– Reports Promising Early Data from Lead Clinical Program, JK07, for the Treatment of Heart Failure with Reduced Ejection Fraction –

– Initiates Enrollment in Second Cohort of JK07 Phase 1 Dose Escalation Study –

(Gaithersburg, MD) – March 7, 2022 – Salubris Biotherapeutics, Inc. (SalubrisBio), a clinical-stage biotechnology company dedicated to discovering and developing novel complex biologic therapeutics, today announced it received $32 million in financing from China-based Shenzhen Salubris Pharmaceuticals Co., Ltd. The investment, which was completed in the fourth quarter of 2021, will be used to advance the current pipeline, including continuation of an ongoing Phase 1b clinical trial and initiation of two additional Phase 1b clinical trials in 2022, and to further expand the pipeline through R&D.

For a small business with a brilliant new idea in the life sciences, a funding infusion can do wonders to help translate that concept into reality. Did you know that the NIH small business programs are the largest source of early-stage capital for the life sciences in the U.S.? These programs set aside over $1.2 billion non-dilutive funds every year -- specifically to support small business research and development. 

Indeed, in 2021, the U.S. bioscience industry represents a unique confluence of characteristics essential for addressing these challenges and realizing societal and economic progress: extraordinary innovation that’s saving and improving lives through advancements in biomedical, energy, and advanced food and industrial technologies, along with an expanding mix of employment opportunities with incomes that support a quality standard of living.

The industry is at the forefront of a host of major global challenges related to diagnosing, treating, and curing disease—especially COVID-19 and other infections with pandemic potential. The industry is also ensuring that the world can rely on a safe, affordable, and more sustainable food supply to feed a growing population, as well as developing biobased fuels, chemicals, and other industrial products to help us address climate change.

The Biotechnology Innovation Organization (BIO) and Council of State Bioscience Associations recently released Driving the Bioscience Economy Forward During the COVID-19 Pandemic: Best Practices in State and Regional Bioscience Economic Development Initiatives. The biennial report provides a summary of state programs serving the bioscience industry.

This year’s report devotes substantial attention to incentives. Many of the incentive policies are intended to support the leading trends in state bioscience support (see below). These include incentives to provide funding for companies coming out of university partnerships, industry workforce training and development, and facility development. Others are intended to provide capital to bioscience companies at the early-stage, mid-stage, and manufacturing stage of development, such as angel investor and seed capital tax credits, R&D and innovation investment tax incentives, and tax exemptions, abatements or discounts.   

Image: https://smartincentives.org

FREDERICK, Md.–(BUSINESS WIRE)–The Maryland Tech Council is proud to announce the finalists for its annual Industry Awards Celebration. The event honors individuals and companies in the life sciences, technology, and government contracting industries that have made a significant impact in their respective fields. For the first time in two years, the awards ceremony will be held in person, with the winners announced live on May 12th at the Bethesda North Marriott Hotel & Conference Center. Last year over 9,000 people tuned in to the virtual Industry Awards Celebration. Click here to learn more about the event. 

WHAT YOU'LL LEARN

• As new markets are embracing the Life Science industry, why are users feeling bullish in investing and developing in the Mid-Atlantic area? How is our region competing with different markets? 
• Strategic Design & Development: How are investors and developers meeting the latest demands when it comes to design and amenities? What is being implemented to ensure purpose-built life science facilities? 
• How are developers and tenants finding more space as demand for facilities continues to rise? Are we seeing more vacant buildings being converted into labs and other biotech facilities to meet the high demand? 
• With the rise in market opportunity, where is the public and private funding coming from for life science real estate? 
• I-270 Corridor Update: What are the newest projects and investments in the development pipeline? What is expected for this life science & biotech corridor in terms of tenants, investments and development in 2022? How are DC & NoVa competing against this corridor and securing their spot in the asset class?

BALTIMORE, March 7, 2022 /PRNewswire/ -- GlycoMantra, a University of Maryland, Baltimore (UMB) startup company developing therapeutics for unmet medical needs in prostate cancer, NASH liver fibrosis, and type 2 diabetes, has been granted worldwide, exclusive rights to a UMB technology to advance the company's pipeline of therapeutics for treating drug-resistant metastatic colorectal cancer (mCRC).

According to the American Society of Cancer Oncology, colorectal cancer (CRC) is the second leading cause of cancer death among men and women in the U.S., totaling about 53,000 deaths per year. Drug resistance to CRC is a primary challenge and mCRC remains a lethal disease. Although 5-fluorouracil (5-FU)—one of the current standards of care for patients with mCRC—exerts clinical benefit, all patients have acquired resistance to the drug over time.

“I never had been in an ecosystem that had more potential, more assets, that was more disconnected, than this region was at that time.” -Rich Bendis of BioHealth Innovation, Inc. on why Maryland was a great place to grow the BioHealth Capital Region.

Watch: https://bit.ly/3trKMYm

Robert Gourdie, a trailblazing cardiovascular scientist at the Fralin Biomedical Research Institute at VTC, is the first Virginia Tech researcher to receive an Outstanding Investigator Award from the National Institutes of Health (NIH).

The seven-year, $6.4 million grant is funded by the National Heart, Lung, and Blood Institute (NHLBI), part of the NIH. Known as an R35, the grant provides Gourdie with increased freedom to carry out inventive research concepts that aren’t tethered to specific, finite projects.

Image: Robert Gourdie, the Commonwealth Research Commercialization Fund Eminent Scholar in Heart Reparative Medicine Research and director of the Fralin Biomedical Research Institute’s Center for Vascular and Heart Research, is Virginia Tech’s first recipient of a National Institutes of Health Outstanding Investigator Award. Photo by Clayton Metz for Virginia Tech.

March 2, 2022 -- The U.S. Centers for Medicare and Medicaid Services (CMS) will offer reimbursement for software from Medimaps Group that performs osteoporosis risk fracture assessment via trabecular bone scores (TBS).

The agency assigned the Current Procedural Terminology (CPT) code 77089 for Medimaps' TBS iNsight, which provides a trabecular bone score for x-ray and dual-energy x-ray absorptiometry. It was effective January 2022.

Image: https://www.auntminnie.com

Foresite Capital, a firm that invests in early-stage healthcare and life sciences companies, today launched a $173 million fund designed to further finance startups launched by its Foresite Labs entrepreneurial innovation hub.

The new fund will be one source of capital for Foresite Labs startups, which will continue to be funded through the $969 million raised last year by Foresite Capital—consisting of the $775-million Fund V and a $193.75 million fund for selectively making additional investments in their highest conviction Fund V portfolio companies, called the Opportunity Fund.

Image: Vikram (Vik) Bajaj, PhD, a managing partner with Foresite Capital and the Co-Founder and CEO of the firm’s Foresite Labs entrepreneurial innovation hub.

SOUTH SAN FRANCISCO, Calif., March 02, 2022 (GLOBE NEWSWIRE) -- CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – today announced that it is teaming up with the National Kidney Foundation (NKF) to support National Kidney Month initiatives aimed at improving outcomes for kidney transplant recipients and those suffering from kidney failure.

This marks the seventh consecutive year that CareDx is supporting NKF’s Kidney Patient Summit on Capitol Hill, which is taking place virtually this year on March 2, 2022. Patient representatives will be advocating for more research funding to accelerate the early detection of chronic kidney disease, which could help physicians reverse or delay the need for transplantation.

Maryland is home to one of the largest life science clusters in the nation. According to the Maryland Department of Commerce, the State has nearly 2,300 life science companies and 476 private research and development biotechnology firms (NAICS 541714), which represents 5.3% of this U.S. industry.

Some of the nation’s most important research occurs within Maryland at National Institute of Health (NIH), Food & Drug Administration (FDA), federal laboratories, Johns Hopkins, and the University of Maryland. In fiscal year 2018, Maryland received $1.5 billion from NIH for biomedical research, behind four other states (NIH 2018 report):

Image: https://www.americangene.com

With the Bisciotti Foundation Translational Fund, John Hopkins University School of Medicine is bringing seed funding to three teams of researchers creating innovative medical devices.

Each of these devices, which are being developed by Hopkins professors and fellows, aim to dramatically decrease costs on hospitals and improve patient care by taking anesthesia out of the equation. Recipients were awarded between $25,000 and $100,000 to conduct their work during a period of up to nine months.

Image: (L to R) Therese Canares, Mathias Unberath, Clifford Weiss and Ethan Tumarkin. (Courtesy image)

D&D Pharmatech, a clinical-stage global biotech company, features a strong research emphasis, with focus on neurodegenerative brain disorders led by Johns Hopkins University School of Medicine neuroscientists, including Ted M. Dawson, MD, PhD, who is a globally recognized authority in this domain.

The company’s founder Lee Seulki, PhD, 45, also working at the university as a radiology professor, is a promising medical scientist who is the youngest `Highly Cited Researcher` named by Clarivate Analytics in 2017.

Ron Kurz, Sr. Director & GM at Canon Virginia, Inc., joins BioTalk to discuss his career, growth opportunities, and Canon’s role in the BioHealth Capital Region

Listen now via Apple https://apple.co/35BlOgJ, Google https://bit.ly/36DvurG, Spotify https://spoti.fi/3sqk8jo, Amazon https://amzn.to/3598voh, and TuneIn https://bit.ly/3Itb16Y

SOUTH SAN FRANCISCO, Calif., Feb. 22, 2022 (GLOBE NEWSWIRE) -- CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – today announced that its non-invasive organ transplant surveillance solutions are being used to help monitor post-operative graft health in the world’s first successful heart xenotransplantation. A genetically modified pig heart was successfully transplanted into a patient at the University of Maryland Medical Center on January 7, 2022.

Johns Hopkins University led all U.S. institutions in total National Institutes of Health (NIH) funding for federal fiscal year 2021, with more than $820 million in awards, $824,856,274 to be exact. The rest of the top ten institutions were:

After struggling through COVID-19 vaccine production woes in 2021, Emergent BioSolutions has another surprise for its investors in early 2022. 

Last month, Emergent projected revenues of $1.4 billion to $1.5 billion for this year. Now, the company has dropped the figure to $1.3 to $1.4 billion. 

Why the adjustment?

In its quarterly report, Emergent credited its decision to undergo maintenance on its troubled Baltimore Bayview facility “earlier than anticipated,” and to expand the project to set the facility up for “future non-pandemic work.”

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.

Learn more

USP Developing mRNA Quality Guidelines to help companies and regulators bring innovative medicines to market faster   Rockville, Md., February 23, 2022 – U.S. Pharmacopeia (USP), a global independent scientific organization, is seeking scientific input on new draft guidelines, “Analytical Procedures for mRNA Vaccine Quality.” USP and a group of leading mRNA experts have identified the need for analytical procedures and best practices to support quality assessments for mRNA vaccines and therapies in development pipelines for infectious diseases, cancer, cystic fibrosis and other disorders.

To build public trust and confidence in innovative products like mRNA-based therapies, they must be of good quality, safe, and effective. Since the successful application of mRNA technology is relatively new, regulatory guidelines and industry standards are still evolving. A common approach for assessing mRNA quality would support developers, manufacturers, regulatory agencies, and national control laboratories worldwide, and provide tools to help accelerate the development of safe and effective mRNA-based products.

The AIM-HI Women’s Venture Competition, in its third year, is open for women entrepreneurs! The program provides early-stage funding, coaching, and networking opportunities to women-led oncology startups to address unmet medical needs.

The winning company will receive a total of $1 million in equity investment from AIM-HI and co-investors, subject to due diligence and negotiation. Click here to download the flyer and help spread the word!

Marty Rosendale, Chief Executive Officer of the Maryland Tech Council, joins BioTalk to discuss MTCs Programs, Accessing Capital, and Goals for 2022

Listen now on Google https://bit.ly/3LQZNLR, Apple https://apple.co/3H6Aly4, Spotify https://spoti.fi/3LQkZRW, and Amazon https://amzn.to/3sZxuSR, and TuneIn https://bit.ly/3sU6Af0.

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.

In this issue of Cell Host and Microbe, Haslwanter et al., 2022 present a comprehensive investigation into the molecular and functional basis of 17D vaccine responses and into differences between antibody neutralization of the 17D and related African lineage strains to contemporary Central/South American strains, including the emergent YFV ES-504 strain.

Image: https://www.cell.com

Sparking innovation at a Big Pharma with a 150-year history can be difficult, so sometimes it takes some outside perspective to get the ball rolling. That's where Leaps by Bayer comes in.

Bayer's venture arm has invested more than $1.5 billion from the balance sheet in the past six years to make bets on disruptive technologies.

Image: Jürgen Eckhardt, M.D., is the head of Leaps by Bayer, the Big Pharma's venture investing arm. (Bayer)

This week, HealthLeaders speaks with Ricardo Johnson, CEO of Healthworx—the innovation and venture capital (VC) arm of CareFirst BlueCross BlueShield. Johnson details the plan's approach to venture decisions and how the best investments are those that increase equity and affordability while benefiting the entire healthcare delivery system.

In a bid to keep and grow its flagship biohealth sector, Montgomery County is dramatically streamlining its regulatory review process for industry players who want to build or expand big lab facilities.

A new zoning text amendment, which the County Council unanimously approved Tuesday, will slash the lab entitlement process time from nearly two years to six months in an effort to “roll out the red carpet” for biotech industry leaders, said Councilman Andrew Friedson, D-District 1, who spearheaded the legislation.

Image: Montgomery County Councilman Andrew Friedson, D-District 1, speaks at a county event to unveil a new zoning process change. The Wednesday gathering was held outside of biotech United Therapeutics' Silver Spring campus. DAN BRENDEL

WILMINGTON, Del.--(BUSINESS WIRE)--Amalgam Rx, Inc., a leader in connecting healthcare providers, payers, and life sciences companies through a SaaS-enabled digital marketplace and product platform, and Privia Health Group, Inc., a national physician enablement company, announced a collaboration for multiple EHR-integrated services.

Leveraging Amalgam’s real-time, point-of-care decision support engine, the companies are working together to simplify and enhance the way providers practice value-based care, recruit for clinical trials, and ensure medication safety. Privia Health selected several offerings from Amalgam’s marketplace including:

Image: https://www.businesswire.com

The University of Maryland named Dr. Dean Chang as its new interim chief innovation officer and associate vice president for innovation and economic development of the research division, according to an email Monday from the interim and incoming vice presidents for research.

Chang served as founding associate vice president for innovation and entrepreneurship for this university’s Academy for Innovation and Entrepreneurship over the last nine years. In the position, he worked with more than 41,000 students in all 12 of the university’s colleges and schools in innovation, the email said.

Image: As the interim chief innovation officer, Dean Chang will oversee the Discovery District. (Jordyn Salow/The Diamondback)

The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs of the National Institutes of Health (NIH) supported the development of 99 drugs from 1996-2020 — a total that includes 16 percent of all such treatments that made a “significant” advance over available medicines. This finding is just one of the impacts that the National Academies of Sciences, Engineering and Medicine (NASEM) attributes to the program in a new report.

The Ellume COVID-19 Home Test is an over-the-counter, rapid self-test which detects SARS-CoV-2 antigen. The test is suitable for ages 2 years and above for over-the-counter home use in the U.S*. Clinically proven for use for people with and without symptoms, with accurate test results in 15 minutes.

Image: https://www.ellumehealth.com

While COVID has most certainly been top-of-mind for companies working to combat infectious disease, we must not forget the other microbes out there that are still cause for concern. 

Tuberculosis (TB) is a prime example. Most have heard of this disease, but probably in the context of their history classes. You might be surprised to hear, then, that tuberculosis caused an estimated 1.5 million deaths in 2020, making it second only to COVID as the leading cause of death due to an infectious agent.

Image: https://biobuzz.io