Based on AEGEAN Phase III trial results which showed Imfinzi-based regimen reduced the risk of recurrence, progression or death by 32% vs. neoadjuvant chemotherapy alone

AstraZeneca’s Imfinzi (durvalumab) in combination with chemotherapy has been approved in the US for the treatment of adult patients with resectable early-stage (IIA-IIIB) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. In this regimen, patients are treated with Imfinzi in combination with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy after surgery.

More than two years ago, President Joe Biden and First Lady Jill Biden reignited the Cancer Moonshot with the goals of reducing the cancer death rate in the United States by at least half—preventing more than 4 million cancer deaths—by 2047, and improving the experience of people who are touched by cancer. As part of this effort, President Biden and Vice President Harris secured bipartisan Congressional support to establish the Advanced Research Projects Agency for Health (ARPA-H) to generate breakthroughs in ways to prevent, detect, and treat cancer and other diseases. In its first two years, ARPA-H has invested more than $400 million to fast-track progress on how we prevent, detect, and treat cancer.

COLUMBIA, Md., (August 13, 2024) — TEDCO, Maryland’s economic engine for technology companies, is pleased to announce the promotion of Kim Mozingo to vice president of Federal Programs. In this role, Mozingo will lead a suite of seven programs designed to transform federal scientific research into economic growth and new job opportunities for Maryland's small businesses.

“We are pleased to have such a dedicated individual as Kim on the TEDCO team,” said Stephen Auvil, chief federal engagement officer. “Under her leadership, TEDCO’s federal programs have experienced significant growth.  Her management of our SBIR Proposal Lab, DefTech, and other federal programs have supported more than 150 companies.  Moreover, she will be launching several new programs in her area over the next six months.  This promotion is well deserved and reflects her accomplishments and growing responsibilities.”

$2.1M invested in seven companies to advance innovations from lab to market in Maryland

COLUMBIA, Md. (August 13, 2024) — TEDCO, Maryland’s economic engine for technology companies, announced a recent round of investments through its Maryland Innovation Initiative (MII), marking a significant milestone in promoting the commercialization of groundbreaking research from Maryland's prestigious academic institutions.

“The latest awards highlight the innovative research in university labs with tremendous commercial potential across multiple industries,” said Abi Kulshreshtha, Ph.D., executive director, MII. “We are excited to continue MII’s role in advancing Maryland’s innovation-driven economic development strategy.”

Multi-billion-dollar US-based biotech firm United Therapeutics has announced that it has purchased 32 acres (13 hectares) of land in Minnesota, US, for US$4.5 million to construct what it called a state-of-the-art facility, which will support clinical research on using gene-edited pig organs for human patients with heart and kidney disease.

The facility site, which is located outside of Rochester, Minnesota, in Stewartville, is roughly 14 miles (22.5km) south of the world-renowned non-profit academic and research medical centre the Mayo Clinic. While the programme is not currently working with the Mayo Clinic, United Therapeutics noted the proximity helped inform its selection of the site. 

Venture capitalists are inserting a record number of "pay to play" provisions into term sheets, according to new data from law firm Cooley.

Why it matters: This is a sharp-elbowed reminder that VCs are facing performance pressure, and that startups are having a tougher time getting funded.

Jargon watch: "Pay to play" provisions also may be known as "cram down" clauses, and basically are designed to benefit new investors at the expense of existing shareholders who don't want to invest additional capital.

• The critical view is that this is unfair to insiders who took a chance when the company's prospects were more speculative, but who've either lost faith or no longer have money to spend (including early employees or VC funds without adequate reserves).
• The more charitable view is that such rounds are for companies that need money — not those that just want to bolster balance sheets — and that the new investors are vital to the company's future success. In short: Get on board or get out.

BALTIMORE, MARYLAND, US, August 12, 2024 /EINPresswire.com/ -- The study, “Advanced Prediction of Respiratory Depression Episodes with the Linshom Continuous Predictive Respiratory Sensor”, completed enrollment of 508 patients well ahead of schedule.

“Preliminary analysis of the data shows that Linshom Medical’s sensor detects respiratory depression 12 minutes before current systems employed”, said Richard Urman, MD, MBA, the principal investigator of the study. “This gives health care providers additional time to take action and intervene before a crisis develops”.

In a recent article by Genetic Engineering & Biotechnology News, Paul Vulto, PhD, CEO of Mimetas, discusses the growing demand for advanced organ modeling in fields like oncology and metabolic diseases. Mimetas is at the forefront of this innovation, creating sophisticated assays that replicate the complex tumor microenvironment and immune interactions. Their groundbreaking work in liver modeling has produced a life-like liver structure, with significant applications in fibrosis, NASH, and gene therapies, enhancing the accuracy of preclinical testing.

We’re just over a month away from the 2024 BioHealth Capital Region Week, which takes place from September 17th, 18th, and 19th at US Pharmacopeia in Rockville, MD. This milestone event marks a decade of transformative discussions and partnerships. Here’s what each day has in store:

BioHealth Capital Region Forum (September 17th-18th)
Celebrating our 10th Annual Forum with a robust lineup of speakers and panels:

• Updates:
  • GEN Top 10 BioCluster Update with Alex Philippidis, Senior Business Editor, Genetic Engineering & Biotechnology News
  • BioHealth Capital Region Update with Pete Briskman, Executive Managing Director, JLL-Jones Lang LaSalle Incorporated

• Keynotes:
  • John F. Crowley, President & CEO, Biotechnology Innovation Organization (BIO)
  • Robert Stoffel, Vice President of Research, Amgen
  • Craig Gravitz, Director, Project Accelerator Transition Innovation Office, ARPA-H
• Panels:
  • Meet Some of the BioHealth Capital Region’s Med Tech Leaders
  • Virginia: Leading the Way in Advanced BioHealth Manufacturing
  • Transforming Healthcare: Innovations and Future Trends in Digital Health
  • The Baltimore Tech Hub: Implementing Equitech Principles to Build a Thriving Ecosystem for AI and Life Sciences
  • How Emerging AI, Machine Learning, and Quantum Technologies Will Impact Discovery and Regulation of New Drugs and Devices: A Peek Into the Future
  • Collaborative Approaches to Support Innovation in Biotechnology in the Capital Region
  • New BHCR Regional Research Initiatives
  • Entrepreneurs in Residence Supporting the BHCR Ecosystem
  • Inside the BioHealth Capital Region, Accessing Early Stage SSBCI Funding
  • Biomedical Engineering: Meet the Region’s Bio Engineering Academic Leaders

Additional Fireside chats and panels are still being finalized. Please check the event agenda regularly for updates.

(Baltimore, MD) - Longeviti Neuro Solutions, a neurotechnology company with a focus on innovative solutions for complex brain surgeries, proudly announces the issuance of a groundbreaking patent for its novel prosthetic translucent, cranial implant. The ClearFit® implant integrates brain-computer interface (BCI), brain mapping, and neurosonography (brain ultrasound). This product sets a new standard in neurosurgical procedures, marking the first time a single implant has been patented to cover three critical areas. ClearFit’s patented technology was recently on the cover of Science Translational Medicine demonstrating promising research around this implant and neurosonography.*   

The 7th Annual Investment Conference, scheduled for September 19th during the BioHealth Capital Region Week at US Pharmacopeia in Rockville, MD, offers a unique platform for companies and investors. Attendees will have the opportunity to create detailed profiles and schedule face-to-face meetings throughout the day to discuss potential collaborations and funding. Simultaneously, the auditorium will feature a series of quick pitches, providing selected companies and some investors with 7 minutes each to introduce themselves and present their ideas in front of an audience of peers and potential partners.

Why Investors Should Attend

For investors, this conference is an indispensable opportunity to access a curated selection of startups with groundbreaking ideas poised for investment. It offers a chance to engage directly with founders, understand their business models, and evaluate their potential in person. Investors can gain early insights into emerging technologies and trends, potentially leading to profitable investment opportunities and partnerships. Register Now.

Why Companies Should Attend

For companies, the Investment Conference is a vital avenue to meet face-to-face with leading investors actively looking to fund innovative projects and businesses. It provides a platform not only for potential funding but also for valuable feedback and advice on scaling their operations. The quick-pitch sessions offer companies a chance to capture attention, showcase their innovations, and articulate their vision to a room full of potential backers. Register Now.

GAITHERSBURG, Md., Aug. 06, 2024 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) announced the introduction of a new NARCANDirect™ distribution center in Nevada to further demonstrate its commitment to broadening access to NARCAN^® Nasal Spray nationwide. This new facility allows Emergent to further meet the increased demand for naloxone by now having coast-to-coast distribution mechanisms in place to continue to provide faster, more efficient delivery to public interest customers, as well as other purchasing entities.

NARCANDirect™ is an online portal that enables qualified direct purchasers, such as emergency medical services, law enforcement, fire departments, government agencies, schools/universities, and community-based naloxone distribution programs, to purchase and ship NARCAN^® Nasal Spray directly.

Rockville, Md. (August 5, 2024) – Cellphire Therapeutics, Inc., a clinical stage biotechnology company developing next-generation allogeneic cellular therapeutics, announced today that Damien Bates, MD, PhD, FRACS, MBA joined the company as Chief Medical Officer.

Cellphire Therapeutics is excited to announce the appointment of Dr. Damien Bates as Chief Medical Officer. Dr. Bates brings a wealth of experience in clinical development and strategic leadership to the role. In his new position, Dr. Bates will spearhead both strategic initiatives in clinical development and daily clinical operations, driving forward the company’s vision of saving lives with transformative stabilized cellular therapeutics. His track record of success in the clinical development and regulatory approval of multiple allogeneic cell therapies, key opinion leader engagement and operational excellence will be instrumental in advancing Cellphire's innovative pipeline and ensuring the successful execution of its clinical programs. We are thrilled to welcome Dr. Bates to the team and look forward to the impact of his expertise on our continued growth and success.

In this episode of BioTalk, Rich Bendis, President and CEO of BioHealth Innovation, Inc., welcomes guests from ARPA-H: Craig Gravitz, Director of the Project Accelerator Transition Innovation Office (PATIO), and Jenica Patterson, Ph.D., Portfolio Lead at ARPA-H. Together, they provide a comprehensive overview of ARPA-H's mission and innovative programs.

Craig Gravitz and Jenica Patterson share their educational and career backgrounds, setting the stage for a discussion about ARPA-H and its various initiatives. They provide insights into how ARPA-H differentiates itself from other agencies like HHS and NIH, while also highlighting their collaborative efforts.

Listen now via your favorite podcast platform:

Apple: https://apple.co/4dy5wmS
Spotify: https://spoti.fi/3yDIV9k 
Amazon Music: https://amzn.to/3AcL3FI 
TuneIn: https://bit.ly/3LV54Dg

Listeners will learn about the Project Accelerator Transition Innovation Office (PATIO) and its crucial role within ARPA-H. Jenica Patterson discusses her portfolio, including key areas and projects, and provides details on the new women's sprint for health initiative and its funding tracks.

GSK and Flagship Pioneering have entered into a partnership worth up to $7bn to discover and develop novel medicines and vaccines for a range of conditions.

Bringing together GSK’s expertise in disease and development capability via Flagship’s ecosystem of bioplatform companies, the collaboration aims to develop a portfolio of up to ten future medicines and vaccines, beginning in respiratory and immunology, which will each be subject to an exclusive option by GSK for further clinical development.

ROCKVILLE, Md., July 31, 2024 (GLOBE NEWSWIRE) -- Theriva™ Biologics, Inc. (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced that the U.S. Food and Drug Administration (FDA) granted Rare Pediatric Drug Designation (RPDD) for VCN-01 for the treatment of retinoblastoma. VCN-01, Theriva’s lead product candidate, is a systemic, selective, stroma-degrading oncolytic adenovirus. Previously, the FDA granted orphan drug designation to VCN-01 for treatment of retinoblastoma.

HONG KONG, GERMANTOWN, Md. and SUZHOU, China, July 31, 2024 /PRNewswire/ -- Sirnaomics Ltd. (the "Company", Stock Code: 2257.HK, together with its subsidiaries, the "Group" or "Sirnaomics"), a leading biopharmaceutical company engaging in discovery and development of advanced RNAi therapeutics, today announced a partnership with Gore Range Capital LLC ("Gore Range Capital") (Dallas, TX, USA) for establishment of a joint venture, Sagesse Bio, Inc., to advance its novel RNAi therapeutic products into aesthetic medicine.

GAITHERSBURG, Md., July 31, 2024 (GLOBE NEWSWIRE) -- Today, Emergent BioSolutions Inc. (NYSE: EBS) announced the sale of RSDL^® (Reactive Skin Decontamination Lotion) kit to SERB Pharmaceuticals, a global pharmaceutical company, for a purchase price of approximately $75 million. In addition, SERB will pay Emergent a $5 million payment upon achievement of a milestone related to the sourcing of a certain component of RSDL^®. The transaction has signed and closed simultaneously. 

In addition, SERB will acquire and maintain operations of Emergent’s leased manufacturing facility in Hattiesburg, Mississippi, and several site-based employees who support RSDL^® will join SERB. SERB will also acquire the RSDL^® product inventory as part of the transaction and will assume certain related contracts. Emergent’s Winnipeg facility will continue to manufacture and supply bulk lotion to SERB under a long-term supply agreement between the two companies.

GAITHERSBURG, Md., July 30, 2024 (GLOBE NEWSWIRE) -- Today, Georgiamune Inc., a privately held, clinical-stage biotechnology company, announced that the first patient has been dosed with GIM-531 in a first-in-human, phase 1 clinical trial for the treatment of advanced cancer patients. GIM-531 development focuses on indications that are currently not addressed with existing or available immunotherapies including anti-PD-1 antibodies. It is an oral therapy that is a first-in-class selective T regulatory cell inhibitor.

ROCKVILLE, Md., July 30, 2024—The Montgomery County Council voted today to approve the Planning Board Draft of the Great Seneca Plan: Connecting Life and Science with revisions. The plan covers 4,330 acres located in the heart of the I-270 Corridor between the cities of Gaithersburg and Rockville and the town of Washington Grove. The Plan makes recommendations to strengthen the economic competitiveness of the Life Sciences Center, guide future developments, and transform public spaces and amenities in the area to provide valuable links and social spaces. 

“The Great Seneca Science Corridor is one of Montgomery County’s most important strategic areas, as the heart of our globally recognized biohealth industry with world-class research, education, and health care facilities,” said Council President Andrew Friedson who also chairs the Planning, Housing and Parks (PHP) Committee. “This plan builds on that strength by creating a more sustainable and vibrant community with greater connectivity to improve quality of life and economic competitiveness.”

By Dan Brendel – Staff Reporter, Washington Business Journal -Jul 29, 2024 - Montgomery County and Metro have announced a formal partnership and preliminary developer solicitation to pave the way for up to 3.7 million square feet of life science-focused mixed-used development in North Bethesda, the economic development apple of Montgomery County’s eye.

The county and transit authority signed a memorandum of understanding and announced a request for qualifications on Monday, beginning the hunt for a development partner to build a University of Maryland-anchored project, integrated with a new North Bethesda Metro station entrance, on 14 noncontiguous acres of vacant Metro-owned land at the southeast corner of Rockville Pike and Old Georgetown Road.

Read more ...

COLUMBIA, Md., (July 29, 2024) — TEDCO, Maryland’s economic engine for technology companies, announced a recent $100,000 Pre-Seed Builder Fund investment in Azadi Health. TEDCO’s Pre-Seed Builder Fund is housed under TEDCO’s Social Impact Funds which were created to engage and invest in economically underserved founders and communities.

BioHealth Innovation, Inc. (BHI) proudly recognizes the $500,000 investment from TEDCO in Solaxa Inc., a Bethesda-based biopharmaceutical company. Led by Founder & CEO Christian Walker, Solaxa is a clinical-stage biopharmaceutical company developing a portfolio of aminopyridine drugs that both detect and treat ion channel dysfunction. Previous research has shown that aminopyridines can improve nerve signaling and muscle function in patients with Multiple Sclerosis, and Solaxa is presently researching additional benefits in patients with other nerve disorders. Solaxa is organized as a for-profit public benefit corporation, with a mission to advance scientific knowledge and deliver impactful and accessible therapies that improve outcomes for patients worldwide.   

Prior to this investment from TEDCO, Solaxa was recognized as the “Best of Montgomery” finalist at the 7^th Annual BioHealth Capital Region Crab Trap Pitch Competition in September 2023. Even more recently, Solaxa was recognized as “Venture of the Year” by the Maryland Tech Council in May 2024.  

In this episode of BioTalk, Rich Bendis, President and CEO of BioHealth Innovation, Inc., speaks with Alex Philippidis, Senior Business Editor at Genetic Engineering & Biotechnology News. Alex joins the podcast to discuss the latest Top 10 U.S. Biopharma Clusters list, where the BioHealth Capital Region secured its #3 ranking for the second consecutive year.

The conversation highlights the factors that contributed to the success of the top biopharma clusters, focusing on early investments in biotech, the generation of high-quality science, building networks with partners, and broadening clusters beyond anchor businesses. Alex elaborates on how these regions have sustained their scientific excellence and the long-lasting impact of pioneering efforts.

Listening now on your favorite podcast platforms:
Apple: https://apple.co/4bYl81G 
Spotify: https://spoti.fi/3zVLIuU
Amazon Music: https://amzn.to/4d6dBiQ
TuneIn:https://bit.ly/4fBDs3R

July 25, 2024 / By Laura Powers: Researchers in George Mason University’s Center for Infectious Disease Research (CIDR) and Tulane National Primate Research Center conducted a breakthrough proof-of-concept study, published in Nature’s Gene Therapy, that found a human immunodeficiency virus (HIV)-like virus particle that could cease the need for lifelong medications. Scientists have made great strides in the treatment of HIV over the past few decades, yet those with the virus must still take antiretroviral therapy for life as the disease is difficult to eradicate. 

In celebration of the three-year anniversary of JLABS @ Washington, DC (JLABS DC), it’s great timing to highlight recent accomplishments and milestones reached by incubating and regional companies. Additionally, JLABS DC is excited to share new access to specialized lab equipment to support more innovators within the region. 

Since the start of 2024, there has been continued success for incubating companies that reside at JLABS DC. Examples with recent funding announcements include Nanochon, raising $4 million in a Series Seed Prime, Acclinate closing $7 million in a Series A round, and Tiny Cargo securing investment from Virginia Ventures Partners. 

WASHINGTON, July 25, 2024 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (the “Company”), a pharmaceutical company focused on developing new medicines for infectious diseases, announced today that it has been awarded a fixed-price contract with the United States Army Medical Materiel Development Activity to support commercial validation of new bottle and replacement blister packaging of ARAKODA^® (tafenoquine), the Company’s malaria prevention product.

This follows the implementation of an increased tablet compression batch size in Q1 2024, planned in anticipation of increasing sales volume in 2024. Recently, 60 Degrees Pharmaceuticals announced that Q1 2024 ARAKODA net sales revenues increased 515% year-over-year to $105.7 thousand.

Ready to take your business to the global stage? Join the Maryland Global Consulting Program through the Robert H. Smith School of Business Center for Global Business and tap into the vibrant export ecosystem right here in Maryland. Gain invaluable insights and resources to expand your company's global footprint and tackle international business challenges head-on.

Benefits of the Program

1. Customized Consulting Support: Work closely with a dedicated team of business students to develop strategies for global market expansion or address specific international business challenges tailored to your company's needs. Student teams dedicate a minimum of 10 hours per week per semester to a single consulting project. 

GAITHERSBURG, Md., July 25, 2024 (GLOBE NEWSWIRE) -- BullFrog AI Holdings, Inc. (NASDAQ: BFRG; BFRGW) ("BullFrog AI" or the "Company"), a leader in AI-driven drug discovery, announced significant advancements in its ongoing collaboration with the Lieber Institute for Brain Development (LIBD). Building on the progress detailed in our May 16, 2024 release, our research has now pinpointed specific molecular pathways associated with bipolar disorder (BD), enabling the identification of new candidate drug targets.

The BioHealth Capital Region (Maryland, Virginia, and Washington, D.C.) has successfully retained its position as the #3 biopharma cluster in the U.S. for 2024. This impressive ranking underscores the region’s ongoing strength in innovation and investment, highlighted by major expansions and investments from leading companies and institutions. Despite facing some challenges, the region continues to lead in patents, NIH funding, and lab space.

From 

Alex Philippidis' remarks:

The BioHealth Capital Region has generated enough positive news to retain the number-three ranking it earned and celebrated last year. QIAGEN and Frederick County, MD, officials on July 12 announced completion of a 40,000-square-foot expansion of the company’s Frederick, MD, facility, creating a 75,000-square-foot site focused on next-generation sequencing, genomics, clinical healthcare, and forensics. AstraZeneca is investing $300 million in a new manufacturing facility in Rockville, MD, with plans to create 150 new jobs when the site opens in 2026. Across the state line, The University of Virginia is constructing the $300 million Paul and Diane Manning Institute of Biotechnology in Charlottesville; named for chairman and CEO of PBM Capital and his wife.

On July 25, 2024, the FDA will host a significant virtual public meeting, "Home as a Health Care Hub – Stakeholder Listening Session," from 12:00 PM to 4:00 PM ET. This session aims to explore how integrating home environments into the healthcare system can enhance health equity and patient care. The FDA seeks input from various stakeholders to identify both barriers and opportunities in this integration. Additionally, the initiative includes developing VR prototypes for managing conditions like diabetes.

Stakeholders are encouraged to register, participate, and submit comments or presentations ahead of the event.

For more information and registration details, Click here.

GERMANTOWN, Md., July 23, 2024 /PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today announced the appointment of Phil Tennant as the Company's chief commercial officer. Mr. Tennant will be responsible for commercial strategy and execution across US and global markets. His initial focus will be on driving commercial readiness activities for the potential launch of the first- and best-in-class PRGN-2012 AdenoVerse gene therapy in recurrent respiratory papillomatosis (RRP). Mr. Tennant will report to Precigen's President and CEO, Helen Sabzevari, PhD, and will join Precigen's executive leadership team.

ROCKVILLE, Md., July 23, 2024 /PRNewswire/ -- Emmes Group, a leading specialty tech-enabled global contract research organization (CRO), today announced a multi-year strategic partnership with Miimansa AI. A critical pillar of the partnership, aimed at revolutionizing clinical research at Emmes, is the acquisition of Miimansa's Clinical Entity Modeling tools based on advanced large language modeling (LLM) techniques and generative AI.

Artificial intelligence (AI) promises to transform all aspects of healthcare including clinical research. Emmes Group is rapidly maturing its technology platform, Veridix AI, and Miimansa's Clinical Entity Modeling technology will serve as a critical building block to accelerate the development of state-of-the-art automated text processing solutions tailored for clinical research.