days—November 29-December 1—in Washington, D.C. at the Ronald Reagan Building and International Trade Center to explore this groundbreaking field. This event welcomes quantum technology visionaries, policymakers, researchers, business and investment leaders, educators, and students to discuss and showcase major developments in quantum solutions, research, education, workforce, thought leadership, policy, business, and investment. Technology builders and buyers will also discuss national and global progress as well as challenges and opportunities in the development of quantum computing, sensing, communications, and materials.

We are pleased to share an exciting new funding opportunity from the NIH Blueprint Innovation Hubs that you or your colleagues may be interested in.

NeuroTech Harbor and CIMIT’s CINTA program, through the NIH Blueprint MedTech Incubator hubs program, are currently seeking proposals from academic and industry applicants who have emerging technologies that aim to improve the diagnosis and/or treatment of disorders of the nervous system. Awards up to $500K per year (up to 4 years) to the most promising and innovative neurotechnologies to help support their development journey toward commercialization.