Biohealth Innovation
BioHealth Innovation (BHI) was prominently represented at the 2024 J.P. Morgan Healthcare Conference, with several Entrepreneurs-in-Residence (EIRs) in attendance. The insights gathered by these experienced professionals provide a comprehensive view of the current trends, challenges, and opportunities in the biohealth industry. Here's a summary of their observations and thoughts.
GERMANTOWN, Md., Jan. 16, 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 that the European Commission (EC) has granted Orphan Drug Designation for the Company's first-in-class investigational medicine PRGN-2012 for the treatment of recurrent respiratory papillomatosis (RRP). RRP is a rare, difficult-to-treat and sometimes fatal neoplastic disease of the upper and lower respiratory tracts caused by human papillomavirus type 6 (HPV 6) or HPV type 11 (HPV 11). PRGN-2012 received Orphan Drug Designation from the United States Food and Drug Administration (FDA) and Precigen was the first company to receive Breakthrough Therapy Designation and an accelerated approval pathway from the FDA for an RRP treatment.
January 16, 2024 - By This email address is being protected from spambots. You need JavaScript enabled to view it. - Principal Investigator Robert K. Ernst, PhD, the Dr. Paul and Mrs. Jean Corcoran Endowed Professor and chair of the Department of Microbial Pathogenesis at the University of Maryland School of Dentistry (UMSOD) and Distinguished University Professor, has been awarded a five-year, $9.4 million contract from the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID) to continue work developing and testing novel adjuvants for the improvement of vaccines. Ernst was awarded $6.4 million in funding through the same NIAID program in 2018, bringing his total funding for adjuvant development to over $16 million.
ROCKVILLE, Md., Jan. 15, 2024 /PRNewswire/ -- NeoImmuneTech, Inc. (NIT or "NeoImmuneTech"), a clinical-stage T cell-focused biopharmaceutical company, today announces the appointment of Luke Oh, Ph.D., as President, effective immediately.
Dr. Oh is an expert in regulatory policies and drug development, encompassing both biologics and small molecules. He brings over six years of regulatory experience at the U.S. FDA. His recent tenure at Samsung Bioepis as Vice-President in charge of Regulatory Development was marked by the successful preparation and submission of seven biosimilar applications to regulatory agencies in the US, EU, UK, and Canada. Prior to this position, he has worked as Senior Staff Fellow at the U.S. FDA Division of Clinical Pharmacology III and Division of Inflammation and Immune Pharmacology, and he has held various roles in research and development for leading organizations such as Mallinckrodt Pharmaceuticals, Human Genome Sciences, and Vertex Pharmaceuticals. Dr. Oh has a Ph.D. in Neuroimmunology from the McGill University (Montreal, Canada).
GAITHERSBURG, Md., Jan. 11, 2024 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced that it has secured an indefinite-delivery, indefinite-quantity (IDIQ) procurement contract with a maximum value up to $235.8 million to supply BioThrax® (Anthrax Vaccine Adsorbed) for use by all branches of the U.S. military as Pre-Exposure Prophylaxis (PrEP) for anthrax disease. The new contract with the U.S. Department of Defense (DoD) and led by the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, is comprised of a five-year base agreement ending on September 30, 2028, and an additional five-year option that would extend the contract to September 30, 2033.
CHARLOTTESVILLE, VA – January 11, 2024 – Luminoah Inc., a medical technology company dedicated to improving the standard of care for patients requiring enteral nutrition, has been awarded a $463,000 grant from Virginia Catalyst. This funding propels Luminoah’s innovative enteral feeding system one step closer to commercialization, poised to grant millions of users the freedom to feed themselves anytime, anywhere, while empowering healthcare providers to support their patients remotely.
The Virginia Catalyst, also known as the Virginia Biosciences Health Research Corporation (VBHRC), announced that it has awarded $2.2 million in grants to four life and bioscience projects in the Commonwealth of Virginia. These grants, which will be met with significant matching funds from partner companies, were awarded through Grant Round 15 of Virginia Catalyst’s ongoing mission to stimulate economic development by promoting collaborative projects that address large, unmet needs for improving human health, and that can create high-paying jobs in the Commonwealth.
SAN FRANCISCO, Jan. 9, 2024 /PRNewswire/ -- Emmes today announced the creation of the Emmes Group, with Sastry Chilukuri serving as its executive chairman and chief executive officer. The company also announced a new board member, Matthew Holt.
The Emmes Group will have two business units: Emmes, its Clinical Research Organization (CRO) led by Peter Ronco, and Veridix AI, the newly launched technology and artificial intelligence (AI) group, led by recently appointed executive Dr. Rama Kondru.
SAN FRANCISCO & LONDON--(BUSINESS WIRE)--GSK plc (LSE/NYSE: GSK) and Aiolos Bio, Inc. (Aiolos) today announced that they have entered into an agreement under which GSK will acquire Aiolos, a clinical-stage biopharmaceutical company focused on addressing the unmet treatment needs of patients with certain respiratory and inflammatory conditions, for a $1 billion upfront payment and up to $400 million in certain success-based regulatory milestone payments.
The acquisition provides GSK with access to Aiolos’ AIO-001, a potentially best-in-class, long-acting anti-thymic stromal lymphopoietin (TSLP) monoclonal antibody ready to enter phase II clinical development for the treatment of adult patients with asthma, with potential for additional indications including chronic rhinosinusitis with nasal polyps. AIO-001 was exclusively licensed to Aiolos outside of Greater China by Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui).
Tony Wood, Chief Scientific Officer, GSK, said: “We have a proud heritage and deep development expertise in respiratory medicines, especially addressing diseases driven by IL-5 with high levels of eosinophils or high T2 inflammation. Adding AIO-001, a potentially best-in-class medicine targeting the TSLP pathway, could expand the reach of our current respiratory biologics portfolio, including to the 40% of severe asthma patients with low T2 inflammation where treatment options are still needed.”1
The Virginia Catalyst, also known as the Virginia Biosciences Health Research Corporation (VBHRC), today announced that it has awarded $2.2 million in grants to four life and bioscience projects in the Commonwealth of Virginia. These four collaborative projects, involving Virginia research universities and industry partners, were awarded through Virginia Catalyst Grant Round 15 to address major unmet healthcare needs and drive job creation and capital formation in Virginia.
Through this 15th round of funding, Virginia Catalyst has awarded 61 grants totaling $29.7 million, resulting in over $47 million in matching funds and an additional $821 million in follow-on funding to date.
January 9, 2024 / By National wastewater viral activity levels for COVID-19 have been very high since December. (It wasn’t your imagination that everyone seemed sick over the holidays.) Currently, wastewater data is the best way to track COVID infections as most people are testing at home and not reporting their status. And currently, wastewater levels indicate that about 2 million Americans are getting infected each day.
This means that we are now in the second-highest COVID surge, after Omicron. As we hover around the fourth year of living with COVID, it is clear COVID could be endemic. With surges such as we are seeing now, personal safety measures are still very much needed—including (and especially) staying up to date on COVID vaccines.
KeifeRx is currently advancing programs investigating KFRX03, KFRX04, KFXR05 and KFX06 in neurodegenerative, neuroinflammatory, and mast cell-associated diseases
WASHINGTON, Jan. 8, 2024 /PRNewswire/ -- KeifeRx, an emerging clinical-stage biopharmaceutical company specializing in the discovery and development of new treatment options for neurodegenerative and immune diseases, announced today entry into an amended exclusive licensing agreement with Georgetown University to advance the development of novel tyrosine kinase inhibitor (TKI) chemical entities (NCE) for the treatment of multiple disease indications. The amendment provides an extension of the exclusively licensed rights to these four novel chemical entities for the treatment of new disease conditions including inflammatory, mast-cell associated diseases, and oncology, in addition to existing rights in neurodegenerative diseases. KeifeRx is currently conducting optimizing and IND-enabling studies involving four separate formulations of the TKI (renamed KFRX03, KFRX04, KFRX05, and KFRX06) with patent life through 2037.
ROCKVILLE, Md., Jan. 8, 2024 /PRNewswire/ -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) ("Shuttle Pharma") today announced they have received the 'Safe to Proceed' letter from the U.S. Food and Drug Administration (FDA) for the Company's investigational new drug (IND) application for its Phase II study of Ropidoxuridine (IPdR) as a radiation sensitizing agent during radiotherapy in patients with newly diagnosed IDH-wildtype glioblastoma with unmethylated MGMT promoter. Receipt of the letter allows Shuttle to commence the Phase II study.
Shuttle Pharma is currently finalizing site enrollment with 'first patient, first dose' expected in the coming months. Ropidoxuridine is Shuttle Pharma's lead radiation sensitizer candidate for use in combination with radiation therapy (RT) to treat glioblastoma, a deadly malignancy of the brain with no known cure.
The Advanced Research Projects Agency for Health (ARPA-H) is soliciting proposals from small business concerns that possess the research and development (R&D) expertise to conduct innovative research that will contribute toward ARPA-H mission needs and Small Business Innovation Research (SBIR) program objectives.
SOLICITATION 75N91024R00006 is anticipated to be made available on or about January 23, 2024 through SAM.gov. This solicitation is anticipated to have a closing date of February 22, 2024 for receipt of proposals.
The purposes of the SBIR program are to: (a) stimulate technological innovation; (b) strengthen the role of small business in meeting Federal research/research & development (R/R&D) needs; (c) foster and encourage participation by socially and economically disadvantaged small business concerns and women-owned business concerns; and (d) increase private sector commercialization of innovations derived from Federal R/R&D, thereby increasing competition, productivity and economic growth.
Are you prepared to discover a transformative shift in orthopedic innovation? Join us in this episode of BioTalk with Rich Bendis as step into the world of Nanochon with CEO Ben Holmes.
Nanochon is leading the charge in the field of medical technology, reimagining the landscape of joint injury treatment. Their inventive implant not only restores damaged cartilage but also fosters fresh tissue growth. Utilizing cutting-edge 3-D printing technology and groundbreaking material, Nanochon's implant serves as both a resilient orthopedic load-bearing device and a scaffold for tissue regeneration. This advancement is poised to redefine patient recoveries, trim healthcare costs, and establish new benchmarks in cartilage rehabilitation.
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The overall deal flow in biopharma tapered off in 2023 but the big companies sure know what they want (what they really, really want), according to a new report from J.P. Morgan.
And that’s antibody-drug conjugates, which drove a fourth-quarter spike in licensing deal proceeds and provided a glimmer of hope to an industry battered by outside forces and grim financing prospects.
2023 was tough, but clinical biotechs still had a lot of opportunities to wheel and deal, according to J.P. Morgan. While licensing deals, venture investments, M&A and IPOs were down overall in the fourth quarter, deal values stayed fairly high thanks to a flurry of late-stage tie ups.
Germantown, Maryland, and Venlo, the Netherlands, Jan. 08, 2024 (GLOBE NEWSWIRE) -- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the U.S. Food and Drug Administration (FDA) clearance for the NeuMoDx CT/NG Assay 2.0, growing its test menu for its integrated PCR-based clinical molecular testing systems NeuMoDx 96 and 288 in the United States.
This assay is designed for direct detection of asymptomatic and symptomatic bacterial infections involving Chlamydia trachomatis (CT) and / or Neisseria gonorrhoeae (NG) – the most common type of bacterial infection among sexually transmitted infections (STIs), according to the U.S. National Institutes of Health. The majority of these infections are asymptomatic and generally curable with existing single-dose regimens of antibiotics. However, the time it takes for results to be received is often long, impeding follow-up care.
Board appointees represent expertise of Maryland's academic research institutions
COLUMBIA, Md., Jan. 4, 2024 /PRNewswire/ -- TEDCO, Maryland's economic engine for technology companies, announced the recent appointment of Christina DeMur, director of technology development at Johns Hopkins Technology Ventures, to the Maryland Innovation Initiative Board of Directors.
The Maryland Innovation Initiative (MII) was created as a collaboration between the State of Maryland and five Maryland academic research institutions: Johns Hopkins University (JHU); Morgan State University (MSU); University of Maryland, College Park (UMCP); University of Maryland, Baltimore (UMB); University of Maryland, Baltimore County (UMBC).
Recently this collaboration has expanded to include two more comprehensive universities – Frostburg State University and Bowie State University. This expansion will allow MII to further its reach and help bring more innovative research to the market.
Thomas (Tommy) Luginbill has accepted the position of executive director of the Pinkney Innovation Complex for Science and Technology at Montgomery College (PIC MC). PIC MC is part of Montgomery College’s efforts to grow a hub of education, business, and entrepreneurship, where industry partners co-locate and actively interact with faculty and students to achieve both educational and economic success. In this capacity, Luginbill will continue to advance the development of this innovative science and technology hub in collaboration with academic, corporate and government partners.
"I am honored to follow in the footsteps of those who have paved the way before me at PIC MC. Their dedication and hard work have laid the foundation for our mission,” Luginbill said. “We are committed to building upon this legacy, creating a vibrant hub for education, business, and innovation that will continue to thrive and benefit the Montgomery County community. Together with our partners, we are ready to embrace this challenge and honor the past while shaping the future."
ROCKVILLE, Md., Jan. 4, 2024 /PRNewswire/ -- MaximBio, a leading Maryland-based manufacturer specializing in lateral flow and diagnostic devices, is announcing the receipt of a $49.5 million award from the U.S. Department of Health and Human Services (HHS) through the Administration for Strategic Preparedness and Response (ASPR). This funding is designated to fortify the domestic manufacturing capabilities for diagnostic tests and enhance preparedness for potential future pandemics. The award is part of a broader initiative awarding $600 million to 12 domestic COVID-19 test manufacturers.
Project NextGen is a $5 billion initiative to develop next-generation medical countermeasures, including vaccines and therapeutics, to enhance preparedness for future COVID-19 strains and variants.
MANASSAS, Va.--(BUSINESS WIRE)--ATCC, the world’s premier biological materials management and standards organization, today announced a five-year, $87 million award from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, to support the development of next-generation medical countermeasures (MCMs) to protect Americans from public health security threats such as coronaviruses.
Through Project NextGen, BARDA is collaborating with the National Institute of Allergy and Infectious Diseases (NIAID), as well as the private sector, to enable decreased cost, accelerated production, increased efficacy and improved access, strengthen a diverse pipeline of next-generation, innovative vaccines through clinical trials, and support the development of next-generation therapeutics. ATCC will provide cold-chain and lifecycle management of biological specimens from Project NextGen clinical studies.
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ROCKVILLE, Md.--(BUSINESS WIRE)--GlycoMimetics, Inc. (Nasdaq: GLYC), a late clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers and inflammatory diseases, today announced positive initial safety, tolerability, and pharmacokinetic results from a Phase 1a study of GMI-1687 in healthy volunteers.
“These positive results represent an important milestone in the development of GMI-1687 as a potential point-of-care treatment option intended to help people living with sickle cell disease when they need it most, at the onset of pain crises,” said Harout Semerjian, Chief Executive Officer of GlycoMimetics. “Our Phase 1a data confirm this highly potent, second-generation E-selectin antagonist has an excellent profile for further development, with no dose-limiting toxicities or safety signals observed along with linear pharmacokinetics. We look forward to completing analysis of the study and advancing partner and financing discussions that support further development of this potentially important new therapeutic option for SCD.”
There’s a lot of talk about artificial intelligence, or AI, these days. AI is everywhere—from virtual assistants to facial recognition software. The technology is even assisting doctors and scientists. So what exactly is AI? And how is it helping advance scientific research?
“AI is basically trying to teach computers to ‘think’ in the same way as the human brain,” says Dr. Despina Kontos, an AI researcher at Columbia University.
One approach to AI uses a process called machine learning. In machine learning, a computer model is built to predict what may happen in the real world. The model is taught to analyze and recognize patterns in a data set. This training enables the model to then make predictions about new data. Some AI programs can also teach themselves to ask new questions and make novel connections between pieces of information.
Maryland biotechnology company promotes improved patient outcomes for infants with body deformities
COLUMBIA, Md. (January 3, 2024) – TEDCO, Maryland’s economic engine for technology companies, announced a recent $200,000 investment from its Life Science Investment Fund (LSIF) into PediaMetrix, a biotechnology company working to detect body deformities in infants and improve patient outcomes. TEDCO’s LSIF lives under the Seed Funds umbrella and invests in companies that have a Federal Drug Administration (FDA) pathway. Participating in this round were also Blu Ventures, as well as a pediatrician.
ROCKVILLE, Md. and SINGAPORE, Jan. 03, 2024 (GLOBE NEWSWIRE) -- MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT), a leading, cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell therapeutics and innovative bioprocessing applications, and Lion TCR, an Asia-based, clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-T cell therapies for solid tumors and life-threatening viral infections today announced the signing of a strategic platform license (SPL). This partnership will enhance MaxCyte's presence in Asia, with anticipated expansion into the US and European markets.
FDA IDE approval of Sonavex's randomized trial comes months after meeting the endpoint of its first clinical study
BALTIMORE, Jan. 2, 2024 /PRNewswire-PRWeb/ -- Sonavex, Inc., a privately held medical device company with ultrasound technologies that deliver quantitative blood flow and other critical vascular data at the point of care, announced that it completed its initial clinical study evaluating the ability to use EchoMark & EchoSure to improve the assessment of arteriovenous (AV) fistula maturation for dialysis patients. Following the positive findings from this study, Sonavex was granted approval from the U.S. Food and Drug Administration under an Investigational Device Exemption (IDE) for its randomized controlled trial, MAFASA (Maturation of Arteriovenous Fistula with Automated Sonography Assessments).
In this episode of BioTalk with Rich Bendis, we’re joined by three guests from Solaxa: CEO & Founder Christian Walker, Chief Operating Officer Luis T. Gutierrez, Jr., and Chief Commercial Officer Jennifer Butler. Solaxa is a pioneering biotech company with a mission to revolutionize the treatment of cerebellar ataxias and acute nerve injuries caused by trauma and chemotherapy.
Discover the compelling story behind Solaxa’s choice to establish its roots in Montgomery County and how the BioHealth Capital Region has played a crucial role in its growth. Learn how Solaxa’s team was assembled, including the inspiring success stories of Luis and Jennifer, both part of the BioHealth Innovation and Montgomery County Maryland’s Executive in Residence program.
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By Anna Zornosa - In the shadow of one very bad, no-good horrible development setting women’s health back decades (the overturning of Roe V. Wade), I spent the year taking note of some amazing advances happening in the pursuit of health solutions for women. Curious if others were also seeing bright spots, I asked some of the smartest women I know if they’d also seen events signaling notable progress.
My timing was bad: with the holidays upon us I knew some could not answer. But to my delight I got observations Barbara Levy, MD, FACOG, FACS : from CEO/Founders Somer Baburek, MBA (Hera Biotech), Melody Roberts (Liv Labs), and Melissa Bowley (Flourish Care); from author Susan Salenger; medtech designer and diversity driver Nada (Osman) Hanafi ; investors Jessica Karr and Susan Solinsky; and Ayse McCracken, Founder of the Ignite Accelerator for women leading life science companies.
What did we miss? A lot, certainly. Please add your own “brightspots of note” to comments. This will create something we can all turn to if (when) bad developments happen in 2024.
Sue Carr clearly remembers the moment that pushed her to become a full-time entrepreneur.
In 2018, Carr was working at a hospital in Montgomery County and responding to a critical situation in the emergency room. She had to administer life-saving medication that was packaged in a glass ampoule — a small glass vial with a bottle head — to a patient.
To open the ampoule, the bottle head must be broken off, which Carr said results in glass shards getting in medication.
OXFORD, United Kingdom, Dec. 21, 2023 (GLOBE NEWSWIRE) -- Barinthus Biotherapeutics plc (NASDAQ: BRNS), formerly Vaccitech plc, today announced a project with the Coalition for Epidemic Preparedness Innovations (CEPI) and the University of Oxford, aiming to fast-track the development of a vaccine candidate known as VTP-500 for the prevention of Middle East Respiratory Syndrome (MERS), the often fatal disease caused by the MERS coronavirus. Barinthus Bio is a clinical-stage biopharmaceutical company developing novel T cell immunotherapeutic candidates designed to guide the immune system to overcome chronic infectious diseases, autoimmunity, and cancer.
ROCKVILLE, Md. & EDMONTON, Alberta--(BUSINESS WIRE)--Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) – Aurinia announced today the submission of its Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) for AUR200, a potential next generation therapy for B-cell mediated autoimmune diseases. Upon receiving FDA clearance to proceed with proposed research, Aurinia plans to initiate a Phase 1 study in the first half of 2024 to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic properties of AUR200 in healthy volunteers.
GERMANTOWN, Md., Dec. 19, 2023 /PRNewswire/ -- Deka Biosciences ("Deka") today announced the appointments of Stanley Frankel, M.D., FACP, as senior clinical advisor, interim chief medical officer and scientific advisory board member, and Stuart Chaffee, Ph.D. as an independent director and chairman of the Board. Deka is a privately held biotech company developing next-generation cytokine therapies to treat cancer and inflammatory diseases based on a patient's individual immune response. Deka's lead asset, DK210 (EGFR), is currently being evaluated for the treatment of multiple solid tumors in a Phase 1 clinical trial.
On December 8, 2023, the National Institute of Standards and Technology (NIST) published a draft guidance document regarding the government’s exercise of “march-in” rights under the Bayh-Dole Act. The following Q&A, in connection with our previously published Client Alert, illuminates the details of the Proposed Framework.
Q: If my company takes SBIR/STTR funding from a federal agency, does the Bayh-Dole Act apply?
A: Yes. A company that receives Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) funding is considered a “contractor” under the Bayh-Dole Act. As such, inventions conceived of or first actually reduced to practice using SBIR or STTR funds will be subject to the Bayh-Dole Act. This applies even if the funds are used only to develop confirmatory data for an invention conceived of without the use of SBIR or STTR funds.
Have you ever wondered about the true impact of Artificial Intelligence (AI) in the BioHealth industry? In this episode of BioTalk with Rich Bendis, we have the privilege of hosting Dr. Juergen Klenk, a Principal at Deloitte and a Board Member at BioHealth Innovation. Dr. Klenk brings a wealth of expertise and experience with a unique background combining formal scientific training and entrepreneurial ventures.
Join us as we embark on an insightful discussion about the current state of AI in the BioHealth industry, diving deep into the realities and challenges of this cutting-edge technology. Dr. Klenk shares his interest in AI and the reasons behind its increasing prominence in the field. We explore the historical origins of the AI hype cycle and how we've reached the stage we're in today.
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Irazu Oncology, which is using a platform built by researchers at University of Maryland, Baltimore to develop cancer vaccines, has secured $2.6 million in debt from an undisclosed source, according to a recent listing on Crunchbase.
Founded by Marco A. Chacón, an industry veteran who founded and ran Paragon Bioservices for over two decades, Irazu Oncology is commercializing UMB’s novel immunotherapeutic vaccine technology. It operates out of the University of Maryland BioPark. The company is a winner of TEDCO’s Maryland Innovation Initiative Company Formation Awards.
Novel Approach
Irazu Oncology has a licensing deal with UMB to commercialize a membrane vesicle vaccine development platform built at the university by a research team led by James Galen, Ph. D. The platform uses the outer membrane of vesicles — a structure within or outside a cell — as cancer vaccines that can stimulate an immune response. Irazu Oncology’s proprietary, attenuated bacteria are engineered to produce OMVs bearing tumor antigens on their surface. These antigens are delivered to various sites in the body, stimulating a natural immune system that can destroy cancerous cells.