GAITHERSBURG, Md., Nov. 01, 2022 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) announced results from a Phase 2 study evaluating the safety and immunogenicity of the company’s adjuvanted single dose chikungunya virus virus-like particle (CHIKV VLP) vaccine candidate in prior recipients of other investigational alphavirus vaccines. The study demonstrated that the CHIKV VLP vaccine candidate was well-tolerated and immunogenic in both alphavirus vaccine-naïve participants and participants previously vaccinated against the Venezuelan equine encephalitis virus. The findings were presented at the American Society of Tropical Medicine and Hygiene (ASTMH) annual meeting.

“We are pleased with these positive Phase 2 study results that support the potential utility and continued development of a chikungunya vaccine candidate to help prevent chikungunya disease, including in those who have previously received another alphavirus vaccine,” said Chris Cabell, M.D., chief medical officer and SVP clinical development at Emergent BioSolutions. “There are currently no approved vaccines or treatments for chikungunya disease, and we are committed to advancing our program to help address this unmet medical need.”

United Therapeutics Corp. (NASDAQ: UTHR) continues to snap up properties near its Silver Spring headquarters — but has largely remained quiet about its long-term plans for the additional space.

The local drugmaker most recently bought a building at 8905 Fairview Road for $11.85 million, according to Montgomery County property records. The transaction, which closed Oct. 5, also includes a parking lot across the street.

Ambix Healthcare Partners Leads Funding Round Bringing New Surgical Robot To Market

BALTIMORE, Nov. 1, 2022 /PRNewswire/ -- Galen Robotics, the Digital-Surgery-as-a-Service ™ pioneer, today announced it has completed the 1st close for an oversubscribed Series A round with $15 million in funding, including investment from Ambix Healthcare Partners, from Menlo Park, CA.

Galen Robotics has submitted a new collaborative soft tissue surgical robot, intended to address unmet needs in the market, to FDA for consideration.  Galen plans to level the surgical playing field by erasing large capital expenditures associated with today's surgical robots. Galen Robotics will be the first surgical robotics company to launch as  "as-a-service" using the per-usage disposable model. Termed Digital-Surgery-as-a-Service, is a new approach to surgical robotics, clearing the way to capture surgical data and promote continuous improvements of surgical techniques, outcomes, and the training of residents. The Series A helped complete the final robot prototype, and submission to FDA. Funds will also be used to develop a clinical sales team, expand engineering, grow product development, and develop surgeon training programs.

Galen Robotics, which is commercializing a surgical robot developed at a Johns Hopkins research lab, has announced the first close of a Series A round, after raising $15 million from investors led by California’s Ambix Healthcare Partners. It simultaneously announced a second close for its Series A worth an additional $5 million.

“We will be the first robotic company to launch using an on-demand business model,” said Galen Robotics CEO Bruce Lichorowic, after the Baltimore startup swiftly pivoted from trying to sell its robots to a so-called “digital-surgery-as-a-service” model. The switch makes Galen’s robotic services more affordable for hospitals that have financially struggled since the coronavirus pandemic amid a sharp drop in elective surgeries.

United Therapeutics is continuing to buy properties near its downtown Silver Spring corporate headquarters at 1040 Spring St.

Dewey Steadman, director of investor relations for the drug manufacturer, confirmed a report in the Washington Business Journal of the purchase of 8905 Fairview Rd. for $11.85 million, including a parking lot across the street.

Image: https://www.sourceofthespring.com

Great entrepreneurs can come from anywhere, but some universities have a truly exceptional track record of producing future entrepreneurs.

PitchBook's annual university rankings compare schools by tallying up the number of alumni entrepreneurs who have founded venture capital-backed companies. The undergraduate and graduate rankings are powered by PitchBook data and are based on an analysis of more than 144,000 VC-backed founders.

Maryland life sciences and biotechnology companies have been at the forefront of the state’s public health response and economic recovery from the COVID-19 pandemic. However, lawmakers are considering policies that weaken the very backbone of Maryland’s robust innovation economy at a time where protecting this industry had never been more critical. Without the necessary policies and protections in place, essential innovation and research, such as COVID-19 clinical trials and cybersecurity development taking place right here in Maryland, could be forced to come to a screeching halt.

Image: Scientists work on the vaccine purification process as they design updates to the Novavax's COVID-19 shots in the company's research laboratory on May 24, 2022, in Gaithersburg, Maryland. In July, the U.S. Food and Drug Administration authorized use of Novavax’s more traditional kind of COVID-19 vaccine, which the company hopes can win over unvaccinated people and become a top choice for boosters. (AP Photo/Angie Wang) (Angie Wang/AP)

An NCI Technology Opportunity Webinar

We invite you to register and join us on November 15 from 11:00 am - 12:00 pm ET for a free NCI technology webinar.

Attendees will hear from Drs. Anand Swaroop, Ph.D. and Kamil Kruczek, Ph.D. of the National Eye Institute about a new gene therapy method for treating CRX-autosomal dominant Leber Congenital Amaurosis (LCA). LCA is a rare genetic disease that is responsible for about 20% of all childhood blindness. It’s caused by mutations in any of at least 25 genes that control photoreceptor development or function. LCA has both recessive and dominant forms. Currently, there is an FDA approved gene therapy for treating only one of the recessive forms of LCA caused by mutations in the RPE65 gene. In addition to most recessive forms, the dominant form of LCA with underlying mutations in CRX remains untreatable.

Click here to register or learn more.

BioHealth Innovation, Inc. (BHI) and Montgomery County are pleased to announce Jennifer R. Butler as the first Montgomery County “Executive in Residence”—a pilot project dedicated to providing 1:1 technical assistance to Montgomery County-based biotech startups.  

This is a year-long collaboration between the county government, which is funding the work as part of its mission to grow the local life sciences cluster, and BHI, a regional innovation intermediary supporting technology commercialization throughout Maryland, D.C., and Virginia.

The Polaris Genomics Leadership team of CEO Charles Cathlin, MPH, CSO Tshaka Cunningham, PhD, and CMO Anne Naclerio, MD, MPH visit BioTalk to discuss competing in the 7th Annual Crab Trap Competition, being a Veteran-Owned Business and growing in BioHealth Capital Region.

Listen now via Apple https://apple.co/3DOUiLK, Google https://bit.ly/3fowyob, or Spotify https://spoti.fi/3DNfd1F3

“There’s more dry powder powder than ever before.”

“There’s never been a better time to start a startup.”

“Discipline is the new scale.” (OK, OK, I made that last one up, but didn’t you kind of believe it?).

The tech industry loves generalizations — and don’t worry, I enjoy my fair share too — but as the downturn continues to play out, it’s increasingly important to think about the structural changes that may be forming in the venture capital landscape. Venture firms, unlike unicorns, often don’t have hundreds of employees to cut. Instead, venture firms cut costs in quieter ways.

SIOUX FALLS, S.D. and GAITHERSBURG, Md., Oct. 27, 2022 (GLOBE NEWSWIRE) -- SAB Biotherapeutics (Nasdaq: SABS), ("SAB”), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that produces specifically targeted, high-potency, fully-human polyclonal antibodies without the need for human donors, today announced the company has entered into an exclusive manufacturing services agreement with Emergent BioSolutions Inc. (NYSE: EBS). Emergent will provide contract development and manufacturing (CDMO) services to produce SAB’s fully-human polyclonal antibody products. Currently, SAB has clinical-stage programs in pan-influenza treatment, treatment of acute and recurrent C. diff., prevention of Type 1 diabetes, and discovery assets in immunology and oncology.

Under the terms of the agreement, Emergent will provide end-to-end Good Manufacturing Practice (cGMP) manufacturing services to SAB, including process development and manufacturing clinical investigational drug product to support SAB’s clinical programs, and commercial manufacturing services upon regulatory approval of SAB’s therapeutics. The agreement also provides the opportunity for Emergent to utilize SAB’s novel DiversitAb™ platform, the only one in the world that produces fully-human polyclonal antibodies utilizing transchromosomic cows, for future development of undisclosed programs. Financial details of the agreement were not disclosed.

Thanks to the Maryland Department of Commerce, an octet of the state’s public and private universities can now commit a collective $16.4 million toward professorships in STEM, health and adjacent fields.

Half of that sum, or $8.2 million, comes from matching grants that the stage agency endowed via its Maryland E-Novation Initiative Fund (MEIF), which it administers to match private fundraising for endowed professorships and chair positions. The other half, per the MEIF’s mandate, came from private fundraising that the beneficiary universities and colleges raised.

Image: Holmes Hall, one of Morgan State University's main campus buildings. (Image via Facebook)

Through this collaboration, FUJIFILM Diosynth Biotechnologies will incorporate RoosterBio's industry-leading process development technology for both MSC and extracellular vesicle (EV) / exosome programs into its manufacturing capabilities and offerings.

FREDERICK, MD. (PRWEB) OCTOBER 25, 2022

FUJIFILM Diosynth Biotechnologies, a world-leading contract development and manufacturing organization (CDMO) for biologics, vaccines, and advanced therapies, announced today a strategic collaboration with RoosterBio, Inc., a leading supplier of human mesenchymal stem/stromal cells (MSCs), highly engineered media, and bioprocess development services. Through this collaboration, FUJIFILM Diosynth Biotechnologies will incorporate RoosterBio's industry-leading process development technology for both MSC and extracellular vesicle (EV) / exosome programs into its manufacturing capabilities and offerings.

MANASSAS, VA. (PRWEB) OCTOBER 26, 2022

Diversity and inclusion in clinical trials are critical to achieving accurate and reliable results.(1) Participation in clinical trials is voluntary, and individuals of different ages, genders, races, ethnicities, genetic backgrounds, geographic locations, and environments will respond differently to the same treatments. An effective way to achieve diversity in clinical trials is through decentralization with standardized procedures across multiple sites.(2) To facilitate the efficient execution of multi-center clinical trials globally, Dr. Harsha Rajasimha, Founder and CEO of Jeeva Informatics, and his team have developed the modular Jeeva™ eClinical Cloud.

GAITHERSBURG, Md.--(BUSINESS WIRE)--Adaptive Phage Therapeutics, Inc. (“APT”), a clinical-stage biotechnology company advancing a phage bank, the world’s largest therapeutic phage initiative for treatment of bacterial infectious diseases, today announced the appointment of Edward Fang, M.D. as Chief Medical Officer. Dr. Fang’s responsibilities include overseeing clinical development for APT's phage bank treatment candidates through commercialization.

Tweet this “I am excited to welcome Dr. Fang, who brings broad expertise in therapeutic approaches to bacterial infectious disease and clinical trial execution to APT,” stated Greg Merril, CEO and Co-Founder of Adaptive Phage Therapeutics. “With Dr. Fang’s addition to APT’s leadership, I am confident that APT will achieve its short-term objective of rapidly progressing ongoing clinical trials, and longer-term objectives of leveraging expanding phage banks to deliver the first antimicrobials that adapt to the emergence of resistance. This approach does not decrease in coverage over time and will not require, or benefit from, market-suppressing stewardship.”

ROCKVILLE, MARYLAND, BioHealth Innovation Inc. (BHI) is pleased to welcome Monique Bennett, Ph.D., as the new Senior Life Sciences Business Strategist. In this role, Dr. Bennett will work one-on-one with entrepreneurs and will lead BHI’s team of strategists that provide a variety of client services including non-dilutive funding assistance and go-to-market strategies.  

FREDERICK, MD (October 24, 2022) – The Maryland Tech Council (MTC), the largest technology and life sciences trade association in the state, has named the Honorable Kelly M. Schulz, a former cybersecurity small business partner, state legislator, and two-time state cabinet secretary, as its new CEO.

As Secretary of the Maryland Department of Commerce from 2019 to 2021, Schulz oversaw the state’s primary economic development agency, responsible for attracting new businesses, promoting innovation, and accelerating job growth. Under her leadership, the department served as the largest resource to provide financial assistance to struggling Maryland companies adversely impacted by COVID-19. She previously served as Secretary of the Maryland Department of Labor from 2015 to 2018. During her tenure, Maryland’s apprenticeship program grew to its highest level since 2008, with more than 10,000 apprentices statewide and received national recognition as one of America’s top programs.

Oct 19 (Reuters) - JPMorgan Chase & Co (JPM.N) is launching a platform that aims to connect startup founders with venture capital investors to simplify the fundraising process, the bank told Reuters.

The new platform, Capital Connect, focuses on serving the financing needs of startups from their early stages, marking the ambition of the biggest U.S. bank by assets to further expand into the private market and build a founder-friendly brand in Silicon Valley.

20 weeks' journey of US Market Entry Program is finally completed. The program is to provide soft landing for medical start-ups from Korea. 5 start-up cohorts, after competitive selection, have been fostered by BioHealth Innovation (BHI) and KOSME (Korea SMEs and Startups Agency).

The synergy between strong Korean Government support and local expertise delivered significant impact to us. Congratulations to 5 cohort start-ups for successfully achieved the mission !

Medtronic (NYSE:MDT) revealed its plans for an incubation and acceleration platform for innovation in the neurovascular space.

In a presentation yesterday at DeviceTalks West in Santa Clara, California, the company unveiled its plan to bring innovations to market to address strokes. Daniel Volz, president of Medtronic Neurovascular, and Derek Crittenden, Medtronic’s new technology & strategy program manager, presented the news.

Image: Dan Volz (right) and Derek Crittenden (left) present the Medtronic Co-Lab program at DeviceTalks West in Santa Clara, California. - https://www.massdevice.com

The entrepreneurial spirit burns bright at Johns Hopkins University, with alumni launching startups in sectors ranging from life sciences to the metaverse.

Enter A-Level Capital, a group of budding undergraduate investors on a mission to help Hopkins-born startups succeed. Founded by Carey Business School alum Elizabeth Galbut and Whiting School of Engineering alum Demi Obayomi, the student-run venture capital firm targets early-stage companies created or run by Hopkins alumni.

Image: https://hub.jhu.edu/

Johns Hopkins University is one of several partners behind the launch of The Light of Baltimore Incubator at Baker Donelson, a partnership with Bloomberg Philanthropies and Goldman Sachs 10,000 Small Businesses, to provide office space, mentorship, and legal and marketing support for 26 HopkinsLocal businesses and other regional small businesses.

Image: https://hub.jhu.edu

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