By Alex Keown
January 24, 2023

BioHealth Innovation’s lofty goal of the BioHealth Capital Region (BHCR) achievement of “Top 3 by 2023” is not likely to be reached this year due to inflation and uncertain economic conditions.

That’s the assessment of Rich Bendis, President and Chief Executive Officer of BHI, who has championed the region’s transition into a top four biopharma hub in the United States. However, given the state of the economy and the amount of money being invested, Bendis said it is unrealistic to expect the region to move up the ranking of the top 10 life sciences regions compiled by Genetic Engineering & Biotechnology News (GEN).

The Bear Institute, a pediatric health IT collaboration between Washington, D.C.-based Children's National Hospital and Oracle Health, has named four startup companies as the winners of its second annual pediatric digital health innovation competition.

The competition, dubbed the Bear Institute Pediatric Accelerator Challenge for Kids, allows startups to share their innovations and receive feedback from judges while competing for a chance to win an on-site pilot and software development support, according to a Jan. 17 release from Children's National.

TEDCO, Maryland’s economic engine for technology companies, unveiled a legislatively mandated Maryland Innovation Competitiveness Study—one that could lead to a 5-year, $250 million down payment for an Equitech Growth Fund and the establishment of a major Kirwan-type commission. The new commission would map out an in-depth strategic plan focused on ensuring Maryland becomes a national model for a thriving, inclusive tech sector and innovation economy.

Luis Gutiérrez and John K. Hsu join the growing collaboration being BHI and NIH in 2023

ROCKVILLE, MARYLAND, January 23, 2021 – BioHealth Innovation Inc. (BHI) announces the addition of Luis Gutiérrez and John K. Hsu, Ph.D., J.D., to the growing Entrepreneurs-in-Residence (EIR) team. Luis will work with the NIH Office of Extramural Research (OER), while John will work with The National Heart, Lung, and Blood Institute (NHLBI).

The OER manages the NIH’s extramural research program, providing guidance and support to staff, grantees, and the public on funding opportunities, policies, and regulations. It also oversees the review, award, and administration of grants and contracts for biomedical and behavioral research conducted outside of the NIH. In addition, the NHLBI conducts and supports research on the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases. It also works to improve the health of individuals and populations through education and public health initiatives.

BioHealth Innovation, Inc. (BHI) and Montgomery County are pleased to announce the selection of Kevin Heller, MD as a part-time “Executive in Residence”—a position dedicated to providing 1:1 technical assistance to Montgomery County-based biotech and medtech startups.

Heller will join two previously announced “MoCo” Executives in Residence, Jen Butler and Luis Guitierrez, who have been working closely with local entrepreneurs since November.

“​I am eager to join Jen and Luis as we strengthen our community’s biohealth cluster,” said Heller. “Starting and growing a successful biotech company takes patience, perseverance, and resources. Supporting the next generation of life sciences entrepreneurs is critical from a long-term public health perspective and from a local economic development standpoint.”

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 who wants to engage with the biohealth industry in new ways.

Our Strategists support selected growth-stage businesses beyond commercialization plans and federal grant proposals—they cultivate important relationships with client entrepreneurs and innovators. The Strategists’ work also includes collaborating with expert Entrepreneurs-In-Residence from around the country and other professionals in BHI’s network who have built careers at the intersection of business and science.

John C. Jacobs joined Novavax as president and chief executive officer, and a member of the board of directors, in January 2023. He is a seasoned industry leader who has more than 25 years of commercial, operations, business and leadership experience across multiple therapeutic areas. Previously, Mr. Jacobs served as president and chief executive officer and a member of the board of directors at Harmony Biosciences from June 2018 to January 2023, and executive vice president and chief commercial officer from October 2017 to June 2018, leading the company through a successful IPO and taking its first product through FDA review, approval and commercialization. Prior to joining Harmony, Mr. Jacobs held leadership roles at Teva Pharmaceuticals beginning in 2014, including senior vice president and general manager of the Respiratory Business Unit, senior vice president of Commercial Operations in North America and general manager of Teva in Canada. Mr. Jacobs has also held positions of increasing scope and responsibility at major pharmaceutical companies including Cephalon, Wyeth and Pfizer. Mr. Jacobs has a proven track record in developing market-leading commercial strategies, major product launches and building and leading highly effective teams and organizations. He received bachelor’s degree in business from State University of New York College at Plattsburgh and a master of business administration from The State University of New York at Binghamton.

• Company has initiated Phase I/II AFFINITY DUCHENNE™ trial of RGX-202
• Company also enrolling newly active observational screening study, AFFINITY BEYOND, evaluating AAV8 antibody prevalence in boys with Duchenne
• Commercial-scale cGMP material from the REGENXBIO Manufacturing Innovation Center to be used in the clinical trial
• RGX-202 is a potential one-time AAV Therapeutic for the treatment of Duchenne and includes an optimized transgene for a novel microdystrophin and REGENXBIO's proprietary NAV® AAV8 vector

ROCKVILLE, Md., Jan. 23, 2023 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that the Phase I/II AFFINITY DUCHENNE™ trial of RGX-202 for the treatment of Duchenne muscular dystrophy (Duchenne) is now active and recruiting patients. RGX-202 is designed to deliver a transgene for a novel microdystrophin protein that includes the functional elements of the C-Terminal (CT) domain found in naturally occurring dystrophin. RGX-202 uses REGENXBIO's proprietary NAV® AAV8 vector.

AFFINITY DUCHENNE is a multicenter, open-label dose evaluation and dose expansion clinical trial to evaluate the safety, tolerability and clinical efficacy of a one-time intravenous (IV) dose of RGX-202 in patients with Duchenne.

The University of Virginia will build a biotechnology institute funded with a $100 million donation from Charlottesville investor Paul Manning and his wife, Diane, the university announced Friday.

Along with the Mannings’ gift, U.Va. will contribute $150 million, and the state has allocated $50 million in initial investments for the institute in its 2022-24 budget, according to the announcement.

Image: Paul Manning. Photo courtesy the University of Virginia

Ahead of his swearing-in on Wednesday, Gov.-elect Wes Moore’s Cabinet is nearly complete. Moore announced his picks for nine additional cabinet positions on Tuesday, filling out key roles including the heads of the departments of Housing, Environment, Planning and Commerce.

The latest appointments include two Maryland mayors — Jake Day of Salisbury and Emily Keller of Hagerstown — meaning a change of leadership elsewhere in the state.

Image: The Great Seal of the State of Maryland on the front of the Maryland State House. Photo by Danielle E. Gaines.

On December 19, 2022, the Department of Defense ("DOD") issued a proposed rule seeking to amend the Defense Federal Acquisition Regulation Supplement (“DFARS”) to implement the data rights portions of recent Small Business Innovation Research Program and Small Business Technology Transfer Program Policy Directive, which emphasizes the need to protect the intellectual property interests of small businesses. In addition to addressing the small business directives, the proposed rule seeks to update markings requirements related to (1) small business data rights and (2) concerns raised by the Federal Circuit’s decision in The Boeing Co. v. Secretary of the Air Force, 983 F.3d 1321 (Fed. Cir. 2020).

Federal innovation and entrepreneurship initiatives would receive substantial new funding under the text of the omnibus spending bill shared on the morning of Dec. 20 by the Senate Committee on Appropriations. The legislation, which totals $1.7 trillion and covers both regular FY 2023 appropriations and supplement funding, provides a total of $1.8 billion for programs authorized by this year’s CHIPS and Science Act and increases funding for multiple long-standing efforts — including each of the SSTI Innovation Advocacy Council’s priority programs. The legislation is expected to pass Congress this week, before the current funding agreement expires on Dec. 23.

Organizations across the globe are pivoting their workplace technology strategy and many employers are grappling with big questions about which tools are needed to create a thriving hybrid environment in 2023.

Based on a JLL survey of over 1,000 companies worldwide, a vast majority expect to make significant changes to their tech stack over the next three years. Download the infographic highlighting the workplace technologies that were consistently mentioned by employers as top priorities and discover why those technologies are prioritized and how they change workplace.

The BioHealth Capital Region (BHCR) and its life science ecosystem have a rich and deep history of pioneering scientific innovation, research, development, and commercialization. The region’s history has been written by life science anchor companies, scientific research universities, government research organizations, rich startup culture, and serial entrepreneurs, all of whom have played critical roles in transforming the BHCR into one of the most innovative and productive biocluster in the world.

Image: https://biobuzz.io/

A new year means new opportunities to grow your business. If you're one of the millions of resolution makers who are using the new year to take their ventures to new heights, Maryland SBDC has the expertise to turn your goals into gains.

Whether your goal is to start a business, grow a business, or just learn something new, Maryland SBDC will jump-start your year with no-cost confidential, one-on-one consulting and low-cost training on topics ranging from business planning and financing to marketing and more.

Norfolk biotech company Embody has racked up a bevy of accomplishments since it was founded in 2014 with just two employees.

It has attracted millions of dollars in grant funding from the Department of Defense, and millions more from local and national stakeholders. Last April, the company announced plans to spend $5 million to expand its lab space by 10,000 feet and add 92 new jobs.

And now a bigger milestone can be added to the list: Embody’s sale to a major sports medicine company.

Zimmer Biomet, a Fortune 500 medical technology company based in Warsaw, Indiana, has signed a deal to acquire Embody for $155 million at closing and an additional $120 million subject to achieving other milestones over a three-year period.

Sanofi has thrown its financial weight behind its venture capital unit, making a $750 million, multi-year commitment to enable the financier to build on a year in which it backed 10 companies globally.

Sanofi Ventures is a well-established player in the biotech VC space, with its roots dating back to the formation of Sanofi-Genzyme BioVentures in 2011 and beyond that to the establishment of Genzyme Ventures a decade earlier. But Sanofi has largely stayed in the shadows, leaving its venture unit to build out a portfolio without publicly disclosing the details of how it supports the fund.

Happy New Year! Maryland is coming off of a busy and successful year of business attraction and expansion. Continue reading to see the companies that committed to Maryland in the 4th quarter of 2022.

Our momentum continues into 2023, with many exciting new projects on the horizon. We look forward to connecting with industry colleagues at events this spring, and as always, we’re standing by to help you make your next project a success.

Total research spending at American universities reached nearly $90 billion in 2021,1 2 and university licensing revenue has climbed to almost $3 billion a year.3 From robotics to agriculture to medicine, useful discoveries constantly emerge from academic labs. Yet policymakers often fail to recognize the critical role of intellectual property in driving all that spending, income, and innovation. Standing up for strong IP rights must be a priority for American universities.

Click here to read the full PDF Briefing.

GAITHERSBURG, Md., January 12, 2023--(BUSINESS WIRE)--Adaptive Phage Therapeutics, Inc., (APT) a clinical-stage biotechnology company advancing the APT phage bank, the world’s largest therapeutic phage initiative for treatment of bacterial infectious diseases, today announced the first patient has been dosed in the PHAGE 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) which consists of more than 100 leading experts, working together to combat the ongoing antibacterial resistance crisis and improve patient care. ARLG is funded by the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH). The investigational phage therapeutic, WRAIR-PAM-CF1, was developed by the Walter Reed Army Institute of Research (WRAIR) and is licensed to and manufactured by APT. The trial is expected to enroll a total of 72 patients at multiple sites across the country.

Image: Photo: Business Wire

COLUMBIA, Md. (January 10, 2023) – TEDCO, Maryland’s economic engine for technology companies, announced a new collaboration between TEDCO’s Maryland Innovation Initiative (MII) and The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF). The MII Pop-up Event will take place on February 8 at HJF home office in Bethesda, Md., including the signing of the Memorandum of Understanding (MOU) and speakers from MII, TEDCO and HJF leadership.

“We’re very proud of MII’s successful track record when it comes to both collaboration and outcomes,” said Dr. Arti Santhanam, executive director of MII. “This MOU gives us the opportunity to expand on that success in partnership with the dedicated team at HJF. Together, we anticipate advancing new business creation with crucial military medical applications.”

The Maryland Industrial Partnerships (MIPS) program offers grants for projects that team Maryland-based companies with University System of Maryland faculty to develop technology products and processes.

Join us for a free webinar to learn how MIPS can help advance your technology-based products by leveraging the facilities, resources, and expertise within Maryland’s public universities to create new products and opportunities!

Next webinar:
Thursday, January 19, 2023, at 1 p.m.
online via Zoom

Click to register

Mentia is honored to be selected for the inaugural Artificial Intelligence and Technology Collaboratory #A2Collective #johnshopkinsuniversity The National Institutes of Health Full story at https://lnkd.in/g6ewtb9W

There are now more Americans aged 65 and older than at any other point in history, and that number is expected to rise, according to the National Institute on Aging (NIA). With longer lifespans come challenges like Alzheimer’s, which about one in nine Americans aged 65 or older have.

The a2 Pilot Awards were created to encourage the development of tech for the elderly. Funded by the NIA with $40 million over the next five years, the awards announced today the first cohort of 33 projects selected for funding. The majority use artificial intelligence or machine learning tech, and 40% are led by women.

Deployed military personnel frequently face numerous health and safety hazards as part of their daily activities in service to their nation. Among many dangers is the possibility of encountering hemorrhagic fever viruses (HFVs), a group of highly infectious pathogens such as the Ebola virus. Many of these diseases do not currently have effective therapeutics and can be prevalent in areas where service members are deployed, putting them at risk of exposure.

George Mason University infectious disease researcher Aarthi Narayanan has partnered with the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) and Cyclica, a biotechnology company based in Canada, to identify potential broad-spectrum therapeutics for illnesses triggered by HFVs and similar pathogens.

Biopharmaceutical company Kite Pharma will expand its footprint in Frederick County with a new warehouse that will bring 100 new jobs to the area, the company announced Tuesday.

Kite, a Los Angeles-based subsidiary of Gilead Sciences (NASDAQ: GILD), will build an approximately 70,000-square-foot raw materials warehouse to support its global cell therapy manufacturing network. The company's CAR T-cell therapy uses a person's own immune system to recognize, attack and destroy certain types of cancer with a one-time, individualized treatment.

Today, College Park, Maryland quantum leader IonQ announced its first-ever acquisition.

The DMV company acquired the operating assets of Entangled Networks, a Toronto, Canada-based startup founded in 2021. Entangled Networks specialized in enabling computing for multiple quantum processors, including those that are distributed. Through the deal, the Entangled team will become the staff of IonQ Canada, the quantum pioneer’s first outpost in the country.

Image: IonQ's Kai Hudek in the lab. (Courtesy photo)

To kick off the new year, The Galien Foundation is delighted to share with you highlights from the 2022 Prix Galien Awards Ceremony and recognize the incredible achievements of the Medalists  of the Prix Galien Golden Jubilee and the Prix Galien USA.

Kite , a global biopharmaceutical company, is adding 100 new jobs and expanding its cell therapy manufacturing operations in Frederick County.

A Gilead company, Kite is planning to construct a 70,000 square-foot warehouse adjacent to its current facility in the Urbana Corporate Center, which will help expand its global manufacturing network. The company originally announced its entry into Maryland back in 2019 , helping form the largest dedicated in-house cell therapy manufacturing network in the world. The company expects to employ more than 500 full-time staff between its two facilities by the end of 2026.

Linshom Medical raising $3M series A to launch respiratory monitor

Ellicott City startup Linshom Medical is looking to raise a $3 million round as it works to develop a medical device that catches the warning signs of a respiratory crisis.

CEO Richard Hughen plans to use the series A raise, as well as a $2.4 million grant from the National Institutes of Health, to fund a study to prove the company’s respiratory monitor is effective at detecting breathing issues. The company previously raised $1.5 million in convertible notes. Linshom has raised $1 million of its $3 million series A goal so far, with support from the Maryland Momentum Fund, the Maryland Technology Development Corp. and other investors.

Once the studies are complete, the three-person company is planning to do a soft launch in a few hospital systems late this year.

· Global biopharmaceutical company focusing on metabolic and digestive diseases

· Proceeds to fund clinical and business development

ROCKVILLE, MD and SHENZHEN, CHINA,January 5, 2023— HighTide Therapeutics Inc. (“HighTide”), a globally integrated clinical-stage biopharmaceutical company developing novel multifunctional therapies for metabolic and digestive diseases, today announced the closing of a $107 million Series C/C+ financing led by the TCM Healthcare Fund of Guangdong, managed by China Development Bank Capital. Other investors included Yuexiu Fund and Yuthai Fund.

On September 30, 2022, the SBIR and STTR Extension Act of 2022 (the Act) was enacted, reauthorizing the SBIR and STTR programs until September 30, 2025. The Act makes several significant changes related to national security risks and foreign influence in the programs. The changes include agency implementation of due diligence procedures, new offeror disclosure and ongoing contractor reporting requirements, and new award eligibility requirements, with an offeror’s or contractor’s omissions or misstatements resulting in repayment of the entire award amount, among other changes to the programs.

WALTHAM, Mass., Jan. 09, 2023 (GLOBE NEWSWIRE) -- CinCor Pharma, Inc. (NASDAQ: CINC) today announced that it has entered into a definitive agreement with AstraZeneca under which AstraZeneca has agreed to acquire CinCor.

Marc de Garidel, Chief Executive Officer at CinCor, said: "We are excited about the proposed acquisition of CinCor Pharma by AstraZeneca as we believe it offers the prospect of accelerating the development timeline and expanding the breadth of benefits patients with cardiorenal diseases might obtain from baxdrostat, if approved. CinCor is committed to ensuring a smooth transition of the development responsibilities to AstraZeneca once the acquisition is consummated. Thank you to all who have played, and will continue to play, essential roles in developing and evaluating baxdrostat as a potential novel treatment for cardiorenal diseases."

The transition will take place in late January.

Image: Stanley Erck is retiring as CEO of Gaithersburg vaccine maker Novavax. EMAN MOHAMMED

Today we announced an agreement to acquire CinCor Pharma, Inc., a US-based clinical-stage biopharmaceutical company, focused on developing novel treatments for resistant and uncontrolled hypertension.

The acquisition will strengthen our cardiorenal pipeline, where there is a high unmet medical need.

This acquisition is expected to close in first quarter of 2023, subject to regulatory approvals and other customary closing conditions. Additional important information can be found here: https://know.az/3IvkzkQ