As Dr. Kurt Newman, President and CEO of Children’s National Hospital, prepares for retirement, BioHealth Innovation, Inc. (BHI) honors his exceptional contributions and visionary leadership in pediatric health and the BioHealth Capital Region. Since assuming the role of CEO in 2011, Dr. Newman has championed patient-centered care and driven innovation in research, operations, and clinical practices at Children’s National Hospital.

Under his guidance, Children’s National has formed successful partnerships with health systems, government entities, and community organizations, boosting pediatric healthcare forward and benefiting countless children and families. Dr. Newman’s advocacy for expanding mental health access for kids has significantly impacted many. He has led national forums on this critical issue, raising awareness and integrating mental health support within pediatric care.

Maryland company focused on innovating solutions for complex brain surgeries

COLUMBIA, Md. (June 26, 2023) – Jesse Christopher, Longeviti co-founder and CEOTEDCO, Maryland’s economic engine for technology companies, announced a $500,000 State Small Business Credit Initiative (SSBCI) investment into Longeviti Neuro Solutions, LLC (Longeviti). This SSBCI investment came out of TEDCO’s Venture Funds.

“We saw an opportunity to improve the lives of patients undergoing complex surgeries, and we’re glad we took it,” said Jesse Christopher, Longeviti co-founder and CEO. “Thanks to TEDCO’s investment, we can continue innovating, working towards solutions and helping patients.”

Are you curious to discover how experts navigate the complex landscape of life sciences real estate? Want to stay ahead of the curve in the market today? Ready to learn about the latest talent dynamics in the field?

Join Rich Bendis on BioTalk as he discusses the world of life sciences real estate and market trends with CBRE’s experts, Dan Grimes, Senior VP at CBRE’s Mid-Atlantic Life Sciences practice, and Ian Anderson, Senior Director of Research and Analysis. Together, they discuss the 2023 “US Life Sciences Research Talent Report” and the BioHealth Capital Region’s Top 3 ranking.

Discover how Dan’s expertise in real estate strategies for BioHealth companies and investors shapes success in the industry. Gain valuable insights from Ian’s extensive experience in commercial real estate and capital markets as he guides decision-making in the life sciences, office, and healthcare sectors. They discuss major BioHealth projects, delve into talent dynamics, and analyze market trends.

Modifying patients’ T-cells with mRNA to express a chimeric antigen receptor (rCAR-T therapy), a novel approach to treat myasthenia gravis and other autoimmune diseases.

Gaithersburg, MD—June 22, 2023 – Cartesian Therapeutics, a clinical-stage biotechnology company pioneering cell therapies for autoimmune diseases, announced today the publication of a landmark paper in The Lancet Neurology. The study describes Descartes-08, a cutting-edge RNA CAR-T (rCAR-T) therapy administered to patients with generalized myasthenia gravis (MG), a debilitating autoimmune neurological disease. The data demonstrate marked and long-lasting clinical improvement in patients with MG. This is the first clinical trial using rCAR-T to treat autoimmunity, and the first successful Phase 2 trial using an engineered cell therapy to treat autoimmunity.

Maryland life sciences company fighting antibiotic resistance, one innovative tech at a time

COLUMBIA, Md. (June 22, 2023) – TEDCO, Maryland’s economic engine for technology companies, announced a Seed Funds investment of $250,000 into Astek Diagnostics, a life sciences company fighting antibiotic resistance through innovative technology. In addition to this investment through the Life Sciences Investment Fund – a funding opportunity under the umbrella of TEDCO’s Seed Funds – Astek Diagnostics has received an additional $325,000 from the State Small Business Credit Initiative (SSBCI) funding.

The transformational investment is one of the hospital’s largest donations ever. It will power discoveries and revolutionize care for children and families who receive a brain tumor diagnosis.

June 21, 2023 - Children’s National Hospital announced a $96 million investment from an anonymous donor family that strengthens its globally recognized leadership to transform rare childhood brain tumor research and care. It is one of the largest donations in the hospital’s history. It allows Children’s National to recruit more top talent and advance the most promising research for safer, more effective treatments. The investment will elevate standards of care to help children with rare brain tumors thrive for a lifetime.

ANNAPOLIS, MARYLAND, UNITED STATES, June 20, 2023/EINPresswire.com/ -- The study, “Advanced Prediction of Respiratory Depression Episodes with Linshom Continuous Predictive Respiratory Monitoring (CPRM)” began patient enrollment in March, 2023 and has enrolled over 90 patients; more than half of the enrollment target for phase one of the study.

“This study intends to prove Linshom Medical’s ability for early detection of patient respiratory decline”, said Richard Hughen, CEO. “Current standard of care and technology provide warnings after the patient is in trouble. If we get in front of this with predictive capability, we should be able to avoid costly rapid response activation, rescue events and ICU transfers”.

Sykesville, Maryland – June 20, 2023
Noble Life Sciences, a leading contract research organization in Maryland, is proud to announce that it has received renewed accreditation from the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International. This recognition validates Noble’s responsible treatment of animals in its research, solidifying it as a top-tier organization serving the biotechnology, biopharmaceutical, and pharmaceutical industries.

As the AAALAC is the foremost authority in accrediting animal care and use programs for research, testing, and teaching worldwide, accreditation from AAALAC International is a significant achievement. With its rigorous evaluation process and commitment to ensuring ethical treatment of animals, AAALAC has become the trusted accreditation agency for professionals across the globe.

GERMANTOWN, Md. , June 20, 2023 /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 that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for the first-in-class investigational PRGN-2012 AdenoVerse immunotherapy for the treatment of recurrent respiratory papillomatosis (RRP).

FDA's Breakthrough Therapy Designation expedites the development and review of medicines which are intended to treat serious or life-threatening diseases, and in which preliminary clinical evidence demonstrates substantial improvement on clinically significant endpoints over available therapies.

— New Financing of $24 Million Fully Funds the Phase 2 Clinical Program for Lead Candidate VLX- 1005

— Company Prepares to Evaluate VLX-1005 in Heparin-Induced Thrombocytopenia (HIT)

FREDERICK, Md., June 20, 2023 (GLOBE NEWSWIRE) — Veralox Therapeutics, a clinical-stage biotechnology company developing a new class of therapies targeting the 12-lipoxygenase (12-LOX) pathway to address some of medicine’s most persistent and serious immune-mediated diseases, today announced the appointment of Jonathan Mow as the company’s new chief executive officer.

Mr. Mow’s appointment comes as Veralox secured $24 million in funding to advance VLX-1005 through a Phase 2a proof-of-concept study evaluating its impact on heparin-induced thromobcytopenia (HIT), a life-threatening rare disease caused by an aberrant immune response to heparin exposure. The investment round included new investors Pappas Capital and NYBC Ventures and existing investors Hatteras Venture Partners, Sanofi Ventures, JDRF T1D Fund and Genesys Capital, amongst others. In conjunction with the financing, the company welcomes Peter Young of Pappas Capital as a director and Meg Wood of NYBC Ventures as an observer.

BioHealth Innovation, Inc. (BHI), in collaboration with the Global Business Center (GBC) – Washington, D.C. of Korea SMEs and Startups Agency (KOSME), is excited to announce the continuation of their highly successful program aimed at facilitating Korean companies' entry into the US market. As the program enters its third year, it continues to empower Korean biotech enterprises, enabling them to establish a strong foothold in the BioHealth Capital Region. KOSME is a Korean-government funded non-profit, currently led by President, Dr. Hakdo Kim, created over forty years ago to support small and medium enterprises in Korea.

"We are thrilled to continue our partnership with BHI for the third year in a row. The program has consistently provided guidance and market knowledge, proving invaluable to Korean biotech companies. We anticipate that our latest cohort will benefit greatly from this collaboration," says Rich Bendis, President and CEO of BHI.

BioHealth Innovations (BHI) is thrilled to welcome Ashleigh Acker and Sebastian Chung as the newest additions to our internship program. Their diverse backgrounds and passion for biotechnology make them valuable assets to our organization.

Sebastian Chung, a graduate student at Johns Hopkins University, is on track to complete his Master's in Biotechnology in the spring of 2024. During his undergraduate years at the University of Washington in Seattle, Sebastian excelled in the study of physiology and sales, all while co-captaining the men's club golf team. His expertise lies within the multi-omic space, having worked as an account manager at NanoString Technologies, a leading biotechnology company. Sebastian's extensive experience in consulting on sequencing and spatial biology projects, particularly with large pharmaceutical companies in the greater New England area, will undoubtedly contribute to our innovative research initiatives. When he's not immersed in the world of biotechnology, Sebastian enjoys playing golf and watching premier league soccer.

In this captivating episode of BioTalk, Rich Bendis sits down with Tom Sadowski, the Executive Director of the Maryland Economic Development Corporation (MEDCO). With over 30 years of experience in economic development, Tom has played a pivotal role in translating vision into action. Together we explore MEDCO’s significant contributions to economic development and their strategic partnerships across Maryland.

Tom shares his remarkable career accomplishments, including successful projects valued at over $10 billion and the creation of 50,000 jobs. His expertise in fostering research partnerships, technology commercialization, and his role in launching the Maryland Momentum Fund bring invaluable insights to the conversation. We uncover MEDCO’s focus on real estate development, financing, infrastructure, and public/private partnerships, all aimed at fueling business retention, development, and employment growth.

The long-anticipated intramural licensing impact study was officially released in conjunction with the BIO Annual Meeting and is now posted to a special section of the NIH Community Tech Transfer Website for further reading and utilization.

The year-long study involved a full download and analysis of NIH TechTracs licensing data and demonstrates the true impact and power that our NIH intramural licensing program has had in three major areas:

AlphaTech, an esteemed initiative focused on fostering innovation within the cybersecurity, big data, analytics, and digital health sectors, is thrilled to announce the induction of a new cohort consisting of exceptional companies. The program, designed to engage with Founders and CEOs of emerging growth companies, aims to provide valuable resources, educational programming, networking opportunities, and meaningful interactions.

Over the course of eight months, this select group of CEOs will have the privilege of connecting with AlphaTech's advisors, speakers, alumni, and industry luminaries. The program's comprehensive approach encourages collaboration and knowledge sharing, ensuring participants gain insights from experienced professionals and industry veterans.

Neuroene Therapeutics has been awarded a Small Business Innovation Research (SBIR) grant by the National Institutes of Health (NIH). The award supports Neuroene’s ongoing research and development of a novel class of well-tolerated compounds protects and ameliorates mitochondrial and neurological diseases.

Neuroene’s lead antiseizure drug (ASD) candidate has demonstrated broad-spectrum antiseizure activity in several animal models of pharmacoresistant seizures and Parkinson’s disease, showcasing its potential both as a fast-acting rescue agent and long-term chronic therapeutic. Intriguingly, the compound’s stability offers significant advantages for long-term storage and stockpiling in case of public health emergencies or bio-incidents.

Frederick-based biopharmaceutical company Theradaptive Thursday announced it has closed a $26 million Series A funding round to advance development of its targeted regenerative therapeutics.

The funds are intended to enable the company to continue its work to meet regulatory requirements and scale up Good Manufacturing Practices in preparation for first-in-human clinical trials later this year. Investment will also support the expansion of the Theradaptive platform beyond orthopedics to additional indications such as oncology and dental. The round brings Theradaptive’s total funding to more than $50 million.

The company has previously been awarded non-dilutive grant funding from the Department of Defense, as well as the Maryland Stem Cell Research Fund.

Click here to read more via The Daily Record.

Countless medicines of tomorrow are being developed right here today — many in Montgomery County, among the country’s top life sciences hubs.

Here’s a look at three potential medical breakthroughs now in development at some of the region’s bioscience firms, how they got there and what to expect next.

Local life sciences, at a glance

Greater Washington and Baltimore combined to be the fifth-largest life science employment cluster in the United States, with roughly 75,000 in the workforce as of the second quarter of 2022, according to an April 2023 CBRE research report. The regions above it: San Francisco Bay Area, Boston/Cambridge, New Jersey and San Diego.

Maryland health technology company developing innovative medicine solutions to promote more personalized care

COLUMBIA, Md. (June 14, 2023) – TEDCO, Maryland’s economic engine for technology companies, announced a recent Seed Funds investment of $250,000 into Aidar Health, Inc., a health technology and digital medicine company. TEDCO’s Seed Funds invest in early-stage, technology and life sciences companies and provide access to gap financing.

On Monday, June 5, 2023, members of the University of Maryland's Center of Excellence in Regulatory Science and Innovation (M-CERSI) met with Korean Regulatory Science Center (KRSC) members Dr. In-sook Park and Mi-rim Baek. Dr. Kyenghee Kwon, a representative from Dongguk University, was also in attendance. The meeting was hosted by Dr. Jim Polli, M-CERSI Co-Director, at the University of Maryland, Baltimore, in the School of Pharmacy building. 

"It is an exciting endeavor to work with the Korean Regulatory Science Center and its universities," said Dr. Bill Bentley, M-CERSI Co-Director. "I am delighted to see M-CERSI's success inspire others." 

At the meeting, the KRSC expressed interest in sending students to participate in UMB’s Master of Science and Graduate Certificate in Regulatory Science, in addition to learning more about the projects, financials, and activities of M-CERSI to learn how to run a similar organization in Korea. 

The KRSC team plans to host their own version of M-CERSI's America Got Regulatory Science Talent Competition in July, with eight universities and colleges participating. The KRSC competition, open to undergraduate students, has more than 17 teams formed already. The goals of the competition are to spread positive regulatory science awareness and encourage the next generation of scientists.

Click here to read more.

Addimmune will build upon the success of American Gene Technologies Phase 1 HIV clinical trial, accelerating the clinical development with dedicated investment and singular focus on HIV.

American Gene Technologies, a clinical-stage biotechnology company based in Rockville, Maryland, is launching a new company — Addimmune — to continue to develop gene and cell therapy technologies to cure HIV. Addimmune will focus solely on advancing an HIV cure, building upon more than a decade of work by AGT that led to a successful Phase 1 HIV gene and cell therapy clinical trial.

Addimmune aims to create tremendous benefits for HIV patients, payers, and the public. Its gene therapy technology has the power to transform millions of lives. The new company’s name represents a fusion of two fundamental concepts: using gene and cell therapy to add new capacity to the human T cell to create an improved immune system to fight HIV.

By Alex Keown
June 8, 2023

This article is sponsored by Noble Life Sciences, a Maryland-based preclinical CRO with distinct expertise in the cell and gene therapy space. Reach out or request a quote to see how they can support your business.

Contract research organizations (CROs) are an essential key to a thriving life sciences ecosystem. Maryland is home to multiple CROs that provide broad support to the development of therapeutics across a broad spectrum of disease indications.

Maryland biotechnology company creating methods for more efficient and reliable research

COLUMBIA, Md. (June 8, 2023) – TEDCO, Maryland’s economic engine for technology companies, announced a recent State Small Business Credit Initiative (SSBCI) investment of $300,000 into Nanocrine, a biotechnology company.

“Without a steady and reliable foundation, research can be unreliable and unpredictable,” said Patrick Calhoun, president and chief science officer of Nanocrine. “Unfortunately, this is where many researchers are when studying living cells; many surfaces that cells interact with are uncharacterized or not made with appropriate lab-specific protocols—Nanocrine is working to change this and advance the scientific research and exploration of living cells.”

New agreement will allow more collaboration to advance technology and life sciences innovations across the state

COLUMBIA, Md. (June 7, 2023) – TEDCO, Maryland’s economic engine for technology companies, announced the signing of a Partner Intermediary Agreement (PIA) with the National Cancer Institute Technology Transfer Center (NCI TTC).

“NCI and TEDCO have collaborated for more than a decade on a variety of initiatives to bring the latest advancements in cancer research and technology to the public through Maryland businesses. These collaborations have helped create a thriving innovation ecosystem that benefits both patients and the economy,” said Tom Stackhouse, PhD, director, NCI TTC.
This agreement will codify the relationship between NCI and TEDCO, allowing the two organizations to help promote and foster more opportunities for Maryland’s life sciences community to work together with NCI on cooperative research.

Recently recognized as a Great Place to Work in the US for the second consecutive year, PQE Group, the woman-owned global consulting company, announces its mission towards innovation in the development of therapies for women’s health challenges.

A year after the foundation of GQC, an internal start-up of the Group focused on medical cannabis therapy solutions, Gilda D’Incerti - CEO and Founder of the company – is now dedicating her interest to FemTech (Female Technology) and the so-called SHEconomy: these primary market trends forecast tremendous growth in terms of profit and growth in the next decade, accelerating drug development for women’s health and well-being.

Maryland biotech company revolutionizing point-of-care testing for viruses and environmental toxins

COLUMBIA, Md. (June 7, 2023) – TEDCO, Maryland’s economic engine for technology companies, announced a $500,000 State Small Business Credit Initiative (SSBCI) investment into Hememics Biotechnologies, Inc., a biotechnology company. The investment came through TEDCO’s Venture Funds.

"I am extremely proud of what the company has achieved," said John Warden, Jr., CEO and co-founder of Hememics Biotechnologies, Inc. "We have generated favorable results from more than 100,000 biosensor tests in the past nine months. The new funding will allow us to put the final touches on our product, and continue to develop early commercial customers."
Hememics Biotechnologies, Inc., based in Gaithersburg, Md., is using graphene monolayer biosensors to revolutionize point-of-care testing for viruses and environmental toxins. The HemBox™, a cellphone-sized reader and chip platform, allows users to test for multiple viruses and toxins from samples as diverse as soil, water, saliva and blood.

Maryland healthcare technology company receives additional funding to support their efforts to improve patient outcomes

COLUMBIA, Md. (June 6, 2023) – TEDCO, Maryland’s economic engine for technology companies, announced a recent investment of $350,000 into Tao Treasures LLC, DBA NanoBioFAB, a woman- and minority-led healthcare technology company. The most recent funding for NanoBioFAB comes from TEDCO’s Builder Fund.

This recent investment, combined with previous TEDCO funding, resulted in another opportunity for NanoBioFAB—$550,000 in Phase II enhancement funding from the Defense Health Agency (DHA) SBIR office. Xiaonao Liu, PhD, founder and CEO of NanoBioFABThe Department of Defense used the two TEDCO investments to deploy a funding match, providing NanoBioFAB with more support to continue their research and innovation.

Recent global disease outbreaks have had devastating impacts, triggering a renewed emphasis on preparation for potential known and unknown health threats. By proactively enhancing preparedness against emerging pathogens, we aim to minimize the scale of future outbreaks, protect vulnerable populations, and ultimately safeguard our health security. 

To that end, Johnson & Johnson Innovation, together with the Biomedical Advanced Research and Development Authority (BARDA), is proud to launch the BLUE KNIGHT™ QuickPitch: Activating for the Future. Innovators are invited to submit potentially ground-breaking ideas or technologies that aim to enhance preparedness toward future known and unknown health threats, including emerging pathogens.

Up to 10 innovator(s) with the best potential solution will earn the opportunity to pitch to a panel of industry experts including Johnson & Johnson and BARDA leadership at JLABS @ Washington, DC on August 29. ** In addition, applicants may be invited to join Blue Knight through residency at the hub at JLABS @ Washington, DC, based on their applications and/or presentations.

**No travel costs will be reimbursed for applicants to attend live pitch event in Washington, DC.

For more information on this challenge, click here.

It was an extraordinary achievement. In less than one year, the biomedical ecosystem helped bring to life an mRNA vaccine with the power to stave off severe disease and death during the worst pandemic since 1918. Of course, this wasn’t really a miracle. It was just one example of what government and partners can do when challenged to develop disruptive innovations.

Government has been a disruptive force for innovation across many sectors, from Defense Advanced Research Projects Agency (DARPA) laying the foundation for the internet in the 1960s, to the role of the National Institutes of Health’s (NIH) and US Department of Energy in the Human Genome Project, which mapped the full genome for the first time in 2003 with an international consortium of thousands of researchers, to the U.S. President’s Emergency Plan for AIDS Relief initiative that has saved more than 25 million lives from HIV/AIDS across the globe.

Three entrepreneurial leaders discuss the support available through the MII program

COLUMBIA, Md. (June 5, 2023) – TEDCO, Maryland’s economic engine for technology companies, released a new episode of its innovation series, TEDCO’s The Leading Edge. Throughout this series, TEDCO thought leaders host a fireside chat with entrepreneurs discussing their experiences, providing advice to aspiring entrepreneurs, and more.

In this episode, TEDCO’s Maryland Innovation Initiative (MII), UM Ventures and Innovate Maryland come together at the University of Maryland, College Park (UMCP) for a live fireside chat. The discussion included Arti Santhanam, PhD, MII executive director; Ken Porter, UM Ventures, College Park director and MII Board member; and Srinivasa Raghavan, PhD, MII awardee, UMCP professor of chemical and biomolecular engineering, and entrepreneur.

Throughout the discussion, the three leaders dove into the MII program and the various support avenues it provides, as well as the success Raghavan has seen throughout his time with MII.

“It's really important [during] those early stages to have sources of support, not just funding…” said Raghavan. “That is [what’s] amazing about MII… you reach out to people who can support you… MII is a wonderful program… it is there for you, and it could really open doors and take you in a new direction.”

GAITHERSBURG, Md., June 5, 2023 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its novel Matrix-M™ adjuvant, has signed a three-year agreement with the Bill & Melinda Gates Medical Research Institute to provide its adjuvant for use in preclinical vaccine research.

"We are excited to partner with the Bill & Melinda Gates Medical Research Institute to include our unique technology in their public health-focused vaccine research efforts," said John C. Jacobs, President and Chief Executive Officer, Novavax. "Our Matrix-M™ adjuvant is proven to enhance and broaden the immune system response when included in vaccines and is already a key component of COVID and malaria vaccines on the market today. We look forward to partnering more broadly with a variety of organizations so that our technology can benefit vaccine development across many disease areas."

"The Bill & Melinda Gates Medical Research Institute is committed to developing biomedical interventions that address global health concerns for those in the greatest need," said Emilio Emini, PhD, chief executive officer of the Bill & Melinda Gates Medical Research Institute. "We look forward to working with Novavax's Matrix-M™ adjuvant in some of our early-stage vaccine programs."

The CBRE Life Sciences Research Talent 2023 Report underscores the BioHealth Capital Region's consistent position in the top three hotspots for life sciences talent in the United States. The report reveals a booming life sciences industry, with a record number of individuals graduating with degrees in biological and biomedical sciences. Over the past two decades, the number of life science professionals in the U.S. increased by 79%, in contrast to the 8% growth rate across all other occupations. This trend has led to the fastest pace of industry growth on record, particularly rebounding after a downturn in 2020.

Among the specific roles and jobs within the sector, medical scientists have seen the greatest increase. However, the report also notes a fierce competition for talent, with the industry facing a "furious search for talent" to meet escalating demands for its products and services. Despite this overall growth and competitiveness across the country, the BioHealth Capital Region stands out for its ability to attract and retain top talent, as evidenced by its position in the top three.

Charlottesville, VA - June 2, 2023 - The Charlottesville Business Innovation Council (CBIC) has awarded AMPEL BioSolutions, a leading data science company, with the prestigious "Innovator-of-Year" title. The recognition was given to AMPEL BioSolutions for the outstanding AMPEL Genomic Platform, which utilizes RNA analytics and Machine Learning for dynamic disease management, including flare prediction and personalized decision support for drug options.

AMPEL BioSolutions is currently in commercialization mode and making significant progress in executing its platform technology. This year, AMPEL is set to make LuGENE, a blood test, available nationwide in the United States through ReLATE. The CBIC award ceremony was a moment of celebration for the AMPEL team, who thanked Angel Williams Derricott, for her unwavering Advocacy for Lupus & celebrating with the AMPEL team at CBIC unwavering advocate for Lupus, joined.

The life sciences industry is seeing tremendous growth in Maryland, particularly in the D.C. suburb of Montgomery County. With nearly $6B invested in life sciences ventures in 2021 alone and more than 40,000 life sciences workers in the state, Montgomery County is the anchor of the fourth-largest biotech hub in the U.S.

The county’s life sciences market continues to expand its footprint with more biotech and pharmaceutical companies setting up shop in Rockville and other areas, drawn in by its skilled workforce. Also fueling the growth is the Montgomery County Economic Development Corp., which helps companies expand, relocate or start in the county. 

“We have the skilled labor force, the support of local universities, the Maryland Tech Council and a diverse population to help expand life sciences not only in Montgomery County but the state of Maryland,” MCEDC Senior Vice President of Business Development Brad Stewart said.

Precigen Receives FDA Clearance of IND to Initiate Phase 2 Study of PRGN-2009 Off-the-Shelf AdenoVerse Immunotherapy in Combination with Pembrolizumab to Treat Patients with Recurrent or Metastatic Cervical Cancer
Published: May 31, 2023

– HPV is responsible for more than 90 percent of cervical cancer cases globally with approximately 300,000 women living with cervical cancer in the US –

– Current response rates to second line treatments in recurrent or metastatic cervical cancer are very low and associated with a high rate of toxicity –

– PRGN-2009 is designed to generate de novo T-cell immune response against HPV 16/18-positive solid tumors cells and is differentiated from other platforms due to the ability of gorilla adenovectors to enable repeat administrations –

– PRGN-2009 Phase 1 data to be presented at the 2023 ASCO annual meeting on June 3 (Abstract # 2628); PRGN-2009 in combination with a checkpoint inhibitor demonstrated a favorable safety profile and resulted in a 30% ORR in patients with heavily pre-treated HPV-associated cancers, including those who have previously failed checkpoint inhibitors –

– Phase 2 study of PRGN-2009 is in combination with pembrolizumab in the second line setting in patients with recurrent or metastatic cervical cancer previously treated with pembrolizumab for recurrent or metastatic disease –

– CMC path in place to support delivery of product for Phase 2 study as well as future framework to support potential pivotal trials –