Join us for an enlightening episode of BioTalk with Rich Bendis as we welcome Dan Berglund, President and CEO of SSTI. With nearly four decades of experience in tech-based economic development (TBED), Dan has been a pivotal figure in shaping the landscape of innovation and entrepreneurship across the nation.

In this episode, Dan shares the history and evolution of Technology Based Economic Development, discussing key initiatives in states like Ohio and Pennsylvania, and at the federal level. He highlights the importance of partnerships, detailing a compendium of state and federal cooperative technology programs that have driven progress in the field.

We explore the early years of SSTI, looking into its creation, mission, and initial goals, and how it has grown to support a nationwide network dedicated to fostering tech-based economies. Dan discusses the evolution and growth of state TBED programs, and the changing role of the federal government in supporting these initiatives through agencies like STCS, OSTP, Commerce, NIST, and EDA.

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Dan also emphasizes the importance of private/public TBED partnerships, sharing insights into how these collaborations have bolstered economic growth and innovation. As he prepares to step down from his role after 28 years,and assume a part time role,  Dan discusses the recruitment of a new CEO and reflects on SSTI's achievements, his legacy, and his vision for the organization's future.

Additionally, Dan talks about Rich Bendis’s role as an original founding board member of SSTI, and his significant help in the early development of the organization. He also highlights the presence of several SSTI members in the BioHealth Capital Region.

College Park, Md.—The University of Maryland was spotlighted for its innovative curriculum and robust student engagement in entrepreneurship at the annual Deshpande Symposium on Innovation and Entrepreneurship in Higher Education held June 12-14 in College Park.

UMD was presented with the Entrepreneurial University Award, an annual honor given to an institution that exemplifies excellence in fostering an entrepreneurial culture across its campus.

“Students, faculty, staff and alums of the University of Maryland have a long and inspiring tradition of innovation that spans the arts, humanities and sciences – from Google and Beyond Meat to The Muppets and Under Armour,” said University of Maryland President Darryll J. Pines. “This award from the Deshpande Symposium will undoubtedly help our university build upon a distinguished past and present in innovation and entrepreneurship.”

By Tammi Thomas – Chief Development and Marketing Officer, TEDCO - Jun 17, 2024

Montgomery County, Maryland, is home to a thriving ecosystem of innovators and researchers who continuously work to enhance our daily experiences. TEDCO, the Maryland Technology Development Corporation, empowers these entrepreneurs by providing crucial funding and resources. Here's how four Montgomery County companies within TEDCO's portfolio are contributing to Maryland's quality of life and supporting a robust entrepreneurial landscape.

GERMANTOWN, MD / ACCESSWIRE / June 14, 2024 / Seraxis, Inc., a regenerative medicine company developing pancreatic islet replacement therapies to transform the lives of patients with Type 1 and insulin-requiring Type 2 diabetes, has been notified that the company is the awardee of a $400,000 Commercialization Program grant from the Maryland Stem Cell Research Fund (MSCRF) that aims to foster Maryland research to enhance and propel stem cell treatments. Seraxis will use the MSCRF grant to accelerate the validation and manufacturing of Seraxis' genetically modified pancreatic cell line (SR-03) that is designed to be a universal allogenic transplant that will not require lifelong anti-rejection immune suppression.

GAITHERSBURG, Md., June 14, 2024/PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that it has submitted an amendment to its Emergency Use Authorization to the U.S. Food and Drug Administration (FDA) for its updated JN.1 COVID-19 vaccine (NVX-CoV2705) for individuals aged 12 and older. The submission is in line with guidance from the U.S. FDA, European Medicines Agency (EMA) and the World Health Organization (WHO) to target the JN.1 lineage this fall.^1-3 

Novavax's JN.1 vaccine has demonstrated broad cross-neutralizing antibodies against multiple variant strains, including KP.2 and KP.3, indicating the potential to protect against forward drift variants. As discussed at the recent FDA Vaccines and Related Biological Products Advisory Committee meeting, there is a public health benefit to target JN.1, the parent strain of the most common currently circulating variants.

ROCKVILLE, Md. and SUZHOU, China, June 14, 2024 /PRNewswire/ -- Ascentage Pharma (6855 HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, chronic hepatitis B (CHB), and age-related diseases, announced today the signing of an option agreement with Takeda to enter into an exclusive license agreement for olverembatinib, an oral, potentially best-in-class third-generation BCR-ABL tyrosine kinase inhibitor (TKI), which is currently in development for chronic myeloid leukemia (CML) and other hematological cancers. If exercised, the option would allow Takeda to license exclusive global rights to develop and commercialize olverembatinib in all territories outside of among others, mainland China, Hong Kong, Macau, Taiwan, China.

Despite the impact TKIs have had in the treatment of patients with CML, there remains a significant unmet need for patients whose disease is resistant to these therapies or who develop hard-to-treat mutations following these treatments.

COLUMBIA, Md., (June 13, 2024) — The Maryland Innovation Initiative (MII) Board of Directors announces the appointment of Abishek Kulshreshtha as the executive director of TEDCO’s MII program. In this position, Kulshreshtha will oversee all MII activities starting July 1, 2024.

As an independent unit within TEDCO, the Maryland Technology Development Corporation, MII was created to promote the commercialization of research conducted in five of Maryland’s academic research institutions (Johns Hopkins University; Morgan State University; University of Maryland, Baltimore; University of Maryland, Baltimore County; and University of Maryland, College Park) while leveraging each institution’s strengths. This collaborative program has supported more than 170 startup companies, created 370 jobs and procured more than $737 million in follow-on funding since its inception nearly 12 years ago.

WASHINGTON, June 13, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. ("Vanda" or the "Company") (Nasdaq: VNDA) today confirmed that it has received a revised unsolicited proposal from Future Pak, LLC ("FP") to acquire Vanda for $8.50-$9.00 per share in cash plus certain Contingent Value Rights.

Consistent with its fiduciary duties, and in consultation with its financial and legal advisors, Vanda's Board will carefully review and evaluate the revised, non-binding proposal to determine the course of action that it believes is in the best interests of the Company and its shareholders.

ROCKVILLE, Md., June 12, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that Curran Simpson, Chief Operating Officer, has been appointed as President, Chief Executive Officer and a member of the Board of Directors, effective July 1, 2024. Co-Founder Kenneth T. Mills will step down as President and Chief Executive Officer following 15 years of leadership at the Company, and he is taking on an expanded role on the Board as Chairman. In connection with these changes, Board member Daniel Tassé has been appointed as REGENXBIO's Lead Independent Director, a role previously held by Jerry Karabelas, Ph.D. Dr. Karabelas and Co-Founder Allan Fox, who has served as Chairman since 2020, will remain on the Board.

Biotechnology company innovates treatment for pets with lumps, bumps and cancer

COLUMBIA, Md., (June 11, 2024) — TEDCO, Maryland’s economic engine for technology companies, announced a recent $200,000 Pre-Seed Builder Fund investment in Kubanda Cryotherapy. The 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.

“Most pet tumors go untreated, and existing treatment options are inaccessible due to high costs and slow healing times,” said Bailey Surtees, CEO of Kubanda Cryotherapy. “We saw this gap in care and built an alternative, non-surgical solution, which offers less down time and better healing outcomes for pets. With TEDCO’s support, we can continue our mission of breaking down barriers to high-quality care.”

COLUMBIA, Md., (June 11, 2024) — Program Updates Unveiled for TEDCO’s Maryland Innovation Initiative TEDCO, Maryland’s economic engine for technology companies, announced recent changes to the Maryland Innovation Initiative (MII) program that will enhance efforts to support bringing innovative research to market. A collaboration between the State of Maryland and the five academic research institutions, MII’s goal is to foster the transition of promising technology and research developed in qualifying university labs to the commercial sector.

“With nearly 12 years of progress, research and continued support, we have witnessed several university researcher’s and faculty’s journey to commercial success,” said Renée Winsky, chair of the MII Board of Directors. “With these changes to our processes, we are confident that we will not only continue the overwhelming success but build on it.”

CHARLOTTESVILLE, VA / ACCESSWIRE / June 11, 2024 / KeViRx, Inc., an innovative, early-stage pharmaceutical company, announced today the receipt of $1.99 million in grant funding from the U.S. Department of Defense's Peer Reviewed Medical Research Program. This grant funding will allow KeViRx to advance its first-in-class small molecule platform technology, KVX-053, toward IND for pulmonary microvascular leakage and inflammation during acute lung injury (ALI). In the U.S., ALI affects 200,000 patients every year and can result from viral infection, sepsis, pneumonia or inhalation of chemical toxins. The most severe form of ALI is referred to as acute respiratory distress syndrome or ARDS.

"There are very limited treatment options for patients with ALI and 40% will die of ARDS," KeViRx Co-founder John S. Lazo said. "KVX-053 is a host-directed, insult-agnostic small molecule that targets the central pathways that are dysfunctional in ARDS. If we are successful, KVX-053 would be transformative for this disease."

BALTIMORE, MD, US, June 10, 2024 /EINPresswire.com/ -- Linshom Medical, a start-up medical device company was selected to present at the TechConnect World Innovation Conference on June 18, 2024 in Washington DC. After a competitive evaluation of over 100 applications, Linshom Medical was chosen as 1 of 13 companies to present at the Medical Threat Reduction Challenge, to an expert panel of judges, including federal funders, Medical CBRN Defense Consortium (MCDC) representatives, investors, and private corporations for a chance to earn a portion of $50,000 in non-dilutive prize money.

Linshom Medical is first to deliver an operating room quality respiratory profile to the patient bedside for continuous, predictive respiratory monitoring (CPRM). Recent data shows that the wearable, FDA cleared sensor provides health care providers 15 minutes of advance notice of respiratory decline compared to current standard of care. Clinical care team intervention during this early notice window is typically simple and inexpensive vs. the costly later alternatives when patients experience respiratory decline and are in trouble. These include rapid response activation, rescue events (codes), ICU transfers and potentially death.

-- Study Deepens Understanding of Treatments for Alzheimer’s Patients, Enabling More Effective Treatments --

POTOMAC, Md.--(June  10, 2024)--IGC Pharma, Inc. (NYSE American: IGC) (“IGC” or the “Company”), today announced the publication of a significant research article in the European Society of Medicine Journal. The study investigates the effects of CYP2C9 polymorphisms on the pharmacokinetics (“PK”) of delta-9-tetrahydrocannabinol (“THC”) and its active metabolite in Alzheimer’s disease (“AD”) patients.

The publication is titled “A study on CYP2C9 polymorphism in Puerto Rican Alzheimer's Patients and its role in the Pharmacokinetics of ∆-9-tetrahydrocannabinol” and is available at https://esmed.org/MRA/mra/article/view/5380.

PHILADELPHIA, June 07, 2024--(BUSINESS WIRE)--GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved AREXVY (Respiratory Syncytial Virus (RSV) Vaccine, Adjuvanted) for the prevention of RSV lower respiratory tract disease (LRTD) in adults 50 through 59 years of age who are at increased risk. In the US, the vaccine is currently approved for use in adults aged 60 and older and recommended by CDC/ACIP using shared clinical decision-making.

OXFORD, United Kingdom, June 06, 2024 (GLOBE NEWSWIRE) -- Barinthus Biotherapeutics plc (NASDAQ: BRNS), a biopharmaceutical company developing novel T cell immunotherapeutic candidates, today announced the presentation of updated data from two clinical trials in people with chronic hepatitis B (CHB) at the European Association for the Study of the Liver (EASL) Congress 2024. The presentations include updated interim data from the Phase 2b clinical trial (HBV003), as well as new interim EOT data from the Phase 2a clinical trial (IM-PROVE II, AB-729-202) in partnership with Arbutus Biopharma (NASDAQ: ABUS), both in people with CHB receiving ongoing SoC NUC therapy.

ROCKVILLE, Md., June 5, 2024 /PRNewswire/ -- I-Mab (NASDAQ: IMAB) (the "Company"), a U.S.-based, global biotech company, exclusively focused on the development and potential commercialization of highly differentiated immunotherapies for the treatment of cancer, today announced that it has entered into a clinical trial collaboration and supply agreement with Bristol Myers Squibb (NYSE: BMY). The collaboration will evaluate the combination of givastomig, an investigational Claudin 18.2 x 4-1BB bispecific antibody jointly developed by I-Mab and ABL Bio (KOSDAQ: 298380), with Bristol Myers Squibb's immune checkpoint inhibitor, nivolumab, and chemotherapy (FOLFOX or CAPOX), as a potential first-line treatment for patients with advanced Claudin 18.2-positive gastric and esophageal cancers.

REPROCELL USA is proud to announce that it has received funding from MSCRF for both proposals it has submitted for the MSCRF's January 2024 grant cycle. These two grants will help us produce Master Cell Banks (MCB) for cell therapy and enhance our capacity to produce therapeutic cell products.

BELTSVILLE, Md., June 5, 2024 /PRNewswire/ -- REPROCELL is a leader in producing clinically relevant human induced pluripotent stem cells (hiPSCs). These hiPSCs are generated from healthy donors that have been screened for eligibility using the questionnaire established by the US Food & Drug Administration (FDA). Further viral testing is performed to satisfy the requirements of FDA, European Medicines Agency (EMA) and Pharmaceutical and Medical Devices Agency (PMDA) of Japan. The first grant titled: "Generation of human iPSC and MSC MCBs and derivative products in an enclosed GMP system" will help REPROCELL offer two GMP grade cell lines in the next 8 to 12 months for commercialization. These products will be tested for quality and ready for off-the-shelf distribution and further differentiation internally, by other companies in Maryland and the rest of the world. This grant is funded by MSCRF under their commercialization grant that provides funding for commercializing the products.

Company Focused on Bringing Industry-Leading Technology to Market in Food Safety and MedTech Industries 

ALEXANDRIA, Va., June 5, 2024 /PRNewswire/ -- HyperSpectral, the world's first AI-powered spectral intelligence company with hardware-agnostic solutions for particle detection, emerged from stealth today with $8.5 million in a Series A funding round. HyperSpectral's Series A round was co-led by RRE Ventures and  Kibo Ventures with participation from Correlation Ventures, and GC&H Investments. The funds will allow the company to ramp up development of the technology, hire key talent, and create wider AI datasets through lab partnerships and testing.

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Montgomery County, Maryland, is a top destination for the life sciences industry. Pete Briskman, JLL’s Executive Managing Director and Chair of BioHealth Innovation Inc.'s (BHI) Board of Directors, highlights several reasons why.

“Montgomery County is poised well in comparison to other regions,” Briskman said, pointing to its proximity to NIH and FDA and the strong talent pipeline from local universities.

Briskman also emphasized creative real estate solutions and the region’s strengths in cell and immunotherapy research. “Health care isn’t going away,” he noted, reflecting optimism about the sector's growth.

Washington, D.C., June 03, 2024 (GLOBE NEWSWIRE) -- Children’s National Hospital is pleased to welcome Alda Mizaku in a newly established role of vice president and chief data and artificial intelligence officer (CDAIO). In this role, Mizaku will lead the execution of enterprise data, analytics and artificial intelligence (AI) strategy at Children’s National.

Mizaku has a track record of leading initiatives with measurable organizational value, from reducing unnecessary length of stay to enhancing operational efficiency and patient outcomes. Prior to joining Children’s National, Mizaku spent 11 years working for Mercy Health System in St. Louis, where she served in various roles, including executive director of Data Engineering and Analytics, and vice president of Analytics Product Management.

Did you know? Each year, the federal government dedicates around $3.6 billion towards SBIR and STTR programs, resulting in awards to over 5,000 innovative projects!

The next deadline for NIH SBIR/STTR proposals is September 5th. As an innovation intermediary, BioHealth Innovation (BHI) is here to help you secure federal funding.

If you're seeking assistance, don't hesitate to reach out to Jon Nelson at This email address is being protected from spambots. You need JavaScript enabled to view it.. Let's innovate together!

At BioHealth Innovation Inc. (BHI), we are happy to celebrate the achievements of our partner company, miRecule, which has recently been named a winner at the INVEST Pitch Perfect competition. miRecule's innovative approach to RNA therapies represents a significant advance in the treatment of cancer and muscular dystrophy. By leveraging genomic data to design highly specific therapeutics, miRecule stands at the forefront of personalized medicine, underscoring our commitment to supporting ground-breaking healthcare solutions.

This recognition is not just a win for miRecule; it's a testament to the power of strategic partnerships and the impact of innovative biotechnological advances in addressing complex health challenges. BHI is proud to be associated with pioneers like miRecule, as we continue to foster a thriving ecosystem that brings revolutionary treatments from the lab to the patients who need them most.

Join us for an enlightening episode of BioTalk with Rich Bendis, featuring Michael J. Tarlov, Chief of the Biomolecular Measurement Division at the Material Measurement Laboratory, NIST. With a distinguished career in analytical chemistry and extensive experience in biochemical sensing and bioprocess measurements, Michael leads critical initiatives to advance biotechnology and healthcare.

In this episode, we delve into the pivotal role of NIST as a non-regulatory agency within the Department of Commerce, highlighting its profound impact on measurement science, gene therapy, gene editing, synthetic biology, and regenerative medicine. Michael shares insights into NIST's collaborations, including local companies like MedImmune/AstraZeneca and Novavax, and the importance of partnerships with academic institutions like the University of Maryland in driving local biotech advancements.

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COLUMBIA, Md. (May 30, 2024) – The Maryland Stem Cell Research Commission (“the Commission”) announces the release of Requests for Applications (RFAs) for the Maryland Stem Cell Research Fund’s (MSCRF) first funding cycle of fiscal year 2025 (FY25).

RFAs for this initial cycle are now available for five grant programs: Manufacturing Assistance, Clinical, Validation, Commercialization, and Launch. All applications are due by July 9, 2024.

Along with this announcement comes the news that the Commission is also extending grant funding to businesses outside of Maryland for the Commercialization grant program, provided the research activities are conducted within the State. The Clinical grant program is available to entities with at least one clinical site in Maryland.

Venlo, the Netherlands, and Salt Lake City, Utah, May 30, 2024 (GLOBE NEWSWIRE) -- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) and Myriad Genetics (NASDAQ: MYGN) today announced they will develop a globally distributable kit-based test for analyzing Homologous Recombination Deficiency (HRD) status. This next-generation sequencing (NGS) test aims to support research into personalized medicine in multiple solid tumor types, including ovarian cancer and is expected to enhance decentralized testing capacities once a regulated product is developed with pharmaceutical partners. The project builds on the recently announced master collaboration agreement between the two companies.

BALTIMORE, MD, US, May 29, 2024 /EINPresswire.com/ -- Linshom Medical, a Maryland-based startup developing a wearable respiratory monitoring system, announced today that it has been awarded a $100,000 grant from the Maryland Industrial Partnerships (MIPS) program to support a clinical study of its respiratory monitoring device.

The study, “Advanced Prediction of Respiratory Depression Episodes with Linshom Continuous Predictive Respiratory Monitoring (CPRM),” will evaluate the Linshom Medical device's ability for early detection of patient respiratory decline in the Post Anesthesia Care Unit. Dr. Samuel M. Galvagno, Executive Vice Chair of Anesthesiology and Interim Chair of the Department of Anesthesiology, will lead this effort for UMSOM as the principal investigator.

NEW YORK – AMPEL BioSolutions is recruiting individuals with systemic lupus erythematosus (SLE) into an observational study of its blood-based prognostic gene expression assay LuGene to demonstrate a correlation between test results and standard clinical evaluations.

In addition, the company has been conducting a study to see whether different lupus subtypes as defined by its test correlate with therapeutic response.

These studies follow another one published in October in the journal Genome Medicine that showed evidence for eight transcriptionally defined SLE endotypes, or subgroups, and demonstrated LuGENE’s ability to predict patients at risk for episodes of worsening symptoms called flares with high sensitivity and specificity.

MANASSAS, Va.--(BUSINESS WIRE)--ATCC, the world’s premier biological materials management and standards organization, today announced that it has been awarded a task order with a ceiling value of $15.5 million, inclusive of base and options, by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). Under this task order 75N93019D00002-75N93024F00001, ATCC will develop well-characterized challenge material (WCCM) for the In Vitro Assessment for Antimicrobial Activity (IVAAA) program. This program aims to evaluate candidate countermeasures against microbial pathogens and vectors, including those derived from clinical specimens. The assessments are conducted in vitro and focus on antiviral screening assays for biosafety level (BSL)-3/4 viruses relevant to human diseases, as well as other rapidly emerging viruses that employ similar assay methodologies.

The acquisition adds two proprietary clinical technologies to its portfolio and enhances Precision's global capabilities in clinical data management, biostatistics and programming.

BETHESDA, Maryland, May 29 – Precision for Medicine, a global leader in biomarker-driven clinical research and development supporting life sciences companies, today announced the acquisition of Algorics, one of the fastest-growing clinical technologies and biometrics service providers to the biopharma industry. The addition of Algorics brings two innovative clinical technologies and further bolsters Precision for Medicine’s reach in the Asia-Pacific region. The acquisition also enhances Precision's global capabilities in clinical data management, biostatistics, and programming.

COLUMBIA, Md., (May 29, 2024) — TEDCO, Maryland’s economic engine for technology companies, unveiled the recently completed “Cybersecurity Workforce Analysis and Study” (“Study”). The Study was commissioned by TEDCO to better understand the current status of Maryland’s cybersecurity workforce pipeline. This knowledge will be used to guide the Cyber Maryland Program (“Program”) and its 18-member board of directors as they develop a statewide cybersecurity workforce development strategic plan.

“The Study confirms what businesses and government agencies in Maryland already know: demand for skilled cybersecurity professionals—who protect our communities from criminals threatening our way of life—is incredibly nuanced. Thankfully, there is support and momentum amongst key stakeholders to bridge our talent gap,” said Roger Austin, chair of the Cyber Maryland board of directors. “My fellow board members and I are committed to address this critical need by developing innovative solutions to overcome our cyber skills talent gaps and provide good, paying jobs for our state’s residents.”

GAITHERSBURG, Md., May 29, 2024 (GLOBE NEWSWIRE) -- Today, Georgiamune Inc., a privately held, clinical-stage biotechnology company, announced the clearance of its second Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for GIM-531, a first-in-class oral treatment that selectively targets T-regulatory cells and spares other immune cells such as CD4 and CD8. The news comes just on the heels of the company’s first-in-class, dual-functioning antibody, GIM-122, progressing to clinical trial for human testing.

BioHealth Innovation Inc. (BHI) congratulates the outstanding winners of the 2024 ICON Awards announced by the Maryland Tech Council. These awards recognize the incredible contributions of individuals and companies in the fields of technology and life sciences, highlighting their impact on millions of lives.

AstraZeneca: with a member of our BHI Board of Directors, Tyrell Rivers, Ph.D., has been honored as the Life Science Company of the Year. Their continued dedication to advancing healthcare through groundbreaking research and development is truly commendable.

Nanochon: We are particularly proud of Nanochon and Benjamin Holmes, the recipients of the Chief Executive Officer of the Year—Life Sciences award. Nanochon is a previous winner of our BioHealth Capital Region Crab Trap, and it’s exciting to see their sustained excellence and innovation being recognized on a larger stage.

Solaxa: A special congratulations to Solaxa, who was awarded the Venture Mentoring Services Venture of the Year. We are pleased to note that two members of Solaxa's leadership team, Luis T. Gutierrez, Jr. and Jennifer Butler, are part of the BHI/Montgomery County Executive-In-Residence Program. This recognition underscores their remarkable leadership and commitment to advancing technology and life sciences.

ROCKVILLE, Md., May 23, 2024 (GLOBE NEWSWIRE) -- Theriva™ Biologics (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) has granted Fast Track Designation (FTD) to lead clinical candidate VCN-01 in combination with gemcitabine and nab-paclitaxel to improve progression-free survival and overall survival in patients with metastatic pancreatic adenocarcinoma. In VIRAGE, the ongoing multinational Phase 2b clinical study, intravenous VCN-01 is being evaluated in combination with standard-of-care (SoC) chemotherapy (gemcitabine/nab-paclitaxel) as a first line therapy for patients with pancreatic ductal adenocarcinoma (PDAC). Previously, the FDA granted orphan drug designation to VCN-01 for treatment of PDAC.